[Federal Register Volume 62, Number 123 (Thursday, June 26, 1997)]
[Notices]
[Pages 34454-34458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16725]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 768]


HIV, STDs, and TB Related Applied Research Projects

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of funds beginning in fiscal year (FY) 1997 for 
cooperative agreements to conduct human immunodeficiency virus (HIV), 
sexually transmitted diseases (STDs), and tuberculosis (TB) related 
applied research into the control and prevention of HIV, STDs and TB.

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    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 relates to the Healthy People 2000 priority areas of 
Educational and Community-Based Programs, HIV Infection, Sexually 
Transmitted Diseases (STDs), and Immunization and Infectious Diseases. 
(For ordering a copy of ``Healthy People 2000,'' see the section 
entitled ``Where to Obtain Additional Information.'')

Authority

    This program is authorized under the Public Health Service Act, 
Sections 317(k)(2)(42 U.S.C. 247b(k)(2), 317E (42 U.S.C.247b-6) and 318 
of the Public Health Service Act, (42 U.S.C. 247c), as amended. 
Regulations governing grants for STD research are codified in Part 51b, 
Subparts A and F of Title 42, Code of Federal Regulations.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and 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

    Eligible applicants will include universities, colleges, research 
institutions, hospitals, public and private non-profit organizations, 
community-based, national, and regional organizations, State and local 
governments or their bona fide agents or instrumentalities, federally 
recognized Indian Tribal governments, Indian tribes or organizations, 
and small, minority-and/or women owned non-profit businesses.

    Note: Organizations described in section 501(c)(4)of the 
Internal Revenue Code of 1986 that engage in lobbying are not 
eligible to receive Federal grant/cooperative agreement funds.

Availability of Funds

    Approximately $500,000 is available in FY 1997 to fund up to three 
awards. The awards will be made for a 12-month budget period within a 
project period of up to five years. Funding will be available during 
the fiscal year for applications submitted that are consistent with the 
National Center for HIV, STD, and TB Prevention (NCHSTP) National 
Program Goals. Funding estimates may vary and are subject to change.
    Continued support in future years will be based on the availability 
of funds and success in demonstrating progress toward achievement of 
objectives.

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, 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 1997 HHS Appropriations Act, which became 
effective October 1, 1996, expressly prohibits the use of 1997 
appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. This new law, Section 503 of Pub. L. No. 104-208, 
provides as follows:
    Sec. 503(a)--No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, 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, . . . except 
in presentation to the Congress or any State legislative body itself.
    (b) 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.
    Department of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, Section 
101(e), Pub. L. No. 104-208 (September 30, 1996).

Program Priority Areas

    In future announcements, CDC will announce priority areas through 
both the Federal Register and the Internet.

Background

    HIV continues to be a major health problem in the Nation with an 
estimated 650,000 to 900,000 persons currently infected. Through the 
end of June 1996, 548,102 AIDS cases and 346,127 deaths were reported. 
AIDS is currently the eighth leading cause of death in Americans of all 
ages and the leading cause of death in persons aged 25 to 44 years.
    STDs are a major public health problem in the United States with 
over 12 million new cases occurring every year. These diseases 
frequently result in severe, irreversible complications, including 
involuntary infertility, fatal ectopic pregnancy, fetal wastage, 
congenital infections, cervical cancer, and at least a three-to five-
fold increased risk of HIV transmission. Effective STDs prevention 
efforts in the United States require a broad base of support and 
collaboration between public and private providers. The prevention of 
STDs will result in achievement of goals for other programs as well as 
including reduction in HIV transmission and healthier women and 
infants.
    Between 1985 and 1992, after more than 3 decades of steady decline, 
there was a resurgence of TB in this country with a 20 percent increase 
in the number of reported cases. In 1992, many State and local TB 
prevention and control programs received funding increases for TB 
control in response to the needs created by this resurgence. These 
programs rapidly mobilized to implement portions of the 1989 Strategic 
Plan for the Elimination of Tuberculosis in the United States and the 
``1992 National Action Plan to Combat Multi-drug Resistant 
Tuberculosis'. The funding increases allowed programs to improve 
laboratory capabilities for prompt diagnosis of TB; pay close attention 
to program performance indicators to measure and improve success; and 
apply techniques to ensure that patients complete therapy and are no 
longer infectious (such as hiring outreach workers to meet with 
patients and provide directly observed therapy). As a result, the 
number of reported cases for 1996 will be the fourth consecutive annual 
decline as compared to the previous year. However, the global TB 
problem (over 8 million cases and 3 million deaths per year) has an 
important impact on the United States, where in 1995 an increasing 
percentage of new cases were

[[Page 34456]]

in foreign-born persons (35 percent). Thus, the efforts responsible for 
the recent decreases in TB cases must be sustained to achieve the 
ultimate elimination of TB from the United States. State and local TB 
control programs are working to prevent, control, and eventually 
eliminate TB in the United States. This effort requires a wide variety 
of activities and collaboration between private and public efforts and 
patients or patient advocates.

Purpose

    The purpose of this program is to provide funding for new and 
innovative methods that further the prevention efforts related to HIV, 
STDs and TB. Projects that will be considered for funding are applied 
research into the control and prevention of HIV, STDs, or TB.

National Program Goals

    CDC's national strategic goals for the programs supported by the 
National Center for HIV, STDs and TB Prevention are:
    1. Increase public understanding of, involvement in, and support 
for HIV, STDs, and TB prevention.
    2. Ensure completion of therapy for persons identified with active 
TB or TB infection.
    3. Prevent or reduce behaviors or practices that place persons at 
risk for HIV and STDs infection or, if already infected, place others 
at risk.
    4. Increase individual knowledge of HIV serostatus and improve 
referral systems to appropriate prevention and treatment services.
    5. Assist in building and maintaining the necessary State, local, 
and community infrastructure and technical capacity to carry out 
necessary prevention programs.
    6. Strengthen the current systems and develop new systems to 
accurately monitor HIV, STDs, and TB, as a basis for assessing and 
directing prevention programs.

Program Requirements

    Recipient activities to achieve the purposes of this program will 
vary by project. Some examples of the range and types of activities are 
described below under Recipient Activities. CDC will be responsible for 
the activities under CDC Activities.

1. Recipient Activities

    A. Develop and implement prevention strategies for HIV, STDs or TB 
transmission.
    B. Develop and implement strategies for identifying and addressing 
behavioral, diagnostic, prevention and treatment problems that have not 
been fully explored.
    C. Develop and implement an evaluation plan that measures the 
effectiveness of the projects.
    D. Ensure that appropriate approvals are secured for the protection 
of human subjects, Office of Management and Budget and Paperwork 
Reduction Act, privacy, confidentiality, and data security.
    E. Compile and disseminate findings.

2. CDC Activities

    A. Monitor and evaluate scientific and operational accomplishments 
of the project through periodic site visits, frequent telephone calls, 
and review of technical reports and interim data analysis.
    B. If an awardee should need to collaborate with a State or local 
health department, CDC will assist in facilitating the planning and 
implementation of the necessary linkages with local or State health 
departments and assist with the developmental strategies for applied 
clinical or prevention oriented research programs.
    C. Assist in the development and implementation of an evaluation 
plan that measures the effectiveness of the projects and their overall 
impact on prevention goals.
    D. Facilitate the technological and methodological dissemination of 
successful prevention and intervention models among appropriate target 
groups, such as, State and local health departments, community based 
organizations, and other health professionals.
    E. Participate in planning, implementing, and evaluating strategies 
and protocols.
    F. Participate in the publication and dissemination of study 
results.

Technical Reporting Requirements

    Progress reports are required annually as part of the continuation 
application (75 days prior to the start of the next budget period). The 
progress reports must contain information on accomplishments during the 
previous budget period. Financial status reports (FSR) are required no 
later than 90 days after the end of the budget period. The final 
performance and financial status reports are required 90 days after the 
end of the project period. The final performance report should include, 
at a minimum, a statement of original objectives, a summary of 
methodology, a summary of positive and negative findings, and a list of 
publications resulting from the project. Research papers, project 
reports, or theses are acceptable items to include in the final report. 
The final report should stand alone rather than citing the original 
application. Three copies of reprints of publications prepared under 
the award should accompany the report. All reports must be submitted to 
the Grants Management Branch, Procurement and Grants Office, CDC.

Letter of Intent (LOI)

    Potential applicants must submit an original and two copies of a 
two-page typewritten Letter of Intent (LOI) that briefly describes the 
title of the project, purpose and need for the project as well as its 
relationship to the National Program Goals, the estimated total cost of 
the proposed project, and the dollar amount and percentage of the total 
cost being requested from CDC. Current recipients of CDC funding must 
provide the award number and title of the funded programs. No 
attachments, booklets, or other documents accompanying the LOI will be 
considered.
    LOI's will be reviewed by CDC program staff and an invitation to 
submit a full application will be made based on the documented need for 
the proposed project, contribution to the National Program Goals, and 
the availability of funds.
    An invitation to submit a full application does not constitute a 
commitment by CDC to fund the applicant.

Application Content

    Applications may be submitted only after a Letter of Intent has 
been approved by the CDC and a written invitation from the CDC has been 
extended to the prospective applicant. Applicants who are invited to 
submit a full application must use Form PHS 398 (OMB Number 0925-0001), 
and submit an original and five copies. The application narrative 
should consist of:
    1. Abstract (Not to exceed 1 page): An executive summary of your 
program covered under this announcement.
    2. Program Plan (Not to exceed 10 pages): In developing the 
application under this announcement, please review the recipient 
activities and evaluation criteria and respond concisely and 
completely.
    3. Budget: Submit an itemized budget that is consistent with your 
proposed program plan.

Evaluation Criteria

    Applications responding to this announcement will be evaluated 
individually according to the following criteria:

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    1. Degree to which proposed objectives are clearly established, 
obtainable, and for which progress toward attainment can be measured, 
are time-phased, and related to the program 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. 
This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
minority populations for appropriate representation;
    b. The proposed justification when representation is limited or 
absent;
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted; and
    d. 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. (40 points)
    2. The degree to which the applicant institution offers a 
supportive environment and documents success in achieving objectives 
similar to those of this project. (30 points)
    3. Extent to which personnel involved in this project are 
qualified, including evidence of past achievements appropriate to the 
project. Evidence of adequacy of facilities and other resources needed 
to carry out the project. (30 points)
    4. Other (not scored).
    (a) Budget: Will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of the 
funds, and allowable. All budget categories should be itemized.
    (b) Human Subjects: Whether or not exempt from the Department of 
Health and Human Services regulations, are procedures adequate for the 
protection of human subjects? Recommendations on the adequacy of 
protections include the following: (a) protections appear adequate and 
there are no comments to make or concerns to raise, (b) protections 
appear adequate, but there are comments regarding the protocol, (c) 
protections appear inadequate and the Objective Review Group (ORG) has 
concerns related to human subjects; or (d) disapproval of the 
application is recommended because the research risks are sufficiently 
serious and protection against the risks are inadequate as to make the 
entire application unacceptable.

Executive Order 12372 Review

    Applications are not subject to review as governed by Executive 
Order 12372, 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

    The Catalog of Federal Domestic Assistance numbers are 93.941, HIV 
Demonstration, Research, Public and Professional Education; 93.943, 
Epidemiologic Research Studies of Acquired Immunodeficiency Virus 
(AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected 
Population Groups; 93.947, Tuberculosis Demonstration, Research, Public 
and Professional Educations; and 93.978, Prevention Health Services--
Sexually Transmitted Diseases Research, Demonstrations, and Public 
Information and Education Grants.

Other Requirements

Human Subjects

    Recipients 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 assurance in accordance with the appropriate guidelines 
provided in the application kit.

Confidentiality

    All personally identifying information obtained in connection with 
the delivery of services provided to any individual under any program 
that is being carried out with a cooperative agreement made under this 
announcement shall not be disclosed unless required by a law of a State 
or political subdivision or unless such an individual provides written, 
voluntary informed consent.

Women, Racial and Ethnic Minorities

    It is the policy of the CDC to ensure that individuals of both 
sexes and the various racial and ethnic groups will be included in CDC-
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, Alaska Native, Asian, 
Pacific Islander, Black and Hispanic. 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, Friday, September 15, 1995, pages 47947-
47951 (a copy is included in the application kit).

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.

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 of which is included in the application kit. At least one 
member of the program review panel must be an employee (or a designated 
representative) of the health department consistent with the 
``Content'' guidelines. The names of the review panel members must be 
listed on the Assurance of Compliance for CDC 0.1113, which is also 
included in the application kit. The recipient must submit, as an 
attachment to the application, the program review panel's report 
affirming that all materials have been reviewed and approved.

Submission Requirements and Deadlines

A. Letter of Intent (LOI)

    ONE ORIGINAL AND TWO COPIES of the LOI must be postmarked on or 
before July 18, 1997. (FACSIMILES ARE NOT ACCEPTABLE.)

B. Application

    ONE ORIGINAL AND FIVE COPIES of the invited applications must be 
submitted on Form PHS 398 (OMB Number 0925-0001) and must be postmarked 
on or before August 15, 1997.

C. Address for Submission of Letter of Intent and Invited Application

    Van Malone, Grants Management Officer, Grants Management Branch, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road NE., Room 300, Mailstop E-15,

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Atlanta, Georgia 30305, ATTN: Juanita Dangerfield.

D. Application Deadline

    Letters of Intent and Applications shall be considered as meeting 
the deadline if they are either:
    1. Received on or before the deadline date, or
    2. Postmarked on or before the deadline date and received in time 
for submission to the objective 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 shall not be acceptable as proof of timely 
mailing.)

E. Late Applications

    Applications that do not meet the criteria in D.1. or D.2. above 
are considered late applications and will be returned to the applicant 
without review.

Where To Obtain Additional Information

    Business management technical assistance may be obtained from 
Juanita Dangerfield, Grants Management Specialist, Grants Management 
Branch, Centers for Disease Control and Prevention (CDC), Procurement 
and Grants Office, 255 East Paces Ferry Road NE., Room 300, Mailstop E-
15, Atlanta, GA 30305, telephone (404) 842-6577, or facsimile at (404) 
842-6513, or INTERNET address: [email protected].
    Programmatic technical assistance may be obtained from the National 
Center for HIV, STDs and TB Prevention, Centers for Disease Control and 
Prevention (CDC), Atlanta, GA 30303, for HIV, contact Lynn Austin, 
telephone (404) 639-0902; for STD, contact Sevgi Aral, telephone (404) 
639-8259; for TB, contact Bess Miller, telephone (404) 639-8120.
    Please refer to Announcement 768 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), ``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: June 20, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-16725 Filed 6-25-97; 8:45 am]
BILLING CODE 4163-18-P