[Federal Register: June 3, 2004 (Volume 69, Number 107)]
[Notices]
[Page 31384-31388]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn04-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Linkage to HIV Care Demonstration Project
Announcement Type: New.
Funding Opportunity Number: 04154.
Catalog of Federal Domestic Assistance Number: 93.941.
Key Dates:
Letter of Intent Deadline: June 18, 2004.
Application Deadline: July 23, 2004.
Executive Summary: Data from several studies indicate that 30 to 40
percent of persons with new HIV diagnoses are not linked to an HIV care
provider within 12 months of their HIV diagnosis. However, such early,
prompt linkage to care is important for the health of the infected
person, as well as putatively that person's potential to infect others.
A recently completed Antiretroviral Treatment Access Study(``ARTAS'')
in four United States (US) cities indicates that providing case
managers to help such newly diagnosed persons into care significantly
increases the percentage of persons who see an HIV care provider once
within six months and twice within twelve months after their initial
HIV diagnoses. Such case management was also cost-effective (about one
thousand dollars per additional person successfully linked). The
purpose of this project is to test the feasibility of providing
intensive case management to HIV-infected persons newly diagnosed at
publicly funded clinics or testing locations throughout the U.S.
I. Funding Opportunity Description
Authority: Section 301(a) and 317(k)(2) of the Public Health
Service Act, (42 U.S.C. 241(a) and 274b(k)(2)), as amended.
Purpose: The purpose of the program is to link HIV-infected persons
recently diagnosed at publicly funded clinics in the U.S. to HIV care
providers. The project is intended for communities with socio-
economically disadvantaged HIV-infected persons. There are compelling
personal and public health benefits to get recently diagnosed HIV-
infected persons into care before they get sick. The personal benefits
include delayed disease progression, early beginning of
antiretrovirals, regular monitoring of their immunologic status (CD4+
cell count) and virologic status (HIV-1 RNA copies in plasma). The
public health benefits include reducing HIV transmission due to earlier
reduction in infectious HIV-1 RNA copies in the blood; and earlier
entry into prevention for positives programs in clinical settings.
Data from the original linkage to care clinical trial ARTAS and
from other research studies indicate that about 40 percent of
socioeconomically disadvantaged HIV-infected individuals are not yet
linked to clinical care within a year of their HIV diagnosis. The ARTAS
research project showed that case managers trained in strengths-based
case management methodology can facilitate entry into clinical care at
a very reasonable cost. After one year, 64 percent of case managed
participants and 50 percent of non-case managed participants were
linked to care. Furthermore, the ARTAS model required only two to three
face-to-face meetings on average with a case manager over a maximum of
three months. The intent of the demonstration project is to determine
how well ARTAS can be implemented locally. Data will be collected at
each local site to determine success rates and costs to implement
linkage case management.
The proposed project should specifically address the following
objectives:
1. To assess and compare linkage to care rates in the existing
referrals program with linkages rates after
[[Page 31385]]
instituting a program of linkage case management in recently HIV-
infected persons in the local area.
2. To evaluate the public health impact, including costs or cost
savings from the project, on local HIV care providers and local
agencies responsible for HIV diagnosis. This program addresses the
``Healthy People 2010'' focus area of HIV.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for HIV, STD and TB
Prevention (NCHSTP): Increase the proportion of HIV-infected people who
are linked to appropriate prevention, care and treatment services.
Performance measure: Increase the proportion of HIV-infected people who
receive some form of medical care within three months of HIV diagnosis.
National target for this measure for FY 2004 is 80 percent.
Measurable outcomes will be in alignment with Strategy number three
of CDC's Advancing HIV Prevention initiative: Prevent new infections by
working with persons diagnosed with HIV.
Activities: Awardee activities for this program are as follows:
To develop, in consultation with CDC, an implementation
plan within 90 days of the award, which specifies how the following
program activities will be carried out:
--Assess the use and availability of HIV-directed case managers in the
local area and determine whether new hires, or re-directed case
managers best achieve the project goals.
--Develop a recruitment plan for connecting HIV-infected persons
recently diagnosed at publicly funded clinics with the case managers
from this project.
--Assess the local publicly funded HIV and sexually transmitted disease
(STD) testing and counseling sites in the local area to determine the
optimum recruitment locations.
--Develop a tracking plan to ensure participants can be located during
the entire required 12-month period.
--Enroll into the project a minimum of 50 (target: 75 percent
underserved) HIV-infected persons within three months of their HIV
diagnoses.
--Abstract participant medical visit and laboratory data from HIV care
provider medical charts to confirm self-reported linkage to care.
To evaluate, with the assistance of CDC, the effect of the
linkage case management program on rates of use of HIV care providers
compared to the existing referrals program rates.
To evaluate, with the assistance of CDC, the overall cost
of linkage case management and the cost per client served.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
Provide technical guidance as needed by the project
through regular site visits and group conference calls.
Arrange separate funding for strengths-based case
management training of the applicant's case managers for the project.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2004.
Approximate Total Funding: $1,750,000.
Approximate Number of Awards: Nine.
Approximate Average Award: $175,000 (This amount is for the first
12-month budget period, and includes both direct and indirect costs.)
Floor of Award Range: None.
Ceiling of Award Range: $275,000 (Ceiling amount will only be
considered if applicant can demonstrate ability to enroll approximately
100 persons. It is anticipated that the average amount will be awarded
to applicants who can demonstrate ability to enroll approximately 50
persons.)
Anticipated Award Date: September 1, 2004.
Budget Period Length: 12 months.
Project Period Length: Two years.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by eligible community-based
organizations (CBO) or state or local governments or their bona fide
Agents. Eligible CBOs must meet all criteria listed below.
A. Have tax-exempt status.
B. Be located in the area(s) where services will be provided or
have provided services in the area for at least three years.
C. Demonstrate a substantial number (more than 50 percent) of
clients currently served are socioeconomically disadvantaged (i.e.,
individuals with no health insurance or with combined annual household
incomes of less than $20,000).
D. Have committed to a Memorandum of Understanding (MOU) with local
health authorities that will ensure ability to recruit recently
diagnosed HIV-infected persons from local health authority clinics as
demonstrated by a letter from the local health authority.
Have sufficient confidential HIV testing and counseling capacity to
enroll these persons as described in `Activities'. The executed MOU
must be submitted to CDC by December 1, 2004. Failure to meet this
deadline will result in suspension of funding.
E. Not be a private or public university or college, or private
hospital.
F. Not be a 501(c)(4) organization.
Eligible state or local governments or their Bona Fide Agents:
Recent CDC Surveillance data indicate the South comprises an increasing
share of the estimated number of new AIDS cases diagnosed each year
compared to the rest of the U.S. In an effort to better address this
disparity by assuring better linkages to care, eligible state or local
government agencies must be from one of the following states: Alabama,
Arkansas, District of Columbia, Florida, Georgia, Kentucky, Louisiana,
Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee,
Texas, Virginia, or West Virginia. If you are applying as a bona fide
Agent of a state or local government, you must provide a letter from
the state or local government as documentation of your status. Place
this documentation behind the first page of your application form.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other Eligibility Information
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying
[[Page 31386]]
activities is not eligible to receive Federal funds constituting an
award, grant, or loan.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity use application form PHS
5161. Application forms and instructions are available on the CDC web
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm
.
If you do not have access to the Internet, or if you have
difficulty accessing the forms online, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Submission
Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: Two
Font size: 12-point unreduced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon
Your LOI must contain the following information:
The proposed principal investigator(s)
The proposed case manager(s), or from where they will be
recruited
The site(s) from which recently diagnosed HIV cases will
be recruited, and their approximate demographic breakdown.
Application: You must submit a project narrative with your
application forms. The narrative must be submitted in the following
format:
Maximum number of pages: 25. If your narrative exceeds the
page limit, only the first pages which are within the page limit will
be reviewed
Font size: 12 point unreduced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Held together only by rubber bands or metal clips; not
bound in any other way
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Overview or Summary
Background and Justification of Need
Objectives
Project Design and Methods (including a timeline and
enrollment and follow-up methods)
Plan for Evaluation
Budget Justification (will not be counted in the stated
page limit)
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit. This additional information includes:
Letter(s) of support from medical provider(s) where
participants will enroll for HIV medical.
Curriculum vitas.
Other letters of support.
Eligibility: Suggested length of ten pages or less.
This section will not count toward the 25 page limit of your
application, but it will determine if you are eligible for funding.
Place all eligibility documents demonstrating eligibility consistent
with section III.1. of this announcement, in Appendix A, labeled Proof
of Eligibility.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-
5711.
For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm
If your application form does not have a
DUNS number field, please write your DUNS number at the top of the
first page of your application, and/or include your DUNS number in your
application cover letter.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
Letter of Intent (LOI) Deadline Date: June 18, 2004.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: July 23, 2004.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline
date. If you send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application after closing due to: (1)
Carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Executive Order 12372 does apply to this program.
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed Federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
.
IV.5. Funding restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
None
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.
[[Page 31387]]
Awards will not allow reimbursement of pre-award costs. Guidance
for completing your budget can be found on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm
.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or E-mail to: Lytt Gardner, CDC/NCHSTP, Mail Stop E-45,
1600 Clifton Rd, Atlanta, GA 30333, Telephone: 404-639-6163, Fax: 404-
639-6127, E-mail: lig0@cdc.gov.
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management-PA 04154, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You are required to provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement. Measures of effectiveness must relate to the
objectives stated at the end of Section I of this announcement.
Measures must be objective and quantitative, and must measure the
intended outcome. These measures of effectiveness must be submitted in
the narrative of the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
1. Ability to recruit and track recently diagnosed HIV-infected
persons not already linked to a care provider. Documentation to
substantiate ability to recruit sufficient number of persons should be
included in an attachment. (30 points)
a. Evidence of ability to recruit, during a 6-month period and
using the existing referral program, at least 25 persons who were
diagnosed with HIV within three months before their recruitment date.
(This constitutes a ``baseline'' or comparison population.)
b. Evidence of ability to recruit, during a 12-month period and
using the new case management program, at least 50 persons who were
diagnosed with HIV within three months before their recruitment date.
(This constitutes the population receiving linkage care management.)
c. Evidence of ability to recruit persons with generally poor
access to health care.
d. Evidence of ability to successfully track and re-interview
project participants.
e. Evidence of ability to collect complete data from project
participants.
2. Documentation that the needs with respect to linkage to care of
recently infected persons are not being met by existing resources. (20
points)
a. Be specific about how this need is not met by existing HRSA or
CDC funding.
b. Applicants are expected to present data or credible estimates of
the percentage of recently diagnosed HIV-infected persons who do not
get quickly linked to a care provider.
3. Description and Justification of Project Plans (25 points)
a. Familiarity and quality of experience pertinent to proposed
public health activities.
b. Understanding of project objectives and activities from Section
I of this announcement, as evidenced by high quality of the proposed
plan.
c. Thoroughness of plans for data management, including medical
record abstraction; reasonableness of data collected; and quality
control measures.
d. Capacity to conduct project as evidenced by the quality of
experience with similar or related work conducted previously, including
demonstration of ability to collect and manage data in a timely manner.
4. Staffing, Facilities and Timeline (25 points)
a. Availability of qualified personnel with realistic and
sufficient percentage time commitments and the clarity of the
descriptions of the duties and responsibilities of project personnel.
b. Adequacy of plans for project oversight to assure quality of
data.
c. Letter(s) of support from medical provider(s) where participants
will enroll for HIV care.
d. Adequacy of facilities, equipment, and systems for management of
data security and patient confidentiality.
e. Adequacy of timeline for completion of project activities.
5. Other (not scored)
a. Budget: Is the budget reasonable, clearly justified, consistent
with the intended use of funds, and allowable? All budget categories
should be itemized.
b. Past Performance: Has the applicant been the recipient of funds
for CDC projects in the past? If so, what was the level of performance?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) staff and for responsiveness by NCHSTP.
Incomplete applications and applications that are non-responsive to the
eligibility criteria will not advance through the review process.
Applicants will be notified that their application did not meet
submission requirements.
An objective review panel will evaluate complete and responsive
applications according to the criteria listed in the ``V.1. Criteria''
section above.
In addition, the following factors may affect the funding decision:
Areas of high HIV/AIDS incidence.
Populations with unique or especially difficult
circumstances.
A balance in the number of awards between CBOs and state
or local government agencies to determine feasibility of implementing
this project in a variety of settings.
V.3. Anticipated Announcement and Award Dates
September 1, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-4 HIV/AIDS Confidentiality Provisions
AR-5 HIV Program Review Panel Requirements
AR-6 Patient Care
AR-7 Executive Order 12372
AR-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
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AR-15 Proof of Non-Profit Status
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting Requirements
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, no less than 90 days before the end of
the budget period. The progress report will serve as your non-competing
continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives
b. Current Budget Period Financial Progress
c. New Budget Period Program Proposed Activity Objectives
d. Budget
e. Additional Requested Information
f. Measures of Effectiveness
2. Financial status report and annual progress report, no more than
90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management or Contract
Specialist listed in the ``Agency Contacts'' section of this
announcement.
VII. Agency Contacts
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact:
Lytt Gardner, CDC/NCHSTP, Mail Stop E-45, 1600 Clifton Rd, Atlanta,
GA 30333, Telephone: 404-639-6163, Fax: 404-639-6127, E-mail:
lig0@cdc.gov.
For financial, grants management, or budget assistance, contact:
Charles Elder, Contract Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2889, E-mail: cfe4@cdc.gov.
Dated: May 27, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-12567 Filed 6-2-04; 8:45 am]
BILLING CODE 4163-18-P