41076 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Notices

Code of Federal Regulations, Title 21,

Part 56. Institutional Review Boards

(FDA)

Code of Federal Regulations, Title 45,

Part 76. HHS Debarment Regulations

Dated: June 27, 2000.

William F. Raub,

Deputy Assistant Secretary for Science Policy,

Office of the Assistant Secretary for Planning

and Evaluation, Department of Health and

Human Services.

[FR Doc. 00–16760 Filed 6–30–00; 8:45 am]

BILLING CODE 4151–05–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00095]

Cooperative Agreement for Birth

Defects Surveillance, Research, and

Prevention Activities; 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 University of South

Alabama Birth Defects Surveillance,

Research, and Prevention Activities.

B. Eligible Applicants

Single Source: Assistance will be

provided only to the University of South

Alabama. No other applications are

solicited.

This authority is granted under the

Consolidated Appropriations Act 2000

(Public Law 106–113), which states:

‘‘* * * under section 1509 of the Public

Health Service Act * * * $1,000,000

shall be for the University of South

Alabama birth defects monitoring and

prevention activities.’’

C. Availability of Funds

Approximately $800,000 is available

in FY 2000 to fund this award. It is

expected that the award will begin on or

about September 30, 2000, and will be

made for a 12-month budget period

within a project period of only 1 year.

Funding estimates may change.

D. Where To Obtain Additional

Information

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from:

William A. Paradies, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341–4146, Telephone number

(770) 488–2721, Email address:

WParadies@cdc.gov.

For program technical assistance,

contact: Larry D. Edmonds, State

Services, Birth Defects and Pediatric

Genetics Branch, Division of Birth

Defects, Child Development, Disability

and Health, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway NE., Mailstop F–

45, Atlanta, GA 30341–3724, Telephone

number (770) 488–7171, E-mail address:

LEdmonds@cdc.gov.

Dated: June 27, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–16719 Filed 6–30–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00105]

TB Epidemiologic and Operational

Research; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of Fiscal Year 2000 funds for

a new cooperative agreement to enhance

the capabilities of recipients of state and

local tuberculosis (TB) elimination and

laboratory agreements to conduct TB

epidemiologic and operational research.

This program addresses the ‘‘Healthy

People 2010’’ 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 cooperative

agreement is to build capacity at state

and local health departments to conduct

and implement protocol-driven

epidemiologic and operational research.

Such actions are consistent with

recommendations issued by the

Advisory Council for the Elimination of

Tuberculosis (ACET) calling for decisive

actions to: Better understand the

changing epidemiology of TB to rebuild

the public health infrastructure; identify

challenges and opportunities for TB

control in an era of changes in health

care organizations and delivery;

recognize the interdependence of global

TB and TB in the United States; and

develop and evaluate new tools for TB

diagnosis, treatment and prevention.

This new cooperative agreement will be

awarded to successful applicants from

state and local health agencies to

support health department-based

investigators with access to patients

with tuberculosis, latent tuberculosis

infection, or recent exposure to persons

with active tuberculosis (‘‘contacts’’) in

the implementation of protocols for

epidemiologic and operational research.

Recipients of this award will be

expected to conduct site-specific

epidemiologic and operational research

activities in TB which rely upon the

implementation of common, agreedupon study protocols. Award recipients

will be expected to successfully

compete for one or more of the specific

TB research projects listed below.

Eligible applicants may request support

for activities under one or more of the

following three separate focus areas. See

Attachments 1–3 in the application kit

for details under each focus area:

1. Development of Contact

Investigation Self-Evaluation Tools: (See

Attachment 1): Assist local TB control

programs in building local-level

capacity for evaluation of contact

investigation processes by providing

them with a package of self-evaluation

tools. These tools will enable programs

to systematically assess contact

investigation processes and target

programmatic revisions accordingly.

The package will include economic

evaluation tools to show how program

changes will impact resource use and

outcomes, thus enabling programs to

plan strategically. The package of tools

will be pilot tested to ensure usefulness

and feasibility. These funds will give

state and local health departments the

ability to develop practical evaluation

tools, based on the CDC’s

Recommended Framework for

Evaluation, that can be used by local TB

programs to use local data to evaluate

contact investigation processes. They

will also provide for the development of

educational support materials to enable

local level program staff to understand

evaluation principles and conduct selfevaluations.

2. Improving Contact Investigations in

Foreign-Born Populations: (See

Attachment 2) Improve contact

identification for foreign-born (FB) TB

cases. Improve completeness and

timeliness of screening for identified

contacts to FB TB cases. Improve the

interpretation of screening results for

contacts to FB TB cases in [a] the

context of screening results for US-born

contacts to the same cases and [b] using

serum immunologic profile (IFN-gamma

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Notices 41077

and TNF-alpha) and results of skin test

screening with non-tuberculous

mycobacterial antigens to aid

interpretation of screening results for FB

contacts. Improve completion of

treatment for latent TB infection for FB

contacts to pulmonary TB cases. These

funds will be used to provide

information for public health officials

and policy makers to better understand

methods for conducting contact

investigations in FB populations and

will provide improved completeness

and timeliness of screening,

interpretation of screening results, and

treatment for latent TB infection for FB

contacts to pulmonary TB cases.

3. The Unmeasured Impact of the TB

Epidemic on TB Programs in Health

Departments: (See Attachment 3)

Describe the burden of investigating,

providing diagnostic and treatment

services, and conducting contact

investigations for persons reported as

suspect TB cases who are not

subsequently verified as a TB case using

the public health surveillance case

definition or who are verified as a TB

case but do not meet the criteria to be

included in the area’s annual morbidity

reported to the national TB surveillance

system. These funds will be used to

allow state or local public health

departments to provide information for

public health officials and policy

makers to better understand the burden

of TB suspects and TB patients who are

not included in annual morbidity TB

counts. In addition, they will be used to

provide a template for approaches to

measuring this burden that may be

useful in other jurisdictions in the

future.

Additional background information

and details for each of the three focus

areas are provided in Attachments 1–3

in the application kit.

B. Eligible Applicants

Applications for this cooperative

agreement award are limited to the

official public health agencies of States

and territories, or their bona-fide agents

that are current recipients of the

Tuberculosis Cooperative Awards

announced in PA 00001, AND which

reported 200 or more TB cases in 1999.

These sites are the states of Alabama,

Arizona, California, Florida, Georgia,

Illinois, Kentucky, Louisiana, Maryland,

Massachusetts, Michigan, Minnesota,

Mississippi, Missouri, New Jersey, New

York, North Carolina, Ohio, Oklahoma,

Pennsylvania, South Carolina,

Tennessee, Texas, Virginia, and

Washington; the cities of Chicago,

Houston, Los Angeles, New York, San

Diego and San Francisco; and Puerto

Rico.

The only additional requirement of

eligibility applies to the research

activity listed in Attachment 2 for

‘‘Improving Contact Investigations in

Foreign-Born Populations’’ which

includes a requirement that of the

reported 200 or more TB cases in 1999,

at least 100 must be among foreign-born

persons. Therefore, eligible applicants

for this cooperative agreement would be

the states of Arizona, California, Florida,

Georgia, Illinois, Maryland,

Massachusetts, Minnesota, New Jersey,

New York, North Carolina,

Pennsylvania, Texas, Virginia, and

Washington and the cities of Chicago,

New York, Houston, Los Angeles, San

Diego, and San Francisco.

C. Availability of Funds

Approximately $1,015,000 is available

in FY 2000 to fund approximately 13

awards. See Attachments 1—3 for the

specific amount of funds available in

each focus area.

It is anticipated that awards will begin

on or about September 30, 2000, and

will be made for a 12-month budget

period within a project period of up to

three years. Funding estimates may

change. Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Direct Assistance

Applicants may request Federal

personnel, equipment, or supplies as

direct assistance in lieu of a portion of

financial assistance.

Use of Funds

Categorical funds are awarded for a

specifically defined purpose and may

not be used for any other purpose or

program. Funds may be used to support

personnel and to purchase equipment,

supplies, and services directly related to

project activities. Funds may not be

used to supplant state or local health

department funds or for inpatient care

or construction of facilities. Funds may

not be used to purchase drugs for

treatment. In addition, recipients must

maintain clear audit records to insure

that the funding awarded under this

cooperative agreement is used toward

the activities under this announcement

and remains separate from any funding

the recipient may be awarded under

other mechanisms.

Funding Preferences

Funding preferences for awards under

this announcement will be given to

those applicants who have

demonstrated the greatest continued

achievement of the following National

TB Program Objectives:

1. At least 90 percent of patients with

newly diagnosed TB, for whom therapy

for one year or less is indicated*, will

complete therapy within 12 months

(*please refer to the definitions in

‘‘Reported Tuberculosis in the United

States, 1997’’ for more information). To

obtain a copy of this report, you may

order through the CDC Website http://

www.cdc.gov/nchstp/tb/ and go to

online ordering; or you may contact the

Communication and Education Branch,

Sherry Hussain, 404–639–8135.

2. At least 85 percent of infected

contacts who are started on treatment

for latent TB infection will complete

therapy.

3. Completeness of RVCT reporting on

HIV status for at least 75 percent of all

newly reported TB cases age 25–44.

In addition, funding preference will

be given to those applicants in areas

with a high number of TB cases in

foreign-born persons and other high-risk

populations (e.g., HIV-infected persons),

and to applicants with a high number of

culture-positive TB cases reported in

urban and rural areas.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

listed under 1. Recipient Activities, and

CDC will be responsible for conducting

activities listed under 2. CDC Activities.

See Attachments 1–3 for specific

Program Requirements for each focus

area.

E. Application Content

Submit separate and complete

narrative and budget sections for each

specific epidemiologic and operations

research focus area addressed. For the

budget section, submit a separate Form

424A (included in the Application

Package) and detailed line-item

justification for each focus area project.

Applications for each of the focus

areas addressed must be developed in

accordance with PHS Form 5161–1

(OMB Number 0937–0189). Pages must

be clearly numbered, and a complete

index to the application and its

appendices must be included. The

original and each copy of the

application must be submitted

unstapled and unbound. Materials

which should be part of the basic plan

should not be in the appendices.

Please label each application request

clearly. See Attachments 1–3 for

specific application content instructions

for each focus area.

41078 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Notices

F. Submission and Deadline

Submit the original and two copies of

the application including the PHS Form

5161–1 (OMB Number 0937–0189) on or

before July 28, 2000 to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the stated criteria

by an independent review group

appointed by CDC. Evaluation Criteria

instructions specific to each focus area

may be found in Attachments 1–3.

H. Other Requirements

Technical Reporting Requirements:

Provide CDC with an original plus two

copies of:

1. Annual progress report, no more

than 90 days after the end of the budget

period;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

report, 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

announcement. For a complete

description of each, See Attachment IV

in the application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–4 HIV/AIDS Confidentiality

Provisions

AR–5 HIV Program Review Panel

Requirements

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 317E of the Public Health

Service Act, 42 U.S.C. section 42 U.S.C.

247b–6, as amended. The Catalog of

Federal Domestic Assistance number is

93.947.

J. Where To Obtain Additional

Information

This and other CDC Announcements

can be found on the CDC homepage on

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

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

Cooperative Agreements’’.

To obtain additional information,

contact: Carrie Clark, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341–2783, Telephone (770) 488–

2783, E-mail address: zri4@cdc.gov

Programmatic technical assistance

may be obtained from: Juanita Elder,

Division of Tuberculosis Elimination,

National Center for Prevention Services,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Mailstop E–10, Atlanta, GA 30333,

Telephone (404) 639–8120, Email

Address: jlc7@cdc.gov.

Dated: June 27, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–16718 Filed 6–30–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability and Injury

Prevention and Control Special

Emphasis Panel: Fiscal Year 2000

Competitive Supplemental Funds for

Comprehensive STD Prevention

Systems: Monitoring Trends in STD

Prevalence, Tuberculosis, and HIV

Risk Behaviors Among Men Who Have

Sex With Men, PA# 99000–H

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: Fiscal Year 2000 Competitive

Supplemental Funds for Comprehensive STD

Prevention Systems: Monitoring Trends in

STD Prevalence, Tuberculosis, and HIV Risk

Behaviors among Men who have Sex with

Men, PA# 99000–H.

Times and Dates: 8:30 a.m.–9 a.m., August

4, 2000 (Open), 9 a.m.–4:30 p.m., August 4,

2000 (Closed).

Place: Centers for Disease Control and

Prevention, Corporate Square, Building 11,

Conference Room 2214, Atlanta, Georgia

30329.

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 Program Announcement 99000–

H.

Contact Person for more Information: Beth

Wolfe, Prevention Support Office, National

Center for HIV, STD, and TB Prevention,

CDC, Corporate Square Office Park, 11

Corporate Square Boulevard, M/S E07,

Atlanta, Georgia 30329, telephone 404/639–

8025, e-mail eow1@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 23, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–16720 Filed 6–30–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability and Injury

Prevention and Control Special

Emphasis Panel: Community-Based

Strategies To Increase HIV Testing of

Persons at High Risk in Communities

of Color, PA# 00100

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