Adaptation and Evaluation of a Brief, Nurse-Delivered Sexual Risk Reduction Intervention for HIV-Positive Women in the South, 32624-32629 [05-10867]

Agencies

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

[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Notices]
[Pages 32624-32629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10867]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Adaptation and Evaluation of a Brief, Nurse-Delivered Sexual Risk 
Reduction Intervention for HIV-Positive Women in the South

    Announcement Type: New.
    Funding Opportunity Number: PS05-083.
    Catalog of Federal Domestic Assistance Number: 93.941.
    Key Dates:sea
    Letter of Intent Deadline: July 5, 2005.
    Application Deadline: July 18, 2006.

I. Funding Opportunity Description

    Authority: The program is authorized under sections 317(k)(2) 
and 318b of the Public Health Service Act [42 U.S.C. Sections 
247b(k)(2) and 247c], as amended.

    Purpose: The purpose of the project is to adapt and evaluate a 
prevention intervention for the growing population of HIV-positive 
women in the Southern United States (U.S.), and to study factors 
associated with risk among women. The primary outcome will be the 
evaluation of a brief, nurse-delivered prevention intervention adapted 
for use with HIV-positive women in the Southern U.S. using behavioral 
risk measures. The project will also conduct a small number of in-depth 
qualitative interviews of young, recently infected women to assess 
social and environmental factors contributing to behavioral risk for 
HIV infection, as well as potential for future interventions that go 
beyond the individual level. This program addresses the ``Healthy 
People 2010'' focus areas of HIV.
    Measurable outcomes of the program will align with one or more of 
the following performance goals for the National Center for HIV, STD, 
and TB Prevention (NCHSTP):
     Decrease the number of persons at high risk for acquiring 
or transmitting HIV infection.
     Strengthen the capacity nationwide to monitor the 
epidemic, develop and implement effective HIV prevention interventions, 
including those based on

[[Page 32625]]

the ``ABC'' approach (Abstinence, Be Faithful, and, as appropriate, 
Correct and Consistent Condom Use), and evaluate prevention programs.
    Research Objectives: The objectives of this study include:
     Using and adopting Demonstration Adaptation of Prevention 
Techniques (ADAPT) guidelines to adapt and tailor ``Sister to Sister: 
the Black Woman's Health Project,'' (a brief nurse-delivered prevention 
intervention) to HIV-positive women in the Southern U.S.
     Training nurses to deliver the single-session HIV 
prevention intervention to HIV-positive women in order to reduce HIV 
transmission risk behavior in this population.
     Monitoring the delivery of the intervention for quality 
assurance.
     Evaluating the intervention by implementing a randomized 
comparison study, including pre-intervention and six-month post-
intervention behavioral risk assessments.
     Conducting qualitative interviews with a subgroup of 
recently diagnosed participants to assess factors contributing to risk, 
and exploring innovative ways to prevent HIV transmission among at-risk 
women in the South.
    Activities: The program will support health departments in one or 
two states in the Southern U.S. Health departments will be expected to 
work collaboratively with federal investigators and another awardee (if 
applicable) in conducting an intervention study to reduce sexual 
transmission risk among HIV-positive women in both rural and urban 
settings in the Southern U.S. It is expected that grantees will enroll 
a total of 330 women (one site or two sites combined), a proportion of 
whom will be living in rural areas. This proportion will be determined 
between CDC and grantee after the award.
    The intervention to be evaluated will be an adaptation of ``Sister 
to Sister: The Black Woman's Health Project,'' a rigorously evaluated, 
20-minute nurse-delivered intervention that was effective in reducing 
sexually-transmitted infection (STI) incidence at a 12-month follow-up 
with HIV-negative urban African American women. The intervention will 
be adapted utilizing the ADAPT guidance (available through the 
Extramural Program Official listed in Section VII of this announcement) 
for adapting and tailoring prevention interventions. The intervention 
would be evaluated with behavior change in a randomized wait list 
comparison design with a six-month follow-up period. That is, six 
months after having delivered the intervention to the first group of 
women, women in the comparison condition would also receive the 
intervention.
    Semi-structured, focused, qualitative interviews will be conducted 
with a subgroup of young, recently-diagnosed participants following 
their participation in the intervention study. During the qualitative 
interviews, women will discuss the behavioral, social, and contextual 
conditions that may have contributed to their risk for HIV infection, 
and ideas about possible ways to address the STI and HIV epidemics in 
this region, i.e., how to prevent other women from becoming infected. 
Ultimately, the qualitative data will be used to inform future social, 
structural, policy, or other interventions. Thus, the proposed project 
will evaluate an individually based approach and gather information for 
approaches with the potential to have greater impact on this epidemic 
than might be anticipated with individual-level interventions alone.
    Awardee activities for this program are as follows:
     Establish a community advisory board comprised of 
representative members of the community to consult on all aspects of 
the study.
     Develop recruitment strategies that will identify a 
minimum of 165 to 330 (depending on the number of awards) HIV-
seropositive women within the applicant state(s), in rural and urban 
areas, and retain 85 percent of participants through their risk 
behavior assessment at six months following the delivery of the 
intervention.
     In collaboration with ODC investigators, adapt the 
existing intervention to the target population.
     In collaboration with CDC and other funded investigators 
(if applicable), develop a plan for a randomized behavioral 
intervention trial with research and intervention protocols and 
assessment instruments.
     In collaboration with CDC and other funded investigators 
(if applicable), develop a semi-structured qualitative individual 
interview protocol focusing on women's perceptions of factors involved 
in their infection, including social and structural parameters of risk. 
The protocol would specify criteria for purposefully selecting a 
subgroup of 25-30 study participants for the qualitative interviews.
     Identify five to ten nurses who will be trained to deliver 
the intervention and arrange for their participation in the proposed 
project.
     Conduct the research study in accordance with the study 
protocol and CDC mutually-established timeline.
     Collaborate with CDC and other funded investigators (if 
applicable) to develop and use common data collection instruments and 
data management and reporting procedures. Recipients will be required 
to pool data for analysis and publication as agreed to by the 
collaborators.
     Attend meetings at CDC and elsewhere to develop a 
collaborative research protocol and monitor progress.
     Participate in regular conference calls with all 
collaborators.
     Develop the research study protocols and standardized data 
collection forms access sites, including standardized measures of HIV-
related risk behavior.
     Establish procedures to maintain the rights and 
confidentially of all study participants.
     Prepare an Institutional Review Board (IRB) protocol for 
approval at the local and CDC levels.
     Identify, recruit, enroll, and obtain informed consent 
from an adequate number of study participants, as determined by the 
study protocols and the program requirements.
     Follow study participants as determined by the study 
protocols.
     Collaborate and share data (when appropriate) with other 
collaborators to answer specific research questions.
     Participate in the presentation and publishing of research 
findings.
     Collaborate with other awardees (if applicable) on all 
aspects of the study.
    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:
     Providing technical assistance, as needed, in intervention 
adaptation and in the design and conduct of research.
     Providing training on the adapted intervention to nurses 
who will deliver the intervention.
     Providing training on HIV-related nursing care, if 
requested by applicant.
     Training project staff to conduct behavioral risk 
assessment interviews and qualitative interviews.
     Assisting in the development of a research protocol for 
IRB review by all cooperating institutions participating in the 
research project. CDC's IRB will review and approve the protocol 
initially and on at least an annual basis until the research project is 
completed.
     Assisting in designing an integrated data management 
system, including coordinating data submission to CDC via the Secure 
Data Network (SDN) and developing cleaned, combined data sets.
     Working collaboratively with investigators to help 
facilitate research activities across sites involved in the same 
research project.

[[Page 32626]]

     Analyzing data and presenting findings at meetings and in 
publications.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above.
    Mechanism of Support: U01.
    Fiscal Year Funds: 2005.
    Approximate Total funding: $200,000. (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: One to Two.
    Approximate Average Award: $100,000 to $200,000. (This amount 
includes both indirect and direct costs for the first 12-month budget 
period, and would increase in subsequent years depending on 
availability of funds.)
    Floor of Award Range: None.
    Ceiling of Award Range: $200,000. (This ceiling is for the first 
12-month budget period.)
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Four years. Throughout the project period, 
CDC's commitment to the 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.
    It is anticipated that in subsequent years of the project, the 
average award will increase in order to support project activities, 
including the staff and materials necessary to conduct recruitment, 
retention, intervention, and evaluation activities.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by:
     State health departments in the following states: North 
Carolina, South Carolina, Georgia, Texas, Delaware, Maryland, Alabama, 
Mississippi, Florida, Louisiana, Tennessee or their Bona Fide Agents.
    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 government, you must provide a letter from the state as 
documentation of your status. Place this documentation behind the first 
page of your application form.
    Eligibility is limited to these state health departments due to 
dramatic increases in HIV, AIDS and STI rates among women, particularly 
among women of color in these states. Over the past 15 years, the HIV 
infection rate among women in the Southern U.S. has steadily increased. 
Seven of the ten states with the highest case rates among women are in 
the South, and the South hs led the way in total number of reported 
AIDS cases among female adults and adolescents, compared to all other 
regions of the country. As is the case nationally, in Southern U.S., 
black women make up the vast majority of newly reported HIV infections.
    Given that women in the Southern U.S. are disproportionately 
affected by HIV, this competition is limited to health departments in 
the Southern U.S. with demonstrated ability to reach HIV positive women 
at risk for further transmission, in adequate numbers to generate the 
required sample size for this project, and with demonstrated research 
capability.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you are requesting 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.
    Special Requirements: If your application is incomplete or not 
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.
     Late applications will be considered nonresponsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.

     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 state health 
department 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 are as follows:
     Experience adapting, delivering, and evaluating HIV 
prevention interventions, including those based on the ``ABC'' approach 
(Abstinence, Be Faithful, and, as appropriate, Correct and Consistent 
Condom Use).
     Knowledge and training in theories of behavioral change.
     A track record of participation in conducting and 
publishing research.

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. 9/2004). Forms and instructions are 
available in an interactive format at https://www.cdc.gov/od/pgo/
forminfo.htm.
    Forms and instructions are also available in an interactive format 
at 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.
     Line spacing: Single.
     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 the PGO-TIM staff at 770-488-2700, or 
contact GrantsInfo by phone at (301) 435-0714 or by e-mail at 
GrantsInfo@nih.gov.

[[Page 32627]]

    Your research plan should address activities to be conducted over 
the entire project period.
    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, go to https://www.dunandbradstreet.com or call 1-866-705-
5711. For more information, go to the CDC Web site at: https://www.
cdc.gov/od/pgo/funding/pubcommt1.htm.
    This announcement uses the modular budgeting as well as non-modular 
budgeting formats. See: https://grants.nih.gov/grants/funding/modular
/modular.htm for additional guidance on modular budgets. Specifically, 
if you are submitting an application with direct costs in each year of 
$250,000 or less, use the modular budget format. Otherwise, follow the 
instructions for non-modular budget research grant applications.
    Additional requirements to submit more documentation with your 
application are listed below in Section ``VI.2. Administrative and 
National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: July 5, 2005.
    CDC requests that you send a 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 to allow CDC 
to plan the application review.
    Application Deadline Date: July 18, 2005.
    Explanation of Deadlines: LOIs must be received in the 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 a 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 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 carriers 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 LOI and application 
content, 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 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 application, first contact 
your courier. If you still have a question, call 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. To 
get the current SPOC list, go to 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 provisional, the agreement should have been made within 
the past 12 months.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail or delivery 
service to: Mary Lerchen, DrPH, Scientific Review Administrator, 
Centers for Disease Control and Prevention, One West Court Square, 
Suite 7000, MS D-72, Decatur, GA 30030, Telephone: 404-371-5277, Fax: 
404-371-5277, Fax: 404-371-5215, E-mail: Mlerchen@cdc.gov.
    LOIs may not be submitted electronically at this time.
    Application Submission Address: Submit the original and one hard 
copy of your application by express mail or delivery service to: 
Technical Information Management--PS05-083, 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, 
Scientific Review Administrator, Centers for Disease Control and 
Prevention, One 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 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 outcomes. 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 the goals appropriate to this announcement.
    The scientific review group will address and consider each of the 
following criteria in assigning 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

[[Page 32628]]

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? Does the applicant demonstrate an understanding 
of the need for and intent of the research? Does the applicant provide 
a description of study activities that are likely to lead to meeting 
the objectives of this project? Are the proposed study activities 
likely to have a positive impact on the field of HIV prevention for HIV 
positive women in the southern U.S.?
    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 address all 
of the activities listed on pages four through eight of this 
announcement? Will the applicant establish a community advisory board 
to assist on all aspects of conducting the study? Does the applicant 
agency demonstrate adequate knowledge of the epidemic in its geographic 
area and the target population? Does the applicant provide a timeframe 
for the proposed project? Does the applicant propose an adequate plan 
to recruit the required minimum number of eligible participants? Does 
the applicant propose an adequate plan to retain at least 85 percent of 
the study sample across the follow-up period? Does the applicant 
present an adequate plan for recruitment and organizational support of 
nurses to deliver the intervention? Does the applicant present an 
adequate plan for quality assurance of the delivery of the 
intervention? Does the applicant present an adequate plan for assuring 
client and data confidentiality?
    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?
    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 investigator have and demonstrate an understanding 
of the issues relating to the proposed target population and experience 
working with this population? Does the investigator have experience 
recruiting the targeted study population and retaining this group in a 
study? Does the investigator have experience with delivery and 
evaluation of behavioral interventions? Does the investigator have 
previous experience conducting a randomized controlled trial? Does the 
key staff have sufficient time devoted to this project to ensure 
success? Does the investigator have experience collaborating with 
community advisory boards? Does the investigator demonstrate a 
willingness to collaborate with CDC and, if applicable, other health 
department, to adapt the intervention and design the intervention 
evaluation and qualitative interviews?
    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? Is the planned location for the 
study in an area with access to adequate numbers of the target 
population? Does the applicant include letters of support demonstrating 
a strong partnership with health care facilities and/or the agencies 
with which it proposes collaboration, including proposed location of 
intervention delivery? Does the applicant demonstrate how levels of 
administrative support, community involvement, facilities, and other 
resources at the research site(s) will contribute to the probability of 
success of the project?
    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 protection from research risks 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 and ethnic and racial groups in the proposed research? This 
includes: (1) The proposed plan for the inclusion of women 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 communities and recognition of mutual 
benefits.
    Budget: Is the proposed budget and the requested period of support 
reasonable 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 criteria listed above. 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 the NCHSTP.
    Award Criteria: Criteria that will be used to make award decisions 
during the programmatic review include:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities

V.3. Anticipated Announcement and Award Dates

    It is anticipated that awards will be made on or before 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, go to the 
National

[[Page 32629]]

Archives and Records Administration Internet address at 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: 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 at: https://www.nih.gov/
grants/funding/2590/2590.htm. Submit report 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 Objectives and Activities.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Objectives and Activity.
    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

    Inquiries concerning this announcement are encouraged.
    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, Extramural 
Program Official, Office of the Associate Director for Science, 
National Center for HIV, STD, and TB Prevention, Centers for Disease 
Control and Prevention, 1600 Clifton Road, NE., MS E07, Atlanta, 
Georgia 30030, Telephone: 404-639-6485, Fax: 404-639-8600, E-mail: 
ASandul@cdc.gov.
    For questions about peer review, contact: Mary Lerchen, DrPH, 
Scientific Review Administrator, Office of Public Health Research, 
Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop 
D72, Atlanta, GA 30030, 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 Officer, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 404-498-
1918, E-mail: mqw6@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, at 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. 05-10867 Filed 5-31-05; 8:45 am]
BILLING CODE 4163-18-M