Improving Sampling and Sexual Behavior Measurement Methods in HIV Behavioral Intervention Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 751]

Improving Sampling and Sexual Behavior Measurement Methods in HIV

Behavioral Intervention Research

Introduction

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

availability of fiscal year (FY) 1997 funds for a cooperative agreement

program to support innovative research to improve the scientific rigor

and credibility in two areas fundamental to the design and assessment

of Human Immunodeficiency Virus (HIV) behavioral risk reduction

interventions with populations at high risk for HIV infection and

transmission. This announcement provides funds for two types of

activities that will supplement or strengthen on-going behavioral

intervention studies designed to prevent HIV infection and

transmission: Activity 1: Obtaining representative samples of

populations at high risk for HIV infection and transmission, and

Activity 2: Minimizing errors in measuring reported sexual behaviors of

persons participating in intervention studies with populations at high

risk for HIV infection and transmission.

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 Health Service 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.

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Eligible Applicants

All Activity 1 and Activity 2 applications must meet the

eligibility criteria described in this section:

1. Applications can be submitted by public and private, nonprofit

organizations and governments and their agencies. Thus, universities,

colleges, research institutions, 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 women-owned non-profit businesses are eligible to apply.

2. Eligible applicants may submit applications for either or both

Activity 1 (sampling) and Activity 2 (sexual behavior measurement). If

applications are submitted for both types of Activities, the applicant

must submit them as separate stand-alone applications. All applicants

must explicitly state the Activity type of their application following

the application's title listed on the application cover page, and again

following the title listed at the top of the first page of the

proposal's Abstract (see Application Content section of this

announcement for further details).

3. For either Activity 1 or 2, applicants must have access to data

collected as part of an on-going HIV behavioral intervention research

study in the United States or its territories; such studies should be

designed to develop and test interventions to reduce HIV risk behaviors

(especially sexual) among populations at high risk for HIV infection or

transmission.

4. 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 or cooperative agreement funds.

Availability of Funds

Approximately $600,000 is available in FY 1997 to fund a total of

approximately six awards. Applications under Activity 1 and 2 will be

ranked separately. CDC anticipates making at least one award under

Activity 1, and at least one award under Activity 2. It is expected

that the average award amount will range from $80,000 to $120,000

covering the entire award period, depending on the number and types of

applications proposed. Awards are expected to be made before September

30, 1997, and will cover a 12-month budget period within a project

period of one year. These funding estimates may vary and are subject to

change based on availability of funds. Applications requesting greater

than $120,000 for their total budget will not be considered for review.

Cooperative agreement funds awarded under this announcement are to

be used to supplement and strengthen the sampling or sexual behavior

measurement methods being used as part of on-going HIV behavioral

intervention studies with high risk populations in the United States or

its territories. Except as they relate directly to the purposes of this

announcement, these funds are NOT TO BE USED for supporting the general

costs of implementing an on-going HIV behavioral intervention, starting

a new HIV behavioral intervention, or for any other purpose not covered

under the intent of this announcement. Moreover, these funds are not to

be used for the purchase of furniture, software, computers, rental of

facilities, or equipment.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds

for lobbying of Federal or State legislative bodies. Under the

provisions of 31 U.S.C. Section 1352 (which has been in effect since

December 23, 1989), recipients (and their subtier contractors) are

prohibited from using appropriated Federal funds (other than profits

from a Federal contract) for lobbying Congress or any Federal agency in

connection with the award of a particular contract, grant, cooperative

agreement, or loan. This includes grants/cooperative agreements that,

in whole or in part, involve conferences for which Federal funds cannot

be used directly or indirectly to encourage participants to lobby or to

instruct participants on how to lobby.

In addition, the FY 1997 HHS Appropriations Act, which became

effective October 1, 1996, expressly prohibits the use of 1997

appropriated funds for indirect or ``grass roots'' lobbying efforts

that are designed to support or defeat legislation pending before State

legislatures. This new law, Section 503 of Pub. L. No. 104-208,

provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act

shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * *

except in presentation to the Congress or any State legislative body

itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract

recipient, or agent acting for such recipient, related to any

activity designed to influence legislation or appropriations pending

before the Congress or any State legislature.

Department of Labor, Health and Human Services, and Education, and

Related Agencies Appropriations Act, 1997, as enacted by the Omnibus

Consolidated Appropriations Act, 1997, Division A, Title I, Section

101(e), Pub. L. No. 104-208 (September 30, 1996).

Background

Regardless of advances in medical treatment of HIV/AIDS, success in

stopping the spread of the disease will rely heavily upon the use of

effective HIV behavioral risk reduction interventions. In assessing

whether an intervention approach works, previous studies have shown the

need for accurate measurement of sexual behaviors and their correlates,

e.g., correct condom use, the number and frequency of sexual partners,

and other related variables. Similarly, earlier research has indicated

the need to test interventions with a sample of persons that is

representative of the wider target population.

Representative samples are essential for knowing the

generalizability of the results obtained from efficacy or effectiveness

intervention studies. However, it is often difficult or impractical to

select a true random sample of high HIV risk populations.

Researchers frequently rely on combinations of probability and non-

probability sampling methods to select their samples, e.g., street

intercept methods, venue sampling, snowball techniques, recruitment

from STD clinics or community based service organizations. While these

methods are often viewed as sufficient to identify and recruit a group

of persons at risk for HIV, the methods might yield unrepresentative

samples. Moreover, even representative sampling protocols are not

always implemented as planned when identifying and selecting potential

study participants. Differential drop-out of sampled persons can also

bias research findings.

Limits on the generalizability of a HIV behavioral intervention

study's findings makes it difficult for public health program managers

to decide whether the intervention would be a useful tool for stopping

the spread of HIV in their jurisdictions. Additional work is needed to

develop ways to improve sampling methods used in HIV behavioral

intervention research.

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HIV intervention researchers must also obtain accurate data on

study participants' sexual behaviors. Because of their highly sensitive

and private nature, measurement of HIV-relevant sexual behaviors relies

heavily upon self-reported information provided by participants in HIV

prevention intervention studies. It is often difficult to ensure that

responses to sexual behavior questions are valid, i.e., true

reflections of a respondent's sexual behaviors.

In the past, different modes of sexual behavior data collection

have been used, e.g., face-to-face interviews, self-administered

questionnaires, audio- and telephone audio-computer assisted

interviews. Efforts have been made to enhance reliability and validity

of data collected, e.g., altering question order and wording, matching

interviewer and respondent social and cultural backgrounds, using

various recall periods, and memory assistance techniques. Other efforts

have included test-retest with the same instrument, comparison of

results using different data collection modes, comparison of a

respondent's sexual behaviors with reports elicited from their sexual

partners, and comparison of reported sexual behaviors with STD clinic

medical records.

However, in spite of this past research experience, there is no

established ``gold standard'' approach for measuring and ensuring the

accuracy of self-reported sexual behaviors. To the greatest extent

possible, it is essential for researchers to minimize sexual behavior

measurement errors and maximize replicability or reliability of their

findings.

Purpose

The purpose of this announcement is to fund innovative and

scientifically sound research projects that will enhance the sampling

(Activity 1) and sexual behavior measurement (Activity 2) methods used

during on-going HIV behavioral intervention studies among populations

at high risk for HIV infection and transmission. This includes sampling

and sexual behavior measurement methods used during formative research

phases preceding the development of behavioral interventions, as well

as the efficacy or effectiveness study phases of interventions designed

to prevent, modify, or decrease HIV sexual risk behaviors of

populations at high risk for HIV infection and transmission.

This announcement solicits proposals to fund research for improving

the sampling of populations and the measurement of sexual behaviors

relevant to HIV behavioral intervention research with populations at

high risk for HIV infection and transmission. In addition to evaluating

the strength of the Activity 1 and Activity 2 applications submitted

under this announcement, CDC may give priority to funding highly

qualified applications that address a diverse range of target

populations engaged in high HIV risk behaviors. Examples of these

populations might include: heterosexual women, men who have sex with

men, drug-using populations, adolescents or youth, or STD clinic

patients. In addition, CDC welcomes applications pertaining to other

groups that may be at high risk of HIV infection and transmission but

which have received comparatively little HIV intervention research

attention in the past, e.g., incarcerated or formerly incarcerated

populations, hearing or visually impaired groups, bisexual women,

severely mentally ill, homeless persons, or others. Regardless of the

study's target population, awards will only be made to applicants that

submit high quality applications, as assessed according to the

``EVALUATION CRITERIA'' and other instructions listed in this

announcement.

This announcement provides funds for two types of activities:

Activity 1 (sampling)--HIV behavioral intervention research to: (1)

compare and contrast innovative methods to obtain representative

samples of populations at high risk for HIV infection and transmission,

(2) examine the extent of statistical representativeness and

generalizability of the data collected from the selected samples, and/

or (3) develop and test methods to improve sampling in future HIV

behavioral studies with high risk populations; Activity 2 (sexual

behavior measurement)--HIV behavioral intervention research to: (1)

compare and contrast innovative methods to elicit respondent-reported

sexual behavior data relevant to the risk of HIV infection and

transmission, (2) examine the extent of reliability or validity of

sexual behavior data obtained through use of different data collection

methods, (3) identify specific sources for and magnitude of measurement

error in obtaining sexual behavior data among different groups of

persons at high risk for HIV infection and transmission, and/or (4)

develop and test methods to improve the accuracy of reported sexual

behavior data in future HIV behavioral studies with high risk

populations.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities listed below under

section ``RECIPIENT ACTIVITIES'' and CDC will be responsible for the

activities listed under section ``CDC ACTIVITIES.''

A. Recipient Activities

1. Design sampling or sexual behavior measurement methods. The

recipient will design innovative and feasible sampling or sexual

behavior measurement methods that will supplement and strengthen the

on-going HIV intervention study.

2. Collect and prepare data for analysis. The recipient will

collect, code, enter, clean, or otherwise prepare all data to be

obtained or used in meeting the objectives of the proposed work.

3. Ensure completion of the project by sustaining capability.

Throughout the course of the project, the recipient has the

responsibility to sustain the level of capability which was presented

in their application, particularly:

a. The scientific skills to understand and conduct the sampling or

sexual behavior measurement research, to conduct relevant analyses, and

to assess the degree and extent of generalizability of the findings

relevant to the objectives described in Activity 1 or Activity 2

sections of this announcement;

b. Adequate and appropriate technical and support services for the

proposed project;

c. Adequate research facilities, computer, software, and other

project resources or management systems needed for completing the

proposed work; and,

d. Plan and capacity for storing the data securely and maintaining

confidentiality. All applicants are fully responsible for ensuring that

all appropriate human subjects review procedures have been followed.

4. Conduct the proposed research. The recipient will conduct all

research-related activities pertaining to the proposed work. This

includes: project design; data collection and preparation; data coding

and analysis; project management and reporting; and preparation of

materials for human subjects review committees and securing all

necessary permissions to implement the project. All work must be

carried out by the applicant in a scientifically acceptable, legal, and

ethical manner.

5. Attend three CDC-organized meetings in Atlanta, GA. After

receipt of their award, all recipients will attend three joint meetings

in Atlanta, GA. For all meetings associated with this project,

recipients are fully responsible for making all necessary travel

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arrangements; applicants should plan their budgets accordingly.

Meeting 1: CDC anticipates that the first three-day meeting will

take place in October or November 1997. At the first meeting, all

recipients will make formal presentations describing their proposed

work, and will participate in joint discussions with other recipients,

CDC staff, and other individuals that may attend the meeting. Based on

the meeting, recipients may choose to revise their study protocol.

Meeting 2: Toward the middle of the funding period, a one-day, mid-

term meeting will be held, probably in March or April 1998. The purpose

of the second meeting will be to share and discuss work progress and

next steps. At the time of the second meeting, each recipient will also

submit to CDC copies of a written mid-project progress report.

Meeting 3: Toward the end of the 12-month budget period, all

applicants will attend a final three-day meeting. CDC anticipates this

meeting will take place in August or September 1998. At the final

meeting, each award recipient will make formal presentations describing

the final results of their research activities related to this project.

Subsequent to the meeting, each applicant will prepare their final

written project report (see TECHNICAL REPORTING REQUIREMENTS section

below).

6. Disseminate results. All recipients are expected to make oral

presentations at professional meetings, write manuscripts, and publish

scientific articles describing the results of this research in peer-

reviewed scientific journals. The published articles form an important

part of the project's permanent contribution to the HIV behavioral

intervention research field as a whole, and also to increasing the

effectiveness of HIV prevention public health efforts. All publications

should be finished in a timely manner shortly after the completion of

the research.

As part of their final project reporting requirements, all

recipients will prepare a written report summarizing their study and

its implications for improving sampling of representative samples, or

for improving sexual behavior measurement in future research and in

public health programs among populations at risk for HIV infection and

transmission (see TECHNICAL REPORTING REQUIREMENTS section below).

Finally, CDC may invite some or all recipients to participate in

developing one or more joint publication(s) discussing sampling and

sexual behavior measurement issues in HIV behavioral intervention

research.

B. CDC Activities

1. Host three meetings of the award recipients. The purpose of

these meetings is to discuss proposed work and study objectives, refine

work plans as needed, review work progress and next steps, and

disseminate final results.

2. Collaborate with the award recipient in the direction of

activities. These activities include assisting in research design,

methods, data analyses, implementation, development of project written

documents, and dissemination of findings.

3. Evaluate progress reports. The purpose of this evaluation is to

ensure that the objectives are being accomplished, and terms and

conditions of the award are being met.

4. Participate in the preparation of results for publication.

5. Conduct site visits. CDC staff may schedule site visits with the

recipients to assess project progress and discuss issues or problems,

as needed.

Technical Reporting Requirements

An original and two complete copies of the following three written

documents are required: (1) the revised (if appropriate) research

protocol following the first Atlanta meeting, (2) the mid-term progress

report at the time of the second Atlanta meeting, and (3) the final

project report after the third Atlanta meeting (see previous RECIPIENT

ACTIVITIES section). These should be sent to the Grants Management

Branch, Procurement and Grants Office, CDC. Time lines for the reports

will be established shortly after award. Financial status and

performance reports are required no later than 90 days after the end of

the project.

Application Content

Applications must be developed in accordance with application PHS

Form 5161-1, (OMB Number 0937-0189), information contained in the

program announcement, and the instructions provided below:

Copies for Submission: Applicants are required to submit an

original plus two complete copies of the application.

Line Spacing and Page Formats: All pages in the application should

be clearly and sequentially numbered. Material in appendices should be

one-sided only. The original and each copy of the application must be

submitted UNSTAPLED and UNBOUND. All applications should be double

spaced, in a 12-point font on 8\1/2\'' by 11'' paper, with at least 1''

margins and printed on one side only.

Table of Contents: A table of contents must list all parts of the

application and its appendices, along with their corresponding page

numbers.

Abstract Section Format: Applicants must provide a one-page,

single-spaced abstract. The abstract is not counted in the 25-page

limit of the narrative. The application title should be at the top of

the first page of the abstract. ``Activity 1'' or ``Activity 2'' must

be included in parentheses immediately following the title. The

abstract should be placed immediately preceding the main body of the

narrative.

Narrative Section Length: The narrative section may not exceed 25

double-spaced pages in length, excluding the abstract and appendices.

Applications with narrative sections longer than the permissible

length, or applications that fail to comply with other requirements

described in this section, will not be reviewed.

Abstract and Narrative Section Content:

1. Title (Activity 1 or Activity 2) and Abstract: The abstract

should be a clear 1-page summary of the proposal.

2. Introduction: Include: (1) a description of the applicant's

understanding of sampling or sexual behavior measurement methods issues

in HIV behavioral intervention research; (2) a brief review of relevant

literature; (3) a brief introductory description of the proposed work,

addressing how it pertains to either the formative research phase of an

on-going behavioral intervention or how it augments the efficacy or

effectiveness phases of testing the intervention; and, (4) an

assessment of the scientific and public health value of the proposed

work.

Provide evidence that: (1) the major intervention-related

activities have already been designed and funded, and are being

implemented at the time of submission of the proposal; (2) the

applicant has access and permission to use data already being collected

or that will be collected as part of the intervention (this evidence

should be corroborated by a letter(s) of permission to use the data

from the current manager of the data set(s) and applicants should

include copies of such letters in the proposal's appendices); and, (3)

the proposal will not conflict with the on-going activities of the

intervention research study.

3. Current Intervention Design and Methods: (1) Applicants should

provide a description of the research design and goals that are

presently being used in the on-going behavioral intervention study; (2)

a description of the target population, including their behavioral risk

factors for HIV infection or transmission; (3) a description of the

sampling methods that are presently

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being used for sampling the intervention study population; and (4) a

description of the data collection methods that are presently being

used to collect sexual behavior and other key information in the

intervention study.

4. Proposed Research Goals and Time Line: (1) Identify the specific

sampling or sexual behavior methods research goals and objectives that

will be addressed by the proposed research; (2) describe how

achievement of these goals and objectives will supplement and

strengthen the sampling or sexual behavior methods currently being used

in the intervention study; and (3) present a detailed time line for

completing the goals and objectives of the proposed project.

5. Proposed Data Set(s): (1) Describe the data set(s) to be

generated and used for completing the proposed work, including data

collection procedures, the specific variables involved, the quantity

and scientific quality of the data, and the nature of the data and, (2)

if applicable, describe any relevant previous analyses conducted on the

data set(s).

6. Data Collection, Management, Analysis, and Dissemination: (1)

Describe the proposed data collection plans in detail; (2) explain what

specific variables will be used and which statistical or ethnographic

methods will be used in the analysis; (3) describe computer and data

management systems, as well as the statistical or ethnographic software

packages to be used for the proposed work; (4) describe the plan and

capacity for storing the data securely and confidentially; and, (5)

describe the plan for disseminating the findings of the research.

7. Research Staffing Plan: (1) Explain the proposed staffing plan

for the research, percentage of time each staff member will commit to

this project, and division of duties and responsibilities for the

project, including brief position descriptions for the proposed

personnel; (2) provide evidence that the proposed staff have the

capacity and experience to conduct the proposed methods research and

analyses; (3) discuss general support activities such as project

oversight or data management activities that will contribute to the

completion of all analytic activities; and, (4) list the names and

roles of staff members who are key to the completion of the project and

include their curriculum vitae, highlighting any statistical and

methodologic publications.

8. Budget: (1) Provide a detailed, line-item budget for the project

(this should include plans for at least three trips to Atlanta to meet

with CDC representatives and other researchers) and (2) a budget

narrative that justifies each line item.

Evaluation Criteria

Applicants will be reviewed and evaluated individually according to

the following criteria:

1. Title, Abstract, and Introduction (12 Points)

Quality and thoroughness of the title and abstract in summarizing

the key features of the proposed research activities. Indication of

whether the proposal falls under Activity 1 or Activity 2 of this

announcement. Strength of the applicant's understanding of the

scientific and public health issues related to sampling or sexual

behavior measurement methods in HIV behavioral intervention research.

Thorough review of relevant scientific literature and previous methods

research.

Scientifically appropriate and feasible work description is

proposed. The proposed work will significantly supplement and

strengthen the sampling or sexual behavior measurement methods being

used in the on-going behavioral intervention project. Significance of

the proposed study's findings for improving the scientific credibility

and public health utility of future HIV behavioral intervention

research.

2. Strength of Current Behavioral Intervention Design and Methods (12

Points)

Scientific and public health merit of the on-going HIV behavioral

intervention study design. The intervention is based on relevant

behavioral science theory. Degree of merit of the research methods

currently being used in the HIV behavioral intervention study. The

applicant provides a thorough description of the intervention's target

population, and provides strong evidence that the target population is

at high behavioral risk for HIV infection. Information should also be

provided on the extent to which the proposed work addresses the

inclusion of women, racial and other ethnic minorities. Current quality

of sampling methodology used for selecting the intervention study

sample. Current quality of the data collection methods used to collect

sexual behavior and other key information in the intervention study.

3. Useful Research Goals(s) and Appropriate Research Time Line (18

Points)

The proposed goals and objectives are practical and are based on

previous scientific research. Achievement of the goals and objectives

will significantly improve the sampling or sexual behavior measurement

components of the intervention study. The applicant provides a clear,

detailed, and realistic time line for completing all phases of the

proposed project. The time line includes participation in the three

Atlanta meetings and submission of required written project documents

as described in previous sections of this announcement.

4. Quality and Access to Proposed Data Set(s) (18 Points)

The applicant provides a clear description of the data set(s) to be

generated and used for completing the current work, including data

collection procedures, the specific variables involved, the quantity

and quality of the data, and nature of the data. The proposed data

set(s) are not likely to contain major scientific flaws. If applicable,

sufficient previous analyses conducted on existing parts of the data

set(s). Strength of evidence that the applicant has or will have access

to all necessary data set(s) and other information needed to achieve

the goals and objectives of the proposal.

5. Quality of Data Collection, Management, Analysis, and Dissemination

Plans (20 Points)

Scientific appropriateness and feasibility of the proposed plan to

collect the data. Clear explanation of what variables will be used in

the analysis. Selection of appropriate statistical or ethnographic

methods for analysis of the data. Adequate research facilities,

computer and data management systems, software, and statistical

packages are available for completing all phases of the proposed work.

Strength of plan to store data securely and maintain confidentiality.

Explicit and clear plan for disseminating the findings of the research,

including submission of articles to peer reviewed scientific journals

and other dissemination activities as described in previous sections of

this announcement.

6. Capability of Staff to Carry out Proposed Work (20 Points)

Clear explanation of the proposed staffing plan. Proposed staff

will be available for sufficient amounts of time to carry out essential

work. A reasonable division of duties and responsibilities for the

project is provided, including brief position descriptions for the

proposed personnel. Strength of evidence that the proposed staff have

the necessary training, capacity and

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experience to conduct the proposed research. Appropriate project

oversight, data management, and analysis plan will contribute to the

timely completion of all project activities. Curriculum vitae for key

staff members are included, and demonstrate that the staff have strong

credentials in terms of relevant experience, training, and capability.

Key staff members have demonstrated a history of completing and

publishing findings from similar or related methods studies.

7. Budget (not scored)

Extent to which the budget is reasonable, itemized, clearly

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

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 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 Rd., NE., Rm 300, Mailstop E15, Atlanta, GA 30305, no

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

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

recommendations it receives after that date.

Indian tribes are strongly urged 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 Rd., NE., Rm

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

30 days after the application deadline. The granting agency does not

guarantee to ``accommodate or explain'' for tribal process

recommendations it receives after that deadline.

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 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 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 to 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 or local health agencies.

If the State 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, HIV

Demonstration, Research, Public and Professional Education.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by the 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 committees. 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.

Women, 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 both sexes and 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 women, racial and ethnic

minority populations are appropriately represented in applications for

research involving human subjects. Where clear and compelling rationale

exist that 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 or sex of subjects. Further guidance to this policy is

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

and 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

[[Page 32351]]

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, Procurement and Grants

Office, CDC (see ``Applications'' for the address). It should be

postmarked no later than July 14, 1997. The letter should identify

announcement number 751, name of principal investigator, and specify

the activity to be addressed by the proposed project. The letter of

intent does not influence review of 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 complete copies of the application, including

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 Rd., NE., Rm 300, Mailstop E-15,

Atlanta, GA 30305, or before August 7, 1997.

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. Applicants 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

A complete program description, information on application

procedures, an application package and business management technical

assistance may be obtained from Van Malone, Grants Management Officer,

Grants Management Branch, Procurement and Grants Office, Centers for

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

300, Mailstop E-15, Atlanta, GA, telephone (404) 842-6575, Internet E-

mail: [email protected].

Programmatic technical assistance may be obtained from Bob

Kohmescher, Deputy Chief, Behavioral Intervention Research Branch,

Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB

Prevention, Centers for Disease Control and Prevention (CDC), 1600

Clifton Rd., NE., Mailstop E37, Atlanta, GA 30333, telephone (404) 639-

8302, Internet E-mail: [email protected].

Please refer to Announcement 751 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.

The announcement will be available on 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.

Dated: June 9, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-15512 Filed 6-12-97; 8:45 am]

BILLING CODE 4163-18-P