Epidemiologic HIV/AIDS Research Among African American and Hispanic Women at Risk for HIV Infection in the Southern United States and Puerto Rico, 31472-31477 [05-10856]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 104 (Wednesday, June 1, 2005)]
[Notices]
[Pages 31472-31477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10856]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Epidemiologic HIV/AIDS Research Among African American and 
Hispanic Women at Risk for HIV Infection in the Southern United States 
and Puerto Rico

    Announcement Type: New Cooperative Agreement.
    Funding Opportunity Number: PS05-107.
    Catalog of Federal Domestic Assistance Number: 93.943.
    Key Dates:
    Letter of Intent Deadline: July 1, 2005.
    Application Deadline: July 18, 2005.

I. Funding Opportunity Description

    Authority: Public Health Service Act, Section 317(k)(2) (42 
U.S.C. Section 247b(k)(2) as amended.

    Background: Since the beginning of the AIDS epidemic, most of the 
persons identified to be at risk for HIV-1 infection in the United 
States have been men who have sex with men or injection drug users. 
However, over the past 15 years, the HIV infection rate among women at 
heterosexual risk has steadily increased. In 2002, surveillance data 
demonstrated that heterosexual transmission accounted for most of the 
AIDS cases reported among U.S. women, particularly affecting women of 
color in the Southern United States. The rate of AIDS diagnoses among 
African American women is 48.6 per 100,000 and among those aged 25-44 
years, AIDS is the second most frequent cause of death. Hispanic women 
of the same age group have the second highest mortality rate from AIDS. 
Limited research data suggest that the character and dynamics of 
women's sexual relationships may be important determinants of risk, 
both for engaging in risk behaviors and for doing so with high-risk 
partners. In addition, their vulnerability is connected to a variety of 
socioeconomic factors, including delayed access to care and support for 
HIV/AIDS.
    Purpose: The purposes of this project are to support research on 
the epidemiologic, socio-cultural, structural, psychological, and 
behavioral factors that promote HIV infection in African American and 
Hispanic women; and to increase understanding of the factors related to 
the prevalence of HIV infection, and incidence of recent infection, in 
these populations. This announcement addresses the ``Healthy People 
2010'' focus areas of HIV and the goals of CDC's HIV prevention 
strategic plan through 2005.
    Measurable outcomes of the program will align with one (or more) of 
the following performance goal(s) for the National Center for HIV, STD, 
and TB Prevention (NCHSTP):
     Decrease the number of persons at high risk of acquiring 
or transmitting HIV infection.
     Increase the proportion of HIV-infected persons who know 
they are infected.
     Increase the number of HIV-infected persons who are linked 
to appropriate prevention, care, and treatment services.
     Strengthen the capacity nationwide to monitor the HIV 
epidemic.
    Research Objectives: The program will support four sites to work

[[Page 31473]]

collaboratively with each other and with CDC investigators in 
conducting a multi-center cross-sectional study that includes 
epidemiologic and behavioral electronic data collection through the use 
of personal digital assistants (PDAs), oral rapid HIV and urine 
sexually transmitted disease (STD) testing, and a qualitative component 
among African American and Hispanic women at risk for HIV infection in 
the Southern United States and Puerto Rico. Applicants should indicate 
clearly whether their application pertains to Hispanic or African 
American women. Applicants are also strongly encouraged to propose two 
site investigators: a junior research investigator as the site primary 
investigator, who is able to devote at least 30 percent full time 
effort to the project, and a senior investigator able to devote at 
least 10 percent full time effort to the project. At each site, 
awardees will be expected to enroll 300-500 women.
    In conducting the research, awardees will be expected to establish 
a partnership with at least one community-based organization (CBO) to 
consult on all aspects of conducting the study, and to help link 
participants to prevention and medical services.
    Assessing the prevalence of HIV infection and incidence of early 
infection is also a central component of the research. Understanding 
the risk factors associated with recent HIV seroconversion will inform 
the design of future prevention interventions or programs. In addition 
to performing rapid oral HIV testing of participants, applicants should 
be prepared to use standard serologic assays to confirm preliminary 
positive results and to process and ship specimens from HIV-infected 
persons to a CDC-designated laboratory facility in New York State for 
testing by using the Serologic Testing Algorithm for Recent HIV 
Seroconversion (STARHS) to identify recent seroconversions. Applicants 
should also indicate how culturally and gender-tailored pre- and post-
test counseling and referral to medical care, prevention services, and 
other services (social, mental health, drug treatment, etc.) will be 
provided to those in need. After sites are funded, but before research 
activities begin, awardees and CDC investigators will work 
collaboratively to refine the protocols so that they fit together as a 
whole and address the research issues in a scientifically rigorous 
manner.
    Activities: In conducting activities to achieve the purpose of 
these programs, the awardee will be responsible for the activities 
listed under ``Awardee Activities,'' and CDC will be responsible for 
conducting activities listed under CDC Activities.
    Awardee Activities for this program are as follows:
    a. Collaborate with other CDC-sponsored researchers, including 
developing and using common data collection instruments, specimen 
collection protocols, and data management procedures, as determined in 
post-award awardee planning conferences. Recipients will be required to 
pool data for analysis and publication.
    b. Attend meeting(s) at CDC to develop collaborative research 
protocol. Must be prepared to attend first meeting on September 29, 
2005.
    c. Identify, recruit, obtain informed consent from, and enroll an 
adequate number of study participants, as determined by the study 
protocol and the program requirements.
    d. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    e. Perform laboratory tests and data analysis as determined in the 
study protocol.
    f. Collaborate and share data and specimens (when appropriate) with 
other collaborators to answer specific research questions.
    g. Conduct data analysis with all collaborators.
    h. Present and publish research findings.
    i. Participate in conference calls (two per month) with all 
collaborators.
    j. Attend biannual CDC meetings with other funded grantees.
    k. Establish a partnership with at least one CBO to consult on all 
aspects of conducting the study and to help link participants to 
prevention and medical services.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
    a. Provide technical assistance as needed in the design and conduct 
of the research.
    b. Facilitate and assist in the development of a research protocol 
for Institutional Review Board (IRB) review by all cooperating 
institutions participating in the research project. The CDC IRB will 
review and approve the protocol initially and on at least an annual 
basis until the research project is completed.
    c. Provide study software and assist in designing data management 
systems.
    d. Assist, as needed, in performance of selected laboratory tests.
    e. Assist in the analysis of research information, and the 
presentation and publication of research findings.
    f. Conduct annual site visits.
    g. Organize and conduct site investigators' meetings in Atlanta.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the preceding Activities section.
    Mechanism of Support: U19.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $1,000,000 (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: Three-Four.
    Approximate Average Award: $250,000-$320,000 per site. (This amount 
is for the first 12-month budget period.)
    Funding Preferences: Funding decisions will attempt to achieve 
ethnic and geographic diversity among the four sites.
    Floor of Award Range: None.
    Ceiling of Award Range: $320,000.
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Four 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 be submitted by public and private nonprofit 
organizations and by governments or their Bona Fide Agents located in 
the southern states of Alabama, Arkansas, Delaware, Florida, Georgia, 
Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, 
South Carolina, Tennessee, Texas, Virginia, and West Virginia, and in 
the District of Columbia and the Commonwealth of Puerto Rico:
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.
    Selection of the listed states, the District of Columbia, and the

[[Page 31474]]

Commonwealth of Puerto Rico is based on 2002 surveillance data that 
demonstrated heterosexual transmission accounted for most AIDS cases 
reported among U.S. women, particularly affecting women of color in the 
southern U.S. The rate of AIDS diagnoses among African American women 
is 48.6 per 100,000 and, among those aged 25-44 years, AIDS is the 
second most frequent cause of death. Hispanic women of the same age 
group have the second highest mortality rate from AIDS.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    Special Requirements: If your application is incomplete or 
nonresponsive 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.
     Late applications will be considered nonresponsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     Applicants must demonstrate research will occur in African 
American or Hispanic female populations at risk for HIV infection by 
including in their research proposal applicable data (state/local 
surveillance or research data) indicating high rates of HIV/AIDS 
diagnoses among women in the proposed research population.
     Priority will be given to applications that include two 
site investigators--a senior research investigator (10 percent full 
time effort) and a junior research investigator (30 percent full time 
effort, who will serve as the primary site investigator)--with direct 
links to or involvement with the specified study population.
     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.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from underrepresented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.
    Additional Principal Investigator qualifications that must be met 
and demonstrated are: (1) Possession of a research or health-
professional doctorate-level degree from an accredited school/program 
within the past 10 years; (2) knowledge about HIV/AIDS epidemiology and 
prevention, as well as basic, but minimal, research experience in or 
related to the field of HIV/AIDS; (3) personal experience working in 
minority communities, and the ability to access female study 
populations from these communities; and (4) the ability to establish 
effective and well-defined working relationships with community 
advisory boards, community-based organizations, or similar entities 
that can ensure the appropriateness of proposed research and 
implementation of the proposed activities.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001 rev. 9/2005). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: https://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: https://grants.nih.gov/grants/funding/phs398/
phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms online, 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

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: Two
     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
    Your LOI must contain the following information:
     Descriptive title of the proposed research
     Name, address, E-mail address, telephone number, and FAX 
number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Announcement
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. If the instructions in this 
announcement differ in any way from the PHS 398 instructions, follow 
the instructions in this announcement. For further assistance with the 
PHS 398 application form, contact PGO-TIM staff at 770-488-2700.
    The research plan should be limited to 25 double-spaced, single-
sided pages of 12-point font. All tables, graphs, figures, diagrams, 
and charts must be included in the 25-page limit. There is no 
requirement to use all 25 pages; however, the additional pages in 
proposals exceeding 25 pages will not be read and considered in the 
scoring. The plan should address activities to be conducted over the 
entire project period. The narrative, at a minimum, should include a 
background of HIV/AIDS in the proposed community, research objectives, 
methods, evaluation, budget, and time line.
    In addition to the 25-page narrative, applicants must also include 
two appendices containing letters of support from community groups and 
other institutions, and curriculum vitas (CVs) of key personnel.
    Applicants should develop and propose in their research plans:
    (1) A variety of effective local sampling and recruitment 
strategies that demonstrate their ability to enroll women at sexual 
risk of HIV infection.
    (2) Explicitly stated conceptual hypotheses, grounded in relevant 
literature, about what might promote HIV risk or serve as a protective 
role among African American and Hispanic women; gender and culturally 
sensitive measures should be incorporated to characterize and assess 
those hypotheses. These measures may consist of epidemiologic, socio-
cultural, structural, psychological, and behavioral factors.
    These factors may include, but are not limited to:
     Cultural attitudes and values
     Social and economic discrimination
     Social and sexual networks
     Acculturation, immigration, and ethnic relations
     Family relations
     Community involvement
     Experience with and influence of correctional systems
     Self-esteem
     Resiliency
     Religious beliefs
     Beliefs about HIV disease and its treatment

[[Page 31475]]

     HIV testing history and perceived and actual barriers to 
testing
     Factors influencing their choice of sexual partners
     Risk behavior and bisexual practices among their sexual 
partners
     Drug use
     Fluidity of risk behavior
     Domestic violence
    (3) Methodology for the conduct of both a quantitative 
epidemiologic survey, as well as a qualitative research survey, with a 
subset of the women.
    (4) Gender and culturally appropriate HIV counseling and testing by 
using rapid oral testing (see second paragraph below).
    (5) Stringent safeguards for protecting confidentiality of research 
study participants.
    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. Your DUNS number must be entered 
on line 11 of the face page of the PHS 398 application form. 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 this 
Internet address: https://www.cdc.gov/od/pgo/funding/pubcommt1.htm.
    This announcement uses the non-modular budgeting format.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: July 1, 2005.
    CDC requests that you submit a letter of intent (LOI) if you intend 
to apply for this program. Although the LOI is not required, not 
binding, and does not enter into the review of your subsequent 
application, the LOI will be used to gauge the level of interest in 
this program and allow CDC to plan the application review.
    Application Deadline Date: July 18, 2005.
    Explanation of Deadlines: LOIs must be received in the CDC Office 
of Public Health Research (OPHR) and applications must be received in 
the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the 
deadline date. If you submit your application by the United States 
Postal Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives your submission after the closing date and time 
because of: (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 
submission as having been received by the deadline.
    This announcement is the definitive guide on the LOI and 
application content, submission address, and deadline. It supersedes 
information provided in the application instructions. If your 
application does not meet the previously cited deadline, it will not be 
eligible for review and will be discarded. You will be notified that 
you did not meet the submission requirements.
    CDC will not notify you upon receipt of your submission. If you 
have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question concerning your LOI, 
contact the OPHR staff at 404-371-5277. If you still have a question 
about your application, contact the PGO-TIM staff at 770-488-2700. 
Before calling, please wait two to three days after the submission 
deadline. This will allow time for submissions to be processed and 
logged.

IV.4. Intergovernmental Review of Applications

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: https://
www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
     Reimbursement of pre-award costs is not allowed.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should have been in 
effect less than 12 months.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Mary Lerchen, DrPH (PS05-107), Scientific 
Review Administrator, CDC/Office of Public Health Research, 1 West 
Court Square, Suite 7000, Mailstop D-72, Decatur, Georgia 30030, 
Telephone: 404-371-5277, Fax: 404-371-5215, E-mail: MLerchen@cdc.gov.
    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management (PS05-107), CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the 
application and all appendices must be sent to: Mary Lerchen, DrPH 
(PS05-107), Scientific Review Administrator, CDC/Office of Public 
Health Research, 1 West Court Square, Suite 7000, MS D-72, Decatur, GA 
30030, Telephone: 404-371-5277, Fax: 404-371-5215, E-mail: 
MLerchen@cdc.gov.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants 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.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    The scientific review group will address and consider each of the 
following criteria equally in assigning

[[Page 31476]]

the application's overall score, weighting them as appropriate for each 
application. The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score. For example, an investigator may propose 
to carry out important work that by its nature is not innovative, but 
is essential to move a field forward.
    The review criteria are as follows:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? Does the applicant have 
extensive knowledge of the issues faced by the study population; and 
experience in working with the population? Are there existing linkages 
to facilitate recruitment from and referral to programs providing 
services for the study population, and letters of support? Are the 
plans to involve the study population, their advocates, or service 
providers in the development of research activities, and to inform them 
of research results feasible? Is there evidence that the plans for 
recruitment and outreach for study participants will include 
establishing partnerships with communities? Is the quality of the 
review of the scientific literature pertinent to the proposed study? 
Does the applicant understand the research objectives as evidenced by 
the quality of the proposed research plan and specific study design? Is 
the plan feasible to sample, recruit, and enroll study participants in 
a culturally and linguistically appropriate manner? Does the plan allow 
for a demographically diverse sample within the African American or 
Hispanic female populations and conducting multi-venue sampling? Does 
the plan include collecting both quantitative and qualitative research 
data? Does the plan protect the rights and confidentiality of all 
participants? Does the plan include conducting HIV counseling and 
testing by using oral rapid HIV tests in a culturally and gender-
sensitive manner? Has the Clinical Laboratory Improvement Amendments 
(CLIA) waiver for testing has been received? Does the plan include 
collecting and testing blood and urine specimens, in addition to 
ability to store and ship blood specimens? Is there evidence of a plan 
to establish a partnership with at least one community-based 
organization (CBO) to consult on aspects of conducting the study, and 
to link participants with prevention and medical services, as needed? 
Is there evidence of commitment and cooperation of current and 
potential partners (e.g., letters of support, memorandums of 
understanding, and examples of prior collaborations)? Is the time line 
for conducting the research adequate?
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies? Is the research original and will it address important 
gaps in knowledge?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)? Does the applicant have the ability to carry out the proposed 
research as demonstrated by the training, experience, and expertise of 
the principal investigator and the proposed research team, and 
organizational setting, including demonstration of ability to collect, 
manage, and analyze accurate data in a timely manner? Is there a 
demonstration of epidemiologic, behavioral, clinical, laboratory, 
administrative, and management expertise needed to conduct the proposed 
research? Does the principal investigator and staff have experience 
working with the targeted population of study participants? Does the 
research team include a staff member with expertise in qualitative data 
analysis? Are qualified personnel with realistic and sufficient 
percentage-time commitments available; Are the described duties and 
responsibilities of project personnel, including clear lines of 
authority and supervisory capacity over the behavioral, epidemiologic, 
administrative, clinical, laboratory, data management, and statistical 
aspects of the research clearly identified. Do staffing plans include, 
at a minimum, a principal investigator, study coordinator, lab 
assistant, and several interviewers/outreach workers? Are there at 
least two site proposed investigators: a junior investigator able to 
serve as the primary investigator and able to devote at least thirty 
percent to the project, and a senior investigator able to devote at 
least ten percent to the project? Can the staff keep pace with the 
anticipated workload?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Are the facilities, equipment, data 
processing and analysis capacity, and systems for management of data 
security and participant confidentiality? Do you have access to 
laboratory facilities and are they able to perform confirmatory HIV and 
STD testing.
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR Part 46 
for the protection of human subjects? The involvement of human subjects 
and protections from research risk relating to their participation in 
the proposed research will be assessed.
    Inclusion of Women and Minorities in Research: Does the application 
adequately address 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; and (4) A statement as 
to whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
community(ies) and recognition of mutual benefits.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) and for responsiveness by OPHR. 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.
    Applications that are complete and responsive to the announcement 
will be evaluated for scientific and technical merit by an appropriate 
peer review group or charter study section convened by OPHR in 
accordance with the review

[[Page 31477]]

criteria listed previously. As part of the initial merit review, all 
applications may:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit by the review group, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique.
     Receive a second programmatic level review by NCHSTP.
    Award Criteria: Award decisions during the programmatic review will 
be based on the following:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities
     Preference to organizations in the Southern United States 
and Puerto Rico

V.3. Anticipated Announcement Date and Award Date

    August 31, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NoA) from the 
CDC Procurement and Grants Office. The NoA shall be the only binding, 
authorizing document between the recipient and CDC. The NoA 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: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements
     AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research
     AR-4 HIV/AIDS Confidentiality Provisions
     AR-5 HIV Program Review Panel Requirements
     AR-6 Patient Care
     AR-7 Executive Order 12372
     AR-9 Paperwork Reduction Act Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-22 Research Integrity
     AR 24 Health Insurance Portability and Accountability Act 
Requirements
     AR-25 Release and Sharing of Data
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: https://www.cdc.gov/od/
pgo/funding/ARs.htm.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004, as posted on the CDC Web site), no less than 90 days 
before the end of the budget period. The progress report will 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. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Financial status 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 Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement.
    For general questions, contact: Technical Information Management 
Section, CDC Procurement and Grants Office, 2920 Brandywine Road, 
Atlanta, GA 30341, Telephone: 770-488-2700.
    For scientific/research issues, contact: Amy L. Sandul, Health 
Science Administrator, Centers for Disease Control and Prevention, 
National Center for HIV, STD, and TB Prevention, 1600 Clifton Road, NE, 
MS E-07, Atlanta, GA 30333, Telephone: 404-639-6485, E-mail: 
ASandul@cdc.gov.
    For questions about peer review, contact: Mary Lerchen, DrPH, 
Scientific Review Administrator, Centers for Disease Control and 
Prevention, 1 West Court Square, Suite 7000, MS D-72, Decatur, GA. 
30330, Telephone: 404-371-5277, Fax: 404-371-5215, E-mail: 
mlerchen@cdc.gov.
    For financial, grants management, or budget assistance, contact: 
Merlin Williams, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 404-
498-1918, E-mail: mqw6@cdc.gov.

VIII. Other Information

    This announcement and other CDC funding opportunity announcements 
can be found on the CDC Web site, Internet address: https://www.cdc.gov. 
Click on ``Funding'' then ``Grants and Cooperative Agreements.''

    Dated: May 24, 2005.
Alan A. Kotch,
Acting Deputy Director, Procurement and Grants Office, Centers for 
Disease Control and Prevention.
[FR Doc. 05-10856 Filed 5-31-05; 8:45 am]
BILLING CODE 4163-18-P