Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Notices 39911

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): NORA

Exploratory/Development Grants

Program (R21), RFA–OH–00–006

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Disease, Disability, and Injury

Prevention and Control Special Emphasis

Panel (SEP): National Occupational Research

Agenda Exploratory/Development Grants

Program (R21), RFA–OH–00–006.

Times and Dates: Noon–12:30 p.m., July

11, 2000 (Open). 12:30 p.m.–5 p.m., July 11,

2000 (Closed). 8 a.m.–Noon, July 12, 2000

(Closed).

Place: Embassy Suites, 1900 Diagonal

Road, Alexandria, Virginia 22314.

Status: Portions of the meeting will be

closed to the public in accordance with

provisions set forth in section 552b(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.

Matters to be Discussed: The meeting will

include the review, discussion, and

evaluation of applications received in

response to RFA–OH–00–006.

This notice is published less than 15 days

in advance of the meeting due to

administrative delays.

Contact person for more Information:

Michael J. Galvin, Jr., Ph.D., Health Science

Administrator, Centers for Disease Control

and Prevention, National Institute for

Occupational Safety and Health, 1600 Clifton

Road, N.E., m/s D30 Atlanta, Georgia 30333.

Telephone 404/639–3525, e-mail

mtg3@cdc.gov.

The Director, Management Analysis and

Services office has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities, for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: June 21, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention CDC.

[FR Doc. 00–16279 Filed 6–27–00; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ceftiofur Sodium Injection for Goats;

Availability of Data

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of effectiveness, target

animal safety, and human food safety

data that may be used in support of a

new animal drug application (NADA) or

supplemental NADA for veterinary

prescription use of ceftiofur sodium

injection for treatment of bacterial

pneumonia in goats. The data,

contained in Public Master File (PMF)

5671, were compiled under National

Research Support Project-7 (NRSP–7), a

national agricultural research program

for obtaining clearances for use of new

drugs in minor animal species and for

special uses.

ADDRESSES: Submit NADA’s or

supplemental NADA’s to the Document

Control Unit (HFV–199), Center for

Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7569.

SUPPLEMENTARY INFORMATION: Ceftiofur

sodium injection, used for the treatment

of goats for bacterial pneumonia, is a

new animal drug under section 201(v) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 321(v)). As a

new animal drug, ceftiofur sodium is

subject to section 512 of the act (21

U.S.C. 360b), requiring that its uses in

goats be the subject of an approved

NADA or supplemental NADA. Goats

are a minor species under

§ 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)).

The NRSP–7 Project, Western Region,

University of California, Davis, CA

95616, has provided target animal

safety, effectiveness, and human food

safety data for veterinary prescription

use of ceftiofur sterile powder for

reconstitution and injection in goats for

treatment of bacterial pneumonia due to

Pasteurella (Mannheimia) haemolytica

and P. multocida. These data are

contained in PMF 5671.

Under 21 CFR 25.15(d) and

§ 25.33(d)(4) (21 CFR 25.33(d)(4)),

sponsors of NADA’s and supplemental

NADA’s for drugs in minor species,

including wildlife and endangered

species, are categorically excluded from

the requirement to prepare an

environmental assessment or an

environmental impact statement when

the drug has been approved for use in

another or the same species where

similar animal management practices

are used. The categorical exclusion

applies unless, as in § 25.21 (21 CFR

25.21), extraordinary circumstances

exist which indicate that the proposed

action may significantly affect the

quality of the human environment.

Therefore, based upon information

available, FDA agrees that when the

application is submitted, the applicant

may claim a categorical exclusion under

§ 25.33(d)(4) provided that the applicant

can state that to the best of the

applicant’s knowledge, as in § 25.21, no

extraordinary circumstances exist. It is

assumed that the applicant has made a

reasonable effort to determine that no

extraordinary circumstances exist.

Sponsors of NADA’s or supplemental

NADA’s may, without further

authorization, reference the PMF to

support approval of an application filed

under § 514.1(d). An NADA or

supplemental NADA must include, in

addition to reference to the PMF, animal

drug labeling and other information

needed for approval, such as: Data

supporting extrapolation from a major

species in which the drug is currently

approved or authorized reference to

such data; data concerning

manufacturing methods, facilities, and

controls; and information addressing

potential environmental impacts of the

manufacturing process. Persons desiring

more information concerning the PMF

or requirements for approval of an

NADA or supplement may contact Naba

K. Das (address above).

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 19, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–16293 Filed 6–27–00; 8:45 am]

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