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59074 Federal Register / Vol. 70, No.

195 / Tuesday, October 11, 2005 / Notices

ways people can enter data into the FDA estimates the burden of the
electronic submission system to protect collection of information as follows:
the database from corruption.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section Form No. Total Hours
Respondents per Response Responses Response

720.1 through 720.4 (new FDA 2512 and 112 12.9 1,446 0.5 723
submissions) FDA 2512a

720.4 and 720.6 (amend- FDA 2512 and 112 0.5 52 0.33 17
ments) FDA 2512a

720.3 and 720.6 (notices FDA 2514 112 1 4 0.1 0.4


of discontinuance)

720.8 (requests for con- 1 1 1 1.5 1.5


fidentiality)

Total 742
1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on FDA’s Management and Budget (OMB) under DEPARTMENT OF HEALTH AND
experience with the Cosmetic Product the Paperwork Reduction Act of 1995. HUMAN SERVICES
Voluntary Reporting Program. The
FOR FURTHER INFORMATION CONTACT: Food and Drug Administration
estimated annual total hours burden is
75 percent of the burden reported in Peggy Robbins, Office of Management
2002 due to decreased submissions. Programs (HFA–250), Food and Drug [Docket No. 2005D–0401]
However, the number of respondents Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223. Draft Guidance for Industry and FDA
doubled, and FDA attributes this to
Staff: Compliance With the Medical
increased interest in the program. FDA SUPPLEMENTARY INFORMATION: In the Device User Fee and Modernization
expects the number of submissions to Federal Register of June 16, 2005 (70 FR Act of 2002, as amended—Prominent
increase accordingly in the next 3 years. 35097), the agency announced that the and Conspicuous Mark of
Dated: October 3, 2005. proposed information collection had Manufacturers on Single-Use Devices;
Jeffrey Shuren, been submitted to OMB for review and Availability
Assistant Commissioner for Policy. clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and AGENCY: Food and Drug Administration,
[FR Doc. 05–20307 Filed 10–7–05; 8:45 am]
HHS.
BILLING CODE 4160–01–S a person is not required to respond to,
a collection of information unless it ACTION: Notice.
displays a currently valid OMB control SUMMARY: The Food and Drug
DEPARTMENT OF HEALTH AND number. OMB has now approved the Administration (FDA) is announcing the
HUMAN SERVICES information collection and has assigned availability of the draft guidance
OMB control number 0910–0374. The entitled ‘‘Compliance With Section 301
Food and Drug Administration approval expires on September 30, of the Medical Device User Fee and
2008. A copy of the supporting Modernization Act of 2002, as
[Docket No. 2005N–0124] statement for this information collection amended—Prominent and Conspicuous
is available on the Internet at http:// Mark of Manufacturers on Single-Use
Agency Information Collection
Activities; Announcement of Office of www.fda.gov/ohrms/dockets. Devices.’’ The Medical Device User Fee
Management and Budget Approval; Dated: October 3, 2005. and Modernization Act of 2002
Guidance for Industry: Notification of a (MDUFMA), as amended by the Medical
Jeffrey Shuren,
Health Claim or Nutrient Content Claim Device User Fee Stabilization Act of
Assistant Commissioner for Policy. 2005 (MDUFSA), requires that FDA
Based on an Authoritative Statement [FR Doc. 05–20308 Filed 10–7–05; 8:45 am]
of a Scientific Body issue guidance within 180 days of
BILLING CODE 4160–01–S enactment (August 1, 2005) identifying
AGENCY: Food and Drug Administration, the circumstances in which the name,
HHS. abbreviation, or symbol identifying the
ACTION: Notice. manufacturer of an original device is not
‘‘prominent and conspicuous.’’
SUMMARY: The Food and Drug DATES: Submit written or electronic
Administration (FDA) is announcing comments on this draft guidance so that
that a collection of information entitled they are received by close of business on
‘‘Guidance for Industry: Notification of November 10, 2005. FDA will not be
a Health Claim or Nutrient Content able to consider comments received
Claim Based on an Authoritative after that date in developing the final
Statement of a Scientific Body’’ has guidance. FDA may consider late
been approved by the Office of comments at a future time if the

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