Center for Scientific Review; Notice of Closed Meeting, 34941 [E8-13509]
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34941
Federal Register / Vol. 73, No. 119 / Thursday, June 19, 2008 / Notices
ingredient will reasonably be expected
to be safe. Part 190 (21 CFR part 190)
implements these statutory provisions.
Section 190.6(a) requires each
manufacturer or distributor of a dietary
supplement containing a new dietary
ingredient, or of a new dietary
ingredient, to submit to the Office of
Nutrition, Labeling, and Dietary
Supplements notification of the basis for
their conclusion that said supplement or
ingredient will reasonably be expected
to be safe. Section 190.6(b) requires that
the notification include the following:
(1) The complete name and address of
the manufacturer or distributor, (2) the
name of the new dietary ingredient, (3)
a description of the dietary supplements
that contain the new dietary ingredient,
and (4) the history of use or other
evidence of safety establishing that the
dietary ingredient will reasonably be
expected to be safe.
The notification requirements
described previously are designed to
enable FDA to monitor the introduction
into the food supply of new dietary
ingredients and dietary supplements
that contain new dietary ingredients, in
order to protect consumers from unsafe
dietary supplements. FDA uses the
information collected under these
regulations to help ensure that a
manufacturer or distributor of a dietary
supplement containing a new dietary
ingredient is in full compliance with the
act.
In the Federal Register of March 26,
2008 (73 FR 16020), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
190.6
1There
71
Total Annual
Responses
1
Hours per
Response
71
Total Hours
20
1,420
are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be
minimal burden on the industry to
generate data to meet the requirements
of the premarket notification program
because the agency is requesting only
that information that the manufacturer
or distributor should already have
developed to satisfy itself that a dietary
supplement containing a new dietary
ingredient is in full compliance with the
act. However, the agency estimates that
extracting and summarizing the relevant
information from the company’s files
and presenting it in a format that will
meet the requirements of section 413 of
the act will require a burden of
approximately 20 hours of work per
submission.
The estimated number of premarket
notifications and hours per response is
an average based on the agency’s
experience with notifications received
during the last 3 years (i.e., 2005, 2006,
and 2007), and information from firms
that have submitted recent premarket
notifications.
Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–13818 Filed 6–18–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Annual Frequency
per Response
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
VerDate Aug<31>2005
19:00 Jun 18, 2008
Jkt 214001
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: June 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–13509 Filed 6–18–08; 8:45 am]
Name of Committee: Center for Scientific
Review Special Emphasis Panel, The
Biochemistry and Molecular Biology of
Pathogens.
Date: June 20, 2008.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Rolf Menzel, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3196,
MSC 7808, Bethesda, MD 20892, 301–435–
0952, menzelro@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, July 21,
2008, 12 p.m. to July 21, 2008, 1:30
p.m., National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD, 20892
which was published in the Federal
Register on June 9, 2008, 73 FR 32589–
32590.
The meeting will be held July 29,
2008, 2 p.m. to 3:30 p.m. The meeting
location remains the same. The meeting
is closed to the public.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Dated: June 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–13510 Filed 6–18–08; 8:45 am]
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[Federal Register Volume 73, Number 119 (Thursday, June 19, 2008)]
[Notices]
[Page 34941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13509]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, The Biochemistry and Molecular Biology of Pathogens.
Date: June 20, 2008.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892. (Telephone Conference Call)
Contact Person: Rolf Menzel, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3196, MSC 7808, Bethesda, MD 20892, 301-435-
0952, menzelro@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: June 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-13509 Filed 6-18-08; 8:45 am]
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