Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices 41855

Time and date: 10 a.m.–3 p.m.,

September 16, 1998.

Location: NIOSH, CDC, Room 1046,

1095 Willowdale Road, Morgantown,

West Virginia 26505.

Status: Open to the public, limited

only by the space available. The meeting

room accommodates approximately 50

people.

Purpose: Participants will provide

NIOSH with their individual advice and

comments regarding the technical and

scientific aspects of the study protocol,

Assessment of Workers’ Postural

Stability and Cardiovascular Reactivity

While Working in a Restricted and

Elevated Space, being conducted at

NIOSH. Participants on the peer review

panel will review the study protocol

and provide individual advice on the

conduct of the study. Viewpoints and

suggestions from industry, labor,

academia, other governmental agencies,

and the public are invited.

CONTACT PERSON FOR ADDITIONAL

INFORMATION: Brian Dotson, M.S.,

NIOSH, CDC, M/S P119, 1095

Willowdale Road, Morgantown, West

Virginia 26505, telephone 304/285–

6142.

Dated: July 28, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–20857 Filed 8–4–98; 8:45 am]

BILLING CODE 4160–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0635]

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 for

polypropylene intended for use in

contact with food.

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 8B4615) 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 polypropylene

complying with § 177.1520(c), items 1.1,

1.2, or 1.3, 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: July 24, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–20824 Filed 8–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Clinical Studies of Safety and

Effectiveness of Orphan Products;

Availability of Grants; Request for

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

changes to its Orphan Products

Development (OPD) grant program for

fiscal year (FY) 1999. The previous

announcement of this program, which

was published in the Federal Register of

July 9, 1997, is superseded by this

announcement. In the future, a new

announcement will be published

annually.

DATES: The application receipt date is

November 2, 1998.

ADDRESSES: Application forms are

available from, and completed

applications should be submitted to:

Robert L. Robins, Grants Management

Officer, Division of Contracts and

Procurement Management (HFA–522),

Food and Drug Administration, 5600

Fishers Lane, rm. 2129, Rockville, MD

20857, 301–827–7185. (Applications

hand-carried or commercially delivered

should be addressed to 5630 Fishers

Lane, rm. 2129, Rockville, MD 20852.)

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Robert L. Robins

(address above).

Regarding the programmatic aspects

of this notice: Ronda A. Balham,

Office of Orphan Products

Development (HF–35), Food and

Drug Administration, 5600 Fishers

Lane, rm. 8–73, Rockville, MD

20857, 301–827–3668.

SUPPLEMENTARY INFORMATION: FDA is

announcing the anticipated availability

of funds for FY 1999 for awarding grants

to support clinical trials on the safety

and effectiveness of products for a rare

disease or condition (i.e., one with a

prevalence, not incidence, of fewer than

200,000 people in the United States).

Contingent on availability of FY 1999

funds, it is anticipated that $11.3

million will be available, of which 8.8

million will be for noncompeting

continuation awards. This will leave

$2.5 million for funding approximately

10 new applications. Any phase clinical

trial is eligible for up to $100,000 in

direct costs per annum plus applicable

indirect costs for up to 3 years. Phase 2

and phase 3 clinical trials are eligible

for up to $200,000 in direct costs per

annum plus applicable indirect costs for

up to 3 years.

FDA will support the clinical studies

covered by this notice under section 301

of the Public Health Service Act (the

PHS Act) (42 U.S.C. 241). FDA’s

research program is described in the

Catalog of Federal Domestic Assistance,

No. 93.103.

The Public Health Service (PHS)

strongly encourages all grant recipients

to provide a smoke-free work place and

to discourage the use of all tobacco

products. This is consistent with the

PHS mission to protect and advance the

physical and mental health of the

American people.

PHS urges applicants to submit work

plans that address specific objectives of

‘‘Healthy People 2000.’’ Potential

applicants may obtain a copy of

‘‘Healthy People 2000’’ (Full Report,

stock No. 017–001–00474–0) through

the Superintendent of Documents,

Government Printing Office,