5874 Federal Register / Vol. 65, No. 25 / Monday, February 7, 2000 / Notices

Frequency of Response: One time.

Affected Public: Individuals or

households. Type of Respondents:

Patients, relatives, friends, and general

public. The annual reporting burden is

as follows: Estimated Number of

Respondents: 333,620 for three

questions and 166,810 for four

questions; Estimated Number of

Responses per Respondent: 1; Average

Burden Hours Per Response: .0033 for 3

questions and .0083 for 4 questions; and

Estimated Total Annual Burden Hours

Requested: 2,479. The annualized cost

to respondents is estimated at: $29,748.

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report.

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses per

respondent

Average

burden hours

per response

Estimated total

annual burden

hours requested

Individuals or households

—3 questions ............................................................................................ 333,620 1 .0033 1,094

—4 questions ............................................................................................ 166,810 1 .0083 1,385

Total ................................................................................................... ........................ ........................ ........................ 2,479

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact Chris Thomsen,

Chief, Cancer Information Service

Branch, Office of Cancer Information,

Communication, and Education,

National Cancer Institute, NIH, Building

31, Room 10A16, 9000 Rockville Pike,

Bethesda, MD 20892, or call non-tollfree number (301) 496–5583 ext. 239 or

E-mail your request, including your

address to: thomsenc@mail.nih.gov

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

April 7, 2000.

Dated: January 28, 2000.

Reesa Nichols,

OMB Clearance Liaison.

[FR Doc. 00–2629 Filed 2–4–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Cooperative Research and

Development Agreement (CRADA) To

Undertake Research and Development

of a Corticotropin Releasing Factor

(CRF) Antagonist(s) for the Treatment

of Cocaine Dependence

AGENCY: National Institute of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The National Institute on

Drug Abuse (NIDA), a component of the

National Institutes of Health, is seeking

proposals from potential collaborators

for a Cooperative Research and

Development Agreement (CRADA) to

test, by scientific means meeting U.S.

Food and Drug Administration (FDA)

standards, the hypothesis that

Corticotropin Releasing Factor (CRF)

antagonists may be useful in the

treatment of cocaine dependence. NIDA

will consider proposals from all

qualified entities and will, subject to

negotiation of a mutually agreed upon

research plan, provide substantial in

kind clinical and preclinical resources

with the understanding that the CRADA

collaborator will be free to utilize data

from the CRADA to pursue regulatory

filings in the U.S. and abroad. Subject

to negotiation of details in a mutually

agreed upon research plan, NIDA will

provide the CRADA collaborator with

access to its preclinical development

components and clinical trials

contractual network. No NIH funding

may be provided to a collaborator under

a CRADA, therefore the collaborator will

bear the financial and organizational

costs of meeting its obligations under

the research plan. It is NIDA’s intention

to provide, at a minimum, clinical trials

services sufficient to permit, subject to

FDA approval, research and

development up to and including Phase

II hypothesis testing trials. Assuming

demonstration of safety and efficacy at

the conclusion of Phase II trials and

subject to negotiation, NIDA will

consider undertaking Phase III trials

sufficient to permit collaborator to seek

a U.S. New Drug Approval (NDA).

DATES: NIDA will consider all proposals

received within 90 days of the date of

publication of this notice. This notice is

active until May 8, 2000.

ADDRESSES: Questions about this notice

may be addressed to Mr. Lee Cummings

(301–443–1143) or Dr. Frank Vocci

(301–443–2711) at the following

address: Division of Treatment Research

and Development, National Institute on

Drug Abuse, 6001 Executive Boulevard,

MSC 9551, Bethesda, Maryland 20892–

9551.

SUPPLEMENTARY INFORMATION: There is

mounting evidence that drugs of abuse

effect the brain systems mediating the

stress response. Evidence suggests that

withdrawal syndromes associated with

chronic use of drugs of abuse results in

elevations of Corticotropin Releasing

Factor (CFR) levels. The effects of

chronic opiate and cocaine abuse in

human subjects have been studied.

Investigators have reported

derangements of the stress response,

even long after cessation of drug use.

Taken together, these results would

suggest a role of the CRF system in acute

and, possibly, protracted abstinence. A

role of stress in relapse to drugs of abuse

is strongly suspected.

Stress has been shown to modify the

intake of drugs of abuse in preclinical

studies of drug self-administration. The

effect of stress to increase drug intake

has been shown for opiates and cocaine.

Moreover, the effects of stress can be

mimicked by CRF administration and

inhibited by CRF antagonists. The

inhibitory effect of CRF antagonists on

stress-induced increases in drug-taking

behavior is impressively robust. Hence,

Federal Register / Vol. 65, No. 25 / Monday, February 7, 2000 / Notices 5875

1A review of the scientific literature on stress,

drugs of abuse, and relapse to drug use is available

upon request.

further study of the modulation of stress

responses by CRF antagonists in drug

dependent and formerly dependent

subjects and the possible relationship to

reduction of drug use or prevention of

relapse is a high priority for NIDA.1

NIDA does not currently own or have

access to a CRF antagonist with which

to undertake this line of research and

development. To this end, NIDA is

seeking collaborations with

pharmaceutical partners to evaluate CRF

antagonists in drug dependent and

formerly drug dependent subjects. NIDA

is seeking to enter into a Cooperative

Research and Development Agreement

(CRADA) with a pharmaceutical

company or its license, the purpose of

which would be to assess the effects of

CRF antagonists in drug dependent

populations. NIDA is willing to provide

both intellectual expertise and

preclinical and clinical support in a

collaboration. While NIDA would prefer

to enter into a CRADA with a company

or licensee that is already in clinical

testing phase with a CRF antagonist, it

would also entertain collaborations

involving drug candidates in the

preclinical stage of testing. NIDA’s

Medications Development Program

possesses the capacity to perform

pharmacological and toxicological

testing, pharmacokinetics, dosage form

development and clinical testing from

Phase I through Phase III testing and is

willing to apply these capacities in the

assessment of a CRF antagonist.

Selection factors of importance of

NIDA include:

(1) It is mandatory that the

collaborator have proprietary rights to

the CRF antagonist sufficient to permit

research and commercial development

for the intended field of use, i.e.,

treatment of cocaine dependence. In the

event the collaborator does not own the

CRF antagonist, collaborator must

provide appropriate documentation of a

commercialization license to the field of

use sufficient to permit the CRADA to

proceed. Collaborator must be able to

supply dosage forms of a CRF antagonist

made to FDA Good Manufacturing

Practices (GMP) standards sufficient to

permit each stage of research and

development to proceed.

(2) NIDA will consider the amount of

research and development

documentation and experience already

in the collaborator’s possession. NIDA

will sign appropriate confidential

disclosure agreements in order to review

proprietary and unpublished data.

While NIDA will consider all proposals,

it will give a higher priority to proposals

that can document a more advanced

level of development with the proposed

CRF antagonist.

(3) NIDA will consider the amount

and type of research and development

resources the collaborator proposes to

undertake as part of a proposed CRADA.

(4) NIDA will consider the

background, experience, and expertise

in medications development of the

proposed collaborator.

Dated: February 1, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 00–2628 Filed 2–4–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; 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 Center for

Research Resources Special Emphasis Panel

Comparative Medicine.

Date: February 10, 2000.

Time: 2:00 PM to 3 PM.

Agenda: To review and evaluate grant

applications.

Place: Office of Review, National Center for

Research Resources, 6705 Rockledge Drive,

Bethesda, MD 20892, (Telephone Conference

Call)

Contact Person: Sybil A. Wellstood, PHD,

Scientific Review Administrator, Office of

Review, National Center for Research

Resources, 6705 Rockledge Drive, MSC 7965,

Room 6018, Bethesda, MD 20892–7965, 301–

435–0814.

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. 93.306,

Comparative Medicine, 93.306; 93.333,

Clinical Research, 93.333; 93.371,

Biomedical Technology; 93.389,

Research Infrastructure, National

Institutes of Health, HHS)

Dated: January 28, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–2625 Filed 2–4–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Human Genome Research

Institute; Notice of 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 a meeting of the

National Advisory Council for Human

Genome Research.

The meeting will be open to the

public as indicated below, with

attendance limited to space available.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the 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/or contract proposals and the

discussions could disclose confidential

trade secrets or commrcial property

such as patentable material, and

personal information concerning

individuals associated with the grant

applications and/or contract proposals,

the disclosure of which would

constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Advisory

Council for Human Genome Research.

Date: February 28–29, 2000.

Open: February 28, 2000, 8:30 AM to 3:00

PM.

Agenda: Discussion of matters of program

relevance.

Place: National Institutes of Health,

Natcher Building, Conference Rooms E1 &

E2, 45 Center Drive, Bethesda, MD 20892.

Closed: February 28, 2000, 3:00 PM to

Adjournment on Tuesday, February 29, 2000.

Agenda: to review and evaluate grant

applications and/or proposals.

Place: National Institutes of Health,

Natcher Building, Conference Rooms E1&E2,

45 Center Drive, Bethesda, MD 20892.

Contact Person: Elke Jordan, Deputy

Director, National Human Genome Research

Institute, National Institutes of Health, PHS,