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Federal Register / Vol. 71, No.

219 / Tuesday, November 14, 2006 / Notices 66335

meetings and other committee that a proposed collection of section 512 of the Federal Food, Drug,
management activities, for both the information has been submitted to the and Cosmetic Act (21 U.S.C. 360b) to
Centers for Disease Control and Office of Management and Budget replace the system for the approval of
Prevention and the Agency for Toxic (OMB) for review and clearance under specific medicated feed with a general
Substances and Disease Registry. the Paperwork Reduction Act of 1995. licensing system for feed mills. Before
Dated: November 6, 2006. DATES: Fax written comments on the passage of the ADAA, medicated feed
Alvin Hall, collection of information by December manufacturers were required to obtain
Director, Management Analysis and Services
14, 2006 approval of Medicated Feed
Office, Centers for Disease Control and ADDRESSES: To ensure that comments on Applications (MFAs) in order to
Prevention. the information collection are received, manufacture certain types of medicated
[FR Doc. E6–19151 Filed 11–13–06; 8:45 am] OMB recommends that written feeds. An individual approved MFA
BILLING CODE 4163–18–P
comments be faxed to the Office of was required for each and every
Information and Regulatory Affairs, applicable medicated feed. The ADAA
OMB, Attn: FDA Desk Officer, FAX: streamlined the paperwork process for
DEPARTMENT OF HEALTH AND 202–395–6974. gaining approval to manufacture
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: medicated feeds by replacing the MFA
Denver Presley, Jr., Office of the Chief system with a facility license for each
Food and Drug Administration Information Officer (HFA–250), Food
medicated feed manufacturing facility.
and Drug Administration, 5600 Fishers
[Docket No. 2006N–0329] Implementing regulations are at part 515
Lane, Rockville, MD 20857, 301–827–
1472. (21 CFR part 515).
Agency Information Collection In the Federal Register of August 25,
Activities; Submission for Office of SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA 2006 (71 FR 50433), FDA solicited
Management and Budget Review; comments on the information collection
Comment Request; Medicated Feed has submitted the following proposed
collection of information to OMB for provisions of this proposed collection.
Mill License Application
review and clearance. In response to that request, FDA
AGENCY: Food and Drug Administration, received no comments.
HHS. Medicated Feed Mill Licensing
Application—21 CFR Part 515 (OMB Description of Respondents:
ACTION: Notice. Control No. 0910–0337)—Extension Medicated feed manufacturers.
SUMMARY: The Food and Drug The Animal Drug Availability Act FDA estimates the burden for this
Administration (FDA) is announcing (ADAA) of October 9, 1996, amended collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Respond- Annual Frequency per Total Annual Re- Hours per
21 CFR Section Total Hours
ents Response sponses Response

515.10(b) 7 1 7 0.25 1.75


515.11(b) 100 1 100 0.25 25
515.23 25 1 25 0.25 6.25
515.30(c) 0.15 1 0.15 24 3.6
Total 36.6
1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


Annual Frequency
No. of Record- Hours per Record-
21 CFR Section per Record- Total Annual Records Total Hours
keepers keeper
keeping

510.305 1,070 1 1,070 0.03 32.10


1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated annual reporting We estimated .03 hours for each of DEPARTMENT OF HEALTH AND
burden on industry is 36.6 hours as approximately 1,070 licensees. Thus, HUMAN SERVICES
shown in table 1 of this document. the total burden for recordkeeping
Industry estimates it takes about 1/4 requirements is 32.10 hours (1,070 x Food and Drug Administration
hour to submit the application. We 0.03).
estimate 132 original and supplemental [Docket No. 2006D–0441]
Dated: November 7, 2006.
applications, and voluntary revocations
for a total of 33 hours (132 submissions Jeffrey Shuren,
Draft Guidance for Industry: Protocols
x 1/4 hour). An additional 3.6 hours is Assistant Commissioner for Policy. for the Conduct of Method Transfer
sroberts on PROD1PC70 with NOTICES

added for the rare notice of opportunity [FR Doc. E6–19152 Filed 11–13–06; 8:45 am] Studies for Type C Medicated Feed
for a hearing to not approve or revoke BILLING CODE 4160–01–S Assay Methods; Availability
an application. Finally, we estimate 36
hours for maintaining and retrieving AGENCY: Food and Drug Administration,
labels as required by 21 CFR 510.305. HHS.

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66336 Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices

ACTION: Notice. This includes a description of guidance practices regulation (21 CFR
practicable methods of analysis (assay 10.115). This draft guidance, when
SUMMARY: The Food and Drug methods) that have adequate sensitivity finalized, will represent the agency’s
Administration (FDA) is announcing the to determine the amount of the new current thinking on the topic. It does not
availability of draft guidance for animal drug in the final dosage form (21 create or confer any rights for or on any
industry (#136) entitled ‘‘Protocols for CFR 514.1(b)(5)(vii)(a)). In the case of a person and does not operate to bind
the Conduct of Method Transfer Studies Type A medicated article, the Type C FDA or the public. An alternate method
for Type C Medicated Feed Assay medicated feed is a final dosage form may be used as long as it satisfies the
Methods.’’ This draft guidance provides used to treat the animal. Thus as part of requirements of applicable statutes and
our recommendations for protocols for the NADA review process, FDA looks at regulations.
conducting the transfer study of a assay methods for determining the
single-laboratory validated Type C IV. Comments
amount of a new animal drug in Type
medicated feed assay method to C medicated feed. This draft guidance is being
laboratories that have no experience This draft guidance provides our (the distributed for comment purposes only
with the test method. Office of New Animal Drug Evaluation and is not intended for implementation
DATES: Submit written or electronic or ONADE) recommendations for at this time. Interested persons may
comments on this draft guidance by protocols for conducting the transfer submit to the Division of Dockets
January 29, 2007, to ensure their study of a single-laboratory validated Management (see ADDRESSES) written or
adequate consideration in preparation of Type C medicated feed assay method to electronic comments regarding this draft
the final document. General comments laboratories that have no experience guidance document. Submit a single
on agency guidance documents are with the test method. Many testing copy of electronic comments or two
welcome at any time. laboratories, including state feed paper copies of any mailed comments,
ADDRESSES: Submit written requests for laboratories and contract laboratories, except that individuals may submit one
single copies of the draft guidance to the use Type C medicated feed assay paper copy. Comments are to be
Communications Staff (HFV–12), Center methods to determine whether the drug identified with the docket number
for Veterinary Medicine, Food and Drug in a medicated feed is within the assay found in brackets in the heading of this
Administration, 7519 Standish Pl., limits. The term ‘‘assay limits’’ refers to document. Received comments may be
Rockville, MD 20855. Send one self- the amount of the drug detected when seen in the Division of Dockets
addressed adhesive label to assist that a Type B/C feed is assayed. The limit is Management between 9 a.m. and 4 p.m.,
office in processing your requests. a range that is codified at 21 CFR Monday through Friday.
Submit written comments to the 558.4(d). When feed assay values fall
within this range, it indicates that the V. Electronic Access
Division of Dockets Management (HFA–
feed has been prepared with the correct Electronic comments may be
305), Food and Drug Administration,
amount of Type A medicated article. submitted on the Internet at http://
5630 Fishers Lane, rm. 1061, Rockville,
Because many different laboratories use www.fda.gov/dockets/ecomments.
MD 20852. Comments should be
medicated feed assays, it is important Copies of the draft guidance document
identified with the full title of the draft
that the assay methods are reproducible. entitled ‘‘Protocols for the Conduct of
guidance and the docket number found
Sponsors should conduct method Method Transfer Studies for Type C
in brackets in the heading of this
transfer studies to evaluate Medicated Feed Assay Methods’’ may
document. Submit electronic comments
reproducibility. A method transfer study be obtained from the CVM Home Page
to http://www.fda.gov/dockets/
is part of the evaluation process for a (http://www.fda.gov/cvm) and from the
ecomments. See the SUPPLEMENTARY
Type C medicated feed assay method Division of Dockets Management Web
INFORMATION section for electronic
and demonstrates the transferability of site (http://www.fda.gov/ohrms/dockets/
access to the draft guidance document.
the feed assay method among different default.htm).
FOR FURTHER INFORMATION CONTACT:
laboratories by comparing the results Dated: November 7, 2006.
Rebecca L. Owen, Center for Veterinary each laboratory obtains when using the
Medicine (HFV–141), Food and Drug Jeffrey Shuren,
method to analyze a specific set of feed Assistant Commissioner for Policy.
Administration, 7500 Standish Pl., samples. Sponsors may expand the
Rockville, MD 20855, 240–276–9842, e- [FR Doc. E6–19204 Filed 11–13–06; 8:45 am]
method transfer study to include other
mail: rebecca.owen@fda.hhs.gov. medicated feed products, such as Top
BILLING CODE 4160–01–S

SUPPLEMENTARY INFORMATION: Dress Type C, Free-Choice Type C, and


I. Background Type B medicated feeds. DEPARTMENT OF HEALTH AND
Section 512(b) of the Federal Food, II. Paperwork Reduction Act of 1995 HUMAN SERVICES
Drug, and Cosmetic Act (21 U.S.C. 360b) This draft guidance refers to Food and Drug Administration
establishes the requirements for a new previously approved collections of
animal drug approval. FDA regulations information found in FDA regulations. [Docket No. 2006D–0419]
specify the information you (the These collections of information are
sponsor) must submit as part of your Draft Voluntary National Retail Food
subject to review by the Office of
new animal drug application (NADA) Regulatory Program Standards;
Management and Budget (OMB) under
and the proper format for the NADA Availability
the Paperwork Reduction Act of 1995
submission (§ 514.1 (21 CFR 514.1)). As (44 U.S.C. 3501–3520). The collections AGENCY: Food and Drug Administration,
part of your NADA submission, you of information in § 514.1 have been HHS.
must describe analytical procedures
sroberts on PROD1PC70 with NOTICES

approved under OMB control nos. ACTION: Notice.


capable of determining the active 0910–0032 and 0910–0154.
component(s) of the new animal drug SUMMARY: The Food and Drug
within a reasonable degree of accuracy III. Significance of Guidance Administration (FDA) is announcing the
and of assuring the identity of such This draft level 1 guidance is being availability of a draft document entitled
components (21 CFR 514.1(b)(5)(vii)). issued consistent with FDA’s good ‘‘Voluntary National Retail Food

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