[Federal Register Volume 68, Number 127 (Wednesday, July 2, 2003)]
[Notices]
[Pages 39572-39574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03157]


Public Health Research Accreditation Project; Notice of 
Availability of Funds

    Application Deadline: August 1, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301 and 317(k)(2) of the 
Public Health Service Act, [42 U.S.C. 241 and 247b(k)(2)], as amended. 
The Catalog of Federal Domestic Assistance number is 93.993.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a grant to assess the 
role of accreditation in enhancing the protection of participants in 
public health research. This program addresses the ``Healthy People 
2010'' focus area 23 Public Health Infrastructure.
    The purpose of the program is to assess the role of accreditation 
of human research protection programs to enhance protections afforded 
to persons involved in the full range of public health research 
programs, e.g., epidemiologic research, health services research, and 
social and behavioral intervention research, as well as traditional 
biomedical research and clinical trials. Voluntary accreditation is one 
component of a national oversight system for protection of human 
subjects. The National Bioethics Advisory Commission (2001) and the 
Institute of Medicine (2001, 2002) recommended that a voluntary system 
for accreditation of human research protection programs be initiated 
and evaluated over the next several years.
    This project will result in the development of pilot measures that 
can be used to assess the improvement of the ability of the public 
health infrastructure (such as state and local public health 
departments, schools of public health, and other public health research 
partners) to assess and monitor research involving human subjects. In 
year two, the pilot measures will be implemented in several locations, 
such as state or local health departments, schools of public health, or 
community-based organizations that engage in public health research, 
and will be evaluated for utility and feasibility in the public health 
setting. In year three, the measures will be refined and made available 
to public health research partners to document and evaluate the impact 
of accreditation as a process to improve protection of human subjects 
in public health research.
    Measurable outcomes of the program will be in alignment with the 
performance goals for the CDC Office of Science Policy and Technology 
Transfer.

C. Eligible Applicants

Limited Eligibility

    Assistance will be provided only to a public, private, for-profit, 
or non-profit organization that is currently actively engaged in the 
process of accrediting human research protection programs that 
represent the full range of activities,

[[Page 39573]]

which are applicable to state, and local public health departments.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501c(4) of the Internal Revenue 
Code that engages in lobbying activities is not eligible to receive 
Federal funds constituting an award, grant or loan.

D. Funding

Availability of Funds

    Approximately $100,000 is available in FY 2003 to fund one award. 
It is expected that the award will begin on or about August 1, 2003 and 
will be made for a 12-month budget period within a project period of up 
to three years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Recipient Financial Participation

    Matching funds are not required for this program.

Funding Priority

    Public comments on the proposed Funding Priority are not being 
solicited due to insufficient time prior to the funding date.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the following activities:
    Phase 1--Develop measures for key indicators of accreditation's 
effectiveness and seek agreement from stakeholders on the measures' 
appropriateness with particular emphasis on their use in the public 
health setting. The public health setting here would include state and 
local health departments, schools of public health, and other public 
health research partners, including community-based organizations or 
other non-traditional research partners. Methods might include such 
strategies as:
    1. Prepare a summary of the relevant literature on accreditation 
and quality improvement, bioethics, and biomedical, social science, and 
public health research to identify potential measures of effectiveness.
    2. Convene a steering committee consisting of persons with 
appropriate expertise in human subject research protections, public 
health research, and state or local health department activities. This 
group could also contain liaison representatives from other government 
agencies or departments with interest or expertise in the role of 
accreditation in improving human research protection programs.
    Phase 2--Develop evaluation methods and data collection instruments 
to examine the impact of the accreditation process in public health 
settings. Phase 2 activities will be largely dependent upon the 
measures generated in Phase 1. Evaluation methods should include plan 
for a longitudinal activity in which organizations that seek 
accreditation are evaluated over time as well as a comparison of 
accredited and non-accredited organizations.
    Phase 3--Pilot test the evaluation methods and validate the 
proposed set of outcome measures in a small number of settings. These 
settings should be generally representative of the types of public 
health settings noted above.
    Phase 4--Refine the initial set of outcome measures and evaluation 
methods and make them accessible to a range of interested parties for 
potential implementation.
    Phases 1 and 2 should be undertaken in Year one, with a general 
outline of Phases 3 and 4 provided for Year two and three.

F. Content

Letter of Intent (LOI)

    A LOI is not required for this program.

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than ten pages, double-spaced, 
printed on one side, with one-inch margins, and unreduced 12-point 
font.
    The narrative should consist of a plan to achieve the full purpose 
of project for the three-year project period, a description of the 
qualifications and background of key personnel, a defined set of 
measurable objectives for year one activities, the proposed methods for 
achieving the objectives, a projected timeline to monitor progress, a 
plan for evaluation of project activities, and a proposed budget.

G. Submission and Deadline

Application Forms

    Submit the signed original and two copies of PHS form 398. (OMB 
Number 0925-0001); adhere to the instructions on the Errata Instruction 
Sheet for PHS 398. Forms are available 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) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Time August 1, 
2003. Submit the application to: Technical Information Management--
PA03157, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Applications shall be considered as meeting the deadline if they 
are received before 4 p.m. Eastern Time on the deadline date. Any 
applicant who sends their application by the United States Postal 
Service or commercial delivery services must ensure that the carrier 
will be able to guarantee delivery of the application by the closing 
date and time. If an application is received 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, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application that does not meet the above criteria will not be 
eligible for competition, and will be discarded. The applicant will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant. 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.

[[Page 39574]]

    An independent review group appointed by CDC will evaluate each 
application against the following criteria:
    1. Plan to achieve the purpose of the program: 25 points.
    2. Background and qualifications of staff: 20 points.
    3. Measurable objectives: 15 points.
    4. Adequacy of methods to achieve objectives: 15 points.
    5. Evaluation plan: 15 points.
    6. Timeline: 10 points.
    7. Budget (reviewed, but not scored).

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    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. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    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.
    Send all reports to the Grants Management Specialist identified in 
the ``Where To Obtain Additional Information'' section of this 
announcement.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
program announcement, as posted on the CDC Web site.

AR-10 Smoke-Free Workplace Requirements
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status

    Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC Web site, Internet address: 
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative 
Agreements''.
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: James 
Masone, Contracts Specialist, Procurement and Grants Office, Centers 
for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 
30341-4146, Telephone: 770-488-2736, E-mail address: [email protected].
    For program technical assistance, contact: John R. Livengood, M.D. 
M. Phil., Deputy Associate Director for Science, Office of Science 
Policy and Technology Transfer, Centers for Disease Control and 
Prevention, MS D-50, 1600 Clifton Road, NE., Atlanta, GA 30333, 
Telephone: 404-639-7260, E-mail address: [email protected].

    Dated: June 26, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-16680 Filed 7-1-03; 8:45 am]
BILLING CODE 4163-18-P