[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