[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37383-37387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18389]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 98098]
Technology Translation and Transfer of Effective HIV Prevention
Interventions; Notice of Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1998 funds for a cooperative agreement
program for the technology translation and transfer of effective HIV
prevention interventions. This program addresses the ``Healthy People
2000'' priority area of Human Immunodeficiency Virus (HIV) Infection.
In order to slow the spread of HIV/AIDS, researchers have developed
and tested prevention interventions that aim to reduce sex-related and
drug-related
[[Page 37384]]
risk behaviors. As a result of these studies, a number of interventions
with credible evidence of effectiveness have been identified. This
project will be a case study of the translation and transfer of an
effective intervention in a non-research setting.
The purpose of this project is to enhance access to and use of
effective interventions by service providers nationwide. Recipients
will develop prevention packages that are readily useable by service
providers. Recipients will develop prevention packages and refine them
as they are piloted in the field setting. This will serve as a case
study of the technology transfer process.
The specific purposes of this program are to: (1) Translate an
individual or small group HIV prevention intervention (especially those
targeted to persons at increased risk of HIV infection) with credible
evidence of effectiveness, i.e., an effective intervention. This first
activity is to be done in collaboration with health departments,
community-based organizations, or other service delivery providers who
can provide feedback and advice; (2) Develop a prevention package that
includes training materials and technical assistance protocols as well
as the intervention itself; and (3) Study the process of technology
transfer, using the prevention package in a field setting.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit and
for-profit organizations and governments and their agencies. Thus,
universities, colleges, research institutions, hospitals, other public
and private organizations, State and local health departments or their
bona fide agents, federally recognized Indian tribal governments,
Indian tribes or Indian tribal organizations.
However, since the purpose of this technology translation and
transfer project is to build on successful research projects,
applicants must clearly demonstrate that their intervention has been
tested under rigorous study design criteria (including the use of a
control or comparison group) and found to be effective with significant
positive results for changing HIV risk behavior. The applicant must
have evidence that a report on this effective intervention has been
submitted for publication or has been published in a peer-reviewed
journal.
Note: Public Law 104-65 states that an organization described in
section 501(c)(4) of the Internal Revenue Code of 1986 that engages
in lobbying activities is not eligible to receive Federal funds
constituting an award, grant, cooperative agreement, contract, loan,
or any other form.
C. Availability of Funds
Approximately $400,000 is available in FY 1998 to fund
approximately 2 awards. It is expected that the average award will be
$190,000, ranging from $180,000 to $200,000. It is expected that the
awards will begin on or about September 30, 1998, and will be made for
a 12-month budget period within a project period of 2 years. Funding
estimates may vary and are subject to change based on availability of
funds. An application requesting greater than $200,000 will not be
considered for review and will be returned to the applicant.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds. Continued funding for year 2 will be
dependent on the completion of required activities for year 1.
Applicants should anticipate that a portion of year 2 funding may be
used in the field setting (approximately $20,000) as needed to
implement the program.
Use of Funds
Collection of new or supplemental intervention research data, data
entry and analysis, purchase of furniture or computers, and rental of
facilities will not be funded under this program.
D. Program Requirements
In conducting activities to achieve the purpose of this
announcement, the recipient will be responsible for the activities
under 1, Recipient Activities, and CDC will be responsible for the
activities listed under 2, CDC Activities.
1. Recipient Activities
a. Develop the intervention portion of the prevention package.
(1) The recipient will develop the package in collaboration with
representatives of HIV prevention service delivery programs, e.g.,
health departments, community-based organizations (CBOs).
(2) Prevention packages should include:
(a) Language and format that are understandable and attractive to
service providers who are nonresearchers.
(b) A full description of the intervention, including the
background and the target population.
(c) A list and description of the core elements for the pre-
implementation, implementation, and maintenance phases.
(d) Protocols for implementing the intervention and ensuring its
quality and consistency.
(e) Specific guidelines for overcoming barriers to implementation.
(f) A list of all staff, facility, and material resources needed to
conduct the intervention, including level of staff skill and time
commitment, and cost breakdowns.
(g) A time line of specific steps for setting up the intervention.
(h) A bibliography of publications based on the intervention.
b. Develop the training and technical assistance portion of the
prevention package.
(1) The recipient should develop training materials that can be
used in preparing providers to use the prevention package. These
materials will assist the user with pre-implementation and
implementation tasks necessary to undertake the intervention during
year 2. The materials should emphasize experiential learning and other
active methods associated with skill building.
(2) The recipient should develop an outline for providing technical
assistance which identifies the likely technical assistance requests
that users may make and an appropriate response for each request.
c. Produce a limited number of draft prevention packages.
The recipient will produce draft packages using less costly
materials than those to be used in the final product, but without
changing the overall effect, e.g., less heavy stock paper for binding
covers but with same logo or design, notebook rather than bound.
d. Identify an organization or field setting for case study.
(1) Compile a list of HIV prevention service agencies in the
recipient's state or within close proximity to the recipient's city
which target populations for whom the intervention is appropriate (for
this announcement, such agencies will be referred to as potential
users);
(2) Create approaches to establish linkages with the potential
users and strategies to market the prevention package to them.
(3) Select ways to inform potential users who express interest
about the availability of a case study experience.
(4) Develop a written agreement with the organization selected for
the case study (for this announcement, such organization will be
referred to as the user).
e. Develop the evaluation plan.
(1) Data should be both quantitative and qualitative and should
include
[[Page 37385]]
observations and reports that permit assessment of the fit between the:
(a) core elements specified in the prevention package and the
content of the implementation.
(b) methods specified in the prevention package and the delivery of
the intervention, but no behavioral or health outcomes data should be
collected.
(2) Process data should include observations and reports of:
(a) barriers to implementation and how they impacted the case study
(b) solutions to barriers
(c) cost containment strategies.
During the second year, the recipient will complete the development
of training materials, technical assistance outlines, and process
evaluation protocols necessary to initiate the case study. Data
collection will take place throughout the case study or for
approximately 6 months (based on an estimated delivery of one program
per week). The final three months of the project will be used to
analyze the process data and refine the prevention package.
2. CDC Activities.
a. Host a meeting with the successful applicants within 60 days of
the notice of grant award to discuss implementation of the project.
b. Provide technical assistance in the general operation of this
HIV prevention project.
c. Consult on the choice of user for a case study with the
prevention package.
d. Monitor and evaluate scientific and operational accomplishments
of this project through frequent telephone contact and review of
technical reports and interim data analyses.
e. Conduct site visits to assess program progress and mutually
solve problems, as needed.
f. At the end of the two year project, CDC, in addition to the
authors, may distribute the package.
E. Application Content
Develop applications in accordance with PHS Form 5161-1 (OMB Number
0937-0189) and the instructions and format provided below.
Submit the original and two copies of PHS Form 5161-1 (OMB Number
0937-0189) and the original and two copies of the application. The
application may not exceed 20 double-spaced pages, excluding abstract,
index, and appendices. Submit the original and each copy of the
application UNSTAPLED and UNBOUND. Print all material double-spaced, in
a 12-point or larger font size on 8\1/2\'' by 11'' paper, with at least
1'' margins, and printed on one side only. Provide a one-page abstract
of the proposal and a complete index to the application and its
appendices. Beginning with the first page of text, number all pages
clearly and sequentially. Number each page of the appendices also,
e.g., for Appendix #1, the pages should be numbered: A1-1, A1-2, A1-3.
Replace double-sided article reprints with a one-sided copy.
Include a general introduction, followed by one narrative
subsection for each of the numbered content elements per application,
in the order in which the elements appear below. Label each narrative
subsection with the element title and include all the information
needed to evaluate that element of the application (except for
curriculum vitae, references, and letters of support, which are
appropriate for the appendices). The application content elements are:
1. Effective intervention
a. Identify the principal investigator(s) and name and location of
the agency(ies) that originally developed, conducted, and evaluated the
small group or individual level intervention research.
b. Provide written permission from the original developers of the
intervention to develop and market materials that may be original or
derived for the prevention package.
c. Describe the study's positive results on behavioral or health
outcomes, including how these results are both statistically and
practically significant.
d. Include in the appendix, a copy of any reports that describe the
study design and the positive behavioral or health outcomes of a small
group or individual level intervention that have been submitted for
publication or published in peer reviewed journals. This portion of the
appendix should be labeled as ``Intervention Study Design and
Results.''
e. Substantiate the need for a prevention package in terms of risk
of target population and potential for generalizability to other target
groups.
f. Describe the feasibility of implementation by other
organizations, particularly those with limited resources.
2. Prevention package
a. Describe the prevention package. Include descriptions of:
(1) Target populations for whom the intervention would be
appropriate;
(2) Pre-implementation phase, including specific steps for setting
up the intervention, necessary collaborators, necessary materials,
other resources, staff commitment (numbers and time) and skills for
conducting the intervention, and training materials;
(3) Implementation phase, including protocols for implementing the
intervention and ensuring quality and consistency and providing
technical assistance, identification of barriers to implementation and
how they may be overcome, and process evaluation methods; and
(4) Maintenance phase, including how to deal with issues of staff
turnover and retraining.
b. Explain how staff from HIV prevention programs (e.g., health
departments and CBOs) within the applicant's state or within close
proximity to the applicant's home city will be involved in the
development of the package. Describe the planned procedures for how
these collaborators will be identified.
c. Present a time line for developing the prevention package.
3. Field site for implementation of the package in year two (2)
a. Discuss a plan to identify and recruit potential users within
your state or within close proximity to your home city and indicate any
which already have shown interest in or may be interested in
implementing this intervention.
b. Elaborate on the criteria and mechanism for selecting the
user(s) who will implement the package.
Note: The agency that originally conducted the intervention is
excluded from consideration as a potential user, as is any agency
that currently or previously implemented the intervention.
4. Strategy to assist implementation
a. Describe the strategy to facilitate implementation of the
package, including provision of training and direct technical
assistance from the recipient to the selected user(s).
b. Discuss procedures to involve user(s) in implementing the
package, including use of user's existing staff and resources, and to
identify barriers to implementation and how to overcome them.
Feasibility and sustainability of the intervention with existing
resources are important for the successful adoption and maintenance of
the package.
5. Plan to evaluate the implementation process
Describe the plan for evaluating the process of implementing the
prevention package. The plan should address (unless not applicable):
(1) methods, (2) quality assurance monitoring of intervention delivery
including documentation of intervention episodes, (3) employee
recruitment and retention, (4) participant recruitment, (5) accuracy
[[Page 37386]]
and completeness of record keeping, and (6) costs of intervention
delivery.
6. Capacity
a. Demonstrate capacity to conduct the proposed activities
including the process evaluation.
b. Describe the proposed staffing, show percentages of each staff
member's commitment to this and other projects, and division of duties
and responsibilities for this project; include brief position
descriptions for existing and proposed personnel.
c. Demonstrate that the staff have the expertise to complete this
project, including ability to produce the intervention product(s).
Demonstration of this capability would include examples of previously
developed fact sheets, web sites, or samples from other intervention
packages.
d. Name the staff members who are key to the completion of the
project. Provide a brief description of the strengths each brings to
this project. Include their curriculum vitae in the appendix.
e. Describe access to graphics expertise for production and editing
of the intervention package.
f. Describe equipment and facilities to be used for the proposed
activities.
7. Budget
Provide a detailed, line-item budget for the project; justify each
line-item, including the need for any proposed consultants and
contractors. Plan for at least two trips to Atlanta to meet with CDC
representatives.
F. Submission and Deadline
Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are in the application kit. On or before August 17, 1998,
submit the application to: Maggie Slay Warren, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement 98098, Centers for Disease Control and Prevention (CDC),
Room 300, 255 East Paces Ferry Road, NE., M/S E-15, Atlanta, Georgia
30305-2209.
If your application does not arrive in time for submission to the
independent review group, it will not be considered in the current
competition unless you can provide proof that you mailed it on or
before the deadline (i.e., receipt from U.S. Postal Service or a
commercial carrier; private metered postmarks are not acceptable).
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent review group appointed by CDC.
1. Behavioral Intervention (20 percent)
The applicant must clearly demonstrate the effectiveness of the
proposed small-group or individual-level intervention in a report that
has been submitted for publication or has been published in a peer-
reviewed journal. This is an absolute criterion. If this evidence is
not present, score as zero.
a. The intervention is directed to small groups or individuals,
especially persons at increased risk of infection.
b. The applicant provides justification if proposing to conduct the
intervention with any groups other than the initial target population.
c. The applicant addresses the feasibility of implementing the
prevention package by organizations with limited resources.
2. Prevention Package (15 percent)
Level of detail in the description or outline of the proposed
package, including materials, protocols, and guidelines. Clarity of
described format and concepts; intended audiences; and objectives.
Justification of the appropriateness of the package's objectives,
format, and concepts to the intended users' needs and capabilities.
Adequacy of input from HIV prevention programs into the development of
the package. Adequacy of planned materials' review, pretesting, and
revision of materials as needed. Adequacy of time scheduled for
completing the proposed steps of the package's development.
3. Plan to Identify Field Site(s) to Implement the Package (10 percent)
Quality of plan to identify appropriate and eligible intended users
and interest them in adopting the package during year 2 of the project.
Selection of proactive methods to identify and solicit intended users.
Adequacy of criteria and mechanism for selecting the users for
implementing the package in year 2, including match of the
intervention's target population with the user's community planning
priorities. Recognition that the agency that originally conducted the
intervention is excluded from implementing the package.
4. Strategy to Assist Implementation (15 percent)
Clarity of the strategy to assist selected users in adopting and
implementing the behavioral intervention. Understanding of barriers to
implementation and how to overcome them. Plan to assist selected users
in implementing the intervention by using their existing resources and
staff, including provision of on-call technical assistance. Plan to
help selected users find additional funds for implementing the package,
if relevant.
5. Plan to Evaluate Implementation Process (15 percent)
Feasibility and appropriateness of the applicant's plan to evaluate
the selected user's implementation of the intervention as specified in
the replication package. Thorough and realistic selection of process
measures to evaluate.
6. Demonstrated Capacity (15 percent)
Overall ability of the applicant to perform the proposed activities
as reflected in their staff's and consultants' qualifications and
availability. The extent to which the applicant's demonstrates that
proposed staff have experience with material development and
dissemination and demonstrated familiarity with HIV behavioral
interventions, in general, and the intervention to be publicized, in
particular. The nature and extent of any partnership between
researchers and HIV prevention programs. Adequacy of existing support
staff, equipment, and facilities.
7. 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 (10 percent)
This includes:
a. The proposed plan for the inclusion of both women and racial and
ethnic 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.
d. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with communities and recognition of mutual benefits.
8. Does the application adequately address the requirements of Title 45
CFR Part 46 for the protection of human subjects?
______YES
______No
Comments:____________________
9. Budget (not scored)
Extent to which the budget is reasonable, itemized, clearly
justified,
[[Page 37387]]
and consistent with the intended use of the funds. Extent to which the
budget includes itemizations, justifications, scope, and deliverables
for consultants or contractors.
H. Other Requirements
Technical Reporting Requirements
An original and two copies of semi-annual progress reports are
required. Timelines for the semi-annual reports will be established at
the time of award. Final financial status and performance reports are
required no later than 90 days after the end of the project period. All
reports are submitted to the Grants Management Branch, CDC.
At the completion of 2 years of funding, recipients will be
expected to share prevention packages with representatives of the
original agencies that conducted the interventions on which the
products are based, if different from those of the recipient.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachments.
AR98-1 Human Subjects Requirements
AR98-2 Requirements for Inclusion of Women, Racial and Ethnic
Minorities in Research
AR98-4 HIV/AIDS Confidentiality Provisions
AR98-5 HIV Program Review Panel Requirements
AR98-7 Executive Order 12373 Review
AR98-8 Public Health System Reporting Requirements
AR98-9 Paperwork Reduction Act Requirements
AR98-10 Smoke-Free Workplace Requirements
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 301 and 317(k), of the
Public Health Service Act [42 U.S.C. 241 and 247b], as amended. The
Catalog of Federal Domestic Assistance number is 93.941.
J. Where to Obtain Additional Information
To receive additional written information, call (888) 472-6874. You
will be asked to leave your name, address, and telephone number. Please
refer to Program Announcement 98098 when you request information. For a
complete program description, information on application procedures, an
application package, and business management technical assistance,
contact: Maggie Slay Warren, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office Announcement 98098,
Centers for Disease Control and Prevention (CDC), Room 300, 255 East
Paces Ferry Road, NE., M/S E-15, Atlanta, GA 30305-2209 telephone (404)
842-6797. Email address http://www[email protected]
See also the CDC home page on the Internet: http://www.cdc.gov
For program technical assistance, contact: Robert Kohmescher,
Division of HIV/AIDS Prevention, National Center for HIV/STD/TB
Prevention, Centers for Disease Control and Prevention (CDC), 1600
Clifton Road, NE., Mailstop E-44, Atlanta, GA 30333 telephone (404)
639-8302 email: www.rnk1@cdc.gov">[email protected]
Please refer to Announcement number 98098 when requesting
information and submitting an application.
Dated: July 6, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 98-18389 Filed 7-9-98; 8:45 am]
BILLING CODE 4163-18-P
