Federal Register / Vol. 62, No. 75 / Friday, April 18, 1997 / Notices 19121

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before April 28, 1997,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time required to make their

comments.

Open committee discussion. The

committee will discuss and vote on a

premarket approval application for a

hyaluronic acid coating solution used to

reduce adhesions resulting from

incidental tissue damage during

abdominal and pelvic surgery.

Closed committee deliberations. FDA

staff will present to the committee trade

secret and/or confidential commercial

information regarding present and

future FDA issues. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

the meeting(s) shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.

Dated: April 15, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–10212 Filed 4–16–97; 12:52 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission of OMB Review; Comment

Request; Women’s Health Initiative

Observational Study

SUMMARY: Under the provisions of

Section 3506(c)(2)(A) of the Paperwork
19122 Federal Register / Vol. 62, No. 75 / Friday, April 18, 1997 / Notices

Reduction Act of 1995, the Office of the

Director (OD), National Institutes of

Health (NIH), has submitted to the

Office of Management and Budget

(OMB) a request for review and

approval of the information collection

listed below. This proposed information

collection was previously published in

the Federal Register on November 4,

1996 (Volume 61, Number 214, Page

56696) and allowed 60-days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30 days for public

comment. The National Institutes of

Health may not conduct or sponsor, and

the respondent is not required to

respond to, an information collection

that has been extended, revised or

implemented on or after October 1, 1995

unless it displays a currently valid OMB

control number.

PROPOSED COLLECTION: Title: Women’s

Health Initiative (WHI) Observational

Study. Type of Information Collection

Request: Revision of OMB #0925–0414.

Exp: 6/30/97. Need for Use of

Information Collection: This study will

be used by NIH to evaluate risk factors

for chronic disease among older women

by developing and following a large

cohort of postmenopausal women and

relating subsequent disease

development to baseline assessments of

historical, physical, psychosocial, and

physiologic characteristics. In addition,

the observational study will

complement the clinical trial (which has

received clinical exemption) and

provide additional information on the

common cause of frailty, disability and

health for postmenopausal women,

namely, coronary heart disease, breast

and colorectal cancer, and osteoporotic

fractures. Frequency of Response: On

occasion. Affected Public: Individuals

and physicians. Type of Respondents:

Women, next of kin, and physicians.

The annual reporting burden is as

follows:

Type of respondents

Estimated

number of

respondents

Estimated

number of responses per

respondent

Average burden hours

per response

Estimated

total annual

hours requested

OS Participants ............................................................................................................. 100,000 1.06667 .819 87,360

Next-of-Kin .................................................................................................................... 2,682 1 .0835 224

Physician ...................................................................................................................... 166 1 .0835 14

Total ................................................................................................................... .................... ...................... ...................... 87,598

The annualized cost to respondents

is: $876,525.

There are no annual Capital Costs,

Operating Costs, and/or Maintenance

Costs to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

should address one or more of the

following points: (1) Evaluate whether

the proposed collection is necessary for

the proper performance of the functions

of the agency, including whether the

information will have practical utility;

(2) Evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used; (3) Enhance the

quality, utility, and clarity of the

information to be collected; and (4)

Minimize the burden of the collection of

information on those who are to

respond, including through the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

Direct Comments to OMB

Written comments and/or suggestions

regarding item(s) contained in this

notice, especially regarding the

estimated public burden and associated

response time, should be directed to the:

Office of Management and Budget,

Office of Regulatory Affairs, New

Executive Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. to request more

information on the proposed project or

to obtain a copy of the data collection

plan and instruments, contact: Dr.

Loretta Finnegan, Women’s Health

Initiative Program Office, 7550

Rockville Pike, Room 6A09, Bethesda,

Maryland 20892–9110 or call non-tollfree number (301) 402–2900, or E-mail

your request, including your address to:

<FinnegaL@od31em1.od.nih.gov>.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before May 19, 1997.

Dated: March 11, 1997.

Stephen Benowitz,

Executive Officer, Office of the Director, NIH.

[FR Doc. 97–9993 Filed 4–17–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following meeting

of the National Cancer Institute

Frederick Cancer Research and

Development Center Advisory

Committee.

The open portion of the meeting will

be limited to space available.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

notify the contact person in advance of

the meeting.

Committee Name: Frederick Cancer

Research and Development Center

Advisory Committee.

Date: June 9–10, 1997.

Place: Frederick Cancer Research and

Development Center, Building 549,

Executive Board Room, Frederick,

Maryland.

Open: June 9—8:30 a.m.–10:00 a.m.

Agenda: Discussion of administrative

matters such as future meetings, budget,

and information items related to the

operation of the NCI Frederick Cancer

Research and Development Center.

Closed: June 9—10 a.m. to recess;

June 10–8:30 a.m. to adjournment.

Agenda/Purpose: Discussion of

previous site visit report and response

for the Molecular Virology and

Carcinogenesis Laboratory review held

December 17–18, 1996. The majority of

the closed session will be devoted to a

site review of the Gene Regulation and

Chromosome Biology Laboratory with

ABL-Basic Research Program Contract.

Also included is a re-review of the

Molecular Aspects of Drug Design

Section, Macromolecular Structure

Laboratory with ABL-Basic Research

Program Contract.

Contact Person: Cedric W. Long,

Ph.D., Frederick Cancer Research and

Development Center, P.O. Box B,