[Federal Register Volume 69, Number 123 (Monday, June 28, 2004)]
[Notices]
[Pages 36091-36093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


State Health Fraud Task Force Grants; Availability of Funds for 
Fiscal Year 2004: Request for Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for State Health Fraud Task Force Grant 
Program support. Grant funds will be used to assist law enforcement 
agencies in identifying and prosecuting perpetrators of health fraud; 
obtain and disseminate information on the use of fraudulent drugs and 
therapies; disseminate information on approved drugs and therapies; and 
provide health fraud information obtained by the State Health Fraud 
Task Force to State health agencies, community based organizations, and 
FDA staff. Approximately $300,000 will be available for this program in 
fiscal year 2004. FDA anticipates making approximately 20 awards, not 
to exceed $15,000 in direct costs only per award per year. Support of 
these grants will be for up to 3 years. The number of grants awarded 
will depend on the quality of the applications received and the 
availability of Federal funds to support the grant. These grants are 
not intended to fund food, medical device, or drug inspections.

DATES:  The application receipt date is August 12, 2004.

ADDRESSES:  Application kits are available from, and completed 
applications should be mailed, hand-carried, or commercially delivered 
to Cynthia M. Polit, Division of Contracts and Grants Management (HFA-
531), Food and Drug Administration, 5630 Fishers Lane, rm. 2142, 
Rockville, MD 20852, 301-827-7180, e-mail: [email protected]. 
Application forms PHS-5161-1 (7/00) are available via the Internet at 
http://www.psc.gov/forms. Do not send the application to the Center for 
Scientific Review, National Institutes of Health (NIH). An application 
not received by FDA in time for orderly processing will be returned to 
the applicant without consideration. FDA cannot receive an application 
electronically.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Cynthia M. Polit (see addresses).
    Regarding the programmatic aspects of this notice: Stephen Toigo, 
Division of Federal-State Relations (HFC-150), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6906, 
e-mail: [email protected]. Internet site: http://www.fda.gov/ora/fed_state/default.htm.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA will support projects covered by this notice under sections 
1702 through 1706 of title XVII of the Public Health Service Act (42 
U.S.C. 300u-1 through 300u-5). FDA's project program is described in 
the Catalog of Federal Domestic Assistance, No. 93.447, and applicants 
are limited to States that have an existing State Health Fraud Task 
Force or States that are in the process of developing a task force.
    Only one award will be made per State. A fiscal agent, who will be 
responsible for the administrative responsibilities for grant funds to 
conduct their activities, must be identified on the application. A 
program director, also known as the State Health Fraud Task Force 
Chair, must be identified as being responsible for submission of the 
application, and a complete listing of all State Health Fraud Task 
Force members and their credentials must be included in the 
application.

II. Background

    The mission of the State Health Fraud Task Force is as follows: (1) 
To assist health professionals and persons with serious illnesses and 
to educate them about the dangers and magnitude of health fraud; (2) to 
assist law enforcement agencies in identifying and prosecuting 
perpetrators of health fraud; (3) to obtain and disseminate information 
on the fraudulent drugs and therapies being used and the consequences 
of their use; (4) to disseminate information on approved drugs and 
therapies; and (5) to provide health fraud information obtained by the 
State Health Fraud Task Force to State health agencies, community based 
organizations, and FDA staff.

III. Project Goals, Definitions, and Examples

    State Health Fraud Task Force grants will be awarded only for 
direct costs incurred to accomplish the mission of the State Health 
Fraud Task Force Program in educating and combating health fraud.
    Examples of direct costs may include the following items: (1) 
Conferences/workshops sponsored by the task force, (2) development of 
public service announcements/campaigns, (3) health fraud brochures, and 
(4) travel expenses for face-to-face State Health Fraud Task Force 
meetings. Grant funds may be used to cover the cost of the program 
director, or task force chair, to attend one non-FDA sponsored health 
fraud related meeting and one FDA-sponsored National Health Fraud Task 
Force Steering Committee meeting per year. Grant funds may not be used 
to purchase meals in conjunction with any activities sponsored by the 
State Health Fraud Task Force or for any Federal employee to travel to 
any task force meeting or to participate in any task force activity. 
FDA region/district representatives may be invited to be liaisons or 
advisors of the State Health Fraud Task Force but each task force 
should develop its own guidelines for work, consensus decision making, 
size and format.
    The Division of Federal-State Relations will provide meeting 
guidelines and organization documents as requested. State Health Fraud 
Task Force grants will be awarded for up to 3 years based on 
availability of funds and satisfactory performance. The budgets for all 
years of requested support must be fully justified in the original 
application.

IV. Reporting Requirements

    Semi-annual progress reports as well as a final program progress 
report are required. The grantee must submit a progress report and two 
copies to FDA's grants management officer in the middle of each budget 
period and also within 90 days after the end of each budget period. The 
final progress report, due 90 days after the end of the project period, 
must provide full written documentation of the project, copies of any 
results (as described in the grant application), and an analysis and 
evaluation of the results of the project.
    An annual financial status report (FSR) is due 90 days after the 
end of each budget period. The final FSR is

[[Page 36092]]

due 90 days after the end of the project period.
    Program monitoring of recipients will be conducted on an ongoing 
basis and written reports will be reviewed and evaluated at least semi-
annually by the project officer. Project monitoring may also be in the 
form of telephone conversations between the project officer/grants 
management specialist and the principal investigator and/or a site 
visit with appropriate officials of the recipient organization. The 
results of these monitoring activities will be recorded in the official 
file and may be available to the recipient upon request.

V. Mechanism of Support

A. Award Instrument

    Support for this program will be in the form of a grant. These 
grants will be subject to all policies and requirements that govern the 
project grant programs of FDA, including the provisions of 42 CFR part 
52, 45 CFR parts 74 and 92, and the Public Health Service (PHS) Grants 
Policy Statement. The regulations issued under Executive Order 12372 
also apply to this program and are implemented through Department of 
Health and Human Services (HHS) regulations at 45 CFR part 100. 
Executive Order 12372 sets up a system for State and local government 
review of applications for Federal financial assistance. Applicants 
(other than Federally recognized Indian tribal governments) should 
contact the State's single point of contact (SPOC) as early as possible 
to alert the SPOC to the prospective application(s) and to receive any 
necessary instructions on the State's review process. A current listing 
of SPOCs is included in the application kit. The SPOC should send any 
State review process recommendations to the FDA administrative contact 
(see ADDRESSES). The due date for the State process recommendations is 
no later than 60 days after the deadline date for the receipt of 
applications. FDA does not guarantee that we will accommodate or 
explain SPOC comments that are received after the 60-day cutoff.

B. Eligibility

    This grant program is only available to one State Health Fraud Task 
Force per State (see Supplementary Information). This program is 
primarily intended for previously established Health Fraud Task Forces. 
However, consideration will be given to newly formed task forces that 
meet the requirements of this request for applications (RFA).

C. Length of Support

    It is anticipated that FDA will fund these grants at a level 
requested but not exceeding $15,000 total direct costs only for the 
first year. An additional 2 years of support up to approximately 
$15,000 total direct costs only each year will be available, depending 
upon the following factors: (1) Performance during the preceding year, 
(2) compliance with regulatory requirements of the award, and (3) 
availability of Federal funds.

D. Funding Plan

    The number of grants funded will depend on the quality of the 
applications received, their relevance to the FDA mission, priorities, 
and the availability of funds.

VI. Review Procedure and Criteria

    All applications submitted in response to this RFA will first be 
reviewed by grants management and program staffs for responsiveness. 
Responsiveness is defined as submission of a complete application with 
original signatures on or before the required submission date as listed 
earlier in this document. If an application is found to be 
nonresponsive, it will be returned to the applicant without further 
consideration. An application will be considered nonresponsive if any 
of the following circumstances are not met: (1) If it is received after 
the specified receipt date; (2) if the total dollar amount requested 
from FDA exceeds $15,000 per year; (3) if all required original 
signatures are not on the face, assurance, or certification pages of 
the application; (4) if there is no original signature copy; (5) if it 
is illegible; (6) if the material presented is insufficient to permit 
an adequate review; (7) if the application demonstrates an inadequate 
understanding of the intent of the RFA.
    Responsive applications will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts in the 
subject field of the specific application. Applications will be 
considered for funding on the basis of their overall technical merit as 
determined through the review process. Other award criteria will 
include availability of funds and overall program balance. Funding 
decisions will be made by the Commissioner of Food and Drugs or his 
designee.
    Applicants are strongly encouraged to contact FDA to resolve any 
questions regarding criteria prior to the submission of their 
applications. All questions of a technical or programmatic nature must 
be directed to the Office of Regulatory Affairs program staff (see 
ADDRESSES) and all questions of an administrative or financial nature 
must be directed to the grants management staff (see ADDRESSES).
    Applications will be given an overall score and judged based on all 
of the following criteria: (1) The content/subject matter and how 
current and appropriate it is for FDA's mission; (2) the educational 
outreach plan and how thorough, reasonable, and appropriate it is for 
accomplishing the mission of the program; (3) the experience, training, 
and competence of the program director and task force members as 
described in the application; (4) the reasonableness of the proposed 
budget given the plan for achieving the objective of the mission of the 
State Health Fraud Task Force Program; (5) a plan for self-sustaining 
the task force program in the event that Federal funding were to become 
unavailable in the future; (6) a brief history of the existing State 
Health Fraud Task Force and its accomplishments, not to exceed two 
typewritten pages; (7) a description of the structure of the existing 
State Health Fraud Task Force including such items as nonprofit 
organizational status, membership guidelines, or other relevant 
information to demonstrate the task force as a recognizable structured 
entity.

VII. Submission Requirements

    The original and two copies of the completed grant application Form 
PHS-5161-1 (revised 07/00) for State and local governments should be 
delivered to the Grants Management Office (see ADDRESSES). The 
application receipt date is 45 days after date of publication in the 
Federal Register, for the first year, and that anniversary date for 
each subsequent year this program is in effect. No supplemental 
material or addenda will be accepted after the receipt date.

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted during working hours, 8 a.m. to 4:30 
p.m., Monday through Friday, on or before the established receipt date. 
Applications will be considered received on time if sent or mailed on 
or before the receipt date as evidenced by a legible U.S. Postal 
Service dated postmark or a legible date receipt from a commercial 
carrier, unless they arrive too late for orderly processing. Private 
metered postmarks shall not be acceptable as proof of timely mailing. 
Applications not received on time will not be considered for review and 
will be

[[Page 36093]]

returned to the applicant. Applicants should note that the U.S. Postal 
Service does not uniformly provide dated postmarks. Before relying on 
this method, applicants should check with their local post office.
    Do not send applications to the Center for Scientific Research, 
NIH. Any application sent to NIH that is then forwarded to FDA and not 
received in time for orderly processing will be deemed unresponsive and 
returned to the applicant. FDA is unable to receive applications via 
the Internet.
    The outside of the mailing package and item 2 of the application 
face page should be labeled ``Response to RFA-FDA-ORA-04-2.'' You must 
submit only one application, an original and two copies, per package.

B. Format for Application

    When using Form PHS 5161-1 (rev 07/00), all instructions for the 
enclosed Standard Form 424 (SF424) should be followed using the 
nonconstruction application pages. A properly formatted sample 
application for grants can be accessed on the Internet at http://www.fda.gov/ora/fed_state/Innovative_Grants.html.
    The face page of the application should indicate ``Response to RFA-
FDA-ORA-04-2.'' The outside of the mailing package should also be 
labeled ``Response to State Health Fraud Task Force Grant Program.''
    Data included in the application, if restricted with the legend 
specified later in this document, may be entitled to confidential 
treatment as trade secret or confidential commercial information within 
the meaning of the Freedom of Information Act (FOIA) (5 U.S.C. 
552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).
    Information collection requirements requested on PHS Form 5161-1 
were approved and issued under Office of Management and Budget Circular 
A-102.

IX. Dun and Bradstreet Number (DUNS) Requirement

    Beginning October 1, 2003, applicants will be required to have a 
DUNS number to apply for a grant or cooperative agreement from the 
Federal government. The DUNS number is a 9-digit identification number, 
which uniquely identifies business entities. Obtaining a DUNS number is 
easy and there is no charge. To obtain a DUNS number, call 1-866-705-
5711. Be certain that you identify yourself as a Federal grant 
applicant when you contact Dun and Bradstreet.

X. Legend

    Unless disclosure is required by FOIA as amended (5 U.S.C. 552), as 
determined by the freedom of information officials of HHS or by a 
court, data contained in the portions of an application which have been 
specifically identified by page number, paragraph, etc., by the 
applicant as containing restricted and/or proprietary information shall 
not be used or disclosed except for evaluation purposes.

    Dated: June 22, 2004.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14593 Filed 6-25-04; 8:45 am]
BILLING CODE 4160-01-S