[Federal Register Volume 69, Number 107 (Thursday, June 3, 2004)]
[Notices]
[Pages 31381-31384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12565]


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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

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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: 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 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

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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.

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

    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