[Federal Register Volume 62, Number 22 (Monday, February 3, 1997)]
[Notices]
[Pages 5012-5015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration


Ryan White Title IV; Grants for Coordinated HIV Services and 
Access to Research for Children, Youth, Women, and Families

AGENCY: Health Resources and Services Administration, HRSA.

ACTION: Notice of availability of funds.

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SUMMARY: The HRSA announces that approximately $15.5 million in fiscal 
year (FY) 1997 funds will be available for project grants that enhance 
access to clinical research trials and other research, and develop and 
support the provision of coordinated comprehensive services and 
activities for children, youth, women and families infected/affected by 
the Human Immunodeficiency Virus (HIV). Grants will be funded that link 
clinical research and other research activities with comprehensive care 
systems, and improve and expand the coordination of a system of 
comprehensive care for children, youth, women, and families who are 
infected/affected by HIV. These projects are authorized under Section 
2671 of the Public Health Service Act, as amended by the Ryan White 
Comprehensive AIDS Resource Emergency (CARE) Act Amendments of 1996, 
Public Law 104-146 (42 U.S.C. 300f-71). Within the HRSA, Ryan White 
Title IV projects are administered by the Maternal and Child Health 
Bureau (MCHB).
    The PHS is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a PHS national activity 
for setting

[[Page 5013]]

priority areas. Title IV directly addresses the Healthy People 2000 
objectives related to the priority area of HIV infection. Potential 
applicants may obtain a copy of Healthy People 2000 (Full Report; Stock 
Number 017-001-0474-0) or Healthy People 2000 (Summary Report: Stock 
No. 017-001-00473-1) through the Superintendent of Documents, 
Government Printing Office, Washington, DC 20402-9325 (telephone 202-
512-1800).
    The PHS strongly encourages all grant recipients to provide a 
smoke-free workplace and to promote the non-use of all tobacco 
products. In addition, Public Law 103-227, the Pro-Children Act of 
1994, prohibits smoking in certain facilities (or in some cases any 
portion of a facility) in which regular routine education, library, day 
care, child care or early development services are provided to 
children.

ADDRESSES: Federal Register notices and application guidance for MCHB 
programs are available on the World Wide Web via the Internet at 
address: http://www.os.dhhs.gov/hrsa/mchb. Click on the file name you 
want to download to your computer. It will be saved as a self-
extracting (Macintosh or) WordPerfect 5.1 file. To decompress the file 
once it is downloaded, type in the file name followed by a . 
The file will expand to a WordPerfect 5.1 file.
    For applicants for Ryan White Title IV Grants who are unable to 
access application materials electronically, a hard copy (Revised PHS 
form 5161-1, approved under OMB clearance number 0937-0189) may be 
obtained from the HRSA Grants Application Center. The Center may be 
contacted at: Telephone Number: 1-888-300-HRSA, FAX Number: 301-309-
0579, E-mail Address: [email protected]. Completed applications 
should be returned to: Grants Management Officer (CFDA #93.153), HRSA 
Grants Application Center, 40 West Gude Drive, Suite 100, Rockville, 
Maryland 20850.

DATES: The application deadline date for Ryan White Title IV grants is 
April 18, 1997. Competing applications will be considered to be on time 
if they are:
    (1) Received on or before the deadline date, or
    (2) Postmarked on or before the deadline date and received in time 
for orderly processing.
    As proof of timely mailing, applicants should obtain a legibly 
dated receipt from the commercial carrier or the U.S. Postal Service; 
private metered postmarks will not be accepted as proof of timely 
mailing. Late applications not accepted for processing will be returned 
to the applicant.

FOR FURTHER INFORMATION CONTACT: Additional information regarding 
technical and program issues may be obtained from: Marilyn J. Vranas, 
Project Officer, Division of Services for Children with Special Health 
Care Needs, Maternal and Child Health Bureau, Health Resources and 
Services Administration, Room 18-A-19, Parklawn Building, 5600 Fishers 
Lane, Rockville, Maryland 20857, telephone 301-443-9051. Requests for 
information concerning administration and business management issues 
should be directed to: Sandra Perry, Chief, Grants Management Branch, 
Maternal and Child Health Bureau, 5600 Fishers Lane, Room 18-12, 
Rockville, Maryland, 20857, telephone 301-443-1440.

SUPPLEMENTARY INFORMATION:

Program Background and Objectives

    The Pediatric AIDS Program was initiated in 1988. The program grew 
from 13 projects funded at $4.4 million to a total of 51 projects 
funded at $27.4 million in FY 1995. Since 1988, the program has evolved 
from a primary focus on the coordination of services for the management 
and care of infected children and their families to also address the 
broader prevention and care needs of youth and women infected/affected 
by HIV. In FY 1994, Congress funded the Pediatric AIDS Program under 
section 2671, Title IV of the Ryan White Comprehensive AIDS Resources 
Emergency (CARE) Act 1990, Public Law 101-381 (Title IV). As a 
consequence of authorization under Title IV, the focus of the program 
was expanded to include the development of innovative models linking 
clinical trials offered by the National Institutes of Health (NIH) and 
other research entities, with systems of comprehensive primary/
community-based medical and social services.
    In 1994, published results from a NIH clinical trial (ACTG 076) 
demonstrated the potential for reducing perinatal HIV transmission by 
two-thirds when pregnant women and their newborns were given zidovidine 
(ZDV). The ZDV therapy regimen has been published in the Centers for 
Disease Control's Morbidity and Mortality Weekly Report (MMWR 
1994:43(RR-11)).
    In 1995, the CDC issued recommendations for enhanced voluntary HIV 
counseling and testing for women of child bearing age, and the HRSA 
issued an Advisory: The Use of Zidovidine (ZDV) to Reduce Perinatal HIV 
Transmission in HRSA-Funded Programs. This advisory contains practical, 
specific steps for implementing PHS recommendations for offering ZDV to 
pregnant women. A copy of this advisory will be included in the 
application kit. All Title IV grantees are expected to implement the 
ZDV recommendations.
    The 1996 amendments to the Ryan White CARE Act impose new 
requirements on the services to be provided or arranged by the 
applicant, require coordination with other providers of health care 
services under the Ryan White Care Act and Title V of the Social 
Security Act, enhance opportunities for and participation in clinical 
and other research by Title IV clients, specify arrangements that must 
exist between Title IV programs and research entities, and enhance 
opportunities for Title IV clients to participate in clinical research. 
The law requires new grantees to enroll a significant number of clients 
in clinical trials or other research by the end of the second grant 
year.
    The amended Ryan White law does not define the term ``significant 
participation''. Nor does it define the type of research in which 
patients are to participate; it specifies only ``research for the 
prevention and treatment of HIV disease''. The law mandates the 
Secretary to establish a group composed of providers, consumers and 
researchers to recommend priority research protocols to be put on a 
list. Given that these two key legislative terms will not be defined 
prior to the application due date, we will not use significant 
participation in research protocols as an evaluation criterion in the 
review of applications for new FY 1997 grants. Rather, new applicants 
will be expected to have demonstrable research linkages or credible 
plans to link services to research; offer clients research 
opportunities; and support client participation in research through 
case management, transportation, and other required services. See 
REVIEW CRITERIA for the list of evaluation criteria.

Eligible Applicants

    Ryan White Title IV grants may be made only to public and nonprofit 
private entities that provide primary care, directly or through 
contracts.

Funding Categories

    For FY 1997, there will be a single funding category for 
competition: Grants for coordinated HIV services and access to research 
for children, youth, women, and families. Applications which do not 
fall within this category will not be considered for funding. Up to 23 
grants,

[[Page 5014]]

at an estimated $15.5 million will be awarded. The project period is 3 
years.
    These grants will develop and support innovative projects that 
foster collaboration between clinical research institutions and family-
centered, primary/community-based medical and social service programs, 
and that coordinate systems of comprehensive HIV care for children, 
youth, women and their families. Projects are expected to focus on 
local capacity-building, making maximum use of all available public and 
private resources, and to strengthen existing comprehensive care 
infrastructures.
    Activities under these grants should address the goals of:

--Increasing client access by linking HIV/AIDS clinical research trials 
and activities with comprehensive care; and
--Fostering the development and support of comprehensive, culturally 
competent, community-based and family-centered care infrastructures; 
and emphasizing prevention within the care system.

    Preference for funding in Category (1) will be given to projects 
that have:

--Established and currently support a comprehensive, coordinated, 
system of HIV care serving either children, youth, women, or families; 
and
--Linked with, or initiated activities to link with, clinical trials or 
other research.

    This means that these projects will be funded ahead of new groups 
of applications in this category.
    Special consideration for funding may be given to projects which 
help to achieve an equitable geographical distribution of projects 
across all States and territories. This means that the score of an 
individual project may be favorably adjusted if it addresses this 
objective.

Special Concerns

    Grantees supported by Title IV of the Ryan White CARE Act should 
coordinate their projects with other Federal, State, and local programs 
concerned with HIV and/or serving the target population of children, 
youth, women and families affected by or at risk for HIV, particularly: 
Title V Maternal and Child Health programs; Ryan White Titles I, II and 
III(b) programs; providers funded by the Substance Abuse and Mental 
Health Services Administration; the Health Resources and Services 
Administration; the Centers for Disease Control and Prevention efforts; 
and clinical trials funded by NIH or other sources.
    HRSA's Maternal and Child Health Bureau places special emphasis on 
improving service delivery to women, children and youth from 
communities with limited access to comprehensive care. In order to 
assure access and cultural competence, it is expected that projects 
will involve individuals from the populations to be served in the 
planning and implementation of the project. The Bureau's intent is to 
ensure that project interventions are responsive to the cultural and 
linguistic needs of special populations, that services are accessible 
to consumers, and that the broadest possible representation of 
culturally distinct and historically underrepresented groups is 
supported through programs and projects sponsored by the MCHB.
    In keeping with the goals of advancing the development of human 
potential, strengthening the Nation's capacity to provide high quality 
education by broadening participation in MCHB programs of institutions 
that may have perspectives uniquely reflecting the Nation's cultural 
and linguistic diversity, and increasing opportunities for all 
Americans to participate in and benefit from Federal public health 
programs, HRSA will place a funding priority on projects from 
Historically Black Colleges and Universities (HBCU) or Hispanic Serving 
Institutions (HSI) in all categories and subcategories in this notice 
for which applications from academic institutions are encouraged. This 
is in conformity with the Federal Government's policies in support of 
White House Initiatives on Historically Black Colleges and Universities 
(Executive Order 12876) and Educational Excellence for Hispanic 
Americans (Executive Order 12900). An approved proposal from a HBCU or 
HSI will receive a 0.5 point favorable adjustment of the priority score 
in a 4 point range before funding decisions are made.

Review Criteria

    Applications will be reviewed with particular attention to 
inclusion of women and persons from culturally distinct populations. 
Funding will be provided to those which, in the Department's view, best 
meet the statutory purposes of the Ryan White Title IV program and 
address achievement of the Healthy People 2000 objectives related to 
HIV infection.
    Applications for grants will be reviewed and rated by objective 
review panels according the following weighted criteria:

--Documentation of the HIV medical and social support service needs of 
children, youth, women and families (weight 15%);
--Demonstration of capacity to coordinate and support a comprehensive 
system of HIV care for this population (weight 20%);
--Demonstrated capacity to enhance client access to clinical trials or 
other research and/or to establish linkages with providers offering 
clinical trials or other research (weight 20%);
--The degree to which the Title IV's program priority of consumer 
involvement has been implemented (weight 10%);
--The degree to which the proposed plan: Addresses the issues 
identified in response to the first criterion on this list; reflects 
the legislative and programmatic priorities of the Title IV program 
(access to clinical trials, reduction of perinatal HIV transmission and 
consumer involvement); contains goals and objectives that are clear, 
measurable, time framed and address identified needs; and presents an 
evaluation strategy capable of documenting the achievement of project 
goals (weight 25%); and
--The degree to which the proposed budget clearly supports 
administrative and programmatic activities necessary to manage the 
program and accomplish proposed goals and activities. (weight 10%)

    Review criteria will be described in further detail in the 
application guidance.

Allowable Costs

    The HRSA may support reasonable and necessary costs of HIV Project 
grants within the scope of approved projects. Allowable costs may 
include salaries, equipment and supplies, travel, contractual 
arrangements, consultants, and others, as well as indirect costs. The 
HRSA adheres to administrative standards reflected in the Code of 
Federal Regulations (45 CFR part 92 and 45 CFR part 74). All other 
sources of funding to support this project must be accurately reflected 
in the applicant's budget.

Reporting Requirements

    A successful applicant under this notice will submit reports in 
accordance with the provisions of the general regulations which apply 
under 45 CFR part 74, subpart J, Monitoring and Reporting of Program 
Performance, with the exception of State and local governments to which 
45 CFR 92.40 will apply. Financial reporting will be required in 
accordance with 45 CFR part 74, subpart I, with the exception of State

[[Page 5015]]

and local governments, to which 45 CFR part 92, subpart C will apply.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements (approved under OMB No. 0937-0195). Under these 
requirements, the community-based nongovernmental applicant must 
prepare and submit a Public Health System Impact Statement (PHSIS). The 
PHSIS is intended to provide information to State and local health 
officials to keep them apprised of proposed health services grant 
applications submitted by community-based nongovernmental organizations 
within their jurisdictions.
    Community-based nongovernmental applicants are required to submit 
the following information to the head of the appropriate State and 
local health agencies in the area(s) to be impacted no later than the 
Federal application receipt due date:
    (a) A copy of the face page of the application (SF 5161).
    (b) A summary of the project (PHSIS), not to exceed one page, which 
provides:
    (1) A description of the population to be served.
    (2) A summary of the services to be provided.
    (3) A description of the coordination planned with the appropriate 
State and local health agencies.
    The project abstract may be used in lieu of the one-page PHSIS, if 
the applicant is required to submit a PHSIS.

Executive Order 12372

    The Title IV Program has been determined to be subject to the 
provisions of Executive Order 12372 concerning intergovernmental review 
of Federal programs by appropriate health planning agencies, as 
implemented by 45 CFR part 100. Executive Order 12372 allows States the 
option of setting up a system for reviewing applications from within 
their States for assistance under certain Federal programs. The 
application packages to be made available under this notice (Form PHS 
5161-1 with revised face sheet HHS Form 424 and with Program Narrative 
and Checklist approved under OMB 0937-0189) will contain a listing of 
States which have chosen to set up such a review system and will 
provide a single point of contact (SPOC) in the States for review. 
Applicants (other than federally-recognized Indian tribal governments) 
should contact their State SPOCs as early as possible to alert them to 
the prospective applications and receive any necessary instructions on 
the State process. For proposed projects serving more than one State, 
the applicant is advised to contact the SPOC of each affected State. 
The due date for State process recommendations is 60 days after the 
application deadline for new and competing awards. The granting agency 
does not guarantee to ``accommodate or explain'' State process 
recommendations it receives after that date. (See part 148, 
Intergovernmental Review of PHS Programs under Executive Order 12372 
and 45 CFR part 100 for a description of the review process and 
requirements.)

(The OMB Catalog of Federal Domestic Assistance number for the HIV 
Program for Children, Youth, Women, and Families is 93.153.)

    Dated: January 27, 1997.
Ciro V. Sumaya,
Administrator.
[FR Doc. 97-2374 Filed 1-31-97; 8:45 am]
BILLING CODE 4160-15-P