[Federal Register Volume 69, Number 134 (Wednesday, July 14, 2004)]
[Notices]
[Pages 42183-42190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Evaluation of Innovative Human Immunodeficiency Virus (HIV) 
Prevention Interventions for High-Risk Minority Populations

    Announcement Type: New.
    Funding Opportunity Number: PA 04249.
    Catalog of Federal Domestic Assistance Number: 93.941.
    Key Dates:
    Application Deadline: August 13, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under Section 317(k) of 
the Public Health Service Act [42 U.S.C. Section 247b(k)], as 
amended.

    Purpose: The purpose of this program is to support evaluations by 
Community-Based Organizations (CBOs) of existing innovative HIV 
behavioral interventions that have been developed and are being 
implemented to serve

[[Page 42184]]

minority populations at high risk for acquiring or transmitting HIV 
infection. The innovative interventions must have demonstrated some 
evidence of promising results in reducing HIV risk behaviors, but must 
not have undergone a previous rigorous outcome evaluation. The intent 
of this announcement is to support the evaluation of existing 
interventions and provide feedback to implementing CBOs for improved 
program effectiveness, not to conduct research.
    This program addresses the ``Healthy People 2010'' focus area(s) of 
HIV. Measurable outcomes of the program will be in alignment with one 
(or more) of the following performance goal(s) for the National Center 
for HIV, STD, and TB Prevention (NCHSTP): Strengthen the capacity 
nationwide to monitor the epidemic; develop and implement effective HIV 
prevention interventions and evaluate prevention programs; and to also 
decrease the number of persons at high risk for acquiring or 
transmitting HIV infection.
    Activities: Throughout this program announcement, CBOs will be 
asked to evaluate the effectiveness of an existing innovative HIV 
behavioral intervention to reduce HIV-related risk behaviors (e.g. sex 
or drug behaviors) and/or reduce incident cases of HIV or STDs.
    For the purpose of this program announcement, an innovative HIV 
behavioral intervention is an intervention to reduce HIV risk 
behavior(s) that uses an approach or method that is different from 
interventions used by other organizations that serve the target 
populations addressed by this announcement. The intervention must also 
have been developed from the ``ground up,'' that is, in close 
collaboration with the community or communities served by the CBO. The 
innovative approach or method can include an expansion or modification 
of existing behavioral theories that results in novel intervention 
strategies or activities and addresses behavior change at either the 
social, structural, or individual levels.
    An intervention that has a published outcome evaluation, or that 
has demonstrated statistically significant positive intervention 
effects on HIV-related behavioral or biologic outcomes using a rigorous 
outcome evaluation, and therefore meets the criteria for inclusion in 
the Compendium of HIV Prevention Interventions with Evidence of 
Effectiveness (http://www.cdc.gov/hiv/pubs/hivcompendium/HIVcompendium.htm), WOULD NOT fulfill the goals of this announcement. 
In addition, an intervention that either replicates or makes limited 
changes to an intervention already in the Compendium WOULD NOT fulfill 
the goals of this announcement.
    An existing innovative HIV behavioral intervention is an 
intervention that has well-defined and documented procedures and 
protocols that is currently being delivered to high-risk, minority 
individuals.
    The CBO must provide evidence from its program operations 
suggesting that the intervention has the potential for reducing HIV 
risk behaviors. This evidence can be based on outcome data (e.g., 
behavioral, psychosocial, or biologic) or process data that can be 
directly attributed to the intervention.
    Furthermore, the innovative HIV behavioral intervention MUST NOT 
have undergone a rigorous outcome evaluation. A rigorous outcome 
evaluation is one that measures the short- or long-term effects of the 
intervention as delivered to one group in comparison to a group that 
has not received the intervention.
    Any minority population at risk for HIV can be studied as part of 
this announcement. Proposals that seek to evaluate interventions 
designed for minority HIV seropositive people or interventions designed 
for minority populations not well-represented among those listed in the 
Compendium of HIV Prevention Interventions with Evidence of 
Effectiveness (examples include but are not limited to men who have sex 
with men, migrants, commercial sex workers, and transgendered) are 
especially welcome.
    If CDC funds your CBO, you will be responsible for the following 
activities:
    1. Secure adequate funding for implementation of the existing 
innovative intervention from sources other than this program 
announcement during the two-year evaluation period.
    2. Provide CDC personnel with your existing intervention protocol, 
including all manuals, procedures, and other relevant materials.
    3. In collaboration with CDC, establish a plan to evaluate your 
innovative intervention. The evaluation plan must include one pre-
intervention baseline assessment, at least one follow-up assessment 
delivered at a minimum of 6 months after completion of the 
intervention, and the inclusion of a comparison group.
    4. Develop measures and related data collection instruments to 
evaluate the effects of the innovative intervention. New instruments 
need to be field-tested.
    5. Develop procedures to ensure confidentiality and informed 
consent, when appropriate, and obtain any other approvals as needed.
    6. Recruit participants for the intervention and comparison groups.
    7. Conduct individual baseline and follow-up assessment(s) 
according to the evaluation design.
    8. Monitor intervention activities for quality assurance such that 
the intervention delivery is consistent with the established protocol.
    9. Establish data management systems, analyze and interpret the 
data.
    10. Prepare a final report for CDC, including submission of a 
cleaned data set.
    11. Develop and implement a plan for using the evaluation results 
to improve implementation of the existing intervention by the CBO.
    12. Develop and implement a plan to disseminate the findings and 
outcomes of the evaluation, including recommendations for the 
implementation of the successful innovative HIV behavioral 
intervention, presentations at state-wide and national health 
professional meetings, and reports of findings and recommendations.
    13. If the innovative HIV behavioral intervention is found not to 
be successful, conduct a thorough examination of process evaluation 
data to explain the lack of success; that is, to identify potential 
problems or barriers in achieving HIV risk reduction.
    In a cooperative agreement, CDC staff will be substantially 
involved in the program activities, above and beyond routine grant 
monitoring. CDC Activities for this program are as follows:
    1. Provide oversight to the cooperative agreement recipients in 
developing evaluation and data collection materials.
    2. Provide assistance and consultation to assist the recipient in 
planning and implementing the evaluation, including technical guidance 
in the development of the evaluation design, data collection 
instruments, selection of comparison groups, outcome measures, data 
collection protocols, and pretesting of methods and instruments.
    3. Ensure that the results of successful innovative HIV behavioral 
interventions and lessons learned from the evaluation are shared among 
grantees through meetings, workshops, conferences, newsletters, and 
other avenues of communication (e.g., internet).
    4. Ensure that the results of the evaluation are used to improve 
the existing intervention by the CBO.
    5. Monitor successes and difficulties in the implementation and 
evaluation of the innovative intervention.
    6. Monitor the protection of client privacy and compliance with 
other local, state and Federal requirements.

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    7. Monitor the award recipients' quality assurance activities and 
progress toward achieving target levels of performance for each core 
activity.
    8. Collaborate and provide guidance in data analysis and 
dissemination of findings.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: The estimated total cost is $2,000,000 
with approximately $1,000,000 awarded during the first fiscal year.
    Approximate Number of Awards: 3 to 4.
    Approximate Average Award: $300,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs).
    Floor of Award Range: None.
    Ceiling of Award Range: $400,000.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: 2 years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may only be submitted by eligible CBOs, including 
faith-based CBOs, that provide HIV prevention services to members of 
racial/ethnic minority communities at high risk for HIV infection.
    To be eligible, your CBO must meet all of the criteria listed 
below. Your CBO must:
    A. Have tax-exempt status.
    B. Be located in the area(s) where services will be provided or 
have provided services in the area for at least three years.
    C. Not be a government or municipal agency, private or public 
university or college, or private hospital.
    D. Not be a 501(c)(4) organization.
    E. Your CBO must provide proof of very significant experience in 
delivering HIV prevention services to the targeted racial/ethnic 
minority populations during each of the last three years, and that the 
CBO has provided HIV prevention services to at least 200 clients in 
your proposed high-risk population during each of the last three years.
    F. Your CBO must provide reasonable proof of adequate funding for 
the intervention during the next two years of this evaluation. If the 
funding is from the Federal Government, then the reasonable proof can 
be a copy of the latest Notice of Grant Award. Reasonable proof from 
other funding sources can include a letter from the funding agency 
indicating that funding will be available for the two years during 
which the intervention will be evaluated. If your agency funds the 
intervention, then reasonable proof can be a letter from the Board of 
Directors stating that the agency has the financial resources to fund 
the intervention and intends to fund the intervention for the next two 
years.

    Note: All information submitted with your application is subject 
to verification during pre-decisional site visits.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.
    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.

    Note: Title 2 of the United States Code Section 1611 states that 
an organization described in Section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity use application form PHS 
5161. Application forms and instructions are available on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Application Submission

    Executive Summary: Applications must include a one-page, double-
spaced executive summary as a cover page.
     Maximum number of pages: 1
     Font size: 12-point unreduced
     Double spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
    Application: You must submit a project narrative with your 
application forms. The narrative must be submitted in the following 
format:
     Maximum number of pages: 25 (not including budget 
justification and appendices). If your narrative exceeds the page 
limit, only the first pages which are within the page limit will be 
reviewed.
     Double spaced
     Font size: 12 point unreduced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
     Held together only by rubber bands or metal clips; not 
stapled or bound in any other way
     MS WORD format
     Cover Page--the program announcement number and title
     Table of contents--with the major sections and page 
numbering including each attachment
     Consecutive page numbering throughout the document, 
including the attachments beginning with the first page of text, number 
all pages clearly and sequentially, including each page in the 
appendices.
    This section of the program announcement defines program 
requirements. You must describe your plans to address each requirement. 
Please answer each item with complete sentences, provide all requested 
documents, and include Appendices as needed. If you fail to provide the 
required documents, your application will not be considered for review.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
A. Eligibility
    This section will not count toward the page limit of your 
application, but it will determine if you are eligible for funding.
    Place all documents requested in this section in an Appendix and 
label

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``Appendix A: Proof of Eligibility''. For the following questions, 
proof of location, history, and service must include at least one copy 
of a progress report describing services to the population served, a 
letter from your funding organizations, process monitoring data, 
service utilization data (which includes client characteristics).
    1. Tax-exempt status organizations are eligible. To demonstrate 
your eligibility, attach a copy of the letter from the Internal Revenue 
Service (IRS) showing that your CBO is a valid IRS 501(c)(3) tax-exempt 
non-profit organization, or attach a copy of your state proof of 
incorporation as a non-profit organization.
    2. Government, municipal agency, university/college, or private 
hospitals are not eligible. To demonstrate your eligibility, provide a 
statement that your CBO is not a governmental or municipal agency, a 
government-affiliated organization or agency (e.g., health department, 
school board, public hospital), or a private or public university or 
college.
    3. IRS 501(c)(4) organizations are not eligible. To demonstrate 
your eligibility, provide a statement that your CBO is not included in 
the category described in section 501(c)(4) of the Internal Revenue 
Code of 1986 that engages in lobbying activities.
    4. Location in area or provision of services in area is required. 
To demonstrate your eligibility, describe your location relative to the 
served area and describe the duration and type of services provided. 
Or, describe how your CBO has provided services in the proposed service 
area for at least three years.
    5. CBOs serving ethnic minority populations are eligible. Provide 
proof that your CBO has very significant experience in delivering HIV 
prevention services to the targeted racial/ethnic minority populations 
during each of the last three years.
    6. CBOs serving at least 200 minority clients per year are 
eligible. Provide proof that your CBO has provided HIV prevention 
services in each of the last three years to at least 200 clients in the 
proposed high-risk minority population.
    7. Adequate funding for existing innovative intervention is 
required. Provide reasonable proof that your CBO has adequate funding 
to support the intervention for the two-year duration of this 
evaluation. If the funding is from the Federal Government, then 
reasonable proof can be a copy of your latest Notice of Grant Award. 
Reasonable proof from other funding sources can include a letter from 
the funding agency indicating that funding will be available for the 
two years during which the intervention will be evaluated. If your 
agency funds the intervention, then reasonable proof can be a letter 
from the Board of Directors stating that the agency has the financial 
resources to fund the intervention and intends to fund the intervention 
for the next two years.
B. Specific Aims
    Describe the objectives of the proposed program.
C. Justification and Significance of the Innovative Intervention
    1. Describe the components of the innovative intervention. Explain 
why this HIV behavioral intervention is innovative, and provide an 
explicit and detailed description of all intervention activities. 
Emphasize novel intervention strategies or approaches, including the 
uniqueness and relevance of the approach to HIV risk reduction.
    2. Describe how the innovative HIV behavioral intervention was 
developed from the ``ground up;'' that is, in collaboration with the 
community or communities that are served by the intervention. Describe 
the rationale for developing the intervention, which could include a 
community-based needs assessment or theoretical basis. Specify the 
involvement of the target population in planning and implementing the 
intervention.
    3. Provide evidence that the innovative intervention has worked in 
the past. This evidence can include data from pre- and post-
intervention monitoring of outcomes such as behavioral, psychosocial, 
or biologic data, or process data that can be directly attributable to 
the innovative intervention.
    4. Explain why you think your CBO's innovative intervention works. 
This explanation can refer to (a) how specific activities, processes or 
steps led to the observed results, and/or (b) how the intervention was 
based or expanded upon current behavior change theories.
D. Justification of HIV Prevention Needs of Minority Target Population

    Note: Contact your health department to obtain HIV/AIDS 
statistics and HIV needs assessment data developed for the community 
planning process. This information will help you answer the 
questions in this section.


    1. Describe the ethnic/racial minority target population being 
served by the innovative intervention. Applicants must include a table 
in their application as Appendix B that describes the target 
population. The table must include the following six categories, and 
provide the numbers (n) and percentages (%) for each subgroup you have 
served over the past year:
    (1) Total sample population;
    (2) Transmission risk including MSM, IDU, MSM/IDU, Heterosexual, 
Other risk group(s);
    (3) Gender including Men, Women, Transgender (total), Transgender 
(male to female), Transgender (female to male);
    (4) Age group including < 20, 20 to 29, 30 to 49, 50+;
    (5) HIV sero-status including HIV positive, HIV negative, HIV 
unknown;
    (6) Race/Ethnicity including American Indian/Alaskan Native, Asian/
Pacific Islander, Black not Hispanic, White not Hispanic, Hispanic, and 
Unknown or multiple race.
    Proposals that seek to evaluate interventions designed for minority 
HIV seropositive people or interventions designed for minority 
populations not well-represented among interventions listed in the 
Compendium of HIV Prevention Interventions with Evidence of 
Effectiveness (examples include but are not limited to men who have sex 
with men, migrants, commercial sex workers, and transgendered) are 
especially welcome.
    2. Describe how the proposed minority target population reflects 
HIV community planning priorities. Describe how the local, regional or 
state HIV prevention community plan, especially the epidemiologic 
profile and behavioral data, were used in the selection of the target 
population.
    3. Provide proof that your CBO has very significant experience in 
delivering HIV prevention services to the targeted racial/ethnic 
minority population. Include a history of your CBO's service to the 
population: Explain how long you have provided services to the 
population, the kinds of services that have been provided, the outcomes 
of services provided, and your relationship with the community.
E. Evaluation Plan
    Describe the proposed evaluation plan (including the evaluation 
question(s), design, methods for recruitment and retention, outcome 
measures, data analysis plan, dissemination activities, and timeline) 
to demonstrate the soundness and capability of producing intended 
results.
    1. State the evaluation question(s).
    2. Describe the design to be used to evaluate the effects of the 
intervention. The evaluation design must meet the following criteria:
    a. A design including a minimum of one pre-intervention and one 
post-

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intervention assessment is required. The post-intervention assessment 
(follow-up) should occur at a minimum of 6 months after completion of 
the intervention activities. Proposals that provide for additional 
follow-ups beyond 6 months are especially welcome.
    b. A design that employs a rigorous evaluation of the effects of 
the intervention is required. A rigorous evaluation can be accomplished 
by including a comparison group that does not receive the innovative 
intervention. Comparison groups can be either concurrent or historical. 
Examples of concurrent comparisons include (1) your CBO administering 
the innovative intervention to one segment of the minority target 
population and not to another during the same period of time, and (2) 
comparison of data from your CBO's use of the innovative intervention 
to that of another CBO not using the innovative intervention for the 
same minority target population. An example of a historical comparison 
includes comparing outcome data from your CBO's current use of the 
innovative intervention with data collected at multiple times from the 
same target population before the implementation of the innovative 
intervention.
    3. Describe how you will recruit participants. A minimum of 200 
people from the target population must complete the pre-intervention 
interview and enroll in the intervention evaluation within one year. 
That is to say, a minimum of 100 people must be included in the group 
that receives the intervention, and a minimum of 100 people must be 
included in the group that does not receive the intervention. Provide 
proof that your CBO has provided HIV prevention services in each of the 
last three years to at least 200 clients in the proposed high-risk 
minority population.
    4. Describe how your CBO will retain at least 75 percent of the 
evaluation cohort for the 6-month follow-up.
    5. Specify the HIV risk reduction outcome measures that will be 
assessed to determine the intervention's effects. Outcomes shall 
include HIV-related risk behaviors (e.g., sex or drug behaviors) and/or 
biologic endpoints (e.g., incident cases of STDs or HIV). Also, 
describe methods that will be used to collect and monitor outcome data.
    6. Provide a plan for data management systems, particularly how 
your CBO will maintain data quality control, and perform statistical 
analyses of the outcome data.
    7. Describe how your CBO intends to use the results of this 
evaluation to improve program capacity and enhance delivery of 
prevention services in the future. In other words, describe in detail 
how your CBO will use the findings from this evaluation to improve 
specific HIV program service components offered by your CBO.
    8. Describe how you will disseminate the findings and outcomes of 
evaluation, including recommendations for the implementation of the 
successful innovative HIV behavioral intervention, through 
presentations at state-wide and national health professional meetings, 
and reports of findings and recommendations.
    9. Provide a detailed 2-year timeline for the proposed evaluation.
    10. Describe, if applicable, how you plan to address 
confidentiality and any other ethical issues related to the 
implementation of the evaluation.
F. Capacity
    1. Describe how your CBO has the technical and programmatic 
capacity and proven track record to implement and evaluate the 
intervention in the community. In Appendix C, provide the curriculum 
vitae or resumes of all key CBO personnel and organizational charts of 
your CBO.
    2. Provide evidence that your CBO has been successful in retaining 
intervention participants in the past, and can recruit and enroll at 
least 200 people for the evaluation within one year.
    3. If your CBO requires assistance with the design and 
implementation of the evaluation and the maintenance of quality control 
during the course of the evaluation, provide a statement of 
partnerships with locally-based evaluation specialists, evaluation 
organizations, universities, or health departments. Also provide, if 
applicable, in Appendix D the curriculum vitae of key personnel of 
partner organizations and Letters of Support regarding the willingness 
of partners to collaborate with the CBO and CDC.
    4. Provide a plan for CBO and, if applicable, partner staffing and 
training, as needed, to ensure that the intervention can be properly 
implemented and evaluated. Provide the qualifications of proposed staff 
needed to conduct activities, and the percentage of time each staff 
member will be assigned to the project. If CBO staff will be used to 
perform the outcome evaluation, then specify how the roles of 
intervention staff and evaluation staff will be kept distinct and 
separate to ensure objectivity.
G. Budget
    Provide a detailed, line-item budget for year one of the project 
and a justification for each line-item. This section will not count 
toward the page limit of your application.
H. Additional Information
    Additional information may be included in the application 
Appendices. The Appendices will not be counted toward the narrative 
page limit, and must include the following additional information:
     Appendix A: Proof of Eligibility
     Appendix B: Attachment 1 table with target population 
characteristics
     Appendix C: Curriculum vitae or resumes of key CBO staff 
and organizational charts
     Appendix D: Letters of Support and curriculum vitae from 
partner organizations, if applicable Letters of Support (LOS): If the 
CBO chooses to partner with another organization or institution that 
will play a role in conducting intervention activities, then 
applications must include Letters of Support (LOS) in Appendix D. Each 
LOS should include a description of the past relationship with the 
applicant and the role(s) the local partner will play in conducting 
intervention activities (e.g., accessing the target population, 
implementing the selected intervention, staff involved). Your LOS must 
be written in the following format:
     Maximum number of pages: 1
     Font size: 12-point unreduced
     Double spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm. If your application form does not have a 
DUNS number field, please write your DUNS number at the top of the 
first page of your application, and/or include your DUNS number in your 
application cover letter.
    Additional requirements that may require you to submit additional

[[Page 42188]]

documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    Application Deadline Date: August 13, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application after closing due to: (1) 
Carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds may be used to hire contractors or support partners 
to assist with the evaluation. CDC encourages you to develop 
partnerships with other prevention providers, locally-based 
researchers, research groups, universities or health departments to 
evaluate your innovative intervention. However, your CBO, not the 
contract organization(s) or the partner(s), must conduct the largest 
portion of the evaluation activities funded by this award.
     Eighty percent (80%) of the funds awarded under 
subcontracts must be applied directly to the evaluation activities.
     Funds cannot be used to provide medical or substance abuse 
treatment.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement in an Appendix. If 
your indirect cost rate is a provisional rate, the agreement should be 
less than 12 months of age.
    Awards will not allow reimbursement of pre-award costs.
    Guidance for completing your budget can be found on the CDC web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

    Application Submission Address: Submit the original and two hard 
copies of your application by mail or express delivery service to: 
Technical Information Management--PA 04249, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    You are required to provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement. Measures of effectiveness must relate to the 
performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    Your application will be evaluated against the following criteria:
Evaluation Plan Requirements (Application Section E) (35 Points)
    1. Rate the evaluation question(s) based on their soundness and 
relevance to HIV behavioral prevention. (3 points)
    2. Does the evaluation design include at a minimum one pre-
intervention and one post-intervention assessment? Does the post-
intervention assessment (i.e., the follow-up) occur at least 6 months 
after completion of the intervention activities? Does the proposed 
evaluation design include a concurrent or historical comparison group? 
(7 points)
    3. Has the applicant proposed an adequate plan to recruit and 
enroll at least 200 participants within one year of the project? Did 
the applicant provide adequate proof that their CBO has provided HIV 
prevention services in each of the last three years to at least 200 
clients in the proposed high-risk minority population? (5 points)
    4. Has the applicant proposed an adequate plan to retain at least 
75 percent of the evaluation cohort for the 6-month follow-up? (5 
points)
    5. Rate the relevance of the proposed outcome measures that will be 
used to determine the intervention's effects with respect to HIV risk 
reduction. Outcomes should assess HIV-related risk behaviors (e.g., sex 
or drug behaviors) and/or biologic endpoints (e.g., incident cases of 
STDs or HIV). Rate the methods described to monitor and collect outcome 
data. (5 points)
    6. Are plans for data management systems, data quality control, and 
statistical analysis of outcome data sufficient and appropriate for 
assessing the effects of the intervention on HIV risk reduction? (2.5 
points)
    7. Has the applicant described how the results of this evaluation 
will be used to improve program capacity and to enhance the delivery of 
prevention services? In other words, does the applicant describe how 
the CBO will feed the information gathered from this evaluation back 
into the program? (2.5 points)
    8. Has the CBO provided an adequate plan for the dissemination of 
results and recommendations from the evaluation? (2.5 points)
    9. Is the proposed timeline detailed and is it sufficient to 
achieve project goals within 2 years? (2.5 points)
    10. Has the CBO provided an adequate plan, if applicable, for 
addressing confidentiality and any other ethical issues related to the 
implementation of the evaluation? (not scored)
Justification and Significance of the Innovative Intervention 
(Application Section C) (30 Points)
    1. Does the applicant provide a thorough description of the 
components of the intervention and explain why the intervention is 
innovative (that is, based on a different intervention approach or 
method)? Rate the innovativeness of the HIV behavioral intervention. 
The rating should be based on a description of the novel intervention 
strategies or approaches, including the uniqueness and relevance to HIV 
risk reduction. (10 points)
    2. Does the applicant provide sufficient evidence that the 
intervention

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was developed from the ``ground up;'' that is, in collaboration with 
the community or communities that are served by the intervention? The 
description could include the relevance of a community-based needs 
assessment or theoretical basis, and should specify the involvement of 
the target population in intervention planning and implementation. (5 
points)
    3. Does the applicant provide sufficient evidence suggesting that 
the innovative HIV behavioral intervention has worked in the past? Do 
they provide data from pre- and post-intervention monitoring of 
outcomes such as behavioral, psychosocial, biologic, or process outcome 
data supporting positive HIV risk reduction that can be directly 
attributed to the intervention? (10 points)
    4. Does the applicant explain why they think the innovative 
intervention works? Do they refer to specific activities, processes or 
steps that led to their observed results, or do they base their 
explanation on current behavioral change theories (which could include 
a logic model)? (5 points)
Capacity (Application Section F) (20 Points)
    1. Does the applicant have sufficient technical and programmatic 
capacity and a proven track record to implement and evaluate the 
intervention in the community? (5 points)
    2. Does the applicant have the capacity to recruit and enroll at 
least 200 people within one year of the evaluation? Have they provided 
evidence of prior success in retaining intervention participants? (5 
points)
    3. If partnerships with locally-based evaluation specialists, 
evaluation organizations, universities, or health departments are cited 
in the application, do the partners demonstrate sufficient expertise to 
help achieve the project goals? (5 points)
    4. Are the staffing and training plans for the CBO and partner 
organization (if applicable) adequate to properly implement and 
evaluate the intervention? If CBO staff will be used to perform the 
outcome evaluation activities, have they demonstrated that the roles of 
intervention staff and evaluation staff will be kept distinct and 
separate to ensure objectivity? (5 points)
Justification of HIV Prevention Needs of Minority Target Population 
(Application Section D) (10 Points)
    1. Does the applicant reasonably justify the HIV prevention needs 
of the targeted minority population? To help answer this question, 
review the information provided in Appendix B (Target Population 
Characteristics) to determine whether the applicant has sufficiently 
described the racial and ethnic composition of the targeted population 
and the behaviors or circumstances that place the targeted population 
at high risk for HIV infection or for transmitting the HIV virus. 
Proposals that seek to evaluate interventions designed for minority HIV 
seropositive people or interventions designed for minority populations 
not well-represented among interventions listed in the Compendium of 
HIV Prevention Interventions with Evidence of Effectiveness (examples 
include but are not limited to men who have sex with men, migrants, 
commercial sex workers, and transgendered) should be given high 
priority. (4 points)
    2. How well does the target population reflect HIV community 
planning priorities? (3 points)
    3. Rate the strength of proof provided by the applicant that it has 
very significant experience in proving HIV prevention services to the 
targeted racial/ethnic minority population. This proof should include a 
history of the CBO's service to the population that includes an 
explanation of how long the CBO has provided services to the 
population, the kinds of services provided, the outcomes of services 
provided, and the CBO's relationship with the community (3 points)
Specific Aims (Application Section B) (5 Points)
    Are the specific aims of the proposed evaluation adequately 
described and consistent with the objectives of this cooperative 
agreement?
Eligibility (Application Section A) (Not Scored)
    This section of your application will be reviewed to determine if 
you are eligible for funding. All supporting documents were placed in 
Appendix A: Proof of Eligibility.
Budget (Application Section G) (Not Scored)
    The budget will be reviewed to determine the extent to which it is 
reasonable, clearly justified, itemized, consistent with the intended 
use of funds, and allowable.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness and eligibility 
(Appendix A: Proof of Eligibility) by NCHSTP. Incomplete applications 
and applications that are non-responsive to the eligibility criteria 
will not advance through the review process. Applicants will be 
notified that their application did not meet submission requirements.
    An objective review panel will evaluate all complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above.

V.3. Anticipated Announcement and Award Dates

    September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

    If your CBO is funded, you will receive a Notice of Grant Award 
(NGA) from the CDC Procurement and Grants Office. The NGA shall be the 
only binding, authorizing document between the recipient and CDC. The 
NGA will be signed by an authorized Grants Management Officer, and 
mailed to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-4 HIV/AIDS Confidentiality Provisions
     AR-5 HIV Program Review Panel Requirements
     AR-8 Public Health System Reporting 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-15 Proof of Non-Profit Status
    Additional information on these requirements can be found on the 
CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will

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serve as your non-competing continuation application, and must contain 
the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    2. Financial status report and annual progress report, no more than 
90 days after the end of the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management or Contract 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, PA 04249, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2700.
    For program technical assistance, contact: Tomas Rodriguez, CDC, 
NCHSTP, Mailstop E-37, 1600 Clifton Rd, NE, Atlanta, GA 30333, ph: 
(404) 639-5240, fax: (404) 639-1950, email: [email protected].
    For financial, grants management, or budget assistance, contact: 
Betty Vannoy, Contract Specialist, CDC Procurement and Grants Office, 
2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2897, E-
mail: [email protected].

    Dated: July 7, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-15916 Filed 7-13-04; 8:45 am]
BILLING CODE 4163-18-P