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Datum 83. The Class E airspace areas AAL AK E5 Kotzebue, AK SUMMARY: The Food and Drug
designated as 700/1200 foot transition Kotzebue, Ralph Wien Memorial Airport, AK Administration (FDA) is proposing to
areas are published in paragraph 6005 of (Lat. 66°53′05′′ N, long. 162°35′55′′ W) amend its regulations pursuant to an
FAA Order 7400.9E, Airspace Kotzebue VOR/DME international agreement that is expected
Designations and Reporting Points, (Lat. 66°53′08′′ N, long. 162°32′24′′ W) to be concluded between the United
dated September 10, 1997, and effective Hotham NDB States and the European Community
(Lat. 66°54′05′′ N, long. 162°33′52′′ W)
September 16, 1997, which is (EC) (Ref. 1). Under the terms of that
incorporated by reference in 14 CFR That airspace extending upward from 700 agreement, FDA may normally endorse
feet above the surface within a 6.8 mile
71.1 (62 FR 52491; October 8, 1997). radius of the Ralph Wien Memorial Airport
good manufacturing practice (GMP)
The Class E airspace designation listed and within 14 miles of the Kotzebue VOR/ inspection reports for pharmaceuticals
in this document would be revised and DME extending clockwise from the 206° provided by equivalent EC Member
published subsequently in the Order. radial to the 130° radial and within 4 miles State regulatory authorities and medical
The FAA has determined that these southeast and 8 miles northwest of the device quality system evaluation reports
proposed regulations only involve an Hotham NDB 039° bearing extending from and certain medical device premarket
established body of technical the NDB to 16 miles northeast of the NDB evaluation reports provided by
regulations for which frequent and and within 4 miles north and 8 miles south equivalent conformity assessment
of the Kotzebue VOR/DME 278° radial
routine amendments are necessary to bodies. FDA is taking this action to
extending from the VOR/DME to 20 miles
keep them operationally current. It, west of the VOR/DME; and that airspace enhance its ability to ensure the safety
therefore—(1) is not a ‘‘significant extending upward from 1,200 feet above the and efficacy of pharmaceuticals and
regulatory action’’ under Executive surface within 18 miles of the Kotzebue medical devices through more efficient
Order 12866; (2) is not a ‘‘significant VOR/DME clockwise from the 020° radial to and effective utilization of its regulatory
rule’’ under DOT Regulatory Policies the 130° radial and within 38 miles of the resources. The agency is requesting
and Procedures (44 FR 11034; February Kotzebue VOR/DME clockwise from the 130° comments on the proposed rule.
26, 1979); and (3) does not warrant radial to the 314° radial and within 4.3 miles
each side of the Kotzebue VOR/DME 103° DATES: Comments by May 11, 1998.
preparation of a regulatory evaluation as Comments must be received by the
radial extending from the VOR/DME to 34
the anticipated impact is so minimal. miles east of the VOR/DME; and that airspace Dockets Management Branch (address
Since this is a routine matter that will extending upward from 5,500 feet MSL below) by 4:30 p.m. Eastern Standard
only affect air traffic procedures and air within 4.3 miles each side of the Kotzebue Time on May 11, 1998.
navigation, it is certified that this rule, VOR/DME 103° radial extending from 34
when promulgated, will not have a miles east of the VOR/DME to 51.3 miles east ADDRESSES: Submit written comments
significant economic impact on a of the VOR/DME; and that airspace extending to the Dockets Management Branch
substantial number of small entities upward from 7,500 feet MSL within 4.3 miles (HFA–305), Food and Drug
under the criteria of the Regulatory each side of the Kotzebue VOR/DME 103° Administration, 12420 Parklawn Dr.,
Flexibility Act. radial at 51.3 miles east of the Kotzebue rm. 1–23, Rockville, MD 20857, fax 301–
VOR/DME widening to 7.4 miles each side of 594–3215.
List of Subjects in 14 CFR Part 71 the 103° radial at 96 miles east of the
Kotzebue VOR/DME. FOR FURTHER INFORMATION CONTACT:
Airspace, Incorporation by reference, Merton V. Smith, Office of International
Navigation (air). * * * * * Affairs (HFG–1), Office of External
Issued in Anchorage, AK, on April 3, 1998.
The Proposed Amendment Affairs, Food and Drug Administration,
Willis C. Nelson,
5600 Fishers Lane, Rockville, MD
In consideration of the foregoing, the Manager, Air Traffic Division, Alaskan 20857, 301–827–0910, or E-mail:
Federal Aviation Administration Region.
‘‘MSmith@bangate.fda.gov’’.
proposes to amend 14 CFR part 71 as [FR Doc. 98–9510 Filed 4–9–98; 8:45 am]
SUPPLEMENTARY INFORMATION:
follows: BILLING CODE 4910–13–M
I. Background and History
PART 71— DESIGNATION OF CLASS
A, CLASS B, CLASS C, CLASS D, AND On June 20, 1997, the United States
DEPARTMENT OF HEALTH AND
CLASS E AIRSPACE AREAS; and the EC concluded negotiations of an
HUMAN SERVICES
AIRWAYS; ROUTES; AND REPORTING agreement entitled ‘‘Agreement on
POINTS Food and Drug Administration Mutual Recognition between the United
States of America and the European
1. The authority citation for 14 CFR 21 CFR Part 26 Community’’ (also called ‘‘the MRA’’).
part 71 continues to read as follows: The MRA includes two sectoral annexes
[Docket No. 95N–0185]
Authority: 49 U.S.C. 106(g), 40103, 40113, covering products regulated by FDA.
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– RIN 0910–ZA11 The medical device sectoral annex
1963 Comp., p. 389. covers medical device quality system-
Mutual Recognition of the Food and related inspection reports and
§ 71.1 [Amended] Drug Administration and European premarket evaluation reports. The
2. The incorporation by reference in Community Member State Conformity pharmaceutical GMP sectoral annex
14 CFR 71.1 of Federal Aviation Assessment Procedures; covers pharmaceutical GMP inspection
Administration Order 7400.9E, Airspace Pharmaceutical GMP Inspection reports. The MRA also includes sectoral
Designations and Reporting Points, Reports, Medical Device Quality annexes covering products regulated by
dated September 10, 1997, and effective System Evaluation Reports, and other U.S. regulatory agencies,
September 16, 1997, is to be amended Certain Medical Device Premarket including telecommunication
as follows: Evaluation Reports equipment, electromagnetic
Paragraph 6005 Class E airspace extending AGENCY: Food and Drug Administration, compatibility, electrical safety, and
upward from 700 feet or more above the recreational craft. Finally, the MRA
HHS.
surface of the earth. includes an ‘‘umbrella’’ agreement that
ACTION: Proposed rule.
* * * * * contains general provisions applicable
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17745
to the operation of all of the sectoral protocols determined by the Secretary approaches that maximize net benefits
annexes. (FDA by delegation) to be appropriate. (including potential economic,
At the conclusion of negotiations, the Additional support for FDA authority environmental, public health and safety,
United States and the EC agreed to to enter into this MRA is found in the and other advantages; distributive
submit the text of the MRA to their PHS Act. Under section 307 of the PHS impacts; and equity). The Regulatory
respective authorities to complete the Act (42 U.S.C. 242l), the Secretary of Flexibility Act requires agencies to
necessary procedures for approval and Health and Human Services (FDA by analyze regulatory options that would
implementation (Ref. 2). For FDA, the delegation) has authority ‘‘to participate minimize any significant impact of a
procedures include publishing this with other countries in cooperative rule on small entities. The Unfunded
proposed rule for public comment. endeavors’’ in biomedical research and Mandates Reform Act requires agencies
In this document, FDA has published health care technology. In addition, the to prepare an assessment of anticipated
relevant provisions of the two FDA Secretary of Health and Human Services costs and benefits before enacting any
sectoral annexes and the umbrella (FDA by delegation) has authority under rule that may result in an expenditure
agreement, some of which create section 301 of the PHS Act (42 U.S.C. by State, local and tribal governments,
binding obligations. FDA will review all 241) to ‘‘cooperate with, and render in the aggregate, or by the private sector,
comments and will consider those assistance to other appropriate public of $100,000,000 (adjusted annually for
comments addressing its binding authorities * * * in the conduct of * * inflation) in any one year.
obligations under the agreement. * investigations * * * relating to the * The agency believes that this
* * prevention of physical and mental proposed rule is consistent with the
II. Statutory Authority diseases and impairments of man * * * regulatory philosophy and principles
.’’ The cooperative activities between identified in the Executive Order and in
FDA has the authority to enter into
FDA and the EC set forth in the MRA these two statutes. Through this
and execute the MRA under the Federal
and this proposed regulation, fall within regulation, the agency is proposing to
Food, Drug, and Cosmetic Act (the act)
FDA’s delegated authority under these set out requirements through which it
(21 U.S.C. 321 et seq.) and the Public
sections of the PHS Act. may normally endorse certain
Health Service Act (the PHS Act) (42 Finally, a provision of the recently conformity assessment procedure
U.S.C. 201 et seq.). For drugs and enacted FDAMA provides authority for reports. Such reports would be provided
medical devices, section 510(i)(3) of the FDA to participate in MRA activities. by equivalent EC Member State
act (21 U.S.C. 360(i)(3)) provides Section 410 of FDAMA authorizes FDA regulatory authorities for manufacturing
authority for FDA to enter into the to ‘‘support the Office of the United site inspections to ascertain conformity
MRA. Section 510(i)(3) of the act States Trade Representative, in with pharmaceutical GMP’s and by
provides that: consultation with the Secretary of equivalent conformity assessment
The Secretary [FDA by delegation] is
authorized to enter into cooperative
Commerce, in efforts to move toward bodies for quality system audits and
arrangements with officials of foreign the acceptance of mutual recognition certain medical device premarket
countries to ensure that adequate and agreements relating to the regulation of evaluations. Obtaining conformity
effective means are available for purposes of drugs, biological products, [and] devices assessment information in the manner
determining, from time to time, whether * * * and the regulation of good described in the proposed rule is
drugs or devices manufactured, prepared, manufacturing practices, between the inherently more efficient and cost-
propagated, compounded, or processed by an European Union and the United States’’ effective than the existing approach,
establishment * * * [described in this (Ref. 5). During negotiation of this MRA, where additional inspection efforts by
section], if imported or offered for import officials from FDA, the Office of the FDA in foreign countries are necessary
into the United States, shall be refused
United States Trade Representative, and because foreign regulatory systems have
admission on any of the grounds set forth in
section 801(a). the Department of Commerce not been found equivalent. The primary
participated in activities in an effort to benefit of the proposed rule is to
(Ref. 3).
move toward acceptance of a mutual provide credible assurance that the
The MRA and the pharmaceutical and rapidly increasing volume of EC
recognition agreement.
medical device annexes represent Member States’ imports into the United
cooperative arrangements with officials III. Environmental Impact States meet pharmaceutical GMP
from foreign countries. The purpose of The agency has determined under 21 requirements, and medical device
these arrangements is, among other CFR 25.30(h) that this action is of a type quality system evaluation and certain
things, to ensure FDA has adequate and that does not individually or premarket evaluation requirements, as
effective means to determine whether cumulatively have a significant effect on specified in U.S. statutes and
drugs or devices offered for import are the human environment. Therefore, regulations. In the future, this credible
adulterated, misbranded, or in violation neither an environmental assessment assurance must be achievable without
of section 505 of the act (21 U.S.C. 355) nor an environmental impact statement resource expenditures by FDA that are
(Ref. 4). FDA’s authority to make these is required. directly proportional to the volume of
determinations is found at section trade.
801(a) of the act (21 U.S.C. 381(a)). IV. Analysis of Impacts In recent years, the credibility of the
Section 803(b) of the act (21 U.S.C. FDA has examined the impacts of the current approach has been strained as
383(b)) provides FDA with authority to proposed rule under Executive Order FDA’s essentially constant foreign
enter into the medical device sectoral 12866, under the Regulatory Flexibility inspection capacity has been stretched
annex. That section authorizes FDA to Act (Pub. L. 96–354, as amended by over an expanding volume of imports
enter into agreements with foreign Pub. L. 104–121), and under the from the EC. In the 3-year interval
countries to facilitate commerce in Unfunded Mandates Reform Act (Pub. between 1994 and 1997, the value of EC
medical devices, consistent with the L. 104–4). Executive Order 12866 pharmaceutical and medical device
provisions of the act. Such agreements directs agencies to assess all costs and imports into the United States has
are to encourage the mutual recognition benefits of available regulatory nearly doubled from $5.5 billion to
of GMP regulations relating to devices, alternatives and, when regulation is more than $10.7 billion. Growth has
as well as other regulations and testing necessary, to select regulatory been greatest in pharmaceuticals, where
17746 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
annual EC exports have increased by recognition agreements. FDA, therefore, transition period, as it has been for the
more than $2 billion in each of the last must proceed to implement these past several years. Other activities
2 years. In 1997, FDA conducted one agreements as a concurrent function related to equivalence determinations,
inspection in the EC for every $60 within normal day-to-day regulatory such as the procedures for exchanging
million in pharmaceutical exports to the activities. The 3-year transition period information and reports, focus on the
United States, which is less than half reflects the necessity to absorb these interface and coordination between
the coverage intensity of 1994. In startup costs within existing regulatory regulatory agencies and, as such, do not
addition, the majority of these budgets. Some activities such as joint affect industry in a cost context.
inspections have been preapproval in inspections may be reasonably easy to The Regulatory Flexibility Act
nature. Continuation of the current absorb as concurrent functions that do requires agencies to analyze regulatory
trend will further decrease FDA’s not require additional funding, while options that would minimize any
coverage intensity to less than one others such as developing and significant impact of a rule on small
inspection per $100 million in EC maintaining systems for routine entities unless the rule is not expected
pharmaceutical exports by the year information exchange may involve new to have a significant impact on a
2000. Equivalence with EC Member activities. These absorbed governmental substantial number of small entities. As
State regulatory systems has the costs will fall heavily on FDA, as it must the proposed regulation is not expected
potential for leveraging FDA’s assess equivalence of multiple EC to impose costs on the regulated
regulatory resources so that necessary Member States and notified bodies. industry, the agency certifies that the
conformity assessments can be ensured For FDA, the absorption of these proposed rule would not have a
for higher volumes of future trade. startup costs will be easier with respect significant impact on a substantial
In addition to coping with higher to those EC Member States with a large number of small entities. Therefore,
trade volumes, mutual recognition or volume of trade, where FDA already under the Regulatory Flexibility Act, no
equivalence-based agreements with conducts enough inspections to gather a further analysis is required.
exporting nations may permit FDA to general understanding of the The Unfunded Mandates Act of 1995
redirect some of its inspectional requirements and regulatory practices of requires that agencies prepare an
resources to risk priorities not covered the exporting country. From this assessment of the anticipated costs and
by such agreements. This flexibility perspective, the pace and priorities for benefits before issuing any final rule
would provide a more responsive level mutual recognition agreements during that may result in expenditures by State,
of U.S. consumer protection in the face the transition period may be dictated by local, and tribal governments, in the
of a changing global marketplace with FDA’s ability to conduct these processes aggregate, or by the private sector, of
inherently variable risk management as concurrent functions within current $100,000,000 or more (adjusted
priorities. activities. annually for inflation) in any one year.
Another important benefit of the In the longer run, an operational This proposed rule does not impose any
proposed rule would be the cost savings system of mutual recognition mandates on State, local or tribal
realized by the regulated industry, agreements could pose additional costs governments, or the private sector that
largely as a result of sharing inspection on regulatory authorities of exporting would result in an annual expenditure
reports among equivalent regulatory countries if equivalence requires a of $100,000,000 or more. Therefore, no
authorities. This exchange, in turn, will frequency, focus or content of further analysis is appropriate for this
eliminate the need for duplicative inspections not presently included in requirement.
inspections and permit individual firms regulatory requirements of the exporting
to undergo fewer inspections of nation. For example, Country A may not V. Paperwork Reduction Act of 1995
manufacturing sites. FDA does not have be able to provide the frequency of This proposed rule does not contain
data on the average administrative cost medical device inspections desired by any information collection provisions
incurred by pharmaceutical (including Country B without conducting that would be subject to review by the
biological) or medical device inspections beyond those required for Office of Management and Budget
manufacturers as they participate in Country A’s domestic inspection (OMB) under the Paperwork Reduction
regulatory inspections, but it is strategy. Conversely, Country B may not Act of 1995 (44 U.S.C. 3501–3520).
reasonable to assume that the avoidance be able to provide to Country A
VI. Request for Comments
of redundant inspections would adequate details of the quality of
generate cost savings. The proposed rule pharmaceutical source materials, Interested persons may, on or before
also may shorten product review times because Country B does not have May 11, 1998, submit to the Dockets
for regulated products as a result of the inspectional authority over Management Branch (address above)
increased efficiency of premarket pharmaceutical starting materials. To written comments regarding this
approval inspection activities and the the extent such costs are insignificant or proposed regulation. Comments must be
third-party evaluation of certain medical offset by other savings, they will not received by the Dockets Management
devices. Quantification of this savings likely be obstacles to reaching Branch by 4:30 p.m. Eastern Standard
will be highly dependent on the specific agreement on equivalence. Time May 11, 1998. Two copies of any
countries that achieve equivalence and This proposal is not expected to comments are to be submitted, except
the number of medical device audits involve any new incremental costs to that individuals may submit one copy.
and evaluations performed by the affected industry. Although joint Comments are to be identified with the
conformity assessment bodies. inspections during the transition period docket number found in brackets in the
The costs of this regulation appear to may create the appearance of more heading of this document. Received
impact more directly on governmental regulatory effort, they should not comments, a copy of the MRA, and a
regulatory agencies than on the impose additional costs on the firms summary explanation of the MRA’s
regulated industry. These governmental inspected. FDA does not anticipate an provisions, to aid in commenting, may
costs involve both startup and increase in the total number of be seen in the office above between 9
operational components. FDA has not inspections, and in fact, the coverage a.m. and 4 p.m., Monday through
received additional government funding intensity of FDA inspections in the EC Friday. In addition, an electronic copy
earmarked for achieving mutual would continue to fall during the of the MRA and the summary
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17747
explanation is available on FDA’s web anticipated signing of the MRA in late economic relations between the EC and the
site at ‘‘http://www.fda.gov’’ under the spring or early summer. United States.
‘‘international’’ heading menu item. The agency also notes that the VIII. Comparison Table
The comment period in this comment period is less than that
document is shorter than the 60 days required by Executive Order 12889 (58 The following table shows the
FDA customarily provides for proposed FR 69681, December 30, 1993). Section relationship of the MRA Articles and
rules (21 CFR 10.40(b)(2)). FDA believes 4 of Executive Order 12889 states that the sections of the Code of Federal
it is unnecessary to provide 60 days for any agency subject to the Regulations (CFR) as proposed under
comment, given the opportunities for Administrative Procedure Act shall this rule:
public comment the agency already has provide a 75-day comment period for
provided. During the course of the any proposed technical regulation. TABLE 1.—RELATIONSHIP OF THE MRA
negotiations of the MRA, FDA provided Because this proposed rule creates no ARTICLES TO SECTIONS IN THE CFR
a number of opportunities for public new technical obligations or mandatory
discussion. For example, on May 9, requirements on the public, FDA MRA Article CFR Section
1996 (61 FR 21194), FDA established a believes that it is not a technical Sectoral Annex for
public docket for information regulation subject to Section 4 of Pharmaceutical Subpart A
concerning the MRA (Ref. 6). In Executive Order 12889. As a result, a GMP’s
addition, on October 18, 1996, FDA 75-day comment period is not required
made available for public comment for this proposed rule. Article 1 ..................... 26.1
copies of a document entitled, ‘‘FDA Article 2 ..................... 26.2
Proposal for an Agreement With the VII. References Article 3 ..................... 26.3
European Union Concerning the Mutual Article 4 ..................... 26.4
1. The European Community consists of Article 5 ..................... 26.5
Recognition of Inspections to Determine the following member States: Austria, Article 6 ..................... 26.6
Adherence to Manufacturing Practices Belgium, Denmark, Finland, France, Article 7 ..................... 26.7
for Pharmaceuticals Including Germany, Greece, Ireland, Italy, Luxembourg, Article 8 ..................... 26.8
Biologicals.’’ FDA formally sought The Netherlands, Portugal, Spain, Sweden, Article 9 ..................... 26.9
public comment on this proposal and the United Kingdom. These countries Article 10 ................... 26.10
through a Federal Register notice (61 FR have vested in the European Commission the Article 11 ................... 26.11
authority to conduct certain international Article 12 ................... 26.12
54448, October 18, 1996). To provide negotiations, on their behalf, with other
opportunity for public input into the Article 13 ................... 26.13
countries such as the United States. Article 14 ................... 26.14
pharmaceutical GMP discussions with 2. On June 20, 1997, U.S. Trade Article 15 ................... 26.15
the European Commission, FDA hosted Representative Charlene Barshefsky and Article 16 ................... 26.16
public exchange meetings in European Commission Vice President Leon Article 17 ................... 26.17
Washington, DC, and Rockville, MD, on Brittan signed ‘‘Agreed Minutes on the Article 18 ................... 26.18
March 31, 1995 (see 60 FR 15934, March Agreement on Mutual Recognition between Article 19 ................... 26.19
28, 1995), and October 30, 1996 (see 61 the United States of America and the Article 20 ................... 26.20
FR 54448, October 18, 1996). On European Community,’’ which states that the Article 21 ................... 26.21
MRA ‘‘represents the text we commit to Appendix 1 ................ Appendix A
November 8 and 9, 1996, a transatlantic submit to our respective authorities with a
business dialogue (TABD) meeting Appendix 2 ................ Appendix B
view to completing the necessary procedures Appendix 3 ................ Appendix C
included an extensive discussion of the for approval and implementation.’’ The Appendix 4 ................ Appendix D
unresolved issues for the complete text of the MRA is available on the Appendix 5 ................ Appendix E
pharmaceutical and medical device Internet at FDA’s web site, ‘‘http://
annexes to the MRA (Ref. 7), and on www.fda.gov’’, under the ‘‘international’’
March 14, 1997, FDA participated in a menu item or on the European Community
meeting of U.S. agencies and web site, ‘‘http://europa.eu.int/en/comm/
nongovernmental organizations, which dg01/mra03.htm’’. MRA Article CFR Section
3. Food and Drug Administration
included several consumer, industry, Modernization Act of 1997 (FDAMA), section Sectoral Annex on
and environmental groups. Finally, FDA Subpart B
417, Pub. L. 105–115, 111 Stat. 2296 (1997) Medical Devices
provided information and solicited (to be codified at 21 U.S.C. 360(i)(3)).
comment on the MRA at a September 4. Provisions in the act that govern FDA Article 1 ..................... 26.31
23, 1997, National Consumer Forum regulation of pharmaceuticals and medical Article 2 ..................... 26.32
held in Washington, DC. The purpose of devices include sections 501, 502, 505, 512, Article 3 ..................... 26.33
the forum was to facilitate dialogue on 513, 520, and 522 (21 U.S.C. 351, 352, 355, Article 4 ..................... 26.34
the MRA between FDA and consumers. 360b, 360c, 360j, and 360l). Article 5 ..................... 26.35
5. FDAMA section 410 (to be codified at 21 Article 6 ..................... 26.36
In light of the extensive opportunities U.S.C. 383(c)(2)). Article 7 ..................... 26.37
for public participation, FDA believes 6. Information in the docket includes Article 8 ..................... 26.38
there is good cause to provide 30 days summaries of minutes of the meetings Article 9 ..................... 26.39
for comment on this proposed rule. The described in this document with written Article 10 ................... 26.40
agency also believes it is in the public comments received from interested parties, Article 11 ................... 26.41
interest to proceed expeditiously to summaries of the various negotiation Article 12 ................... 26.42
implement the MRA, so that it can sessions between FDA and the European Article 13 ................... 26.43
proceed toward the anticipated resource Commission and EC Member State Article 14 ................... 26.44
representatives, and copies of draft Article 15 ................... 26.45
efficiencies and enhancement of Article 16 ................... 26.46
agreements covering pharmaceutical GMP’s
product safety, effectiveness, and and medical devices that were exchanged Article 17 ................... 26.47
quality that the MRA can provide. The between the EC and FDA in December 1996 Article 18 ................... 26.48
30-day comment period provides and January 1997. Article 19 ................... 26.49
sufficient opportunity to receive and 7. The TABD is an industry-driven Article 20 ................... 26.50
consider comments before the initiative that aims to facilitate closer Appendix 1 ................ Appendix A
17748 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
sectoral annexes cited in this section. of the product and/or process from the products for human use, and active
For codification purposes, certain marketing authorization/product pharmaceutical ingredients (as referred
provisions of the MRA have been authorization or license holder or to in the United States), only to the
modified for use in this part. This applicant and ensures the product is extent they are regulated by the
modification is done for purposes of made in compliance with its authorities of both parties as listed in
clarity only and shall not affect the text specifications (qualified person Appendix B of this subpart.
of the MRA to be concluded between certification in the European (b) Human blood, human plasma,
the United States and the EC, or the Community (EC)). human tissues and organs, and
rights and obligations of the United (d) Inspection means an onsite veterinary immunologicals (under 9
States or EC under that agreement. evaluation of a manufacturing facility to CFR 101.2, ‘‘veterinary
References to the terms ‘‘party’’ or determine whether such manufacturing immunologicals’’ are referred to as
‘‘parties’’ reflect FDA’s proposed facility is operating in compliance with
‘‘veterinary biologicals’’) are excluded
implementation of the MRA and its GMP’s and/or commitments made as
sectoral annexes. It is understood that from the scope of this subpart. Human
part of the approval to market a product.
the EC will also be a party to the MRA plasma derivatives (such as
(e) Inspection Report means the
and that it will implement the MRA in immunoglobulins and albumin),
written observations and GMP’s
accordance with its internal procedures. investigational medicinal products/new
compliance assessment completed by an
If the parties to the MRA subsequently drugs, human radiopharmaceuticals,
authority listed in Appendix B of this
amend or terminate the MRA, FDA will and medicinal gases are also excluded
subpart.
modify this part accordingly, using (f) Regulatory System means the body during the transition phase, their
appropriate administrative procedures. of legal requirements for GMP’s, situation will be reconsidered at the end
inspections, and enforcements that of the transition period. Products
Subpart A—Specific Sector Provisions for regulated by FDA’s Center for Biologics
Pharmaceutical Good Manufacturing ensure public health protection and
Practices legal authority to assure adherence to Evaluation and Research as devices are
these requirements. not covered under this subpart.
§ 26.1 Definitions. (c) Appendix C of this subpart
(a) Enforcement means action taken § 26.2 Purpose. contains an indicative list of products
by an authority to protect the public The provisions of this subpart govern covered by this subpart.
from products of suspect quality, safety, the exchange between the parties and
and efficacy or to assure that products normal endorsement by the receiving § 26.5 Length of transition period.
are manufactured in compliance with regulatory authority of official good A 3-year transition period will start
appropriate laws, regulations, standards, manufacturing practice (GMP) immediately after the effective date
and commitments made as part of the inspection reports after a transitional described in § 26.80(a).
approval to market a product. period aimed at determination of the
(b) Equivalence of the regulatory equivalence of the regulatory systems of § 26.6 Equivalence assessment.
systems means that the systems are the parties, which is the cornerstone of
sufficiently comparable to assure that (a) The criteria to be used by the
this subpart.
the process of inspection and the parties to assess equivalence are listed
ensuing inspection reports will provide § 26.3 Scope. in Appendix D of this subpart.
adequate information to determine (a) The provisions of this subpart Information pertaining to the criteria
whether respective statutory and shall apply to pharmaceutical under European Community (EC)
regulatory requirements of the inspections carried out in the United competence will be provided by the EC.
authorities have been fulfilled. States and Member States of the (b) The authorities of the parties will
Equivalence does not require that the European Community (EC) before establish and communicate to each
respective regulatory systems have products are marketed (hereafter other their draft programs for assessing
identical procedures. referred to as ‘‘preapproval the equivalence of the respective
(c) Good Manufacturing Practices inspections’’) as well as during their regulatory systems in terms of quality
(GMP’s): [These GMP conceptual marketing (hereafter referred to as assurance of the products and consumer
definitions are to be merged by the ‘‘postapproval inspections’’). protection. These programs will be
parties at a future date.] (b) Appendix A of this subpart names carried out, as deemed necessary by the
(1) GMP’s mean the requirements the laws, regulations, and regulatory authorities, for post- and
found in the respective legislations, administrative provisions governing preapproval inspections and for various
regulations, and administrative these inspections and the good product classes or processes.
provisions for methods to be used in, manufacturing practice (GMP)
and the facilities or controls to be used (c) The equivalence assessment shall
requirements. include information exchanges
for, the manufacturing, processing, (c) Appendix B of this subpart lists
packing, and/or holding of a drug to (including inspection reports), joint
the authorities participating in activities training, and joint inspections for the
assure that such drug meets the under this subpart.
requirements as to safety, and has the purpose of assessing regulatory systems
(d) Sections 26.65, 26.66, 26.67, 26.68,
identity and strength, and meets the and the authorities’ capabilities. In
26.69, and 26.70 of subpart C of this part
quality and purity characteristics that it conducting the equivalence assessment,
do not apply to this subpart.
purports or is represented to possess. the parties will ensure that efforts are
(2) GMP’s are that part of quality § 26.4 Product coverage. made to save resources.
assurance which ensures that products (a) These provisions will apply to (d) Equivalence assessment for
are consistently produced and medicinal products for human or animal authorities added to Appendix B of this
controlled to quality standards. For the use, intermediates and starting materials subpart after the effective date of this
purpose of this subpart, GMP’s include, (as referred to in the European part as described in § 26.80(a) will be
therefore, the system whereby the Community (EC)) and to drugs for conducted as described in this subpart,
manufacturer receives the specifications human or animal use, biological as soon as practicable.
17750 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
§ 26.7 Participation in the equivalence performed can guarantee enforcement of Should a new inspection be needed, the
assessment and determination. the findings of the inspection report and inspection report will be transmitted
The authorities listed in Appendix B require that corrective measures be within 90 calendar days of the request.
of this subpart will actively participate taken when necessary. FDA has the
in these programs to build a sufficient option to participate in these § 26.14 Transmission of preapproval
body of evidence for their equivalence inspection reports.
inspections, and based on experience
determination. Both parties will gained during the transition period, the (a) A preliminary notification that an
exercise good faith efforts to complete parties will agree on procedures for inspection may have to take place will
equivalence assessment as expeditiously exercising this option. be made as soon as possible.
as possible to the extent the resources of (c) In the European Community (EC), (b) Within 15 calendar days, the
the authorities allow. the qualified person will be relieved of relevant authority will acknowledge
responsibility for carrying the controls receipt of the request and confirm its
§ 26.8 Other transition activities. ability to carry out the inspection. In the
laid down in Article 22 paragraph 1(b)
As soon as possible, the authorities of Council Directive 75/319/EEC (see European Community (EC), requests
will jointly determine the essential Appendix A of this subpart) provided will be sent directly to the relevant
information which must be present in that these controls have been carried out authority, with a copy to the European
inspection reports and will cooperate to in the United States and that each Agency for the Evaluation of Medicinal
develop mutually agreed inspection Products (EMEA). If the authority
batch/lot is accompanied by a batch
report format(s). receiving the request cannot carry out
certificate (in accordance with the
§ 26.9 Equivalence determination. World Health Organization Certification the inspection as requested, the
Scheme on the Quality of Medicinal requesting authority shall have the right
(a) Equivalence is established by
Products) issued by the manufacturer to conduct the inspection.
having in place regulatory systems
certifying that the product complies (c) Reports of preapproval inspections
covering the criteria referred to in
with requirements of the marketing will be sent within 45 calendar days of
Appendix D of this subpart, and a
authorization and signed by the person the request that transmitted the
demonstrated pattern of consistent
responsible for releasing the batch/lot. appropriate information and detailed
performance in accordance with these
the precise issues to be addressed
criteria. A list of authorities determined § 26.12 Nature of recognition of inspection during the inspection. A shorter time
as equivalent shall be agreed to by the reports. may be necessary in exceptional cases
Joint Sectoral Committee at the end of
(a) Inspection reports (containing and these will be described in the
the transition period, with reference to
information as established under § 26.8), request.
any limitation in terms of inspection
including a good manufacturing practice
type (e.g., postapproval or preapproval) § 26.15 Monitoring continued equivalence.
(GMP) compliance assessment, prepared
or product classes or processes. Monitoring activities for the purpose
(b) The parties will document by authorities listed as equivalent, will
be provided to the authority of the of maintaining equivalence shall
insufficient evidence of equivalence,
importing party. Based on the include review of the exchange of
lack of opportunity to assess
determination of equivalence in light of inspection reports and their quality and
equivalence or a determination of
the experience gained, these inspection timeliness; performance of a limited
nonequivalence, in sufficient detail to
reports will normally be endorsed by number of joint inspections; and the
allow the authority being assessed to
the authority of the importing party, conduct of common training sessions.
know how to attain equivalence.
except under specific and delineated § 26.16 Suspension.
§ 26.10 Regulatory authorities not listed as circumstances. Examples of such
currently equivalent. circumstances include indications of (a) Each party has the right to contest
Authorities not currently listed as material inconsistencies or inadequacies the equivalence of a regulatory
equivalent, or not equivalent for certain in an inspection report, quality defects authority. This right will be exercised in
types of inspections, product classes or identified in the postmarket an objective and reasoned manner in
processes may apply for reconsideration surveillance or other specific evidence writing to the other party.
of their status once the necessary of serious concern in relation to product (b) The issue shall be discussed in the
corrective measures have been taken or quality or consumer safety. In such Joint Sectoral Committee promptly upon
additional experience is gained. cases, the authority of the importing such notification. Where the Joint
party may request clarification from the Sectoral Committee determines that
§ 26.11 Start of operational period.
authority of the exporting party which verification of equivalence is required, it
(a) The operational period shall start may lead to a request for reinspection. may be carried out jointly by the parties
at the end of the transition period and The authorities will endeavor to in a timely manner, under § 26.6.
its provisions apply to inspection respond to requests for clarification in a (c) Efforts will be made by the Joint
reports generated by authorities listed as timely manner. Sectoral Committee to reach unanimous
equivalent for the inspections (b) Where divergence is not clarified consent on the appropriate action. If
performed in their territory. in this process, an authority of the agreement to suspend is reached in the
(b) In addition, when an authority is importing country may carry out an Joint Sectoral Committee, an authority
not listed as equivalent based on inspection of the production facility. may be suspended immediately
adequate experience gained during the thereafter. If no agreement is reached in
transition period, FDA will accept for § 26.13 Transmission of postapproval the Joint Sectoral Committee, the matter
normal endorsement (as provided in inspection reports. is referred to the Joint Committee as
§ 26.12) inspection reports generated as Postapproval good manufacturing described in § 26.73. If no unanimous
a result of inspections conducted jointly practice (GMP) inspection reports consent is reached within 30 days after
by that authority on its territory and concerning products covered by this such notification, the contested
another authority listed as equivalent, subpart will be transmitted to the authority will be suspended.
provided that the authority of the authority of the importing country (d) Upon the suspension of authority
Member State in which the inspection is within 60 calendar days of the request. previously listed as equivalent, a party
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17751
is no longer obligated to normally information on any confirmed problem Council Regulation No (EEC) 2309/93 of 23
endorse the inspection reports of the reports, corrective actions, recalls, July 1993 laying down Community
suspended authority. A party shall rejected import consignments and other procedures for the authorization and
continue to normally endorse the regulatory and enforcement problems supervision of medicinal products for human
and veterinary use and establishing a
inspection reports of that authority prior for products subject to this subpart.
European Agency for the Evaluation of
to suspension, unless the authority of Medicinal Products.
§ 26.20 Alert system.
the receiving party decides otherwise Council Directive 92/25/EEC of 31 March
based on health or safety considerations. (a) The details of an alert system will
1992 on the wholesale distribution of
The suspension will remain in effect be developed during the transitional medicinal products for human use & Guide
until unanimous consent has been period. The system will be maintained to Good Distribution Practice.
reached by the parties on the future in place at all times. Elements to be Current version of the Guide to Good
status of that authority. considered in developing such a system Manufacturing Practice, Rules Governing
are described in Appendix E of this Medicinal Products in the European
§ 26.17 Role and composition of the Joint subpart. Community, Volume IV.
Sectoral Committee. (b) Contact points will be agreed 2. For the United States :
(a) A Joint Sectoral Committee is set between both parties to permit
[Copies of FDA documents may be
up to monitor the activities under both authorities to be made aware with the obtained from the Government Printing
the transitional and operational phases appropriate speed in case of quality Office, 1510 H St. NW., Washington, DC
of this subpart. defect, recalls, counterfeiting, and other 20005. FDA documents, except the FDA
(b) The Joint Sectoral Committee will problems concerning quality, which Compliance Program Guidance Manual, may
be cochaired by a representative of FDA could necessitate additional controls or be viewed on FDA’s Internet web site at
for the United States and a suspension of the distribution of the ‘‘http://www.FDA.gov’’.]
representative of the European product. Relevant sections of the United States
Community (EC) who each will have Federal Food, Drug, and Cosmetic Act and
one vote. Decisions will be taken by § 26.21 Safeguard clause. the United States Public Health Service Act.
unanimous consent. Each party recognizes that the Relevant sections of Title 21, United States
(c) The Joint Sectoral Committee’s importing country has a right to fulfill Code of Federal Regulations (CFR) Parts 1–
its legal responsibilities by taking 99, Parts 200–299, Parts 500–599, and Parts
functions will include: 600–799.
(1) Making a joint assessment, which actions necessary to ensure the Relevant sections of the FDA Investigations
must be agreed by both parties, of the protection of human and animal health Operations Manual, the FDA Regulatory
equivalence of the respective at the level of protection it deems Procedures Manual, the FDA Compliance
authorities; appropriate. This includes the Policy Guidance Manual, the FDA
(2) Developing and maintaining the suspension of the distribution, product Compliance Program Guidance Manual, and
list of equivalent authorities, including detention at the border of the importing other FDA guidances.
any limitation in terms of inspecting country, withdrawal of the batches and Appendix B of Subpart A—List of
type or products, and communicating any request for additional information Authorities
the list to all authorities and the Joint or inspection as provided in § 26.12. 1. For the United States:
Committee; Appendix A of Subpart A—List of
(3) Providing a forum to discuss In the United States, the regulatory authority
Applicable Laws, Regulations, and is the Food and Drug Administration.
issues relating to this subpart, including Administrative Provisions
concerns that an authority may be no 2. For the European Community:
1. For the European Community:
longer equivalent and opportunity to In the European Community, the regulatory
review product coverage; and [Copies of EC documents may be obtained authorities are the following :
(4) Consideration of the issue of from the European Document Research, 1100 Austria: Bundesministerium Fur Arbeit,
17th St. NW., suite 301, Washington, DC Gesundheit, und Soziales, Wien.
suspension. 20036. EC documents may be viewed on the
(d) The Joint Sectoral Committee shall Belgium: Ministèrie van Sociale Zakem,
European Commission Pharmaceuticals Units Volksgezondheid en Leefmilieu /Ministere
meet at the request of either party and, web site at ‘‘http://dg3.eudra.org.’’]
unless the cochairs otherwise agree, at des Affaires Sociales, Sante Publique et
Council Directive 65/65/EEC of 26 January
Environment/ Algemeine Farmaceutische
least once each year. The Joint 1965 on the approximation of provisions laid
Inspectie, Inspection Generale de la
Committee will be kept informed of the down by law, regulation, or administrative
Pharmacie, Bruxelles, Brussel.
agenda and conclusions of meetings of action relating to proprietary medicinal
products as extended, widened, and Denmark: Laegemiddelstryelsen, (Danish
the Joint Sectoral Committee. Medicines Agency), Bronshoj.
amended.
Council Directive 75/319/EEC of 20 May Finland: Laakelaittos/Lakemedelsverket
§ 26.18 Regulatory collaboration. (National Agency for Medicines), Helsinki.
1975 on the approximation of provisions laid
(a) The parties and authorities shall down by law, regulation or administrative France: Agence du Médicament, Direction de
inform and consult one another, as action relating to proprietary medicinal l’inspection et des établissements, Saint
permitted by law, on proposals to products as extended, widened and Denis. (Human). Agence Nationale du
introduce new controls or to change amended. Médicament Vétérinaire, Fougères
existing technical regulations or Council Directive 81/851/EEC of 6 November (Veterinary).
inspection procedures and to provide 1981 on the approximation of the laws of the Germany: Bundesgesundheitsministerium,
Member States relating to veterinary Bonn. Paul-Ehrlich Institut, Langen
the opportunity to comment on such (biologicals only). Zustandige Behorden der
proposals. medicinal products as widened and
amended. 16 Bundeslander: Bayern, Berlin
(b) The parties shall notify each other Commission Directive 91/356/EEC of 13 June Brandenberg, Bremen, Hamburg, Hessen,
in writing of any changes to Appendix 1991 laying down the principles and Niedersachsen, Nordrhein-Westfalen,
B of this subpart. guidelines of good manufacturing practice for Rheinland-Pfalz, Mecklenberg-Vorpommern,
medicinal products for human use. Saarland, Sachsen, Sachsenanhalt,
§ 26.19 Information relating to quality Commission Directive 91/412/EEC of 23 July Schleswog-Holstein, Thuringen.
aspects. 1991 laying down the principles and Greece: Ministry of Health and Welfare,
The authorities will establish an guidelines of good manufacturing practice for National Drug Organisation (E.O.F.), Athens.
appropriate means of exchanging veterinary medicinal products. Ireland: Irish Medicines Board, Dublin.
17752 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
Italy: Ministero della Sanità, Dipartimento analytical data, and other firm/product Appendix E of Subpart A—Elements to be
Farmaci e Farmacovigilanza, Roma. (Human). information relating to matters covered by Considered in Developing a Two-way Alert
Ministero della Sanità, Dipartimento alimenti subpart A of this part. System
e nutrizione e sanità pubblica veterinaria - II. Mechanisms in place to assure appropriate 1. Documentation
Div. IX, Roma (Veterinary). professional standards and avoidance of
Luxembourg: Direction de la Santé, Division - Definition of a crisis/emergency and under
conflicts of interest. what circumstances an alert is required
de la Pharmacie et des Médicaments,
Luxembourg. III. Administration of the regulatory - Standard Operating Procedures (SOP’s)
The Netherlands: Staatstoezicht op de authority: - Mechanism of health hazards evaluation
Volksgezondheid, Inspectie voor de and classification
A. Standards of education/qualification and
Gezondheidszorg, Rijswijk. - Language of communication and
training.
Portugal: Instituto da Farmácia e do transmission of information
B. Effective quality assurance systems
Medicamento (INFARMED), Lisboa. measures to ensure adequate job 2. Crisis Management System
Spain: Ministerio Sanidad y Consumo, performance.
Subdirección. General de Control - Crisis analysis and communication
C. Appropriate staffing and resources to mechanisms
Farmacéutico, Madrid. (Human) Ministerio enforce laws and regulations.
de Agricultura Pesca y Alimentación, - Establishment of contact points
Madrid, (Veterinary). IV. Conduct of inspections: - Reporting mechanisms
Sweden: Läkemedelsverket (Medical A. Adequate preinspection preparation, 3. Enforcement Procedures
Products Agency), Uppsala. including appropriate expertise of - Followup mechanisms
United Kingdom: Medicines Control Agency, investigator/team, review of firm/product - Corrective action procedures
London. Veterinary Medicines Directorate, and databases, and availability of appropriate
Addlestone. inspection equipment. 4. Quality Assurance System
European Union: European Commission, B. Adequate conduct of inspection, including - Pharmacovigilance programme
Brussels. European Agency for the Evaluation statutory access to facilities, effective - Surveillance/monitoring of implementation
of Medicinal Products (EMEA), London. response to refusals, depth and competence of corrective action
of evaluation of operations, systems, and
Appendix C of Subpart A—Indicative List of 5. Contact Points
documentation; collection of evidence;
Products Covered by Subpart A appropriate duration of inspection and For the purpose of subpart A of this part, the
Recognizing that precise definition of completeness of written report of contact points for the alert system will be:
medicinal products and drugs are to be found observations to firm management. A. For the European Community:
in the legislations referred to above, an C. Adequate postinspection activities,
indicative list of products covered by this including completeness of inspectors’ report, the Executive Director of the European
arrangement is given below: inspection report review where appropriate, Agency for the Evaluation of Medicinal
- human medicinal products including and conduct of followup inspections and Products, 7, Westferry Circus, Canary Wharf,
prescription and nonprescription drugs; other activities where appropriate, assurance UK - London E14 4HB, England. Telephone
- human biologicals including vaccines, of preservation and retrieval of records. 44–171–418 8400, Fax 418 8416.
and immunologicals; B. For the United States :
V. Execution of regulatory enforcement
- veterinary pharmaceuticals, including
actions to achieve corrections, designed to Division of Emergency and Investigational
prescription and nonprescription drugs,
prevent future violations, and to remove Operations (DEIO), Food and Drug
with the exclusion of veterinary
immunologicals (Under 9 CFR 101.2 products found in violation of requirements Administration, 5600 Fishers Lane,
‘‘veterinary immunologicals’’ are referred from the market. Rockville, MD 20857. Telephone 301–443–
to as ‘‘veterinary biologicals.’’); 1240, Fax 301–443–3757.
VI. Effective use of surveillance systems:
- premixes for the preparation of veterinary Subpart B—Specific Sector Provisions
A. Sampling and analysis.
medicated feeds (EC), Type A medicated for Medical Devices
B. Recall monitoring.
articles for the preparation of veterinary
C. Product defect reporting system.
medicated feeds (United States); § 26.31 Purpose.
D. Routine surveillance inspections.
- intermediate products and active
pharmaceutical ingredients or bulk E. Verification of approved manufacturing (a) The purpose of this subpart is to
pharmaceuticals (United States)/starting process changes to marketing authorizations/ specify the conditions under which a
materials (EC). approved applications. party will accept the results of quality
VII. Additional specific criteria for system-related evaluations and
Appendix D of Subpart A—Criteria for preapproval inspections:
Assessing Equivalence for Post- and
inspections and premarket evaluations
Preapproval A. Satisfactory demonstration through a of the other party with regard to medical
jointly developed and administered training devices as conducted by listed
I. Legal/Regulatory authority and structures program and joint inspections to assess the
and procedures providing for post- and
conformity assessment bodies (CAB’s)
regulatory authorities’ capabilities. and to provide for other related
preapproval: B. Preinspection preparation includes the cooperative activities.
A. Appropriate statutory mandate and review of appropriate records, including site
(b) This subpart is intended to evolve
jurisdiction. plans and drug master file or similar
B. Ability to issue and update binding documentation to enable adequate as programs and policies of the parties
requirements on GMP’s and guidance inspections. evolve. The parties will review this
documents. C. Ability to verify chemistry, manufacturing, subpart periodically, in order to assess
C. Authority to make inspections, review and and control data supporting an application is progress and identify potential
copy documents, and to take samples and authentic and complete. enhancements to this subpart as FDA
collect other evidence. D. Ability to assess and evaluate research and and European Community (EC) policies
D. Ability to enforce requirements and to development data as scientifically sound, evolve over time.
remove products found in violation of such especially transfer technology of pilot, scale
requirements from the market. up and full scale production batches. § 26.32 Scope.
E. Substantive current good manufacturing E. Ability to verify conformity of the onsite (a) The provisions of this subpart
requirements. processes and procedures with those
F. Accountability of the regulatory authority. described in the application.
shall apply to the exchange and, where
G. Inventory of current products and F. Review and evaluate equipment appropriate, endorsement of the
manufacturers. installation, operational and performance following types of reports from
H. System for maintaining or accessing qualification data, and evaluate test method conformity assessment bodies (CAB’s)
inspection reports, samples and other validation. assessed to be equivalent:
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17753
(1) Under the U.S. system, party in writing of any change in the (d) Both parties will exercise good
surveillance/postmarket and initial/ regulatory authority for a country. faith efforts to complete the confidence
preapproval inspection reports; building activities as expeditiously as
§ 26.35 Length and purpose of transition
(2) Under the U.S. system, premarket possible to the extent that the resources
period.
(510(k)) product evaluation reports; of the parties allow.
(3) Under the European Community There will be a 3-year transition
period immediately following the date (e) Both the parties will each prepare
(EC) system, quality system evaluation annual progress reports which will
reports; and described in § 26.80(a). During the
transition period, the parties will engage describe the confidence building
(4) Under the EC system, EC type
in confidence-building activities for the activities undertaken during each year
examination and verification reports.
purpose of obtaining sufficient evidence of the transition period. The form and
(b) Appendix A of this subpart names
to make determinations concerning the content of the reports will be
the legislation, regulations, and related
equivalence of conformity assessment determined by the parties through the
procedures under which:
(1) Products are regulated as medical bodies (CAB’s) of the other party with Joint Sectoral Committee.
devices by each party; respect to the ability to perform quality
system and product evaluations or other § 26.38 Other transition period activities.
(2) CAB’s are designated and
confirmed; and reviews resulting in reports to be (a) During the transition period, the
(3) These reports are prepared. exchanged under this subpart. parties will jointly determine the
(c) For purposes of this subpart, § 26.36 Listing of CAB’s. necessary information which must be
equivalence means that: CAB’s in the EC present in quality system and product
Each party shall designate conformity
are capable of conducting product and evaluation reports.
assessment bodies (CAB’s) to participate
quality systems evaluations against U.S. in confidence-building activities by (b) The parties will jointly develop a
regulatory requirements in a manner transmitting to the other party a list of notification and alert system to be used
equivalent to those conducted by FDA; CAB’s which meet the criteria for in case of defects, recalls, and other
and CAB’s in the United States are technical competence and problems concerning product quality
capable of conducting product and independence, as identified in that could necessitate additional actions
quality systems evaluations against EC Appendix A of this subpart. The list (e.g., inspections by the parties of the
regulatory requirements in a manner shall be accompanied by supporting importing country) or suspension of the
equivalent to those conducted by EC evidence. Designated CAB’s will be distribution of the product.
CAB’s. listed in Appendix D of this subpart for
participation in the confidence building § 26.39 Equivalence assessment.
§ 26.33 Product coverage.
activities once confirmed by the (a) In the final 6 months of the
(a) There are three components to this
importing party. Nonconfirmation transition period, the parties shall
subpart each covering a discrete range of
would have to be justified based on proceed to a joint assessment of the
products:
(1) Quality System Evaluations. U.S.- documented evidence. equivalence of the conformity
type surveillance/postmarket and § 26.37 Confidence building activities. assessment bodies (CAB’s) that
initial/preapproval inspection reports participated in the confidence building
(a) At the beginning of the transitional
and European Community (EC)-type period, the Joint Sectoral Group will activities. CAB’s will be determined to
quality system evaluation reports will establish a joint confidence building be equivalent provided they have
be exchanged with regard to all program calculated to provide sufficient demonstrated proficiency through the
products regulated under both U.S. and evidence of the capabilities of the submission of a sufficient number of
EC law as medical devices. designated conformity assessment adequate reports. CAB’s may be
(2) Product Evaluation. U.S.-type bodies (CAB’s) to perform quality determined to be equivalent with regard
premarket (510(k)) product evaluation system or product evaluations to the to the ability to perform any type of
reports and EC-type-testing reports will specifications of the parties. quality system or product evaluation
be exchanged only with regard to those (b) The joint confidence building covered by this subpart and with regard
products classified under the U.S. program should include the following to any type of product covered by this
system as Class I/Class II-Tier 2 medical actions and activities: subpart. The parties shall develop a list
devices which are listed in Appendix B (1) Seminars designed to inform the contained in Appendix E of this subpart
of this subpart. parties and CAB’s about each party’s of CAB’s determined to be equivalent
(3) Postmarket Vigilance Reports. regulatory system, procedures, and which shall contain a full explanation of
Postmarket vigilance reports will be requirements; the scope of the equivalency
exchanged with regard to all products (2) Workshops designed to provide determination, including any
regulated under both U.S. and EC law as the parties with information regarding appropriate limitations, with regard to
medical devices. requirements and procedures for the performing any type of quality system or
(b) Additional products and designation and surveillance of CAB’s; product evaluation.
procedures may be made subject to this (3) Exchange of information about (b) The parties shall allow CAB’s not
subpart by agreement of the parties. reports prepared during the transition listed for participation in this subpart,
period; or listed for participation only as to
§ 26.34 Regulatory authorities. (4) Joint training exercises; and
The regulatory authorities shall have (5) Observed inspections. certain types of evaluations, to apply for
the responsibility of implementing the (c) During the transition period, any participation in this subpart once the
provisions of this subpart, including the significant problem that is identified necessary measures have been taken or
designation and monitoring of with a CAB may be the subject of sufficient experience has been gained,
conformity assessment bodies (CAB’s). cooperative activities, as resources in accordance with § 26.46.
Regulatory authorities will be specified allow and as agreed to by the regulatory (c) Decisions concerning the
in Appendix C of this subpart.. Each authorities, aimed at resolving the equivalence of CAB’s must be agreed to
party will promptly notify the other problem. by both parties.
17754 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
§ 26.40 Start of the operational period. § 26.42 Exchange and endorsement of equivalence using the procedures and
product evaluation reports. criteria described in §§ 26.36, 26.37, and
(a) The operational period will start at
the end of the transition period after the (a) European Community (EC) 26.39, taking into account the level of
parties have developed the list of conformity assessment bodies (CAB’s) confidence gained in the overall
conformity assessment bodies (CAB’s) listed for this purpose will, subject to regulatory system of the other party.
the specifications and limitations on the (b) Once a designating authority
found to be equivalent. The provisions
list, provide to FDA 510(k) premarket considers that such CAB’s, having
of §§ 26.40, 26.41, 26.42, 26.43, 26.44,
notification assessment reports prepared undergone the procedures of §§ 26.36,
26.45, and 26.46 will apply only with
to U.S. medical device requirements. 26.37, and 26.39, may be determined to
regard to listed CAB’s and only to the (b) U.S. CAB’s will, subject to the
extent of any specifications and be equivalent, it will then designate
specifications and limitations on the those bodies on an annual basis. Such
limitations contained on the list with list, provide to the EC Notified Body of
regard to a CAB. procedures satisfy the procedures of
the manufacturer’s choice, type § 26.66(a) and (b).
(b) The operational period will apply examination, and verification reports (c) Following such annual
to quality system evaluation reports and prepared to EC medical device designations, the procedures for
product evaluation reports generated by requirements. confirmation of CAB’s under § 26.66(c)
CAB’s listed in accordance with this (c) Based on the determination of and (d) shall apply.
subpart for the evaluations performed in equivalence in light of the experience
the respective territories of the parties, gained, the product evaluation reports § 26.47 Role and composition of the Joint
except if the parties agree otherwise. prepared by the CAB’s listed as Sectoral Committee.
equivalent will normally be endorsed by (a) The Joint Sectoral Committee for
§ 26.41 Exchange and endorsement of
the importing party, except under this subpart is set up to monitor the
quality system evaluation reports.
specific and delineated circumstances. activities under both the transitional
(a) Listed European Community (EC) Examples of such circumstances include and operational phases of this subpart.
conformity assessment bodies (CAB’s) indications of material inconsistencies, (b) The Joint Sectoral Committee will
will provide FDA with reports of quality inadequacies, or incompleteness in a be cochaired by a representative of the
system evaluations, as follows: product evaluation report, or other Food and Drug Administration (FDA)
(1) For preapproval quality system specific evidence of serious concern in for the United States and a
evaluations, EC CAB’s will provide full relation to product safety, performance, representative of the European
reports; and or quality. In such cases, the importing Community (EC) who will each have
(2) For surveillance quality system party may request clarification from the one vote. Decisions will be taken by
evaluations, EC CAB’s will provide exporting party which may lead to a unanimous consent.
abbreviated reports. request for a reevaluation. The parties (c) The Joint Sectoral Committee’s
will endeavor to respond to requests for functions will include:
(b) Listed U.S. CAB’s will provide to clarification in a timely manner. (1) Making a joint assessment of the
the EC Notified Body of the Endorsement remains the responsibility equivalence of conformity assessment
manufacturer’s choice: of the importing party. bodies (CAB’s);
(1) Full reports of initial quality (2) Developing and maintaining the
system evaluations; § 26.43 Transmission of quality system
list of equivalent CAB’s, including any
evaluation reports.
(2) Abbreviated reports of quality limitation in terms of their scope of
Quality system evaluation reports activities and communicating the list to
systems surveillance audits.
covered by § 26.41 concerning products all authorities and the Joint Committee
(c) If the abbreviated reports do not covered by this subpart shall be
provide sufficient information, the described in subpart C of this part;
transmitted to the importing party (3) Providing a forum to discuss
importing party may request additional within 60 calendar days of a request by
clarification from the CAB. issues relating to this subpart, including
the importing party. Should a new concerns that a CAB may no longer be
(d) Based on the determination of inspection be requested, the time period equivalent and opportunity to review
equivalence in light of the experience shall be extended by an additional 30 product coverage; and
gained, the quality system evaluation calendar days. A party may request a (4) Consideration of the issue of
reports prepared by the CAB’s listed as new inspection, for cause, identified to suspension.
equivalent will normally be endorsed by the other party. If the exporting party
the importing party, except under cannot perform an inspection within a § 26.48 Harmonization.
specific and delineated circumstances. specified period of time, the importing During both the transitional and
Examples of such circumstances include party may perform an inspection on its operational phases of this subpart, both
indications of material inconsistencies own. parties intend to continue to participate
or inadequacies in a report, quality in the activities of the Global
§ 26.44 Transmission of product
defects identified in postmarket Harmonization Task Force and utilize
evaluation reports.
surveillance or other specific evidence the results of those activities to the
of serious concern in relation to product Transmission of product evaluation
reports will take place according to the extent possible. Such participation
quality or consumer safety. In such involves developing and reviewing
cases, the importing party may request importing party’s specified procedures.
documents developed by the Global
clarification from the exporting party § 26.45 Monitoring continued equivalence. Harmonization Task Force and jointly
which may lead to a request for Monitoring activities will be carried determining whether they are applicable
reinspection. The parties will endeavor out in accordance with § 26.69. to the implementation of this subpart.
to respond to requests for clarification
in a timely manner. Where divergence is § 26.46 Listing of additional CAB’s. § 26.49 Regulatory cooperation.
not clarified in this process, the (a) During the operational phase, (a) The parties and authorities shall
importing party may carry out the additional conformity assessment inform and consult with one another, as
quality system evaluation. bodies (CAB’s) will be considered for permitted by law, of proposals to
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17755
introduce new controls or to change Annex 2 (with the exception of section 4) accessories, in line with their respective
existing technical regulations or Annex 4 priorities as follows:
inspection procedures and to provide Annex 5 a. Those for which review may be based
b. Council Directive 93/42/EEC of 14 June primarily on written guidance which the
the opportunity to comment on such
1993 on Medical Devices OJ No. L
proposals. parties will use their best efforts to
169,12.7.1993, p.1. Conformity assessment
(b) The parties shall notify each other procedures. prepare expeditiously; and
in writing of any changes to Appendix Annex 2 (with the exception of section 4) b. Those for which review may be based
A of this subpart. Annex 3 primarily on international standards, in
Annex 4 order for the parties to gain the requisite
§ 26.50 Alert system and exchange of Annex 5 experience.
postmarket vigilance reports. Annex 6 The corresponding additional product lists
(a) An alert system will be set up 2. For the United States, the following will be phased in on an annual basis. The
during the transition period and legislation applies to § 26.32(a): parties may consult with industry and other
maintained thereafter by which the [Copies of FDA documents may be interested parties in determining which
parties will notify each other when obtained from the Government Printing products will be added.
there is an immediate danger to public Office, 1510 H St. NW., Washington, DC 3. Commencement of the Operational Period
health. Elements of such a system will 20005. FDA documents may be viewed on
be described in an Appendix F of this FDA’s Internet web site at ‘‘http:// a. At the commencement of the operational
subpart. As part of that system, each www.fda.gov’’.] period, product coverage shall extend to
party shall notify the other party of any a. The Federal Food, Drug and Cosmetic Act, all Class I/II products covered during the
confirmed problem reports, corrective 21 U.S.C. 321 et seq. transition period.
b. The Public Health Service Act, 42 U.S.C. b. FDA will expand the program to
actions, or recalls. These reports are 201 et seq.
regarded as part of ongoing categories of Class II devices as is
c. Regulations of the United States Food and consistent with the results of the pilot,
investigations. Drug Administration found at 21 CFR, in
(b) Contact points will be agreed particular, Parts 800 to 1299. and with FDA’s ability to write guidance
between both parties to permit d. Medical Devices; Third Party Review of documents if the device pilot for the
authorities to be made aware with the Selected Premarket Notifications; Pilot third party review of medical devices is
appropriate speed in case of quality Program, 61 FR 14789-14796 (April 3, 1996). successful. The MRA will cover to the
defect, batch recalls, counterfeiting and maximum extent feasible all Class II
Appendix B of Subpart B—Scope of Product
other problems concerning quality, devices listed in Table 3 for which FDA-
Coverage
which could necessitate additional accredited third party review is available
1. Initial Coverage of the Transition Period in the United States.
controls or suspension of the
Upon entry into force of this subpart as 4. Unless explicitly included by joint
distribution of the product. described in § 26.80 (it is understood that the decision of the parties, this part does not
Appendix A of Subpart B—Relevant date of entry into force will not occur prior cover any U.S. Class II-tier 3 or any Class III
Legislation, Regulations and Procedures to June 1, 1998, unless the parties decide product under either system.
1. For the European Community (EC) the otherwise), products qualifying for the
transitional arrangements under this subpart [FDA is codifying the lists of medical
following legislation applies to § 26.42(a) of
include: devices contained in the following tables as
this subpart:
a. All Class I products requiring premarket they appear in the medical device annex of
[Copies of EC documents may be obtained evaluations in the United States—see the ‘‘Agreement on Mutual Recognition
from the European Document Research, 1100 Table 1. Between the United States of America and
17th St. NW., suite 301, Washington, DC b. Those Class II products listed in Table
20036.] the European Community.’’ As a result of the
2. Food and Drug Administration
a. Council Directive 90/385/EEC of 20 June
1990 on active implantable medical devices 2. During the Transition Period Modernization Act of 1997, however, the
OJ No. L 189, 20.7. 1990, p. 17. Conformity The parties will jointly identify additional medical devices included in these tables will
assessment procedures. product groups, including their related change.]
TABLE 1.—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF
PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1
21 CFR Section No. Regulation Name
TABLE 1.—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF
PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1—Continued
21 CFR Section No. Regulation Name
Cardiovascular Panel
(None)
Dental Panel (21 CFR Part 872)
872.3400 Karaya and Sodium Borate With or Without Acacia Denture Adhe-
sive
KOM—Adhesive, Denture, Acacia and Karaya With Sodium Borate
872.3700 Dental Mercury (U.S.P.)
ELY—Mercury
872.4200 Dental Handpiece and Accessories
EBW—Controller, Food, Handpiece and Cord
EFB—Handpiece, Air-Powered, Dental
EFA—Handpiece, Belt and/or Gear Driven, Dental
EGS—Handpiece, Contra- and Right-Angle Attachment, Dental
EKX—Handpiece, Direct Drive, AC-Powered
EKY—Handpiece, Water-Powered
872.6640 Dental Operative Unit and Accessories
EIA—Unit, Operative Dental
Ear, Nose, and Throat Panel (21 CFR Part 874)
874.1070 Short Increment Sensitivity Index (SISI) Adapter
ETR—Adapter, Short Increment Sensitivity Index (SISI)
874.1500 Gustometer
ETM—Gustometer
874.1800 Air or Water Caloric Stimulator
KHH—Stimulator, Caloric-Air
ETP—Stimulator, Caloric-Water
874.1925 Toynbee Diagnostic Tube
ETK—Tube, Toynbee Diagnostic
874.3300 Hearing Aid
LRB—Face Plate Hearing-Aid
ESD—Hearing-aid, Air-Conduction
874.4100 Epistaxis Balloon
EMX—Balloon, Epistaxis
874.5300 ENT Examination and Treatment Unit
ETF—Unit, Examining/Treatment, ENT
874.5550 Powered Nasal Irrigator
KMA—Irrigator, Powered Nasal
874.5840 Antistammering Device
KTH—Device, Anti-Stammering
Gastroenterology—Urology Panel (21 CFR Part 876)
876.5160 Urological Clamp for Males
FHA—Clamp, Penile
876.5210 Enema Kit
FCE—Kit, Enema, (for Cleaning Purpose)
876.5250 Urine Collector and Accessories
FAQ—Bag, Urine Collection, Leg, for External Use
General Hospital Panel (21 CFR Part 880)
880.5270 Neonatal Eye Pad
FOK—Pad, Neonatal Eye
880.5420 Pressure Infusor for an I.V. Bag
KZD—Infusor, Pressure, for I.V. Bags
880.5680 Pediatric Position Holder
FRP—Holder, Infant Position
880.6250 Patient Examination Glove
LZB—Finger Cot
FMC—Glove, Patient Examination
LYY—Glove, Patient Examination, Latex
LZA—Glove, Patient Examination, Poly
LZC—Glove, Patient Examination, Speciality
LYZ—Glove, Patient Examination, Vinyl
880.6375 Patient Lubricant
KMJ—Lubricant, Patient
880.6760 Protective Restraint
BRT—Restraint, Patient, Conductive
FMQ—Restraint, Protective
Neurology Panel (21 CFR Part 882)
882.1030 Ataxiagraph
GWW—Ataxiagraph
882.1420 Electroencephalogram (EEG) Signal Spectrum Analyzer
GWS—Analyzer, Spectrum, Electroencephalogram Signal
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17757
TABLE 1.—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF
PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1—Continued
21 CFR Section No. Regulation Name
TABLE 1.—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF
PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1—Continued
21 CFR Section No. Regulation Name
GBZ—Catheter, Cholangiography
GBQ—Catheter, Continuous Irrigation
GBY—Catheter, Eustachian, General & Plastic Surgery
JCY—Catheter, Infusion
GBX—Catheter, Irrigation
GBP—Catheter, Multiple Lumen
GBO—Catheter, Nephrostomy, General & Plastic Surgery
GBN—Catheter, Pediatric, General & Plastic Surgery
GBW—Catheter, Peritoneal
GBS—Catheter, Ventricular, General & Plastic Surgery
GCD—Connector, Catheter
GCC—Dilator, Catheter
GCB—Needle, Catheter
878.4320 Removable Skin Clip
FZQ—Clip, Removable (Skin)
878.4460 Surgeon’s Gloves
KGO—Surgeon’s Gloves
878.4680 Nonpowered, Single Patient, Portable Suction Apparatus
GCY—Apparatus, Suction, Single Patient Use, Portable, Nonpow-
ered
878.4760 Removable Skin Staple
GDT—Staple, Removable (Skin)
878.4820 AC–Powered, Battery-Powered, and Pneumatically Powered Sur-
gical Instrument Motors and Accessories/Attachments
GFG—Bit, Surgical
GFA—Blade, Saw, General & Plastic Surgery
DWH—Blade, Saw, Surgical, Cardiovascular
BRZ—Board, Arm (With Cover)
GFE—Brush, Dermabrasion
GFF—Bur, Surgical, General & Plastic Surgery
KDG—Chisel (Osteotome)
GFD—Dermatome
GFC—Driver, Surgical, Pin
GFB—Head, Surgical, Hammer
GEY—Motor, Surgical Instrument, AC-Powered
GET—Motor, Surgical Instrument, Pneumatic Powered
DWI—Saw, Electrically Powered
KFK—Saw, Pneumatically Powered
HAB—Saw, Powered, and Accessories
878.4960 Air or AC-Powered Operating Table and Air or AC-Powered Oper-
ating Chair & Accessories
GBB—Chair, Surgical, AC-Powered
FQO—Table, Operating-Room, AC-Powered
GDC—Table, Operating-Room, Electrical
FWW—Table, Operating-Room, Pneumatic
JEA—Table, Surgical with Orthopedic Accessories, AC-Powered
880.5090 Liquid Bandage
KMF—Bandage, Liquid
1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA’s Internet Web Site at
‘‘http://www.fda.gov/cdrh/prodcode.html’’.
TABLE 2.—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PE-
RIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. REQUIREMENTS AND EUROPEAN COM-
MUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC REQUIREMENTS)1
TABLE 2.—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PE-
RIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. REQUIREMENTS AND EUROPEAN COM-
MUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC REQUIREMENTS)1—Continued
TABLE 2.—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PE-
RIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. REQUIREMENTS AND EUROPEAN COM-
MUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC REQUIREMENTS)1—Continued
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1
Product Family 21 CFR Section No Device Name Tier
Anesthesiology Panel
Anesthesia Devices 868.5160 Gas machine for anesthesia or 2
analgesia
868.5270 Breathing system heater 2
868.5440 Portable oxygen generator 2
868.5450 Respiratory gas humidifier 2
868.5630 Nebulizer 2
868.5710 Electrically powered oxygen tent 2
868.5880 Anesthetic vaporizer 2
Gas Analyser 868.1040 Powered Algesimeter 2
868.1075 Argon gas analyzer 2
868.1400 Carbon dioxide gas analyzer 2
868.1430 Carbon monoxide gas analyzer 2
868.1500 Enflurane gas analyzer 2
868.1620 Halothane gas analyzer 2
868.1640 Helium gas analyzer 2
868.1670 Neon gas analyzer 2
868.1690 Nitrogen gas analyzer 2
868.1700 Nitrous oxide gas analyzer 2
868.1720 Oxygen gas analyzer 2
868.1730 Oxygen uptake computer 2
Peripheral Nerve Stimulators 868.2775 Electrical peripheral nerve stimu- 2
lator
Respiratory Monitoring 868.1750 Pressure plethysmograph 2
868.1760 Volume plethysmograph 2
868.1780 Inspiratory airway pressure meter 2
868.1800 Rhinoanemometer 2
868.1840 Diagnostic spirometer 2
868.1850 Monitoring spirometer 2
868.1860 Peak-flow meter for spirometry 2
868.1880 Pulmonary-function data calcula- 2
tor
868.1890 Predictive pulmonary-function 2
value calculator
868.1900 Diagnostic pulmonary-function in- 2
terpretation calculator
868.2025 Ultrasonic air embolism monitor 2
868.2375 Breathing frequency monitor (ex- 2
cept apnea detectors)
868.2480 Cutaneous carbon dioxide 2
(PcCO2) monitor
868.2500 Cutaneous oxygen monitor (for an 2
infant not under gas anesthe-
sia)
868.2550 Pneumotachomometer 2
868.2600 Airway pressure monitor 2
868.5665 Powered percussor 2
868.5690 Incentive spirometer 2
Ventilator 868.5905 Noncontinuous ventilator (IPPB) 2
868.5925 Powered emergency ventilator 2
868.5935 External negative pressure ven- 2
tilator
868.5895 Continuous ventilator 2
868.5955 Intermittent mandatory ventilation 2
attachment
868.6250 Portable air compressor 2
Cardiovascular Panel
Cardiovascular Diagnostic 870.1425 Programmable diagnostic com- 2
puter
870.1450 Densitometer 2
870.2310 Apex cardiograph 2
(vibrocardiograph)
870.2320 Ballistocardiograph 2
870.2340 Electrocardiograph 2
870.2350 Electrocardiograph lead switching 1
adaptor
870.2360 Electrocardiograph electrode 2
870.2370 Electrocardiograph surface elec- 2
trode tester
870.2400 Vectorcardiograph 1
870.2450 Medical cathode-ray tube display 1
17762 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
870.2675 Oscillometer 2
870.2840 Apex cardiographic transducer 2
870.2860 Heart sound transducer 2
Cardiovascular Monitoring Valve, pressure relief,
cardiopulmonary bypass
870.1100 Blood pressure alarm 2
870.1110 Blood pressure computer 2
870.1120 Blood pressure cuff 2
870.1130 Noninvasive blood pressure 2
measurement system
870.1140 Venous blood pressure manom- 2
eter
870.1220 Electrode recording catheter or 2
electrode recording probe
870.1270 Intracavitary phonocatheter sys- 2
tem
870.1875 Stethoscope (electronic) 2
870.2050 Biopotential amplifier and signal 2
conditioner
870.2060 Transducer signal amplifier and 2
conditioner
870.2100 Cardiovascular blood flow-meter 2
870.2120 Extravascular blood flow probe 2
870.2300 Cardiac monitor (including 2
cardiotachometer and rate
alarm)
870.2700 Oximeter 2
870.2710 Ear oximeter 2
870.2750 Impedance phlebograph 2
870.2770 Impedance plethysmograph 2
870.2780 Hydraulic, pneumatic, or photo- 2
electric plethysmographs
870.2850 Extravascular blood pressure 2
transducer
870.2870 Catheter tip pressure transducer 2
870.2880 Ultrasonic transducer 2
870.2890 Vessel occlusion transducer 2
870.2900 Patient transducer and electrode 2
cable (including connector)
870.2910 Radiofrequency physiological sig- 2
nal transmitter and receiver
870.2920 Telephone electrocardiograph 2
transmitter and receiver
870.4205 Cardiopulmonary bypass bubble 2
detector
870.4220 Cardiopulmonary bypass heart- 2
lung machine console
870.4240 Cardiovascular bypass heat ex- 2
changer
870.4250 Cardiopulmonary bypass tempera- 2
ture controller
870.4300 Cardiopulmonary bypass gas con- 2
trol unit
870.4310 Cardiopulmonary bypass coronary 2
pressure gauge
870.4330 Cardiopulmonary bypass on-line 2
blood gas monitor
870.4340 Cardiopulmonary bypass level 2
sensing monitor and/or control
870.4370 Roller-type cardiopulmonary by- 2
pass blood pump
870.4380 Cardiopulmonary bypass pump 2
speed control
870.4410 Cardiopulmonary bypass in-line 2
blood gas sensor
Cardiovascular Therapeutic 870.5050 Patient care suction apparatus 2
870.5900 Thermal regulation system 2
Defibrillator 870.5300 DC-defribrillator (including pad- 2
dles)
870.5325 Defibrillator tester 2
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17763
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
TABLE 3.—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL
PERIOD1—Continued
Product Family 21 CFR Section No Device Name Tier
Appendix C of Subpart B [Reserved] Switzerland, or on the Internet at ‘‘http:/ in subparts A and B of this part, accept
Appendix D of Subpart B [Reserved] /www.iso.ch’’ or may be examined at or recognize results of specified
the Food and Drug Administration’s procedures, used in assessing
Appendix E of Subpart B [Reserved] Medical Library, 5600 Fishers Lane, rm. conformity to specified legislative,
Appendix F of Subpart B [Reserved] 11B–40, Rockville, MD 20857, or the regulatory, and administrative
Office of the Federal Register, 800 North provisions of the EC and its Member
Subpart C—Framework or ‘‘Umbrella’’
Capitol St. NW., suite 700, Washington, States, produced by the other party’s
Provisions
DC. CAB’s and/or authorities.
§ 26.60 Definitions. (c) Where sectoral transition
§ 26.61 Purpose of this part. arrangements have been specified in
(a) The following terms and
definitions shall apply to this part only: This part specifies the conditions by subparts A and B of this part, the above
(1) Designating Authority means a which each party will accept or obligations will apply following the
body with power to designate, monitor, recognize results of conformity successful completion of those sectoral
suspend, remove suspension of, or assessment procedures, produced by the transition arrangements, with the
withdraw conformity assessment bodies other party’s conformity assessment understanding that the conformity
as specified under this part. bodies (CAB’s) or authorities, in assessment procedures utilized assure
(2) Designation means the assessing conformity to the importing conformity to the satisfaction of the
identification by a designating authority party’s requirements, as specified on a receiving party, with applicable
of a conformity assessment body to sector-specific basis in subparts A and legislative, regulatory, and
perform conformity assessment B of this part, and to provide for other administrative provisions of that party,
procedures under this part. related cooperative activities. The equivalent to the assurance offered by
(3) Regulatory Authority means a objective of such mutual recognition is the receiving party’s own procedures.
government agency or entity that to provide effective market access
exercises a legal right to control the use throughout the territories of the parties § 26.63 General coverage of this part.
or sale of products within a party’s with regard to conformity assessment (a) This part applies to conformity
jurisdiction and may take enforcement for all products covered under this part. assessment procedures for products
action to ensure that products marketed If any obstacles to such access arise, and/or processes and to other related
within its jurisdiction comply with legal consultations will promptly be held. In cooperative activities as described in
requirements. the absence of a satisfactory outcome of this part.
(b) Other terms concerning conformity such consultations, the party alleging its (b) Subparts A and B of this part may
assessment used in this part shall have market access has been denied, may, include:
the meaning given elsewhere in this part within 90 days of such consultation, (1) A description of the relevant
or in the definitions contained in Guide invoke its right to terminate this part in legislative, regulatory, and
2 (1996 edition) of the International accordance with § 26.80. administrative provisions pertaining to
Organization for Standardization (ISO) the conformity assessment procedures
and the International Electrotechnical § 26.62 General obligations. and technical regulations;
Commission (IEC). In the event of an (a) The United States shall, as (2) A statement on the product scope
inconsistency between the ISO/IEC specified in subparts A and B of this and coverage;
Guide 2 and definitions in this part, the part, accept or recognize results of (3) A list of designating authorities;
definitions in this part shall prevail. The specified procedures, used in assessing (4) A list of agreed conformity
ISO/IEC Guide 2 is incorporated by conformity to specified legislative, assessment bodies (CAB’s) or authorities
reference with the approval of the regulatory, and administrative or a source from which to obtain a list
Director of the Federal Register in provisions of the United States, of such bodies or authorities and a
accordance with 5 U.S.C. 552(a) and 1 produced by the other party’s statement of the scope of the conformity
CFR part 51. Copies are available from conformity assessment bodies (CAB’s) assessment procedures for which each
the International Organization for and/or authorities. has been agreed;
Standardization, 1, rue de Varembé, (b) The European Community (EC) (5) The procedures and criteria for
Case postale 56, CH–1211 Genève 20, and its Member States shall, as specified designating the CAB’s;
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17769
(6) A description of the mutual (d) In the event that the other party (f) Upon the suspension of a CAB
recognition obligations; contests on the basis of documented listed in subpart B of this part, a party
(7) A sectoral transition arrangement; evidence the technical competence or is no longer obligated to accept or
(8) The identity of a sectoral contact compliance of a proposed CAB, or recognize the results of conformity
point in each party’s territory; and indicates in writing that it requires an assessment procedures performed by
(9) A statement regarding the additional 30 days to more fully verify that CAB subsequent to suspension. A
establishment of a Joint Sectoral such evidence, such CAB shall not be party shall continue to accept the results
Committee. included on the list of CAB’s in subpart of conformity assessment procedures
(c) This part shall not be construed to B of this part. In this instance, the Joint performed by that CAB prior to
entail mutual acceptance of standards or Committee may decide that the body suspension, unless a regulatory
technical regulations of the parties and, concerned be verified. After the authority of the party decides otherwise
unless otherwise specified in subpart A completion of such verification, the based on health, safety or environmental
or B of this part, shall not entail the proposal to list the CAB in subpart B considerations or failure to satisfy other
mutual recognition of the equivalence of may be resubmitted to the other party. requirements within the scope of
standards or technical regulations. subpart B of this part; and
§ 26.67 Suspension of listed conformity
assessment bodies.
(g) The suspension shall remain in
§ 26.64 Transitional arrangements.
effect until agreement has been reached
The parties agree to implement the The following procedures shall apply
by the parties upon the future status of
transitional commitments on confidence with regard to the suspension of a
that body.
building as specified in subparts A and conformity assessment body (CAB)
B of this part. listed in subpart B of this part. § 26.68 Withdrawal of listed conformity
(a) The parties agree that each sectoral (a) A party shall notify the other party assessment bodies.
transitional arrangement shall specify a of its contestation of the technical The following procedures shall apply
time period for completion. competence or compliance of a CAB with regard to the withdrawal from
(b) The parties may amend any listed in subpart B of this part and the subpart B of this part of a conformity
transitional arrangement by mutual contesting party’s intent to suspend assessment body (CAB):
agreement. such CAB. Such contestation shall be (a) A party proposing to withdraw a
(c) Passage from the transitional phase exercised when justified in an objective CAB listed in subpart B of this part shall
to the operational phase shall proceed and reasoned manner in writing to the forward its proposal in writing to the
as specified in subparts A and B of this other party; other party;
part, unless either party documents that (b) The CAB shall be given prompt
notice by the other party and an (b) Such CAB shall be promptly
the conditions provided in such subpart notified by the other party and shall be
for a successful transition are not met. opportunity to present information in
order to refute the contestation or to provided a period of at least 30 days
§ 26.65 Designating authorities. correct the deficiencies which form the from receipt to provide information in
basis of the contestation; order to refute or to correct the
The parties shall ensure that the
(c) Any such contestation shall be deficiencies which form the basis of the
designating authorities specified in
discussed between the parties in the proposed withdrawal;
subpart B of this part have the power
Joint Sectoral Committee described in (c) Within 60 days following receipt
and competence in their respective
subpart B of this part. If there is no Joint of the proposal, the other party shall
territories to carry out decisions under
Sectoral Committee, the contesting party indicate its position regarding either its
this part to designate, monitor, suspend,
shall refer the matter directly to the confirmation or its opposition. Upon
remove suspension of, or withdraw
Joint Committee. If agreement to confirmation, the withdrawal from the
conformity assessment bodies (CAB’s).
suspend is reached by the Joint Sectoral list in subpart B of this part of the CAB
§ 26.66 Designation and listing Committee or, if there is no Joint shall take effect;
procedures. Sectoral Committee, by the Joint (d) In the event the other party
The following procedures shall apply Committee, the CAB shall be opposes the proposal to withdraw by
with regard to the designation of suspended; supporting the technical competence
conformity assessment bodies (CAB’s) (d) Where the Joint Sectoral and compliance of the CAB, the CAB
and the inclusion of such bodies in the Committee or Joint Committee decides shall not at that time be withdrawn from
list of CAB’s in subpart B of this part: that verification of technical the list of CAB’s in subpart B of this
(a) The designating authority competence or compliance is required, part. In this instance, the Joint Sectoral
identified in subpart B of this part shall it shall normally be carried out in a Committee or the Joint Committee may
designate CAB’s in accordance with the timely manner by the party in whose decide to carry out a joint verification of
procedures and criteria set forth in territory the body in question is located, the body concerned. After the
subpart B of this part; but may be carried out jointly by the completion of such verification, the
(b) A party proposing to add a CAB parties in justified cases; proposal for withdrawal of the CAB may
to the list of such bodies in subpart B (e) If the matter has not been resolved be resubmitted to the other party; and
of this part shall forward its proposal of by the Joint Sectoral Committee within (e) Subsequent to the withdrawal of a
one or more designated CAB’s in writing 10 days of the notice of contestation, the CAB listed in subpart B of this part, a
to the other party with a view to a matter shall be referred to the Joint party shall continue to accept the results
decision by the Joint Committee; Committee for a decision. If there is no of conformity assessment procedures
(c) Within 60 days following receipt Joint Sectoral Committee, the matter performed by that CAB prior to
of the proposal, the other party shall shall be referred directly to the Joint withdrawal, unless a regulatory
indicate its position regarding either its Committee. If no decision is reached by authority of the party decides otherwise
confirmation or its opposition. Upon the Joint Committee within 10 days of based on health, safety, and
confirmation, the inclusion in subpart B the referral to it, the CAB shall be environmental considerations or failure
of this part of the proposed CAB or suspended upon the request of the to satisfy other requirements within the
CAB’s shall take effect; and contesting party; scope of subpart B of this part.
17770 Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules
§ 26.69 Monitoring of conformity (c) Each party shall promptly notify procedures affecting subpart A or B of
assessment bodies. the other party of any changes to its this part, the parties shall discuss the
The following shall apply with regard designating authorities and/or matter in the Joint Committee with a
to the monitoring of conformity conformity assessment bodies (CAB’s). view to bringing such new or additional
assessment bodies (CAB’s) listed in (d) The parties shall exchange procedures within the scope of this part,
subpart B of this part: information concerning the procedures where relevant.
(a) Designating authorities shall used to ensure that the listed CAB’s
assure that their CAB’s listed in subpart under their responsibility comply with § 26.74 Preservation of regulatory
authority.
B of this part are capable and remain the legislative, regulatory, and
capable of properly assessing administrative provisions outlined in (a) Nothing in this part shall be
conformity of products or processes, as subpart B of this part. construed to limit the authority of a
applicable, and as covered in subpart B (e) Regulatory authorities identified in party to determine, through its
of this part. In this regard, designating subparts A and B of this part shall legislative, regulatory, and
authorities shall maintain, or cause to consult as necessary with their administrative measures, the level of
maintain, ongoing surveillance over counterparts, to ensure the maintenance protection it considers appropriate for
their CAB’s by means of regular audit or of confidence in conformity assessment safety; for protection of human, animal,
assessment; procedures and to ensure that all or plant life or health; for the
(b) The parties undertake to compare technical requirements are identified environment; for consumers; and
methods used to verify that the CAB’s and are satisfactorily addressed. otherwise with regard to risks within
listed in subpart B of this part comply the scope of the applicable subpart A or
§ 26.72 Sectoral contact points. B of this part.
with the relevant requirements of
Each party shall appoint and confirm (b) Nothing in this part shall be
subpart B of this part. Existing systems
in writing contact points to be construed to limit the authority of a
for the evaluation of CAB’s may be used
responsible for activities under subparts regulatory authority to take all
as part of such comparison procedures;
A and B of this part. appropriate and immediate measures
(c) Designating authorities shall
whenever it ascertains that a product
consult as necessary with their § 26.73 Joint Committee. may:
counterparts, to ensure the maintenance (a) A Joint Committee consisting of (1) Compromise the health or safety of
of confidence in conformity assessment representatives of the United States and persons in its territory;
procedures. With the consent of both the European Community (EC) will be (2) Not meet the legislative,
parties, this consultation may include established. The Joint Committee shall regulatory, or administrative provisions
joint participation in audits/inspections be responsible for the effective within the scope of the applicable
related to conformity assessment functioning of this part. subpart A or B of this part; or
activities or other assessments of CAB’s (b) The Joint Committee may establish (3) Otherwise fail to satisfy a
listed in subpart B of this part; and Joint Sectoral Committees comprised of requirement within the scope of the
(d) Designating authorities shall appropriate regulatory authorities and applicable subpart A or B of this part.
consult, as necessary, with the relevant others deemed necessary. Such measures may include
regulatory authorities of the other party (c) The United States and the EC shall withdrawing the products from the
to ensure that all technical requirements have one vote in the Joint Committee. market, prohibiting their placement on
are identified and are satisfactorily The Joint Committee shall make its the market, restricting their free
addressed. decisions by unanimous consent. The movement, initiating a product recall,
§ 26.70 Conformity assessment bodies.
Joint Committee shall determine its own and preventing the recurrence of such
rules and procedures. problems, including through a
Each party recognizes that the (d) The Joint Committee may consider prohibition on imports. If the regulatory
conformity assessment bodies (CAB’s) any matter relating to the effective authority takes such action, it shall
listed in subpart B of this part fulfill the functioning of this part. In particular it inform its counterpart authority and the
conditions of eligibility to assess shall be responsible for: other party within 15 days of taking
conformity in relation to its (1) Listing, suspension, withdrawal such action, providing its reasons.
requirements as specified in subpart B and verification of conformity
of this part. The parties shall specify the assessment bodies (CAB’s) in § 26.75 Suspension of recognition
scope of the conformity assessment obligations.
accordance with this subpart and
procedures for which such bodies are subpart B of this part; Either party may suspend its
listed. (2) Amending transitional obligations under subpart A or B of this
arrangements in subparts A and B of part, in whole or in part, if:
§ 26.71 Exchange of information. (a) A party suffers a loss of market
this part;
(a) The parties shall exchange (3) Resolving any questions relating to access for the party’s products within
information concerning the the application of this part not the scope of subpart A or B of this part
implementation of the legislative, otherwise resolved in the respective as a result of the failure of the other
regulatory, and administrative Joint Sectoral Committees; party to fulfill its obligations under this
provisions identified in subparts A and (4) Providing a forum for discussion part;
B of this part. of issues that may arise concerning the (b) The adoption of new or additional
(b) Each party shall notify the other implementation of this part; conformity assessment requirements as
party of legislative, regulatory, and (5) Considering ways to enhance the referenced in § 26.73(e) results in a loss
administrative changes related to the operation of this part; of market access for the party’s products
subject matter of this part at least 60 (6) Coordinating the negotiation of within the scope of subpart B of this
days before their entry into force. Where additional subparts; and part because conformity assessment
considerations of safety, health or (7) Considering whether to amend this bodies (CAB’s) designated by the party
environmental protection require more part in accordance with § 26.80. in order to meet such requirements have
urgent action, a party shall notify the (e) When a party introduces new or not been recognized by the party
other party as soon as practicable. additional conformity assessment implementing the requirements; or
Federal Register / Vol. 63, No. 69 / Friday, April 10, 1998 / Proposed Rules 17771
(c) The other party fails to maintain on telecommunications equipment, prevail, to the extent of that
legal and regulatory authorities capable electromagnetic compatibility, electrical inconsistency.
of implementing the provisions of this safety, recreational craft, pharmaceutical (c) The agreement from which this
part. GMP inspections, and medical devices part is derived shall not affect the rights
shall enter into force on the first day of and obligations of the parties under any
§ 26.76 Confidentiality. the second month following the date on other international agreement.
(a) Each party agrees to maintain, to which the parties have exchanged (d) In the case of subpart B of this
the extent required under its laws, the letters confirming the completion of part, the parties shall review the status
confidentiality of information their respective procedures for the entry of such subpart at the end of 3 years
exchanged under this part. into force of that agreement. from entry into force of subpart B.
(b) In particular, neither party shall (b) That agreement including any
disclose to the public, nor permit a Dated: April 6, 1998.
sectoral annex may, through the Joint
conformity assessment body (CAB) to William B. Schultz,
Committee, be amended in writing by
disclose to the public, information the parties to that agreement. Those Deputy Commissioner for Policy.
exchanged under this part that parties may add a sectoral annex upon [FR Doc. 98–9486 Filed 4–9–98; 8:45 am]
constitutes trade secrets, confidential the exchange of letters. Such annex BILLING CODE 4160–01–F
commercial or financial information, or shall enter into force 30 days following
information that relates to an ongoing the date on which those parties have
investigation. exchanged letters confirming the DEPARTMENT OF JUSTICE
(c) A party or a CAB may, upon completion of their respective
exchanging information with the other procedures for the entry into force of the Parole Commission
party or with a CAB of the other party, sectoral annex.
designate the portions of the (c) Either party to that agreement may 28 CFR Part 2
information that it considers to be terminate that agreement in its entirety
exempt from disclosure. Paroling, Recommitting, and
or any individual sectoral annex thereof
(d) Each party shall take all Supervising Federal Prisoners:
by giving the other party to that
precautions reasonably necessary to Prisoners Serving Sentences Under
agreement 6 months notice in writing.
protect information exchanged under the District of Columbia Code
In the case of termination of one or more
this part from unauthorized disclosure. sectoral annexes, the parties to that AGENCY: United States Parole
§ 26.77 Fees. agreement will seek to achieve by Commission, Justice.
consensus to amend that agreement, ACTION: Proposed rule.
Each party shall endeavor to ensure
with a view to preserving the remaining
that fees imposed for services under this SUMMARY: The U.S. Parole Commission
Sectoral Annexes, in accordance with
part shall be commensurate with the is proposing to incorporate into the
the procedures in this section. Failing
services provided. Each party shall Code of Federal Regulations, in
such consensus, that agreement shall
ensure that, for the sectors and amended and supplemented form, the
terminate at the end of 6 months.
conformity assessment procedures (d) Following termination of that regulations of the District of Columbia
covered under this part, it shall charge agreement in its entirety or any that govern the paroling authority that
no fees with respect to conformity individual sectoral annex thereof, a will be assumed by the U.S. Parole
assessment services provided by the party to that agreement shall continue to Commission on August 5, 1998. The
other party. accept the results of conformity paroling authority of the District of
§ 26.78 Agreements with other countries. assessment procedures performed by Columbia Board of Parole will be
Except where there is written conformity assessment bodies under transferred to the U.S. Parole
agreement between the parties, that agreement prior to termination, Commission under the National Capital
obligations contained in mutual unless a regulatory authority in the Revitalization and Self-Government
recognition agreements concluded by party decides otherwise based on Improvement Act of 1997, which
either party with a party not a party to health, safety and environmental permits the Commission to amend and
this part (a third party) shall have no considerations or failure to satisfy other supplement the District’s parole
force and effect with regard to the other requirements within the scope of the regulations pursuant to federal
party in terms of acceptance of the applicable sectoral annex. rulemaking procedures.
results of conformity assessment DATES: Comments must be received by
§ 26.81 Final provisions.
procedures in the third party. June 9, 1998.
(a) The sectoral annexes referred to in
ADDRESSES: Send comments to Office of
§ 26.79 Territorial application. § 26.80(a), as well as any new sectoral
annexes added pursuant to § 26.80(b), General Counsel, U.S. Parole
This part shall apply, on the one Commission, 5550 Friendship Blvd.,
hand, to the territories in which the shall form an integral part of the
‘‘Agreement on Mutual Recognition Chevy Chase, Maryland 20815.
Treaty establishing the European FOR FURTHER INFORMATION CONTACT:
Community (EC) is applied, and under Between the United States of America
and the European Community,’’ from Pamela A. Posch, Office of General
the conditions laid down in that Treaty Counsel, U.S. Parole Commission, 5550
and, on the other hand, to the territory which this part is derived.
(b) For a given product or sector, the Friendship Blvd., Chevy Chase,
of the United States. Maryland 20815, telephone (301) 492–
provisions contained in subparts A and
§ 26.80 Entry into force, amendment and B of this part shall apply in the first 5959.
termination. place, and the provisions of subpart C SUPPLEMENTARY INFORMATION: Under
(a) The ‘‘Agreement on Mutual of this part in addition to those Section 11231 of the National Capital
Recognition Between the United States provisions. In the case of any Revitalization and Self-Government
of America and the European inconsistency between the provisions of Improvement Act of 1997 (Pub. L. 105–
Community,’’ from which this part is subpart A or B of this part and subpart 33) the U.S. Parole Commission is
derived, including its sectoral annexes C of this part, subpart A or B shall required, not later than August 5, 1998,