Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 59633 

Estimated Total Annual Burden 

Hours: 841.50. 

In compliance with the requirements 

of section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: October 3, 2008. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E8–23884 Filed 10–8–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1999–D–0128] (formerly 

Docket No. 1999D–2013) 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry: Cooperative 

Manufacturing Arrangements for 

Licensed Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry: Cooperative 

Manufacturing Arrangements for 

Licensed Biologics’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

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 the 

Federal Register of November 19, 2007 

(72 FR 65034), the agency announced 

that the proposed information collection 

had been submitted to OMB for review 

and clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0629. The 

approval expires on September 30, 

2011. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: September 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23907 Filed 10–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0314] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recall Regulations 

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 November 

10, 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 0910–0249. 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. 

FDA Recall Regulations—21 CFR Part 

7—(OMB Control Number 0910–0249— 

Extension) 

Section 701 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 371) and 

part 7, subpart C (21 CFR part 7, subpart 

C), set forth the recall regulations 

(guidelines) and provide guidance to 

manufacturers on recall responsibilities. 

The guidelines apply to all FDA 

regulated products (i.e., food, including 

animal feed; drugs, including animal 

drugs; medical devices, including in 

vitro diagnostic products; cosmetics; 

and biological products intended for 

human use). These responsibilities 

include: (1) developing a recall strategy 

that requires time by the firm to 

determine the actions or procedures 

required to manage the recall (§ 7.42); 

(2) providing FDA with complete details 

of the recall including reason(s) for the 

removal or correction, risk evaluation, 

quantity produced, distribution 

information, firm’s recall strategy, a 

copy of any recall communication(s), 

and a contact official (§ 7.46); (3) 

notifying direct accounts of the recall, 

providing guidance regarding further 

distribution, giving instructions as to 

what to do with the product, providing 

recipients with a ready means of 

reporting to the recalling firm (§ 7.49); 

(4) submitting periodic status reports so 

that FDA may assess the progress of the 

recall (status report information may be 

determined by, among other things, 

evaluation return reply cards, 

effectiveness checks, and product 

returns) (§ 7.53); and (5) providing the 

opportunity for a firm to request in 

writing that FDA terminate the recall 

(§ 7.55). 

A search of the FDA database was 

performed to determine the number of 

recalls that took place during fiscal year 

2007. The resulting number of recalls 

from this database search (2,166) is used 

in estimating the current annual 

reporting burden for this report. FDA 


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