33264 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Notices 

TABLE 5.—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS—Continued 

PHS Guideline Section Description of Collection of Information Activity 21 CFR Section (unless otherwise stated) 

4.2.3.1 Develop educational materials (sponsor provides investigators with information 

needed to conduct investigation properly) 

312.50 

4.3 Sponsor to keep records of receipt, shipment, and disposition of investigative 

drug; investigator to keep records of case histories 

312.57 and 312.62(b) 

1The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (http://www.grants.nih.gov/grants/olaw/references/ 

phspol.htm). (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site address after this document 

publishes in the Federal Register.) 2AAALAC International Rules of Accreditation (http://www.aaalac.org/accreditation/rules.cfm). (FDA has verified the Web site address, but is 

not responsible for subsequent changes to the Web site address after this document publishes in the Federal Register.) 3The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals’’ (1996). 

Dated: July 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16334 Filed 7–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Tribal TANF Data Report, TANF 

Annual Report, and Reasonable Cause/ 

Corrective Action Documentation 

Process—Final. 

OMB No.: 0970–0215. 

Description: 42 U.S.C. 612 (section 

412 of the Social Security Act as 

amended by Public Law 104–193, the 

Personal Responsibility and Work 

Opportunity Reconciliation Act of 1996 

(PRWORA), mandates that federally 

recognized Indian Tribes with an 

approved Tribal TANF program collect 

and submit to the Secretary of the 

Department of Health and Human 

Services data on the recipients served 

by the Tribes programs. This 

information includes both aggregated 

and disaggregated data on case 

characteristics and individual 

characteristics. In addition, Tribes that 

are subject to a penalty are allowed to 

provide reasonable cause justifications 

as to why a penalty should not be 

imposed or may develop and implement 

corrective compliance procedures to 

eliminate the source of the penalty. 

Finally, there is an annual report, which 

requires the Tribes to describe program 

characteristics. All of the above 

requirements are currently approved by 

OMB and the Administration for 

Children and Families is simply 

proposing to extend them without any 

changes. 

Respondents: Indian Tribes. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Final Tribal TANF Data Report ........................................................................ 62 4 451 111,848 

Tribal TANF Annual Report ............................................................................. 62 1 40 2,480 

Tribal TANF Reasonable Cause/Corrective .................................................... 62 1 60 3,720 

Estimated Total Annual Burden 

Hours: 118,048. 

Additional Information: Copies of the 

proposed collection may be obtained 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. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 

202–395–7245. Attn: Desk Officer for 

the Administration for Children and 

Families. 

Dated: July 7, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–16320 Filed 7–9–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Developmental Disabilities 

Protection & Advocacy Program 

Statement of Goals and Priorities. 

OMB No.: 0980–0270. 

Description: Federal statute and 

regulation require each State Protection 

and Advocacy (P&A) System to prepare 

and submit to public comment a 

Statement of Goals and Priorities (SGP) 

for the P&A for Developmental 

Disabilities (PADD) program for each 

coming fiscal year. While the P&A is 

mandated to protect and advocate under 

a range of different Federally authorized 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Notices 33265 

disabilities programs, only the PADD 

program requires an SGP. Following the 

required public input for the coming 

fiscal year, the P&As submit the final 

version of this SGP to the 

Administration on Developmental 

Disabilities (ADD). ADD will aggregate 

the information in the SGPs into a 

national profile of programmatic 

emphasis for P&A Systems in the 

coming year. This aggregation will 

provide ADD with a tool for monitoring 

of the public input requirement. 

Furthermore, it will provide an 

overview of program direction, and 

permit ADD to track accomplishments 

against goals/targets, permitting the 

formulation of technical assistance and 

compliance with the Government 

Performance and Results Act of 1993. 

Respondents: State and Tribal 

Governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

P&A SGP ................................................................................................. 57 1 44 2,508 

Estimated Total Annual Burden 

Hours: 2,508. 

Additional Information 

Copies of the proposed collection may 

be obtained 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. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project; Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: July 7, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–16317 Filed 7–9–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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(c)(4) and 552b(c)(6), 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 grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel, NIH Pathway to Independence 

Awards. 

Date: July 27–28, 2009. 

Time: 7 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Meredith D. TempleO’Connor, PhD, Scientific Review Officer, 

Office of Scientific Review, National Institute 

of General Medical Sciences, National 

Institutes of Health, 45 Center Drive, Room 

3AN12C, Bethesda, MD 20892, 301–594– 

2772, templeocm@mail.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel, Faculty Recruitment—ARRA Funds. 

Date: July 28–29, 2009. 

Time: 6 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Rebecca H. Johnson, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18, Bethesda, 

MD 20892, 301–594–2771, 

johnsonrh@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel, Faculty Recruitment— ARRA Funds. 

Date: July 28–29, 2009. 

Time: 6 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Meredith D. TempleO’Connor, PhD, Scientific Review Officer, 

Office of Scientific Review, National Institute 

of General Medical Sciences, National 

Institutes of Health, 45 Center Drive, Room 

3AN12C, Bethesda, MD 20892, 301–594– 

2772, templeocm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.701, ARRA 

Related Biomedical Research and Research 

Support Awards, National Institutes of 

Health, HHS) 

Dated: July 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–16068 Filed 7–9–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0295] 

Providing Effective Information to 

Consumers About Prescription Drug 

Risks and Benefits; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for Drug 

Evaluation and Research (CDER), in 

collaboration with FDA’s Office of the 

Commissioner (OC), is announcing a 

public workshop entitled ‘‘Providing 

Effective Information to Consumers 

About Prescription Drug Risks and 

Benefits.’’ This public workshop is 

intended to explore potential 

approaches that will result in written 


sroberts on DSKD5P82C1PROD with NOTICES