[Federal Register: April 1, 2004 (Volume 69, Number 63)]
[Notices]
[Page 17163-17166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap04-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Evaluation of the Use of Rapid HIV Testing in the United States
Announcement Type: New.
Funding Opportunity Number: 04138.
Catalog of Federal Domestic Assistance Number: 93.941.
Key Dates:
Letter of Intent Deadline: May 3, 2004.
Application Deadline: June 1, 2004.
I. Funding Opportunity Description
Authority: This program is authorized under section 317(k)(2) of
the Public Health Service Act, 42 U.S.C. section 247b(k)(2), as
amended.
Purpose: The purpose of the program is to evaluate how rapid tests
for HIV are being implemented and used in clinical practice and
identify potential opportunities to provide guidance to assist sites in
making decisions on the appropriate use of these tests. Rapid HIV
testing is a new and growing segment of laboratory testing and of HIV
diagnosis in this country. These tests can be used in place of the more
complex and time-consuming conventional enzyme immunoassay screening
tests. Rapid tests can provide test results in a single patient visit,
providing earlier opportunities for intervention and decreasing the
percentage of HIV-infected people who fail to learn their status using
the multi-visit algorithm. Several new rapid HIV tests have been
approved by the United States Food and Drug Administration (FDA) during
the past year (Reveal TM Rapid HIV-1 Antibody Test,
OraQuick[reg] Rapid HIV-1 Antibody Test, and Uni-gold TM
Recombigen[reg] HIV) and others are in the FDA pipeline. The OraQuick
test has been waived from the bulk of the regulatory requirements of
the Clinical Laboratory Improvement Amendments (CLIA) and is being
implemented in sites that have not typically performed testing before,
such as outreach clinics, community-based organizations (CBO), and
mobile units. The other two tests are currently categorized as moderate
complexity under CLIA, thus requiring users to meet CLIA requirements
for non-waived testing, at minimum.
In an effort to assure safe and effective use of these devices, the
FDA specified restrictions for their sale and distribution. These
restrictions are as follows (from the manufacturer's package insert):
1. ``Sale of the test is restricted to clinical laboratories that
have an adequate quality assurance program, including planned
systematic activities to provide adequate confidence that requirements
for quality will be met and where there is assurance that operators
will receive and use the instructional materials.
2. The test is approved for use only by an agent of a clinical
laboratory;
3. Test subjects must receive the ``Subject Information'' leaflet
prior to specimen collection, and appropriate information when test
results are provided;
4. The test is not approved for use to screen donors of blood,
plasma, cells or tissues.''
Since HIV testing is an integral part of HIV diagnosis and
surveillance, Centers for Disease Control and Prevention (CDC) also has
an interest in ensuring patient safety and the appropriate use of rapid
HIV testing. This project will be helpful in determining whether sites
using these tests are following the FDA sales restrictions and meeting
CLIA requirements, as well as whether there is a need for additional
guidance to improve test utilization and testing quality.
This program addresses the ``Healthy People 2010'' focus area(s) of
(1) Reducing the burden of HIV infection and the rate of increase of
new infections; and (2) Access to Quality Health Services.
Measurable outcomes of the program will be in alignment with the
following performance goal for the Public Health Practice Program
Office (PHPPO): Assure the public health infrastructure at the Federal,
State and local levels has the capacity to provide essential public
health services to the citizens of the nation to respond to
bioterrorism, other infectious disease outbreaks, and other public
health threats and emergencies and prepare frontline state and local
health departments and laboratories to respond to current and emerging
public health threats.
Activities:
Awardee activities for this program are as follows:
Provide leadership in developing a program to
determine the scope of rapid HIV test utilization, including the number
of sites where rapid HIV tests are offered, the specific tests used,
testing volume, purpose for testing, patient populations, and other
characteristics related to the sites where rapid HIV testing is being
implemented and used.
Evaluate how these tests are integrated into the
health delivery system, for example methods used for specimen
collection and handling, results reporting, confirmation of preliminary
positive results, and use of results by practitioners.
Assess the practices used to assure quality
(e.g., quality control and quality assurance) and testing personnel
training and competency.
Catalog problem sites that have been identified
and reported using these tests, such as follow-up on preliminary
positives, false positive or negative results, testing delivery, costs
of testing, provision of training to testing personnel.
Evaluate the financial costs associated with
using rapid and conventional (enzyme immunoassay) HIV screening tests
in various types of practice settings.
Recommend specific interventions, such as
practice guidelines or training that could improve the utilization and
quality of testing using rapid tests.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
[[Page 17164]]
CDC Activities for this program are as follows:
Assist the Awardee in identifying sites using
rapid HIV tests.
Provide background information on accepted
practices and guidelines for HIV testing.
Provide technical assistance with the
development of data collection instruments.
Identify subject matter experts on HIV testing
and promote collaboration.
Work with the Awardee to identify potential
systematic interventions to promote quality improvement.
If requested, provide a Health Economist to
assist with economic evaluations.
Collaborate in analyzing the data and
information collected and in preparing written summaries.
Assist in the preparation of manuscripts for
peer-reviewed publications.
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: $ 200,000.
Approximate Number of Awards: one.
Approximate Average Award: $ 200,000 (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: $200,000 (This ceiling is for the first 12-
month budget period.).
Anticipated Award Date: September 1, 2004.
Budget Period Length: 12 months.
Project Period Length: Three years.
Throughout the project period, CDC's commitment to the 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 public and private nonprofit
organizations and by governments and their agencies, such as:
Public nonprofit organizations.
Private nonprofit organizations.
Universities.
Colleges.
Research institutions.
Community-based organizations.
Faith-based organizations.
Federally recognized Indian tribal governments.
Indian tribes.
Indian tribal 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. Your application should indicate the extent of
your experience in working with clinical laboratories.
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
Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: Five.
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.
Written in plain language, avoid jargon.
Your LOI must contain the following information:
Goals and objectives.
Methods and Technical Approach.
Project Management and Staffing.
Budget--total funds to be requested.
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.
Double spaced.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Purpose and Need.
Goals and Objectives.
Methods and Technical Approach.
Project Management and Staffing.
Measures of effectiveness to demonstrate
accomplishment of program activities.
Timeline.
Evaluation Plan.
Required Resources with budget and
justification.
Performance Measures.
Note: the budget and performance measures sections will not
count toward the page limitation.
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, Resumes, and Organizational
Charts.
Letters of Support.
References.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a
[[Page 17165]]
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
LOI Deadline Date: May 3, 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: June 1, 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.
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.
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: Tracy L. Carter, M.P.H., Laboratory Program
Specialist, Centers for Disease Control and Prevention, PHPPO/DLS
Mailstop G-25, 4770 Buford Highway, Atlanta, GA 30341, Telephone: 770-
488-2523, Fax: 770-488-8282, E-mail: tsc1@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 04138, 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. Methods and Technical Approach (30 points).
a. Does the applicant clearly and succinctly describe the steps to
be taken in the planning and implementation of the proposed cooperative
agreement?
b. Are the methods to be used to carry out the responsibilities of
the proposed cooperative agreement feasible and explained in sufficient
detail?
2. Project Management and Staffing (30 points).
a. Does the applicant describe a project management and staffing
plan, and demonstrate sufficient knowledge, expertise, and other
resources required to perform the responsibilities in this project?
b. Does the applicant describe the staff qualifications and time
allocations of key personnel to be assigned to this project, facilities
and equipment, and other resources available for performance of this
project?
3. Goals and Objectives (20 points).
a. Does the applicant clearly describe an understanding of the
objectives of this project, the relevance of the proposal to the stated
objectives, and any unique characteristics of populations to be
studied?
b. Are the goals and objectives measurable, specific, and
achievable?
4. Evaluation Plan and Timeline (20 points).
Does the applicant describe the schedule for accomplishing the
activities to be carried out in this project and methods for evaluating
the accomplishments?
5. Proposed Budget (reviewed but not scored).
Is the proposed budget reasonable, clearly justified, and
consistent with the intended use of funds?
6. Performance Goals (reviewed but not scored).
Is the application consistent with the Government Performance and
Results Act of 1993?
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 PHPPO.
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
[[Page 17166]]
listed in the ``V.1. Criteria'' section above.
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-10 Smoke-Free Workplace Requirements.
AR-11 Healthy People 2010.
AR-12 Lobbying Restrictions.
AR-15 Proof of Non-Profit Status.
Executive Order 12372 does apply to this
announcement.
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, 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: James V. Lange, Ph.D.,
Project Officer, Centers for Disease Control and Prevention, PHPPO/DLS
MS G-23, 4770 Buford Hwy, Atlanta, GA 30341-3717, Telephone: 770-488-
8096, E-mail: JLange@cdc.gov.
For financial, grants management, or budget assistance, contact:
Sharon Robertson, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2748, E-mail: sqr2@cdc.gov.
Dated: March 26, 2004.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-7325 Filed 3-31-04; 8:45 am]
BILLING CODE 4163-18-P