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

55054 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 

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 on 

Alcohol Abuse and Alcoholism; Special 

Emphasis Panel Review of AIDS Related 

Research Applications. 

Date: November 5, 2009. 

Time: 4 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane Bethesda, MD 20892. 

(Telephone Conference Call) 

Contact Person: Lorraine Gunzerath, PhD, 

MBA, Scientific Review Officer, National 

Institute on Alcohol Abuse and Alcoholism, 

Office Of Extramural Activities, Extramural 

Project Review Branch, 5635 Fishers Lane, 

Room 2121, Bethesda, MD 20892–9304, 301– 

443–2369, lgunzera@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the securing of 

meeting attendees. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards., National 

Institutes of Health, HHS) 

Dated: October 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25509 Filed 10–23–09; 8:45 am] 

BILLING CODE M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts. 

Date: October 26, 2009. 

Time: 3 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Ryan G. Morris, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4205, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1501, morrisr@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25508 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 

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 on 

Alcohol Abuse and Alcoholism; Special 

Emphasis Panel AA–3 Study Section 

Members Conflict. 

Date: November 19, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Lorraine Gunzerath, PhD, 

MBA, Scientific Review Officer, National 

Institute on Alcohol Abuse and Alcoholism 

Office of Extramural Activities, Extramural 

Project Review Branch, 5635 Fishers Lane, 

Room 2121, Bethesda, MD 20892–9304, 301– 

443–2369, lgunzera@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 

Dated: October 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25507 Filed 10–23–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; 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: Center for Inherited 

Disease Research Access Committee. 

Date: November 13, 2009. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Camilla E. Day, PhD, 

Scientific Review Officer, CIDR, National 

Human Genome Research Institute, National 

Institutes of Health, 5635 Fishers Lane, Suite 

mstockstill on DSKH9S0YB1PROD with NOTICES