Federal Register / Vol. 62, No. 179 / Tuesday, September 16, 1997 / Notices 48665

Respondents Number of

respondents

Number of

responses/respondent

Average

burden/

response

(in hrs.)

Training Grant Application

ERC .............................................................................................................................................. 3 1 348

Training Grant .............................................................................................................................. 12 1 63

Continuation Grant Application

ERC .............................................................................................................................................. 11 1 189

Training Grant .............................................................................................................................. 28 1 27

Dated: September 10, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–24482 Filed 9–15–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0375]

General Electric Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that General Electric Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the expanded safe use of phosphorous

acid, cyclic butylethyl propanediol,

2,4,6-tri-tert-butylphenyl ester, which

may contain up to 1 percent by weight

of triisopropanolamine, as an

antioxidant and/or stabilizer in olefin

copolymers intended for use in contact

with food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), 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 7B4553) has been filed by

General Electric Co., One Lexan Lane,

Mt. Vernon, IN 47620–9364. The

petition proposes to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the expanded safe use of

phosphorous acid, cyclic butylethyl

propanediol, 2,4,6-tri-tert-butylphenyl

ester, which may contain up to 1

percent by weight of

triisopropanolamine, as an antioxidant

and/or stabilizer for olefin copolymers

complying with 21 CFR 177.1520(c),

items 3.1 and 3.2, intended for use in

contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: August 29, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–24424 Filed 9–15–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Obstetrics and

Gynecology Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on October 6, 1997, 8:30 a.m. to 5

p.m., and October 7, 1997, 8:30 a.m. to

2 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Elisa D. Harvey,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1180, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), Obstetrics

and Gynecology Devices Panel, code

12524. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On October 6, 1997, the

committee will discuss and make

recommendations on a premarket

approval application for a thermal

endometrial ablation device. On October

7, 1997, the committee will discuss and

advise FDA on a petition for

reclassification of home uterine activity

monitors from class III (premarket

approval) to class II (special controls).

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by September 29, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. on October 6 and 7,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 29, 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 presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: September 8, 1997

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–24509 Filed 9–15–97; 8:45 am]

BILLING CODE 4160–01–F