59632 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 

call to order by the Council Chair and 

approval of previous Council minutes. 

The AHRQ director will present her 

update on current research, programs, 

and initiatives. The agenda will include 

a discussion on Patient-centered Health 

Care and Cost Effective Health Care by 

the Council. 

The final agenda will be available on 

the AHRQ Web site at http:// 

www.ahrq.gov no later than November 

3, 2008. 

Dated: October 1, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E8–23732 Filed 10–8–08; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: State Developmental Disabilities 

Council 5-Year State Plan. 

OMB No.: 0980–0162. 

Description: A Plan developed by the 

State Council on Developmental 

Disabilities is required by federal 

statute. Each State Council on 

Developmental Disabilities must 

develop the plan, provide for public 

comments in the State, provide for 

approval by the State’s Governor, and 

finally submit the plan on a five-year 

basis. On an annual basis, the Council 

must review the plan and make any 

amendments. The State Plan will be 

used (1) By the Council as a planning 

document; (2) by the citizenry of the 

State as a mechanism for commenting 

on the plans of the Council; and (3) by 

the Department as a stewardship tool, 

for ensuring compliance with the 

Developmental Disabilities Assistance 

and Bill of Rights Act, as one basis for 

providing technical assistance (e.g., 

during site visits), and as a support for 

management decision making. 

Respondents: State Governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

State Developmental Disabilities Council 5–Year State Plan ......................... 55 1 367 20,185 

Estimated Total Annual Burden 

Hours: 20,185. 

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. E8–23881 Filed 10–8–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Financial Status Reporting Form 

for State Councils on Developmental 

Disabilities Program. 

OMB No.: 0980–0212. 

Description: For the program of the 

State Councils on Developmental 

Disabilities, funds are awarded to State 

agencies contingent on fiscal 

requirements in subtitle B of the 

Developmental Disabilities Assistance 

and Bill of Rights Act. The SF–269, 

ordinarily mandated in the revised OMB 

Circular A–102, provides no accounting 

breakouts necessary for proper 

stewardship. Consequently, the 

proposed streamlined form will 

substitute for the SF–269 and will allow 

compliance monitoring and proactive 

compliance maintenance and technical 

assistance. 

Respondents: State Councils and 

Designated State Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

esponses 

per 

espondent 

Average 

burden hours 

per response 

Total burden 

hours 

Financial Status Reporting Form for State Councils on Developmental Disabilities Program .......................................................................................... 55 3 5.10 841.50 


sroberts on PROD1PC70 with NOTICES
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 


sroberts on PROD1PC70 with NOTICES