[Federal Register: June 23, 2004 (Volume 69, Number 120)]
[Notices]
[Page 35035-35039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Demonstration Projects for Implementation of Rapid HIV Testing in
Historically Black Colleges and Universities and Alternative Venues and
Populations
Announcement Type: New.
Funding Opportunity Number: 04158.
Catalog of Federal Domestic Assistance Number: 93.943.
DATES: Application Deadline: July 23, 2004.
SUMMARY: The purpose of this project is to demonstrate new models for
diagnosing HIV infection, a priority strategy in the context of the
Advancing HIV Prevention Initiative (AHP). AHP is aimed at reducing the
number of new infections caused by Human Immunodeficiency Virus (HIV)
each year in the United States by emphasizing greater access to HIV
testing and provision of prevention and care services for persons
infected with HIV. Demonstration projects will be funded to show the
feasibility, and demonstrate best methods of, integrating routine HIV
testing programs (including rapid testing), in a variety of venues.
Current HIV screening programs rely on individual, provider-
administered assessments of risks for HIV infection, and do not
identify risks which would indicate HIV testing for all HIV-infected
persons. The alternative to individual risk assessment is the offering
of HIV testing on a routine basis. Where routine offering of HIV
testing has been utilized in areas with high HIV prevalence, the rate
of HIV positive tests (two to seven percent in hospitals and emergency
rooms) is similar to or exceeds that observed nationally in publicly
funded HIV counseling and testing sites (two percent) and Sexually
Transmitted Disease (STD) clinics (1.5 percent). HIV prevalence among
persons tested in outreach settings is also consistently higher than
among those tested at traditional testing clinics.
Historically, many persons tested in outreach settings never
receive their test results. Because results of rapid HIV tests are
available within 30 minutes, rapid HIV testing offered routinely in a
variety of clinical settings and outreach efforts in nonclinical
settings in high-risk communities has the potential to both reach
persons at high-risk for HIV infection and to ensure that they will
receive their test results.
The first part of this announcement describes a funding opportunity
for demonstration projects to provide rapid HIV testing at Historically
Black Colleges and Universities (HBCUs). Recent presidential
proclamations support the development of research aimed at, and
resources earmarked for HBCUs. There are between 102 and 118 HBCUs in
the US, mostly in the South. The collective African-American student
body of these schools exceeds 150,000 with an approximate age range of
18-35.
New and innovative HIV prevention programs that focus on young
African American college students are needed; this is made clear by the
epidemiology of HIV in the United States, and by a recently identified
cluster of HIV infections among young African American male college
students attending HBCUs in the South. Black males (and to a lesser
extent Black females), ages 18-44 are the racial/ethnic group most
disproportionately affected by HIV in the entire United States. A
recent cluster of HIV infections among black male college students in
North Carolina underscored the urgency of focusing attention and
prevention efforts on young adults who may not have been previously or
adequately served by HIV prevention programs.
CDC will use findings from these demonstration projects to design
and implement HIV/AIDS prevention messages and activities in diverse
settings, and serving diverse populations.
The second part of this announcement includes new strategies to
identify HIV positive persons in order to provide assistance for
linkage to treatment, care and prevention services. Because many newly
diagnosed HIV positive persons have received care in medical settings
in the year preceding their diagnosis without being offered HIV
testing, diverse medical settings are the focus of the second part of
this announcement. CDC will support primary care clinics, or
alternative medicine clinics (homeopathic, naturopathic or
chiropractic), that service high risk populations and/or communities,
to develop demonstration projects to offer HIV testing to their
clients. The Primary Care clinics will include, but will not to be
limited to: public or private health centers; ambulatory clinics; WIC
clinics; managed care organizations; or other primary care facilities,
either affiliated with a university, health department, or community
based organization.
The third part of the announcement focuses on Native Americans,
migrant farm workers and pre-or post-operative transgendered persons.
These are communities that are disproportionately affected by HIV or
are at increased risk for emerging HIV epidemics because of high levels
of risk behaviors associated with HIV transmission. We will fund health
departments and community based organizations to create projects to
demonstrate new outreach models for rapid HIV testing in these
populations.
I. Funding Opportunity Description
Authority: This program is authorized under the Public Health
Service Act sections 301, 311, and 317 (42 U.S.C. 241, 243 and
247(b)), as amended.
Purpose: The purpose of the program is to: (PART 1) introduce rapid
HIV testing programs to serve attendees of HBCUs and Hispanic Serving
Institutions (HSIs); (PART 2) develop and evaluate new models for
providing rapid and conventional HIV testing into clinical venues that
have not offered routine HIV screening in the past in high risk
communities ; and (PART 3) introduce rapid HIV testing in clinical
[[Page 35036]]
and nonclinical settings that serve three specific populations
disproportionately affected by HIV: Native Americans, migrant worker
populations, and pre-or post-operative transgendered persons.
Organizations may apply for one or more parts of this announcement.
This program addresses the AHP goals of CDC's initiative, Advancing HIV
Prevention: New Strategies for a Changing Epidemic, aimed at reducing
barriers to early diagnosis of HIV infection and increasing access to
quality medical care, treatment, and ongoing prevention services for
those diagnosed with HIV. This program addresses the ``Healthy People
2010'' focus area of identifying new HIV infections.
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): Strengthen the capacity nationwide to monitor the
epidemic, develop and implement effective HIV prevention interventions
and evaluate prevention programs. In addition, this program addresses
the Division of HIV/AIDS Prevention priorities: Develop new methods for
diagnosing HIV infection, and institute integrated surveillance with
emphasis on incidence, behavioral surveillance, and evaluation.
Activities: Activities for awardees under any part of this program
are as follows:
Develop a program plan in collaboration with CDC and other
participating sites.
Conduct routine HIV testing (using HIV rapid tests or
conventional HIV screening tests depending on venue) in the funded
facilities and for the funded populations. For these facilities, offer
HIV testing to all patients between 18 and 49 years of age during the
project year.
Throughout the project, keep detailed records of barriers
and successes in developing an HIV testing program within the
population targeted or venue, to serve as guidance on how to create and
implement similar programs in other venues.
Collect and maintain a database of information linked to
screening and confirmatory tests, including data routinely collected on
patient characteristics, testing site, HIV test(s) performed, reasons
for refusal of testing, modes of follow up and results of follow up,
disposition of clients with confirmed positive tests with respect to
services received, and other information deemed necessary by CDC and
grantees. For persons with confirmed positive HIV tests, additional
information will be collected at the time of receipt of confirmatory
tests and at some point after (e.g., six months) to determine potential
and actual barriers to access to care and other qualitative information
deemed important by funded organizations, the CDC and grantees.
Develop a plan for evaluation of the project in
conjunction with CDC, and conduct evaluations of the project near the
end of the project period. Evaluations may include process outcomes
such as numbers of clients tested and seropositivity rates, as well as
comparisons to historical data on HIV testing in the facility or a
description of uptake of testing by the populations served.
Participate in periodic conference calls, site visits and
grantee meetings with other funded sites and the CDC.
Disseminate findings jointly with CDC and other
participating sites.
In addition to the above activities, grantees for Part 1 may
propose the following:
During the first 6 months of the project period, develop
and conduct a focus program of formative research to determine factors
or services which might contribute to increasing acceptance of testing
among students attending HBCUs.
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:
Assist in the development and review of required program
plans, protocols, evaluation plans, and data collection tools.
Provide guidelines for HIV counseling and testing and for
rapid HIV testing.
Provide guidance and assistance in the development of data
management systems and procedures.
Facilitate conference calls, grantee meetings, and site
visits.
Assist in the analysis and dissemination of single-site
and multi-site data.
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: $ 2,480,020.
Approximate Number of Awards:
Part 1: Two to three awards for the development of rapid HIV
testing programs for attendees of HBCUs.
Part 2: Up to four awards for routine HIV testing in primary care
clinics, community health centers, managed care organizations and
alternative health clinics.
Part 3: Four to six awards for rapid HIV testing in
disproportionately affected populations.
Approximate Average Award:
Part 1: Historically Black Colleges and Universities: $250,000.
Part 2: Primary care clinics and alternative health clinics:
$250,000.
Part 3: Native American, migrant farm workers, and pre- or post-
operative transgendered persons: $250,000.
Floor of Award Range: None.
Ceiling Award Range: None.
Anticipated Award Date: September 1, 2004.
Budget Period Length: 12 months.
Project Period Length: 12 months.
III. Eligibility Information
III.1. Eligible Applicants
Part 1. Applications may be submitted by:
Historically Black Colleges and Universities
Community-based organizations serving or collaborating with
HBCUs
Part 2. Applications may be submitted by public and non-profit
organizations, such as:
Community-based organizations
Primary care clinics, either free-standing or in affiliation
with hospitals
Community Health Centers
Managed care organizations
Private non-profit organizations
Part 3. Applications may be submitted by:
Federally recognized Indian tribal governments
Indian tribes
Indian tribal organizations
Community based organizations
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
CDC will accept and review applications with budgets greater than
the ceiling of the award range.
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.
Part 1: For HBCUs, applicants must be colleges and universities
with at least 50% Black enrollment and having a total student
enrollment of at least 5,000 full and part time students. HBCUs who do
not meet the minimum enrollment criteria may submit applications with
strategies to include 2 or more HBCUs
[[Page 35037]]
located in the same geographic area in order to meet minimum enrollment
requirements. In this latter case, one HBCU should take the lead on
developing the proposal for submission.
This announcement is not intended to provide funds to support
direct instruction or curriculum implementation and training, nor are
they intended to solely provide resources for HIV counseling and
testing in the student health center, although this may be part of a
larger strategy for providing HIV counseling and testing to this
population.
For community based organizations who apply for Part 1, a letter of
collaboration or support from an HBCU or HBCUs serving a total
enrollment of at least 5,000 full or part time students must be
included.
Part 2: Preference will also be given to programs that propose
routine screening rather than targeted HIV testing or HIV testing based
on risk assessment. Preference will be given to programs that propose
to implement HIV testing with existing clinical staff. Additional non-
clinical staff, for example for data collection or entry, may be
proposed.
Health care settings that already routinely offer HIV testing to
all patients (e.g., sexually transmitted disease clinics) will not be
considered. Primary care clinics affiliated with hospitals and managed
care organizations are encouraged to apply.
Alternative health care facilities must be able to document at
least 3,000 patient visits per year, be staffed by two or more
clinicians, and demonstrate that the facility serves high risk
populations. Alternatively, a high HIV prevalence in the population
served by the facility may be demonstrated by satisfying at least one
of the criteria listed below.
High HIV prevalence may be demonstrated by: (1) HIV prevalence data
demonstrating prevalence of at least one percent in the population
served by the facility; (2) HIV or AIDS diagnosis rate of at least one
per thousand hospital discharges for health centers and clinics in the
referral network for the hospital; (3) eligibility for Title II Ryan
White Care Act funds; (4) comparison data demonstrating that the
facility's patient population is similar to that of other medical care
facilities with HIV/AIDS prevalence rates of at least one percent; (5)
demonstration that the facility serves a high risk population.
Part 3: Preference will be given to programs that propose routine
screening rather than targeted HIV testing or HIV testing based on risk
assessment. Preference will be given to programs that propose to
implement HIV testing with existing clinical staff. Additional non-
clinical staff, for example for data collection or entry, may be
proposed.
For populations of Native Americans and migrant farm workers,
outreach programs must be able to identify and test a minimum of 1000
persons per year in outreach or clinical settings from the population
of interest, preferably using the HIV rapid test. For pre-or post-
operative transgendered persons, outreach programs must be able to
identify and test a minimum of 250 persons per year in outreach or
clinical settings from this population. Primary care or specialty
medical clinics that primarily serve these populations are encouraged
to apply.
CBOs and Indian tribes are encouraged to apply and should
collaborate with their respective Health Departments and other
appropriate organizations. If non-tribal organizations apply to work
with American Indian populations, they must show a past record of
collaboration with these populations.
In addition, organizations should coordinate program activities
with health department HIV/AIDS programs, and comply with all health
department requirements regarding HIV counseling, testing and referral;
HIV/AIDS reporting; partner counseling and referral services; and other
program activities. Funded organizations should collect and report all
information required by the health department related to services
provided under this announcement.
Note: Title 2 of the United States Code 1611 states that an
organization described in section 501(c)(4) of the Internal Revenue
Code that engages in lobbying 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
Application: You must submit a project narrative with your
application forms. The narrative must be submitted in the following
format:
Maximum number of pages: [20] 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
Double spaced
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: Understanding of the Need; Objectives; Methods; Timeline;
Evaluation Plan; Staff; Budget and Justification.
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit. This additional information includes: resumes of key staff;
staffing plans; training agreements and other memoranda of
understanding to assure that linkages with other appropriate
organizations are in place; descriptive information regarding the
applicant's organization or affiliated programs, i.e., pamphlets,
brochures, other documents; appropriate reference materials to support
applicant's application, i.e., publications concerning risk within the
communities served by the organization; references from other funding
organizations that have previously funded the applicant for HIV
prevention projects.
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. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. 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
[[Page 35038]]
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
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
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:
Awards will not allow reimbursement of pre-award costs.
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.
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
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management-PA 04158, 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
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria,
whether you are applying to Part 1, Part 2 or Part 3:
1. Methods (40 points): Are the proposed methods feasible? Will
they accomplish program goals? Can the proposed methods for offering
routine testing be sustainable by existing staff after the project
period (especially important for Part 2)? Does the applicant describe a
plan for routinely recommending voluntary HIV testing in the identified
setting or to the identified populations; the process for promoting and
offering rapid or conventional HIV tests; the setting in which HIV
counseling, testing, and referral services will be provided; clearly
defined mechanisms for referral into care, treatment, and prevention
services for patients testing positive for HIV; training for project
staff; a reasoned approach of how to contact clients when necessary to
ensure receipt of confirmatory test results for all positives; and a
system for reporting HIV-positive test results to the health
department, where required? Is a time line with realistic and
measurable milestones for major project activities provided?
2. Capacity (20 points): Does the applicant have the appropriate
facilities and staff to conduct this program? Is adequate and objective
information provided to demonstrate the availability of sufficient
numbers of clients and sufficient prevalence of HIV risk behaviors or
rates of seroprevalence in the populations being targeted? Is the
project director well qualified, by education and experience, to lead
the project team, hire and train appropriate staff, and provide
programmatic and scientific oversight? Has the applicant established
relationships to assure oversight, supervision, and regulatory
compliance for rapid HIV testing?
3. Objectives (20 points): Are the objectives reasonable, time-
phased and measurable? Does the applicant provide reasonable methods to
evaluate their progress toward the timely accomplishment of objectives?
4. Evaluation (20 points): Are evaluation methods described? Are
the outcome measures clearly related to the objectives? Are the types
of process and outcome data proposed in the evaluation plan readily
collected? To determine the effectiveness of the program, does the
applicant have access to counseling and testing data for their area to
serve as a comparison group; or does the applicant intend to use data
from existing counseling and testing programs within the proposed
venue(s) as a comparison group; or does the applicant intend to compare
different methods of delivering counseling and testing programs to a
particular population or in a particular venue?
5. Budget (not scored): Is the budget reasonable for the proposed
activities? Does the budget allow for sufficient time--approximately
three to six months--for the development of the program plan and review
by CDC and other entities?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) staff and for responsiveness by the National
Center for HIV/STD/TB Prevention, Division of HIV/AIDS Prevention.
Incomplete
[[Page 35039]]
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.
Applicants may apply for any or all of the target populations or
settings. A separate application should be submitted for each setting
or population proposed. Applications from each target population will
be evaluated independently by the objective review panel and will be
ranked against applications from the same target population according
to the Evaluation Criteria.
In addition, the following factors may affect the funding decision:
Preference will be given to applicants who propose settings which
will provide a diverse ethnic, racial or risk population with regard to
the overall selection of venues participating in the demonstration
projects.
V.3. Anticipated Announcement and Award Dates
Awards will be issued on or about 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-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
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-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
AR-15 Proof of Non-Profit Status
AR-21 Small, Minority, and Women-Owned Business
AR-24 Health Insurance Portability and Accountability Act
Requirements
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 first 12-month 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, 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 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: Scott Kellerman, MD,
MPH, Extramural Project Officer, 1600 Clifton Road, MS E-46, Atlanta,
Georgia 30333, Telephone: 404-639-4484, E-mail: SKellerman@CDC.GOV.
For financial, grants management, or budget assistance, contact:
Betty Vannoy, Contract Specialist, CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2897, E-
mail: bbv9@cdc.gov.
Dated: June 16, 2004.
William Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-14174 Filed 6-22-04; 8:45 am]
BILLING CODE 4163-18-P