95-9879. Innovations in Syphilis Prevention in the United States: Reconsidering the Epidemiology and Involving Communities  

  • [Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
    [Notices]
    [Pages 19943-19948]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-9879]
    
    
    
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    [Announcement 523]
    
    
    Innovations in Syphilis Prevention in the United States: 
    Reconsidering the Epidemiology and Involving Communities
    
    Introduction
    
        The Centers for Disease Control and Prevention (CDC) announces the 
    availability of fiscal year (FY) 1995 funds for cooperative agreements 
    to conduct research toward substantially reducing syphilis in the 
    United States, especially in the southeastern United States, the region 
    with the highest syphilis rates. Syphilis is linked to substantial 
    mortality and morbidity through congenital syphilis, and through its 
    ecologic relationship with and cofactor role in HIV transmission. 
    Therefore, effective, innovative, community-based approaches to 
    syphilis prevention may have an important multiplier effect on HIV 
    prevention and adult and infant health in the communities where 
    syphilis is most prevalent.
        The Public Health Service (PHS) is committed to achieving the 
    health promotion and disease prevention objectives of Healthy People 
    2000, a PHS-led national activity to reduce morbidity and mortality and 
    improve the quality of life. This announcement is related to the 
    priority area of Sexually Transmitted Diseases. (To order a copy of 
    ``Healthy People 2000,'' see the section ``Where to Obtain Additional 
    Information.'')
    
    Authority
    
        These cooperative agreements are authorized under Section 318(b) of 
    the Public Health Service Act (42 U.S.C. 247c(b)) as amended. 
    Applicable program regulations are found in part 51 (b), subparts A and 
    F of title 42, Code of Federal Regulations.
    
    Smoke-Free Workplace
    
        The PHS strongly encourages all grant recipients to provide a 
    smoke-free workplace and to promote the non-use of all tobacco 
    products, and Public Law 103-227, the Pro-Children Act of 1994, 
    prohibits smoking in certain facilities that receive Federal funds in 
    which education, library, day care, health care, and early childhood 
    development services are provided to children.
    
    Eligible Applicants
    
        Applications may be submitted by public and private, nonprofit and 
    for-profit organizations and governments and their agencies. 
    Universities, colleges, research institutions, hospitals, other public 
    and private organizations, State and local governments or their bona 
    fide agents, federally recognized Indian tribal governments, Indian 
    tribes or Indian tribal organizations, and small, minority- or women-
    owned businesses are eligible to apply. Applicants must, however, 
    document collaboration with each of the following entities:
        1. At least one non-profit, public or private research institution 
    (e.g., university, college, hospital, laboratory);
        2. A public health agency in State or local government; and
        3. At least one community-based organization (CBO) or other 
    institution or agency with a track record for working with communities 
    affected by syphilis in the project area. The CBO does not need to have 
    a record of working on the problem of sexually transmitted diseases, 
    only to have [[Page 19944]] worked with the communities that are 
    affected.
        To be eligible, the project area as defined under ``Program 
    Requirements'' must have an incidence of primary and secondary (P&S) 
    syphilis in calendar year (CY) 1993 above the PHS year 2000 objective 
    of 10/100,000 and a total of more than 150 cases of P&S syphilis in CY 
    1993.
    
    Availability of Funds
    
        Approximately $1 million is available in FY 1995 for a 12-month 
    budget period; the project period for Phase I (Preparation) is expected 
    to be for two years. Four to five awards will be funded for Phase I. 
    The awards are expected to range from $200,000 to $250,000, beginning 
    in September 1995. Shortly before the completion of Phase I, recipients 
    will compete for continuation of award in years 3 through 5 (Phase II--
    Implementation). Two to three awards are anticipated for expansion into 
    Phase II research activities for the remaining three years of the 
    project period. (Further details on Phases I and II is presented below 
    under the heading ``Purpose and Outline of Program Plan.'') Funding 
    estimates may vary and are subject to change. Continuation awards 
    within an approved project period will be based on satisfactory 
    progress and the availability of funds.
    
    Program Goals
    
        By the end of Phase I (24 months), it is expected that:
        1. Strong partnerships among research institutions, health 
    departments, and at least one community-based organization will have 
    been established or strengthened.
        2. The epidemiology of the transmission of syphilis will have been 
    analyzed to identify characteristics and target interventions to the 
    most important mechanisms that sustain syphilis spread and persistence 
    in the community (Component 1).
        3. A programmatic intervention will have been pilot tested and 
    assessed for its potential for measurably lowering syphilis 
    transmission in a defined area while being acceptable to members of the 
    affected communities and to participating organizations or agencies 
    (Component 2).
        4. A sensitive surveillance system for following trends in syphilis 
    transmission in a population will have been implemented and at least 
    one full year of baseline data collected.
        5. A management information system will have been implemented to 
    track activities and costs in syphilis prevention activities (Component 
    3).
        At approximately month 18 of the project, applications for a 
    competitive continuation award for the implementation and evaluation of 
    a population-level intervention (Phase II) will be due. Fewer, larger, 
    Phase II awards are foreseen for interventions that show the greatest 
    potential impact and that are based on well-conducted research from 
    Phase I. Supplementary guidance for Phase II awards will be provided to 
    the recipients of Phase I awards.
    
    Purpose and Outline of Program Plan
    
        The purpose of this announcement is to generate new knowledge, 
    tools, and strategies toward sharply reducing syphilis incidence, 
    particularly in the southeastern States where incidence is 
    disproportionately high. Congenital syphilis is closely linked to newly 
    acquired syphilis infections in women, so an intensified focus on 
    syphilis transmissions is expected to contribute directly to a 
    principal, short-term PHS goal of eliminating congenital syphilis.
        Phase I and Phase II of the research program. This research program 
    is separated into two phases of activity and funding (Table 1). The 
    fundamental goal is best understood in the context of Phase II (years 3 
    to 5 of the anticipated 5-year project), in which the grantees will 
    implement and evaluate an innovative, science-based, cost-effective 
    approach to reducing the transmission of syphilis in a project area.
    
                                     Table 1                                
    ------------------------------------------------------------------------
                            Grantees                                        
     Phase  Project years    (No.)              Focus of activities         
    ------------------------------------------------------------------------
    I.....  1 and 2......        4-5  Preparation for innovative approaches 
                                       to syphilis control and prevention.  
    II....  3 to 5.......        2-3  Implementation of interventions and   
                                       evaluation of impact on population.  
    ------------------------------------------------------------------------
    
        However, CDC is not seeking final proposals for such Phase II 
    intervention trials at this time because science-based, innovative 
    approaches to syphilis prevention will require multifaceted preparation 
    and planning. In particular, communities affected by syphilis should be 
    represented more substantively than in the past in developing new 
    approaches to syphilis prevention. This announcement, therefore, 
    focuses on Phase I subject areas and solicits research proposals that 
    will yield scientific findings and stimulate the building of multi-
    disciplinary research teams needed to guide and implement the Phase II 
    intervention trial.
        Areas of preparatory research in Phase I. During Phase I of this 
    program, three key research components will be addressed:
        1. Innovative uses of epidemiologic and behavioral science methods 
    and findings about syphilis transmission in communities to direct 
    prevention strategies.
        2. Development of a programmatic intervention and pilot test of 
    that proposed intervention before large-scale implementation; 
    development of partnerships with communities affected by syphilis.
        3. Development of a sensitive syphilis surveillance activity to be 
    used in evaluating the efficacy and cost-effectiveness of efforts to 
    prevent syphilis.
        Further explanation of these Phase I activities can be found in the 
    section ``Program Requirements.''
    
    Program Requirements
    
        This cooperative agreement is foreseen as an important element in a 
    national reassessment of our approaches to syphilis control and 
    prevention. To achieve the purpose of this program, the recipient will 
    be responsible for activities under A. and CDC for activities under B., 
    below:
    
    A. Recipient Activities
    
        1. Develop an overall framework to design an effective, innovative 
    approach to syphilis prevention and to evaluate its impact on a 
    population.
        2. Define a project area. The geographic area defined as the 
    project area for this program announcement must have reported at least 
    150 cases of P&S syphilis in 1993. An entire State could be defined as 
    the project area for this cooperative agreement, or several counties 
    could be combined to establish the minimum number of syphilis cases. 
    Applications are especially encouraged from rural areas that meet this 
    minimum morbidity requirement (150 cases of P&S syphilis). 
    [[Page 19945]] 
        3. Undertake the following three research components during Phase I 
    of this cooperative agreement:
        A. Analyze the epidemiology of syphilis transmission within the 
    project area with the goal of identifying more efficacious and cost-
    effective ways to prevent syphilis.
        B. Develop an intervention and conduct a pre-implementation of that 
    evaluation. In collaboration with representatives from affected 
    communities, consider hypotheses about barriers to or opportunities for 
    more efficacious and cost-effective innovations in syphilis prevention.
        C. Establish surveillance and information systems adequate for 
    monitoring and evaluating innovative syphilis prevention activities.
    
        Note: Traditional disease surveillance for syphilis demonstrates 
    substantial year-to-year variability as well as incompletely 
    understood cyclic oscillations over periods of 5 to 10 years.
    
        During Phase I, you will be expected to implement: (1) A sensitive, 
    population-level surveillance system for syphilis incidence; and (2) a 
    management information system (MIS) for estimating the cost of syphilis 
    prevention, including the costs of collecting and analyzing program 
    data. Although components 1 and 2 are distinct foci of activity that 
    involve different types of expertise, they are related in that 
    interventions that do not focus prevention resources on settings, 
    social contexts, or individuals who help maintain syphilis transmission 
    in the community are unlikely to be effective. Likewise, components 1 
    and 3 are related in that a sensitive surveillance system that truly 
    reflects incident syphilis cases should have some direct relationship 
    to syphilis transmission events characterized by the ``epidemiologic 
    model'' of syphilis for that community.
        4. Include affected communities as partners in the research. 
    Syphilis generally is concentrated in communities with limited 
    resources. In many communities, syphilis is also a stigmatizing 
    condition and one for which the most important consequences (congenital 
    syphilis and facilitation of HIV transmission) often occur 
    unrecognized. Furthermore, some past control efforts and research 
    activities may have damaged community rapport with the health 
    departments and with CDC rather than building trust in a common 
    purpose. Partnerships with communities affected by syphilis, including 
    many African American communities where racism may have a continuing 
    effect, is essential to building trust and to finding solutions.
        5. Linkage to other public health programs. Research on syphilis 
    prevention in the 1990s should occur in the context of other major 
    public health program areas. These include:
        A. Prenatal care (required). The first priority in syphilis 
    prevention is the elimination of congenital syphilis, which can be 
    accomplished through prenatal care for women at risk for syphilis and 
    the appropriate screening for and management of syphilis during 
    pregnancy. However, it is possible that many pregnant women with 
    syphilis have a low risk for transmitting syphilis to other adults, and 
    therefore, are not central to the persistence of syphilis among adults 
    in the community.
        B. HIV Prevention (required). Communities, sub-populations, and 
    individuals with syphilis are probably at high risk for HIV infection 
    because of common modes of transmission, the usually higher prevalence 
    of syphilis and HIV in the same communities, infection, and the role of 
    genital ulcer diseases as cofactors for sexual transmission of HIV. 
    Syphilis prevention should be coordinated with and should reinforce 
    community intervention strategies and other efforts to change sexual 
    behavior as are associated with HIV prevention. Because syphilis is a 
    curable communicable disease, screening, health care seeking, and 
    treatment will likely play prominent roles in syphilis prevention. 
    Nonetheless, some effort to change behavior must be a component of a 
    responsible syphilis prevention activity, both to prevent HIV infection 
    and other STDs in the community from which one is trying to eliminate 
    syphilis, and to lower the risk of spread if syphilis is reintroduced.
        C. Substance abuse (optional). A number of studies have shown that 
    crack cocaine was closely linked to local epidemics of syphilis in the 
    late 1980s. People who inject drugs are at high risk for STDs. 
    Effective, innovative, epidemiologically focused syphilis prevention 
    activities may be augmented if they are closely linked to substance 
    abuse treatment. Explain how the proposed syphilis prevention 
    activities interact with, and possibly reinforce, efforts to prevent 
    drug abuse.
        D. Correctional systems (optional). Because of the association of 
    syphilis with substance abuse and prostitution, collaboration with the 
    criminal justice system (e.g., correctional health programs, probation 
    officers, court referral, juvenile justice) could result in highly 
    effective approaches to syphilis and HIV prevention. Explain any 
    interaction between the proposed syphilis prevention activities and 
    criminal justice programs.
        6. Manage, analyze, and interpret data. Data from the three core 
    activities in part 3 should be secure and confidential. In 
    collaboration with CDC, analyze, interpret, and publish data promptly 
    in scientific, programmatic, and policy-making forums. Data should 
    regularly be communicated to community partners in language that they 
    can understand.
        7. Build a multidisciplinary research team and program 
    implementation capability. Assemble a multidisciplinary team with the 
    appropriate expertise (such as in microbiology, medicine, epidemiology, 
    behavioral sciences, health care services research) to undertake each 
    of the enumerated steps or activities.
        8. Implement a unified core protocol common to all grant recipients 
    that will be established for component 3 of the required activities 
    (population-based surveillance for new syphilis transmissions) and 
    implemented by each recipient. The final core multicenter protocol for 
    component 3 will likely differ somewhat from the protocol specified by 
    any individual recipient. Core protocols or common approaches will be 
    encouraged but will not be required for other components, especially 
    component 1.
        9. Each grantee will participate with other recipients and CDC 
    representatives in as many as four meetings during the first 24 months, 
    during which the core protocol for component 3 will be established, and 
    strategies for and progress toward achieving the goals of the program 
    announcement will be assessed.
        10. The recipient will share reports on progress toward goals with 
    representatives of communities affected by syphilis and other involved 
    organizations, agencies, and persons.
        11. The recipients will take the lead in data analysis and 
    publication of data from their own research centers, with participation 
    and support from CDC.
    
    B. CDC Activities
    
        1. Provide scientific and technical assistance in the general 
    operation of this syphilis prevention project and in the three key 
    research components in Phase I.
        2. Within 45 days of the notice of grant award, host a meeting of 
    the successful applicants to develop the core protocol for component 3 
    and to plan other aspects of the research program. CDC will host as 
    many as three other meetings of investigators during the first 24 
    months of the project to [[Page 19946]] promote progress toward core 
    and national objectives.
        3. Assist in monitoring and evaluating scientific and operational 
    accomplishments of this syphilis elimination project through periodic 
    site visits for research program reviews, frequent telephone calls, and 
    review of technical reports and interim data analyses.
        4. CDC will assist in data analysis and in the presentation and 
    publication of data from Phase I and Phase II activities in scientific, 
    programmatic, and policy-making forums. CDC will actively participate 
    in evaluating the multicenter core protocol data for component 3 
    (surveillance and evaluation).
    
    Review Conditions and Evaluation Criteria
    
        To be referred to the independent review group for consideration, 
    applications must:
        1. Document effective partnerships among research institutions, 
    State or local health departments, and CBOs; and
        2. Address the specific requirements in all three research 
    components.
        Applications not meeting these two requirements will be returned to 
    the applicant without being reviewed. Applications that meet the 
    preceding requirements will be evaluated according to the following 
    criteria:
    
    1. Understanding of Goals, Purpose, and Context
    
        Understanding of the objectives of this research and evaluation 
    program as reflected in statement of research background, program 
    objectives, and linkage of the specific activities of Phase I to a 
    well-articulated vision of what is needed to substantially reduce the 
    prevalence of syphilis in the United States (5 points). Extent the 
    choice of a project area in which to conduct this research is 
    appropriate to the research objectives and is explained and justified 
    in those terms, and extent in the proposed project area the 
    epidemiology of syphilis, barriers to its reduction or elimination, and 
    resources available to STD/HIV prevention are well-described (5 
    points). (Total, 10 points.) (APPLICATION CONTENT items 1 and 2.)
    
    2. Quality and Focus of Proposed Phase I Research
    
        The extent to which excellent research designs address the three 
    major components of the program announcement while avoiding extraneous 
    efforts. (APPLICATION CONTENT item 9.)
        Component 1: Innovative uses of epidemiologic methods and findings 
    about syphilis transmission in communities to direct prevention 
    strategies. The extent to which the proposal is theoretically sound and 
    reflects detailed knowledge of the meaning of the underlying data, such 
    as reported syphilis cases of different durations (primary, secondary, 
    early latent, late latent), reports of sexual contacts among patients, 
    syphilis seroprevalence from screening data, and other data sources. 
    The extent to which the planned approaches to analyzing, interpreting, 
    and using data are innovative and likely to yield new insights into the 
    transmission of syphilis and the opportunities for prevention and 
    elimination within the study community (10 points). The extent to which 
    the findings might be directly translated into public health practice 
    (e.g., changes in screening criteria or the location for syphilis 
    serologic testing; changes in PN practices or priorities; relocation or 
    reorganization of clinical services; development of community-based 
    interventions), and the clarity with which that potential for 
    translation is explained in the application (5 points). (Total, 15 
    points.)
        Component 2: Development of a programmatic intervention and pilot 
    test of that proposed intervention before large-scale implementation; 
    developing partnerships with communities affected by syphilis. Choice 
    of an appropriate potential intervention, based on syphilis 
    epidemiology in the study region plus analysis of community, program, 
    or other factors that compose an important barrier or opportunity for 
    more effective, epidemiologic programs (10 points). Scientifically 
    sound plan for evaluating, during this pre-implementation phase, the 
    potential impact of the proposed intervention on syphilis transmission 
    (5 points) and on community perceptions and support for those 
    prevention activities (5 points). The extent to which the planned 
    research findings from this component could be directly translated into 
    public health practice, and the clarity with which that translation is 
    explained in the application (5 points). (Total, 25 points.)
        Component 3: Development of a sensitive syphilis surveillance 
    activity to serve as a basis for evaluating the efficacy and cost-
    effectiveness of syphilis prevention efforts. The extent to which the 
    proposal is theoretically sound for evaluating the sensitivity and 
    cost-effectiveness of estimating and following population and sub-
    population trends in the transmission of syphilis (5 points). The 
    extent to which the proposal demonstrates detailed familiarity with 
    public health disease surveillance and the complexity of trying to 
    change practices in disease surveillance settings proposed (e.g., 
    jails, maternity wards delivery suites) (5 points). Implementation of a 
    management information system adequate for a cost-effectiveness 
    analysis of new approaches to prevention programs 5 points). (Total, 15 
    points.)
    
    3. Capacity, Interdisciplinary Involvement, and Partnerships
    
        Overall ability of a multidisciplinary research team (including 
    persons in various academic disciplines, public health practitioners, 
    and community collaborators) to perform the technical aspects of the 
    project(s) (i.e., qualified and experienced personnel with a record of 
    excellent scientific achievement) (15 points); appropriate facilities 
    and plans for the administration of the project(s), and a detailed and 
    realistic schedule for the specified activities (5 points). (Total, 20 
    points: APPLICATION CONTENT items 3, 4, 5, and 6.)
    
    4. Inclusion of Affected Communities
    
        The extent to which communities affected by syphilis are involved 
    in all parts of these research and demonstration activities (5 points). 
    The extent to which the effective work of one or more CBOs is 
    documented in attachments to the application and the collaboration and 
    support of a CBO is thoroughly incorporated into the work of the 
    multidisciplinary team (5 points). (Total, 10 points: APPLICATION 
    CONTENT items 3 and 6.)
    
    5. Linkage to Related Prevention Activities
    
        The extent to which the proposed research agenda and the 
    intervention reflect awareness of other critical prevention services in 
    the community (pre-natal care, HIV, drug abuse, correctional health) 
    and are synergistic or at least well-coordinated with those other 
    preventive health services. (Total, 5 points: APPLICATION CONTENT item 
    7.)
        In addition, consideration will be given to the extent to which the 
    budget is reasonable, clearly justified, and consistent with the 
    intended use of the funds. (APPLICATION CONTENT item 8
    
    Funding Priorities
    
        CDC intends to achieve some geographic diversity of project sites 
    while retaining a principal focus on syphilis in the southeastern 
    United [[Page 19947]] States. It is the intention to fund at least two 
    Phase I projects that address syphilis in rural areas in the 
    southeastern United States, if those applications are fully 
    competitive.
        Interested persons are invited to comment on the proposed funding 
    priority. All comments received on or before May 19, 1995, will be 
    considered before the funding priority is established. If the funding 
    priority should change as a result of any comments received, a revised 
    Announcement will be published in the Federal Register and revised 
    applications accepted.
        Written comments should be addressed to: Henry S. Cassell III, 
    Grants Management Officer, Grants Management Branch, Procurement and 
    Grants Office, Centers for Disease Control and Prevention (CDC), 255 
    East Paces Ferry Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305.
    
    Executive Order 12372 Review
    
        Applications are subject to Intergovernmental Review of Federal 
    Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets 
    up a system for State and local government review of proposed Federal 
    assistance applications. Applicants (other than federally recognized 
    Indian tribal governments) should contact their State Single Point of 
    Contact (SPOC) as early as possible to alert them to the prospective 
    applications and receive any necessary instructions on the State 
    process. For proposed projects serving more than one State, the 
    applicant is advised to contact the SPOC for each affected State. A 
    current list of SPOCs is included in the application kit. If SPOCs have 
    any State process recommendations on applications submitted to CDC, 
    they should send them to Henry S. Cassell III, Grants Management 
    Officer, Grants Management Branch, Procurement and Grants Office, 
    Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
    Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305, not later than 
    60 days after due date for receipt of applications. The Program 
    Announcement Number and Program Title should be referenced on the 
    document. CDC does not guarantee to ``accommodate or explain'' State 
    process recommendations it receives after that date. Indian tribes are 
    strongly encouraged to request tribal government review of the proposed 
    application. If tribal governments have any tribal process 
    recommendations on applications submitted to CDC, they should forward 
    them to Henry S. Cassell III, Grants Management Officer, Grants 
    Management Branch, Centers for Disease Control and Prevention (CDC), 
    255 East Paces Ferry Road, NE., Room 300, Mailstop E-16, Atlanta, GA 
    30305. This should be done no later than 60 days after the application 
    deadline date. The granting agency does not guarantee to ``accommodate 
    or explain'' for tribal process recommendations it receives after that 
    date.
    
    Public Health System Reporting Requirements
    
        This program is subject to the Public Health System Reporting 
    Requirements. Under these requirements, all community-based 
    nongovernmental applicants must prepare and submit the items identified 
    below to the head of the appropriate State and/or health agency(s) in 
    the program area(s) that may be impacted by the proposed project no 
    later than the receipt date of the Federal application. The appropriate 
    State and/or local health agency is determined by the applicant. The 
    following information must be provided:
        A. A copy of the face page of the application (SF 424).
        B. A summary of the project that should be titled ``Public Health 
    System Impact Statement'' (PHSIS), not exceeding one page, and 
    including the following:
        1. A description of the population to be served;
        2. A summary of the services to be provided; and
        3. A description of the coordination plans with the appropriate 
    State and/or local health agencies.
    
    Catalog of Federal Domestic Assistance Number
    
        The Catalog of Federal Domestic Assistance Number is 93.978, 
    Preventive Health Services--Sexually Transmitted Diseases Research, 
    Demonstration, and Public Information and Education Grants.
    
    Other Requirements
    
    Paperwork Reduction Act
    
        Projects that involve the collection of information from 10 or more 
    individuals and funded by the cooperative agreement will be subject to 
    review by the Office of Management and Budget (OMB) under the Paperwork 
    Reduction Act.
    
    Confidentiality
    
        Applicants must have in place systems to ensure the confidentiality 
    of patient records.
    
    HIV/AIDS Requirements
    
        Recipients must comply with the document entitled Content of AIDS-
    Related Written Materials, Pictorials, Audiovisuals, Questionnaires, 
    Survey Instruments, and Educational Sessions (June 1992) (a copy is in 
    the application kit). To meet the requirements for a program review 
    panel, recipients are encouraged to use an existing program review 
    panel, such as the one created by the State health department's HIV/
    AIDS Prevention Program. If the recipient forms its own program review 
    panel, at least one member must also be an employee (or a designated 
    representative) of a State or local health department. The names of the 
    review panel members must be listed on the Assurance of Compliance form 
    CDC 0.1113, which is also included in the application kit. The 
    recipient must submit the program review panel's report that indicates 
    all materials have been reviewed and approved.
        Before funds can be used to develop HIV/AIDS-related materials, 
    determine whether suitable materials are already available at the CDC 
    National AIDS Clearinghouse.
    
    Human Subjects
    
        If your project involves research on human subjects, you must 
    comply with the Department of Health and Human Services Regulations, 45 
    CFR Part 46, regarding the protection of human subjects. Provide 
    assurance that the project will be subject to initial and continuing 
    review by an appropriate institutional review committee. You must 
    provide assurance in accordance with the guidelines and form provided 
    in the application kit.
        In addition to other applicable committees, Indian Health Service 
    (IHS) institutional review committees also must review the project if 
    any component of IHS will be involved or will support the research. If 
    any American Indian community is involved, its tribal government must 
    also approve that portion of the project applicable to it.
    
    Letters of Intent
    
        Letters of intent are required. On or before May 15, 1995, submit 
    the original and two copies of a letter of intent to submit an 
    application to: Henry S. Cassell III, Grants Management Officer, Grants 
    Management Branch, Procurement and Grants Office, Centers for Disease 
    Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, 
    Mailstop E-16, Atlanta, GA 30305. [[Page 19948]] 
    
    Application Submission and Deadline
    
        On or before July 3, 1995, submit the original and two copies of 
    the application (Form PHS 5161-1--OMB Number 0937-0189) and one 
    electronic copy on disk to: Henry S. Cassell III, Grants Management 
    Officer, Procurement and Grants Office, Grants Management Branch, 
    Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
    Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305.
        1. Deadline: Applications shall be considered as meeting the 
    deadline if they are:
        A. Received on or before the deadline or
        B. Sent on or before the deadline date and received in time for 
    submission to the independent review committee. (Applicants must 
    request a legibly dated U.S. Postal Service postmark or obtain a 
    legibly dated receipt from a commercial carrier or U.S. Postal Service. 
    Private metered postmarks will not be acceptable proof of timely 
    mailing.)
        2. Late Applications: Applications that do not meet the criteria in 
    1.A. or 1.B. are considered late applications and will not be 
    considered in the current competition and will be returned to the 
    applicant.
    
    Where to Obtain Additional Information
    
        A complete program description, information on application 
    procedures, an application package, and business management technical 
    assistance may be obtained from: Manuel Lambrinos, Grants Management 
    Specialist, Grants Management Branch, Procurement and Grants Office, 
    Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
    Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305, telephone (404) 
    842-6777. Programmatic technical assistance may be obtained from: Sevgi 
    Aral, Ph.D., Division of STD/HIV Prevention, National Center for 
    Prevention Services, Centers for Disease Control and Prevention (CDC), 
    1600 Clifton Road, NE., Mailstop E-02, Atlanta, GA 30333, telephone 
    (404) 639-8259.
        Please refer to Announcement 523 when requesting information and 
    submitting an application.
        Potential applicants may obtain a copy of ``Healthy People 2000'' 
    (Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
    (Summary Report, Stock No. 017-001-00473-1) referenced in the 
    ``Introduction'' through the Superintendent of Documents, Government 
    Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.
    
        Dated: April 14, 1995.
    Joseph R. Carter,
    Acting Associate Director for Management and Operations, Centers for 
    Disease Control and Prevention (CDC).
    [FR Doc. 95-9879 Filed 4-20-95; 8:45 am]
    BILLING CODE 4163-18-P
    
    

Document Information

Published:
04/21/1995
Department:
Health and Human Services Department
Entry Type:
Notice
Document Number:
95-9879
Pages:
19943-19948 (6 pages)
Docket Numbers:
Announcement 523
PDF File:
95-9879.pdf