Federal Register / Vol. 66, No. 122 / Monday, June 25, 2001 / Notices 33711

Dated: June 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15780 Filed 6–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0132]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Institutional Review Boards

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by July 25,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

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.

Institutional Review Boards (OMB

Control Number 0910–0130)—Extension

When reviewing clinical research

studies regulated by FDA, IRBs are

required to create and maintain records

describing their operations, and make

the records available for FDA inspection

when requested. These records include:

Written procedures describing the

structure and membership of the IRB

and the methods which the IRB will use

in performing its functions; the research

protocols, informed consent documents,

progress reports, and reports of injuries

to subjects submitted by investigators to

the IRB; minutes of meetings showing

attendance, votes and decisions made

by the IRB, the number of votes on each

decision for, against, and abstaining, the

basis for requiring changes in or

disapproving research; records of

continuing review activities; copies of

all correspondence between

investigators and the IRB; statement of

significant new findings provided to

subjects of the research; and a list of IRB

members by name, showing each

member’s earned degrees, representative

capacity, and experience in sufficient

detail to describe each member’s

contributions to the IRBs deliberations,

and any employment relationship

between each member and the IRBs

institution. This information is used by

FDA in conducting audit inspections of

IRBs to determine whether IRBs and

clinical investigators are providing

adequate protections to human subjects

participating in clinical research.

In the Federal Register of March 30,

2001 (66 FR 17427), the agency

requested comments on the proposed

collection of information. There were no

comments received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

56.115 2,000 14.6 29,200 4.5 131,400

Total 131,400

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The recordkeeping requirement

burden is based on the following

formula: Approximately 2,000 IRBs

review FDA-regulated research

involving human subjects annually. The

burden for each of the paragraphs under

§ 56.115 has been considered as one for

the purpose of estimating the burden.

Each paragraph cannot reasonably be

segregated from one another because all

are interrelated. FDA has about 2,000

IRBs in its inventory. The 2,000 IRBs

meet on an average of 14.6 times

annually. The agency estimates that

approximately 4.5 hours of person time

per meeting are required to transcribe

and type the minutes of the meeting; to

maintain records of continuing review

activities; and to make copies of all

correspondence between the IRB and

investigator’s member records, and

written IRB procedures which are

approximately five pages per IRB.

In the Federal Register of June 9, 1998

(63 FR 31502), the agency requested

comments on the proposed collections

of information. No significant comments

were received.

Dated: June 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15781 Filed 6–22–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Substance Abuse and

Mental Health Services Administration

(SAMHSA) will publish a list of

information collection requests under

OMB review, in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

documents, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Participant Feedback on Training

Under the Cooperative Agreement for

Mental Health Care Provider Education

in HIV/AIDS Program II (OMB No.

0930–0195, Extension)—The Substance

Abuse and Mental Health Services

Administration’s (SAMHSA) Center for

Mental Health Services (CMHS) intends

to continue to conduct a multi-site

assessment of its Cooperative

Agreement for Mental Health Care

Provider Education in HIV/AIDS

Program II until the end of the sites’

expenditure of Program II funds

(anticipated end date of September

2002). The education programs funded

under this cooperative agreement are