[Federal Register: June 3, 2004 (Volume 69, Number 107)]
[Notices]
[Page 31381-31384]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn04-62]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Simplified Procedures for Routine HIV Screening in Acute Care
Settings
Announcement Type: New.
Funding Opportunity Number: 04156.
Catalog of Federal Domestic Assistance Number: 93.943.
Key Dates: Application Deadline: August 2, 2004.
Executive Summary
Approximately 250,000 people living with HIV in the United States
are undiagnosed. Many persons with AIDS made multiple visits to
hospitals, acute care clinics and managed-care organizations before
their AIDS diagnosis, but were never tested for HIV. These encounters
are missed opportunities for earlier detection of HIV infection. When
HIV testing has been offered on a routine basis (independent of risk
factors or symptoms suggestive of HIV) to patients in high-prevalence,
high-volume acute care settings, many HIV-infected patients have been
identified and the proportion of positive tests has often been equal to
or greater than among publicly funded HIV counseling and testing sites
and sexually transmitted disease (STD) clinics. Such findings suggest
that broader implementation of routine HIV screening in high-prevalence
health care settings is an important component of our national strategy
aimed at identifying persons with undiagnosed HIV infection.
Many patients in high volume, high HIV prevalence acute care
facilities that have implemented routine rapid HIV testing have not
been offered HIV testing because of the limitations imposed by the
required procedures and staffing. Many providers perceive pre-test
discussions as too time-consuming. In addition, it may not be practical
to commit sufficient staff to approach all patients to offer HIV
testing and provide prior counseling during peak time periods.
Prevention counseling may not be appropriate or feasible during many
episodic or acute care visits. Thus, mandatory individual pretest
counseling may be a barrier to offering HIV testing in these settings.
Written brochures, when used to replace formal verbal pretest
discussions, have been shown to increase the numbers of patients who
can be offered HIV testing. In order to be successful in implementing
routine HIV testing programs, pre-test procedures must be simplified to
ensure that large numbers of patients can be screened for HIV in busy
clinical settings.
The goal of this program is to examine changes in pre-test
screening and education procedures which may increase the number of
patients who test for HIV and who receive their results. The objectives
of this program are to modify procedures and materials for providing
pre-test information and to evaluate the feasibility, acceptability,
and success of these simplified procedures at the participating
site(s).
I. Funding Opportunity Description
Authority: This program is authorized under the Public Health
Service Act, sections 301, 311, and 317 (42 U.S.C sections 241, 243
and 247(b)), as amended.
Purpose: The purpose of the program is to develop and evaluate
simplified procedures and materials to improve the programmatic success
of existing routine HIV screening projects in acute care settings.
Simplified procedures are necessary to ensure that large numbers of
patients can be screened for HIV in busy clinical settings. This
program addresses the ``Healthy People 2010'' focus area(s) of HIV.
Measurable outcomes of the program will be in alignment with one (or
more) of the following performance goal(s) 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.
Activities
Awardee activities for this program are as follows:
Modify the facility's existing procedures for HIV pre-test
education and recruitment in order to increase the number of patients
tested and who receive their results, by developing materials or
procedures such as brochures, posters, videos, or group waiting room
activities to promote routine HIV screening and provide pre-test
information.
Continue to routinely offer rapid HIV testing to patients
in the acute care center with the modified pre-test procedures.
Assess the programmatic outcomes of the modified
procedures (e.g., number of patients offered testing, number of
patients accepting testing, number of patients tested, number of newly
diagnosed HIV infections, seropositivity rate among persons tested).
Periodically provide CDC with these data.
Assess patient and provider satisfaction with the modified
procedures.
Assess patient comprehension of pre-test messages
delivered through modified materials relative to existing procedures.
Utilize program data to revise the procedures to improve
the project's effectiveness.
Participate in conference calls, meetings, and site
visits.
Collaborate with CDC to disseminate the findings and
details on modified procedures and materials.
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 the modified pre-
test counseling procedures, activities, and printed materials.
Provide guidance and assistance in the development of data
collection instruments as well as data management systems and
procedures.
Facilitate conference calls, grantee meetings, and site
visits.
Assist in the analysis and dissemination of findings.
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: $120,000.
Approximate Number of Awards: One-Two.
Approximate Average Award: $60,000-$120,000 (This amount includes
both direct and indirect costs).
Floor of Award Range: $60,000.
Ceiling of Award Range: $120,000.
Anticipated Award Date: September 1, 2004.
Budget Period Length: 12 months.
Project Period Length: one year.
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
[[Page 31382]]
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 public and private nonprofit
organizations or by governments and their Bona Fide Agents, such as:
Universities
Colleges
Research institutions
Hospitals
Community-based organizations
State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau)
Political subdivisions of States (in consultation with
States)
A Bona Fide Agent is an agency/organization identified by the State
as eligible to submit an application under the State eligibility in
lieu of a State application. 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
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.
Eligibility will be limited to organizations that are currently
conducting a systematic evaluation of the implementation of routine
rapid HIV testing in high volume, high HIV prevalence acute care
facilities. Facilities must have implemented procedures for routine,
voluntary HIV screening with rapid HIV tests consistent with CDC's
Program Announcement 01187, entitled, ``Routinely recommending HIV and
STD Counseling and Testing in Ambulatory Care Clinics and Emergency
Rooms'' (the program announcement and examples of protocols developed
by successful applicants are available for review at [Web site]).
Applicants must have conducted such a program for a minimum of four
months by the time of application and collected data throughout this
time period regarding the numbers of patients who were seen in the
facility, were offered HIV testing, accepted testing, were tested, and
were newly diagnosed with HIV. Only these facilities will have
historical data regarding the barriers and outcomes of current
procedures, which will be required for comparison to modified
procedures.
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 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 on-line, 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 program 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
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: Background and Need, Objectives, Methods, Monitoring and
Evaluation, Timeline, Staffing, Budget Justification. The 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:
Curriculum Vitaes, Organizational Charts, Letters of
Support and commitment indicating the funding basis for the routine HIV
screening program upon which this project will be based, etc.
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
Application Deadline Date: August 2, 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
[[Page 31383]]
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:
Funds may not be used for the purchase of HIV testing
kits. Funds are to be used for developing and evaluating modified
procedures, not to provide the entire financial basis for the HIV
screening program. Applicants must demonstrate that there is a
mechanism in place to support routine HIV screening activities.
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.
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
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management-PA--04156, 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:
1. Background, Need, and Objectives (20 Points)
Does the applicant summarize pertinent data from ongoing activities
and outcomes regarding the implementation of routine rapid HIV testing
in acute care facilities? Does the applicant use existing programmatic
data to identify goals and propose modifications consistent with the
objectives of this project? Does the applicant identify potential
alterations to the existing procedures that are likely to increase the
number and proportion of patients tested for HIV? Does the applicant
discuss the potential effectiveness of these modifications? Are goals
and objectives for the program modifications and evaluations clearly
stated? Are the objectives reasonable and measurable?
2. Methods (30 Points)
Are the proposed methods scientifically sound and appropriate to
the program objectives and the time frame of the project period? Do
they demonstrate an understanding of the issues to be addressed and
evaluated? Are they feasible? Does the applicant describe how the
proposed procedures differ from the existing pre-test activities and
procedures conducted according to standard procedures? Will the
proposed methods and changes accomplish the program goals? Are the
methods designed to utilize feedback and revise and improve program
effectiveness?
3. Monitoring and Evaluation (30 Points)
Does the applicant provide a plan for evaluating the effectiveness
of the programmatic changes? Is the project designed in such a way that
the assessment of satisfaction will not interfere with the assessment
of programmatic outcomes of the new procedures? Can the outcomes be
compared to those from the prior project activities?
4. Capacity (20 Points)
Does the applicant have sufficient facilities and the staff to
conduct this project and the ability to train the necessary staff? Does
the institution support a routine approach to HIV screening? Does the
applicant demonstrate that a mechanism is in place to fund routine HIV
screening activities, such that awarded funds will be used to develop
and evaluate modified procedures rather than to provide the entire
financial basis for the screening program per se?
5. Budget (Not Scored)
Is the budget reasonable and justification adequate for the
proposed activities?
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:
Preference will be given to organizations who have demonstrated their
ability to implement and evaluate existing programs which evaluate the
routine use of rapid HIV tests in high prevalence, high volume acute
care facilities.
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.
[[Page 31384]]
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-15 Proof of Non-Profit Status
AR-24 Health Insurance Portability and Accountability Act
Requirements
AR-25 Release and Sharing of Data
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: Sheryl Lyss, MD,
Extramural Project Officer, Division of HIV/AIDS Prevention, National
Center for HIV/STD and TB Prevention, 1600 Clifton Road, MS E-46,
Atlanta, Georgia 30333, Telephone: (404) 639-2093, E-mail:
SLyss@cdc.gov.
For financial, grants management, or budget assistance, contact:
Julia Valentine, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone:
(770) 488-2732, E-mail: jvx1@cdc.gov.
Dated: May 27, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-12565 Filed 6-2-04; 8:45 am]
BILLING CODE 4163-18-P