Special Projects of National Significance

Federal RegisterJun 10, 1994

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[PN 2243]

RIN 0905-ZA 63

Special Projects of National Significance

AGENCY: Health Resources and Services Administration.

ACTION: Notice of availability of funds.

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SUMMARY: The Health Resources and Services Administration (HRSA)

announces the availability of up to $10.5 million in fiscal year (FY)

1994 funds to be awarded as cooperative agreements under the Special

Projects of National Significance (SPNS) program. The SPNS program,

authorized by section 2618(a) of the Public Health Service Act,

receives its appropriation of funds through Public Law 103-112. Project

periods can be from three to five years, subject to Congressional

reauthorization in FY 1996 of the Ryan White CARE Act. This

announcement solicits two types of applications: (1) HIV service

delivery model demonstration projects, or (2) HIV service delivery

model demonstration projects in conjunction with an evaluation and

dissemination center. The SPNS program, in collaboration with the

evaluation and dissemination center(s), will sponsor multi-site program

evaluation studies. All HIV service delivery model demonstration

projects agree, as a condition of grant award, to participate in these

studies. Awards will be made to achieve population and geographic

diversity.

The SPNS program is designed to demonstrate and evaluate innovative

and potentially 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 HIV service delivery model demonstration

projects will include the applicant's plan for conducting an evaluation

of the model, the program's potential to improve access to,

coordination of, and quality of, HIV service delivery, and a plan for

disseminating findings about the model's effectiveness.

Because of the complexity of this program, a cooperative agreement

mechanism is being utilized to allow for substantial Federal

programmatic participation in the conduct of the program, and to

facilitate communication and coordination in the overall implementation

and evaluation of the program. A steering committee will be established

to facilitate coordination and cooperation among the service

demonstration projects and the evaluation and dissemination center(s),

and to oversee the cooperative agreements.

DATES: Applications for these announced cooperative agreements must be

received in the Grants Management Office by the close of business July

20, 1994, to be considered for competition. An advance notice of the

application deadline date for the Special Projects of National

Significance for FY 1994 was published in the Federal Register on April

26, 1994 at 59 FR 21769. 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 in lieu 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. Completed applications should be sent to the Grants Management

Officer.

FOR FURTHER INFORMATION CONTACT: Additional technical information may

be obtained from Mr. George Sonsel or Mr. Russell Brady, SPNS Branch,

Office of Science and Epidemiology, Bureau of Health Resources

Development, Health Resources and Services Administration, 5600 Fishers

Lane, room 7A-19, Rockville, MD 20857. The telephone number is (301)

443-9976 and the FAX number is (301) 594-2511.

SUPPLEMENTARY INFORMATION:

Background and Objectives

The SPNS program endeavors to advance knowledge and skills in HIV

service delivery, stimulate the design of innovative models of care,

and support the development of effective delivery systems for these

services. SPNS accomplishes its purpose through funding and technical

support of innovative HIV service delivery models. For purposes of this

announcement, models seeking SPNS support must address at least one of

the four (4) new service delivery system categories described below.

Additional funding will be provided to one or more interested grantees

to establish, either on site or by subcontract, evaluation and

dissemination center(s) to provide technical assistance to grantees in

the design and implementation of evaluation studies and dissemination

activities, in collaboration with the SPNS program and the funded

applicants.

In establishing the current special project categories,

consideration was given to the priority service areas identified in the

concept paper, ``Future Directions: Increasing Knowledge about Health

and Support Service Delivery to People with HIV Disease.'' This

document was developed through interviews with, and written comments

from, key HRSA staff and experts inside and outside the U.S. Public

Health Service, and through a review of relevant HIV-related service

delivery, research, evaluation, policy, and planning documents.

Descriptions: HIV Service Delivery Model Categories

The Special Project Categories for FY 1994 will support the

implementation and evaluation of innovative HIV service delivery

models. SPNS funds cannot be used for expenses related to the provision

of medical care; supportive services; or any other expenses currently

reimbursed, subsidized or eligible for reimbursement through third

party payors, grants awarded under Titles I-IV of the Ryan White CARE

Act, or other grant and foundation sources. Applicants may not submit

proposals for more than one subcategory in a category.

Proposals will be accepted for HIV service delivery model projects

that demonstrate and evaluate:

(1) Comprehensive primary care service delivery systems for people

with HIV within one of the distinct environments or settings described

in the six following sub-categories.

(a) Develop and evaluate the effectiveness of including new or

existing support services as part of the basic benefits of a managed

care plan or a comprehensive, coordinated care system.

Because one of the potential strengths of managed care plans or

coordinated care systems is their capacity to coordinate the services

of several providers, the proposed service delivery model must test its

ability to meet the wide range of service needs required by individuals

with HIV. These service needs, in addition to primary care, may

include, but are not limited to, specialty medical care, mental health

services, substance abuse treatment, and/or assistance with locating

housing, transportation, child care, etc. Grantees must evaluate

changes in: (1) Patient adherence to medical treatment plans; (2)

access to and use of medical and support services; (3) costs per-

patient of providing both medical and support services; and (4) patient

satisfaction with services.

(b) Test the feasibility of providing comprehensive HIV services

under a capitated reimbursement system (including, but not limited to,

Ryan White CARE Act Title I and Title II funds).

Grantees must evaluate patterns of utilization of medical and

support services under a capitated system, compare the costs of

delivering services under a capitated reimbursement system with a fee-

for-service system, and evaluate client satisfaction.

(c) Add primary care services to an intermediate level of care, i.

e., subsidized housing, residential care, shelter, partial

hospitalization, or other type of ``step down'' setting, for

individuals with HIV disease.

Grantees must evaluate the effectiveness of primary care services

provided in this environment on reducing dependence on inpatient

hospitalization, increasing the continuity of medical care, and

improving client satisfaction.

(d) Develop, in a geographically defined rural area, a

comprehensive continuum of care for the purpose of increasing

accessibility and quality of primary and specialty medical care to its

residents with HIV disease.

Grantees must explain how the proposed model accommodates the needs

of the residents with HIV disease in relation to the health service

delivery system characteristics of the area. Based on the needs of the

area, models that supplement primary medical care with case management,

psychosocial support, and other non-medical support services are

encouraged.

(e) Develop a service delivery model for adolescents and young

adults (up to age 25) with CDC-defined Stage III or IV HIV disease that

effectively manages their medical and, when appropriate, substance

abuse treatment needs.

Grantees should evaluate the model's effectiveness in meeting the

full range of physical, psychological, social, and spiritual needs of

adolescents and young adults who are seriously or terminally ill.

(f) Develop a service delivery model for women with HIV disease

that emphasizes the coordination of services from outreach, counseling

and HIV testing, including expanded counseling and testing during

pregnancy, through early intervention and care, including appropriate

therapeutic drug regimens, for asymptomatic and symptomatic disease,

and for prevention of transmission of HIV during pregnancy and

delivery.

Grantees must describe how the proposed model is using innovative

features to reach pregnant women and women at high risk (e.g.,

substance abusing women) who have been reluctant to become engaged in

traditional counseling/testing services, and how these women will be

engaged and retained in care systems for themselves during and after

pregnancy. Priority will be given to applicants in States or cities

which have made the decision to ``routinely recommend'' that women

(during pregnancy and/or whenever they receive primary care services)

learn their HIV infection status for the purposes of improving their

own care and health status; preventing transmission to their infants

during pregnancy; and preventing transmission during breastfeeding. The

funds will be used primarily to support system development and

organizing and training providers. The intent of this sub-category is

to foster systems of care for women with HIV; to encourage more women

to know their infection status; to encourage States and cities to

develop plans for accomplishing this; and to assess the reasons for and

impact of the various decisions women make regarding HIV testing, use

of AZT during pregnancy, and adherence to follow-up care decisions made

jointly with providers.

(2) Coordinated delivery of HIV health and support services to

specific mobile populations in the United States, ensuring the delivery

of continuous services throughout the course of HIV disease.

For the purposes of this category, mobile populations are defined

as border populations; populations with migration patterns primarily

between the continental United States and its territories and

commonwealths and between the United States and other countries;

migrant farm labor workers; and, undocumented workers and residents.

Examples of services needed by these populations include primary

medical care, mental health services, and advocacy or other legal

support services that address AIDS discrimination and access to care.

Special attention must be paid to ensuring and documenting continuity

of care for clients that receive care from providers located in

different geographical locations. SPNS is seeking innovative methods of

interagency communication and for tracking referrals between providers

so that longitudinal follow-up of clients from provider to provider

will be possible. Grantees must evaluate their success at ensuring

continuity of medical care and access to needed support services.

(3) Reduction of cultural, linguistic, and/or organizational

barriers to care in a geographically defined area (e.g., neighborhood,

community, region, state).

Grantees must have the capacity to analyze reductions in

organizational barriers to accessing care. AIDS service providers and

other community-based organizations located in the geographic area and

staffed by the cultural and/or linguistic group to be served by the

proposed service delivery model are encouraged to apply under this

category. Grantees submitting a proposal under Category #3 must address

one of the following four populations:

(a) An underserved population group experiencing significant

barriers to care (e.g., men of color, HIV infected women, AIDS

survivors, etc.) by addressing their access to care issues through

organizational collaboration and inclusion in policy development.

The grantee chooses the target population in this sub-category

based on documented evidence that this population affected by HIV

disease is not receiving services. At a minimum, collaboration among

providers must include all Ryan White CARE Act-funded grantees in the

area that serve the targeted population.

(b) An ethnic group facing both linguistic and cultural barriers.

A critical component of a proposed model in this sub-category must

be the involvement of individuals and/or community-based organizations

with established service relationships with the targeted special

population.

(c) Active substance abusers utilizing primary care on an

intermittent basis or who do not adhere to their treatment regiment.

Models for expanding enrollment and enhancing retention of HIV

infected substance users, particularly active users, in primary care

may include methods of increasing primary care providers' knowledge,

receptiveness, and skill in treating this population.

(d) Individuals or special populations experiencing HIV-based

discrimination in health care, employment, and/or housing, that

inhibits their receipt and/or utilization of health care services.

Grantees must demonstrate and evaluate how innovative advocacy

services targeting HIV discrimination impacts access to and utilization

of appropriate health care for people whose needs are already

complicated by cultural, linguistic or organizational issues.

(4) Provider training and education models that develop, test, and

evaluate strategies for increasing, improving or updating knowledge

about HIV disease and its treatment for providers in rural areas,

correctional facilities or mental health services programs and

facilities.

Grantees should collaborate, when feasible, with existing AIDS

Education and Training Centers (AETC) and other training centers

already providing education services to a wide variety of health care

providers. Adoption, or adaptation to local conditions, of existing

training models with outcome oriented evaluation is encouraged. The

project's evaluation must specify the extent to which providers

incorporate new skills and knowledge into their practices, and if there

are any changes in numbers of people with HIV disease served by the

provider. Evaluation designs comparing the results between different

levels or intensity of training are encouraged.

Review Criteria: HIV Service Delivery Models

All applications for HIV Service Delivery Model cooperative

agreements described under Category (1) through (4) above and submitted

to the SPNS program will be reviewed and rated by an objective review

panel. Factors for the technical review of applications are as follows:

Factor 1 (10 points). Adequacy of justification of need within the

community and target population for the proposed program.

Factor 2 (25 points). The feasibility, clarity of the description,

appropriateness, innovative quality, and potential for replication and

dissemination of the proposed model.

Factor 3 (15 points). Comprehensiveness of the program plan as

described in clearly stated goals, time-limited and measurable

objectives for each goal, activities for each objective, and a time

line that shows the scheduled production of materials that corresponds

to milestones stated in the objectives and program evaluation.

Factor 4 (20 points). Thoroughness, feasibility and appropriateness

of the project's capability to conduct and collaborate on a

comprehensive evaluation design and a plan for dissemination of the

project's findings.

Factor 5 (15 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 being proposed to conduct a

quality evaluation of the project; and (d) appropriate confidential

handling of medical, social service, and epidemiological data of

clients served.

Factor 6 (15 points). Extensiveness of coordination and

collaboration with related HIV activities within the project's

catchment area as documented by the applicant.

Additional Funding for SPNS Evaluation & Dissemination Center(s)

In addition to the funds provided to successful applicants for

development of service delivery model demonstration projects,

additional funds will be provided to one or more successful applicants

to establish, either on site or by subcontract, evaluation and

dissemination center(s) to work with all of the SPNS grantees funded

under the HIV Service Delivery Models Categories [1] through [4]. The

Center(s) will have two primary responsibilities: (1) to provide

technical assistance to SPNS grantees in designing and implementing

evaluation studies and dissemination activities for their individual

projects; and, (2) to develop and coordinate the implementation of

cross-cutting evaluations within groups of similar projects. HRSA staff

will offer advice and guidance and participate in each of these areas

as well as monitor the Center's work to assure its progress is in

accordance with program objectives and Federal requirements. HRSA staff

may accomplish this task, in part, through an advisory panel composed

of Federal employees and external consultants.

Inclusion of a request for additional funding for the SPNS

Evaluation and Dissemination Center is not a mandatory requirement of

the application. Those applications not requesting this additional

funding will be given equal consideration for service delivery model

funding. All applications, regardless of inclusion of a request for

evaluation center funding, will be scored first only on the applicant's

proposal for the service delivery model. Service delivery model

applications which are approved for funding will then be reviewed for

interest in the additional funding. Only then will proposals for an

evaluation and dissemination be reviewed and scored according to the

following.

Review Criteria: Additional Funding for SPNS Evaluation & Dissemination

Center(s)

Those successful service delivery model applications which include

a request for funding for the SPNS Evaluation and Dissemination Center

(Part B) will be eligible for review and rating by an objective review

panel of that part of the application. Applications will be considered

for funding on the basis of overall technical merit as determined

through the review process, and the proposed center's suitability for

working with the funded SPNS projects. Factors for the technical review

of Part B of the applications will include the following:

Factor 1 (25 points). Qualifications and experience of the

principal investigator, the proposed staff and consultants in designing

and conducting health service evaluation studies, disseminating study

findings and in providing technical assistance on evaluation and

dissemination issues.

Factor 2 (30 points). Adequacy of plans for providing technical

assistance to SPNS grantees on program evaluation and information

dissemination.

Factor 3 (25 points). Adequacy of plans for designing and

implementing cross-cutting evaluations within groups of similar

projects and for assuring data quality.

Factor 4 (20 points). Appropriateness of budget, staffing plans,

facilities and information management resources, and time frame for

implementing the project's operational and programmatic objectives.

Role of Federal Staff in Cooperative Agreements

The cooperative agreement mechanism allows for substantial post-

award programmatic participation by SPNS staff in the projects'

operations. In addition to the project officer's monitoring function,

SPNS staff will be active participants in the operations of the HIV

service delivery model demonstration projects and the SPNS evaluation

and dissemination center. SPNS staff will facilitate the exchange of

relevant information among the HIV service delivery model projects and

provide support for training and consultation. SPNS staff will also

monitor the function and activities of the center, assuring

satisfactory progress and timely reporting.

``Substantial programmatic participation'' means that SPNS staff

will provide guidance and coordination for certain programmatic

activities to a degree beyond their customary stewardship

responsibilities in grants administration. This may include, but is not

limited to, the following: participating in the design and direction of

activities to develop cross-cutting evaluation studies; assisting in

the selection of project director and/or other key staff; assisting in

the selection of contractors; participating in the analysis of data;

coordinating or providing training of project staff; participating in

selection and approval of analysis mechanisms; participating in

selection of results for publication; and providing assistance in the

management and technical performance of the project's activities.

Availability of Funds

Section 2618, subsection (a) of the Public Health Service Act,

``Special Projects of National Significance,'' permits the Secretary to

allocate up to ten percent of the funds provided for Part B of Title

XXVI to award grants directly to public and non-profit private entities

to promote the statute's objectives. Approximately $9.7 million is

available in FY 1994, to fund 25 HIV service delivery model

demonstration projects estimating an average annual project budget of

$350,000. The evaluation and dissemination center budget will be based

on the availability of funds in relation to the objective review

panel's recommendations. Approximately $600,000 is available in FY 1994

for this Center. The budget and project periods for approved and funded

projects will begin October 1, 1994.

Project periods may be requested for up to five years. However,

recommended support beyond the third year is subject to a determination

by an objective review panel in conjunction with an assessment by the

SPNS staff of the project's progress to date. All grants to support

projects beyond the first budget year will be contingent upon the

availability of funds, Congressional reauthorization of Ryan White CARE

Act funding within the second project year, and satisfactory progress

each year in meeting the project's objectives.

All grantees funded to support HIV service delivery model

demonstration projects under this Notice are encouraged to secure and

show evidence of non-SPNS funding support equal to 20 percent of the

approved project budget by the fourth project year, and equal to 40

percent of the approved project budget by the fifth year. Applicants

are required to submit, in the initial application, budgets for each

proposed project year.

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 entities 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, AIDS discrimination and advocacy organizations,

hemophilia centers, community mental health centers, substance abuse

treatment centers, urban Indian health centers, migrant health centers,

Ryan White CARE Act Title IIIb clinics, etc.); institutions of higher

education; and national service provider and/or policy development

associations/organizations.

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

nonprofit organizations.

Reporting and Other Requirements

A successful applicant under this notice will submit semi-annual

activity summary reports 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. As a condition of all awards funded under this

Notice, grantees will be required to cooperate with HRSA and the SPNS

Evaluation and Dissemination center(s) in any multi-site evaluation

studies sponsored by the SPNS Program.

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).

Federal Smoke-Free Compliance

The Public Health Service strongly encourages all grant recipients

to provide a smoke-free workplace and promote the non-use of all

tobacco products. This is consistent with the PHS mission to protect

and advance the physical and mental health of the American people.

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. 937-0195. 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.

Community-based, non-governmental 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: May 3, 1994.

John H. Kelso,

Acting Administrator.

[FR Doc. 94-14088 Filed 6-9-94; 8:45 am]

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