Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Notices 14683

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Current Good Manufacturing Practices

for Blood and Blood Components:

Notification of Consignees Receiving

Blood and Blood Components at

Increased Risk for Transmitting HIV’’

has been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 27, 1996

(61 FR 68268), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507). OMB has now approved

the information collection and has

assigned OMB control number 0910–

0336. The approval expires on February

28, 2000. An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number.

Dated: March 19, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7726 Filed 3–26–97; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Nonprescription Drugs Advisory

Committee

Date, time, and place. April 15, 1997,

8 a.m.; Holiday Inn—Gaithersburg,

Goshen Room, Two Montgomery Village

Ave., Gaithersburg, MD.

Type of meeting and contact person.

Open committee discussion, 8 a.m. to

1:30 p.m.; open public hearing 1:30 p.m.

to 2:30 p.m., unless public participation

does not last that long; open committee

discussion, 2:30 p.m. to 5 p.m.; closed

committee deliberations, 5 p.m. to 6

p.m.; Andrea G. Neal, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Nonprescription

Drugs Advisory Committee, code 12541.

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee reviews and evaluates

available data concerning the safety and

effectiveness of over-the-counter

(nonprescription) human drug products

for use in the treatment of a broad

spectrum of human symptoms and

diseases.

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 1, 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 a possible

association between vaginal douching

and adverse consequences. FDA is

aware of a number of case-control

epidemiologic studies in the literature

that suggest a possible association

between vaginal douching and several

conditions, such as pelvic inflammatory

disease, ectopic pregnancy, and cervical

cancer (letter from D. Bowen, FDA, to R.

W. Soller, Nonprescription Drug

Manufacturers Association, LET 105,

Docket No. 75N–0183, Dockets

Management Branch). The committee’s

discussion will include issues relating

to behavioral, epidemiological, and

microbiological aspects of vaginal

douching. Regulatory issues related to

over-the-counter vaginal-douche drugs,

cosmetics, and devices (douching

equipment) will also be addressed.

Closed committee deliberations. The

committee will review trade secret and/

or confidential commercial information

relevant to pending investigational new

drugs applications (IND’s) or new drug

applications (NDA’s). This portion of

the meeting will be closed to permit

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

552b (c)(4)).

Dermatologic and Ophthalmic Drugs

Advisory Committee

Date, time, and place. April 17 and

18, 1997, 8:30 a.m., Holiday Inn—

Gaithersburg, Grand Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Type of meeting and contact person.

Open public hearing, April 17, 1997,

8:30 a.m. to 9:30 a.m., unless public

participation does not last that long;

open committee discussion, 9:30 a.m. to

5:30 p.m.; closed presentation of data,

April 18, 1997, 8:30 a.m. to 11 a.m.;

closed committee deliberations, 11 a.m.

to 1 p.m.; Tracy Riley or Angie

Whitacre, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Dermatologic and Ophthalmic Drugs

Advisory Committee, code 12534.

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee reviews and evaluates

available data concerning the safety and

effectiveness of marketed and

investigational human drug products for

use in the treatment of dermatologic and

ophthalmic disorders.

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 11, 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
14684 Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Notices

approximate time required to make their

comments.

Open committee discussion. On April

17, 1997, the committee will hear

presentations and discuss the

teratogenicity and labeling issues

regarding approved NDA 19–821 for

Soriatane (acitretin capsules, HoffmanLaRoche, Inc.) for use in treating severe

psoriasis.

Closed presentation of data. On April

18, 1997, the committee will hear trade

secret and/or confidential commercial

information relevant to pending IND’s

or NDA’s. This portion of the meeting

will be closed to permit discussion of

this information (5 U.S.C. 552b(c)(4)).

Closed committee deliberations. On

April 18, 1997, the committee will

review trade secret and/or confidential

commercial information relevant to

pending IND’s and/or NDA’s. 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: March 21, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–7790 Filed 3–26–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Special Project Grants; Traumatic

Brain Injury Demonstration Grants

AGENCY: Health Resources and Services

Administration (HRSA).

ACTION: Notice of availability of funds.

SUMMARY: The HRSA announces that

approximately $2.8 million in fiscal

year (FY) 1997 funds will be available

for demonstration projects to improve

access to health and other services for

people who have sustained a traumatic

brain injury (TBI). Discretionary grants