97-12607. Cooperative Agreements to Conduct Research and Education Programs on Lyme Disease in the United States  

  • [Federal Register Volume 62, Number 93 (Wednesday, May 14, 1997)]
    [Notices]
    [Pages 26516-26520]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-12607]
    
    
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Centers for Disease Control and Prevention
    [Program Announcement Number 801]
    
    
    Cooperative Agreements to Conduct Research and Education Programs 
    on Lyme Disease in the United States
    
    Introduction
    
        The Centers for Disease Control and Prevention (CDC) announces the 
    expected availability of FY 1998 funds for a cooperative agreement 
    program to conduct research on Lyme disease and illnesses caused by 
    other related Borrelia species. Topics include: disease surveillance 
    and epidemiologic studies, ecologic studies, and the development, 
    implementation, and evaluation of prevention/control strategies. In 
    addition, funds are available for the development of educational 
    programs. This program's overall objective is to lower the incidence of 
    Lyme disease in hyperendemic states to 5 per 100,000 population or less 
    by the year 2000.
        CDC is committed to achieving the health promotion and disease 
    prevention objectives of ``Healthy People 2000,'' a national activity 
    to reduce morbidity and mortality and improve the quality of life. This 
    announcement is related to the priority area of Immunization and 
    Infectious Diseases. (For ordering a copy of ``Healthy People 2000,'' 
    see the Section ``Where to Obtain Additional Information.'')
    
    Authority
    
        This program is authorized under Sections 301 and 317(k)(2) of the 
    Public Health Service Act, as amended (42 U.S.C. 241 and 247b(k)(2)).
    
    Smoke-Free Workplace
    
        CDC encourages all grant recipients to provide a smoke-free 
    workplace and to promote the non-use of all tobacco products. Public 
    Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
    facilities that receive Federal funds in which education, library, 
    daycare, health care, and early childhood development services are 
    provided to children.
    
    Eligible Applicants
    
        Applications may be submitted by public and private nonprofit 
    organizations and governments and their agencies within the United 
    States. Thus, universities, colleges, research institutions, hospitals, 
    other public and private organizations, State and local health 
    departments, or their bona fide agents, federally recognized Indian 
    tribal governments, Indian tribes or Indian tribal organizations, and 
    small, minority and/or women-owned, nonprofit businesses are eligible 
    to apply as the principal investigating entities. These United States 
    entities may propose collaborative arrangements with investigators 
    outside the United States, provided the proposal has a direct impact on 
    United States public health.
        Participation in proposed activities by scientists, health 
    professionals and educators with expertise and experience in Lyme 
    disease and its associated epidemiologic, environmental and 
    entomological aspects is desirable. In addition, combined program 
    activities involving State and local health departments, universities, 
    colleges, and private nonprofit organizations are encouraged.
    
        Note: Effective January 1, 1996, Public Law 104-65 states that 
    an organization described in section 501(c)(4) of the Internal 
    Revenue Code of 1986 which engages in lobbying activities will not 
    be eligible for the receipt of Federal funds constituting an award, 
    grant, cooperative agreement, contract, loan, or any other form.
    
    Availability of Funds
    
        CDC projects approximately $1,700,000 of the President's budget 
    will be available for FY 1998 for cooperative agreements to conduct 
    research and education programs on Lyme disease in the United States. 
    However, this announcement is made prior to the actual appropriation of 
    fiscal year 1998 funds to allow new and competing continuation 
    applicants sufficient time to prepare applications, and to enable 
    timely award of the cooperative agreements. Approximately 10 to 15 new 
    and competing continuation awards will be made with a median award of 
    $150,000 ranging from $50,000 to $250,000. It is expected that the 
    awards will begin on or about February 15, 1998. Awards will be funded 
    for a 12-month budget period within a project period of up to three 
    years. Funding estimates may vary and are subject to change. 
    Continuation awards within the project period are made on the basis of 
    satisfactory progress and the availability of funds.
        Applicants may apply for and receive support for activities under 
    one or more of the three activity areas (A.1., A.2., and/or A.3.) 
    listed in the Recipient Activities section. Approximately 35% of the 
    available funds will be allocated to develop improved disease 
    surveillance and conduct epidemiologic studies; approximately 40% of 
    the available funds will be allocated to conduct ecologic studies and 
    develop and implement strategies for prevention and control; and, 
    approximately 25% of the available funds will be allocated to educate 
    the public and health professionals on the primary and secondary 
    prevention of Lyme disease. Applications may be submitted for any or 
    all of the activities described above (any one or combination of the 
    three subjects areas). Each category will be scored separately.
    
    Recipient Financial Participation
    
        There are no matching or cost participation requirements; however, 
    the applicant's anticipated contribution to the overall program costs, 
    if any, should be provided on the application. These funds should not 
    supplant existing expenditures in this disease area.
    
    Background
    
        Lyme disease is one of the most important emerging infectious 
    diseases in the United States, accounting for more than 90% of all 
    reported vector-borne illness. The numbers of reported cases have 
    increased steadily, resulting in a thirty-fold rise between 1982 and 
    1996. More than 16,000 cases were reported by 44 States to the CDC in 
    1996.
        Lyme borreliosis is a potentially serious and debilitating 
    infection that may lead to subacute and chronic disease of the joints, 
    the peripheral and central nervous system, the heart, and the skin. 
    Questions have been raised about microbial persistence and chronic Lyme 
    disease. Although transplacental transmission has been reported, 
    epidemiologic studies have not shown an association between Lyme 
    disease and adverse outcomes of pregnancy.
        Lyme disease cases have been reported nationwide; however, the 
    disease is concentrated in three regions: the northeast and mid-
    Atlantic, the north central, and the Pacific coastal regions. 
    Distribution of cases is principally related to the density of infected 
    tick vectors. Ixodes scapularis is the principal vector throughout the 
    northeastern, mid-Atlantic, and north central States, and is the cause 
    of
    
    [[Page 26517]]
    
    significant peridomestic transmission. Ixodes pacificus transmits the 
    disease in Pacific coastal areas. Ixodes spinipalpis maintains an 
    enzootic cycle in Colorado and California. The role of the putative 
    vectors in southern regions of the United States, Ixodes scapularis and 
    Amblyomma americanum, is not clear.
        CDC has maintained a system of national surveillance for Lyme 
    disease since 1982. This system depends upon reporting of cases by 
    State health departments to CDC. It provides basic descriptive 
    epidemiologic information, defines trends in established endemic areas, 
    and monitors the emergence of the disease in new areas. The usefulness 
    of these surveillance data is limited by the application among States 
    of different surveillance methods--some active, some passive. In 
    addition, there is considerable lack of detection, under-reporting, and 
    misclassification of cases. The national surveillance system has not 
    provided reliable estimates of the total disease burden, but has given 
    a rough index for monitoring trends of incidences. The emergence of the 
    disease in new areas has been linked with geographic spread and 
    increased density of infected tick vectors, although the dynamics of 
    emergence are poorly understood.
        There exists a great need to improve surveillance of human cases, 
    to identify and characterize the cycle of transmission among animal 
    reservoirs and arthropod vectors, to better define the geographic 
    distribution and ecologic determinants of these cycles throughout the 
    United States, and to quantify the risk of transmission to persons 
    under various circumstances of exposure. Epidemiologic and behavioral 
    studies are needed to better define risk factors for human infection so 
    that more effective strategies for prevention and control of disease 
    can be devised and implemented.
        Research is needed on primary strategies involving community 
    participation in integrated pest management (suppression of tick 
    vectors, environmental modification, and vertebrate host management), 
    personal protection measures to reduce human contact with infected 
    ticks, the targeting, cost-benefits, and impact of anticipated 
    vaccines, and other specific prevention methods.
        Education of the public and health care professionals is a 
    principal goal leading to primary prevention, and to secondary 
    prevention through early detection, diagnosis, and appropriate 
    treatment of infected persons. The effectiveness of education in 
    preventing infection under various circumstances of exposure, such as 
    periresidential, recreational, and occupational, needs to be evaluated 
    or adequately described in terms of health behavior.
    
    Purpose
    
        The purposes of these cooperative agreements are to: (1) Provide 
    assistance in determining the incidence and trends of Lyme disease in 
    various geographic regions of the United States, (2) measure the public 
    health impact of early and late stages of Lyme disease, (3) assess risk 
    factors associated with the transmission of the disease, including 
    behavioral and environmental factors, (4) determine the distribution 
    and density of vector tick species, determine B. burgdorferi infection 
    rates of these vectors, and characterize the ecologic factors which 
    result in high infection rates in tick and vertebrate host populations, 
    (5) develop, implement, and evaluate more effective prevention and 
    control strategies using a community intervention approach, and (6) 
    educate health professionals and the public on prevention through 
    personal protection and environmental interventions, and on the need 
    for early and accurate diagnosis, and appropriate treatment.
    
    Program Requirements
    
        In conducting activities to achieve the purpose of this program, 
    the recipient will be responsible for conducting selected activities 
    under A.1., A.2., and/or A.3. below, and CDC will be responsible for 
    conducting activities under B., below:
    
    A. Recipient Activities
    
    1. Disease Surveillance and Epidemiologic Studies (Conduct One or More 
    of the Following):
        a. Implement, maintain, and evaluate an active Lyme disease 
    surveillance system based on the 1990 (or subsequent) national case 
    definition adopted by the Council of State and Territorial 
    Epidemiologists (CSTE). Determine the utility of laboratory-based 
    surveillance using standardized serologic tests for Lyme disease.
        b. Conduct epidemiologic studies, utilizing descriptive, 
    correlative, analytical and seroepidemiologic methods to better 
    understand the epidemiology of the disease and to elucidate risk 
    factors for infection and disease in specific geographic foci.
        c. Carry out studies to measure the public health burden of Lyme 
    disease and to determine the efficacy of various intervention 
    strategies for primary and secondary prevention.
        d. Conduct studies to identify human populations at high risk of 
    infection and disease, including risks from periresidential, 
    occupational, and recreational exposures, and design studies to measure 
    the costs and benefits of various intervention strategies, including 
    behavior modification, integrated pest management, and vaccine use.
        e. Conduct studies to identify and describe the emergence of Lyme 
    disease in previously nonendemic regions.
    2. Conduct Ecologic Studies, Develop and Evaluate Prevention/Control 
    Strategies (Conduct One or More of the Following):
        a. Initiate ecologic studies that will contribute information for 
    development of a nationwide map of Lyme disease risk based on ecologic, 
    entomologic, and epidemiologic data. Risk factors to be evaluated may 
    include distribution of vector ticks, density of vector ticks, 
    infection rate of vector ticks, efficiency of transmission of Lyme 
    disease spirochetes, reservoir competence of vertebrate hosts of B. 
    burgdorferi, density distribution of principal tick maintenance hosts, 
    and contact between infected ticks and humans.
        b. Design, implement, and evaluate an Integrated Pest Management 
    (IPM) program that can be used to reduce Lyme disease in residential 
    and/or recreational settings. The proposed methods may include 
    community participation, acaricides in an area-wide or host-targeted 
    applications, alternative acaricides, habitat modification, host 
    management, or biological control. Emphasis should be placed on 
    adapting the use of an IPM program to communities or large scale 
    recreational areas.
        c. Evaluate in tick and animal models whether commercial Lyme 
    disease vaccine preparations protect against various strains of B. 
    burgdorferi and closely related Borrelia species found in common 
    anthropophilic ticks in the United States. Develop anti-tick vaccines 
    that interrupt transmission of Ixodes scapularis-borne pathogens.
        d. Culture and characterize the newly described spirochete B. 
    lonestari found in Amblyomma americanum ticks. Determine whether this 
    spirochete infects and causes disease in vertebrates, including humans.
    3. Develop and Disseminate Prevention and Control Information on Lyme 
    Disease (Conduct One or More of the Following):
        a. Provide information for health care providers and the public on 
    the distribution of Lyme disease in the geographic area being served by 
    the applicant. Update these data annually,
    
    [[Page 26518]]
    
    showing trends of incidence and other descriptive epidemiologic 
    characteristics of the disease in tabular and map formats.
        b. Devise new and innovative methods for disseminating currently 
    developed educational materials to health care providers and the 
    general public on measures to prevent Lyme disease and on the early and 
    appropriate diagnosis and management of Lyme disease.
        c. Develop informational materials for specific geographical areas 
    on the ecology, environmental and behavioral risk factors, and 
    prevention of Lyme disease.
         d. Develop and publish information outlining practical methods to 
    reduce vector tick densities, based on research in residential areas of 
    high Lyme disease transmission.
        e. Devise new and innovative methods to educate physicians, nurses, 
    physician assistants, and other front line health care providers about 
    Lyme disease, especially those that serve populations at high risk 
    because of periresidential, occupational or recreational exposures.
        f. Devise new and innovative health communication methods to 
    increase awareness and knowledge of the general public about prevention 
    and control of Lyme disease.
    
    B. CDC Activities
    
        1. Provide technical assistance in the design and conduct of 
    research.
        2. Assist in performing selected laboratory tests, as appropriate, 
    depending on the needs of the recipient.
        3. Assist in the coordination of research activities among 
    different recipient sites.
        4. Assist in the analysis of research data.
        5. Assist in reviewing educational materials for medical and 
    scientific accuracy.
    
    Technical Reporting Requirements
    
        Semiannual progress reports are required and must be submitted no 
    later than 30 days after each semiannual reporting period. The 
    semiannual progress reports must include the following for each 
    program, function, or activity involved: (1) A comparison of actual 
    accomplishments to the goal established for the period; (2) the reasons 
    for failure, if established goals were not met; and (3) other pertinent 
    information including, when appropriate, analysis and explanation of 
    performance costs significantly higher than expected. The final 
    progress report is required no later than 90 days after the end of the 
    project period. All manuscripts published as a result of the work 
    supported in part or whole by the cooperative agreement will be 
    submitted with the progress reports.
        An annual Financial Status Report (FSR) is required no later than 
    90 days after the end of each budget period.
        An original and two copies of all reports should be submitted to 
    the Grants Management Branch, CDC.
    
    Application Content
    
        Applicants may apply for assistance for projects in one or more of 
    the subject areas as described in the Recipient Activities section. If 
    the applicant is applying under more than one subject area, a separate 
    narrative, budget, and budget justification must be submitted for each 
    subject area. Each application should consist of the following:
        1. The abstract should summarize the background, needs, goals, 
    objective and methods of the proposal on one page.
        2. The program narrative should include the following sections: 
    background, objectives, methods, plan of operation, and plan of 
    evaluation. List and briefly describe specific, measurable, realistic, 
    and time-phased objectives.
        3. A budget justification is required for all budget items and must 
    be submitted with Standard Form 424A, ``Budget Information,'' as part 
    of PHS 5161-1 (Revised 7/92). The budget should include the total funds 
    requested for the project, with separate budgets and justifications for 
    each recipient activity/component, i.e., surveillance and 
    epidemiological studies; ecologic studies and prevention and control 
    activities; and education (development and dissemination of disease 
    information). For applicants requesting funding for subcontracts, 
    include the name of the person or organization to receive the 
    subcontract, the method of selection, the period of performance, and a 
    description of the subcontracted service requested.
        4. If the proposed project involves human subjects, whether or not 
    exempt from Department of Health and Human Services (DHHS) regulations, 
    describe in the narrative adequate procedures for the protection of 
    human subjects.
        5. Also, ensure that women, racial and ethnic minority populations 
    are appropriately represented in applications for research involving 
    human subjects by including a description of the composition of the 
    proposed study population (for example, addressing the inclusion of 
    women and members of minority groups and their sub-populations in the 
    section that will describe the research design). The applicant will 
    provide an explanation when the investigator cannot control the race, 
    ethnicity and/or sex of the subjects. See Other Requirements for 
    additional information.
        When applicable, letters of support must be included in an appendix 
    if applicants anticipate the participation of other organizations or 
    political subdivisions in conducting proposed activities. Specific 
    roles and responsibilities must be delineated.
    
    Notice of Intent To Apply
    
        In order to assist CDC in planning for and executing the evaluation 
    of applications submitted under this Program Announcement, all parties 
    intending to submit an application are requested to inform CDC of their 
    intention to do so no later than June 13, 1997. Notification should 
    include: (1) Name and address of institution, (2) name, address and 
    telephone number of contact person, and (3) which recipient 
    activity(ies) application will be submitted under. Notification may be 
    provided by facsimile or postal mail to Sharron P. Orum, Grants 
    Management Officer, Grants Management Branch, Centers for Disease 
    Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 305, 
    Mailstop E-18, Atlanta, GA 30305, facsimile (404) 842-6513.
    
    Required Format for Applications
    
        Due to the need to reproduce copies of the applications for the 
    reviewers, ALL pages of the application MUST be in the following 
    format.
        1. The original and two copies must be UNSTAPLED and UNBOUND.
        2. ALL pages must be clearly numbered, and a complete index to the 
    application and its appendices must be included.
        3. Begin each separate section on a new page.
        4. All materials must be typewritten, single-spaced, using a font 
    no smaller than a size 10, and typed ONLY on 8\1/2\'' by 11'' paper.
        5. Any reprints, brochures, or other enclosures must be copied onto 
    8\1/2\'' by 11'' paper by the applicant.
        6. All pages must be printed on ONE side only, with at least 1'' 
    margins, headers, and footers.
        7. The application narrative for each recipient activity subject 
    area (of the three subject areas) must be limited to 10 pages, 
    excluding abstract, budget, and appendices.
        8. Materials that are part of the basic plan must not be placed in 
    the appendices.
        9. If the applicant is applying for assistance for more than one of 
    the three
    
    [[Page 26519]]
    
    focus areas/components, a separate narrative and budget must be 
    submitted for each focus area/component.
    
    Evaluation Criteria
    
    Evaluation Criteria for Proposals for Activity A.1., Disease 
    Surveillance and Epidemiological Studies; Activity A.2., Ecologic 
    Studies and Prevention/Control Strategies
    
        Applications will be reviewed and evaluated according to the 
    following criteria: (Total 100 points).
        1. The applicant's understanding of the purpose of the proposed 
    activity and the feasibility of accomplishing the outcomes desired. (5 
    points)
        2. The extent to which background information and other data 
    demonstrate that the applicant has the appropriate organizational 
    structure, administrative support, and technical expertise to conduct 
    the work proposed and has access to stated target populations or other 
    study objects. (10 points)
        3. The degree to which the proposed objectives are consistent with 
    the purpose as defined in the ``Purpose'' section of this application 
    and are specific, measurable, and time-phased. (5 points)
        4. The degree to which the research plans will enable the applicant 
    to achieve the stated objectives. The plans should specify the who, 
    what, where, how, and timing for the start and completion of each 
    activity. (25 points)
        5. The quality of the research methods and instruments to be used. 
    (If the proposal involves human subjects, the degree to which the 
    applicant has met CDC Policy requirements regarding the inclusion of 
    women, ethnic, and racial groups in the proposed research will be 
    evaluated. 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.) (25 points)
        6. The quality of the proposed methods for evaluating the project. 
    (5 points)
        7. The extent to which qualifications (including expertise and 
    experience in relevant work) of project personnel, and the projected 
    level of effort by each toward accomplishment of the proposed 
    activities demonstrate the ability to successfully conduct the proposed 
    work. (10 points)
        8. The degree to which the proposal addresses one or more of the 
    priority funding areas:
        a. Surveillance and epidemiological studies that target geographic 
    areas of high endemicity/enzooticity and human populations at high 
    risk, and populations in circumstances of emerging risk (5 points);
        b. The development, implementation, and evaluation of community-
    based strategies of primary prevention and control, including methods 
    for vector suppression and personal protection (5 points);
        c. Studies that measure the public health impact of Lyme disease, 
    or that estimate the costs and benefits of various strategies of 
    prevention and control, including vaccination (5 points).
        9. The extent to which the budget is reasonable, clearly justified, 
    and consistent with the intended use of cooperative agreement funds. 
    (not scored)
    
    Evaluation Criteria for Proposals for Activity A.3., Development and 
    Dissemination of Disease Information/Education
    
        Applications will be reviewed and evaluated according to the 
    following criteria: (Total 100 points)
        1. The applicant's understanding of the purpose of the proposed 
    educational intervention/activity and the feasibility of accomplishing 
    the outcomes desired. (10 points)
        2. The extent to which background information and other data 
    demonstrate that the applicant has the appropriate organizational 
    structure, administrative support, and technical expertise to research, 
    design, develop, and disseminate the proposed educational materials, 
    and to access appropriate target populations. (15 points)
        3. The degree to which the proposed objectives are consistent with 
    the defined purpose as defined in the ``Purpose'' section of this 
    application and are specific, measurable, and time-phased. (10 points)
        4. The degree to which the educational research, design, 
    development, and dissemination plans demonstrate the ability of the 
    applicant to achieve the stated objectives. The plan will specify the 
    who, what, where, how, and timing for the start and completion of each 
    activity. (20 points)
        5. The quality of the educational research, design, development, 
    and dissemination methods and instruments to be used. (If the proposal 
    involves human subjects, the following will be evaluated: the degree to 
    which the applicant has met 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. (20 points)
        6. The soundness of the proposed methods for measuring changes in 
    behavior and prevention effectiveness of the educational activity/
    intervention, including the pre-and post-testing of a representative 
    sample of the intended target population. (15 points)
        7. The extent to which qualifications (including training and 
    experience in work with Lyme disease) of project personnel, and the 
    projected level of effort by each toward accomplishment of the proposed 
    activities are described. (10 points)
        8. The extent to which the budget is reasonable, clearly justified, 
    and consistent with the intended use of cooperative agreement funds. 
    (not scored)
    
    Funding Priorities
    
        Priority will be given to applications in the areas of surveillance 
    and epidemiologic studies that target geographic areas of high 
    endemicity/enzooticity and human populations at high risk; to 
    applications that relate to studies of community-based strategies of 
    primary prevention and control, including methods for vector 
    suppression and personal protection; and to applications which focus on 
    education of health care providers and on the evaluation of education 
    effectiveness.
        Interested persons are invited to comment on the proposed funding 
    priorities. All comments received on or before June 26, 1997, will be 
    considered before the final funding priorities are established. If any 
    funding priority should change as a result of any comments received, a 
    revised Announcement will be published in the Federal Register and 
    revised applications will be accepted prior to the final receipt of 
    applications.
        Written comments should be addressed to: Sharron Orum, Grants 
    Management Officer, Grants
    
    [[Page 26520]]
    
    Management Branch, Procurement and Grants Office, Centers for Disease 
    Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 305, 
    Mailstop E-18, Atlanta, GA 30305. All comments should reference the 
    Program Announcement Number 801.
    
    Executive Order 12372 Review
    
        This program is not subject to the Executive Order 12372 review.
    
    Public Health System Reporting Requirements
    
        This program is not subject to the Public Health System Reporting 
    Requirements.
    
    Catalog of Federal Domestic Assistance Number
    
        The Catalog of Federal Domestic Assistance Number is 93.942.
    
    Other Requirements
    
    Paperwork Reduction Act
    
        Projects that involve collection of information from 10 or more 
    individuals and funded by cooperative agreements will be subject to 
    review and approval by the Office of Management and Budget (OMB) under 
    the Paperwork Reduction Act.
    
    Human Subjects
    
        If the proposed project involves research on human subjects, the 
    applicant must comply with the Department of Health and Human Services 
    Regulations (45 CFR Part 46) regarding the protection of human 
    subjects. Assurance must be provided which demonstrates that the 
    project will be subject to initial and continuing review by an 
    appropriate institutional review committee. 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. The applicant will be responsible for 
    providing evidence of this assurance in accordance with the appropriate 
    guidelines and forms provided in the application kit.
    
    Animal Subjects
    
        If the proposed project involves research on animal subjects, the 
    applicant must comply with the ``PHS Policy on Humane Care and Use of 
    Laboratory Animals to Awardee Institutions.'' An applicant organization 
    proposing to use vertebrate animals in CDC-supported activities must 
    file an Animal Welfare Assurance with the Office for the Protection 
    from Research Risks at the National Institutes of Health.
    
    Women, Racial and Ethnic Minorities
    
        It is the policy of the Centers for Disease Control and Prevention 
    (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
    to ensure that individuals of both sexes and the various racial and 
    ethnic groups will be included in CDC/ATSDR-supported research projects 
    involving human subjects, whenever feasible and appropriate. Racial and 
    ethnic groups are those defined in OMB Directive No. 15 and include 
    American Indian, Alaskan Native, Asian, Pacific Islander, Black and 
    Hispanic. Applicants will ensure that women, racial and ethnic minority 
    populations are appropriately represented in applications for research 
    involving human subjects. Where clear and compelling rationale exist 
    that inclusion is inappropriate or not feasible, this situation must be 
    explained as part of the application. This policy does not apply to 
    research studies when the investigator cannot control the race, 
    ethnicity and/or sex of subjects. Further guidance to this policy is 
    contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, 
    dated Friday, September 15, 1995.
    
    Application Submission and Deadline
    
        The original and two copies of the application form PHS 5161-1 
    (Revised 7-92, OMB number 0937-0189) must be submitted to Sharron Orum, 
    Grants Management Officer, Grants Management Branch, Procurement and 
    Grants Office, Centers for Disease Control and Prevention (CDC), 255 
    East Paces Ferry Road, NE., Room 305, Mailstop E-18, Atlanta, GA 30305, 
    on or before August 1, 1997.
        1. Deadline: Applications will be considered as meeting the 
    deadline if they are either:
        a. Received on or before the deadline date; or
        b. Sent on or before the deadline date and received in time for 
    submission to the objective review group. (Applicants must request a 
    legibly dated U.S. Postal Service postmark or obtain a legibly dated 
    receipt from a commercial carrier or the U.S. Postal Service. Private 
    metered postmarks will not be acceptable as proof of timely mailing).
        2. Late Applications: Applications which do not meet the criteria 
    in 1.a. or 1.b. above are considered late applications. Late 
    applications will not be considered and will be returned to the 
    applicant.
    
    Where To Obtain Additional Information
    
        To receive additional written information, call (404) 332-4561. You 
    will be asked to leave your name, address, and telephone number. Please 
    refer to Announcement #801. You will receive a complete program 
    description, information on application procedures and application 
    forms. If you have questions after reviewing the contents of all the 
    documents, business management technical assistance may be obtained 
    from Gladys T. Gissentanna, Grants Management Specialist, Grants 
    Management Branch, Procurement and Grants Office, Centers for Disease 
    Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314, 
    Mailstop E-18, Atlanta, GA 30305, telephone (404) 842-6801. 
    Programmatic technical assistance may be obtained from David Dennis, 
    M.D. or Duane Gubler, Sc.D., Division of Vector-Borne Infectious 
    Diseases, National Center for Infectious Diseases, Centers for Disease 
    Control and Prevention (CDC), Fort Collins, CO 80522, telephone (970) 
    221-6400. You may also obtain this announcement from one of two 
    Internet sites on the actual publication date: CDC's homepage at http:/
    /www.cdc.gov or the Government Printing Office homepage (including free 
    on-line access to the Federal Register at http://www.access.gpo.gov). 
    Other CDC Announcements are also listed on the Internet on the CDC 
    homepage.
        Please refer to Announcement Number 801 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, D.C. 20402-9325, telephone (202) 512-1800.
    
        Dated: May 8, 1997.
    Joseph R. Carter,
    Acting Associate Director for Management and Operations, Centers for 
    Disease Control and Prevention (CDC).
    [FR Doc. 97-12607 Filed 5-13-97; 8:45 am]
    BILLING CODE 4163-18-P
    
    
    

Document Information

Published:
05/14/1997
Department:
Centers for Disease Control and Prevention
Entry Type:
Notice
Document Number:
97-12607
Dates:
CDC's homepage at http:/ /www.cdc.gov or the Government Printing Office homepage (including free on-line access to the Federal Register at http://www.access.gpo.gov). Other CDC Announcements are also listed on the Internet on the CDC homepage.
Pages:
26516-26520 (5 pages)
Docket Numbers:
Program Announcement Number 801
PDF File:
97-12607.pdf