6216 Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices

and whether the information in a

previously approved application is

sufficient or new information would be

needed. Comments provide additional

information to assist the sponsor. In this

way, the draft guidance specifies data

requirements that will avoid duplication

of previously submitted data. It also

refers drug sponsors to related guidance

documents that will aid them in the

preparation of supplemental NADA’s.

This draft guidance does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirement of the applicable statute,

regulations, or both.

IV. Section 403(b)(3): Define

Supplemental Applications That Are

Eligible for Priority Review

When CVM determines that a product

represents an important advance in

animal health, it may expedite the

review of original and supplemental

applications. The circumstances in

which CVM may make such a

determination are outlined in an

existing guidance entitled ‘‘CVM

Program Policy and Procedures Guide

1240.3135,’’ available at the address

above.

V. Section 403(c): Responsibilities of

Centers

FDA has designated the following

individual within CVM to be

responsible for encouraging prompt

review of supplemental applications for

approved articles and for working with

sponsors to facilitate the development

and submission of data to support the

approval of supplemental applications

in accordance with section 403(c) of

FDAMA:

Director, Office of New Animal Drug

Evaluation (ONADE), Center for

Veterinary Medicine, (HFV–100), Food

and Drug Administration, 7500 Standish

Place, Rockville MD 20855, 301–594–

1620.

VI. Section 403(d): Collaboration to

Identify Published and Unpublished

Studies

CVM currently collaborates with the

U.S. Department of Agriculture (USDA)

National Research Support Project #7

(NRSP–7) and others, including state

agencies, extension agents, universities,

the National Coordinator for

Aquaculture NADA’s, and other USDA

agencies, to encourage sponsors to make

supplemental applications for minor use

new animal drugs by encouraging

development of Public Master Files

(PMF’s). Minor use new animal drugs

are drugs used in minor animal species

or drugs used in any animal species for

the control of a disease that occurs

infrequently or occurs in limited

geographic areas. Minor species are

defined in 21 CFR 514.1(d). PMF’s

contain public data from unpublished

and published studies that can be used

in conjunction with data already

available in a major use product’s

original NADA to support a

supplemental NADA. The majority of

approved minor use drugs have been

approved as supplements to products

approved for use in major species.

In a notice entitled ‘‘Proposals to

Increase the Legal Availability of

Animal Drugs for Minor Species and

Minor Uses; Availability’’ published in

the Federal Register (63 FR 58056,

October 29, 1998), CVM proposed other

methods of collaboration to make data

available for minor use supplemental

applications.

In addition, CVM frequently

participates in discussions with animal

industry trade associations to help

clarify the new animal drug approval

process. These discussions encourage

university researchers and others to

identify or initiate studies that may be

used to support supplemental

applications.

VII. Comments

The draft guidance discussed in

section III of this document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance.

Written comments may be submitted at

any time, however, comments should be

submitted by May 8, 2000, to ensure

adequate consideration in preparation of

the final document. Comments should

be identified with the full title of the

draft guidance and the docket number

found in brackets in the heading of this

document. Two copies of any comments

are to be submitted, except individuals

may submit one copy. Comments

should be identified with the docket

number found in the brackets in the

heading of this document. A copy of the

document and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

Dated: January 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–2767 Filed 2–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Heart, Lung,

and Blood Institute Special Emphasis Panel.

Date: February 28, 2000.

Time: 1:30 pm to 6 pm.

Agenda: To review and evaluate grant

applications.

Place: Hyatt Regency Bethesda, One

Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: Joyce A. Hunter, PHD,

NIH, NHLBI, DEA, Rockledge Center, II, 6701

Rockledge Drive, Suite 7192, Bethesda, MD

20892–7924, (301) 435–0287.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.233, National Center for

Sleep Disorders Research; 93.837, Heart and

Vascular Diseases Research; 93.838, Lung

Diseases Research; 93.839, Blood diseases

and Resources Research, National Institutes

of Health, HHS)

Dated: January 31, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–2757 Filed 2–7–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Aging; Notice of

Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and

Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices 6217

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute on

Aging Special Emphasis Panel, CONTRACT

REVIEW RFP.

Date: February 8, 2000.

Time: 1 pm to 6 pm.

Agenda: To review and evaluate contract

proposals.

Place: Gateway Building, 7201 Wisconsin

Avenue, Suite 2C212, Bethesda, MD 20892,

(Telephone Conference Call).

Contact Person: Arthur Schaerdel, DVM,

Scientific Review Administrator, The

Bethesda Gateway Building, 7201 Wisconsin

Avenue/Suite 2C212, Bethesda, MD 20892,

(301) 496–9666.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Name of Committee: National Institute on

Aging Special Emphasis Panel ‘‘Oxidative

Stress in Age Associated

Neurodegeneration.’’

Date: February 23, 2000.

Time: 1 pm to 3 pm.

Agenda: To review and evaluate grant

applications.

Place: 7201 Wisconsin Ave., Suite 502C,

MD 20891, (Telephone Conference Call).

Contact Person: Paul Lenz, PhD, Scientific

Review Administrator, The Bethesda

Gateway Building, 7201 Wisconsin Avenue/

Suite 2C212, Bethesda, MD 20892, (301) 496–

9666.

Name of Committee: National Institute on

Aging Initial Review Group, Clinical Aging

Review Committee.

Date: March 2–3, 2000.

Time: 7 pm to 4 pm.

Agenda: To review and evaluate grant

applications.

Place: Bethesda Marriott, 5151 Pooks Hill

Rd, Bethesda, MD 20814.

Contact Person: William A. Kachadorian,

PhD, The Bethesda Gateway Building, 7201

Wisconsin Avenue/Suite 2C212, Bethesda,

MD 20892, (301) 496–9666.

Name of Committee: National Institute on

Aging Initial Review Group, Neuroscience of

Aging Review Committee.

Date: March 13–15, 2000.

Time: 7 pm to 12 pm.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn, 2 Montgomery Village

Avenue, Gaithersburg, MD 20879.

Contact Person: Louise L. Hsu, PhD, The

Bethesda Gateway Building, 7201 Wisconsin

Avenue/Suite 2C212, Bethesda, MD 20892,

(301) 496–9666.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.866, Aging Research,

National Institutes of Health, HHS)

Dated: January 31, 2000.

Anna Snouffer,

Deputy Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–2754 Filed 2–7–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Notice of Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute on

Drug Abuse Special Emphasis Panel, SBIR—

‘‘Measurement Modules for Prevention

Interventions.’’

Date: February 3, 2000.

Time: 9:30 am to 10:30 am.

Agenda: To review and evaluate contract

proposals.

Place: Doubletree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Lyle Furr, Contract Review

Specialist, Office of Extramural Affairs,

National Institute on Drug Abuse, National

Institutes of Health, DHHS, 6001 Executive

Boulevard, Room 3158, MSC 9547, Bethesda,

MD 20892–9547, (301) 435–1439.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Name of Committee: National Institute on

Drug Abuse Special Emphaisis Panel, SBIR—

‘‘Develop Prevention Research

Dissemination.’’

Date: February 3, 2000.

Time: 10:30 am to 3 pm.

Agenda: To review and evaluate contract

proposals.

Place: Doubletree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Lyle Furr, Contract Review

Specialist, Office of Extramural Affairs,

National Institute on Drug Abuse, National

Institutes of Health, DHHS, 6001 Executive

Boulevard, Room 3158, MSC 9547, Bethesda,

MD 20892–9547, (301) 435–1439.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.277, Drug Abuse Scientist

Development Award for Clinicians, Scientist

Development Awards, and Research Scientist

Awards; 93.278, Drug Abuse National

Research Service Awards for Research

Training; 93.279, Drug Abuse Research

Programs, National Institutes of Health, HHS)

Dated: January 31, 2000.

Anna Snouffer,

Deputy Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–2755 Filed 2–7–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Closed

Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Environmental Health Sciences Special

Emphasis Panel, Development of Effective

Mitigation Methods or Devices for Reduction

of Indoor Allergens (SBIR Topic 72 & 73).

Date: February 4, 2000.

Time: 1 p.m. to 3:30 p.m.

Agenda: To review and evaluate contract

proposals.

Place: NIEHS, 79 T.W. Alexander Drive,

Building 4401, Conference Room 3446,

Research Triangle Park, NC 27709,

(Telephone Conference Call).

Contact Person: David P. Brown, MPH,

Scientific Review Administrator, Nat’l

Institute of Environmental Health Sciences,

P.O. Box 12233, Research Triangle Park, NC

27709, (919) 541–4964.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Name of Committee: National Institute of

Environmental Health Sciences Special

Emphasis Panel, Construction of Xenopus

cDNA ‘‘chips’’ for Analysis of Gene

Expression (SBIR Topic 74).