[Federal Register Volume 69, Number 63 (Thursday, April 1, 2004)]
[Notices]
[Pages 17163-17166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7325]


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

    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