[Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
[Notices]
[Pages 29386-29389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14554]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 638]


Development and Feasibility Testing of Interventions to Increase 
Health-Seeking Behaviors in, and Health Care for, Populations at High 
Risk for Gonorrhea

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a cooperative agreement 
program to conduct research to: (a) Identify factors (at the client, 
provider, and systems levels) that influence the health-seeking 
behaviors of, and health services for, populations at high risk of 
transmitting and acquiring gonorrhea; (b) use the above information to 
develop and test interventions to increase health care seeking and 
improve health care; and (c) develop interdisciplinary approaches and 
augment a behavioral research infrastructure related to sexually 
transmitted diseases (STDs).
    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 is related to the priority areas of STDs and HIV 
Infection. (For ordering a copy of ``Healthy People 2000,'' see the 
section ``WHERE TO OBTAIN ADDITIONAL INFORMATION.'')

Authority

    This program is authorized under section 318 of the Public Health 
Act [42 U.S.C. 247c], as amended.

Smoke-Free Workplace

    The CDC strongly encourages all grant recipients to provide a 
smoke-free workplace and to 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

    Applications may be submitted by public and private, nonprofit and 
for-profit research organizations and their agencies. Thus, 
universities, colleges, hospitals, research institutions and other 
public and private organizations and small, minority and/or women-owned 
businesses are eligible to apply. Also, 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.

Avaliability of Funds

    Approximately $1 million is available in FY 1996 to fund 
approximately 5 awards. The project will be conducted in two stages. 
The project period for Stage I is expected to be two years. For Stage 
I, it is expected that the average award will be $250,000, ranging from 
$200,000 to $300,000. It is expected that the awards will begin on or 
about September 30, 1996, and will be made for a 12-month budget 
period. Funding estimates may vary and are subject to change. Before 
completion of Stage I, recipients will compete for continuation awards 
for Stage II which is expected to be an additional two years. 
Successful completion of Stage I is required to compete for Stage II.

Stage I--(Years 1 & 2)

    Focuses on formative research to identify client, provider, and 
system level determinants of health care seeking by, and health care 
for, populations at high risk of transmitting and acquiring gonorrhea.

Stage II--(Years 3 & 4)

    Focuses on developing and testing the client, provider, and system 
level interventions to increase health care seeking by, and to improve 
health care for, populations at risk for gonorrhea.
    Further detail on Stages I and II is presented below under the 
``PURPOSE'' section. Continuation awards within an approved project 
period will be based on satisfactory progress and the availability of 
funds.

Purpose

    The overall purpose of this program is to assist the recipients in 
developing and utilizing behavioral and social science research methods 
to learn the influences on health care seeking and health care at the 
client, provider, and system levels, and to use this information to 
develop:
    * Community-level behavioral interventions to increase health care 
seeking and;
    * Provider and systems interventions to improve health care for 
populations at high risk of transmitting and acquiring gonorrhea.
    The research program has two stages of activity and funding:
    Stage I: Formative Research and Intervention Development.
    Stage II: Intervention Implementation and Feasibility Testing.
    The fundamental goal of this program announcement is best 
understood in the context of Stage II (years 3 and 4 of the anticipated 
4-year project), in which the grantees will implement and evaluate the 
feasibility of a science-based community intervention to increase 
health care seeking among those at high risk for gonorrhea. In 
addition, the recipients will implement and evaluate the feasibility of 
science-based provider and systems interventions to improve health care 
for this same population. Applications for such Stage II intervention 
activities are not required at this time because well-developed, 
science-based, promising approaches to changing health-seeking behavior 
or the provision of health care will be based upon the aggregate 
results of the research conducted by grantees during Stage I.

Program Requirements

    The following are applicant requirements:
    (1) For research institutions, a documented research partnership 
with a public health agency of a State or local government or their 
bona fide agents. For health agencies, a documented research 
partnership with a university or other qualified research institution. 
Applicants are also encouraged to demonstrate ongoing collaboration 
with community-based organizations (CBOs)

[[Page 29387]]

that have histories of access to and success with the target 
population;
    (2) Proof that the catchment area has
    (a) A calendar year (CY) 1995 gonorrhea incidence rate that is 
higher than 225 per 100,000 or 750 per 100,000 for 15 to 19 year olds, 
and
    (b) Access to at least 500 new cases of gonorrhea per year;
    (3) Include documentation of a multi-disciplinary research team 
with behavioral, clinical, epidemiologic, and health economics or 
health services research expertise, as well as in statistics or data 
management;
    (4) State a willingness to participate in the development and 
implementation of common protocols and methods for formative research 
on client, provider, and system determinants of health care seeking by, 
and health care provision to, populations at high risk of transmitting 
and acquiring gonorrhea.
    Applications that do not satisfy these eligibility requirements 
will not be considered and will be returned.

Cooperative Activities

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for the activities 
under B. (CDC Activities), as listed below:

A. Recipient Activities

    1. Develop an overall framework that would allow gonorrhea research 
to be conducted that would validate, verify, and expand upon the 
initial choice of a catchment area and target population. Specify the 
demographics of the target population and any subgroups.
    2. Develop an intervention and justify the selection of a 
particular subgroup toward which to direct future interventions.
    3. Verify access sites within the catchment area (e.g., STD 
clinics, school-based clinics, job training sites, health centers, 
substance abuse treatment facilities; shelters or drop-in facilities 
for runaway and homeless youth, mental health clinics, other health 
care facilities such as community health centers, facilities ``without 
walls'' that provide outreach to ``hard-to-reach'' populations; units 
within the criminal justice system) where populations at risk for 
gonorrhea will potentially be accessible for interviewing and for the 
intervention.
    4. Conduct qualitative and quantitative behavioral and psychosocial 
research to identify client, provider, and system factors influencing 
health care seeking by, and health care for, populations in the 
catchment areas at risk of acquiring and transmitting gonorrhea.
    5. Develop common protocols to conduct this formative research. In 
particular, CDC and the recipient will agree on appropriate sampling 
approaches for the collection of behavioral and psychosocial data. 
Recipients may enhance the common protocol or develop additional 
protocols to address questions and issues specific to their local 
conditions.
    6. Develop assessment instruments and participate in cross-site 
implementation of those instruments. Each recipient will analyze and 
report results of this three-level assessment and will produce a report 
synthesizing knowledge about the community. This report should reflect 
the community's health care system in the current era of health care 
reform, with particular attention to the type of health care coverage 
extended to subgroups in the community and the number of persons 
enrolled in these plans.
    7. Manage, analyze, and interpret data. Data from the Stage I 
activities must be collected, managed, and stored securely and 
confidentially. Recipients will use common computer and data management 
systems and will have submitted the data from their client, provider, 
and system assessments in appropriate format to CDC.
    Any materials developed in whole or in part with CDC funds shall be 
subject to a nonexclusive, irrevocable, royalty-free license to the 
government to reproduce, translate, publish, or otherwise use and 
authorize others to use for government purposes.
    8. Travel to Atlanta or another location and participate with other 
recipients and CDC representatives in four meetings during Stage I. The 
first meeting will be held within 60 days after awards are made to 
develop common approaches and instruments for the Stage I formative 
research.
    9. Assemble a local Internal Review Board (IRB) for each catchment 
area to review protocols developed under this program and submit 
approvals to CDC.
    10. Provide progress reports to representatives of communities 
affected by gonorrhea and other involved organizations, agencies, and 
persons.
    By the end of Stage I (24 months), it is expected that each 
recipient will have:
    1. Completed formative research, data reduction, and will have 
prepared research summaries and a final report. This report should, at 
a minimum, identify client, provider, and system determinants of health 
care seeking and health care provision behaviors.
    2. Established access to the target population in sufficient 
numbers to provide meaningful sample sizes for feasibility studies of 
community interventions as a condition of going on to Stage II 
feasibility research.
    3. Established access to providers or health care systems in order 
to carry out provider and system interventions as a condition of going 
on to Stage II research.
    4. Demonstrated that their proposed catchment areas are minimally 
affected by confounding factors or have identified appropriate methods 
for controlling competing interventions and research.

B. CDC Activities

    1. Provide scientific and technical oversight in the general 
operation of the formative stage of the gonorrhea prevention and health 
care behavior project.
    2. Host a meeting of the recipients to plan common approaches and 
protocols for the formative research stage (years 1 and 2) of this 
initiative. CDC will host three other meetings of recipients during 
Stage I to promote collaboration.
    3. Monitor and evaluate scientific and operational accomplishments 
of this project through periodic site visits, frequent telephone calls, 
and review of technical reports and interim data analyses.
    4. Assist recipients in the aggregation of data and analysis and 
distribution of results of multisite analyses.

Evaluation Criteria

    Applications that meet the eligibility requirements will be 
reviewed and evaluated according to the following criteria:
    1. Understanding of the objectives of this research as reflected in 
the statement of research background and research questions. (15 
points)
    2. Documentation of the epidemiologic, demographic, and health care 
and prevention program characteristics of geographical catchment area 
in which the applicant will have access to at least 500 cases of new 
gonorrhea per year. (15 points)
    3. Appropriateness of the methodologies initially proposed for 
formative research on client, provider, and system determinants of 
health care seeking by and health care for populations at high risk of 
transmitting and acquiring gonorrhea. (20 points)
    4. Overall ability (that of the applicant and proposed sites) to 
perform the technical aspects of the project as reflected in the 
availability of qualified and experienced personnel for a multi-
disciplinary team; facilities and plans

[[Page 29388]]

for the administration of the project, including a detailed and 
realistic schedule for the specified activities and access to study 
populations, providers, and health care institutions. (20 points)
    5. The extent to which the research approach is interdisciplinary 
and culturally and programmatically relevant. (5 points)
    6. 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 will be 
documented. (5 points)
    7. The extent to which collaborations among health departments, 
research institutions, and other participating health care entities are 
likely to be sustained for the duration of the project. (5 points)
    8. Documentation of experience with behavioral interventions for 
bacterial STDs. (5 points)
    9. Consideration of the extent to which the formative research 
activities conducted in Stage I will result in Stage II pilot 
intervention protocols for testing the feasibility of client, provider, 
and system interventions. (10 points)
    10. In addition, consideration will be given to the extent to which 
the budget is reasonable, clearly justified, and consistent with the 
intended use of the funds. (Not scored)

Funding Preferences

    Final determination may be influenced by the geographic 
distribution of project sites. In addition, due to the changes in the 
health care system, consideration will be given to funding at least one 
applicant who has contractual research agreements with a managed care 
organization.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets 
up a system for State and local government review of proposed Federal 
assistance applications. Applicants should contact their State Single 
Point of Contact (SPOC) as early as possible to alert them to the 
prospective applications and receive any necessary instructions on the 
State process. A current list of SPOCs is included in the application 
kit. For proposed projects serving more than one State, the applicant 
is advised to contact the SPOC for each affected State. A current list 
of SPOCs is included in the application kit. If SPOCs have any State 
process recommendations on applications submitted to CDC, they should 
send them to Van Malone, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-15, 
Atlanta, GA 30305, no later than 60 days after the application 
deadline. The Program Announcement Number and Program Title should be 
referenced on the document. The granting agency does not guarantee to 
``accommodate or explain'' State process recommendations it received 
after that date.

Public Health System Reporting Requirement

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernment applicants must prepare and submit the items identified 
below to the head of the appropriate State or local health agency in 
the program areas(s) that may be affected by the proposed project no 
later than the receipt date of the Federal application. The appropriate 
State and/or local health agency is determined by the applicant. The 
following information must be provided:
    A. A copy of the face page of the application (SF424); and
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and include 
the following:
    1. A description of the population to be served;
    2. A summary of the services to be provided; and
    3. A description of the coordination plans with the appropriate 
Sate and/or local health agencies.
    If the State and/or local health officials should desire a copy of 
the entire application, it may be obtained from the State Single Point 
of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.978.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Confidentiality

    Applicants must have in place systems to ensure the confidentiality 
of patient records.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant 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 and 
form provided in the application kit.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR- 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, Alaskan 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. In conducting review for 
scientific merit, review groups will evaluate proposed plans for 
inclusion of minorities and both sexes as part of the scientific 
assessment and scoring.
    This policy does not apply to research studies when the 
investigator cannot control the race, ethnicity and/or sex of the 
subjects. Further guidance to this

[[Page 29389]]

policy is contained in the Federal Register, Vol. 60, No. 179, pages 
47947-47951, dated Friday, September 15, 1995.

Application Submission and Deadline

A. Preapplication Letters of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. On or before 
July 5, 1996, the letter should be submitted to Kimberly P. Boyd, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 300, Atlanta GA 30305. The letter 
should identify the announcement number and the name of the 
investigator. The letter does not influence review or funding 
decisions, but will enable CDC to plan the review more efficiently, and 
will ensure that each applicant receives timely and relevant 
information prior to application submission.

B. Applications

    The original and two copies of the application PHS 5161-1 (OMB 
Number 0937-0189) must be submitted on or before August 5, 1996, to Mr. 
Van Malone, Grants Management Officer, Attention: Kimberly Boyd, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305.

C. Deadline

    Applications shall be considered as meeting the deadline if they 
are either:
    (a) Received on or before the deadline date, or
    (b) Sent on or before the deadline date and received in time for 
submission to the objective review group.

(Applicants must request a legibly dated receipt from a commercial 
carrier or the U.S. Postal Service. Private metered postmarks are not 
acceptable as proof of timely mailing.)
    (c) Late Applications: Applications which do not meet the criteria 
in (a) or (b) above are considered late applications. Late applications 
will not be considered in the current competition and will be returned 
to the applicant.

Where to Obtain Additional Information

    A complete program description, information on application 
procedures, an application package, and business management technical 
assistance may be obtained from Kimberly Boyd, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Mailstop E15, Atlanta GA 30305, telephone (404) 
842-6592, Facsimile (404) 842-6513, or Internet at 
. Programmatic technical assistance may be 
obtained from Sevgi Aral, Ph.D., Division of STD Prevention, Behavioral 
Interventions and Research Branch (BIRB), National Center for STD, HIV, 
and TB Prevention, Centers for Disease Control and Prevention (CDC), 
1600 Clifton Road, NE., Mailstop E02, Atlanta, GA 30333, telephone 
(404) 639-8259, Facsimile (404) 639-8608.
    Please refer to Announcement Number 638 ``Development and 
Feasibility Testing of Interventions to Increase Health-Seeking 
Behaviors in, and Health Care for, Populations at High Risk for 
Gonorrhea'' when requesting information and submitting an application.
    You may obtain a copy of ``Healthy People 2000,'' (Full Report, 
Stock No. 017-001-00474-0) or ``Healthy People 2000,'' (Summary Report, 
Stock No. 017-001-00473-1) referenced in the ``INTRODUCTION'' from the 
Superintendent of Documents, Government Printing Office, Washington, DC 
20402-9325, telephone (202) 512-1800.
    There may be delays in mail delivery and difficulty in reaching the 
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC 
suggest applicants use Internet, follow all instructions in this 
announcement and leave messages on the contact person's voice mail for 
more timely responses to any questions.

    Dated: June 4, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-14554 Filed 6-7-96; 8:45 am]
BILLING CODE 4163-18-P