Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 55516-55517 [E8-22636]
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Federal Register / Vol. 73, No. 187 / Thursday, September 25, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Respondents
No. of
respondents
No. of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
State Medicaid Programs ................................................................................
51
1
0.5
26
........................
........................
........................
26
Total ..........................................................................................................
Dated: September 16, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–22594 Filed 9–24–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Community Services
Office of Community Services,
ACF, DHHS.
ACTION: Notice To Award a Program
Expansion Supplement to the National
Association for State Community
Services Program (NASCSP) in
Washington, DC.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
CFDA#: 53.570.
Legislative Authority: Section
678A(a)(1)(A) of the Community
Services Block Grant (CSBG) Act of
1981, (Pub. L. 97–35) as amended by the
Community Opportunities,
Accountability, and Training and
Educational Services (COATES) Human
Services Reauthorization Act of 1998,
(Pub. L. 105–285) authorizes the
Secretary of Health and Human Services
(HHS) to use a percentage of
appropriated funds for training,
technical assistance, planning,
evaluation, performance measurement,
monitoring, assistance for States in
carrying out corrective actions and the
correction of programmatic deficiencies
of eligible entities under the CSBG Act.
Amount of Award: $125,000.
Project Period: 9/30/2007–9/29/2010.
Summary:
The purpose of this supplemental
request is for the NASCSP to further
improve the general capacity and
technical competency of states to
administer the Community Services
Block Grant (CSBG). Targeted assistance
will be provided to states for
improvement in the areas of state plan
development and Results Oriented
Management and Accountability
(ROMA) focused monitoring. Emerging
training and technical assistance needs
VerDate Aug<31>2005
17:50 Sep 24, 2008
Jkt 214001
for states and local agencies receiving
CSBG funds will also be assessed and a
plan will be developed for strategic
assistance in the areas identified.
Additionally, this supplemental aims to
enhance the capacity of the Office of
Community Services (OCS) to continue
to convene its Monitoring Task Force
(MTF) and provide updates on its
comprehensive response to the
Government Accountability Office’s
report on the CSBG program. Specific
emphasis will be placed on monitoring
states for compliance while encouraging
excellence
Contact for Further Information:
Josephine B. Robinson, Director, Office
of Community Services, 370 L’Enfant
Promenade, SW., Washington, DC
20047, Telephone: 202/401–9333.
Dated: September 16, 2008.
Josephine B. Robinson,
Director, OCS.
[FR Doc. E8–22476 Filed 9–24–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0272]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 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 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 October 27,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
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 0910–0374. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Notification of a Health Claim or
Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body—(OMB Control Number 0910–
0374—Extension)
Section 403(r)(2)(G) and (r)(3)(C) of
the Federal Food, Drug and Cosmetic
Act (the act) (21 U.S.C. 343(r)(2)(G) and
(r)(3)(C)), as amended by the FDA
Modernization Act of 1997, provides
that any person may market a food
product whose label bears a nutrient
content claim or a health claim that is
based on an authoritative statement of a
scientific body of the U.S. Government
or the National Academy of Sciences
(NAS). Under this section of the act, a
person that intends to use such a claim
must submit a notification of its
intention to use the claim 120 days
before it begins marketing the product
bearing the claim. In the Federal
Register of June 11, 1998 (63 FR 32102),
FDA announced the availability of a
guidance entitled ‘‘Guidance for
Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body.’’ The guidance provides the
agency’s interpretation of terms central
to the submission of a notification and
the agency’s views on the information
that should be included in the
notification. The agency believes that
the guidance will enable persons to
E:\FR\FM\25SEN1.SGM
25SEN1
55517
Federal Register / Vol. 73, No. 187 / Thursday, September 25, 2008 / Notices
meet the criteria for notifications that
are established in section 403(r)(2)(G)
and (r)(3)(C) of the act. In addition to the
information specifically required by the
act to be in such notifications, the
guidance states that the notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. FDA intends
to review the notifications the agency
receives to ensure that they comply with
the criteria established by the act.
In the Federal Register of May 7, 2008
(73 FR 25749), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
FDA received one letter of comment that
was not related to the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Act/Basis of
Burden
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
403(r)(2)(G) (nutrient content claims)
1
1
1
250
250
403(r)(2)(C) (health claims)
2
1
2
450
900
Guidance for notifications
3
1
3
1
3
Total
mstockstill on PROD1PC66 with NOTICES
1 There
1,153
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
the agency’s jurisdiction. FDA estimates
that it will receive one nutrient content
claim notification and two health claim
notifications per year.
Section 403(r)(2)(G) and 403(r)(3)(C)
of the act requires that the notification
include the exact words of the claim, a
copy of the authoritative statement, a
concise description of the basis upon
which such person relied for
determining that this is an authoritative
statement as outlined in the act, and a
balanced representation of the scientific
literature relating to the relationship
between a nutrient and a disease or
health-related condition to which a
health claim refers or to the nutrient
level to which the nutrient content
claim refers. This balanced
representation of the scientific literature
is expected to include a bibliography of
the scientific literature on the topic of
the claim and a brief, balanced account
or analysis of how this literature either
supports or fails to support the
authoritative statement.
Since the claims are based on
authoritative statements of a scientific
body of the Federal Government or
NAS, FDA believes that the information
that is required by the act to be
submitted with a notification will be
readily available to a respondent.
However, the respondent will have to
collect and assemble that information.
Based on communications with firms
that have submitted notifications, FDA
estimates that it will take a respondent
250 hours to collect and assemble the
information required by the statute for
nutrient content claim notifications and
450 hours to collect and assemble the
VerDate Aug<31>2005
17:50 Sep 24, 2008
Jkt 214001
information required by the statute for
health claim notifications.
Under the guidance, notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. The
guidance applies to both nutrient
content claim and health claim
notifications. FDA has determined that
this information should be readily
available to a respondent and, thus, the
agency estimates that it will take a
respondent 1 hour to incorporate the
information into the notification.
Dated: September 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22636 Filed 9–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(cX4) and 552b(cX6), 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 giant
PO 00000
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Fmt 4703
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applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Integrative
Signaling.
Date: October 9, 2008.
Time: 1:30 p.m. to 3:30 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: Russell T. Dowell, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4128,
MSC 7814, Bethesda, MD 20892, (301) 435–
1850, dowellr@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.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Musculoskeletal Tissue Engineering Study
Section.
Date: October 13–14, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Jean D. Sipe, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4106,
MSC 7814, Bethesda, MD 20892, 301/435–
1743, sipej@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.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Skeletal Biology Development and Disease
Study Section.
Date: October 13–14, 2008.
Time: 8 a.m. to 5 p.m.
E:\FR\FM\25SEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 187 (Thursday, September 25, 2008)]
[Notices]
[Pages 55516-55517]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22636]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0272]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 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
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 October
27, 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 0910-0374. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Notification of a Health Claim or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific Body--(OMB Control Number 0910-
0374--Extension)
Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and
Cosmetic Act (the act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as
amended by the FDA Modernization Act of 1997, provides that any person
may market a food product whose label bears a nutrient content claim or
a health claim that is based on an authoritative statement of a
scientific body of the U.S. Government or the National Academy of
Sciences (NAS). Under this section of the act, a person that intends to
use such a claim must submit a notification of its intention to use the
claim 120 days before it begins marketing the product bearing the
claim. In the Federal Register of June 11, 1998 (63 FR 32102), FDA
announced the availability of a guidance entitled ``Guidance for
Industry: Notification of a Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of a Scientific Body.'' The
guidance provides the agency's interpretation of terms central to the
submission of a notification and the agency's views on the information
that should be included in the notification. The agency believes that
the guidance will enable persons to
[[Page 55517]]
meet the criteria for notifications that are established in section
403(r)(2)(G) and (r)(3)(C) of the act. In addition to the information
specifically required by the act to be in such notifications, the
guidance states that the notifications should also contain information
on analytical methodology for the nutrient that is the subject of a
claim based on an authoritative statement. FDA intends to review the
notifications the agency receives to ensure that they comply with the
criteria established by the act.
In the Federal Register of May 7, 2008 (73 FR 25749), FDA published
a 60-day notice requesting public comment on the information collection
provisions. FDA received one letter of comment that was not related to
the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section of the Act/Basis of No. of Annual Frequency Total Annual Hours Per
Burden Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) (nutrient 1 1 1 250 250
content claims)
----------------------------------------------------------------------------------------------------------------
403(r)(2)(C) (health claims) 2 1 2 450 900
----------------------------------------------------------------------------------------------------------------
Guidance for notifications 3 1 3 1 3
----------------------------------------------------------------------------------------------------------------
Total 1,153
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on FDA's experience with health claims,
nutrient content claims, and other similar notification procedures that
fall under the agency's jurisdiction. FDA estimates that it will
receive one nutrient content claim notification and two health claim
notifications per year.
Section 403(r)(2)(G) and 403(r)(3)(C) of the act requires that the
notification include the exact words of the claim, a copy of the
authoritative statement, a concise description of the basis upon which
such person relied for determining that this is an authoritative
statement as outlined in the act, and a balanced representation of the
scientific literature relating to the relationship between a nutrient
and a disease or health-related condition to which a health claim
refers or to the nutrient level to which the nutrient content claim
refers. This balanced representation of the scientific literature is
expected to include a bibliography of the scientific literature on the
topic of the claim and a brief, balanced account or analysis of how
this literature either supports or fails to support the authoritative
statement.
Since the claims are based on authoritative statements of a
scientific body of the Federal Government or NAS, FDA believes that the
information that is required by the act to be submitted with a
notification will be readily available to a respondent. However, the
respondent will have to collect and assemble that information. Based on
communications with firms that have submitted notifications, FDA
estimates that it will take a respondent 250 hours to collect and
assemble the information required by the statute for nutrient content
claim notifications and 450 hours to collect and assemble the
information required by the statute for health claim notifications.
Under the guidance, notifications should also contain information
on analytical methodology for the nutrient that is the subject of a
claim based on an authoritative statement. The guidance applies to both
nutrient content claim and health claim notifications. FDA has
determined that this information should be readily available to a
respondent and, thus, the agency estimates that it will take a
respondent 1 hour to incorporate the information into the notification.
Dated: September 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22636 Filed 9-25-08; 8:45 am]
BILLING CODE 4160-01-S
