[Federal Register Volume 66, Number 228 (Tuesday, November 27, 2001)]
[Notices]
[Pages 59255-59259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02008]


Integrated, Multi-Level Interventions To Improve Adolescent 
Health Through the Prevention of Sexually Transmitted Diseases, 
Including HIV, and Teen Pregnancy; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
research program for Integrated, Multi-level Interventions to Improve 
Adolescent Health through the Prevention of Sexually Transmitted 
Diseases, including HIV, and Teen Pregnancy. This program addresses the 
``Healthy People 2010'' priority area(s) of Sexually Transmitted 
Diseases, HIV, and Family Planning. For the conference copy of 
``Healthy People 2010'', visit the Internet site: http://www.health.gov/healthypeople. 
    The goal of this cooperative agreement research program is to 
develop, implement and evaluate interventions to prevent STD, including 
HIV, and pregnancy among adolescents. These interventions should be 
multi-level and should be integrated, interactive, and synergistic. CDC 
expects that continuation funds will be available for project periods 
of up to eight years.
    The goal of this research program is to take a developmental 
approach to delivering multi-level interventions, that change over time 
to be age appropriate. Applications should include three groups of 
adolescents: (1) Younger adolescents (i.e, about 11 to 13 years of age) 
who will be followed through late adolescence (i.e., about 16 to 18 
years of age); (2) middle adolescents (i.e, about 14-16 years) who will 
be followed through late adolescence (i.e., 2-3 years); and (3) younger 
(i.e, about 11 to 13 years of age) adolescents who will be recruited 2 
to 3 years after groups 1 and 2 and followed for a shorter duration 
(e.g., 2-3 years). These three groups will allow examination of both 
longitudinal and cross-sectional effects as well as cohort effects of 
integrated multi-level interventions. Interventions should target 
adolescents at high risk for STD, including HIV, and teen pregnancy. 
Catchment areas should have rates of chlamydia and teen pregnancy that 
exceed ``Healthy People 2010'' targets. Interventions should be 
community-wide, with sufficient numbers of communities to appropriately 
address study questions, and contamination across communities should be 
minimal.

Study Objectives

    Note:  Please see Appendix A for a complete background and 
level-specific objectives for this research program. Appendix A is 
available as part of this program announcement contained in the 
application kit (available by calling 1-888-GRANTS4) and on the CDC 
home page Internet address--http://www.cdc.gov. Click on ``Funding'' 
then ``Grants and Cooperative Agreements.''

    The overall objectives of this research program are:
    1. To design developmentally appropriate, interactive and 
synergistic interventions to prevent STD, including HIV, and teen 
pregnancy.
    2. To develop and implement interventions at a minimum of three 
social context levels, including (1) parents, and (2) providers or 
medical institutions, and (3) at least one other level of the 
applicants' choice. Interventions should address level-specific 
objectives as presented in Appendix A and may include existing 
interventions, new interventions or some combination of both.
    3. To develop, implement and evaluate the main and interactive 
effects of these multi-level interventions using strong experimental or 
quasi-experimental research designs.
    4. To examine the effects of integrated, multi-level interventions 
on: (1) Behavioral outcomes: rates of unprotected intercourse, delay of 
coital debut among non-sexually active adolescents, and return to 
abstinence after coital debut; (2) Process outcomes: annual clinical 
preventative health services utilization among adolescents and annual 
chlamydia screening; (3) Morbidity outcomes: Rates of STD, HIV, and 
teen pregnancy among adolescents in the target community. (Assessment 
of outcomes should be age-appropriate.)

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, including the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
Northern Mariana Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau, and federally recognized Indian tribal governments, Indian 
tribes, or Indian tribal organizations.


    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible

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to receive Federal funds constituting an award, grant, cooperative 
agreement, contract, loan, or any other form.

C. Availability of Funds

    Approximately $1,000,000 is available in FY 2002 to fund up to 
three awards. It is expected that the average award will range from 
$300,000 to $500,000, including indirect costs. It is expected that the 
awards will begin on or about September 30, 2002, and will be made for 
a 12-month budget period within a project period for up to eight years. 
Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Use of Funds

    Funds are awarded for a specifically defined purpose and may not be 
used for any other purpose or program. Funds may be used to support 
personnel and to purchase equipment, supplies and services directly 
related to project activities. Funds may not be used to supplant state 
or local health department funds. Funds may not be used to provide 
direct medical care or prevention case management.

Funding Preferences

    Funds may be awarded in such a way as to achieve geographic 
distribution.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Design and conduct research to address the study objectives (s) 
as listed above and in Appendix A.
    b. Design and conduct necessary formative research and pilot 
testing of interventions in Years 1 and 2. Implementation and 
evaluation of interventions will begin in Year 3.
    c. Collaborate with other recipients in developing and collecting a 
common set of core variables to permit systematic comparisons.
    d. Collaborate with other recipients and CDC during the 
development, implementation and evaluation of the project.
    e. Collaborate with other recipients and CDC to disseminate interim 
reports of research activities to regional, state and local partners.
    f. Submit and receive approval of study protocol by the recipient's 
local Institutional Human Investigation Review Board (IRB) and the CDC 
IRB.
    g. Establish procedures to maintain the rights and confidentiality 
of all study participants, including securing any assurances necessary 
to conduct research involving human subjects.
    h. Conduct local data management activities.
    i. Analyze and disseminate results.

2. CDC Activities

    A cooperative agreement reflects an assistance relationship between 
the Federal Government and the recipient in which substantial 
programmatic involvement is anticipated about the scientific or 
technical management of an activity during its performance. CDC will:
    a. Provide up-to-date scientific information, technical assistance, 
and guidance in the design and conduct of the research as needed.
    b. Provide technical advice as needed to awardees in developing and 
collecting a common set of core variables to enable comparisons. 
Collaborative activities may include technical advice on awardee-
development of common data collection instruments.
    c. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project as needed. The CDC IRB will 
review and approve the protocol initially and on at least an annual 
basis until the research project is completed.
    d. Assist in ensuring human subjects assurances are in place as 
needed.
    e. Assist in analysis and dissemination of results as needed.
    f. Monitor and evaluate the scientific and operational 
accomplishments of the project as needed. This will be accomplished 
through periodic site visits, telephone calls, and review of technical 
reports and interim data analyses.
    g. Convene a first meeting within three months of funding and 
annual meetings of all grantees for the exchange of information.

E. Content

    Applications must be developed in accordance with the information 
contained in this program announcement, the PHS 398 Grant Application, 
and the instructions provided in this section. Use the information in 
the Program Requirements, Other Requirements, and Evaluation Criteria 
sections to develop the application content. Your application will be 
evaluated on the criteria listed, so it is important to follow them in 
describing your program plan. The program narrative for sections 1-5 
below should be no more than 25 single-spaced pages, printed on one 
side, with one-inch margins, and unreduced font. All pages, including 
appendices, should be numbered sequentially. The narrative must contain 
the following sections in the order presented below:

1. Abstract

    Provide a brief abstract of the project. The abstract must reflect 
the project's focus and the length of the project period (maximum is 8 
years) for which assistance is being requested (see ``Availability of 
Funds'' for additional information).

2. Specific Aims/Objectives

    List the broad, long-term objectives and the specific research 
questions this application is intended to address. State the hypotheses 
to be tested. One page is recommended.

3. Background and Significance

    Briefly sketch the background leading to the present application, 
including the theoretical or conceptual framework, critically evaluate 
existing knowledge, and specifically identify the gaps which the 
project is intended to fill. State concisely the importance and health 
relevance of the research described in this application by relating the 
specific aims to the broad, long-term objectives. Two to three pages 
are recommended.

4. Preliminary Studies

    Use this section to provide an account of the research team 
members' preliminary studies pertinent to the application that will 
help to establish the experience and competence of the research team 
members to pursue the proposed project. Include information about the 
research team members' experience with the target population, levels of 
intervention, and history of collaboration with relevant community 
partners. The complete references to appropriate publications and 
manuscripts submitted or accepted for publication may be listed and are 
not part of the page limitations. Five collated sets of no more than 10 
such items of background material may be submitted in an appendix. Six 
to eight pages are recommended for the narrative portion of the 
Preliminary Studies section.

5. Research Design and Methods

    (a) Describe the research design and the procedures to be used to 
accomplish the specific aims of the project.

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Applications must include three groups of adolescents: (1) Younger 
adolescents (i.e., about 11 to 13 years of age) who will be followed 
through late adolescence; (2) middle adolescents (i.e., about 14-16 
years) who will be followed through late adolescence; and (3) younger 
adolescents who will be followed for a shorter duration (e.g., 2 to 3 
years). Applications must include community-wide interventions, 
communities must be randomized and must include sufficient numbers of 
communities. (b) Describe intervention development process, content and 
delivery for each level, including specific intervention protocols or 
plans for the development of intervention protocols. Applications must 
take an interactive, synergistic as well as developmental approach to 
multi-level intervention design. Applications must address three or 
more intervention levels, including provider/medical institution, 
parent, and at least one additional level of the applicants choice. 
Describe how the interventions within the package will be linked and 
interactive so that they reinforce each other. Although applicants are 
not required to measure the synergistic nature of the intervention 
package, such demonstration would be valuable. Include a description of 
how members of the target population will be involved in the planning 
and development of intervention activities. (c) Describe the 
recruitment plan and how participants will be sampled and retained. (d) 
Describe the measures to be used. Applications must include the use of 
self-report, behavioral and biological measures. Outcomes should 
include: (1) Behavioral outcomes (e.g., rates of unprotected 
intercourse, delay of coital debut among non-sexually active 
adolescents, and return to abstinence after coital debut); (2) Process 
outcomes (e.g., annual clinical preventative health services 
utilization among adolescents and annual chlamydia screening); and (3) 
Morbidity outcomes (e.g., rates of STD, HIV, and teen pregnancy among 
adolescents in the target community). Assessment of outcomes should be 
age-appropriate. (e) Describe how the data will be collected. Sampling 
schemes should be the same across all three groups of adolescents. 
Choose and justify the sample size (s) considering the various levels 
of the intervention and the different outcomes of interest. (f) 
Describe the data analysis plan, including a justification for the 
statistical techniques chosen to analyze the multi-level intervention 
data. (f) Describe quality assurance plans. (g) Provide a tentative 
sequence or timetable for the project. (h) Describe the nature and 
extent of collaboration with CDC and/or others during various phases of 
the project.

6. Inclusion of Women and Racial and Ethnic Populations

    Describe the proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations for appropriate representation. 
Describe the proposed justification when representation is limited or 
absent. Include a statement as to whether the design of the study is 
adequate to measure differences when warranted. Include a statement as 
to whether the plans for recruitment and outreach for the study 
participants include the process of establishing partnerships with 
communities and recognition of mutual benefits.

7. Human Subject Involvement

    Describe procedures that will provide for the protection of human 
subjects, including procedures to obtain appropriate parental consent 
where necessary. Address how these procedures adequately address the 
requirements of 45 CFR part 46 for the protection of human subjects.

F. Submission and Deadline

Letter of Intent (LOI)

    A LOI is requested and appreciated but is not required for this 
program. The narrative should be no more than three, double spaced 
pages, printed on one side, with one inch margins, and unreduced font. 
Your letter of intent will be used for planning purposes, and should 
include the following information: Program Announcement Number [02008], 
name and address of institution; name, address, and telephone number of 
contact person; and specific objectives to be addressed by the proposed 
project.
    On or before March 1, 2002, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001). Forms are available in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm 
    Adhere to the instructions on the Errata Sheet for form PHS 398. 
The Errata Sheet is attached at the end of this program announcement 
posted in the internet Web site: www.cdc.gov/od/pgo/funding/grantmain.htm.
    On or before June 1, 2002, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    Late: Applications which do not meet the criteria in (a) or
    (b) above will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by a special emphasis panel appointed by CDC. 
Applications will be reviewed by CDC for completeness and 
responsiveness to the purpose of this program announcement (as 
described in Section A), and as outlined under Eligible Applicants and 
Program Requirements (Items A to B). Incomplete applications and 
applications that are not responsive will be returned to the applicant 
without further consideration. It is important that the applicant's 
abstract reflects the project's focus, because the abstract will be 
used to help determine the responsiveness of the application.
    All applications will be independently reviewed for scientific 
merit to evaluate the methods and scientific quality of the 
application. Factors to be considered will include:
    1. Specific Aims. (5 percent) The specific aims of the research 
project, i.e., the intended accomplishment of the specific research 
project, and the hypotheses to be tested. Whether the specific aims of 
the project appropriately address the overall objectives and level-
specific objectives for a minimum of three contextual levels as 
described in Appendix A.
    2. Background. (5 percent) The background of the project, i.e., the 
basis for the present proposal, the critical evaluation of existing 
knowledge, and identification of specific knowledge gaps which the 
proposal is intended to fill.
    3. Significance. (15 percent) The significance and innovation from 
scientific and programmatic standpoints of the proposed research, 
including the adequacy of the theoretical and

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conceptual framework for the research and the rigor and appropriateness 
with which the outcomes are evaluated.
    4. Research Design. (35 percent) (a) The adequacy of the proposed 
research design to address the overall objectives and the appropriate 
level-specific objectives. (b) Plans for formative work, the 
development of intervention content and delivery plans for each level, 
including specific intervention protocols or plans for the development 
of intervention protocols, and how members of the target population are 
involved in that process. (c) The inclusion of a strong experimental or 
quasi-experimental design, including whether the applicant plans to 
include three groups of adolescents as described in the program 
announcement. (d) The recruitment and retention plan. (e) The self-
report, behavioral and biological outcome measures to be assessed. 
Outcomes should include: (1) Behavioral outcomes (rates of unprotected 
intercourse, delay of coital debut among non-sexually active 
adolescents, and return to abstinence after coital debut); (2) process 
outcomes (annual clinical preventative health services utilization 
among adolescents and annual chlamydia screening); and (3) morbidity 
outcomes (rates of STD, HIV, and teen pregnancy among adolescents in 
the target community). Assessment of outcomes should be age-
appropriate. (f) The plan for data collection and data management, 
including quality assurance procedures. (g) A statistical analysis plan 
appropriate to multi-level intervention evaluation. (h) The tentative 
sequence or timetable for the project. (i) The degree to which the 
applicant has met the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research. This 
includes: (1) The proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations for appropriate representation; 
(2) the proposed justification when representation is limited or 
absent; (3) a statement as to whether the design of the study is 
adequate to measure differences when warranted; (4) a statement as to 
whether the plans for recruitment and outreach for study participants 
include the process of establishing partnerships with communities and 
recognition of mutual benefits.
    5. Intervention levels. (15 percent) Applications must address 
three or more intervention levels, including provider/medical 
institution, parent, and at least one additional level of the 
applicants choice. The adequacy with which the applicant describes the 
rationale for the intervention levels (i.e, provider, parent, school, 
peer and community) chosen, the feasibility of the proposed 
interventions, how well they will be linked and integrated, how that 
integration will be measured, and which levels will receive most 
emphasis at particular age periods. Applications must include 
community-wide interventions, communities must be randomized and must 
include sufficient numbers of communities.
    6. Research team. (15 percent) The qualifications and 
appropriateness of the proposed personnel to accomplish the proposed 
activities. Applicants should include multi-disciplinary teams, 
including (but not limited to) epidemiologists, behavioral scientists, 
health services researchers, and statisticians. The combined members of 
the research team must demonstrate a history of familiarity with, 
access to, and success working with the target populations (e.g., 
adolescents, health care providers, parents, community members, etc.) 
and each level of intervention. This familiarity, access and success 
will be demonstrated through biographical sketches, previous studies, 
letters of support. Applicants are also expected to collaborate with 
their local or state health department because this linkage is critical 
to the successful conduct of this research. The degree of commitment 
and cooperation of proposed collaborators, including the health 
department, and organizations (as evidenced by letters detailing the 
nature and extent of the involvement) should be presented.
    7. Research Capacity. (10 percent) The adequacy of existing and 
proposed facilities and resources.
    8. Human Subjects. (Not Scored) What are the strategies for the 
recruitment and retention of human subjects? How will the applicant 
obtain appropriate parental consent when necessary. Are the procedures 
proposed adequate for the protection of human subjects and are they 
fully documented? Does the application adequately address the 
requirements of Title 45 CFR part 46 for the protection of human 
subjects?
    9. Budget. (Not Scored) The reasonableness of the proposed budget 
to the proposed research and demonstration program.

H. Other Requirements

    Technical Reporting Requirements
    Provide CDC with original plus two copies of
    1. Annual progress reports;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period. Send all reports to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-5  HIV Program Review Panel Requirements
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-14  Accounting System Requirements
AR-21  Small, Minority, And Women-owned Business
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 318 of the Public Health 
Service Act, (42 U.S.C. 247c (b(c)): 318a (42 U.S.C. 241 et seq and 42 
CFR part 51b), as amended. The Catalog of Federal Domestic Assistance 
number is 93.977.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Kang Lee, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-4146, 
Telephone number: (770) 488-2733, Email address: [email protected].
    For program technical assistance, contact: Janet St. Lawrence, 
Ph.D., Chief, Behavioral Interventions and Research Branch, Division of 
STD

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Prevention, Centers for Disease Control and Prevention (CDC), Mail Stop 
E44, 1600 Clifton Road NE, Atlanta, GA 30333, Telephone number: (404) 
639-8298, Email address: [email protected].

    Dated: November 20, 2001.
Rebecca B. O'Kelly,
Acting Chief, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 01-29431 Filed 11-26-01; 8:45 am]
BILLING CODE 4163-18-P