41672 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00138]

Youth-Focused HIV/AIDS Prevention

Program Development and Technical

Assistance Collaboration With

Countries Targeted by the Leadership

and Investment in Fighting the

Epidemic (LIFE) Initiative; 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 HIV/AIDS Prevention

Program Development and Technical

Assistance Collaboration with Countries

Targeted by the LIFE (Leadership and

Investment in Fighting an Epidemic)

Initiative.

In July 1999, the Administration

announced the LIFE Initiative to address

the global AIDS pandemic. The LIFE

Initiative, an effort to expand and

intensify the global response to the

growing AIDS pandemic and its serious

impact, is part of the United States

(U.S.) Government’s participation in the

International Partnership Against HIV/

AIDS in Africa (IPAA). A central feature

of the LIFE Initiative is a $100 million

increase in U.S. support for sub-Saharan

African countries and India, which are

working to prevent the further spread of

HIV and to care for those affected by

this devastating disease. This additional

funding is a critical step by the U.S.

Government in recognizing the impact

that AIDS continues to have on

individuals, families, communities, and

nations and responding to the

imperative to do more. The Department

of Health and Human Services (HHS),

through its agency, the Centers for

Disease Control and Prevention (CDC) is

administering $35 million of the $100

million allocated to the LIFE Initiative

by the U.S. Congress.

The purpose of the program is to

support HIV/AIDS prevention program

development and technical assistance

for countries designated by the U.S.

Congress under the LIFE Initiative. At

present, those countries are Botswana,

Cote D’Ivoire, Kenya, South Africa,

Uganda, Rwanda, Zimbabwe, Ethiopia,

Mozambique, Malawi, Tanzania,

Nigeria, Senegal, Zambia and India. The

countries targeted represent those with

the most severe epidemic and the

highest number of new infections. They

also represent countries where the

potential for impact is greatest and

where U.S. government agencies are

already active.

The goals of the program are to

address and support three program

elements of the LIFE initiative: Primary

Prevention, Capacity and Infrastructure

Development, and Community and

Home-Based Care and Treatment. The

program described in this

announcement calls for the delivery of

HIV/AIDS prevention program

development and technical assistance to

the LIFE countries through a variety of

recipient activities. The technical

assistance will enhance the skills of

LIFE country national AIDS program

officials in strategic planning,

evaluation, and communication relating

to youth HIV/AIDS prevention care

programs.

B. Eligible Applicants

Assistance will be provided only to a

non-profit non-governmental

organization. The eligible applicant

must meet these criteria:

1. Have been granted tax-exempt

status under Section 501(c)(3), as

evidenced by an Internal Revenue

Service (IRS) determination letter.

2. Have youth representation on their

governing body, board, or on an

advisory committee.

3. Have a minimum of one year

documented experience in operating

and centrally administering a

coordinated program to serve youth

with HIV prevention education and

services within a major portion or

region (multi-state or multi-territory) of

the United States.

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 $1 million is available

in FY 2000 to support one 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 up to 3 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.

Use of Funds

Funds received from this announcement

will not be used for the purchase of

antiretroviral drugs for treatment of

established HIV infection, occupational

exposures, and non-occupational exposures

and will not be used for the purchase of

machines and reagents to conduct the

necessary laboratory monitoring for patient

care.

Applicant may contract with other

organizations under this cooperative

agreement, however, applicant must

perform a substantial portion of the

activities (including program

management and operations and

delivery of prevention services) for

which funds are requested.

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 the activities

listed under 2. CDC Activities.

1. Recipient Activities

a. Provide technical assistance to

national AIDS control programs in LIFE

countries on how to collect, synthesize,

and disseminate global youth-focused

best-practices information. This will

also help the youth-serving

organizations (YSOs) and nongovernmental organizations working

with national AIDS control programs in

the LIFE countries to meet the needs of

young people. Activities could include,

but are not limited to, peer education,

adolescent development, adolescent

sexual and reproductive health issues,

and youth development as a prevention

strategy.

b. Identify and implement peer-topeer training opportunities and

technical assistance needs for young

people and their providers from

national AIDS control programs in LIFE

countries. This peer-to-peer training and

technical assistance will help LIFE

country public health providers plan,

implement, and evaluate HIV/AIDS

prevention and care programs to meet

the in-country needs of young people.

Such peer-to-peer technical assistance

may include, but is not limited to,

identifying and facilitating training

experiences for young people or their

providers from LIFE countries; bringing

young people or their providers from

LIFE countries to the U.S. to participate

in conferences, meetings, and/or

developmental experiences; and/or

agency or its approved representatives

embarking on temporary assignments in

LIFE countries. Topics may include but

are not limited to counseling and testing

with young people, how to make HIV/

AIDS medical services youth accessible,

mother-to-child transmission,

contraception supply and accessibility

for youth, and development for

vulnerable youth.

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices 41673

c. Provide public health officials,

young people, youth-serving providers

from national AIDS control programs,

NGOs and YSOs in LIFE countries with

technical assistance throughout the

project period on developing and

implementing strategic youth-focused

HIV/AIDS prevention and care plans.

Such plans will consist of goals and

measurable objectives. This technical

assistance will include how to monitor

implementation of objectives in order to

assess effectiveness and how to

determine the timing and content of

mid-course corrections to accomplish

objectives.

d. Provide public health officials from

national AIDS control programs, YSOs,

and young people in LIFE countries

with technical assistance, working with

such officials to identify local HIV/AIDS

prevention and care program and policy

issues as they are evolving, and helping

to determine how to use this feedback

to refine and improve HIV prevention

and care plans and programs.

e. Provide partnering organizations in

LIFE countries with technical assistance

to develop systems for timely

distribution and dissemination of youthspecific HIV/AIDS program and policy

information for continuing modification

and improvement of AIDS control

policies.

f. Develop and sustain, beyond project

period, a communications systems to

keep all stakeholders (officials from

LIFE country national AIDS control

programs, U.S. partners, CBOs, young

people, YSOs, CDC, and others)

informed of project progress and to

share technical assistance and capacity

building information.

g. Document, monitor, and record

outcome indicators of successful

activities under this cooperative

agreement and include such evaluation

information in the required annual

progress reports.

2. CDC Activities

a. Provide technical advice to partners

and national AIDS control programs of

LIFE countries on development of

systems to identify and improve youthfocused HIV/AIDS program and policy

issues.

b. Provide consultation, scientific and

technical assistance to partners and

national AIDS control programs of LIFE

countries on planning, operating,

analyzing, and evaluating youth-focused

HIV prevention programs.

c. Provide program and policy

information to partners and national

AIDS control programs of LIFE

countries for rapid dissemination,

coordination, and implementation of

youth-focused HIV prevention efforts.

d. Assist in assessing program

operations and evaluating overall

effectiveness of programs.

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 20 double-spaced pages, printed on

one side, with one inch margins, and

unreduced font. Pages should be

numbered and a complete index to the

application and its appendixes must be

included. Begin each separate section

on a new page. The original and each

copy of the application set must be

submitted unstapled and unbound. The

following format should be used when

developing your narrative.

Format

1. Abstract

2. Justification of Need

3. Organizational Capacity

4. Staffing Plans

5. Collaboration

6. Management and Evaluation Plan

7. Budget

F. Submission and Deadline

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are in the application kit. On or

before August 21, 2000, submit the

application 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 reviewed and

evaluated against the following criteria

by an independent review group

appointed by CDC:

1. Justification of Need (20 Points)

The extent to which the applicant

demonstrates understanding of the

requirements, problems, objectives,

complexities, and interactions required

of the cooperative agreement.

2. Organizational Capacity (30 Points)

a. Degree to which the applicant

provides evidence of an ability to carryout the proposed project and the extent

to which the applicant institution

documents the capability to achieve

objectives similar to those of this

project.

b. Degree to which applicant has

developed their expertise, services, and

experience in youth-oriented HIV

prevention, rather than just adapting

such resources from an adult to a youth

perspective.

c. Degree to which applicant has

established mechanisms for

communicating youth-focused HIV/

AIDS prevention information in LIFE

countries.

d. Degree to which proposed

objectives are clearly stated, realistic,

measurable, time-phased, related to the

purpose of this project.

3. Staffing Plan (20 Points)

Extent to which professional

personnel involved in this project are

qualified, including evidence of past

achievements relevant to this project.

4. Collaboration (10 Points)

a. Degree to which applicant possess

established networks of contacts and

knowledge of youth-serving HIV

prevention institutions, people, and

resources in order to identify people

and programs for technical assistance

and capacity building in LIFE countries.

b. Degree to which applicant has

already developed national and global

networks among officials in

governments, non-governmental

organizations (NGOs), and communitybased organizations (CBOs) throughout

the U.S. and in the LIFE countries.

5. Management and Evaluation Plan (20

Points)

Extent to which applicant

demonstrates the adequacy of plans for

administering and evaluating the

project.

6. Budget (Not Scored)

Extent to which project budget is

reasonable.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of

41674 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

1. Annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period;

3. Final financial report 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–4 HIV/AIDS Confidentiality

Provisions

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 317(k) (2) of the Public Health

Service Act, 42 U.S.C. 247b(k)(2). The

Catalog of Federal Domestic Assistance

number is 93.941, HIV Demonstration,

Research, Public and Professional

Education Projects.

J. Where To Obtain Additional

Information

This and other CDC [ATSDR]

announcements can be found on the

CDC home page Internet: http://

www.cdc.gov. Click on ‘‘Funding’’, then

‘‘Grants and Cooperative Agreements.’’

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Annie

H. Camacho, Grants Management

Specialist, Centers for Disease Control

and Prevention (CDC), Procurement and

Grants Office, Room 3000, 2920

Brandywine Road, Mailstop E–15,

Atlanta, GA 30341–4146, Telephone:

(770) 488–2735, Email: atc4@cdc.gov.

For program technical assistance,

contact: Leo Weakland, Deputy

Coordinator, Global AIDS Activity

(GAA), National Center for HIV, STD,

and TB Prevention, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, Mailstop E–07, Atlanta,

GA 30333, Telephone number (404)

639–8016, Email address: lfw0@cdc.gov.

Dated: June 29, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control (CDC).

[FR Doc. 00–17011 Filed 7–5–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1353]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Current Good

Manufacturing Practices and Related

Regulations for Blood and Blood

Components

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

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the information collection requirement

relating to the regulation of FDA’s

current good manufacturing practice

(CGMP) and related regulations for

blood and blood components.

DATES: Submit written comments on the

collection of information by September

5, 2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’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 respondents, including through the

use of automated collection techniques

when appropriate, and other forms of

information technology.

Current Good Manufacturing Practices

and Related Regulations for Blood and

Blood Components—Parts 606 and 640

(21 CFR Parts 606 and 640) (OMB

Control Number 0910–0116)—Extension

Under the statutory requirements

contained in the Public Health Service

Act (42 U.S.C. 262), no blood, blood

component, or derivative may move in

interstate commerce unless: (1) It is

propagated or manufactured and

prepared at an establishment holding an

unsuspended and unrevoked license; (2)

the product complies with regulatory

standards designed to ensure safety,

purity, and potency; and (3) it bears a

label plainly marked with the product’s

proper name, manufacturer, and

expiration date.

The CGMP and related regulations

implement FDA’s statutory authority to

ensure the safety, purity, and potency of

blood and blood components. The

information collection requirements in

the CGMP regulations provide FDA with

the necessary information to perform its

duty to ensure the safety, purity, and

potency of blood and blood

components. These requirements

establish accountability and traceability

in the processing and handling of blood