[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Notices]
[Pages 31530-31536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15570]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 601]
Prevention of HIV Infection in Youth at Risk: Developing
Community-Level Strategies That Work
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
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availability of fiscal year (FY) 1996 funds for a cooperative agreement
program for the prevention of HIV infection in youth at risk.
CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a national activity
to reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of Human Immunodeficiency
Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,''
see the section ``WHERE TO OBTAIN ADDITIONAL INFORMATION.'')
Authority
This program is authorized under Sections 301 and 317(k)(2), of the
Public Service Health Act (42 U.S.C. 241 and 247b(k)(2)) as amended.
Smoke-Free Workplace
CDC strongly encourages all recipients to provide a smoke-free
workplace and to promote the nonuse of all tobacco products, and Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities that receive Federal funds in which education, library, day
care, health care, and early childhood development services are
provided to children.
Eligible Applicants
Applications may be submitted by public and private, nonprofit and
for-profit organizations and governments and their agencies. Thus,
universities, colleges, research institutes, hospitals, other public
and private organizations, State and local health departments or their
bona fide agents or instrumentalities, federally recognized Indian
tribal governments, Indian tribes or Indian tribal organizations, and
small, minority- and/or women-owned businesses are eligible to apply.
Each applicant must demonstrate collaboration with community-based
organizations (CBOs) that have histories of familiarity with, access
to, and success working with the target population. Collaboration with
CBOs will be demonstrated through letters from the organizations
stating their willingness to participate in the proposed project. It is
the intention of this announcement to stimulate collaborative,
interdisciplinary research between research institutions and public
health agencies and CBOs; therefore, applications by agencies taking
the lead with teams composed of collaborators from each of the other
entities are encouraged. The application should be submitted by the
lead institution, agency, or organization. Applicants who have
conducted formative research on the target population are encouraged to
apply.
Note: Organizations described in section 501(c)(4) of the
Internal Revenue Code of 1986 that engage in lobbying are not
eligible to receive Federal grant/cooperative agreement funds.
Availability of Funds
Approximately $2.8 million will be available in FY 1996 to fund
approximately six awards. It is expected that the average award will be
$500,000, ranging from $400,000 to $900,000. Awards are expected to
begin on or about September 30, 1996, and will be made for a 12-month
budget period within a project period of up to five years (two years
for all Phase I recipients and three additional years for successful
recipients of Phase II. Approximately three Phase I recipients will
receive Phase II funding through a competitive announcement). Funding
estimates may vary and are subject to change.
Phase II competition will in part include the following factors:
1. Have completed their formative research and summaries, pilot-
testing, data reduction, and final Phase I report;
2. Have established access to the target population in sufficient
numbers to provide meaningful sample sizes for intervention and control
areas;
3. Have demonstrated that their proposed catchment areas are
minimally affected by confounding factors of competing interventions
and research;
4. Have demonstrated data collection and analysis capacity to
execute the protocols for data analysis and evaluation of impact;
5. Be able to implement the common intervention selected through
consensus, including having a sufficient number of trained staff to
devote full-time to the intervention and;
6. Have written the final draft of at least one publication on
Phase I data.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Definitions
Youths are defined as persons 15 to 25 years of age. Men who have
sex with men (MSM) are men who have sex with men, regardless of their
declared sexual identity. Young men who have sex with men (YMSM) are
males 15 to 25 years of age who have sex with other males, express
intention to have sex with other males, or acknowledge sexual
attraction to other males. Communities can be groups defined by
behavior (sexual orientation, IV drug use), by identification
(ethnicity, sexual identity), by geographic boundaries, or by places
where people are available for education (schools, prisons). Catchment
area is the contiguous geographic area that encompasses at least one
access site and that is distinct in geography and population
membership. Access site is a location within a catchment area where the
target population congregates and is available for intervention.
Community-level intervention is an approach to HIV prevention that (1)
Results from a mobilization of community members and institutions; (2)
can be expected to reach a large proportion of the population at risk
in their daily setting; (3) may involve the use of outreach and
facility-based services; and (4) can be expected to alter individual
behaviors and community norms. Community assessment is the systematic
collection and critical analysis of data to determine the adequacy and
effectiveness of specific services, infrastructure, and formal and
informal resources available to a community. Multi-site is defined as
the same or similar intervention, sampling methods and measurements
used in multiple sites, but does not imply a nationally representative
sample of sites.
Purpose
This program is to conduct research that will develop and evaluate
approaches to encourage youth who engage in risky behaviors associated
with HIV acquisition and transmission to change these behaviors. This
program also seeks to develop methods that may build on evaluated,
community-level intervention efforts, and where advisable, previous
work, but will focus entirely on YMSM, including those who are members
of racial or ethnic minorities.
Funds will be used in two phases to develop, implement, analyze,
and evaluate an effective community-level behavioral change
intervention, with potential for sustainability, to prevent HIV in YMSM
who engage in high-risk behaviors related to the acquisition and
transmission of HIV.
Phase I of the research program will focus on formative research to
characterize populations, identify constraints on and opportunities for
behavior change, and identify components of a targeted intervention and
determine its feasibility. Approximately six awards will be made for a
12-month budget period within a project period of up to two years.
Phase II of the research program will focus on the implementation
of a common intervention protocol, randomization of catchment areas,
and
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systematic analysis and evaluation of the intervention's impact.
Eligible applicants for Phase II will be recipients of Phase I. Phase
II will be competitively announced. Approximately three awards will be
made for a 12-month budget period within a project period of up to
three years.
The intervention for this project will be based on the combined
formative research completed by award recipients in Phase I and will be
implemented in Phase II. Although CDC is not requiring proposals for
Phase II intervention activities at this time, a brief description of
Phase II is included here for the applicants' information. In the first
eight months of Phase II, recipients will conduct two to three baseline
assessments. The recipients then will implement, analyze, and evaluate
the impact of the community-level intervention. Examples of behaviors
that may be appropriate for the intervention to address are:
1. Maintaining abstinence;
2. Reducing high-risk sexual behaviors among sexually active YMSM
and;
3. Using barrier methods when engaging in sexual activity.
By the end of the 5-year project, recipients and participating
agencies will produce guidelines for technology transfer of the
intervention to control sites and other interested organizations.
Recipients are also encouraged to assist participating agencies in
developing the skills to sustain successful intervention components
after the study.
Applicants must agree to follow the intervention and implementation
protocol developed jointly by recipients with input from CDC project
officers. It is anticipated that the Phase II protocol for
intervention, analysis, and evaluation will be a common protocol with
many components that are applicable to all study areas. Such a protocol
also will permit tailoring to individual communities to accommodate
variations (e.g., cultural, geographic) among them. YMSM representing
diverse segments of the target population should participate actively
in research and intervention design and review in Phase I and Phase II.
Program Requirements
Work performed under this agreement will be the result of
collaborative efforts among recipients, resulting in common protocols
and methods across sites. Individual recipients will be responsible for
research design, intervention development and implementation, data
collection and analysis, and publication. CDC will coordinate these
collaborative efforts and expects to work closely with each award
recipient.
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC will be responsible for the activities
listed under B. (CDC Activities).
A. Recipient Activities
1. Characterize the HIV risk of the target population and any
subgroups in at least two matched catchment areas and prioritize the
subgroups according to probable risk and other criteria.
a. The recipient will have proposed in their application at least
two catchment areas that are matched in:
(1) Population demographic characteristics:
(2) Risk behaviors;
(3) Population sizes;
(4) Numbers of the same types of access sites (e.g., bars,
bookstores, parks) and;
(5) Other relevant variables.
b. During Phase I, the recipient will further study the proposed
catchment areas to finalize selection of catchment areas for conducting
the Phase II intervention:
(1) The selected catchment areas must be geographically discrete
and have less than 10% overlap of the target population in each area.
(2) The catchment areas will be places where (a) hundreds of
eligible subjects can be reached, (b) that have an estimated high HIV
seroprevalence rate among youth, and (c) that, ideally, have minimal
confounding factors introduced by ongoing or proposed HIV prevention
efforts.
(3) After Phase I, the catchment areas will be randomly assigned to
a study condition--the intervention or comparison.
c. The recipient will characterize the target population and any of
its subgroups in each catchment area.
d. The recipient will document, using whatever qualitative and
quantitative data are available, that the targeted populations and any
of their subgroups in the selected catchment areas are at risk for HIV
infection and will prioritize the subgroups according to the relative
risk.
e. The recipient will justify its identifications of catchment
areas, access sites, subgroup, and YMSM accessible at those sites in
terms of the potential to address the research goals of this program
announcement and in terms of ultimately translating the research
findings into HIV prevention activities among the target populations.
By the end of Phase I, the recipient will have finalized the
selection of a minimum of two matched catchment areas and conducted
research to justify the selection of catchment areas, determine the
demographic characterization of the target population and any
subgroups, and justify selection of a particular subgroup. The
recipient also will have identified sites within the catchment areas
where YMSM are accessible both for interviewing and for the
intervention and will have secured commitment of collaborating
organizations in these catchment areas and access sites to participate
in Phase II and to be randomly assigned to a research condition.
2. Conduct qualitative and quantitative behavioral research of YMSM
at risk in the study catchment areas.
a. The recipient will build a multi disciplinary research team and
program support capability:
(1) A multi disciplinary team should be assembled with the
appropriate expertise to undertake Phase I activities. Such a team will
include experienced senior researchers, technical staff, and support
staff and will be led by behavioral scientists;
(2) The team will have CBO members or collaborators and;
(3) The team will involve persons from the target population in
research and intervention design.
b. The recipient will develop a common protocol to conduct the
behavioral research:
(1) The research will include sexual behavior, partner
characteristics, social networks, substance abuse behavior, trading sex
for money or drugs, perceptions of social norms, attitudes, self-
efficacy, perceptions of current HIV interventions, health-care-seeking
behaviors, health-information-seeking behaviors, developmental issues
influencing the above, and structural influences on behavior to
identify which segments or subgroups of YMSM would be best served by
the intervention;
(2) Questionnaires and survey instruments will be constructed at a
literacy level appropriate to the target population;
(3) The research will involve members of the targeted population
and other community partners in determining which types, designs, and
deliveries of interventions would be (a) best accepted and most
influential in their communities, (b) most likely to work
synergistically with other community efforts, (c) most likely to
stimulate changes in community norms, and (d) most likely to be
sustained.
The recipient will demonstrate further understanding of factors
influencing the
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behavior of YMSM, document the participation of the target population
in the formative research design and their contribution in development
of the intervention to be pilot-tested, and propose a sound theoretical
and data-driven approach to influencing behaviors of YMSM.
3. Use an existing or develop and conduct a community assessment
and document HIV interventions and research involving the target
population in the catchment areas.
a. The purpose of the community assessment is to determine:
(1) Community-wide needs for HIV/AIDS prevention among YMSM;
(2) Existing and potential capacity;
(3) Available resources and;
(4) Current prevention efforts and further understand key issues
(e.g., identifying access sites, influences of political climate)
relevant to intervening with the target population.
b. Recipients will:
(1) Review community needs assessments and community planning
documents and;
(2) Summarize what is known about the proposed communities, and if
necessary, recipients will develop, in collaboration with CDC and other
recipients, a common assessment instrument to be implemented in Phase
I.
c. Part of the community assessment must include:
(1) The current activities and functions of the health department's
HIV program in the catchment areas;
(2) Implications of the formative research and potential
interventions on those activities and functions and;
(3) The HIV community planning priorities related to YMSM.
The recipient will have produced a summary synthesizing knowledge
of the community's HIV needs and planning, participated in cross-site
implementation of the assessment instrument, as appropriate, and
analyzed and reported the results of the assessment.
4. In partnership with persons from relevant communities, other
recipients, and CDC project officers, develop an appropriate community-
level intervention to reduce HIV risk behaviors in the target
population.
a. Recipients will collaborate in developing a common intervention
and research protocol for all recipients to implement in Phase II:
(1) The basis for the intervention should include (a) the
recipient's experience with the target population, (b) formative
research from Phase I, and (c) a review of current primary prevention
strategies and research;
(2) The intervention selection should be a logical result of
program requirements 4.a.(1)(a-c) above, but not be limited to their
exclusive consideration;
(3) The intervention approach should be culturally sensitive,
developmentally appropriate, and suitable for the target population's
literacy level and should stimulate community action, mobilization, and
adoption of a supportive environment and community norms and;
(4) An effective community-level intervention for these youth may
combine several elements, e.g., (a) efficient targeting of outreach,
(b) development of an environment supportive of long-term HIV/AIDS risk
reduction, and (c) links to local resources that encourage healthy
behaviors.
b. Local resources that encourage healthy behaviors may include:
(1) STD treatment and prevention services;
(2) Substance abuse treatment facilities;
(3) Shelters or drop-in facilities for runaway and homeless youth;
(4) Mental health clinics;
(5) Other health care facilities such as community health centers;
(6) Facilities ``without walls'' that provide outreach to street
youth and;
(7) Providers of foster care and supervised independent living.
c. Recipients will participate in monthly conference calls with CDC
project officers and other recipients.
d. Each recipient will travel to Atlanta or another location and
participate with other recipients and CDC representatives in four
meetings during Phase I. At one of these meetings, the Phase II
intervention design and protocols for pilot testing will be
established.
e. The protocols for the Phase II intervention will be finalized at
a later meeting.
At the end of Phase I, the recipient will have summarized
activities and participated in the development of a common
intervention, research protocol, operational plan, process and impact
objectives, analysis strategies, and evaluation instruments for Phase
II.
5. Through pilot-testing, determine the feasibility and
sustainability of implementing the proposed intervention, including
cost, acceptance, and participation by the target population.
a. During the second year of Phase I, components of the
collaboratively developed intervention will be pilot-tested by the
recipients to determine modifications in design, implementation, and
other relevant considerations.
These considerations may include:
(1) The likelihood that the intervention will change behavior among
YMSM;
(2) The probable level of acceptability of the intervention to the
target populations and to the communities around the intervention
access sites;
(3) The recipient's potential for recruiting, training, and
retaining intervention workers;
(4) The acceptability of intervention workers to the targeted
population;
(5) The likelihood that the intervention will stimulate changes in
community norms;
(6) Clarity of or difficulties with data collection instruments;
(7) The projected overall cost of the intervention component;
(8) The likelihood that the intervention can be maintained during
the entirety of Phase II;
(9) The likelihood that successful components of the intervention
will be institutionalized in the community after Phase II and;
(10) More effective ways for project staff to systematically focus
resources (i.e., financial and personnel).
b. Recipients with substantial, previously collected formative data
from their finalized catchment areas may pilot-test potential
intervention components in the first year of Phase I instead of
collecting additional formative data.
Recipients will have conducted and reported pilot-test results of
one or more components of the common intervention. The primary
expectation at the completion of Phase I is a finalized common protocol
for implementation, analysis, and evaluation, including validated
instruments, for a community-level intervention that can reasonably be
expected to influence behaviors related to HIV transmission in the
study population.
6. Recipients and CDC project officers collaboratively develop a
common research protocol for the proposed intervention to be conducted
during Phase II
a. The recipients, in collaboration with CDC, will select and
develop a common research protocol, including:
(1) A common research design;
(2) Operational plan and;
(3) Analysis and evaluation methods and instruments.
b. The protocol will include a within-catchment-area sampling
strategy and mechanisms for obtaining the consent and protecting the
confidentiality of study subjects.
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c. Analysis and evaluation plans will be developed concurrently
with intervention plans.
d. Recipients will establish a set of outcomes to determine the
effectiveness or impact of the intervention that are measurable, valid,
and reliable in terms of behavioral and social science theories. It is
expected that the evaluation will measure changes in behaviors,
intentions, and attitudes and the target population's awareness and
acceptance of the intervention.
e. To evaluate a common intervention, the recipients and CDC
project officers must:
(1) Reach consensus concerning the specific outcomes to target;
(2) Develop methods of measuring these outcomes, including common
data collection instruments and;
(3) Pilot-test measures and instruments.
Recipients will have established a common research protocol,
operational plan, process and impact objectives, and instruments for
systematically analyzing and evaluating the intervention in Phase II.
Each recipient must agree, if selected for continuation into Phase II,
to implement this common protocol and accept randomization of their
selected catchment areas (as specified above).
7. Manage, analyze, and interpret data.
a. Data from the Phase I activities must be collected, managed, and
stored securely and confidentially.
b. Recipients will use common computer and data management systems.
c. Recipients will be primarily responsible for site-specific
analyses.
d. Recipients will share data for aggregate analyses with CDC
project officers.
Recipients will have common computer and data management systems
and will have submitted the cleaned data on their intervention trials
to CDC project officers.
B. CDC Activities
1. Host a meeting of the recipients to plan the research program
(e.g., the format for community assessments). CDC will host
approximately three additional meetings of recipients during Phase I to
promote progress toward national objectives.
2. Act as mediator on the recipients' collaborative design or
selection of the assessment plan and instruments, research protocol,
operational plan, objectives, analysis strategies, and evaluation
instruments.
3. Provide technical assistance on pilot testing the common
intervention, or elements thereof, and on tailoring the collaboratively
designed, common intervention for local applications.
4. Provide scientific and technical coordination of the general
operation of this HIV prevention project and of the specific Phase I
activities in order to keep all recipients on track with the common
protocols and their timelines.
5. Conduct the random selection of intervention and control
catchment areas among those presented by each recipient, according to a
randomization protocol collaboratively determined by the recipients.
6. Coordinate cross-site aggregation of data and its analysis.
7. Conduct site visits to assess program progress and mutually
solve problems, as needed.
At approximately month 12 of the project, recipients and CDC
project officers will meet to design the common intervention and pilot
tests of its components. At approximately month 20 of the project,
recipients and CDC project officers will meet to finalize the common
intervention for Phase II. At approximately month 22 of the project,
applications for a competing continuation award for the implementation
and evaluation of community-level intervention (Phase II) will be due.
Supplementary guidance for Phase II awards will be provided to the
recipients of Phase I awards.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
1. Applicant's Team (15 points)
The extent to which all items in the application content element
are addressed, including the extent to which the applicant has:
a. Involved other key organizations on the project team;
b. Clearly defined the responsibilities of these other
organizations;
c. Involved team members in planning and developing the application
and demonstrated their commitment to the project (as evidenced by
letters of support or memoranda of agreement) and;
d. Previously worked with other team members, including potential
CBO collaborators if they are not part of the team.
2. Research and Intervention Capability (20 points)
The extent to which all items in the application content element
are addressed:
a. Capacity of the applicant research team to conduct the proposed
research as evidenced by their previous related research;
b. Experience with multisite research designs and formative
research on MSM;
c. Extent of the team's familiarity with, access to, and good
working relations with MSM, as evidenced by service or research
involving this population and;
d. Capacity of the team to conduct behavioral interventions as
evidenced by description of their previous experience.
3. Identification of Catchment Areas (20 points)
The extent to which all items in the application content element
are addressed:
a. Extent to which the catchment areas meet matching criteria
(e.g., matched population demographics, risk behaviors, population
sizes that are similar and of sufficient size, access sites), and the
extent to which the matching was based on available data;
b. Extent to which the target populations within the catchment
areas have similar rates of HIV infection and the extent to which the
rates are based on available data and;
c. Thoroughness of description of potential conflict between the
proposed research and other research or prevention efforts in the
catchment areas.
4. Proposed Research Plan--Formative and Intervention (25 points)
The extent to which all items in the application content element
are addressed:
a. Quality of the proposed formative research plan, sampling
strategies, sample size estimates, power analysis, and mechanisms to
obtain subjects' consent and protect their confidentiality;
b. Appropriateness of the theoretical bases for the proposed
intervention;
c. Quality of the type of multi-site intervention proposed and its
likelihood to yield new insights on opportunities for long-term risk
reduction among the targeted population and;
d. Feasibility of the strategy to involve the target population and
affected communities in the research and intervention design and to
inform them of research results:
(1) The proposed plan for the inclusion of racial and ethnic
minority populations for appropriate representation;
(2) The proposed justification when representation is limited or
absent;
(3) A statement as to whether the design of the study is adequate
to measure differences when warranted and;
(4) A statement as to whether the plans for recruitment and
outreach for
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study participants include the process of establishing partnerships
with community(ies) and recognition of mutual benefits will be
documented.
5. Project Management (20 points):
The extent to which all items in the application content element
are addressed:
a. Adequacy of staffing to carry out proposed activities (i.e.,
sufficient in number, percentage of time commitments, behavioral
scientists in key project positions, and qualifications), as evidenced
by their curriculum vitae and position descriptions;
b. Adequacy of facilities, data processing and analysis capacity,
and systems for management of data security and participant
confidentiality and;
c. Extent to which the applicant demonstrates assurance of
compliance with the multisite research requirements (e.g.,
randomization of catchment areas and common protocol, data collection,
and computer and data management systems).
6. Budget (Not scored)
Extent to which the budget is reasonable, itemized, clearly
justified, and consistent with the intended use of the funds.
7. Human Subjects (Not scored)
The applicant must clearly state whether or not human subjects will
be used in research.
Funding Preferences
CDC's intention is to achieve a long-term health benefit for youth
at risk for HIV infection. This announcement is exclusively for
proposals that address HIV risk reduction for YMSM. Consideration will
be given to obtaining diversity of target population sub-groups and
geographic representation among proposals selected for funding. YMSM of
color are of particular interest.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants (other than federally recognized
Indian tribal governments) should contact their State Single Point of
Contact (SPOC) as early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of SPOCs is included in the application kit. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should send them to Van Malone, Grants Management Officer, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,
Mailstop E15, Atlanta, GA 30305, no later than 30 days after the
application deadline (the appropriation for this financial assistance
program was received late in the fiscal year and would not allow for an
application receipt date which would accommodate the 60-day State
recommendation process period). The granting agency does not guarantee
to ``accommodate or explain'' for State process recommendations it
receives after that date.
Indian tribes are strongly encouraged to request tribal government
review of the proposed application. If tribal governments have any
tribal process recommendations on applications submitted to the CDC,
they should forward them to Van Malone, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later
than 30 days after the application deadline date. The granting agency
does not guarantee to ``accommodate or explain'' for tribal process
recommendations it receives after that date.
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting
Requirements. Under these requirements, all community-based
nongovernmental applicants must prepare and submit the items identified
below to the head of the appropriate State and/or local health
agency(s) in the program area(s) that may be impacted by the proposed
project no later than the receipt date of the Federal application. The
appropriate State and/or local health agency is determined by the
applicant. The following information must be provided:
A. A copy of the face page of the application (SF 424).
B. A summary of the project that should be titled ``Public Health
System Impact Statement'' (PHSIS), not exceed one page, and include the
following:
1. A description of the population to be served;
2. A summary of the services to be provided; and
3. A description of the coordination plans with the appropriate
State and/or local health agencies.
If the State and/or local health official should desire a copy of
the entire application, it may be obtained from the Single Point of
Contact (SPOC) or directly from the applicant.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.941.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations, 45 CFR Part 46, regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. In addition to other applicable
committees, Indian Health Service (IHS) institutional review committees
also must review the project if any component of IHS will be involved
or will support the research. If any American Indian community is
involved, its tribal government must also approve that portion of the
project applicable to it. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Racial and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of the various racial and ethnic groups will
be included in CDC/ATSDR-supported research projects involving human
subjects, whenever feasible and appropriate. Racial and ethnic groups
are those defined in OMB Directive No. 15 and include American Indian,
Alaskan Native, Asian, Pacific Islander, Black and Hispanic. Applicants
shall ensure that racial and ethnic minority populations are
appropriately represented in applications for research involving human
subjects. Where clear and compelling rationale exist that
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inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. This policy does not apply to
research studies when the investigator cannot control the race,
ethnicity and/or sex of subjects. Further guidance to this policy is
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951,
dated Friday, September 15, 1995.
HIV/AIDS Requirements
Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires,
Survey Instruments, and Educational Sessions (June 1992) (a copy is in
the application kit). To meet the requirements for a program review
panel, recipients are encouraged to use an existing program review
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review
panel, at least one member must be an employee (or designated
representative) of a State or local health department. The names of the
review panel members must be listed on the Assurance of Compliance for
CDC 0.1113, which is also included in the application kit. The
recipient must submit the program review panel's report that indicates
all materials have been reviewed and approved.
Application Submission and Deadlines
1. Preapplication Letter of Intent
A non-binding letter of intent-to-apply is required from potential
applicants. An original and two copies of the letter should be
submitted to the Grants Management Branch, CDC (see ``Applications''
for the address). It should be postmarked no later than July 19, 1996.
The letter should identify the announcement number, name of principal
investigator, and specify the activity(ies) to be addressed by the
proposed project. The letter of intent does not influence review or
funding decisions, but it will enable CDC to plan the review more
efficiently, and will ensure that each applicant receives timely and
relevant information prior to application submission.
2. Applications
An original and two copies of the application PHS Form 5161-1 (OMB
Number 0937-0189) must be submitted to Van Malone, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before
August 21, 1996.
3. Deadlines
A. Applications shall be considered as meeting the deadline if they
are either:
1. Received on or before the deadline date; or
2. Sent on or before the deadline date and received in time for
submission to the objective review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.)
B. Applications that do not meet the criteria in 3.A.1. or 3.A.2.
above are considered late applications. Late applications will not be
considered in the current competition and will be returned to the
applicant.
Where to Obtain Additional Information
To receive additional written information call (404) 332-4561. You
will be asked to leave your name, address, and telephone number and
will need to refer to Announcment 601. You will receive a complete
program description, information on application procedures and
application forms. If you have questions after reviewing the contents
of all the documents, business management technical assistance may be
obtained from Adrienne Brown, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,
Mailstop E-15, Atlanta, GA 30305, telephone (404) 842-6634, email:
asm1@opspgo1.em.cdc.gov>. Programmatic technical assistance may be
obtained from Robert Kohmescher, Division of HIV/AIDS Prevention,
National Center for HIV/STD/TB Prevention, Centers for Disease Control
and Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-44, Atlanta,
GA 30333, telephone (404) 639-8302, email: rnk1@cidhiv2.em.cdc.gov>.
Please refer to Announcement 601 when requesting information and
submitting an application.
Potential applicants may obtain a copy of ``Healthy People 2000,''
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000,''
(Summary Report, Stock No. 017-001-00473-1) referenced in the
``INTRODUCTION,'' through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.
Internet Home Page
The announcement will be available on one of two Internet sites on
the publication date: CDC's home page at http://www.cdc.gov>, or at
the Government Printing Office home page (including free access to the
Federal Register) at http://www.access.gpo.gov.>.
There may be delays in mail delivery and difficulty in reaching the
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC
suggests using Internet, following all instructions in this
announcement and leaving messages on the contact person's voice mail
for more timely responses to any questions.
Dated: June 13, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 96-15570 Filed 6-19-96; 8:45 am]
BILLING CODE 4163-18-P
