Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient, 34940-34941 [E8-13818]
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Federal Register / Vol. 73, No. 119 / Thursday, June 19, 2008 / Notices
(CHMI). Demonstration programs have
been funded through Child Support
Enforcement waivers authorized under
section 1115 of the Social Security Act
to support healthy marriage, improve
child well-being and increase the
financial security of children. The
objective of the evaluation is to: (1)
Assess the implementation of
community interventions designed to
provide marriage education by
examining the way the projects operate
and by examining child support
outcomes among low-income families in
the community; and (2) evaluate the
community impacts of these
interventions on marital stability and
satisfaction, child well-being and child
support outcomes among low-income
families.
The purpose of this information
collection is to continue to collect
implementation data under the
protocols previously approved by the
Office of Management and Budget
(OMB), OMB Approval No. 0970–0283.
Primary data for the implementation
evaluation will come from observations,
interviews, focus groups and records.
One-on-one and small group interviews
with project staff and marriage
education service providers in the
community will provide a detailed
understanding of the administration and
operation of the demonstrations. Focus
group discussions will provide insights
into participants’ perspectives on
marriage education and their
experiences with the CHMI
interventions.
In addition to the implementation
information collected under this
request, an impact evaluation will be
integrated with the implementation
study and will assess the effects of
healthy marriage initiatives by
comparing family and child well-being
outcomes in the CHMI communities
with similar outcomes in comparison
communities that are well matched to
the project sites. Data from the
implementation studies will provide the
basis for the instrumental variable
models of CHMI impacts to help
determine direct or indirect exposure to
marriage-related services. Baseline data
collected under the impact evaluation
has been approved by OMB (see OMB
Approval No. 0970–0322).
Respondents: Lead Project Staff,
Service Provider Organization Staff, Key
Community, Civic Stakeholders, and
Program Participants.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Administrative interviews ...............................................................................
Small group interviews ..................................................................................
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Estimated Total Annual Burden
Hours: 440.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
OPREInfoCollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for ACF.
Dated: June 9, 2008.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E8–13433 Filed 6–18–08; 8:45 am]
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Average
number of
responses per
respondent
Average burden
hours per
response
2
1
1
1.6
200
25
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0170]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 21,
2008.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
ADDRESSES:
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Total burden
hours
400
40
should be identified with the OMB
control number 0910–0330. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Premarket Notification for a New
Dietary Ingredient—(OMB Control
Number 0910–0330)—Extension
Section 413(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 350b(a)) provides that at least 75
days before the introduction or delivery
for introduction into interstate
commerce of a dietary supplement that
contains a new dietary ingredient, a
manufacturer or distributor of dietary
supplements or of a new dietary
ingredient is to submit to FDA (as
delegate for the Secretary of Health and
Human Services) information upon
which the manufacturer or distributor
has based its conclusion that a dietary
supplement containing a new dietary
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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
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19:00 Jun 18, 2008
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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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]]>Agencies
[Federal Register Volume 73, Number 119 (Thursday, June 19, 2008)]
[Notices]
[Pages 34940-34941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13818]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0170]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification for a New Dietary Ingredient
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
21, 2008.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0330. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Premarket Notification for a New Dietary Ingredient--(OMB Control
Number 0910-0330)--Extension
Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 350b(a)) provides that at least 75 days before the
introduction or delivery for introduction into interstate commerce of a
dietary supplement that contains a new dietary ingredient, a
manufacturer or distributor of dietary supplements or of a new dietary
ingredient is to submit to FDA (as delegate for the Secretary of Health
and Human Services) information upon which the manufacturer or
distributor has based its conclusion that a dietary supplement
containing a new dietary
[[Page 34941]]
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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6 71 1 71 20 1,420
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There 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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