[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
