Office of Community Services, 55108 [E8-22319]
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55108
Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Food and Drug Administration
Office of Community Services
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals
[Docket No. FDA–2008–N–0240]
Office of Community Services,
ACF, DHHS.
ACTION: Notice to Award a Program
Expansion Supplement for the
Community Action Partnership (CAP) in
Washington, DC.
AGENCY:
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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: $40,000.
Project Period: 9/30/2006–9/29/2009.
SUMMARY: This supplement would
enhance the ability for the CAP to find
new ways to address training and
technical assistance needs. After
gathering information from the
Community Action Network, the
applicant will provide a report to the
Office of Community Services (OCS)
containing recommendations about
creative approaches and strategies for
providing technical assistance and
training to Community Action Agencies
(CAAs). The applicant will compile
information gathered thru:
Brainstorming sessions with members of
the Community Action Network and the
Virtual CAP. The report to OCS will
include sections on major
recommendations and a strategy for
implementation. These will be
supported by summaries of the ideas
presented at the sessions and input
compiled by Virtual CAP.
FOR FURTHER INFORMATION CONTACT:
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. E8–22319 Filed 9–23–08; 8:45 am]
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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 24,
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 0910–0139. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Current Good Manufacturing Practice
Regulations for Finished
Pharmaceuticals (OMB Control Number
0910–0139)—Extension
Under section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 351(a)(2)(B)), a drug
is adulterated if the methods used in, or
the facilities or controls used for, its
manufacture, processing, packing, or
holding do not conform to or are not
operated or administered in conformity
with current good manufacturing
practice (CGMPs) to ensure that such
drug meets the requirements of the act
as to safety, and has the identity and
PO 00000
Frm 00088
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strength, and meets the quality and
purity characteristics, which it purports
or is represented to possess.
FDA has the authority under section
701(a) of the act (21 U.S.C. 371(a)) to
issue regulations for the efficient
enforcement of the act regarding CGMP
procedures for manufacturing,
processing, and holding drugs and drug
products. The CGMP regulations help
ensure that drug products meet the
statutory requirements for safety and
have their purported or represented
identity, strength, quality, and purity
characteristics. The information
collection requirements in the CGMP
regulations provide FDA with the
necessary information to perform its
duty to protect public health and safety.
CGMP requirements establish
accountability in the manufacturing and
processing of drug products, provide for
meaningful FDA inspections, and
enable manufacturers to improve the
quality of drug products over time. The
CGMP recordkeeping requirements also
serve preventive and remedial purposes
and provide crucial information if it is
necessary to recall a drug product.
The general requirements for
recordkeeping under part 211 (21 CFR
part 211) are set forth in § 211.180. Any
production, control, or distribution
record associated with a batch and
required to be maintained in
compliance with part 211 must be
retained for at least 1 year after the
expiration date of the batch and, for
certain over-the-counter (OTC) drugs, 3
years after distribution of the batch
(§ 211.180(a)). Records for all
components, drug product containers,
closures, and labeling are required to be
maintained for at least 1 year after the
expiration date and 3 years for certain
OTC products (§ 211.180(b)).
All part 211 records must be readily
available for authorized inspections
during the retention period
(§ 211.180(c)), and such records may be
retained either as original records or as
true copies (§ 211.180(d)). In addition,
21 CFR 11.2(a) provides that ‘‘for
records required to be maintained but
not submitted to the agency, persons
may use electronic records in lieu of
paper records or electronic signatures in
lieu of traditional signatures, in whole
or in part, provided that the
requirements of this part are met.’’ To
the extent this electronic option is used,
the burden of maintaining paper records
should be substantially reduced, as
should any review of such records.
In order to facilitate improvements
and corrective actions, records must be
maintained so that data can be used for
evaluating, at least annually, the quality
standards of each drug product to
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]]>Agencies
[Federal Register Volume 73, Number 186 (Wednesday, September 24, 2008)]
[Notices]
[Page 55108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22319]
[[Page 55108]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Office of Community Services
AGENCY: Office of Community Services, ACF, DHHS.
ACTION: Notice to Award a Program Expansion Supplement for the
Community Action Partnership (CAP) in Washington, DC.
-----------------------------------------------------------------------
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: $40,000.
Project Period: 9/30/2006-9/29/2009.
SUMMARY: This supplement would enhance the ability for the CAP to find
new ways to address training and technical assistance needs. After
gathering information from the Community Action Network, the applicant
will provide a report to the Office of Community Services (OCS)
containing recommendations about creative approaches and strategies for
providing technical assistance and training to Community Action
Agencies (CAAs). The applicant will compile information gathered thru:
Brainstorming sessions with members of the Community Action Network and
the Virtual CAP. The report to OCS will include sections on major
recommendations and a strategy for implementation. These will be
supported by summaries of the ideas presented at the sessions and input
compiled by Virtual CAP.
FOR FURTHER INFORMATION CONTACT: 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. E8-22319 Filed 9-23-08; 8:45 am]
BILLING CODE 4184-01-P
