33710 Federal Register / Vol. 66, No. 122 / Monday, June 25, 2001 / Notices

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 Information Services,

370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Report Clearance Officer. 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 collection; and (3)

ways to minimize the burden of the

collection 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 within 60 days of this

publication.

Dated: June 19, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–15802 Filed 5–22–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0129]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Implementation of the Biomaterials

Access Assurance Act of 1998

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:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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.

Implementation of the Biomaterials

Access Assurance Act of 1998

The Biomaterials Access Assurance

Act of 1998 (BAA98) (21 U.S.C. 1601–

1606) establishes a mechanism to

protect biomaterial suppliers of

implanted medical devices from

liability in civil actions. BAA98

includes exceptions for when protection

from liability is not available to

suppliers. One of those exceptions is

when a supplier acts as a manufacturer

of the implanted device. BAA98 says

that a biomaterials supplier may be

considered a manufacturer of a medical

device if the supplier is the subject of

an FDA declaration that the supplier

was required to register under section

510 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360)

and failed to do so, or was required to

list its device under section 520(j) of the

act (21 U.S.C. 360(j)) and failed to do so.

BAA98 allows persons to petition

FDA for a declaration that a biomaterials

supplier should have registered its

establishment or listed its device with

FDA, and failed to do so. Petitioners are

requested to include information about

the prerequisites for filing a petition.

This information includes the following:

(1) A civil suit has been filed in State

or Federal court alleging that an implant

directly or indirectly caused harm; (2)

the suit was filed after August 13, 1998;

and (3) the manufacturer of the implant

was named as a party to the civil action.

Petitioners are also requested to include

information to identify the following: (1)

The final product and how it is

intended to be used, (2) the activities

the supplier performs on the device, and

(3) the name as well as type of entity or

person to which the supplier sends the

device. These draft reporting

requirements are intended to provide

FDA with sufficient information to

show that the prerequisites for filing the

petition are met and determine whether

a biomaterial supplier should have

registered its establishment or listed its

device with FDA, and failed to do so.

In the Federal Register of April 2,

2001 (66 FR 17562), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per

Response

Total Annual

Responses Hours per Response Total Hours

5 1 5 15

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

BAA98 became effective August 13,

1998. Up until the current date, no

petitions for declaration have been filed

with FDA. However, FDA believes that

in future years a handful (estimated at

5) of petitioners may file with the

agency. FDA estimates that respondents

would take approximately 1 hour to

gather the requisite information and

draft a petition. The likely respondents

to this collection of information are

persons involved in civil actions based

on harm arising from an implanted

medical device.

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