[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
[Notices]
[Pages 8962-8965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5209]



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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), PHS.

ACTION: Notice of availability of funds.

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SUMMARY: The HRSA announces that applications will be accepted for 
fiscal year (FY) 1996 funds for grants for projects 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). Projects will be funded to implement 
programs of family-centered, community-based coordinated care and 
research for children, youth, women, and families infected/affected by 
HIV, or those at risk for developing infection. These projects are 
authorized under, and expected to meet provisions contained within, 
Section 2671 of the Public Health Service Act [as enacted by Title IV, 
of the Ryan White Comprehensive AIDS Resource Emergency (CARE) Act of 
1990, Public Law 101-381 (42 U.S.C. 300ff-11 et seq.)]. Within the 
HRSA, Ryan White Title IV projects are administered by the Maternal and 
Child Health Bureau (MCHB).
    This program announcement is subject to the appropriation of funds. 
Applicants are advised that this program announcement is a contingency 
action being taken to assure that should funds become available for 
this purpose, they can be awarded in a timely fashion consistent with 
the needs of the program as well as to provide for even distribution of 
funds throughout the fiscal year. At this time, given a continuing 
resolution and the absence of FY 1996 appropriations for the EMSC 
program, the amount of available funding for this specific grant 
program cannot be estimated. In addition, reauthorization of the Ryan 
White CARE Act, currently pending in Congress, could add new Title IV 
grant requirements in addition to those included in this notice.
    The PHS is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a PHS national activity 
for setting 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 202 783-3238).
    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: Grant applications for the Ryan White Title IV Program (PHS 
form #5161-1, approved under OMB #0937-0189) must be obtained from and 
submitted to: Mona D. Thompson, Grants Management Branch, Office of 
Program Support, Maternal and Child Health Bureau, HRSA, Room 18-12, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, (301) 
443-3429. You must obtain application materials in the mail.
    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. If you have difficulty accessing the MCHB Home 
Page via the Internet and need technical assistance, please contact 
Linda L. Schneider at 301-443-0767 or ``[email protected]''.

DATES: The application deadline date is April 19, 1996. 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 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 or those sent to an 
address other than specified in the ADDRESSES section will be returned 
to the applicant.

FOR FURTHER INFORMATION CONTACT:
Additional information regarding technical and program issues may be 
obtained from: the Division of Services for Children with Special 
Health Needs, Maternal and Child Health Bureau, Health Resources and 
Services Administration, Room 18A-19, Parklawn Building, 5600 Fishers 
Lane, Rockville, Maryland 20857, Telephone (301) 443-9051. Requests for 
information concerning business management issues should be directed 
to: Sandra Perry, Acting Grants Management Officer (GMO), Maternal and 
Child Health Bureau, at the address specified in the ADDRESSES section.

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 59 projects 
funded at $25.4 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 result 
of 

[[Page 8963]]
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).
    Over the past year, the CDC has 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 U.S. Public Health 
Services recommendations for offering zidovidine (ZDV) to pregnant 
women. A copy of this advisory will be mailed to all Title IV 
applicants with the application guidance. Applicants are expected to 
review this advisory and describe how they will implement these 
recommendations in their application.
    Reauthorization of the Ryan White CARE Act is pending in Congress. 
The final version of the Act, which will include Title IV, is expected 
to contain new requirements concerning arrangements between Title IV 
programs and research entities and enhancement of opportunities for 
Title IV Clients to participate in clinical research. Reauthorization 
of the Ryan White CARE Act could result in incorporation of additional 
requirements for Title IV grants in the applications guidance for these 
projects.

Purpose

    The purpose of Title IV funding is to link clinical research and 
other research activities with comprehensive care systems, and to 
improve and expand the coordination of a system of comprehensive care 
for children, youth, women, and families who are infected/affected by 
HIV. Funds will be used to support programs that: (1) cross established 
systems of care to coordinate service delivery, HIV prevention efforts, 
and clinical research and other research activities; and (2) address 
the barriers to comprehensive care and research experienced by 
children, youth, women, and families infected/affected by HIV.
    While children, youth, and women represent the most recently 
impacted and rapidly growing population groups affected by HIV, they 
also represent the groups facing the greatest barriers in accessing 
care and research. These groups are disproportionately members of 
communities of color with limited economic resources. Given these 
realities, children, youth, and women affected by HIV are confronted 
with a complex array of economic and social issues that increase their 
need for comprehensive services and increase the cost and intensity of 
care. Existing systems of care are often not prepared to respond to 
these needs and require targeted resources and interventions in order 
to develop infrastructures and provider capacities that would allow 
them to provide quality care to these populations.
    Given these unmet needs, activities under these grants should 
address the following goals:

--Link HIV/AIDS clinical research trials and other research activities 
with comprehensive systems of care, resulting in increased access for 
children, youth, women, and their families.
--Foster the development and support of comprehensive care 
infrastructures, including primary care, that increase access to 
culturally-competent, family-centered, community-based, coordinated 
care.
--Emphasize prevention within the comprehensive care system in order to 
reduce the spread of the HIV infection to vulnerable populations.

Funding Category

    Applications which do not fall within this program category will 
not be considered for funding.
    The Ryan White Title IV Program for Children, Youth, Women, and 
Families develops and supports 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 will focus on local capacity-
building, making maximum use of all available public and private 
resources for reaching and providing health care and supportive 
services to the target population. Projects should strengthen existing 
comprehensive care infrastructures by: (1) broadening the coalition of 
agencies, providers, community organizations and consumers that 
participate in the identification of needs, services planning, the 
coordination and delivery of services, and the financing of services 
for HIV affected populations; and (2) identifying and addressing 
systemic issues that affect provider collaboration and impact the 
provision of coordinated high quality comprehensive care.
    Preference for funding in this category will be given to projects 
that have: (1) established and currently support a comprehensive, 
coordinated, system of HIV care serving either children, youth, women, 
or families; and (2) 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 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 ad 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 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 

[[Page 8964]]
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.
    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 Health People 2000 objectives related to HIV 
infection.

Review Criteria

    Applications for grant categories will be reviewed and rated by 
objective review panels according to the following weighted criteria:
    1. Documentation of the HIV medical and social support service 
needs of children, youth, women and families. Weight: 15 percent.
    2. Demonstration of capacity to coordinate and support a 
comprehensive system of HIV care for children, youth, women and 
families. Weight: 25 percent.
    3. Demonstrated capacity to provide clinical trials or to establish 
linkages with providers offering clinical trials, or other research.
Weight: 15 percent.
    4. The degree to which the Title IV's program priority of consumer 
involvement has been implemented. Weight: 10 percent.
    5. The degree to which the proposed plan:
     Addresses the issues identified in response to Review 
Criteria I;
     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, 
and time framed; and
     Presents an evaluation strategy capable of documenting the 
achievement of project goals. Weight: 25 percent.
    6. 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 
percent.

Eligible Applicants

    Grants may be awarded to public or nonprofit private entities that 
provide or arrange for primary health care. Eligible entities may 
include, but are not limited to, State or local health departments, 
university medical centers, public or nonprofit private hospitals, 
community health centers (as defined in section 330(a) of the Act), 
hemophilia treatment centers, drug abuse treatment agencies, tribal 
health programs, school based clinics and institutions of higher 
education.
    If any additional eligibility requirements are established in a 
reauthorized Ryan White CARE Act, they will be clearly identified 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 Part 92.40 will apply. Financial reporting will be required in 
accordance with 45 CFR Part 74, Subpart I, with the exception of State 
and local governments, to which 45 CFR 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 

[[Page 8965]]
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: February 29, 1996.
Ciro V. Sumaya,
Administrator.
[FR Doc. 96-5209 Filed 3-5-96; 8:45 am]
BILLING CODE 4160-15-M