Federal Register / Vol. 63, No. 131 /Thursday, July 9, 1998 / Notices 37121

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 318 and 318A of the Public

Health Service Act, 42 U.S.C. sections

247c and 247c–1, as amended. The

Catalog of Federal Domestic Assistance

number is 93.941.

J. Where To Obtain Additional

Information

A complete program description,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from Kathy Raible, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE, Room 300, Mail

Stop E–15, Atlanta, Georgia 30305,

telephone (404) 842–6649, or via email

at: <kcr8@cdc.gov>.

Programmatic technical assistance

may be obtained from Julie Schillinger,

MD, MSc, Division of STD Prevention,

NCHSTP, CDC, 1600 Clifton Road;

Mailstop E–02, Atlanta, Georgia 30333,

telephone (404) 639–8368, or via email

at: <jus8@cdc.gov>.

This and other CDC announcements

can be found on the CDC homepage

(http://www.cdc.gov) under the

‘‘Funding’’ section. For your

convenience, you may be able to

retrieve a copy of the PHS Form 398

from (http://www.nih.gov/grants/

funding/phs398/phs398.html).

Please Refer to Announcement Number

98094 When Requesting Information and

Submitting an Application.

CDC will not send application kits by

facsimile or express mail.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: July 2, 1998.

John L. Williams,

Director, Procurement and Grants Office.

[FR Doc. 98–18199 Filed 7–8–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 98097]

Behavioral Intervention Research on

The Prevention of Sexual

Transmission of HIV By HIVSeropositive Men Who Have Sex With

Men

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for a cooperative agreement

program for the prevention of HIV

transmission by HIV-seropositive men.

This program addresses the ‘‘Healthy

People 2000’’ priority area Human

Immunodeficiency Virus (HIV)

Infection.

The purpose of this program is to

support research evaluating the outcome

of interventions based on formative

research that reduce the spread of HIV

by men who have sex with men who

know they are HIV seropositive.

Consistent with this goal, funding under

this program will support a randomized

controlled trial to evaluate the

effectiveness of intervention activities

designed to motivate and support HIVseropositive men who have sex with

men in sustaining sexual practices that

reduce the risk and prevent HIV

transmission to partners who are seronegative or of unknown serostatus.

The intervention proposed for the

trial must be based on formative

research, behavioral theory, and results

of prior pilot evaluations. Because of the

differential impact of HIV on men of

color, both the prior formative research

and the proposed intervention trial must

be based on samples in which the

majority of participants are men of

color. The ultimate goal of this research

is the identification of successful

intervention strategies for HIVseropositive men who have sex with

men that are appropriate for

implementation in community settings

(e.g., local health departments,

community-based organizations, health

maintenance organizations) and that are

suitable for replication in other

community settings.

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, hospitals,

other public and private nonprofit

organizations, state and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations. 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.

1. Funding Preference

This announcement is for behavioral

intervention studies that build upon

formative research findings regarding

transmission risk among HIVseropositive men who have sex with

men. Because of the differential impact

of HIV among men of color, preference

will be given to applicants with

documented ability to recruit research

samples of HIV-seropositive men who

have sex with men in which the

majority of participants are men of

color. In order to ensure the success of

the proposed project, it is essential that

applicants have access to sufficient

numbers of HIV-seropositive men who

have sex with men. Therefore,

preference will also be given to

applications from metropolitan areas

having a 1997 AIDS incidence rate

exceeding 50 per 100,000.

2. Funding Priorities

This announcement is for behavioral

intervention studies that build upon

research findings regarding transmission

risk among HIV-seropositive men who

have sex with men. This announcement

will support behavioral intervention

studies that build upon research

findings regarding transmission risk

among HIV-seropositive men from

formative studies. This new research

initiative will lead to the development

of effective, feasible, and sustainable

interventions that reduce the spread of

HIV by men who know they are HIV

seropositive. Consistent with this goal,

funding under this program will support

a randomized controlled trial to

evaluate the effectiveness of

intervention activities designed to

motivate and support HIV-seropositive

men who have sex with men in

sustaining sexual practices that reduce

the risk and prevent HIV transmission to

partners who are sero-negative or of

unknown serostatus.

C. Availability of Funds

Approximately $800,000 is available

in FY 1998 to fund two awards. It is

expected that the average award will be

$400,000. Awards are expected to begin

on or about September 30, 1998, and
37122 Federal Register / Vol. 63, No. 131 /Thursday, July 9, 1998 / Notices

will be made for a 12-month budget

period within a project period of up to

three years. The funding estimate is

subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress 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

identified under Recipient Activities

below and CDC will be responsible for

the activities identified under CDC

Activities below:

Recipient Activities

a. Develop research and intervention

protocols and data collection

instruments appropriate to conduct a

randomized controlled intervention

trial.

b. Establish procedures to maintain

the rights and confidentiality of all

study participants, including review of

research activities by recipient’s and

CDC’s Institutional Review Board (IRB).

c. Identify, recruit, obtain informed

consent, and enroll an adequate number

of research participants according to

procedures specified in the study

protocol.

d. Conduct intervention sessions,

interviews, and other assessments

according to the research protocol.

e. Summarize data and conduct data

analyses.

f. Disseminate research findings in

peer-reviewed journals and at

professional meetings.

CDC Activities

a. Provide scientific and technical

assistance in the design and

development of the research, and

evaluation protocols, selection of

measures and instruments, operational

plans and objectives, and data analysis

strategies.

b. Provide scientific and technical

coordination of the general operation of

the research project, including data

management support.

c. Participate in the analysis of data

gathered from program activities and the

reporting of results.

d. Conduct site visits to assess

program progress.

e. Assist 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

The application may not exceed 30

double-spaced pages in length,

excluding appendices (The appendices

are the appropriate location for

intervention protocols, references, and

memoranda of agreement documenting

collaboration with other agencies).

Provide a one-page abstract of the

proposal. Number all pages clearly and

sequentially and include a complete

index to the application and its

appendices. Submit the original and

each copy of the application

UNSTAPLED and UNBOUND. Print all

material, double spaced, in a 12-point or

larger font on 81⁄2′′ by 11′′ paper, with

at least 1′′ margins and printed on one

side only.

Use the following outline.

1. Ability To Recruit HIV-Seropositive

Men

a. Describe methods previously used

to recruit community-based research

samples of HIV seropositive men who

have sex with men;

b. Describe the differential success of

various recruitment strategies;

c. Describe the ethnic/racial

background of participants in the

research sample(s).

2. Formative Research With HIVSeropositive Men

a. Describe methods used to collect

qualitative and quantitative formative

data regarding the HIV transmission risk

and its determinants among HIVseropositive men who have sex with

men;

b. Summarize findings from the

formative research phase, highlighting

those with special relevance for the

design of HIV prevention efforts;

c. Attach copies of all abstracts,

presentations, and manuscripts that

describe findings from the formative

research phase;

d. Discuss ways in which HIVseropositive men and their advocates or

service providers were involved in the

formative research phase.

3. Intervention Research Plan

a. Describe the hypotheses and

outcomes that will be addressed as part

of the intervention trial;

b. Describe the characteristics of HIVseropositive men who have sex with

men in the proposed study population

and define the specific subgroups of

HIV-seropositive men that will be the

primary focus of the proposed research.

Using available data, provide a rationale

for any focus on specific population

subgroups. Document ability to recruit

sufficient numbers of men from the

proposed target population;

c. Describe the research design and

methods that will be employed in the

intervention trial. Include information

about randomization procedures,

statistical power to detect hypothesized

differences, primary (behavioral and

biological) and secondary (relevant

mediating variables) outcome measures,

the reliability and validity of measures

that will be used, and procedures for

maximizing external and internal

validity (e.g., sampling strategies and

retention procedures, respectively);

d. Provide a detailed description of all

intervention and comparison conditions

that are proposed for the trial and give

a rationale for each. Clearly specify the

way in which proposed intervention

activities are based on findings from the

formative research and behavioral

theory (include the intervention

curriculum in the Appendix;

e. Describe procedures for involving

the target population and their

advocates or service providers in the

design of research and intervention

activities;

(1) State whether the plans for

recruitment and outreach for study

participants include the process of

establishing partnerships with

communities and recognition of mutual

benefits will be documented.

(2) Describe the proposed plan for the

inclusion of racial and ethnic minority

populations for appropriate

representation.

f. Describe procedures for obtaining

informed consent and maintaining

participant confidentiality and;

g. Describe plans to develop specific

documents necessary to replicate the

intervention and to disseminate study

findings to community and scientific

audiences.

4. Research and Intervention Capability

a. Describe the research team and

organizational setting;

b. Describe the professional training

and relevant research experience of all

staff;

c. Include in the appendix,

memoranda of agreement that clearly

and specifically document activities to

be performed by any external experts,

consultants, or collaborating agencies

under the cooperative agreement.

5. Staffing, Facilities, And Time Line

a. Explain the proposed staffing,

percentage of time each staff member

commits to this and other projects, and

division of duties and responsibilities

for the project;

b. Describe support activities such as

project oversight or data management

that will contribute to the completion of

all research activities;
Federal Register / Vol. 63, No. 131 /Thursday, July 9, 1998 / Notices 37123

c. Describe existing facilities,

equipment, computer software, and data

processing capacity;

d. Describe the procedures to ensure

the security of research data and;

e. Provide a time line for the

completion of the proposed research.

6. Budget

Provide a detailed, line-item budget

for the project and a budget narrative

that justifies each line-item.

F. Submission and Deadline

Submit the original and five copies of

PHS–398 (OMB Number 0925–0001)

(adhere to the instructions on the Errata

Instruction Sheet for PHS 398). Forms

are in the application kit.

On or before August 24, 1998, submit

the application to: Julia Valentine,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement 98097,

Centers for Disease Control and

Prevention (CDC), Room 300, 255 East

Paces Ferry Road, NE, M/S E15, Atlanta,

Georgia 30305–2209.

If your application does not arrive in

time for submission to the independent

review group, it will not be considered

in the current competition unless you

can provide proof that you mailed it on

or before the deadline (i.e., receipt from

U.S. Postal Service or a commercial

carrier; private metered postmarks are

not acceptable).

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Ability To Recruit HIV-Seropositive

Men Who Have Sex With Men (20

points)

a. Quality and diversity of methods

used to recruit community-based

sample(s) of HIV-seropositive men who

have sex with men;

b. Ability of applicant to provide data

regarding the relative effectiveness of

various strategies to recruit communitybased samples of HIV-seropositive men

who have sex with men;

c. Documented ability to recruit a

research sample of HIV-seropositive

men who have sex with men in which

the majority of participants are men of

color.

2. Familiarity With And Access to HIVSeropositive Men (35 points)

a. Quality of the description of

methods used to collect qualitative and

quantitative data during formative

research phase, including the

documented ability to recruit adequate

numbers of study participants;

b. Extent to which findings from the

applicant’s formative research

demonstrates an in-depth understanding

of the formative data regarding the HIV

transmission risk, factors influencing

risk taking behaviors, as well as the

intervention and service needs of the

proposed study population;

c. Extent to which the applicant has

disseminated formative research

findings regarding HIV-seropositive men

who have sex with men to appropriate

scientific and community audiences;

d. Quality and depth of the strategies

used to involve and solicit input from

a diverse group of HIV-seropositive

men, their advocates, or service

providers.

3. Intervention Research Plan (30

points)

a. Appropriateness of the proposed

research hypotheses and intervention

outcome measures;

b. Suitability of the proposed

intervention subgroups and documented

ability to recruit sufficient numbers of

men who have sex with men from the

proposed study population;

c. Quality and scientific rigor of the

research design and methods that will

be employed in the intervention trial;

d. Quality of the rationale and

curricula for the intervention and

comparison conditions, including the

extent to which the proposed

intervention activities are based on

findings from the formative research

and behavioral theory;

e. Extent to which the target

population, their advocates, or service

providers will be involved in the design

of research and intervention activities;

f. Adequacy of procedures for

obtaining informed consent and

maintaining participant confidentiality

and;

g. Quality of plans to develop

appropriate materials for intervention

replication and to disseminate study

findings to community and scientific

audiences.

4. Research and Intervention Capability

(5 points)

a. Applicant’s ability to carry out the

proposed research as demonstrated by

the training and experience of the

proposed research team and

organizational setting;

b. Ability of the applicant to conduct

the proposed research as reflected in the

training, research, and behavioral

intervention experience of staff

members and;

c. Extent to which services to be

provided by external experts,

consultants, or collaborating agencies

are documented by memoranda of

agreement in the appendix.

5. Staffing, Facilities, And Time Line (5

points)

a. Availability of qualified and

experienced personnel with sufficient

time dedicated to the proposed project.

Presence of behavioral scientists in key

leadership positions on the project;

b. Clarity of the described duties and

responsibilities of project personnel;

c. Adequacy of the facilities,

equipment, data management resources,

and systems for ensuring data security

and;

d. Specificity and reasonableness of

time line.

6. The Degree to Which the Applicant

Has Met the CDC Policy Requirements

Regarding the Inclusion of Ethnic and

Racial Groups in the Proposed Research

(5 points)

This includes:

a. The proposed plan for the inclusion

of racial and ethnic minority

populations for appropriate

representation;

b. The proposed justification when

representation is limited or absent;

c. A statement as to whether the

design of the study is adequate to

measure differences when warranted;

d. A statement as to whether the plans

for recruitment and outreach for study

participants include the process of

establishing partnerships with

communities and recognition of mutual

benefits.

7. Does the Application Adequately

Address the Requirements of Title 45

CFR Part 46 For The Protection of

Human Subjects?

ll YES ll No

Comments: llllll

8. Budget (not scored)

Extent to which the budget is

reasonable, itemized, clearly justified,

and consistent with the intended use of

funds.

H. Other Requirements

1. Technical Reporting Requirements

Provide CDC with original plus two

copies of

a. Semi-annual progress reports, no

more than 30 days after the end of each

reporting period. The progress reports

must include the following for each

program, function, or activity involved:

(1) A comparison of accomplishments

of the goals established for the period;

(2) Reasons that any goals were not

met and;

(3) A description of steps taken to

overcome barriers to the goals for the

period.
37124 Federal Register / Vol. 63, No. 131 /Thursday, July 9, 1998 / Notices

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to: Julia Valentine,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), Room

300, 255 East Paces Ferry Road, NE, M/

S E–15, Atlanta, GA 30305–2209.

4. The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachments.

AR98–1 Human Subjects Requirements

AR98–2 Requirements for Inclusion of

Racial and Ethnic Minorities in Research

AR98–4 HIV/AIDS Confidentiality

Provisions

AR98–5 HIV Program Review Panel

Requirements

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

Section 301 and 317(k)(2), of the Public

Health Service Act (42 U.S.C. 241 and

247b(k)(2)) as amended. The Catalog of

Federal Domestic Assistance number is

93.941.

J. Where to Obtain Additional

Information

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: Julia

Valentine, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE,

Room 300, Mailstop E–15, Atlanta, GA

30305, telephone: (404) 842–6871;

Email JXV1@CDC.GOV.

Programmatic technical assistance

may be obtained from: Robert

Kohmescher Division of HIV/AIDS

Prevention, National Center for HIV/

STD/TB Prevention, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE, Mailstop E–44,

Atlanta, GA 30333, telephone (404)

639–8302 Email RNK1@CDC.GOV.

This announcement will be available

on CDC’s home page at http://

www.cdc.gov.

John L. Williams,

Director, Procurement and Grants Office.

[FR Doc. 98–18200 Filed 7–8–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 98081]

Notice of Availability of Fiscal Year

1998 Funds National Diabetes

Prevention Center

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for a cooperative agreement

program for a National Diabetes

Prevention Center whose functions will

be to provide guidance and technical

support regarding diabetes mellitus

(DM) in Native American communities

throughout the United States. Initial

activities will target the challenges of

DM in the Navajo Nation and the Zuni

Pueblo tribe in the southwestern United

States. If, and as additional funds

become available, it is CDC’s intent to

expand this program to other Native

American populations through

collaboration with other federal

agencies, such as, Indian Health Service

(IHS). This program addresses the

‘‘Healthy People 2000’’ priority area(s)

of Diabetes and Chronic Disabling

Conditions. Native American

populations have a high incidence and

prevalence of diabetes and diabetes

complications. The purpose of this

initiative is to establish a National

Diabetes Prevention Center in Gallup,

New Mexico, that will serve as a focal

point for developing and testing new

prevention and control strategies to

address the burden of diabetes in Native

Americans. Components of the center

will include, but are not limited to,

systematic community needs

assessment, design, and development of

coherent, theory-based community

programs, implementation of

community interventions, and focused

interventional research, surveillance,

program evaluation, health professional

and community training, and tribal

capacity building activities for diabetes

prevention and control. The goal is to

develop, evaluate and disseminate

culturally relevant community based

public health prevention strategies for

Native Americans. It is envisioned that

documented experiences, qualitative,

and quantitative research findings,

strategies, and benefits from all center

activities including initial targeted

programs, will ultimately be applicable

to other Indian tribes and similar

populations. All these activities will

require established experiences in

qualitative and quantitative assessment,

creative theory-based program

development, systematic program

evaluation, and management and

supervisory activities. Cooperative

partnerships will be important in center

activities.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and governments and

their agencies. Thus, universities,

colleges, research institutions, hospitals,

other public and private organizations,

including State and local governments

or their bona fide agents, federally

recognized Indian tribal governments,

Indian tribes or Indian tribal

organizations may apply.

Congress, through the Departments of

Labor, Health and Human Services,

Education, and Related Agencies

Appropriations Act, H.R. 2264, 1998

Conference Report, page S–12088

directed CDC to establish a National

Diabetes Prevention Center in Gallup,

New Mexico, with initial activities

involving and targeting the Navajo

Nation and Zuni Pueblo tribe in the

southwest U.S.

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 $2.3 million is

available in FY 1998 to fund this

program. It is expected that this one

award will begin on or about September

30, 1998, and will be made for a 12-

month budget period within a project

period of up to five 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.