Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Notices 30123

Scholars who received support in FY

1999.

Estimate of Burden: The Foundation

estimates that, on average, 0.5 hours per

Scholar applying for funds will be

required to complete the Payment

Request Form, for a total annual burden

of 136.5 hours for all applicants.

Respondents: Individuals.

Estimated Number of Responses: 273.

Estimated Total Annual Burden on

Respondents: 136.5 hours.

Dated: May 4, 2000.

Louis H . Blair,

Executive Secretary.

[FR Doc. 00–11726 Filed 5–9–00; 8:45 am]

BILLING CODE 6820–AD–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00063]

Interdisciplinary Evaluation of

Combination Therapy for

Uncomplicated Malaria; 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 Interdisciplinary

Evaluations of Combination Therapy for

Uncomplicated Malaria. 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. The purpose of the

program is to evaluate the effectiveness

of combination antimalarial therapy at

district or multidistrict level in subSaharan Africa.

B. Eligible Applicants

Assistance will be provided only to

Ifakara Health and Research

Development Center (IHRDC), in Ifakara,

United Republic of Tanzania. No other

applications are solicited.

The United Republic of Tanzania is

the only country located in sub-Saharan

Africa where large portions of the

country are located in areas of active,

and intense, transmission of the parasite

Plasmodium falciparum. They represent

one of only a few countries where drug

policy reform is underway because of

antimalarial drug resistance and is

actively engaged in developing and

testing strategies for addressing the

problem of antimalarial drug resistance.

Antimalarial drug resistance to

chloroquine, the traditional first-line

treatment for uncomplicated malaria,

has intensified to a point where the

Ministry of Health has decided to

switch to an alternative medicine,

sulfadoxine/pyrimethamine (SP), for

first-line treatment of malaria. Because

of concerns that this strategy will be

short lived due to pre-existing levels of

drug resistance to SP, the Ministry of

Health is keenly interested in

understanding potential future options

for addressing this pressing public

health challenge.

The IHRDC in Ifakara, Tanzania, is a

non-government organization that

comes under the jurisdiction of the

United Republic of Tanzania, Ministry

of Health. The Ministry of Health has

oversight of the IHRDC and must

approve all actions taken on behalf of

the United Republic of Tanzania. IHRDC

is the only institution in sub-Saharan

Africa that is located in an area of very

intense malaria transmission, that is

located in a country that: Is poised to

adopt a national malaria treatment

policy of SP while actively engaged in

investigating future treatment options; is

actively engaged in research activities

that are directly related to the objectives

listed above; and has the needed

experience and capacity. Because of its

work in malaria for more than a decade,

IHRDC is an internationally respected

research institution. Investigators at

IHRDC have a detailed understanding of

the epidemiologic patterns and

geographic distribution of malaria

infection and transmission in their area,

are actively engaged in using state-ofthe-art techniques for evaluating

antimalarial drug resistance, and have

needed and proven expertise in sociobehavioral research related to malaria.

In addition, the IHRDC maintains a

demographic surveillance system (DSS)

covering approximately 55,000

individuals, allowing for measurement

of public health impact of malaria

treatment policies, and, through its

existing collaborative links to other

institutions and projects, has the ability

to access comparable data from 2

additional DSS data bases (covering a

total population of over 300,000

individuals). The IHRDC is the only

organization that has the capacity to

carry out large-scale community-based

public health interventions, to conduct

malaria research, and to correctly

diagnose drug resistant malaria

infections in its laboratories and field

activities. They have the required field

experience and demonstrated capacity

in areas directly related to all 6

principal objectives of this proposed

evaluation: (1) Using state-of-the-art

methods of diagnosing antimalarial drug

resistance, including in vivo, in vitro,

and molecular methods; (2) monitoring

for changes in gametocytemia rates; (3)

socio-behavioral research related to

malaria, malaria drug use practices, and

malaria treatment seeking practices; (4)

economics of malaria and malaria

treatment; (5) research into the process

development of public health policy

related to malaria; and (6) monitoring

for public health impact, including on a

population level.

C. Availability of Funds

Approximately $500,000 is available

in FY 2000 to fund one award. It is

expected that 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 five

years. The funding estimate may

change.

Continuation awards within an

approved project period may 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 conducting the

activities under 1. (Recipient Activities)

and CDC will be responsible for

conducting the activities under 2. (CDC

Activities).

1. Recipient Activities

a. Identify an appropriate set of

districts for the evaluation of a pilot

policy of antimalarial combination

therapy, including comparison areas

using SP monotherapy for treatment of

all cases of uncomplicated malaria.

b. Design a multifaceted evaluation

program to determine the effectiveness

of antimalarial combination therapy on

inhibiting development of drug

resistance and decreasing malaria

transmission, as well as to elucidate

programmatic, behavioral, economic, or

policy aspects of combination therapy

that could either enhance or limit this

effectiveness.

c. Define, collect, and analyze

baseline data: Collect baseline data so

that the public health impact of the

interventions can be evaluated

(including impact on mortality rates).

d. Carry out the evaluation activities.

e. Measure the effect of the national

treatment policy compared with the

pilot policy of combination therapy in

terms of (1) inhibiting the development

of resistance to SP; (2) interrupting

30124 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Notices

transmission of the parasite; and (3)

describing the behavioral, economic,

and policy determinants of the policies.

f. Disseminate research results by

appropriate methods such as

publication in journals, presentation at

meetings, conferences, etc.

g. Develop a research protocol for

Institutional Review Board (IRB) review

by all cooperating institutions

participating in the research project.

2. CDC Activities

CDC will provide technical assistance

in the design and conduct of the

research as needed to possibly include:

a. Providing assistance in the

evaluation methods and analytic

approach.

b. Performing selected laboratory

tests, as requested by IHRDC, including

analysis of drug resistance conferring

mutations in parasite samples by

polymerase chain reaction (PCR) or gene

sequencing, testing of biologic samples

for presence of antimalarial drugs;

testing of pharmaceutical samples for

quality.

c. Assisting in data collection, data

management, analysis of research data,

interpretation, and dissemination of

research findings.

d. Collaborating in the design of the

evaluation.

e. Providing educational and training

materials, as appropriate.

f. Assisting 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 Application

Deadline

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are in the application kit. On or

before June 30, 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.

1. Background and Need (10 points)

Extent to which applicant’s

discussion of the background for the

proposed project demonstrates a clear

understanding of the purpose and

objectives of this cooperative agreement

program. Extent to which applicant

illustrates and justifies the need for the

proposed project that is consistent with

the purpose and objectives of this

program.

2. Capacity (30 points total)

a. Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. This includes

the capacity to conduct quality

laboratory measurements. (15 points)

b. Extent to which applicant

documents that professional personnel

involved in the project are qualified and

have past experience and achievements

in research and programs related to that

proposed as evidenced by curriculum

vitae, publications, etc. (10 points)

c. Extent to which applicant includes

letters of support from non-applicant

organizations, individuals, etc. Extent to

which the letters clearly indicate the

author’s commitment to participate as

described in the operational plan. (5

points)

3. Objectives and Technical Approach

(60 points total)

a. Extent to which applicant describes

specific objectives of the proposed

project which are consistent with the

purpose and goals of this program and

which are measurable and time-phased.

(10 points)

b. Extent to which the applicant

identifies appropriate populations for

study, with an adequate size to evaluate

the program. Extent to which adequate

procedures are described for the

protection of human subjects. (10

points)

c. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project, which

clearly and appropriately addresses all

recipient activities. Extent to which

applicant clearly identifies specific

assigned responsibilities for all key

professional personnel. 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: (1) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation, (2) the

proposed justification when

representation is limited or absent, (3) a

statement as to whether the design of

the study is adequate to measure

differences when warranted, and (4) 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. The extent to which

applicant describes the existence of or

plans to establish partnerships. (30

points)

d. Extent to which applicant provides

a detailed and adequate plan for

evaluating study results (including

laboratory data and data on prescribing

practices), as well as plans for

evaluating progress toward achieving

project objectives. (10 points)

4. Budget (not scored)

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

cooperative agreement funds.

5. Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Annual progress reports,

2. Financial status report, no more

than 90 days after the end of the budget

period, and

3. Final financial status 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–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 the

Public Health Service Act, Sections

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Notices 30125

301(a) [42 U.S.C. 241(a)], 307 [42 U.S.C.

2421], as amended. The Catalog of

Federal Domestic Assistance number is

93.283.

J. Where To Obtain Additional

Information

If you have any questions after

reviewing the contents of all documents,

business management technical

assistance may be obtained from: Van

Malone, 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

(770) 488–2764, Email address

vxm7@cdc.gov.

For program technical assistance,

contact: Peter B. Bloland, DVM, MPVM,

Division of Parasitic Diseases, National

Center for Infectious Diseases, Centers

for Disease Control and Prevention,

1600 Clifton Road, Mailstop F–22,

Atlanta, GA 30333, Telephone (770)

488–7760, Email address:

pbloland@cdc.gov.

Dated: May 4, 2000.

Henry S. Cassell III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–11647 Filed 5–9–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Subcommittee on Prevention of

Intimate Partner Violence and Sexual

Violence and the Injury Research Grant

Review Committee (IRGRC): Meetings

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 subcommittee

and conference call committee

meetings.

Name: Subcommittee on Prevention of

Intimate Partner Violence and Sexual

Violence of the IRGRC.

Times and Dates: 6:30 p.m.–9 p.m., June 4,

2000. 8 a.m–4 p.m., June 5, 2000.

Place: The Westin Atlanta Airport, 4736

Best Road, College Park, Georgia 30337

Status: Open: 6:30 p.m.–7 p.m., June 4,

2000. Closed: 7 p.m.–9 p.m., June 4, 2000,

through 4 p.m., June 5, 2000.

Purpose: The Subcommittee advises IRGRC

on the technical and scientific merit of injury

prevention research grant applications on

Prevention of Intimate Partner Violence and

Sexual Violence.

Matters To Be Discussed: Agenda items

include a description of the Subcommittee’s

responsibilities and review process, and

review of grant applications.

Name: Injury Research Grant Review

Committee.

Time and Date: 4:30 p.m.–5:30 p.m., June

5, 2000.

Place: The Westin Atlanta Airport, 4736

Best Road, College Park, Georgia 30337

Status: Open: 4:30 p.m.–4:45 p.m., June 5,

2000. Closed: 4:45 p.m.–5:30 p.m., June 5,

2000.

Purpose: This committee is charged with

advising the Secretary of Health and Human

Services, the Assistant Secretary for Health,

and the Director, CDC, regarding the

scientific merit and technical feasibility of

grant applications received from academic

institutions and other public and private

profit and nonprofit organizations, including

State and local government agencies, to

conduct specific injury research that focus on

prevention and control and to support injury

prevention research centers.

Matters To Be Discussed: Agenda items

include the purpose of the meeting and

discussion and vote on the report of the

Subcommittee on Prevention of Intimate

Partner Violence and Sexual Violence.

Beginning at 7 p.m., June 4, through 4 p.m.,

June 5, the Subcommittee on Prevention of

Intimate Partner Violence and Sexual

Violence of the IRGRC will meet, and from

4:45–5:30 p.m., June 5, IRGRC will meet to

conduct a review of grant applications. These

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 Pub. L. 92–463.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Linda L. Dahlberg, Ph.D., Acting Executive

Secretary, IRGRC, National Center for Injury

Prevention and Control, CDC, 4770 Buford

Highway, NE, M/S K60, Atlanta, Georgia

30341–3724, telephone 770/488–4496.

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: May 3, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–11648 Filed 5–9–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Center for Disease Control and

Prevention

Statement of Organization, Functions,

and Delegations of Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 65 FR 4979, dated

February 2, 2000) is a amended to

reflect the restructuring of the Office of

Health and Safety, Office of the Director,

Centers for Disease Control and

Prevention (CDC).

Section C–B, Organization and

Functions, is hereby amended as

follows:

Add the following item to the mission

statement for the Office of Health and

Safety (CA1): (7) provides advice and

counsel to the CDC Office of the

Director on health and safety related

matters.

After the functional statement for the

Office of the Director (CA11), insert the

following:

External Activities (CA112). (1)

Manages CDC regulatory programs for

which the Office of Health and Safety is

responsible (i.e., import permit program

[42 CFR 71], laboratory registration/

select agent transfer program [42 CFR

72.6], and infectious agents shipping

regulation [42 CFR 72]; (2) develops and

reviews national safety guidelines

including the ‘‘CDC/NIH Biosafety in

Microbiological and Biomedical

Laboratories’’ and the infectious agent

shipping regulations; (3) participates in

CDC, HHS, and interagency committees

and workgroups considering matters

related to laboratory safety including the

public health response to bioterrorism;

(4) provides consultations and technical

assistance to State and local health

departments on matters related to

laboratory safety; (5) provides

consultation and technical assistance to

CDC laboratories located outside the US;

(6) manages the WHO Collaborating

Center for Applied Biosafety and

Training at CDC; (7) participates in

other domestic and international

laboratory safety activities as requested.

Resource Management Activity

(CA113). (1) Develops and coordinates

budgets for OHS; (2) plans, coordinates,

and provides administrative, fiscal and

management assistance, including

personnel, travel, training, and contract