[Federal Register Volume 61, Number 46 (Thursday, March 7, 1996)]
[Notices]
[Pages 9186-9189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5361]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Special Projects of National Significance; Health Care Services 
Demonstration Models for Youth Infected With HIV

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of availability of funds.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
announces the availability of $1,900,000 in fiscal year (FY) 1996 funds 
to be awarded under the Special Projects of National Significance 
(SPNS) program. HRSA expects to award three to five grants for 
approximately $380,000 - $633,000 each for a three year project period 
for Health Care Services Demonstration Models for Youth Infected with 
HIV. The SPNS program is authorized by Section 2618 (a) of the Public 
Health Service Act. This announcement solicits innovative services 
demonstration models of providing health and related support services 
for youth with HIV infection.

[[Page 9187]]

An HIV Evaluation Technical Assistance Center and SPNS Models of 
Integrated Service Delivery for Persons with HIV Disease are being 
solicited under separate announcements. The HIV Evaluation Technical 
Assistance Center will provide technical assistance to SPNS grantees in 
the design and implementation of evaluation studies and dissemination 
activities for individual projects and develop and coordinate the 
implementation of any multi-site evaluations.
    Eligible projects include those serving pediatric and adolescent 
populations from 0-20 years of age. Care should include age-appropriate 
services for HIV testing and counseling. Models of care which target 
hard-to-reach youth, such as those who are/were clients of the criminal 
justice system, drug users, homeless or runaway youth, pregnant 
teenagers, are encouraged. Projects directed towards perinatally HIV 
infected youth and older children who face the psychosocial changes of 
adolescence also are encouraged.
    Service models created or expanded through the projects should 
incorporate innovative health, nursing, and ancillary care services 
(such as mental health and substance abuse treatment) to improve 
participation by youth in HIV counseling and testing, diagnosis, 
prophylaxis, and treatment of manifestations and complications of HIV 
infection and AIDS, including: a) antiretroviral therapy to children 
and youth, and b) prophylactic therapy for opportunistic infections for 
children and youth, including tuberculosis. Models of care should 
determine: the spectrum of HIV disease among treated and untreated 
children/adolescents (upon entry into care), the progression of HIV 
disease among children/adolescents, physical growth and development, 
adherence to antiretroviral treatment and PCP prophylaxis, and the 
impact of the model of care upon these parameters longitudinally. By 
definition, these service models will go beyond the service 
configurations currently funded by Title IV or other Titles of the Ryan 
White CARE Act.
    The SPNS program is designed to demonstrate and evaluate innovative 
and replicable HIV service delivery models. The authorizing legislation 
specifies three SPNS program objectives: (1) to support the development 
of innovative models of HIV care; (2) to evaluate the effectiveness of 
innovative program designs; and (3) to promote replication of effective 
models. Therefore, crucial factors in appraising proposals for the 
health care services demonstration models will include, among other 
factors, the degree to which the applicant's plan for conducting an 
evaluation of the model includes: (1) client health outcomes, such as 
stabilization of CD4 counts, adherence to antiretroviral therapy and 
PCP prophylaxis, delaying the progression to AIDS, and quality of life; 
(2) systems outcomes, such as regular/routine provision of HIV 
counseling and testing services to youth at risk, documentation of 
maintenance in primary care, adherence to published disease treatment 
and prophylaxis guidelines (including PHS recommendations for treatment 
of HIV infected pregnant women and youth with zidovudine to reduce 
perinatal HIV transmission), and avoidance of inappropriate inpatient 
hospital and emergency room care through innovative service strategies; 
(3) the applicant's evidence of ability to incorporate experienced 
evaluators and medical providers with HIV/AIDS expertise into the 
project or the applicant's history of successfully conducting process 
and outcomes evaluation activities; (4) the program's potential to 
improve access to and coordination of high quality HIV service 
delivery; and (5) a plan for disseminating findings about the model's 
effectiveness.

DATES: Letter of Intent: To allow HRSA to plan for the Objective Review 
Process, all applicants are encouraged to contact the grants office in 
writing to Ms. Glenna Wilcom, Grants Management Branch, Bureau of 
Health Resources Development, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 7-15, Rockville, MD 20857. If 
notification is offered, it should be received within 30 days after the 
publication of the Notice of Availability of Funds in the Federal 
Register.
    Applications: Applications must be received in the Grants 
Management Office by the close of business May 6, 1996 to be considered 
for competition. Applications will meet 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 panel. A legibly dated receipt from a commercial 
carrier or U.S. Postal Service will be accepted instead of a postmark. 
Private metered postmarks shall not be accepted as proof of timely 
mailing. Applications received after the deadline will be returned.

ADDRESSES: Grant applications, guidance materials, and additional 
information regarding business, administrative, and fiscal issues 
related to the awarding of grants under this Notice may be requested 
from Ms. Glenna Wilcom, Grants Management Officer, Bureau of Health 
Resources Development, Health Resources and Services Administration, 
5600 Fishers Lane, Room 7-15, Rockville, MD 20857. The telephone number 
is (301) 443-2280 and the FAX number is (301) 594-6096. Applicants for 
grants will use Form PHS 5161-1, approved under OMB Control No. 0937-
0189. Mail completed applications to the Grants Management Officer.

FOR FURTHER INFORMATION CONTACT: Additional technical information may 
be obtained from Evelyn M. Rodriguez M.D., M.P.H., Office of the 
Director, Bureau of Health Resources Development, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 7-13, Rockville, MD 
20857. The telephone number is (301) 443-9530 and the FAX number is 
(301) 443-9645. Questions concerning the HIV Evaluation Technical 
Assistance Center and the Models of Integrated Service Delivery for 
Persons with HIV Disease may be directed to the SPNS Branch, Office of 
Science and Epidemiology, Bureau of Health Resources Development, 
Health Resources and Services Administration, 5600 Fishers Lane, Room 
7A-07, Rockville, MD 20857. The telephone number is (301) 443-9976 and 
the FAX number is (301) 594-2511.

Healthy People 2000 Objectives

    The Public Health Service urges applicants to address a specific 
objective of the Healthy People 2000 in their work plans. Potential 
applicants may obtain a copy of Healthy People 2000 (Full Report; Stock 
No. 017-001-00473-0) 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).

SUPPLEMENTARY INFORMATION:

Background and Objectives

    The SPNS program endeavors to advance knowledge and skills in HIV 
service delivery, to stimulate the design of innovative models of care, 
and to support the development of effective delivery systems for these 
services. SPNS accomplishes its purpose through funding, technical 
support and evaluation of innovative HIV service delivery models. This 
announcement seeks applications for a program ``Health Care Services 
Demonstration Models for Youth Infected with HIV.'' For the purposes of 
this announcement,

[[Page 9188]]

projects seeking SPNS support must propose models of care that address 
innovative medical, nursing, and ancillary care services (such as 
mental health and substance abuse treatment).
    A ``health care services demonstration model'' refers to a 
mechanism and method for provision of health services. For example, 
antiretroviral therapy is not a model; however, a method for improving 
access to or utilization of antiretroviral therapy is an appropriate 
model for consideration under this amendment. SPNS funds may be used to 
establish or to augment models of care and to evaluate the effects of 
establishing or augmenting that model.
    The SPNS program encourages innovative projects to rigorously 
evaluate implementation, utilization, costs, and process and health 
outcomes. Therefore, the program has not narrowly defined the nature of 
appropriate applications beyond that stated above. Proposed process and 
outcomes evaluation designs by demonstration services grantees will 
form the basis for the cross-site evaluation. SPNS funds should be used 
to create models of care that would likely not exist without SPNS 
support, or would extend the care model to previously unserved 
populations defined either geographically or demographically. Services 
provided through SPNS funding currently should not be reimbursed or 
eligible for current reimbursement through other sources, including 
Medicaid, third party payers, or other Ryan White programs. A model may 
deliver services or products that are reimbursable, but the services 
supported by SPNS should not be.

Review Criteria

A. Health Care Services Demonstration Models for Youth Infected With 
HIV

    All applications submitted to the SPNS program will be reviewed and 
rated by an objective review panel. The application narrative may total 
no more than 40 single spaced pages.
    Factors for the technical review of applications are as follows:
    Factor 1 (15 points) Adequacy of justification of need within the 
community and target population for the proposed program. This 
justification of need should go beyond documenting the existence of an 
available population that needs HIV services; rather, it should justify 
the need for the particular model being proposed and the need for its 
evaluation.
    Factor 2 (10 points) Adequacy of the identification of past/
existing/future systematic or programmatic barriers that prevent the 
provision of comprehensive care to hard-to-reach children/adolescents 
with HIV with suggested or actual strategies for overcoming or 
compensating for these barriers.
    Factor 3 (10 points) The degree to which there is evidence of 
substantial collaboration between community based providers of non-
medical services for youth and a board certified pediatric or 
adolescent health care provider(s) with extensive HIV/AIDS clinical and 
research expertise; the likelihood of the project's significantly 
contributing to HIV care and the contribution to knowledge of HIV 
related health outcomes among children/adolescents; and the 
comprehensiveness of the program plan.
    Factor 4 (20 points) Thoroughness, feasibility and appropriateness 
of the project's evaluation design from a methodological and 
statistical perspective. Process evaluation should allow identification 
of what worked in the health care demonstration services model and why. 
The design of the evaluation should allow a generalizable conclusion to 
be reached regarding the health outcomes of the model and its 
suitability for replication. Adequacy of computer hardware, software, 
and personnel to carry out data activities needed to evaluate the 
proposed project.
    Factor 5 (15 points) The feasibility, clarity of the description, 
appropriateness, innovative quality, and potential for replication and 
plans for dissemination of the proposed model.
    Factor 6 (10 points) Adequacy of the director's documentation of a 
successful history of completing HIV medical or health service related 
studies, or community-based process and outcomes evaluation studies. 
History of dissemination of the results of those studies through peer 
reviewed, professional publications and through presentations at 
scientific conferences.
    Factor 7 (10 points) Competency of the applicant organization in 
fiscal and program management as evidenced by (a) the consistency 
between the proposed level of effort and the budget justification; (b) 
skill level and time commitment required in the personnel 
specifications; (c) the level of resources and evaluation staff being 
proposed to conduct a quality evaluation of the project; (d) an 
organizational structure conducive to evaluation and health outcomes 
studies, and (e) appropriate confidential handling of medical, social 
service, and epidemiological data.
    Factor 8 (10 points) Extent of documentation of coordination and 
formal collaboration and specific linkages with related HIV activities, 
including other Ryan White activities, within the project's catchment 
area.

Availability of Funds

    The SPNS program is authorized by Section 2618(a) of the Public 
Health Service (PHS) Act. Grants may be awarded directly to public and 
non-profit private entities to promote the statute's objectives. For 
this initiative, the program has $1.9 million dollars available, and it 
is expected that approximately three to five awards for demonstration 
programs will be made with an average annual budget of about $126,000 
to $211,000. The budget and project periods for approved and funded 
projects will begin on or about July 1, 1996. Project periods must be 
requested for three years. Applicants are required to submit, in the 
initial application, budgets for each proposed project year.
    All grants funded should recognize that this initiative is not 
designed to provide continuous support once the SPNS demonstration 
project is complete and evaluated. Demonstration programs are strongly 
encouraged to secure non-SPNS funding support during their projects if 
the evaluation suggests that the model is effective and merits 
continuation.

Eligible Applicants

    The statute, Section 2618(a)(1), specifies that grants may be 
awarded to public and non-profit private entities to fund special 
programs for the care and treatment of people with HIV disease. 
Eligible applicants should have experience in serving youth, actively 
encourage youth at risk to know their HIV serostatus, and provide or 
refer youth for HIV counseling and testing. The project director or co-
project director of the demonstration projects must be a medical 
provider with experience in HIV/AIDS. Eligible entities for the 
demonstration services models may include, but are not limited to, 
State, local, or tribal public health, mental health, or substance 
abuse departments; public or non-profit hospitals; community-based 
service organizations (e.g., AIDS service organizations, primary health 
care clinics, family planning centers, organizations serving the 
homeless or runaway youth, family planning centers, community mental 
health centers, substance abuse treatment centers, urban Indian health 
centers, migrant health centers, organizations receiving funds from 
Ryan White CARE Act Title I, II, IIIb and IV clinics, etc.); 
institutions of higher education; non-profit research organizations; 
national associations; and policy development organizations.

[[Page 9189]]

Allowable Costs

    The basis for determining allocable and allowable costs to be 
charged to PHS grants is set forth in 45 CFR Part 74, Subpart Q and 45 
CFR Part 92 for State, local or tribal governments. The four separate 
sets of cost principles prescribed for public and private non-profit 
recipients are: OMB Circular A-87 for State, local or tribal 
governments; OMB Circular A-21 for institutions of higher education; 45 
CFR Part 74, Appendix E for hospitals; and OMB Circular A-122 for non-
profit organizations.

Reporting and Other Requirements

    A successful applicant under this notice will submit an annual 
activity summary report in accordance with 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, Subpart C reporting 
requirements apply. The applicant must be prepared to collaborate with 
other funded projects working with similar populations in developing an 
evaluation strategy.

Federal Smoke-Free Compliance

    The Public Health Service strongly encourages all grant and 
contract 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 or 
routine education, library, day care, health care or early childhood 
development services are provided to children.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements which have been approved by the Office of Management and 
Budget under No. 0937-0195. Under these requirements, any community-
based, non-governmental applicant must prepare and submit a Public 
Health System Impact Statement (PHSIS). The PHSIS is intended to keep 
State and local health officials apprised of proposed health services 
grant applications submitted from within their jurisdictions.
    All applicants are required to submit, no later than the Federal 
due date for receipt of the application, the following information to 
the administrator of the State and local health agencies and to the 
State and local AIDS program director in the area(s) to be impacted by 
the proposal: (1) a copy of the face page of the application (SF 424); 
and, (2) a summary of the project, not to exceed one page, which 
provides: (a) a description of the population to be served; (b) a 
summary of the services to be provided; and, (c) a description of the 
coordination planned with the appropriate State or local health 
agencies. Copies of the letters forwarding the PHSIS to these 
authorities must be contained in the application materials submitted to 
this program.

Executive Order 12372

    The Special Projects of National Significance Grant Program has 
been determined to be a program subject to the provisions of Executive 
Order 12372, concerning intergovernmental review of Federal Programs, 
as implemented by 45 CFR Part 100. Under urgent conditions, the 
Secretary may waive any provision of this regulation. (See 45 CFR Part 
100.13.) The Secretary has waived 45 CFR Part 100 due to the compelling 
need to get funds to grantees.

    The OMB Catalog of Federal Domestic Assistance number for the 
Special Projects of National Significance is 93.928.

    Dated: February 29, 1996.
Ciro V. Sumaya,
Administrator.
[FR Doc. 96-5361 Filed 3-6-96; 8:45 am]
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