04-8875. Monitoring Atypical HIV Strains Among Persons Newly Diagnosed With HIV Using Dried Blood Spots vs. Diagnostic Sera  

  • [Federal Register Volume 69, Number 76 (Tuesday, April 20, 2004)]
    [Notices]
    [Pages 21117-21121]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 04-8875]
    
    
    -----------------------------------------------------------------------
    
    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: May 20, 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.
        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
    
    [[Page 21118]]
    
    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 a 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.
    
    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
    
    [[Page 21119]]
    
    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://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 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: May 20, 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.)
        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,
    
    [[Page 21120]]
    
    Scientific Review Administrator, CDC, National Center for HIV, STD and 
    TB Prevention, Office of the 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:
        <> 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.
    
    [[Page 21121]]
    
        <> Programmatic priorities.
    
    V.3. Anticipated Announcement and Award Dates
    
        September 17, 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 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. 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, Atlanta, Georgia 30333; 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-S top 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: April 14, 2004.
    William P. Nichols,
    Acting Director, Procurement and Grants Office, Centers for Disease 
    Control and Prevention.
    [FR Doc. 04-8875 Filed 4-19-04; 8:45 am]
    BILLING CODE 4163-18-P
    
    
    

Document Information

Published:
04/20/2004
Department:
Centers for Disease Control and Prevention
Entry Type:
Notice
Document Number:
04-8875
Dates:
Letter of Intent Deadline: May 20, 2004. Application Deadline: June 21, 2004.
Pages:
21117-21121 (5 pages)
PDF File:
04-8875.pdf