26808 Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 / Notices

Causal research to identify and investigate

the relationships between hazardous working

conditions and associated occupational

disease and injury; (b) the nature and

magnitude of special risk factors experienced

by older and/or minority workers; (c)

methods research to develop more sensitive

means of evaluating hazards at work sites;

and (d) evaluations of the effectiveness of

new approaches or combinations of

techniques such as control technologies and

personal protective equipment, work

organization changes, worker participation

programs, and training in reducing or

eliminating traumatic injuries and workrelated musculoskeletal injuries.

Request For Application Number 98030

entitled, ‘‘Occupational Radiation and

Energy-Related Health Research Grants,’’

which pertains to research endeavors

outlined as follows:

(a) Research to identify and investigate the

relationships between health outcomes and

occupational exposure to radiation and other

hazardous agents; (b) epidemiological

methods research relevant to energy-related

occupational health research; and (c)

research related to assessing occupational

exposures. The focus of proposed research

should reflect the following topical areas,

emphasizing field research: (1) Retrospective

exposure assessment; (2) radiation

measurement issues; (3) non-cancer

morbidity and mortality outcomes; (4) metaanalysis and combined analysis

methodologies; (5) uncertainty analysis; (6)

effects of measurement error on risk

estimates; (7) studies of current workers; and

(8) risk communication and worker outreach.

It is the intent of NIOSH to support broadbased research endeavors in keeping with the

Institute’s program goals as outlined above

which will lead to improved understanding

and appreciation for the magnitude of the

aggregate health burden associated with

occupational injuries and illnesses. It is

anticipated that research funded will

promote these program goals.

Matters To Be Discussed: The meeting will

convene in open session from 8–8:30 a.m. on

August 5, 1998, to address matters related to

the conduct of Study Section business. The

remainder of the meeting will proceed in

closed sessions. The purpose of the closed

sessions is for the Task Group to consider

safety and occupational health grant

applications related to the cited solicitation.

These portions of the meeting will be closed

to the public in accordance with provisions

set forth in section 552(c)(4) and (6), title 5

U.S.C., and the Determination of the

Associate Director for Management and

Operations, CDC, pursuant to Public Law 92–

463.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Pervis C. Major, Ph.D., Scientific Review

Administrator, Office of Extramural

Coordination and Special Projects, Office of

the Director, NIOSH, 1095 Willowdale Road,

Morgantown, West Virginia 26505.

Telephone 304/285–5979.

Dated: May 7, 1998.

John C. Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–12825 Filed 5–13–98; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs 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: Oncologic Drugs

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 June 1, 1998, 8:30 a.m. to 5:30

p.m., and June 2, 1998, 8 a.m. to 5:30

p.m.

Location: Gaithersburg Hilton, Grand

Ballroom, 620 Perry Pkwy.,

Gaithersburg, MD.

Contact Person: Karen M. TempletonSomers, Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4090, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On June 1, 1998, the

committee will discuss: (1) New drug

application (NDA) 20–892 AD 32

(valrubicin 40 milligrams/milliliter),

Anthra Pharmaceuticals, Inc., indicated

for the treatment of refractory carcinoma

in situ of the urinary bladder; and (2)

NDA supplement 20–449/S–005

Taxotere (docetaxel) for injection

concentrate, Rhone-Polenc Rorer

Pharmaceuticals, Inc., indicated for the

treatment of patients with locally

advanced or metastatic breast cancer

who have failed previous

chemotherapy. On June 2, 1998, the

committee will discuss: (1) Biologics

license application (BLA) 97–1325

ONTAKTM (denileukin diftitox)

injection (DAB389 IL–2), Seragen, Inc.,

indicated for the treatment of cutaneous

T-cell lymphoma (CTCL); and (2) NDA

supplement 20–671/S–004 Hycamtin

(topotecan HCl) for injection,

SmithKline Beecham Pharmaceuticals,

indicated for the second-line treatment

of patients with small cell lung cancer.

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 May 22, 1998. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:15 a.m., on June 1, 1998, and

between approximately 8:15 a.m. and

8:45 a.m., on June 2, 1998. Time allotted

for each presentation may be limited.

Those desiring to make formal oral

presentations should notify the contact

person before May 15, 1998, 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

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 7, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–12756 Filed 5–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0284]

Guidance for Industry on Classifying

Resubmissions in Response to Action

Letters; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Classifying Resubmissions in

Response to Action Letters.’’ This

guidance explains how the agency will

classify resubmissions of new drug

applications (NDA’s) and license

applications (LA’s) and specifies the

agency’s response timeframes. The

guidance also recommends procedures

for making resubmissions.

DATES: Written comments may be

submitted on the guidance by August

12, 1998. General comments on the

agency guidance documents are

welcome at any time.