[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Notices]
[Pages 32345-32351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15512]


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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.

[[Page 32346]]

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.

[[Page 32347]]

    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

[[Page 32349]]

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

[[Page 32350]]

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