25490 Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices

Atlanta, GA 30341–4146, Telephone

number (770) 488–2753, E-mail address

gcg4@cdc.gov.

For program technical assistance,

contact: Linda Moyer, Centers for

Disease Control and Prevention,

National Center for Infectious Diseases,

Division of Rickettsial Diseases,

Hepatitis Branch, 1600 Clifton Road,

NE, M/S G–37, Atlanta, GA 30333,

Telephone: (404) 371–5460, E-mail

address: lam1@cdc.gov.

Dated: April 26, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–10877 Filed 5–1–00; 8:45 am]

BILLING CODE 4163–18–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 00056]

Development and Testing of New

Antimalarial Drugs; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for the Development and

Testing of New Antimalarial Drugs. CDC

is committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2010’’, a

national activity to reduce morbidity

and mortality and improve the quality

of life. This announcement is related to

the focus areas of Immunization and

Infectious Diseases. For the conference

copy of ‘‘Healthy People 2010’’, visit the

internet site http://www.health.gov/

healthypeople.

The purpose of this program is to

support research projects to develop and

test new antimalarial drugs. Projects

may include, but not be limited to a

range of activities such as identifying

promising agents, purifying or creating

them, optimizing them for clinical use,

and testing them in in vitro and in vivo

systems. Applications may include

components to develop national centers

of excellence that would serve as

national repositories of expertise and

experience. For example, an application

to establish a national center of

excellence for computer-assisted drug

design for malaria and for screening

potential candidate drugs could be

considered. This might include high

throughput testing of potential

antimalarial compounds. Second and

third year plans may include clinical

trials.

B. Eligible Applicants

Assistance will be provided only to

the University of Mississippi. No other

applications are solicited.

The FY 2000 United States Senate

Labor-Health and Human Services

Appropriations Report: Report 106–166

(S 1650), recognized the unique

qualifications of the consortium of the

University of Mississippi Laboratory for

Applied Drug Design and Synthesis and

the Tulane University Center for

Infectious Diseases for carrying out the

activities specified in this cooperative

agreement.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $5,000,000 is available

in FY 2000 to fund one award. It is

expected the award will begin on or

about August 30, 2000, and will be

made for a 12-month budget period

within a project period of up to three

years. The funding estimate may

change.

A continuation award within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities) and CDC

will be responsible for conducting

activities under 2. (CDC Activities):

1. Recipient Activities

a. Develop and implement strategies

for acquiring or developing new

antimalarial compounds. This may

include the use of natural products,

computer-aided drug design, and

development of analogs of known drugs.

b. Develop and implement a rational

approach to selecting promising drug

candidates.

c. Develop strategies and capacity to

produce adequate quantities of

compound, for example, by using an

automated organic synthesizer or other

technology.

d. Develop and implement a

systematic approach to in vitro testing

of drug candidates. Develop and

evaluate in vitro systems for drug testing

where results allow prediction of the

risk of development of in vivo resistance

and the rate at which resistance is likely

to develop.

e. Conduct in vivo testing of

promising candidates, including the use

of primate models.

f. Develop a plan for enhancing

commercial interest in promising drugs.

g. Disseminate results of research.

2. CDC Activities

a. Provide technical assistance in the

design and conduct of the research.

b. Provide selected laboratory tests, as

necessary or appropriate.

c. Provide biological materials (e.g.,

strains, reagents, etc.) as necessary or

appropriate.

d. Upon request, assist in the

development of assays for evaluating

pharmacokinetics of new antimalarial

drugs.

e. Upon request, provide in vitro

testing for P. vivax, as well as in vivo

testing for malaria parasites.

f. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

cooperating institutions participating in

the research project. The CDC IRB will

review and approve the protocol

initially and on at least an annual basis

until the research project is completed.

E. Application Content

Use the information in the Program

Requirements, Other Requirements and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 10 double-spaced pages printed on

one side, with one inch margins and

unreduced font.

F. Submission and Deadline

Application

Submit the original and five copies of

PHS 398 (OMB Number 0925–0001)

(adhere to the instructions on the Errata

Instruction Sheet for PHS 398). Forms

are in the application kit.

On or before June 1, 2000, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ Section

of this announcement.

G. Evaluation Criteria

The application will be evaluated

against the following criteria by an

independent review group appointed by

CDC.

Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices 25491

1. Background and Need (10 points)

Extent to which applicant

demonstrates a clear understanding of

the background, purpose, and objectives

of the focus area being addressed. Extent

to which applicant demonstrates that

the proposed project addresses the

purpose. Extent to which the applicant

demonstrates that the proposed program

collaborates with and does not duplicate

existing rational development efforts.

2. Capacity (45 points)

Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. Extent to which

applicant documents that professional

personnel involved in the project are

qualified and have past experience and

achievements in research related to that

proposed as evidenced by curriculum

vitae, publications, etc. If applicable,

extent to which applicant includes

letters of support from participating

non-applicant organizations,

individuals, etc., and the extent to

which such letters clearly indicate the

author’s commitment to participate as

described in the operational plan.

3. Objectives and Technical Approach

(45 points total)

a. Extent to which applicant describes

measurable and time-phased objectives

of the proposed project which are

consistent with the purpose of the focus

area being addressed. (10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project which

clearly and appropriately addresses all

recipient activities for the specific

programmatic focus area being

addressed. Extent to which applicant

clearly identifies specific assigned

responsibilities of all key professional

personnel. Extent to which the plan

clearly describes applicant’s technical

approach/methods for conducting the

proposed studies and extent to which

the approach/methods are feasible,

appropriate, and adequate to

accomplish the objectives.

Extent to which applicant describes

specific study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. Extent to which applicant

clearly describes collaboration with

CDC and/or others during various

phases of the project. (25 points)

c. Extent to which applicant provides

a detailed and adequate plan for

evaluating progress toward achieving

project process and outcome objectives.

(5 points)

d. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes (a) the

proposed plan for the inclusion of both

sexes and racial and ethnic minority

populations for appropriate

representation, (b) the proposed

justification when representation is

limited or absent, (c) a statement as to

whether the design of the study is

adequate to measure differences when

warranted and (d) a statement as to

whether the plans for recruitment and

outreach for study participants include

the process of establishing partnerships

with community(ies) and recognition of

mutual benefits. (5 points)

4. Budget (not scored)

Extent to which the line-item budget

is detailed, clearly justified, and

consistent with the purpose and

objectives of this program.

5. Human Subjects (not scored)

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

6. Animal Subjects (not scored)

Does the application adequately

address the requirements of PHS Policy

on Humane Care and Use of Laboratory

Animals by Awardee Institutions?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. progress reports (semiannual);

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period. Send all

reports to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–3 Animal Subjects Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) and 317(k)(1)(2) of the

Public Health Service Act, [42 U.S.C.

sections 241(a) and 247b(k)(1)(2)], as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where to Obtain Additional

Information

This and other CDC announcements

can be found on the CDC Homepage

Internet address-http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements’’.

To obtain additional information,

contact: Gladys T. Gissentanna, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Room 3000,

2920 Brandywine Road, Atlanta, GA

30341–4146, Telephone number 770–

488–2753, Email address gcg4@cdc.gov

For program technical assistance,

contact: John W. Barnwell, Division of

Parasitic Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, 4770 Buford

Highway, N.E., Atlanta, GA 30333,

Telephone number 770–488–4528,

Email address wzb3@cdc.gov

Dated: April 26, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–10878 Filed 5–1–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1246]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Food Safety

Survey

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of