[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.
[[Page 34455]]
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:
[[Page 34457]]
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,
[[Page 34458]]
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: jdd2@cdc.gov.
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
