Federal Register / Vol. 65, No. 83 / Friday, April 28, 2000 / Notices 24961

comments and recommendations for the

proposed information collection should

be sent directly to the OMB desk officer

designated above at the following

address: Human Resources and Housing

Branch, Office of Management and

Budget, New Executive Office Building,

Room 10235, 725 17th Street N.W.,

Washington, D.C. 20503.

Comments may also be sent to

Cynthia Agens Bauer, OS Reports

Clearance Officer, Room 503H,

Humphrey Building, 200 Independence

Avenue S.W., Washington, DC 20201.

Written comments should be received

within 30 days of this notice.

Dated: April 20, 2000.

Dennis P. Williams,

Deputy Assistant Secretary, Budget.

[FR Doc. 00–10558 Filed 4–27–00; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00048]

Patient Follow-Up Study of Prevention

of the Joint Complications of

Hemophilia; 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 Mountain State

Regional Hemophilia Treatment Center

(MSRHTC), University of Colorado

Health Sciences Center to conduct a

follow-up study of patients enrolled in

a trial of primary prophylactic therapy

for the prevention of joint disease in

children with hemophilia. 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 Diabetes. For the

conference copy of ‘‘Healthy People

2010’’, visit the internet site http://

www.health.gov/healthypeople.

The purpose of the program is to

provide continued assistance MSRHC in

the follow-up of patients enrolled in the

current randomized, controlled trial of

primary prophylaxis in previously

untreated patients with severe

hemophilia A and no demonstrable

factor VIII inhibitors. Cost and efficacy

of early intervention to prevent joint

complications should be determined in

the treatment groups and should be

compared to similar data from

appropriately treated, control subjects.

The cumulative risk of factor VIII

inhibitor development should be

determined for each treatment group

and total costs and complication rates

ascertained as well. Molecular

characterization of factor VIII defects in

an effort to predict which subjects will

develop inhibitors should be carried

out.

Further, follow-up of patients will

continue to improve understanding of

specific public health issues and

enhance preparedness to meet changes.

B. Eligible Applicants

Assistance will be provided only to

the MSRHTC. No other applications are

solicited. The MSRHTC was the only

applicant that applied under the

original Program Announcement 95019

and was subsequently awarded. It is the

only Hemophilia Treatment Center

(HTC) capable of carrying out the

follow-up of the hemophilia patients

enrolled in this clinical trial because

they began and continue the enrollment

of patients under the original clinical

trial. The enrollment of Hemophilia

patients for this program will be

completed on September 29, 2000, and

it is the intention of CDC to allow for

a smooth transition into this follow-up

study.

MSRHTC already possesses the

necessary data required for the followup study for the prevention of the joint

complications of hemophilia.

MSRHTC’s patient data is proprietary,

and no other HTC would have ready

access.

C. Availability of Funds

Approximately $250,000 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 up to 4 years.

The funding estimate 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.

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. Develop standardized study

protocols, data collection instruments,

interview questionnaires, progress

report forms.

b. Train study coordinators and

medical personnel in methods of data

collection and patient assessment in the

use of standard data abstraction

instruments, in techniques of reviewing

medical records, in interviewing

patients, and in other methods of data

collection as appropriate and provided

for in the study protocols. It is the

responsibility of the recipient to ensure

uniform training of study personnel at

all data collection sites. The recipient

must ensure that the data is collected in

a uniform manner at all data collection

sites.

c. Develop appropriate management

and evaluation systems to ensure that

study personnel use data collection and

interview instruments according to

standard study protocols.

d. Collect and edit all data from all

sites, including cost effectiveness data.

e. Obtain sufficient clinical specimens

for specialized laboratory analysis and

genetic testing, including plasma and

cell pellets, to meet the requirements of

the study.

f. Develop papers and publish the

results.

2. CDC Activities

a. Provide consultation, scientific and

technical assistance in planning and

implementing the study protocol, as

requested. This assistance may include

the development of study protocols,

data abstraction instruments, interview

questionnaires, consent forms, support

in statistical and epidemiologic methods

to conduct data analysis, and

development of the clinical laboratory

specimen testing.

b. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

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.

c. Collaborate in the planning,

coordination, and facilitation of initial

and periodic meetings.

d. Perform sufficient clinical

specimens for specialized laboratory

analysis and genetic testing, including

plasma and cell pellets, as requested.

E. Application Content

Use the information in the Purpose,

Program Requirements, Other

Requirements, and Evaluation Criteria

sections to develop the application

content. The application should

describe MSRHTC’s ability to address

the purpose and required activities of

this announcement. The application

24962 Federal Register / Vol. 65, No. 83 / Friday, April 28, 2000 / Notices

will be evaluated on the criteria listed,

so it is important to follow them

specifically in laying out the program

plan. The narrative should be no more

than 20 double-spaced pages, printed on

one side, with one inch margins, and

unreduced font.

F. Submission and Deadline

Application

Submit the original and two copies of

the PHS–5161–1 (OMB Number 0920–

0428). Forms are available at the

following Internet address:

www.cdc.gov/Forms, or 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

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Background and Need: (10 Points)

Extent to which applicant summarizes

new information (literature) on the

prevention of joint disease among

persons with hemophilia; describes how

this information enhances the need for

the clinical trial; describes in as much

detail as possible, how the study will

enhance future management of children

less than six years old with hemophilia.

2. Goals and Objectives: (15 Points)

Extent to which the proposed goals

and objectives meet the purpose of the

collaborative agreement and the

required activities specified in the

‘‘Recipient Activities’’ section of this

announcement and that are measurable,

specific, time-phased, and realistic.

3. Capacity: (35 Points)

a. Extent to which knowledge, ability,

and experience with primary

prophylaxis studies initiated early in

life as a form of ‘‘low-dose’’ immune

tolerance are described in a plan to

ensure a high level of follow-up among

patients enrolled on the current study.

Extent to which applicant describes, in

detail, how a high loss to follow-up will

affect the results and conclusions that

can be drawn from the final analysis of

the study. (30 points) b. Extent to which applicant details

the qualifications of the current staff to

meet the stated objectives and goals, and

the availability of facilities to be used

during the project follow-up period. The

person (or persons) who will be directly

responsible for the follow-up should be

identified and their duties specified in

detail. (5 points)

4. Methods and Activities: (25 Points)

a. The quality of the applicant’s plan

for conducting program activities and

the extent to which the study design

proposed is (1) appropriate to

accomplish the stated goals and

objectives; (2) acceptable to the needs of

the patient population (e.g., likely to

produce compliance); and (3) feasible

within the programmatic and fiscal

restrictions. (10 points)

b. Extent to which applicant

demonstrates knowledge of

implementing patient follow-up

procedures and describes methods for

patient follow-up among all currently

collaborating sites.

Note: Description of patient follow-up

protocol is critical for ascertaining that longterm follow-up of enrolled patients will

occur over the project period. The applicant

should indicate in the application how they

plan to monitor sites to identify problems

with maintaining an acceptable loss to

follow-up rate as described in section 3.a.

above. (15 points)

5. Program Management and

Evaluation: (15 Points)

a. Extent to which applicant should

describes the information management

systems currently available for this

study, detailing any system

modifications required to accomplish

collecting follow-up data versus

enrollment data. Extent to which

applicant describes, in detail, specific

plans to evaluate data on a quarterly

basis, quality assurance measures to be

used and how operations will be

changed based on the above

information. Extent to which applicant

describes study close-out procedures

once all patients have completed followup data collection. Extent to which

applicant demonstrates adequate

biostatistical support for study

completion, data management and data

analysis. (10 points)

b. 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, 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. (5 points)

6. Budget

The extent to which the budget is

reasonable and consistent with the

intended use of the cooperative

agreement funds. (Not scored)

7. Human Subjects Requirements

Does the application adequately

address the requirements of Title 45

CFR part 46 for the protection of human

subjects? (not scored)

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Progress reports quarterly;

2. Financial Status Report (FSR), no

more than 90 days after the end of the

budget period; and

3. Final FSR 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–7 Executive Order 12372

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–15 Proof of Non-profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) [42 U.S.C. 241(a)] and

317(k)(2) [42 U.S.C. 247b(k)], as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

To obtain additional information,

contact: Merlin Williams, 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: (770) 488–

2765, E-mail address: mqw6@cdc.gov.

For program technical assistance,

contact: Lisa Richardson, MD, MPH,

Hematologic Diseases, Branch, Division

of AIDS, STD, and TB Laboratory

Federal Register / Vol. 65, No. 83 / Friday, April 28, 2000 / Notices 24963

Research, National Center for Infectious

Diseases, Centers for Disease Control

and Prevention (CDC), 1600 Clifton

Road, NE, Mail-stop E–64. Atlanta, GA

30333, Telephone: (404) 371–5264, Email address: lfr8@cdc.gov.

The CDC Homepage address on the

Internet is: http://www.cdc.gov

Dated: April 24, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–10680 Filed 4–27–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00053]

Cooperative Agreement for

Collaborating Centers for Public Health

Law; 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

operation of a collaborating center (or

centers) for public health law. This

program addresses all the Healthy

People 2010 focus areas, but especially

focus area 23, the public health

infrastructure objectives. For the

conference copy of ‘‘Healthy People

2010’’ visit the Internet site: http://

www.health.gov/healthypeople.

Laws serve as a framework for public

health and can be used as a public

health intervention. A large and diverse

array of laws and legally enforceable

policies of federal, state, and local

jurisdictions affect public health. These

laws include statutes, ordinances, and

bylaws that authorize public health

programs and specific authorities of

public health agencies and officials;

case law; taxes and fees; rules,

regulations, and contracts; and laws

enacted for other purposes that

indirectly or directly affect public

health.

Healthy People 2010 recognizes that

laws are an essential part of the public

health infrastructure, and calls on local,

State, Tribal, and federal jurisdictions to

‘‘review and evaluate the extent to

which their statutes, ordinances, and

bylaws assure the delivery of essential

public health services.’’ In support of

this goal, CDC proposes to fund one or

more organizations that will work

toward establishing a strong legal

foundation for effective public health

practice through training and education,

collaboration, communication, and

analysis. Specific goals of the

collaborating center(s) will be to: (a)

improve the effectiveness of laws as a

type of public health intervention; (b)

improve the quality, accessibility, and

scientific basis of information about

laws related to public health; (c)

improve the knowledge of laws related

to public health among public health

practitioners, the legal community, and

public policy makers; and (d) stimulate

contributions by organizations and

individuals to improvement of the legal

foundation for public health. (See

Addendum 1 for the definition of the

term ‘‘public health law’’ used in this

announcement.)

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, other

public and private nonprofit

organizations, and State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations. CDC specifically

encourages applications from consortia

composed of accredited schools of

public health or medicine, accredited

schools of law, and accredited schools

of public policy and/or public

administration.

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 $300,000 is available

in FY 2000 to fund one to three awards.

It is expected that the 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

3 years. Funding estimates may change,

and awards could be supplemented by

additional funding.

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.

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. Identify and evaluate existing

training and continuing education in the

area of public health law for public

health practitioners, professionals in the

legal community, and public policy

makers; develop training and continuing

education to address identified gaps;

conduct training using both existing and

newly developed training and

continuing education materials, with

priority on training for public health

practitioners. Newly developed training

and continuing education materials

should support core competencies as

outlined in Essential Service 6 of ‘‘The

Public Health Workforce: An Agenda for

the 21st Century’’. Addendum 2, full

text available at the following Internet

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

phfunctions/pubhlth.pdf

b. Research laws that affect public

health, addressing the following general

objectives: (1) Identify and analyze

existing and proposed laws relevant to

public health; (2) assess the distribution,

provisions, and trends in laws that

affect public health; (3) develop and

implement a research agenda for public

health law with broad stakeholder

involvement; (4) synthesize and

translate research on laws affecting

public health; and (5) disseminate

results and findings from analyses.

c. Stimulate collaboration and

communication among organizations

active in public health, law, public

policy, and related fields by developing,

linking, and disseminating information

regarding laws and public health

through an Internet website and/or other

means; convening conferences and other

meetings; and producing, sponsoring,

and disseminating reports, analyses, and

other publications.

2. CDC Activities

a. Provide technical assistance to the

grantee(s) on an as-needed basis.

b. Collaborate with the grantee(s) to

identify appropriate audiences, content,

and media for training and continuing

education, for information

dissemination, for conferences and

other meetings, and for publications.

c. Collaborate with the grantee(s) in

developing a research agenda for public

health law.

d. Provide appropriate scientific

information and data relating to

prevention, health promotion, public

health practice, and related topics.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and