[Federal Register Volume 69, Number 96 (Tuesday, May 18, 2004)]
[Notices]
[Pages 28128-28132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11192]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Monitoring Atypical HIV Strains Among Persons Newly Diagnosed 
With HIV Using Dried Blood Spots vs. Diagnostic Sera

    Announcement Type: New.
    Funding Opportunity Number: 04118.
    Catalog of Federal Domestic Assistance Number: 93.944.
    Key Dates:
    Letter of Intent Deadline: June 1, 2004.
    Application Deadline: June 21, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under the Public Health 
Service Act Sections 301 and 318(b) (42 U.S.C. 241 and 247c), as 
amended.

    Purpose: The purpose of the program is to expand the ability of 
health departments to perform surveillance of the prevalence of 
atypical strains of HIV, including drug resistant strains and non-B 
subtypes, by piloting the use of dried blood spots as an additional 
specimen type for this purpose. The use of serum from an HIV diagnostic 
blood draw for surveillance of atypical strains is the methodology used 
in several HIV resistance surveillance projects in various stages of 
implementation with different health departments. Some diagnostic sites 
and clinical centers cannot currently be included in these projects, 
due to logistical problems with specimen availability, processing or 
volume. The purpose of CDC funding for this activity is to allow state 
and local health departments, including both those already 
participating in atypical HIV strain surveillance and those not yet 
participating, to:
    (1) Evaluate the feasibility and efficiency of routine use of dried 
blood spots (DBS) for surveillance of atypical strains of HIV, 
including drug resistant strains and non-B subtypes, in persons newly 
diagnosed with HIV.
    (2) Monitor the prevalence of atypical HIV strains, including 
antiretroviral drug resistant strains and non-B subtypes, among persons 
newly diagnosed with HIV, including those for whom sera from a 
diagnostic blood draw are not available for surveillance purposes, and 
those for whom diagnostic sera are used for surveillance of atypical 
strains. Compare the prevalence among the two groups.
    This project will fulfill the purpose of monitoring prevalence of 
atypical strains by extending surveillance to sites that would 
currently be unable to provide sera for genotyping. DBS may also be 
collected for atypical strain surveillance in other sites where the 
collection of DBS may be more acceptable or require fewer resources 
than the collection of diagnostic sera. A comparison of resource 
requirements for the two methods in a variety of site types will be an 
important part of the evaluation. 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.
    The expected outcome is an enhanced ability to collect data on 
atypical HIV strains in persons newly diagnosed with HIV. Data from 
surveillance of atypical strains of HIV are used to identify emerging 
epidemics, monitor trends in transmission, target prevention resources 
and interventions to areas and populations most heavily affected, and 
evaluate programs designed to prevent the transmission of HIV.

Research Objectives

    (1) To monitor the prevalence of HIV drug resistant strains and 
non-B HIV-1 subtypes in persons newly diagnosed with HIV in public or 
private settings, including those in which sera are not available for 
HIV genotyping and those in which sera are used.
    (2) To compare the results of HIV genotyping for atypical strain 
surveillance purposes from both a serum or plasma specimen and a dried 
blood spot collected not more than three months after diagnosis for at 
least 20 newly diagnosed persons per area.
    (3) To compare the prevalence of atypical strains of HIV among 
persons diagnosed at sites where HIV diagnostic specimens are used for 
HIV drug resistance and subtype surveillance, and sites where HIV 
diagnostic specimens cannot be used, such as:
    a. Sites where blood draws are not used for HIV diagnosis.
    b. Sites where blood draw volumes are consistently too low for 1 ml 
of serum to be set aside for HIV genotyping for the purpose of atypical 
strain surveillance.
    c. Sites where the use of sera from the diagnostic blood draw for 
HIV genotyping is not practical because the time between blood draw and 
processing is consistently greater than 96 hours, rendering the 
amplification of virus for HIV drug resistance genotyping problematic.
    d. Sites where the use of DBS for atypical HIV strain surveillance 
is more acceptable than the use of sera to staff or participants, or 
where fewer resources may be required to collect DBS than sera.
    (4) To evaluate the resources needed and the logistics involved in 
collecting and transporting specimens and amplifying HIV for genotyping 
from DBS, compared with using HIV diagnostic sera, for routine atypical 
HIV strain surveillance.

Activities

    Awardee activities for this program are as follows:
    1. Identify HIV diagnostic sites, Counseling, Testing and Referral 
Centers, and/or clinical sites where HIV drug resistance surveillance 
in newly diagnosed persons cannot take place using the serum/plasma 
based methodology funded under PA 01194, PA 04017, and PA 00005 because 
of one of the following conditions:
    a. Blood draws are not used for HIV diagnosis.
    b. Blood draw volumes are consistently too low for 1 ml of serum to 
be set aside for HIV drug resistance genotyping.
    c. The use of sera from the diagnostic blood draw for HIV 
genotyping is not practical because the time between blood draw and 
processing is consistently greater than 96 hours, rendering the 
amplification of virus for HIV drug resistance genotyping problematic.
    d. DBS are more acceptable to staff or participants, or their 
collection, processing, and transport may require fewer resources than 
sera.
    2. Identify the subset of those sites from which DBS could be 
obtained for equal to or greater than 90 percent of persons newly 
diagnosed with HIV in each site, either at the time of HIV diagnosis or 
no more than three months after diagnosis.

[[Page 28129]]

    3. Identify comparison sites from which HIV diagnostic sera are 
being used, or can be used, for routine surveillance of atypical 
strains of HIV, in which logistics, resources, and staff time needed to 
collect and process specimens can be compared to those in sites where 
DBS will be collected. These sites may include, but are not limited to, 
sites already participating in atypical HIV strain surveillance under 
PA 00005, PA 01194, or PA 04017.
    4. Identify one or more sites in which paired specimens (sera or 
plasma + DBS) can be collected no more than three months after 
diagnosis from at least 20 persons newly diagnosed with HIV annually. 
(Note that the paired specimens may be collected from a blood draw 
required for routine surveillance or clinical purposes no more than 
three months following diagnosis, but need not necessarily be collected 
as part of a diagnostic blood draw.)
    5. Develop and implement (after appropriate ethics review) a 
protocol to obtain and transfer DBS from selected sites identified in 
(2), sera from sites identified in (3), and at least 20 paired 
specimens consisting of sera or plasma + DBS from any atypical strain 
surveillance site, to a laboratory collaborating with CDC and local 
health department staff on surveillance of HIV drug resistance in newly 
diagnosed persons through HIV drug resistance genotyping under PA 
00005, PA 01194, or PA 04017.
    6. Record or download minimum specimen tracking and non-identifying 
demographic and clinical information, in formats currently used in HIV 
drug resistance surveillance funded under 00005, 01194, and 04017, to 
be transferred to CDC.
    7. Make available the option for each participant to designate a 
provider to receive a clinician-friendly hard copy report of HIV drug 
resistance and subtype results from the genotyping laboratory, similar 
to that currently produced in current HIV drug resistance surveillance 
protocols.
    8. Store HIV drug resistance genotyping data electronically and 
analyze them along with risk factor information for use in HIV 
prevention and public health programs.
    9. Record minimum data to evaluate labor and resources used to 
collect and process DBS, and to collect and process diagnostic sera, 
for surveillance of atypical strains of HIV.
    10. Collaborate with CDC in analyzing the data.
    11. Provide results and share data with network participants, other 
collaborators in the field, and with CDC.
    12. Attend an annual meeting to discuss project activities and 
methods for data and specimen collection to facilitate representative 
surveillance.
    13. Collaborate with CDC in evaluating the feasibility and 
efficiency of using DBS to supplement or replace serum-based 
surveillance to monitor prevalence of HIV drug resistance and non-B HIV 
subtypes in persons newly infected or newly diagnosed with HIV. Further 
collaborate with CDC in planning the extension of the method as part of 
routine surveillance of atypical HIV strains, if the method proves 
successful and if funds are available.
    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:
    1. Assist in the development of a protocol or project description 
for Institutional Review Board (IRB) review at all cooperating 
institutions participating in the project to request a non-research 
determination. The IRB review at each cooperating institution will be 
done by an Office of Human Research Protection (OHRP)-approved IRB with 
either a single, multiple, or federal-wide project assurance. The CDC 
IRB will review and approve the protocol initially and on at least an 
annual basis until the project is completed, or until a non-research 
determination is received.
    2. Provide assistance in the design and conduct of the project and 
statistical analysis.
    3. Provide assistance in training, if requested.
    4. Provide assistance in locating or contracting with a laboratory 
participating in CDC-funded HIV drug resistance surveillance genotyping 
to provide HIV genotypic testing of the DBS and sera (or plasma). Work 
with participating laboratories to develop laboratory procedures to 
extend and validate current HIV genotyping methods for use with DBS.
    5. Assist in the analysis of the data and the presentation and 
publication of results.
    6. Collaborate with participants in evaluating the feasibility and 
cost effectiveness of using DBS to supplement or replace collection of 
diagnostic sera to monitor prevalence of atypical strains in persons 
newly infected or newly diagnosed with HIV. Further collaborate in 
planning the extension of the project as a long-term network, if the 
pilot is successful and if funds are available.

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: $500,000.
    Approximate Number of Awards: Six.
    Approximate Average Award: $83,000 (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: $200,000 (This ceiling is for the first 12-
month budget period.).
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Five 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 health departments of States, U.S. 
territories or their bona fide agents, including the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, and the 
six independently-funded city health departments of Chicago, Houston, 
Los Angeles, New York City, Philadelphia, and San Francisco.
    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.
    Areas conducting these activities must have a sufficient volume of 
newly diagnosed HIV cases in order to assess the correlation in results 
between DBS and sera or plasma with adequate statistical precision.
    Eligible applicants are limited to areas that have an HIV case 
reporting system in place as of April 1, 2004.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

[[Page 28130]]

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    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.
    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.

    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 398 
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: http://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: http://www.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 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

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: three.
     Font size: 12-point unreduced.
     Single 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.
     Evidence that at least 40 cases of HIV were diagnosed in 
the area in the latest 12 months for which data are available, 
accompanied by a brief description of the method by which the figures 
were obtained (including the elimination of duplicates).
     Name, address, E-mail address, and telephone number of the 
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement (PA).
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or 
contact GrantsInfo, telephone (301) 435-0714, e-mail: 
[email protected].
    Your research plan should address activities to be conducted over 
the entire five-year project period. Your detailed line-item budget 
narrative should cover the costs of activities for first one-year 
budget 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, access http://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.
    This PA uses just-in-time concepts.
    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: June 1, 2004.
    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: June 21, 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 carriers 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

    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: http://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:
    Funding cannot be used for purchase of major laboratory equipment 
for the performance of HIV genotyping. (Laboratory supplies and labor 
for specimen processing may be included.)

[[Page 28131]]

    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 be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or e-mail to: Andrew Vernon, Scientific Review 
Administrator, CDC, National Center for HIV, STD and TB Prevention, 
Office of the Director, Associate Director for Science, 1600 Clifton 
Road, Mail-Stop E-07, Atlanta, Georgia, 30333, telephone number: 404-
639-8000, fax: 404-639-8600, e-mail address: [email protected].
    Application Submission Address: Submit the original and five hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 04118, 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.
    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 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 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: Applicants should demonstrate the ability to collect 
adequate numbers of DBS and sera specimens.
    1. Areas having at least 100 newly diagnosed cases of HIV annually 
should demonstrate that they are able to provide ALL of the following:
    a. At least 80 specimens (sera, plasma, or DBS) annually for 
atypical strain surveillance.
    b. At least 30 dried blood spot specimens annually.
    c. At least 20 paired sera or plasma + DBS annually.
    2. Areas having 40-99 cases of HIV diagnosed annually should 
demonstrate that they are able to provide ALL of the following:
    a. Specimens (sera, plasma, or DBS) from at least 80 percent of 
newly diagnosed cases annually for atypical strain surveillance.
    b. DBS specimens from at least 20 HIV cases reported in the state 
or local area annually.
    c. At least 20 paired sera or plasma/DBS specimens (these may 
include specimens in categories 2b and 2c).
    Other issues to be examined in applicant's approach include:
     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?
     Is there evidence that the health department has an 
agreement to collaborate with one or more sites in the area to collect 
DBS at the diagnostic blood draw or another routine blood draw from at 
least 90 percent of persons newly diagnosed with HIV at that site/those 
sites annually?
    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)?
    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? Has the applicant demonstrated 
collaborative planning by the state and local health department, the 
state or local HIV diagnostic laboratory, and one or more HIV 
diagnostic or clinical sites from which DBS can be obtained?
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of 45 CFR part 46 for 
the protection of human subjects? This will not be scored; however, an 
application can be disapproved if the research risks are sufficiently 
serious and protection against risks is so inadequate as to make the 
entire application unacceptable.
    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 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.
    Applications that are complete and responsive to the PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group or charter study section convened by NCHSTP in accordance 
with the review criteria listed above. As part of the initial merit 
review, all applications may:

[[Page 28132]]

     Undergo a process in which only those applications deemed 
to have the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score.
     Receive a written critique.
     Receive a second level review by the CDC, NCHSTP, Division 
of HIV/AIDS Prevention (DHAP) Senior Staff.
    Award Criteria: Criteria that will be used to make award decisions 
include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

    October 15, 2004.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants 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-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-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-14 Accounting System Requirements
     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: http://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. 5/2001 as posted on the CDC website) 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. 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 Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    For general questions about this announcement, 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:
    Diane Bennett, M.D., Extramural Project Officer, CDC, National 
Center for HIV, STD and TB Prevention, Division of HIV/AIDS Prevention, 
1600 Clifton Road, Mail-Stop E-47, telephone: 404-639-5349, e-mail: 
[email protected].
    For questions about peer review, contact: Andrew Vernon, Scientific 
Review Administrator, CDC, National Center for HIV, STD and TB 
Prevention, Office of the Director, Associate Director for Science, 
1600 Clifton Road, Mail-Stop E-07, Atlanta, Georgia 30333, telephone: 
404-639-8000, e-mail: [email protected].
    For financial, grants management, or budget assistance, contact: 
Brenda Hayes, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, telephone: 770-488-
2741, e-mail: [email protected].
    For financial, grants management, or budget assistance in the 
territories, contact: Vincent Falzone, Contract Specialist, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, 
telephone: 770-488-2763, e-mail: [email protected].

    Dated: May 11, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-11192 Filed 5-17-04; 8:45 am]
BILLING CODE 4163-18-P