98-12236. Programs To Prevent the Emergence and Spread of Antimicrobial Resistance; Notice of Availability of Fiscal Year 1998 Funds  

  • [Federal Register Volume 63, Number 89 (Friday, May 8, 1998)]
    [Notices]
    [Pages 25483-25488]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-12236]
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Centers for Disease Control and Prevention
    [Announcement Number 98039]
    
    
    Programs To Prevent the Emergence and Spread of Antimicrobial 
    Resistance; Notice of Availability of Fiscal Year 1998 Funds
    
    Introduction
    
        The Centers for Disease Control and Prevention (CDC) is 
    implementing a multifaceted effort to address the problem of 
    antimicrobial resistance. As part of this, CDC announces the 
    availability of fiscal year (FY) 1998 funds for a cooperative agreement 
    program to provide assistance for the development and evaluation of 
    demonstration projects to prevent and control the emergence and spread 
    of antimicrobial resistance.
        The 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(a), 317(k)(1), and 
    317(k)(2) of the Public Health Service Act, as amended (42 U.S.C. 
    241(a), 247b(k)(1), and 247b(k)(2)).
    
    Smoke-Free Workplace
    
        CDC strongly encourages all grant recipients to provide a smoke-
    free workplace and to promote the non-use of all tobacco products, and 
    Pub. L. 103-227, the Pro-Children's 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 
    organizations and governments and their agencies in the United States 
    (U.S.). Thus, universities, colleges, research institutions, hospitals, 
    other public and private nonprofit organizations, including State and 
    local governments or their bona fide agents, federally recognized 
    Indian tribal governments, Indian tribes or Indian tribal 
    organizations, and small, minority- and/or women-owned businesses are 
    eligible to apply.
    
        Note: An organization described in Section 501(c)(4) of the 
    Internal Revenue Code of 1986 which engages in lobbying activities 
    shall not be eligible to receive Federal funds constituting an 
    award, grant, contract, loan, or any other form.
    
    Also, only one application will be accepted from any single applicant.
    
    Availability of Funds
    
        Approximately $1.2 million is available in FY 1998 to fund 
    approximately 2 to 3 awards. It is expected that awards will begin on 
    or about August 15, 1998, and will be made for a 12-month budget period 
    within a project period of up to 5 years. It is expected that the 
    average annual award for the first 3 years of the project period will 
    be $450,000 (direct costs and indirect costs), ranging from $300,000 to 
    $600,000. The last 2 years will involve data collection and analysis 
    only for purposes of evaluating the program; therefore, it is 
    anticipated that lesser amounts of funding will be needed in these 
    years.
        Continuation awards within the project period will be made on the 
    basis of satisfactory progress and availability of funds.
    
        Note: Approximately 50 percent of the available funds are 
    allocated for projects focusing on community-based projects. 
    Approximately 50 percent of the available funds are allocated for 
    projects focusing on integrated health care delivery systems. 
    Applicants should indicate clearly whether they consider their 
    application to be primarily directed at community-based 
    interventions or interventions in integrated health care delivery 
    systems. (Applications addressing both are encouraged. However, for 
    purposes of the evaluation process, the application must clearly 
    state whether it is primarily addressing community-based 
    interventions or interventions in integrated health care delivery 
    systems.)
    
    Use of Funds
    
    Restrictions on Lobbying
    
        Applicants should be aware of restrictions on the use of HHS funds 
    for lobbying of Federal or State legislative bodies. Under the 
    provisions of 31 U.S.C. section 1352 (which has been in effect since 
    December 23, 1989), recipients (and their subtier contractors) are 
    prohibited from using appropriated Federal funds (other than profits 
    from a Federal contract) for lobbying Congress or any Federal agency in 
    connection with the award of a particular contract, grant, cooperative 
    agreement, or loan. This includes grants/cooperative agreements that, 
    in whole or in part,
    
    [[Page 25484]]
    
    involve conferences for which Federal funds cannot be used directly or 
    indirectly to encourage participants to lobby or to instruct 
    participants on how to lobby.
        In addition, the FY 1998 Department of Labor, Health and Human 
    Services, and Education, and Related Agencies Appropriations Act (Pub. 
    L. 105-78) states in section 503(a) and (b) that no part of any 
    appropriation contained in this Act shall be used, other than for 
    normal and recognized executive-legislative relations, for publicity or 
    propaganda purposes, for the preparation, distribution, or use of any 
    kit, pamphlet, booklet, publication, radio, television, or video 
    presentation designed to support or defeat legislation pending before 
    the Congress or any State legislature, except in presentation to the 
    Congress or any State legislature itself. No part of any appropriation 
    contained in this Act shall be used to pay the salary or expenses of 
    any grant or contract recipient, or agent acting for such recipient, 
    related to any activity designed to influence legislation or 
    appropriations pending before the Congress or any State legislature.
    
    Background
    
        The introduction of antibacterial drug therapy in the 1940s led to 
    a dramatic reduction in illness and death from infectious diseases over 
    the past 50 years. Worldwide, antimicrobial drugs have spared the lives 
    of millions of people for whom premature death or crippling 
    complications would have been unavoidable. However, this situation is 
    changing rapidly. Emergence of drug resistance in bacteria, fungi, 
    parasites, and viruses is swiftly reversing the miracles of the past 50 
    years and threatens to create an era where antimicrobial agents are no 
    longer useful for many common diseases. The identification this year of 
    Staphylococcus aureus with reduced susceptibility to vancomycin in both 
    Japan and the United States (U.S.) is particular cause for concern. At 
    least 70 percent of the bacteria-causing, hospital-acquired infections 
    are resistant to at least one antimicrobial agent commonly used for 
    treatment. Among community-acquired pathogens, drug resistance among 
    respiratory tract pathogens, particularly pneumococci, represents a 
    growing problem. Pneumococcal strains have been identified that are not 
    susceptible to any of the oral agents commonly used as therapy, and 
    combination therapy with vancomycin now is recommended for life 
    threatening pneumococcal infections due to increasing resistance among 
    extended spectrum cephalosporins. The spread of resistance means that 
    more toxic, more difficult to administer, more costly, or experimental 
    antimicrobial agents must be used for therapy.
        Factors that promote the spread of resistance differ between 
    pathogens. In the community, transmission within families and in other 
    settings where close contact may occur (e.g., child care facilities); 
    rates of antibiotic therapy, the agents used and their dose; and the 
    impact of resistance on the fitness of a pathogen, all may affect the 
    spread of resistance. For pathogens that cause nosocomial infections, 
    health-care-associated transmission involving acute-care hospitals, 
    long-term-care institutions, such as nursing homes, and non-
    institutionalized persons in the community receiving health care in 
    their homes and/or ambulatory clinical settings also may be important. 
    Few programs to reduce the development and spread of antimicrobial 
    resistance have been implemented in whole communities. Strategies to 
    prevent the spread of resistance among nosocomial pathogens which have 
    proven successful within a single institution or a limited population 
    of patients include the implementation of infection control guidelines 
    and controls on antibiotics to limit inappropriate use. Antibiotic use 
    has been controlled with formulary restrictions, intervention by 
    infectious disease consultants and/or clinical pharmacologists, 
    clinical practice guidelines for physicians, computer-assisted 
    prescribing, and physician and patient educational programs.
        Infection control guidelines include the use of barrier 
    precautions, pre-admission and discharge screening, environmental 
    controls, and cohorting. In the community, successful interventions 
    have included education of physicians and patients, the development of 
    clinical practice guidelines and their promotion by peer educators and 
    opinion leaders, feedback to clinicians comparing their practices with 
    those of their peers, decreasing availability of antibiotics, and 
    changing the agents used, their dose, and the duration of therapy.
    
    Purpose
    
        This program is intended to evaluate the effectiveness and impact 
    of strategies to control the spread of antimicrobial resistance within 
    a larger population, such as a geographically defined community, the 
    catchment area of large health-care delivery organization, or the 
    population of one or more integrated health-care delivery systems.
        Another purpose of this program is to conduct research which 
    develop, implement, and evaluate programs designed to reduce the 
    emergence and spread of antimicrobial resistance. It is anticipated 
    that these programs will be effective and that they could subsequently 
    be replicated widely in order to reduce antimicrobial resistance 
    throughout the U.S. Applicants may submit applications that focus 
    primarily on either (1) communities or (2) integrated networks of 
    health facilities. This program is not intended to support an infection 
    control program at an individual health-care facility or evaluation of 
    a single intervention in a community or health-care setting.
        Programs will address the problem of antimicrobial resistance 
    through interventions potentially including, but not limited to:
        1. Promoting more judicious antimicrobial use (e.g., using 
    antimicrobials only when needed, using appropriate doses of 
    antimicrobial agents, etc.).
        2. Reducing transmission of antimicrobial resistant microorganisms.
        3. Preventing colonization and infection through the use of 
    vaccines.
        4. Improving the ability to provide effective narrow spectrum 
    therapy by rapidly and accurately diagnosing resistant microorgansims 
    through the use of improved laboratory testing procedures and improved 
    quality and flow of laboratory data.
        5. Using improved means of communication with health-care providers 
    to improve their use of antimicrobials, such as through the use of 
    information management systems and Internet-based technology.
        It is envisioned that funded projects will use a combination of 
    approaches to achieve judicious antimicrobial use and other changes 
    that will result in decreased appearance and spread of resistance. 
    Funded projects will also be expected to conduct a multifaceted 
    evaluation of many aspects of the program. An essential part of such an 
    evaluation will be assessing the costs and cost savings associated with 
    any proposed intervention.
    
    Program Requirements
    
        In conducting activities to achieve the purpose of this program, 
    the recipient will be responsible for the activities under A, 
    (Recipient Activities), and CDC will be responsible for conducting 
    activities under B (CDC Activities).
    
    A. Recipient Activities
    
    1. Select Community or Health Facility Focus and Define Pathogens of 
    Interest
        Identify whether the primary focus of activities will be on 
    decreasing spread
    
    [[Page 25485]]
    
    of resistance among community-or health-care-associated pathogens and 
    define the pathogen/resistance patterns that will be evaluated in the 
    project.
    2. Select Study Population
        Identify a population of adequate size for study purposes.
        a. If the primary focus of the application is to address 
    antimicrobial resistance in community settings, the population should 
    be defined by a geographic area and should include a variety of health-
    care providers and health-care provider organizations. (One example of 
    an appropriate approach would be to define the population to be 
    addressed as metropolitan area or part of a State in which case the 
    project might involve, at a minimum, public health entities and 
    providers of outpatient health care in this area.)
        b. If the primary focus of the application is on integrated health 
    care delivery systems or networks, the population should be defined 
    such that interventions could be conducted in multiple settings in 
    which antimicrobial resistance among the target pathogens can develop 
    or be spread (for example, inpatient hospital settings, emergency 
    rooms, ambulatory care facilities, home health settings, long term care 
    facilities, etc.). One example of an appropriate approach would be to 
    define the population as those receiving hospital, long-term care 
    services, and ambulatory care services through a network of related 
    organizations, in which case the project might involve the targeted 
    health facilities, as well as public health authorities in the area.
    3. Define, Collect, and Analyze Baseline Data
        Collect baseline data so that evaluation of the interventions can 
    be done. This includes, at a minimum, collecting incidence and/or 
    prevalence data on antimicrobial resistance among the target pathogens 
    and measuring indicators of prescribing practices of providers serving 
    the population under study.
    4. Design and Implement an Intervention Promoting Judicious 
    Antimicrobial Use and Other Approaches to Reducing Antimicrobial 
    Resistance
        It is anticipated that this will involve developing coalitions 
    among public health agencies, health-care providers, professional 
    societies, and others, as well as implementing specific strategies. 
    These strategies may include peer education of physicians, public 
    education campaigns, clinical practice guidelines, formulary 
    guidelines, prescribing restrictions, pre-admission and pre-discharge 
    screening and the implementation of admission and discharge guidelines, 
    cohorting, barrier precautions, isolation precautions, and other 
    strategies which are likely to be efficacious. The choice of strategies 
    should be justified based on the nature of the study population and the 
    structure of the health care delivery system(s) within which the study 
    population receives health care.
    5. Measure Effect of the Intervention
        a. Measure the change in rates of antimicrobial resistance of the 
    organisms over time. Changes in rates of resistance among organisms 
    that are carried (e.g., in the nasopharynx) may be evaluated in 
    addition to changes in rates of resistant infections. Measurement of 
    antimicrobial resistance should be by a laboratory with proven ability 
    to do these measurements well.
        b. As decreases in resistance as a result of the program may take 
    several months to years to manifest themselves, measure outcomes 
    related to how well the interventions have been implemented and whether 
    they have resulted in behavior change.
        c. Measure cost implications of the intervention. This should 
    include impact of the intervention on direct costs (e.g., costs of 
    antibiotics, medical care visits, duration of hospitalization, etc.) 
    and indirect costs (e.g., time lost from work or child care). Costs 
    should be differentiated from charges, and the perspective of the costs 
    should be defined (e.g., societal, payer, patient, provider). Costs of 
    the intervention program must be differentiated from those of the 
    evaluation.
        d. Other possible outcomes that could be measured include changes 
    in parent or provider knowledge and attitudes regarding antimicrobial 
    use.
    6. Disseminate Research Findings
        Disseminate research results by appropriate methods such as 
    publication in journals, presentation at meetings, conferences, etc.
    
    B. CDC Activities
    
        CDC will provide technical assistance in the design and conduct of 
    the research. This may include:
        1. Provide technical assistance in the design and conduct of the 
    project, including intervention methods and analytic approach.
        2. Upon recipient's request, perform selected laboratory tests as 
    appropriate.
        3. Participate in data management, the analysis of research data, 
    and the interpretation and dissemination of research findings as 
    appropriate.
        4. Assist in the design of the evaluation, in particular, in the 
    identification of outcome measures that will allow for later analysis 
    of economic benefits.
        5. Provide educational materials, including working with grantees 
    to develop new materials that might be needed at multiple sites.
        6. Facilitate exchange of information between recipients.
    
    Technical Reporting Requirements
    
        Narrative progress reports are required semiannually. The first 
    semiannual report is required with each year's noncompeting 
    continuation application and should cover program activities from date 
    of the previous report (or date of award for reporting in the first 
    year of the project). The second semiannual report is due 90 days after 
    the end of each budget period and should cover activities from the date 
    of previous report. Progress reports should address the status of 
    progress toward specific project objectives and should include copies 
    of any publications resulting from the project.
        An original and two copies of a Financial Status Report (FSR) are 
    required no later than 90 days after the end of each budget period. A 
    final performance report and FSR are due no later than 90 days after 
    the end of the project period. All reports are submitted to the Grants 
    Management Branch, CDC.
    
    Application
    
    1. Pre-application Letter of Intent
    
        In order to assist CDC in planning and executing the evaluation of 
    applications submitted under this program announcement, all parties 
    intending to submit application(s) are requested to submit a non-
    binding letter of intent. Notification should be provided as soon as 
    possible but not later than 30 business days prior to the application 
    due date. Notification should include: (1) Name and address of 
    institution, (2) name, address, and telephone number of contact person, 
    and (3) whether the application will primarily address community-based 
    interventions or interventions in integrated health care delivery 
    systems. Notification can be provided by facsimile, postal mail, or 
    electronic mail (E-mail) to Suzanne Binder, M.D., National Center for 
    Infectious Diseases, Mailstop F-22, 1600 Clifton Road, NE., Atlanta, 
    Georgia 30333, Facsimile (770) 488-7794, Internet scb1@cdc.gov.
    
    2. Application Content
    
        Applicants are required to submit an original and two copies of the
    
    [[Page 25486]]
    
    application and must develop their application in accordance with the 
    PHS Form 5161-1 (Revised 7/92, OMB Control number 0937-0189), 
    information contained in this program announcement, and the 
    instructions outlined below. In order to ensure an objective, 
    impartial, and prompt review, applications which do not conform to 
    these instructions may be disqualified.
        All pages must be clearly numbered, and a complete index to the 
    application and its appendixes must be included. The application must 
    be submitted unstapled and unbound. Bound materials (e.g., pamphlets, 
    booklets, etc.) will not be accepted in the narrative or appendices. To 
    submit such materials, copy them onto 8\1/2\'' x 11'' white paper, one-
    side only. All materials must be typewritten, single spaced, and in 
    unreduced type (no smaller than font size 12) with at least 1'' 
    margins, headers, and footers.
        The application narrative must not exceed 20 pages (excluding 
    budget and appendixes). Unless indicated otherwise, all information 
    requested below must appear in the narrative. Materials or information 
    that should be part of the narrative will not be accepted if placed in 
    the appendices. The application narrative must contain the following 
    sections in the order presented below.
    a. Abstract
        Provide a brief (two pages maximum) abstract of the project. State 
    the length of the project period for which assistance is being 
    requested (see AVAILABILITY OF FUNDS Section for additional information 
    regarding project period). Indicate clearly whether this project 
    primarily addresses antimicrobial resistance in communities or in 
    integrated health-care networks.
    b. Background and Need
        Discuss the background and need for the proposed project. 
    Illustrate and justify the need for the proposed project that is 
    consistent with the purpose and objectives of this cooperative 
    agreement program.
    c. Capacity and Personnel
        Describe applicant's past experience in conducting projects/studies 
    similar to that being proposed. Describe applicant's resources, 
    laboratory and other facilities, and professional personnel that will 
    be involved in conducting the project. Include in an appendix 
    curriculum vitae for all professional personnel involved with the 
    project. Describe plans for administration of the project and identify 
    administrative resources that will be assigned to the project. Provide 
    in an appendix letters of support from all key participating non-
    applicant organizations, individuals, etc., which clearly indicate 
    their commitment to participate as described in the operational plan. 
    (Do not include letters of support from CDC personnel--they will not be 
    accepted in the application.)
    d. Objectives and Technical Approach
        Describe specific objectives for the proposed project which are 
    measurable and time-phased and are consistent with the purpose and 
    goals of this cooperative agreement program. Include a detailed 
    timeline for completion of key activities. Provide a detailed 
    operational plan for initiating and conducting the project which 
    clearly and appropriately addresses all recipient activities. Include a 
    clear description of applicant's technical approach/methods which are 
    directly relevant to the study objectives. Clearly identify specific 
    assigned responsibilities/tasks for all key professional personnel. 
    Describe the nature and extent of collaboration with CDC and/or others 
    during various phases of the project. If the applicant is not a health 
    department, describe plans for involving local and State health 
    departments. Clearly describe the population to be studied. Describe in 
    detail a plan for evaluating study results (including how data on 
    prescribing practices, costs, and charges will be obtained) and for 
    evaluating progress toward achieving project objectives. Justify the 
    choice of organisms and antimicrobial susceptibility that will be used 
    for evaluation, and include a description about how quality of 
    laboratory measurements will be assured. Clearly state the proposed 
    length of the project period.
    e. Budget
        Provide in an appendix a budget and accompanying detailed 
    justification for the first year of the project that is consistent with 
    the purpose and objectives of this program. Provide estimated total 
    budgets for subsequent years. If requesting funds for any contracts, 
    provide the following information for each proposed contract: (1) Name 
    of proposed contractor, (2) breakdown and justification for estimated 
    costs, (3) description and scope of activities to be performed by 
    contractor, (4) period of performance, and (5) method of contractor 
    selection (e.g., sole-source or competitive solicitation). (See sample 
    budget included in application package.)
    
        Note: If indirect costs are requested, a copy of the applicant 
    organization's current negotiated Federal indirect cost rate 
    agreement or cost allocation plan must be provided.
    f. Human Subjects
        Whether or not exempt from DHHS regulations, if the proposed 
    project involves human subjects, describe in an appendix adequate 
    procedures for the protection of human subjects. Also, ensure that 
    women, racial and ethnic minority populations are appropriately 
    represented in applications for research involving human subjects (see 
    OTHER REQUIREMENTS Section for additional information).
    
    Evaluation Criteria
    
        The applications will be reviewed and evaluated according to the 
    following criteria:
        1. Background and Need (10 points): Extent to which applicant's 
    discussion of the background for the proposed project demonstrates a 
    clear understanding of the purpose and objectives of this cooperative 
    agreement program. Extent to which applicant illustrates and justifies 
    the need for the proposed project that is consistent with the purpose 
    and objectives of this program.
        2. Capacity (30 points total):
        a. Extent to which applicant describes adequate resources and 
    facilities (both technical and administrative) for conducting the 
    project. This includes the capacity to conduct quality laboratory 
    measurements. (10 points)
        b. Extent to which applicant documents that professional personnel 
    involved in the project are qualified and have past experience and 
    achievements in research and programs related to that proposed as 
    evidenced by curriculum vitae, publications, etc. (15 points)
        c. Extent to which applicant includes letters of support from non-
    applicant organizations, individuals, etc. Extent to which the letters 
    clearly indicate the author's commitment to participate as described in 
    the operational plan. (5 points)
        3. Objectives and Technical Approach (60 points total):
        a. Extent to which applicant describes specific objectives of the 
    proposed project which are consistent with the purpose and goals of 
    this program and which are measurable and time-phased. (10 points)
        b. Extent to which the applicant identifies an appropriate 
    population for study, including whether the results of a study in this 
    population will be generalizable to other populations in the U.S. 
    Extent to which adequate procedures are described for the protection of 
    human subjects. Extent to
    
    [[Page 25487]]
    
    which the applicant identifies microbes/resistance patterns for study 
    that are of public health importance. (10 points)
        c. Extent to which applicant presents a detailed operational plan 
    for initiating and conducting the project, which clearly and 
    appropriately addresses all recipient activities. Extent to which 
    applicant clearly identifies specific assigned responsibilities for all 
    key professional personnel. Extent to which the plan clearly describes 
    applicant's technical approach/methods for developing and conducting 
    the proposed program and evaluation and extent to which the plan is 
    adequate to accomplish the study objectives. The degree to which the 
    applicant has met the CDC Policy requirements regarding the inclusion 
    of women, ethnic, and racial groups in the proposed research. The 
    extent to which applicant describes the existence of or plans to 
    establish partnerships. (20 points)
        d. Extent to which applicant describes adequate and appropriate 
    collaboration with CDC and/or others during various phases of the 
    project. (10 points)
        e. Extent to which applicant provides a detailed and adequate plan 
    for evaluating study results (including laboratory data and data on 
    prescribing practices), as well as plans for evaluating progress toward 
    achieving project objectives. (10 points)
        4. Budget (not scored): Extent to which the proposed budget is 
    reasonable, clearly justifiable, and consistent with the intended use 
    of cooperative agreement funds.
    
    Executive Order 12372 Review
    
        This program is not subject to Executive Order 12372 Review, 
    Intergovernmental Review of Federal Programs.
    
    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 93.283.
    
    Other Requirements
    
    Paperwork Reduction Act
    
        Projects that involve the collection of information from ten or 
    more individuals and funded by the cooperative agreement 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 to demonstrate that the project 
    will be subject to initial and continuing review by an appropriate 
    institutional review committee. The applicant will be responsible for 
    providing evidence of this assurance in accordance with the appropriate 
    guidelines and form provided in the application kit.
    
    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 or Alaska Native, Asian, Black or African American, 
    Hispanic or Latino, Native Hawaiian or Other Pacific Islander. 
    Applicants shall 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, 
    and dated Friday, September 15, 1995.
    
    Application Submission and Deadline
    
        The original and two copies of the application PHS Form 5161-1 
    (Revised 7/92, OMB Control number 0937-0189), must be submitted to 
    Sharron P. Orum, Grants Management Officer, Grants Management Branch, 
    Procurement and Grants Office, Centers for Disease Control and 
    Prevention (CDC), Room 300, Mailstop E-18, 255 East Paces Ferry Road, 
    NE., Atlanta, Georgia 30305, on or before June 29, 1998.
        1. Deadline: Applications shall 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 U.S. Postal Service. Private 
    metered postmarks shall 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 and to request an 
    application kit, call 1-888-GRANTS (1-888-472-6874). You will be asked 
    to leave your name and address and will be instructed to identify the 
    Announcement number of interest. (Please refer to Announcement Number 
    98039.) 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 Oppie M. Byrd, Grants 
    Management Specialist, Grants Management Branch, Procurement and Grants 
    Office, Centers for Disease Control and Prevention (CDC), Room 314, 
    Mailstop E-18, 255 East Paces Ferry Road, NE., Atlanta, Georgia 30305, 
    telephone (404) 842-6546, Facsimile (404) 842-6513, Internet 
    oxb3@cdc.gov.
        Programmatic technical assistance may be obtained from David Bell, 
    telephone (404) 639-2603 or Suzanne Binder, M.D., National Center for 
    Infectious Diseases, Centers for Disease Control and Prevention (CDC), 
    Mailstop F-22, 1600 Clifton Road, NE., Atlanta, Georgia 30333, 
    telephone (770) 488-7793, Facsimile (770) 488-7794, Internet 
    scb1@cdc.gov.
        Please refer to Announcement Number 98039 when requesting 
    information regarding this program.
        You may obtain this announcement from one of two Internet sites on 
    the actual publication date: CDC's homepage at http://www.cdc.gov or at 
    the Government Printing Office homepage (including free on-line access 
    to the Federal Register at http://www.access.gpo.gov).
        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,
    
    [[Page 25488]]
    
    Washington, DC 20402-9325, telephone: (202) 512-1800.
    
        Dated: May 4, 1998.
    Joseph R. Carter,
    Acting Associate Director for Management and Operations, Centers for 
    Disease Control and Prevention (CDC).
    [FR Doc. 98-12236 Filed 5-7-98; 8:45 am]
    BILLING CODE 4163-18-P
    
    
    

Document Information

Published:
05/08/1998
Department:
Centers for Disease Control and Prevention
Entry Type:
Notice
Document Number:
98-12236
Dates:
CDC's homepage at http://www.cdc.gov or at the Government Printing Office homepage (including free on-line access to the Federal Register at http://www.access.gpo.gov).
Pages:
25483-25488 (6 pages)
Docket Numbers:
Announcement Number 98039
PDF File:
98-12236.pdf