Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 59074 [05-20308]
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59074
Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices
ways people can enter data into the
electronic submission system to protect
the database from corruption.
FDA estimates the burden of the
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Form No.
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
720.1 through 720.4 (new
submissions)
FDA 2512 and
FDA 2512a
112
12.9
1,446
720.4 and 720.6 (amendments)
FDA 2512 and
FDA 2512a
112
0.5
720.3 and 720.6 (notices
of discontinuance)
FDA 2514
112
1
720.8 (requests for confidentiality)
Total Hours
0.5
723
52
0.33
17
1
4
0.1
0.4
1
1
1.5
1.5
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
experience with the Cosmetic Product
Voluntary Reporting Program. The
estimated annual total hours burden is
75 percent of the burden reported in
2002 due to decreased submissions.
However, the number of respondents
doubled, and FDA attributes this to
increased interest in the program. FDA
expects the number of submissions to
increase accordingly in the next 3 years.
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20307 Filed 10–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0124]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement
of a Scientific Body
AGENCY:
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of June 16, 2005 (70 FR
35097), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0374. The
approval expires on September 30,
2008. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20308 Filed 10–7–05; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body’’ has
been approved by the Office of
VerDate Aug<31>2005
16:40 Oct 07, 2005
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[Docket No. 2005D–0401]
Draft Guidance for Industry and FDA
Staff: Compliance With the Medical
Device User Fee and Modernization
Act of 2002, as amended—Prominent
and Conspicuous Mark of
Manufacturers on Single-Use Devices;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Compliance With Section 301
of the Medical Device User Fee and
Modernization Act of 2002, as
amended—Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices.’’ The Medical Device User Fee
and Modernization Act of 2002
(MDUFMA), as amended by the Medical
Device User Fee Stabilization Act of
2005 (MDUFSA), requires that FDA
issue guidance within 180 days of
enactment (August 1, 2005) identifying
the circumstances in which the name,
abbreviation, or symbol identifying the
manufacturer of an original device is not
‘‘prominent and conspicuous.’’
DATES: Submit written or electronic
comments on this draft guidance so that
they are received by close of business on
November 10, 2005. FDA will not be
able to consider comments received
after that date in developing the final
guidance. FDA may consider late
comments at a future time if the
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Page 59074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20308]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0124]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry: Notification
of a Health Claim or Nutrient Content Claim Based on an Authoritative
Statement of a Scientific Body
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry:
Notification of a Health Claim or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific Body'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 16, 2005 (70
FR 35097), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0374.
The approval expires on September 30, 2008. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20308 Filed 10-7-05; 8:45 am]
BILLING CODE 4160-01-S
