Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 55051 

• Press release announcing the 

effective date of the cigarette flavor ban, 

• Flavored tobacco products fact 

sheet, and 

• Flavored tobacco products parental 

advisory. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

Activity and Form 

FDA 3734 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Minutes per 

Response Total Hours 

Reporting violations of section 907(a)(1)(A) of the 

FDCA 1,700 1 1,700 10 283 

Dated: October 15, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25604 Filed 10–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: Community Services Block 

Grant (CSBG) Program Model Plan 

Application. 

OMB No.: New collection. 

Description: Sections 676 and 677 of 

the Community Services Block Grant 

Act require States, including the District 

of Columbia and the Commonwealth of 

Puerto Rico, Tribes, Tribal organizations 

and U.S. territories applying for 

Community Services Block Grant 

(CSBG) funds to submit an application 

and plan (Model Application Plan). The 

application plan must meet statutory 

requirements prior to being funded with 

CSBG funds. Applicants have the option 

to submit a detailed application 

annually or biannually. Entities that 

submit a biannual application must 

provide an abbreviated application the 

following year if substantial changes to 

the initial application will occur. OMB 

approval is being sought. 

Respondents: State Governments, 

including the District of Columbia and 

the Commonwealth of Puerto Rico, 

Tribal Governments, Tribal 

Organizations, and U.S. territories. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Model State CSBG Application ....................................................................... 56 1 10 560 

Model Indian Tribes & Tribal Organizations CSBG Application ...................... 30 1 10 300 

Estimated Total Annual Burden 

Hours: 860 

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 21, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–25650 Filed 10–23–09; 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: Cross-Site Evaluation of the 

Children’s Bureau Grantee Cluster: 

Supporting Evidence-Based Home 

Visiting Programs to Prevent Child 

Maltreatment (EBHV). 

OMB No.: New collection. 

Description: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is proposing this crosssite evaluation data collection activity to 

identify successful strategies for 

adopting, implementing, and sustaining 

high-quality home visitation programs 

to prevent child maltreatment. An 

evaluation study will address four 

domains: (1) Systems change to develop 

infrastructure, (2) fidelity to evidencemstockstill on DSKH9S0YB1PROD with NOTICES

55052 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 

based models, (3) costs of home visiting 

programs, and (4) family and child 

outcomes (via a review of grantee 

analysis reports). A process study will 

focus on the broader grant initiative to 

understand how programs plan and 

develop the infrastructure needed to 

support home visitation services and 

how they ensure service quality. 

Information will be collected through 

biennial site visits, web-based data 

entry, a data quality progress table, a 

relationship questionnaire completed by 

participants and home visitors, and a 

grantee-partner network survey. In 

particular, site visits will include 

interviews with key grantee staff and 

stakeholders involved in the execution 

of the grant and in the efforts to make 

system changes. Grantees will complete 

systems web-based data entry on goals 

and operations every six months while 

agencies implementing home visiting 

programs associated with the grantee 

will utilize the fidelity/cost web-based 

data entry to provide EBHV program, 

provider, and participant characteristics 

along with yearly data on costs of home 

visiting programs. 

Respondents: EBHV grantee and key 

staff (evaluators, home visitors and 

supervisors), partners, implementing 

agencies, home visiting participants, 

and home visitors. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hour 

per response 

Estimated 

annual burden 

hours 

EBHV grantee and key staff-partner interview guide ...................................... 249 2 1.60 797 

EBHV grantee systems web-based data entry ............................................... 17 2 1.00 34 

EBHV agency fidelity/cost web-based data entry ........................................... 50 12 9.00 5,400 

EBHV grantee data quality progress table ...................................................... 17 4 4.25 289 

Participant-home visitor relationship questionnaire ......................................... 4,716 2 0.25 2,358 

Home visitor-participant relationship questionnaire ......................................... 4,716 2 0.25 2,358 

EBHV grantee-partner network survey ............................................................ 142 2 0.42 119 

Estimated Total Burden Hours ................................................................. ........................ ........................ ........................ 11,355 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. E-mail address: 

OPREinfocollection@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: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: October 14, 2009. 

Seth F. Chamberlain, 

OPRE Reports Clearance Officer. 

[FR Doc. E9–25259 Filed 10–23–09; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0307 (formerly 

Docket No. 2007–D–0173)] 

Guidance for Industry on Investigator 

Responsibilities—Protecting the 

Rights, Safety, and Welfare of Study 

Subjects; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Investigator Responsibilities— 

Protecting the Rights, Safety, and 

Welfare of Study Subjects.’’ This 

guidance is intended to assist 

investigators in meeting their 

responsibilities with respect to 

protecting human subjects and ensuring 

the integrity of data in the conduct of 

clinical investigations. The guidance 

also clarifies FDA’s expectations 

concerning the investigator’s 

responsibility for supervising a clinical 

study in which some study tasks are 

delegated to employees of the 

investigator or to outside parties. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Griffin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4204, 

Silver Spring, MD 20993, 301–796– 

2270, Joseph.Griffin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Investigator Responsibilities— 

Protecting the Rights, Safety, and 

Welfare of Study Subjects.’’ Under the 

regulations in part 312 (21 CFR part 

312) (Investigational New Drug 

Application) and part 812 (21 CFR part 

812) (Investigational Device 

Exemptions), an investigator is 

responsible for ensuring that a clinical 

investigation is conducted according to 

the signed investigator statement, the 

mstockstill on DSKH9S0YB1PROD with NOTICES