55108 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0240] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Finished Pharmaceuticals 

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 

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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