Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices 22579

which counts only those cases that are

reported.

There is a need for collection of

standardized data on a consistent and

continual basis, at the state and

community levels in order to target

limited resources towards populations

in greatest need of prevention and

intervention programs and services. As

a result CDC plans to develop and pilot

test two surveys on IPV and SV for

possible inclusion in the Behavioral

Risk Factor Surveillance System

(BRFSS). The surveys will be

administered to non-institutionalized

women and men, 18 years of age and

older. The pilot test will be conducted

through a computer-assisted telephone

interviewing system, using a sample of

women and men randomly selected

from six states. The overall benefit of

this pilot is to increase knowledge

regarding the magnitude and scope of

violence against women and men in the

U.S. Ultimately, the CDC intends to

establish an on-going data collection

system for monitoring IPV and SV at the

state level.

The goals of the project are to: (1)

determine the questions’ utility,

participant reactions, and length of

surveys; and (2) compile and

disseminate the results of the pilot test

and prepare a report for submission to

the BRFSS coordinators for

consideration for inclusion as an

optional module for FY 2003. There are

no costs to respondents.

Survey IPV/SV Type of respondent

No. of respondents

per survey

No. responses per

respondent

Avg. burden

per response

in hours

Total burden

in hours

State 1 ................................................... Female/Male ......................................... 2400 1 30/60 1,200

State 2 ................................................... Female/Male ......................................... 2400 1 30/60 1,200

State 3 ................................................... Female/Male ......................................... 2400 1 30/60 1,200

State 4 ................................................... Female/Male ......................................... 2400 1 30/60 1,200

State 5 ................................................... Female/Male ......................................... 2400 1 30/60 1,200

State 6 ................................................... Female/Male ......................................... 2400 1 30/60 1,200

Total ........................................... ............................................................... ...................... ...................... ...................... 7,200

Dated: April 27, 2001.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation Centers for Disease Control

and Prevention.

[FR Doc. 01–11190 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01049]

Prevention of the Complications of

Bleeding Disorders through

Hemophilia Treatment Centers; Notice

of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for the Prevention of the

Complications of Bleeding Disorders

through Hemophilia Treatment Centers.

This program addresses the ‘‘Healthy

People 2010’’ focus areas of Access to

Quality Health-Services, Disability and

Secondary Conditions, HIV, and

Immunization and Infectious Diseases.

For more information on ‘‘Healthy

People 2010’’ visit the internet site:

http://www.health.gov/healthypeople.

The purpose of the hemophilia

complications prevention cooperative

agreement program is to assist in: (1)

Providing a regional network of

comprehensive prevention services

through hemophilia treatment centers to

persons with hemophilia and related

disorders including women with

bleeding disorders to prevent

complications through assessment,

surveillance, outreach, education,

consultation, and management; (2)

maintaining a prevention evaluation

network to assess the efficacy of these

prevention services; (3) participating in

blood safety monitoring and

surveillance efforts; and (4)

collaborating with lay organizations to

deliver consistent prevention messages

aimed at preventing complications.

B. Eligible Applicants

Assistance will be provided only to

hemophilia regional core centers,

defined as public or private non-profit

entities that provide regional services

and support to a network of

comprehensive hemophilia treatment

centers (HTCs) within their regional

catchment area. A HTC is defined as a

specialty, prevention, diagnostic and

treatment program with the goal of

providing family-centered, state-of-theart medical and psycho-social

evaluation and care, dental, education,

genetic, research, and support services

for individuals and families with

bleeding disorders.

Note: Title 2 of the United States Code,

chapter 26, section 1611 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 $6,700,000 is available

in FY 2001 to fund approximately 12

awards. It is expected that the average

award will be $400,000, ranging from

$200,000 to $875,000. It is expected that

the awards will begin on or about

September 30, 2001, and will be made

for a 12-month budget period within a

project period of up to five years. The

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.

Funding Preference

One award per region will be made to

support the core center and other

collaborating HTC performance sites in

the region. For the purposes of these

awards, regional breakdowns are as

follows: Region I: Connecticut, Maine,

Massachusetts, New Hampshire, Rhode

Island, and Vermont; Region II: New

Jersey, New York, Puerto Rico, and the

U.S. Virgin Islands; Region III:

Delaware, the District of Columbia,

Maryland, Pennsylvania, Virginia, and

West Virginia; Region IV-North:

Kentucky, North Carolina, South

Carolina, and Tennessee; Region IVSouth: Alabama, Florida, Georgia, and

Mississippi; Region V-East: Indiana,

Michigan, and Ohio; Region V-West:

Illinois, Minnesota, North Dakota, South

Dakota, and Wisconsin; Region VI:

Arkansas, Louisiana, Oklahoma, and

Texas; Region VII: Iowa, Kansas,

Missouri, and Nebraska; Region VIII:

22580 Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices

Arizona, Colorado, Montana, New

Mexico, Utah, and Wyoming; Region IX:

California, Hawaii, Nevada, American

Samoa, Northern Mariana Islands and

Guam; Region X: Alaska, Idaho, Oregon,

and Washington.

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. On the regional level, the regional

core center should:

(1) Develop appropriate management

and evaluation systems to ensure that

HTCs within the region implement the

activities of this program appropriately

and comply with federal and other

required regulations. Conduct program

assessments, site visits, assist HTCs

with problem solving, assess local needs

and recommend support for

subcontracts to a network of centers in

their region, and provide technical

assistance when needed;

(2) Serve as liaison with CDC to

provide input and feedback regarding

national programs, implementation and

evaluation. Coordinate CDC

consultation when necessary;

(3) Facilitate communication within

the region to foster opportunities to

promote the exchange of information

among health care providers;

(4) Increase awareness about the

prevention of complications by

promoting prevention services and

programs within the region among

community-based organizations (CBOs)

and persons with bleeding disorders to

identify new patients eligible for care,

and to reestablish contact with patients

lost to follow-up;

(5) Facilitate collaborative program

development, planning, and

communication between the region’s

HTCs and chapter or other consumer

organizations to promote referral to the

centers and provide access to

educational and support services;

(6) Encourage expansion of HTC

populations to include services to

women with bleeding disorders and

develop programs to identify under

served populations including minorities

and women;

(7) Coordinate development of HTC

program plans, goals and objectives, and

progress tracking and reporting for

HTCs in the region;

(8) Facilitate access to appropriate

training resources and opportunities to

orient new HTC personnel, and enhance

the skills of current HTC personnel to

increase the quality of prevention

services; and

(9) Coordinate, annually or biannually, with CDC participation, a

regional meeting for HTCs and CBOs or

ad hoc consumer consultation

committees to share information and

plan programs. Regional meetings may

be jointly sponsored with other regions

that have similar needs.

b. The regional core centers should

develop and coordinate a plan where

HTCs within the region would:

(1) Provide comprehensive prevention

services to persons with bleeding

disorders directed at attaining and

measuring specific outcomes to reduce

complications by using a multidisciplinary team approach. HTC

services are provided by a multidisciplinary team. The core team

includes: adult or pediatric

hematologist, nurse coordinator, social

worker and physical therapist. HTC

services include medical and psychosocial assessment and monitoring, home

therapy teaching and monitoring,

infectious disease management,

physical therapy, dental services,

rehabilitation and support services. The

HTC team works closely with other

specialists and local health care

providers to meet specific needs of

persons with bleeding disorders to

increase quality of life from birth

throughout life, and assist individuals

with the prevention and management of

complications.

(2) Assess unmet needs and under

served populations, including

minorities and women, participate in

outreach efforts to identify patients who

can benefit from prevention services,

and encourage patient participation in

HTCs;

(3) Develop mechanisms to deliver

prevention programs, messages, and

materials to persons with hemophilia

and their family members;

(4) Participate in CDC surveillance

efforts (including the Universal Data

Collection Program, Creutz-feldt Jakob

Disease (CJD) Program, investigations of

sero-conversions and suspected

bloodborne agents) and other data

collection and surveillance efforts by

complying with federal and other

required regulations and offering

programs to all active eligible patients;

(5) Advise CDC of any patients who

have become infected with HIV or

hepatitis A, B, or C viruses (HAV, HBV,

or HCV), possibly as a result of

contaminated clotting factor

concentrates;

(6) Obtain approval from local

Institutional Review Board (IRB) for all

protocols. Obtain appropriate

assurances as required by Office of

Human Research Protections (OHRP),

OPHS, DHHS. Develop and maintain

strict policies on protecting the

confidentiality of patients, and ensure

the security of databases and other

records through controlled access to

areas with confidential information,

database password protection, locking

file cabinets, and other security features;

and

(7) Establish mechanism for consumer

input and involvement in planning,

implementing, and assessing HTC

prevention activities that include

education and outreach by collaborating

with local community based hemophilia

consumer organizations, or ad hoc

consumer consultation committee.

2. CDC Activities

a. Assist in determining priority areas

and long-term goals for prevention of

complications of hemophilia as a

collaborative effort by encouraging

regional core centers to seek input from

providers, CBOs and consumer

representatives.

b. Provide consultation, scientific and

technical assistance in planning,

implementing, and evaluating activities

to prevent the complications of

hemophilia by using surveillance data

to develop interventions and assess

their effectiveness, coordinate the

development, implementation, and

evaluation of prevention intervention

protocols.

c. Assist in the development of

research protocols for IRB review by

CDC and 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.

d. Assist in the analysis and reporting

of aggregate clinical outcomes data,

coordinate and consolidate the transfer

of tabulated data, analyses, and

conclusions among participating HTCs.

e. Provide follow-up and technical

assistance to HTCs implementing

changes or recommendations resulting

from program evaluations, assessments,

or activities required to meet required

federal and other regulations;

f. Provide information and feedback

regularly via teleconference, email and

in person meetings to regional

coordinators and regional directors

serving as liaisons to CDC and their

respective regional HTCs.

g. Provide technical assistance and

coordinate routine annual testing of

patient samples for HAV, HBV, HCV,

and reporting of results back to HTCs.

Provide technical assistance to

designated laboratory for permanent

storage of blood samples.

Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices 22581

h. Collaborate with HTCs and

appropriate State or local health

departments to investigate any

suspected HIV, HAV, HBV, HCV

seroconversions or other reported

potential bloodborne agents.

i. Collaborate with Regional

Coordinators, National Hemophilia

Foundation, HTC personnel, consumers,

and designated training centers to

develop and provide training resources

for providers and consumers.

j. Disseminate current information

related to the development,

implementation, and evaluation of these

regional programs to the funded HTCs

and the public as necessary and as

requested.

k. Facilitate collaborative research

efforts among HTCs to enhance the

quality of life of persons with bleeding

disorders.

E. Applications

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.

Budgetary Information

Include all major cost items for

implementing the proposed program for

twelve months. Submit line-item

descriptive justifications for personnel,

travel, supplies, and other services on

Standard Form 424A, ‘‘Budget

Information’’, provided with PHS 5161–

1 (Revised 6/99). Separate budgets

should be submitted for the regional

core center and each HTC performance

site that is included in the regional

application, plus a totaled budget

request for the region.

If the regional core center also serves

as an HTC performance site providing

prevention services to patients, provide

a separate budget for related costs. For

each HTC performance site request,

include the name and address of the

person and organization to receive the

contract, as well as a detailed line-item

descriptive justification.

Each applicant must provide a brief

listing of budgetary requests included in

its FY 2001 HRSA HTC comprehensive

care grant application, specifying

personnel, service, and other costs that

are anticipated to be funded by HRSA

for the twelve-month period. A budget

guidance and preferred format will be

included in the application kit.

Supporting Materials

1. Letters of agreement from all

contracting or voluntary collaborating

HTCs in region detailing specific roles

and responsibilities of each party.

2. Letters of support from local

consumer organizations representing

areas coinciding with HTCs included in

application. If areas do not have existing

consumer organizations, include letters

of support from local consumer leaders

indicating their willingness to

collaborate in prevention programming.

3. Copies of policies protecting the

confidentiality of persons with

hemophilia and the security of patient

information and records. A copy of the

local IRB approval letter, copy of

consent form, and assurance

information (multiple project assurance

number, single project assurance

approval letter or signed collaborative

inter-institutional amendment) for the

regional core center and each

participating HTC.

F. Submission and Deadline

Submit the original and three copies

of PHS 5161–1 (OMB Number 0937–

0189). Forms are available in the

application kit and at the following

Internet address: www.cdc.gov/od/pgo/

forminfo.htm. On or before June 15,

2001, 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 evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Background and need (20 Points

Total)

a. The extent to which the applicant

describes the regional hemophilia

population in terms of known

morbidity, demographics, sources of

care, and experience in data collection

and surveillance. (10 points)

b. The extent to which the applicant

identifies significant problems

experienced by the hemophilia

community, and how this regional

network of HTCs can appropriately

address the issues of the target

community. (10 points)

2. Goals and Objectives (20 Points)

The extent to which the applicant has

included goals which are relevant to the

purpose of the proposal and feasible to

be accomplished during the project

period, and the extent to which these

are specific and measurable. The extent

to which the applicant has included

objectives which are feasible to be

accomplished during the budget period,

and which address all activities

necessary to accomplish the purpose of

the proposal. The extent to which the

objectives are specific, time-phased, and

measurable.

3. Methods and Activities (50 Points

Total)

The extent to which the applicant

provides:

a. A detailed description of proposed

activities and methods used to

accomplish each objective within the

time frame indicated. (15 points)

b. A description of how proposed

methods will provide valid and reliable

outcomes needed to accomplish

proposed objectives. (10 points)

c. A description of the limitations and

anticipated implementation barriers of

the principal methods, and how these

problems are expected to be resolved.

(15 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: (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. (10 points)

4. Program Management and Evaluation

(10 Points)

The extent to which the management

systems and specific plans of evaluation

22582 Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices

were used to ensure sufficient progress

towards achievement of proposed goals

and objectives are discussed. The extent

to how HTC performance sites were

selected is discussed. The extent that

the types, frequency, and methods of

evaluation were used are described. The

extent to how the above information

will be used to improve or redirect

program operations is explained.

5. Budget (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with stated

objectives and planned program

activities.

6. Human Subjects (Not Scored)

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 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 report and

performance report, no more than 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist with a copy to

the Project Officer 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 Review

AR–8 Public Health System Reporting

Requirements

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

sections 301(a)(42 U.S.C. 241 (a)) and

317(k)(2)(42 U.S.C. 247b(k)(2)) of the

Public Health Service Act, 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 home page

Internet address—http://www.cdc.gov

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

Cooperative Agreements.’’

To obtain business management

technical assistance, contact: Merlin

Williams, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Room 3000, 2920 Brandywine Road,

Mailstop K–75, Atlanta, GA 30341–

4146, Telephone number: 770–488–

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

For program technical assistance,

contact: Sally O. Crudder, Director,

Hemophilia Treatment Center Program,

Hematologic Diseases Branch, National

Center for Infectious Diseases, Centers

for Diseases Control and Prevention,

1600 Clifton Road, Mailstop E–64,

Atlanta, GA 30333, Ph: 404–371–5270

or 5903, Email: sic4@cdc.gov

Dated: April 30, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11217 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01071]

National Health Promotion and

Information Center for People With

Paralysis; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program to establish a National Health

Promotion and Information Center

(NHPIC) for People with Paralysis.

The purpose of this cooperative

agreement is to develop and expand

national efforts for the prevention of

secondary conditions and

complications, and to improve

outcomes and the quality of life for

people living with paralysis from

multiple causes.

B. Eligible Applicant

Assistance will only be provided to

the Christopher Reeve Paralysis

Foundation. No other applications are

solicited. FY 2001 Federal

appropriations specifically direct CDC

to award funds to this organization.

C. Availability of Funds

Approximately $1,568,000 is available

in FY 2001 to fund this award. It is

expected that the award will begin on or

about September 30, 2001, and will be

made for a 12 month budget period

within a one year project period.

D. Where To Obtain Additional

Information

This and other CDC announcements

may be found on the CDC home page on

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

To obtain business management

technical assistance may be obtained

from: Nancy Pillar, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office Centers

for Disease Control and Prevention

(CDC), 2920 Brandywine Road, Room

3000, Mailstop E–13, Atlanta, Georgia

30341–4146, Telephone: (770) 488–

2710, E-Mail address: nfp6@cdc.gov.

General program assistance can be

obtained from: Joseph B. Smith, Senior

Project Officer, Disability and Health

Branch, National Center for Birth

Defects and Developmental Disabilities,

Disability and Health Branch, 4770

Buford Highway, Building 101, Mailstop

F–35, Atlanta, Georgia 30341,

Telephone: (770) 488–7082, E-Mail

address: jos4@cdc.gov.

Dated: April 30, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11216 Filed 5–3–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01072]

Public Health Laboratory

Biomonitoring Planning Grant; Notice

of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a grant program to promote

planning for the development,

implementation, and expansion of StateVerDate 11<MAY>2000 17:31 May 03, 2001 Jkt 194001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM pfrm10 PsN: 04MYN1