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

Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 55053 

investigational plan, and applicable 

regulations; for protecting the rights, 

safety, and welfare of subjects under the 

investigator’s care; and for the control of 

drugs, biological products, and devices 

under investigation (§§ 312.60 and 

812.100). This guidance clarifies the 

responsibilities of investigators in the 

conduct of clinical investigations 

conducted under parts 312 and 812, 

particularly the responsibilities to 

supervise the conduct of the clinical 

investigation, and to protect the rights, 

safety, and welfare of study participants 

in drug, biologic, and medical device 

clinical trials. The guidance also 

provides recommendations on how 

investigators should supervise the 

study-related actions of persons not in 

the direct employ of the investigator, 

including certain study staff and parties 

conducting associated testing and 

assessments. 

On May 10, 2007 (72 FR 26639), FDA 

issued a draft of this guidance with the 

goal of received input from the public. 

During the finalization of this guidance, 

FDA carefully considered all 

substantive comments concerning the 

content of the guidance. During 

finalization, FDA’s major emphasis was 

on clarifying issues that were identified 

as confusing and correcting apparent 

errors. These efforts resulted in 

relatively minor changes throughout the 

guidance. FDA also removed a 

significant amount of content from the 

background section because it was 

duplicative of content in the guidance 

appendices. FDA also reordered section 

III.A.3 of the guidance concerning 

adequate supervision of the conduct of 

a clinical trial to make the sequence 

more logical. We reversed the order of 

presentation so that the section begins 

with the factors that may predispose to 

inadequate supervision, and ends with 

the steps that could be taken to mitigate 

the potential for inadequate supervision. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on investigator 

responsibilities. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

part 312 have been approved under 

OMB control number 0910–0014; and 

the collections of information in part 

812 have been approved under OMB 

control number 0910–0078. The 

information requested for general 

investigator responsibilities is covered 

by the collection of information in 

FDA’s regulations for investigational 

new drug applications (part 312) and 

investigational device exemptions (part 

812) and FDA Form 1572. The guidance 

also refers to FDA’s requirements in 21 

CFR parts 11, 50, 54, and 56 for the 

conduct of clinical trials of drugs, 

biologics, and medical devices. The 

collections of information in 21 CFR 

part 11 have been approved under OMB 

control number 0910–0303; the 

collections of information in 21 CFR 

part 54 have been approved under OMB 

control number 0910–0396; and the 

collections of information in 21 CFR 

part 56 (including information required 

under 21 CFR part 50) have been 

approved under OMB control number 

0910–0130. The collection of 

information for form FDA 3674 has been 

approved under OMB control number 

0910–0616. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: October 20, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25629 Filed 10–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

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 meeting. 

The meeting 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 Trauma and Burn. 

Date: November 19, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN34, 45 Center 

Drive, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Brian R. Pike, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18, Bethesda, MD 

20892, 301–594–3907, 

pikbr@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, National 

Institutes of Health, HHS) 

Dated: October 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25513 Filed 10–23–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

mstockstill on DSKH9S0YB1PROD with NOTICES