Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Notices 41053

organization indicating an interest in

participating in the selection process to

consult with the others in selecting a

single member representing industry

interests for the committee within 60

days after receipt of the letter. If no

individual is selected within 60 days,

the agency will select the nonvoting

member representing industry interests. This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2), relating to advisory

committees.

Dated: July 24, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–20080 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Members

on Public Advisory Committees;

Science Board to the Food and Drug

Administration

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for members to serve on

the Science Board to the Food and Drug

Administration (the board) administered

from FDA’s Office of Science.

Nominations will be accepted for

upcoming vacancies that may or will

occur on the board during the next 24

months.

FDA has a special interest in ensuring

that women, minority groups, and

individuals with disabilities are

adequately represented on advisory

committees, and therefore, extends

particular encouragement to

nominations for appropriately qualified

female, minority, or physically disabled

candidates. Final selections from among

qualified candidates for each vacancy

will be determined by the expertise

required to meet specific agency needs

and in a manner to ensure appropriate

balance of membership.

DATES: All nominations must be

received by September 2, 1997.

ADDRESSES: All nominations for

membership and curricula vitae from

academia, industry, and government,

except for general public representatives

(consumer-nominated members), should

be sent to Susan K. Meadows (address

below). All nominations for general

public representatives (consumernominated members) should be sent to

Annette J. Funn (address below).

FOR FURTHER INFORMATION CONTACT:

Regarding all nominations for

membership, except for general

public representatives: Susan K.

Meadows, Office of Science (HF–

32), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–4591.

Regarding all nominations for general

public representatives: Annette J.

Funn, Office of Consumer Affairs

(HFE–88), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

5006.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for members to

serve on the board for upcoming

vacancies that may or will occur on the

board during the next 24 months.

Function

The function of the board is to

provide advice primarily to the agency’s

Senior Science Advisor and, as needed,

to the Commissioner of Food and Drugs

and other appropriate officials on

specific complex and technical issues as

well as emerging issues within the

scientific community in academia and

industry. Additionally, the board

provides advice to the agency on

keeping pace with technical and

scientific evolutions in the field of

regulatory science, on formulating an

appropriate research agenda and on

upgrading its scientific and research

facilities to keep pace with these

changes. The board also provides the

means for critical review of agencysponsored intramural and extramural

scientific research programs.

Criteria for Members

Persons nominated for membership

shall have exceptional accomplishments

and expertise in science, or executive

level experience in scientific

programmatic or laboratory management

involving scientific endeavors

appropriate to the work of the board and

the interests of FDA. Disciplines or

expertise of particular interest include

biomedical technology with application

to medical devices, biologics and

vaccine development and research, and

genetics. The term of office is 4 years.

General Public Representatives

(Consumer-nominated Members)

FDA currently attempts to place

members on advisory committees who

are nominated by consumer

organizations. These members are

recommended by a consortium of 12

consumer organizations that has the

responsibility for screening,

interviewing, and recommending

consumer-nominated candidates with

appropriate scientific credentials.

Candidates are sought who are aware of

the consumer impact of committee

issues, but who also possess enough

technical background to understand and

contribute to the committee’s work. The

agency notes, however, that for some

advisory committees, it may require

such nominees to meet the same

technical qualifications and specialized

training required of other expert

members of the committee. The term of

office for these members is up to 4

years, depending on the appointment

date. Nominations are invited for

consideration for membership as

openings become available.

Nomination Procedures

Any interested person may nominate

one or more qualified persons for

membership on the board. Nominations

shall state that the nominee is aware of

the nomination, is willing to serve as a

member of the board, and appears to

have no conflict of interest that would

preclude board membership. Potential

candidates will be asked by FDA to

provide detailed information concerning

such matters as financial holdings,

consultancies, and research grants or

contracts in order to permit evaluation

of possible sources of conflict of

interest.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: July 24, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–20082 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F-0305]

Goldschmidt Chemical Corp.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Goldschmidt Chemical Corp. has

filed a petition proposing that the food

additive regulations be amended to

provide for the expanded safe use of

siloxanes and silicones; cetylmethyl,

dimethyl, methyl 11-methoxy-11-

oxoundecyl as a pigment dispersant in

all pigmented polymers intended for use

in contact with food.
41054 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Notices

DATES: Written comments on the

petitioner’s environmental assessment

by September 2, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA-305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS-216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4550) has been filed by

Goldschmidt Chemical Corp., c/o Keller

and Heckman, 1001 G St., NW., suite

500 West, Washington, DC 20001. The

petition proposes to amend the food

additive regulations in § 178.3725

Pigment dispersants (21 CFR 178.3725)

to provide for the expanded safe use of

siloxanes and silicones; cetylmethyl,

dimethyl, methyl 11-methoxy-11-

oxoundecyl as a pigment dispersant in

all pigmented polymers intended for use

in contact with food.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before September 2,

1997, submit to the Dockets

Management Branch (address above)

written comments. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: July 11, 1997.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 97–20079 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0299]

International Conference on

Harmonisation; Draft Guideline on

Ethnic Factors in the Acceptability of

Foreign Clinical Data; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

draft guideline entitled ‘‘Ethnic Factors

in the Acceptability of Foreign Clinical

Data.’’ The draft guideline was prepared

under the auspices of the International

Conference on Harmonisation of

Technical Requirements for Registration

of Pharmaceuticals for Human Use

(ICH). The draft guideline provides

guidance on regulatory and

development strategies to permit

clinical data collected in one region to

be used for the support of drug and

biologic registrations in another region

while allowing for the influence of

ethnic factors.

DATES: Written comments by October

29, 1997.

ADDRESSES: Submit written comments

on the draft guideline to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Copies of the draft guideline are

available from the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4573. Single copies of the guideline may

be obtained by mail from the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), 1401 Rockville Pike,

Rockville, MD 20852–1448, or by calling

the CBER Voice Information System at

1–800–835–4709 or 301–827–1800.

Copies may be obtained from CBER’s

FAX Information System at 1–888–

CBER–FAX or 301–827–3844.

FOR FURTHER INFORMATION CONTACT:

Regarding the guideline: Barbara G.

Matthews, Center for Biologics

Evaluation and Research (HFM–

570), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–

827–5094.

Regarding the ICH: Janet J. Showalter,

Office of Health Affairs (HFY–20),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–0864.

SUPPLEMENTARY INFORMATION: In recent

years, many important initiatives have

been undertaken by regulatory

authorities and industry associations to

promote international harmonization of

regulatory requirements. FDA has

participated in many meetings designed

to enhance harmonization and is

committed to seeking scientifically

based harmonized technical procedures

for pharmaceutical development. One of

the goals of harmonization is to identify

and then reduce differences in technical

requirements for drug development

among regulatory agencies.

ICH was organized to provide an

opportunity for tripartite harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. FDA also seeks input

from consumer representatives and

others. ICH is concerned with

harmonization of technical

requirements for the registration of

pharmaceutical products among three

regions: The European Union, Japan,

and the United States. The six ICH

sponsors are the European Commission,

the European Federation of

Pharmaceutical Industries Associations,

the Japanese Ministry of Health and

Welfare, the Japanese Pharmaceutical

Manufacturers Association, the Centers

for Drug Evaluation and Research and

Biologics Evaluation and Research,

FDA, and the Pharmaceutical Research

and Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian Health

Protection Branch, and the European

Free Trade Area.

In March 1997, the ICH Steering

Committee agreed that a draft guideline

entitled ‘‘Ethnic Factors in the

Acceptability of Foreign Clinical Data’’

should be made available for public

comment. The draft guideline is the

product of the Efficacy Expert Working

Group of the ICH. Comments about this