Prevention of HIV Infection in Youth at Risk: Developing Community-Level Strategies That Work

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 601]

Prevention of HIV Infection in Youth at Risk: Developing

Community-Level Strategies That Work

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

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availability of fiscal year (FY) 1996 funds for a cooperative agreement

program for the prevention of HIV infection in youth at risk.

CDC is committed to achieving the health promotion and disease

prevention objectives of ``Healthy People 2000,'' a national activity

to reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of Human Immunodeficiency

Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,''

see the section ``WHERE TO OBTAIN ADDITIONAL INFORMATION.'')

Authority

This program is authorized under Sections 301 and 317(k)(2), of the

Public Service Health Act (42 U.S.C. 241 and 247b(k)(2)) as amended.

Smoke-Free Workplace

CDC strongly encourages all recipients to provide a smoke-free

workplace and to promote the nonuse of all tobacco products, and Public

Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain

facilities that receive Federal funds in which education, library, day

care, health care, and early childhood development services are

provided to children.

Eligible Applicants

Applications may be submitted by public and private, nonprofit and

for-profit organizations and governments and their agencies. Thus,

universities, colleges, research institutes, hospitals, other public

and private organizations, State and local health departments or their

bona fide agents or instrumentalities, federally recognized Indian

tribal governments, Indian tribes or Indian tribal organizations, and

small, minority- and/or women-owned businesses are eligible to apply.

Each applicant must demonstrate collaboration with community-based

organizations (CBOs) that have histories of familiarity with, access

to, and success working with the target population. Collaboration with

CBOs will be demonstrated through letters from the organizations

stating their willingness to participate in the proposed project. It is

the intention of this announcement to stimulate collaborative,

interdisciplinary research between research institutions and public

health agencies and CBOs; therefore, applications by agencies taking

the lead with teams composed of collaborators from each of the other

entities are encouraged. The application should be submitted by the

lead institution, agency, or organization. Applicants who have

conducted formative research on the target population are encouraged to

apply.

Note: Organizations described in section 501(c)(4) of the

Internal Revenue Code of 1986 that engage in lobbying are not

eligible to receive Federal grant/cooperative agreement funds.

Availability of Funds

Approximately $2.8 million will be available in FY 1996 to fund

approximately six awards. It is expected that the average award will be

$500,000, ranging from $400,000 to $900,000. Awards are expected to

begin on or about September 30, 1996, and will be made for a 12-month

budget period within a project period of up to five years (two years

for all Phase I recipients and three additional years for successful

recipients of Phase II. Approximately three Phase I recipients will

receive Phase II funding through a competitive announcement). Funding

estimates may vary and are subject to change.

Phase II competition will in part include the following factors:

1. Have completed their formative research and summaries, pilot-

testing, data reduction, and final Phase I report;

2. Have established access to the target population in sufficient

numbers to provide meaningful sample sizes for intervention and control

areas;

3. Have demonstrated that their proposed catchment areas are

minimally affected by confounding factors of competing interventions

and research;

4. Have demonstrated data collection and analysis capacity to

execute the protocols for data analysis and evaluation of impact;

5. Be able to implement the common intervention selected through

consensus, including having a sufficient number of trained staff to

devote full-time to the intervention and;

6. Have written the final draft of at least one publication on

Phase I data.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Definitions

Youths are defined as persons 15 to 25 years of age. Men who have

sex with men (MSM) are men who have sex with men, regardless of their

declared sexual identity. Young men who have sex with men (YMSM) are

males 15 to 25 years of age who have sex with other males, express

intention to have sex with other males, or acknowledge sexual

attraction to other males. Communities can be groups defined by

behavior (sexual orientation, IV drug use), by identification

(ethnicity, sexual identity), by geographic boundaries, or by places

where people are available for education (schools, prisons). Catchment

area is the contiguous geographic area that encompasses at least one

access site and that is distinct in geography and population

membership. Access site is a location within a catchment area where the

target population congregates and is available for intervention.

Community-level intervention is an approach to HIV prevention that (1)

Results from a mobilization of community members and institutions; (2)

can be expected to reach a large proportion of the population at risk

in their daily setting; (3) may involve the use of outreach and

facility-based services; and (4) can be expected to alter individual

behaviors and community norms. Community assessment is the systematic

collection and critical analysis of data to determine the adequacy and

effectiveness of specific services, infrastructure, and formal and

informal resources available to a community. Multi-site is defined as

the same or similar intervention, sampling methods and measurements

used in multiple sites, but does not imply a nationally representative

sample of sites.

Purpose

This program is to conduct research that will develop and evaluate

approaches to encourage youth who engage in risky behaviors associated

with HIV acquisition and transmission to change these behaviors. This

program also seeks to develop methods that may build on evaluated,

community-level intervention efforts, and where advisable, previous

work, but will focus entirely on YMSM, including those who are members

of racial or ethnic minorities.

Funds will be used in two phases to develop, implement, analyze,

and evaluate an effective community-level behavioral change

intervention, with potential for sustainability, to prevent HIV in YMSM

who engage in high-risk behaviors related to the acquisition and

transmission of HIV.

Phase I of the research program will focus on formative research to

characterize populations, identify constraints on and opportunities for

behavior change, and identify components of a targeted intervention and

determine its feasibility. Approximately six awards will be made for a

12-month budget period within a project period of up to two years.

Phase II of the research program will focus on the implementation

of a common intervention protocol, randomization of catchment areas,

and

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systematic analysis and evaluation of the intervention's impact.

Eligible applicants for Phase II will be recipients of Phase I. Phase

II will be competitively announced. Approximately three awards will be

made for a 12-month budget period within a project period of up to

three years.

The intervention for this project will be based on the combined

formative research completed by award recipients in Phase I and will be

implemented in Phase II. Although CDC is not requiring proposals for

Phase II intervention activities at this time, a brief description of

Phase II is included here for the applicants' information. In the first

eight months of Phase II, recipients will conduct two to three baseline

assessments. The recipients then will implement, analyze, and evaluate

the impact of the community-level intervention. Examples of behaviors

that may be appropriate for the intervention to address are:

1. Maintaining abstinence;

2. Reducing high-risk sexual behaviors among sexually active YMSM

and;

3. Using barrier methods when engaging in sexual activity.

By the end of the 5-year project, recipients and participating

agencies will produce guidelines for technology transfer of the

intervention to control sites and other interested organizations.

Recipients are also encouraged to assist participating agencies in

developing the skills to sustain successful intervention components

after the study.

Applicants must agree to follow the intervention and implementation

protocol developed jointly by recipients with input from CDC project

officers. It is anticipated that the Phase II protocol for

intervention, analysis, and evaluation will be a common protocol with

many components that are applicable to all study areas. Such a protocol

also will permit tailoring to individual communities to accommodate

variations (e.g., cultural, geographic) among them. YMSM representing

diverse segments of the target population should participate actively

in research and intervention design and review in Phase I and Phase II.

Program Requirements

Work performed under this agreement will be the result of

collaborative efforts among recipients, resulting in common protocols

and methods across sites. Individual recipients will be responsible for

research design, intervention development and implementation, data

collection and analysis, and publication. CDC will coordinate these

collaborative efforts and expects to work closely with each award

recipient.

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities under A.

(Recipient Activities), and CDC will be responsible for the activities

listed under B. (CDC Activities).

A. Recipient Activities

1. Characterize the HIV risk of the target population and any

subgroups in at least two matched catchment areas and prioritize the

subgroups according to probable risk and other criteria.

a. The recipient will have proposed in their application at least

two catchment areas that are matched in:

(1) Population demographic characteristics:

(2) Risk behaviors;

(3) Population sizes;

(4) Numbers of the same types of access sites (e.g., bars,

bookstores, parks) and;

(5) Other relevant variables.

b. During Phase I, the recipient will further study the proposed

catchment areas to finalize selection of catchment areas for conducting

the Phase II intervention:

(1) The selected catchment areas must be geographically discrete

and have less than 10% overlap of the target population in each area.

(2) The catchment areas will be places where (a) hundreds of

eligible subjects can be reached, (b) that have an estimated high HIV

seroprevalence rate among youth, and (c) that, ideally, have minimal

confounding factors introduced by ongoing or proposed HIV prevention

efforts.

(3) After Phase I, the catchment areas will be randomly assigned to

a study condition--the intervention or comparison.

c. The recipient will characterize the target population and any of

its subgroups in each catchment area.

d. The recipient will document, using whatever qualitative and

quantitative data are available, that the targeted populations and any

of their subgroups in the selected catchment areas are at risk for HIV

infection and will prioritize the subgroups according to the relative

risk.

e. The recipient will justify its identifications of catchment

areas, access sites, subgroup, and YMSM accessible at those sites in

terms of the potential to address the research goals of this program

announcement and in terms of ultimately translating the research

findings into HIV prevention activities among the target populations.

By the end of Phase I, the recipient will have finalized the

selection of a minimum of two matched catchment areas and conducted

research to justify the selection of catchment areas, determine the

demographic characterization of the target population and any

subgroups, and justify selection of a particular subgroup. The

recipient also will have identified sites within the catchment areas

where YMSM are accessible both for interviewing and for the

intervention and will have secured commitment of collaborating

organizations in these catchment areas and access sites to participate

in Phase II and to be randomly assigned to a research condition.

2. Conduct qualitative and quantitative behavioral research of YMSM

at risk in the study catchment areas.

a. The recipient will build a multi disciplinary research team and

program support capability:

(1) A multi disciplinary team should be assembled with the

appropriate expertise to undertake Phase I activities. Such a team will

include experienced senior researchers, technical staff, and support

staff and will be led by behavioral scientists;

(2) The team will have CBO members or collaborators and;

(3) The team will involve persons from the target population in

research and intervention design.

b. The recipient will develop a common protocol to conduct the

behavioral research:

(1) The research will include sexual behavior, partner

characteristics, social networks, substance abuse behavior, trading sex

for money or drugs, perceptions of social norms, attitudes, self-

efficacy, perceptions of current HIV interventions, health-care-seeking

behaviors, health-information-seeking behaviors, developmental issues

influencing the above, and structural influences on behavior to

identify which segments or subgroups of YMSM would be best served by

the intervention;

(2) Questionnaires and survey instruments will be constructed at a

literacy level appropriate to the target population;

(3) The research will involve members of the targeted population

and other community partners in determining which types, designs, and

deliveries of interventions would be (a) best accepted and most

influential in their communities, (b) most likely to work

synergistically with other community efforts, (c) most likely to

stimulate changes in community norms, and (d) most likely to be

sustained.

The recipient will demonstrate further understanding of factors

influencing the

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behavior of YMSM, document the participation of the target population

in the formative research design and their contribution in development

of the intervention to be pilot-tested, and propose a sound theoretical

and data-driven approach to influencing behaviors of YMSM.

3. Use an existing or develop and conduct a community assessment

and document HIV interventions and research involving the target

population in the catchment areas.

a. The purpose of the community assessment is to determine:

(1) Community-wide needs for HIV/AIDS prevention among YMSM;

(2) Existing and potential capacity;

(3) Available resources and;

(4) Current prevention efforts and further understand key issues

(e.g., identifying access sites, influences of political climate)

relevant to intervening with the target population.

b. Recipients will:

(1) Review community needs assessments and community planning

documents and;

(2) Summarize what is known about the proposed communities, and if

necessary, recipients will develop, in collaboration with CDC and other

recipients, a common assessment instrument to be implemented in Phase

I.

c. Part of the community assessment must include:

(1) The current activities and functions of the health department's

HIV program in the catchment areas;

(2) Implications of the formative research and potential

interventions on those activities and functions and;

(3) The HIV community planning priorities related to YMSM.

The recipient will have produced a summary synthesizing knowledge

of the community's HIV needs and planning, participated in cross-site

implementation of the assessment instrument, as appropriate, and

analyzed and reported the results of the assessment.

4. In partnership with persons from relevant communities, other

recipients, and CDC project officers, develop an appropriate community-

level intervention to reduce HIV risk behaviors in the target

population.

a. Recipients will collaborate in developing a common intervention

and research protocol for all recipients to implement in Phase II:

(1) The basis for the intervention should include (a) the

recipient's experience with the target population, (b) formative

research from Phase I, and (c) a review of current primary prevention

strategies and research;

(2) The intervention selection should be a logical result of

program requirements 4.a.(1)(a-c) above, but not be limited to their

exclusive consideration;

(3) The intervention approach should be culturally sensitive,

developmentally appropriate, and suitable for the target population's

literacy level and should stimulate community action, mobilization, and

adoption of a supportive environment and community norms and;

(4) An effective community-level intervention for these youth may

combine several elements, e.g., (a) efficient targeting of outreach,

(b) development of an environment supportive of long-term HIV/AIDS risk

reduction, and (c) links to local resources that encourage healthy

behaviors.

b. Local resources that encourage healthy behaviors may include:

(1) STD treatment and prevention services;

(2) Substance abuse treatment facilities;

(3) Shelters or drop-in facilities for runaway and homeless youth;

(4) Mental health clinics;

(5) Other health care facilities such as community health centers;

(6) Facilities ``without walls'' that provide outreach to street

youth and;

(7) Providers of foster care and supervised independent living.

c. Recipients will participate in monthly conference calls with CDC

project officers and other recipients.

d. Each recipient will travel to Atlanta or another location and

participate with other recipients and CDC representatives in four

meetings during Phase I. At one of these meetings, the Phase II

intervention design and protocols for pilot testing will be

established.

e. The protocols for the Phase II intervention will be finalized at

a later meeting.

At the end of Phase I, the recipient will have summarized

activities and participated in the development of a common

intervention, research protocol, operational plan, process and impact

objectives, analysis strategies, and evaluation instruments for Phase

II.

5. Through pilot-testing, determine the feasibility and

sustainability of implementing the proposed intervention, including

cost, acceptance, and participation by the target population.

a. During the second year of Phase I, components of the

collaboratively developed intervention will be pilot-tested by the

recipients to determine modifications in design, implementation, and

other relevant considerations.

These considerations may include:

(1) The likelihood that the intervention will change behavior among

YMSM;

(2) The probable level of acceptability of the intervention to the

target populations and to the communities around the intervention

access sites;

(3) The recipient's potential for recruiting, training, and

retaining intervention workers;

(4) The acceptability of intervention workers to the targeted

population;

(5) The likelihood that the intervention will stimulate changes in

community norms;

(6) Clarity of or difficulties with data collection instruments;

(7) The projected overall cost of the intervention component;

(8) The likelihood that the intervention can be maintained during

the entirety of Phase II;

(9) The likelihood that successful components of the intervention

will be institutionalized in the community after Phase II and;

(10) More effective ways for project staff to systematically focus

resources (i.e., financial and personnel).

b. Recipients with substantial, previously collected formative data

from their finalized catchment areas may pilot-test potential

intervention components in the first year of Phase I instead of

collecting additional formative data.

Recipients will have conducted and reported pilot-test results of

one or more components of the common intervention. The primary

expectation at the completion of Phase I is a finalized common protocol

for implementation, analysis, and evaluation, including validated

instruments, for a community-level intervention that can reasonably be

expected to influence behaviors related to HIV transmission in the

study population.

6. Recipients and CDC project officers collaboratively develop a

common research protocol for the proposed intervention to be conducted

during Phase II

a. The recipients, in collaboration with CDC, will select and

develop a common research protocol, including:

(1) A common research design;

(2) Operational plan and;

(3) Analysis and evaluation methods and instruments.

b. The protocol will include a within-catchment-area sampling

strategy and mechanisms for obtaining the consent and protecting the

confidentiality of study subjects.

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c. Analysis and evaluation plans will be developed concurrently

with intervention plans.

d. Recipients will establish a set of outcomes to determine the

effectiveness or impact of the intervention that are measurable, valid,

and reliable in terms of behavioral and social science theories. It is

expected that the evaluation will measure changes in behaviors,

intentions, and attitudes and the target population's awareness and

acceptance of the intervention.

e. To evaluate a common intervention, the recipients and CDC

project officers must:

(1) Reach consensus concerning the specific outcomes to target;

(2) Develop methods of measuring these outcomes, including common

data collection instruments and;

(3) Pilot-test measures and instruments.

Recipients will have established a common research protocol,

operational plan, process and impact objectives, and instruments for

systematically analyzing and evaluating the intervention in Phase II.

Each recipient must agree, if selected for continuation into Phase II,

to implement this common protocol and accept randomization of their

selected catchment areas (as specified above).

7. Manage, analyze, and interpret data.

a. Data from the Phase I activities must be collected, managed, and

stored securely and confidentially.

b. Recipients will use common computer and data management systems.

c. Recipients will be primarily responsible for site-specific

analyses.

d. Recipients will share data for aggregate analyses with CDC

project officers.

Recipients will have common computer and data management systems

and will have submitted the cleaned data on their intervention trials

to CDC project officers.

B. CDC Activities

1. Host a meeting of the recipients to plan the research program

(e.g., the format for community assessments). CDC will host

approximately three additional meetings of recipients during Phase I to

promote progress toward national objectives.

2. Act as mediator on the recipients' collaborative design or

selection of the assessment plan and instruments, research protocol,

operational plan, objectives, analysis strategies, and evaluation

instruments.

3. Provide technical assistance on pilot testing the common

intervention, or elements thereof, and on tailoring the collaboratively

designed, common intervention for local applications.

4. Provide scientific and technical coordination of the general

operation of this HIV prevention project and of the specific Phase I

activities in order to keep all recipients on track with the common

protocols and their timelines.

5. Conduct the random selection of intervention and control

catchment areas among those presented by each recipient, according to a

randomization protocol collaboratively determined by the recipients.

6. Coordinate cross-site aggregation of data and its analysis.

7. Conduct site visits to assess program progress and mutually

solve problems, as needed.

At approximately month 12 of the project, recipients and CDC

project officers will meet to design the common intervention and pilot

tests of its components. At approximately month 20 of the project,

recipients and CDC project officers will meet to finalize the common

intervention for Phase II. At approximately month 22 of the project,

applications for a competing continuation award for the implementation

and evaluation of community-level intervention (Phase II) will be due.

Supplementary guidance for Phase II awards will be provided to the

recipients of Phase I awards.

Evaluation Criteria

Applications will be reviewed and evaluated according to the

following criteria:

1. Applicant's Team (15 points)

The extent to which all items in the application content element

are addressed, including the extent to which the applicant has:

a. Involved other key organizations on the project team;

b. Clearly defined the responsibilities of these other

organizations;

c. Involved team members in planning and developing the application

and demonstrated their commitment to the project (as evidenced by

letters of support or memoranda of agreement) and;

d. Previously worked with other team members, including potential

CBO collaborators if they are not part of the team.

2. Research and Intervention Capability (20 points)

The extent to which all items in the application content element

are addressed:

a. Capacity of the applicant research team to conduct the proposed

research as evidenced by their previous related research;

b. Experience with multisite research designs and formative

research on MSM;

c. Extent of the team's familiarity with, access to, and good

working relations with MSM, as evidenced by service or research

involving this population and;

d. Capacity of the team to conduct behavioral interventions as

evidenced by description of their previous experience.

3. Identification of Catchment Areas (20 points)

The extent to which all items in the application content element

are addressed:

a. Extent to which the catchment areas meet matching criteria

(e.g., matched population demographics, risk behaviors, population

sizes that are similar and of sufficient size, access sites), and the

extent to which the matching was based on available data;

b. Extent to which the target populations within the catchment

areas have similar rates of HIV infection and the extent to which the

rates are based on available data and;

c. Thoroughness of description of potential conflict between the

proposed research and other research or prevention efforts in the

catchment areas.

4. Proposed Research Plan--Formative and Intervention (25 points)

The extent to which all items in the application content element

are addressed:

a. Quality of the proposed formative research plan, sampling

strategies, sample size estimates, power analysis, and mechanisms to

obtain subjects' consent and protect their confidentiality;

b. Appropriateness of the theoretical bases for the proposed

intervention;

c. Quality of the type of multi-site intervention proposed and its

likelihood to yield new insights on opportunities for long-term risk

reduction among the targeted population and;

d. Feasibility of the strategy to involve the target population and

affected communities in the research and intervention design and to

inform them of research results:

(1) The proposed plan for the inclusion of 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

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study participants include the process of establishing partnerships

with community(ies) and recognition of mutual benefits will be

documented.

5. Project Management (20 points):

The extent to which all items in the application content element

are addressed:

a. Adequacy of staffing to carry out proposed activities (i.e.,

sufficient in number, percentage of time commitments, behavioral

scientists in key project positions, and qualifications), as evidenced

by their curriculum vitae and position descriptions;

b. Adequacy of facilities, data processing and analysis capacity,

and systems for management of data security and participant

confidentiality and;

c. Extent to which the applicant demonstrates assurance of

compliance with the multisite research requirements (e.g.,

randomization of catchment areas and common protocol, data collection,

and computer and data management systems).

6. Budget (Not scored)

Extent to which the budget is reasonable, itemized, clearly

justified, and consistent with the intended use of the funds.

7. Human Subjects (Not scored)

The applicant must clearly state whether or not human subjects will

be used in research.

Funding Preferences

CDC's intention is to achieve a long-term health benefit for youth

at risk for HIV infection. This announcement is exclusively for

proposals that address HIV risk reduction for YMSM. Consideration will

be given to obtaining diversity of target population sub-groups and

geographic representation among proposals selected for funding. YMSM of

color are of particular interest.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets

up a system for State and local government review of proposed Federal

assistance applications. Applicants (other than federally recognized

Indian tribal governments) should contact their State Single Point of

Contact (SPOC) as early as possible to alert them to the prospective

applications and receive any necessary instructions on the State

process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC for each affected State. A

current list of SPOCs is included in the application kit. If SPOCs have

any State process recommendations on applications submitted to CDC,

they should send them to Van Malone, Grants Management Officer, Grants

Management Branch, Procurement and Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,

Mailstop E15, Atlanta, GA 30305, no later than 30 days after the

application deadline (the appropriation for this financial assistance

program was received late in the fiscal year and would not allow for an

application receipt date which would accommodate the 60-day State

recommendation process period). The granting agency does not guarantee

to ``accommodate or explain'' for State process recommendations it

receives after that date.

Indian tribes are strongly encouraged to request tribal government

review of the proposed application. If tribal governments have any

tribal process recommendations on applications submitted to the CDC,

they should forward them to Van Malone, Grants Management Officer,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later

than 30 days after the application deadline date. The granting agency

does not guarantee to ``accommodate or explain'' for tribal process

recommendations it receives after that date.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting

Requirements. Under these requirements, all community-based

nongovernmental applicants must prepare and submit the items identified

below to the head of the appropriate State and/or local health

agency(s) in the program area(s) that may be impacted by the proposed

project no later than the receipt date of the Federal application. The

appropriate State and/or local health agency is determined by the

applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled ``Public Health

System Impact Statement'' (PHSIS), not exceed one page, and include the

following:

1. A description of the population to be served;

2. A summary of the services to be provided; and

3. A description of the coordination plans with the appropriate

State and/or local health agencies.

If the State and/or local health official should desire a copy of

the entire application, it may be obtained from the Single Point of

Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.941.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by cooperative agreement will be subject to

review by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the Department of Health and Human Services

Regulations, 45 CFR Part 46, regarding the protection of human

subjects. Assurance must be provided to demonstrate that the project

will be subject to initial and continuing review by an appropriate

institutional review committee. In addition to other applicable

committees, Indian Health Service (IHS) institutional review committees

also must review the project if any component of IHS will be involved

or will support the research. If any American Indian community is

involved, its tribal government must also approve that portion of the

project applicable to it. The applicant will be responsible for

providing assurance in accordance with the appropriate guidelines and

form provided in the application kit.

Racial and Ethnic Minorities

It is the policy of the Centers for Disease Control and Prevention

(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)

to ensure that individuals of the various racial and ethnic groups will

be included in CDC/ATSDR-supported research projects involving human

subjects, whenever feasible and appropriate. Racial and ethnic groups

are those defined in OMB Directive No. 15 and include American Indian,

Alaskan Native, Asian, Pacific Islander, Black and Hispanic. Applicants

shall ensure that racial and ethnic minority populations are

appropriately represented in applications for research involving human

subjects. Where clear and compelling rationale exist that

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inclusion is inappropriate or not feasible, this situation must be

explained as part of the application. This policy does not apply to

research studies when the investigator cannot control the race,

ethnicity and/or sex of subjects. Further guidance to this policy is

contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951,

dated Friday, September 15, 1995.

HIV/AIDS Requirements

Recipients must comply with the document entitled Content of AIDS-

Related Written Materials, Pictorials, Audiovisuals, Questionnaires,

Survey Instruments, and Educational Sessions (June 1992) (a copy is in

the application kit). To meet the requirements for a program review

panel, recipients are encouraged to use an existing program review

panel, such as the one created by the State health department's HIV/

AIDS prevention program. If the recipient forms its own program review

panel, at least one member must be an employee (or designated

representative) of a State or local health department. The names of the

review panel members must be listed on the Assurance of Compliance for

CDC 0.1113, which is also included in the application kit. The

recipient must submit the program review panel's report that indicates

all materials have been reviewed and approved.

Application Submission and Deadlines

1. Preapplication Letter of Intent

A non-binding letter of intent-to-apply is required from potential

applicants. An original and two copies of the letter should be

submitted to the Grants Management Branch, CDC (see ``Applications''

for the address). It should be postmarked no later than July 19, 1996.

The letter should identify the announcement number, name of principal

investigator, and specify the activity(ies) to be addressed by the

proposed project. The letter of intent does not influence review or

funding decisions, but it will enable CDC to plan the review more

efficiently, and will ensure that each applicant receives timely and

relevant information prior to application submission.

2. Applications

An original and two copies of the application PHS Form 5161-1 (OMB

Number 0937-0189) must be submitted to Van Malone, Grants Management

Officer, 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, on or before

August 21, 1996.

3. Deadlines

A. Applications shall be considered as meeting the deadline if they

are either:

1. Received on or before the deadline date; or

2. Sent on or before the deadline date and received in time for

submission to the objective review group. (Applicants must request a

legibly dated U.S. Postal Service postmark or obtain a legibly dated

receipt from a commercial carrier or the U.S. Postal Service. Private

metered postmarks shall not be acceptable as proof of timely mailing.)

B. Applications that do not meet the criteria in 3.A.1. or 3.A.2.

above are considered late applications. Late applications will not be

considered in the current competition and will be returned to the

applicant.

Where to Obtain Additional Information

To receive additional written information call (404) 332-4561. You

will be asked to leave your name, address, and telephone number and

will need to refer to Announcment 601. You will receive a complete

program description, information on application procedures and

application forms. If you have questions after reviewing the contents

of all the documents, business management technical assistance may be

obtained from Adrienne Brown, 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) 842-6634, email:

[email protected]>. 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: [email protected]>.

Please refer to Announcement 601 when requesting information and

submitting an application.

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) referenced in the

``INTRODUCTION,'' through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

Internet Home Page

The announcement will be available on one of two Internet sites on

the publication date: CDC's home page at http://www.cdc.gov>, or at

the Government Printing Office home page (including free access to the

Federal Register) at http://www.access.gpo.gov.>.

There may be delays in mail delivery and difficulty in reaching the

CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC

suggests using Internet, following all instructions in this

announcement and leaving messages on the contact person's voice mail

for more timely responses to any questions.

Dated: June 13, 1996.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96-15570 Filed 6-19-96; 8:45 am]

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