Grants and cooperative agreements; availability, etc.: HIV and sexually transmitted diseases; routinely recommended counseling and testing in ambulatory care clinics and emergency rooms; research studies,

[Federal Register: July 20, 2001 (Volume 66, Number 140)]

[Notices]

[Page 37966-37969]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr20jy01-49]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01187]

Human Immunodeficiency Virus (HIV) Prevention Intervention Research Studies--Routinely Recommending HIV and Sexually Transmitted Disease (STD) Counseling and Testing in Ambulatory Care Clinics and Emergency Rooms; Notice of Availability of Funds

1. Purpose

   The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001

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   funds for a cooperative agreement program to reduce HIV incidence through prevention intervention research studies that routinely recommend HIV and STD counseling and testing in ambulatory care clinics and emergency rooms. This program addresses the ``Healthy People 2010'' focus area of HIV.

   The purpose of this activity is to study the outcome of routinely recommending HIV counseling and testing and STD screening in ambulatory care clinics and emergency rooms.

2. Eligible Applicants

   Applications may be submitted by public and private nonprofit and for-profit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations, small, minority, women-owned businesses.

   Note: Title 2 of the United States Code, chapter 26, section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

3. Availability of Funds

   Approximately $600,000 is available in FY 2001 to fund approximately two to three awards. It is expected that the average award will be $200,000, ranging from $150,000 to $250,000. It is expected that the awards will begin on or about September 30, 2001, and will be made for a 12-month budget period within a project period of up to two years. Funding estimates may change.

   Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

   Use of Funds

   Funds are awarded for a specifically defined purpose and may not be used for any other purpose or program. Funds may be used to support personnel and to purchase equipment, supplies, and services directly related to project activities. Funds may not be used to supplant State or local funds available for HIV Prevention. Funds may not be used to provide direct medical care or prevention case management.

   Funding Preference

   Funding preference may be given to achieve geographical diversity.

4. Program Requirements

   In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities).

   1. Recipient Activities

      1. Review existing information, research study protocols, and data collection forms to build on existing knowledge and to establish the basis for the application.

      2. Develop a research protocol and plans for conducting this research, with appropriate participation of State and local health departments, hospitals and other public and private organizations; professional associations, community groups and organizations, especially those with a racial and ethnic minority membership and focus; HIV/AIDS service organizations; and organizations that serve persons with HIV disease, STD, or AIDS.

      3. Establish procedures to maintain the rights and confidentiality of all study participants. Prior to implementation, this study must be submitted to the local and CDC Institutional Review Boards (IRBs) for review and approval or deferral. The IRB review at each cooperating institution will be done by an Office for Human Research Protections (OHRP)-approved IRB with either a single, multiple, or federal-wide project assurance.

      4. Identify, recruit, obtain informed consent (when appropriate), enroll, and follow an adequate number of study participants as determined by study protocol and the program requirements.

      5. Perform testing for chlamydia, gonorrhea and HIV.

      6. Perform data analysis as determined in the study protocol.

      7. Disseminate the findings.

   2. CDC Activities

      1. Provide technical assistance, if requested, in the design and conduct of the research.

      2. The CDC IRB will review and approve each protocol initially and on at least an annual basis until the research project is completed.

      3. As needed, assist in designing a data management system and data analysis.

5. Application Content

   Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to follow them in laying out your program plan. The narrative should be no more than 25 pages double-spaced, printed on one side, with one inch margins, and unreduced font.

   The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation and Budget.

6. Submission and Deadline

   Submit the original and five copies of PHS-398 (OMB 0925-0001) (adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are available in the application kit and at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm

   On or before August 30, 2001, submit the application to the Grants Management Specialist identified in the ``Where to Obtain Additional Information'' section of this announcement.

   Deadline: Applications shall be considered as meeting the deadline if they are either:

   1. Received on or before the deadline date; or

   2. Sent on or before the deadline date and received in time for submission to the Special Emphasis Panel. (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.)

   Late: Applications which do not meet the criteria in 1. or 2. above will be returned to the applicant.

7. Evaluation Criteria

   Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

   1. Background and Objectives (10 points):

      To the degree to which the applicant includes: (1) A detailed review of the scientific literature pertinent to testing in ambulatory care clinics and emergency rooms; (2) clearly stated goals and objectives for the research; and (3) a description of how the intervention would impact HIV and STD prevention in the community.

   2. Site Selection (15 points)

      The extent to which the application includes a description of: (1) The

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      current magnitude and characteristics of the HIV epidemic; (2) STD disease burden; (3) the number of persons served by the clinics; and (4) the expected number of newly-identified HIV infections that will be detected. Letters of support from cooperating organizations should be included which clearly describe the nature and extent of such cooperation.

   3. Methods (30 points)

      To the extent the application describes the potential intervention and how it might impact on HIV and STD incidence in the study area. It should specify potential barriers to implementing the intervention and how they will be overcome. The methods for assessing the increase in number of persons tested, as well as the number of infected persons identified and successfully referred for treatment, should also be addressed. In addition, applications will be evaluated on 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. 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.

      4. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with communities and recognition of mutual benefits.

   4. Research Capacity (20 points)

      The extent to which the application describes the capacity and experience of the research team which includes curriculum vitae and position descriptions for key staff. The percentage-time commitments, duties, and responsibilities of project personnel and involvement of state and local health department personnel should be sufficient to operationalize the proposed methodology. Letters of support from key collaborators, community groups, State and local health departments, should be included. The letters of support must include a brief description of the specific support to be provided, and should be limited to three pages each. The application should document that there is sufficient space available in the ambulatory care clinic or emergency room for the addition of the testing program. The application should also provide evidence that at least 500 persons per year visit the ambulatory care facility or emergency room, many of whom may be HIV-infected and who do not know they are HIV-infected. The application should demonstrate the applicant's ability to do testing for chlamydia, gonorrhea, and HIV, either in house or through contractual services.

   5. Sustainability of the intervention (15 points)

      Strength of plans, time-lines, and objectives for how project will be sustained.

   6. Evaluation Plan (10 points)

      Appropriateness and comprehensiveness of: (a) The schedule for accomplishing the activities of the research; (b) an evaluation plan that identifies methods and instruments for evaluating progress in implementing the research objectives; and (c) a proposal to complete and submit for publication, a report of research findings.

   7. Budget (not scored)

      The extent to which the budget is reasonable, clearly justified, and consistent with the intent of the announcement.

   8. Human Subjects (not scored)

      Does the application adequately address the requirements of 45 CFR part 46 for the protection of human subjects? (Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks are so inadequate as to make the entire application unacceptable.)

8. Other Requirements

   Technical Reporting Requirements

   Provide CDC with the original and two copies of:

   1. Annual progress reports to be submitted with subsequent continuation applications;

   2. Financial status report, no more than 90 days after the end of the budget period;

   3. Final financial report and performance report, no more than 90 days after the end of the project period.

   Send all reports to the Grants Management Specialist identified in the ``Where to Obtain Additional Information'' section of this announcement.

   Projects that involve the collection of information from 10 or more individuals and funded by cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

   The following additional requirements are applicable to this program. For a complete description of each, see Attachment I and Attachment II of the announcement.

   AR-1 Human Subjects Requirements AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research AR-4 HIV/AIDS Confidentiality Provisions AR-5 HIV Program Review Panel Requirements AR-7 Executive Order 12372 Review AR-9 Paperwork Reduction Act Requirements AR-10 Smoke-Free Workplace Requirements AR-11 Healthy People 2010 AR-12 Lobbying Restrictions AR-22 Research Integrity

   1. Authority and Catalog of Federal Domestic Assistance Number

   This program is authorized under the Public Health Service Act sections 317 (42 U.S.C. 241(a) and 247b); 301 (42 U.S.C. 241); and 311 (42 U.S.C. 243), as amended. The Catalog of Federal Domestic Assistance number is 93.941.

10. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page Internet address http://www.cdc.gov Click on ``Funding'' then ``Grants and Cooperative Agreements.''

    To receive additional written information and to request an application kit, call 1-888-GRANTS4 (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.

    If you have questions after reviewing the contents of all the documentation, business management technical assistance may be obtained from: Brenda Hayes, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Mailstop E-15, Atlanta, GA 30341-4146, Telephone: (770) 488-2741, Email address: bkh4@cdc.gov

    For program technical assistance, contact: Cassandra Walker, MPH, Acting Deputy Chief Prevention Services Research Branch, Division of HIV/AIDS Prevention, Surveillance & Epidemiology National Center for HIV, STD, TB Prevention Centers for Disease Control and Prevention 1600 Clifton Road, Mailstop E-46, Atlanta, GA 30333, Telephone Number: (404) 639-6191, Email address: cwalker5@cdc.gov

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    Dated: July 13, 2001. John L. Williams, Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

    [FR Doc. 01-18047Filed7-19-01; 8:45 am]

    BILLING CODE 4163-18-P