Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13655

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 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–7188 Filed 3–20–97; 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:

Technical Electronic Product

Radiation Safety Standards Committee

Date, time, and place. April 8 and 9,

1997, 8:30 a.m., Corporate Bldg.,

conference rm. 020B, 9200 Corporate

Blvd., Rockville, MD. A limited number

of overnight accommodations have been

reserved at the Gaithersburg Marriott

Washingtonian Center, 9751

Washingtonian Blvd., Gaithersburg, MD.

Attendees requiring overnight

accommodations may contact the hotel

at 800–228–9290 or 301–590–0044 and

reference the FDA Advisory Committee

meeting block. Reservations will be

confirmed at the group rate based on

availability. Attendees with a disability

requiring special accommodations

should contact Christie Wyatt, KRA

Corp., 301–495–1591, ext. 267.

Type of meeting and contact person.

Open committee discussion, April 8,

1997, 8:30 a.m. to 10:15 a.m.; open

public hearing, 10:15 a.m. to 11 a.m.,

unless public participation does not last

that long; open committee discussion,

11 a.m. to 3 p.m.; open public hearing,

3 p.m. to 4 p.m., unless public

participation does not last that long;

open committee discussion, 4 p.m. to 5

p.m.; open committee discussion, April

9, 1997, 8:30 a.m. to 11 a.m.; open

public hearing, 11 a.m. to 12 m., unless

public participation does not last that

long; open committee discussion, 12 m.

to 2:15 p.m.; Orhan H. Suleiman, Center

for Devices and Radiological Health

(HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–594–3332, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Technical Electronic Product Radiation

Safety Standards Committee, code

12399. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee advises on technical

feasibility, reasonableness, and

practicability of performance standards

for electronic products to control the

emission of radiation under 42 U.S.C.

263f(f)(1)(A).

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
13656 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

contact person before March 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 specifically discuss draft

amendments to performance standards

for ionizing radiation-emitting products

(i.e., mammography equipment (21 CFR

1020.31), and laser products (21 CFR

1040.10). There will be updates to the

committee on cellular telephone

research, environmental electromagnetic

radiation, diagnostic ultrasound,

microwave clothes dryers, and

commercially used mercury lamps. In

addition, a notice of intent to propose

amendments to fluoroscopic equipment

will be discussed (21 CFR 1020.32).

Pulmonary Allergy Drugs Advisory

Committee

Date, time, and place. April 11, 1997,

8 a.m., Quality Hotel, Maryland

Ballroom, 8727 Colesville Rd., Silver

Spring, MD.

Type of meeting and contact person.

Open committee discussion, 8 a.m. to

9:30 a.m.; open public hearing, 9:30 a.m.

to 12:30 p.m., unless public

participation does not last that long;

open committee discussion, 12:30 p.m.

to 4:30 p.m.; Leander B. Madoo, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–4695, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), PulmonaryAllergy Drugs Advisory Committee,

code 12545. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in the treatment of

pulmonary disease and diseases with

allergic and/or immunologic

mechanisms.

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 4, 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. FDA staff

will present to the committee the

agency’s advance notice of proposed

rulemaking, which proposes a strategy

for the withdrawal of the essential use

status of marketed chlorofluorocarbon

(CFC) products as proven alternatives

become available. A representative from

the U.S. Environmental Protection

Agency will present an overview of the

environmental impact of CFC’s and a

review of the Montreal Protocol on

ozone-depleting substances. The

committee will discuss and comment

upon the agency’s proposed strategy for

the CFC-transition process and on

presentations made during the open

public hearing. Advisory committee

input, in addition to open public

hearing comments, will be considered

by the agency as it formulates

subsequent rulemaking related to the

CFC-transition process.

Advisory Committee for

Pharmaceutical Science

Date, time, and place. May 7, 1997,

8:30 a.m., and May 8, 1997, 8 a.m.,

Holiday Inn—Gaithersburg, Goshen

Ballroom, Two Montgomery Village

Ave., Gaithersburg, MD.

Type of meeting and contact person.

Open committee discussion, May 7,

1997, 8:30 a.m. to 1 p.m.; open public

hearing, 1 p.m. to 2 p.m., unless public

participation does not last that long;

open committee discussion, 2 p.m. to

5:30 p.m.; open committee discussion,

May 8, 1997, 8 a.m. to 1 p.m.; open

public hearing, 1 p.m. to 2 p.m., unless

public participation does not last that

long; open committee discussion, 2 p.m.

to 5:30 p.m.; Kimberly L. Topper, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–5455, e-mail:

TOPPERK@CDER.FDA.GOV, or FDA

Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Advisory Committee for Pharmaceutical

Science, code 12539. Please call the

hotline for information concerning any

possible changes.

General function of the committee.

The committee gives advice on

scientific and technical issues

concerning the safety and effectiveness

of human generic drug products for use

in the treatment of a broad spectrum of

human 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. On May

7, 1997, the committee will discuss the

Biopharmaceutics Research and Policy

Issues and Chemistry Research and

Policy Issues. On May 8, 1997, the

committee will discuss Pharmacology/

Toxicology Research Programs:

Objectives and Status.

FDA public advisory committee

meetings 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. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open 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
Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13657

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, rm. 12A–16, 5600

Fishers Lane, 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,

rm. 1–23, 12420 Parklawn Dr.,

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.

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 13, 1997.

Michael A. Friedman, M.D.,

Deputy Commissioner for Operations.

[FR Doc. 97–7136 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Program Announcement for

Scholarships for Health Professions

Students From Disadvantaged

Backgrounds

The Health Resources and Services

Administration (HRSA) announces that

applications for fiscal year (FY) 1997

Scholarships for Disadvantaged

Students (SDS) program are being

accepted under the authority of section

737 of the Public Health Service Act

(the Act), Title VII, Part B, as amended

by the Health Professions Education

Extension Amendments of 1992, Pub. L.

102–408, dated October 13, 1992.

Schools that received funds for

academic year 1996–97 will be funded

based on the information provided in

last year’s Financial Status Report

(FSR), and do not need to reapply.

Purpose

The SDS program provides funds to

health professions and nursing schools

for the purpose of assisting such schools

in providing scholarships to individuals

from disadvantaged backgrounds who

are enrolled (or accepted for enrollment)

as full-time students in the schools, as

well as to undergraduate students who

have demonstrated a commitment to

pursuing a career in health professions.

For purposes of the SDS program in

FY 1997, an ‘‘individual from

disadvantaged background’’ is defined

in 42 CFR part 57.1804, subpart S, as

one who:

(1) Comes from an environment that

has inhibited the individual from

obtaining the knowledge, skill, and

abilities required to enroll in and

graduate from a health professions

school, or from a program providing

education or training in allied health

professions; or

(2) Comes from a family with an

annual income below a level based on

low-income thresholds according to

family size published by the U.S.

Bureau of the Census, adjusted annually

for changes in the Consumer Price

Index, and adjusted by the Secretary for

use in all health professions and nursing

programs. The Secretary will

periodically publish these low income

levels in the Federal Register.

The following income figures

determine what constitutes a lowincome family for purposes of the SDS

program for FY 1997.

Size of parents’ family 1 Income

level 2

1 .................................................... $10,500

2 .................................................... 13,700

3 .................................................... 16,300

4 .................................................... 20,800

5 .................................................... 24,600

6 or more ...................................... 27,600

1 Includes only dependents listed on Federal

income tax forms. 2Adjusted gross income for calendar year

1996, rounded to nearest $100. These low income figures are published in this issue of the

FEDERAL REGISTER.

Under the Omnibus Consolidated

Appropriations Act, for FY 1997,

approximately $18.6 million has been

appropriated for this program. Of the

funds available for FY 1997, 30 percent

shall be made available to schools

agreeing to expend the funds only for

nursing scholarships. An estimated $5.6

million will support approximately

4,300 scholarships averaging $1,300 for

students at schools of nursing. The

balance of $13 million will support

approximately 4,225 scholarships

averaging $3,100 for eligible health

professions students. The period of fund

availability will be for one academic

year.

Use of Funds

Funds awarded to a school under this

program may be used as follows:

(1) To award scholarships to eligible

students enrolled in the school, to be

expended only for tuition expenses,

other reasonable educational expenses,

and reasonable living expenses (as

defined by the school for all students

attending the school) incurred while

enrolled in a school as a full-time

student. The amount of the scholarship

may not, for any year of attendance,

exceed the total amount required for the

year for the expenses specified above.

(2) To provide financial assistance to

undergraduate students who have

demonstrated a commitment to

pursuing a career in the health

professions, in order to facilitate the

completion of the educational

requirements for such careers, provided

that the total amount used for this

purpose may not exceed 25 percent of

the funds awarded to the school under

this program.

Any school receiving SDS funds will

be required to maintain separate

accountability for these funds.

School Eligibility

Funds under this program will be

made available to accredited public or

nonprofit private health professions

schools. For purposes of the SDS

program, as defined in section 737(a)(3)

of the Act, the term ‘‘health professions

schools’’ means schools of medicine,

nursing, osteopathic medicine,

dentistry, pharmacy, podiatric

medicine, optometry, veterinary

medicine, public health, or allied health

or schools offering graduate programs in

clinical psychology and which are

accredited as provided in section

799(l)(E) of the Act, schools of allied

health as defined in section 799(4) of

the Act, and which are located in States

as defined in section 799(9) of the Act,

and schools of nursing as defined in

section 853 of the Act.

As required by statute, to qualify for

participation in the SDS program, a

school must be:

(1) carrying out a program for

recruiting and retaining students from

disadvantaged backgrounds, including

racial and ethnic minorities; and

(2) carrying out a program for

recruiting and retaining minority

faculty.

In addition, each school that received

funds in FY 1996 must be carrying out