[Federal Register Volume 69, Number 107 (Thursday, June 3, 2004)]
[Notices]
[Pages 31384-31388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12567]


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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: [email protected].
    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

[[Page 31388]]

     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: 
[email protected].
    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: [email protected].

    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