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[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Notices]
[Pages 74063-74065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30054]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0576]

Supplemental Funding Under the Food and Drug Administration's 
Convener of Active Medical Product Surveillance Discussions (U13) RFA-
FD-09-012; Request for Supplemental Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a program 
expansion of its Conference Cooperative Agreement Program (U13), 
awarded to the Engelberg Center for Health Care Reform at the Brookings 
Institution (Brookings). The goal of this expansion is to plan and hold 
meetings and conferences that will ensure broad stakeholder input on 
FDA programs and initiatives related to disseminating information from 
active medical product surveillance activities and other sources of 
product information.

DATES: Important dates are as follows:
    1. The supplemental application due date is December 13, 2010.
    2. The award anticipated start date is January 1, 2011.
    3. The opening date is November 30, 2010.
    4. The expiration date is December 14, 2010.

For Further Information and Additional Requirements Contact:

Melissa Robb, Office of Medical Policy, Food and Drug Administration, 
10903 New Hampshire Ave, Bldg. 51, rm. 6360, Silver Spring, MD 20993-
0002, 301-796-2500, e-mail: [email protected]; or

Camille R. Peake, Division of Acquisition Support and Grants, Food and 
Drug Administration, 5630 Fishers Lane (HFA-500), Rockville, MD 20857, 
301-827-7175, FAX: 301-827-7101, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 74064]]

I. Funding Opportunity Description

    For more information on the original full funding opportunity 
announcement (FOA) RFA-FD-09-012, go to http://www.fda.gov/Safety/FDAsSentinelInitiative/ucm168759.htm.

A. Background

    This FOA, issued by FDA, announces a proposed program expansion of 
FDA's Conference Cooperative Agreement Grant U13 FD003802 awarded to 
Brookings. The goal of this program is to plan and hold meetings and 
conferences that will ensure broad stakeholder input on FDA programs 
and initiatives related to disseminating information from active 
medical product surveillance activities and other sources of product 
information. The information obtained through these meetings and 
workshops is being used to develop, implement, and evaluate medical 
product surveillance methods and systems, which support the gathering, 
analysis, and communication of medical product safety information.
    Supplementing the parent grant to incorporate expansion of the 
scope of work would support activities including convening discussions, 
leveraging the information learned from medical product surveillance, 
and engaging stakeholders, namely the health care community, consumers 
and industry, on topics related to patient counseling and dissemination 
of product information on the risks, benefits, and safe use of 
prescription drugs. Discussions would cover issues related to 
developing a quality systems approach to make sure that user-friendly, 
easily accessible, up-to-date information is available to the public 
and health care practitioners who are interacting with patients to 
prescribe and dispense medications. It is important that practitioners 
and pharmacists are able to adequately inform patients about the proper 
use of medications being prescribed or dispensed. This supplement would 
include convening meetings and synthesizing, summarizing, and 
communicating the findings on topics such as those listed in the 
Research Objectives. (See section B of this document.)
    During Year 1, a supplement was awarded that allowed for the 
convening of discussions on topics related to the development and 
appropriate dissemination of Patient Medication Information (PMI). With 
this FOA, FDA proposes to further expand the scope of work of the 2009 
supplement and increase the amount of supplemental funding for each 
budget year to $501,534 total cost (direct costs only), beginning in 
2010, and future years 2011, 2012, and 2013. (Funding for this 
supplement will be subject to availability of funds and satisfactory 
progress of the project).

B. Research Objectives

    This supplement will expand the existing program to convene 
meetings and synthesize, summarize, and communicate relevant findings 
on topics such as those discussed in the following paragraphs.
 Patient Medication Information (PMI)
    To be able to use prescription medications safely, consumers need 
to receive clear, actionable medication information that is accurate, 
balanced, and delivered in a consistent and easily understood format. 
In February 2009, FDA's Risk Communication Advisory Committee 
recommended FDA adopt a single, standard document for communicating 
essential information about prescription drugs, which would replace 
Consumer Medical Information, Patient Package Insert (PPI), and 
Medication Guides. Such changes to the delivery of PMI may require 
changes to the Federal Food, Drug, and Cosmetics Act law and/or 
regulations to implement. Following a series of public workshops 
convened by FDA, the Agency developed three draft patient information 
prototypes as well as a strategy for evaluating the prototypes. Upon 
approval from the Office of Management and Budget, FDA plans to 
evaluate the three prototypes using an experimental consumer testing 
study. As part of its evaluation process, FDA intends to hold a series 
of workshops to ensure continued, broad public input on the prototypes. 
In addition, Brookings also convened three workshops in cooperation 
with FDA (Year 1) to discuss optimizing, implementing, and evaluating 
adoption of a single, standard medication information document. As a 
followup to the outcomes and recommendations received from the meetings 
described previously, FDA is interested in obtaining additional 
feedback, guidance, and expert opinion from a broad range of 
stakeholders during the supplemented years needed to move the PMI 
initiative forward, including, for example, through pilot projects for 
PMI distribution using modern media and exploration of additional 
issues related to PMI monitoring, compliance, and enforcement, as well 
as by developing processes for follow-up assessments.
 Professional Labeling
    In the Federal Register of January 24, 2006 (71 FR 3922), FDA 
published a final rule that amended the requirements for the content 
and format of the package insert for human prescription drug and 
biologic products. The purpose of the new requirements was to improve 
the management of the risks of medical product use and reduce medical 
errors by health care professionals, as well as enable health care 
practitioners to better communicate risk information to their patients. 
The new regulation (21 CFR 201.57) was designed to make information in 
the prescription package insert easier for health care practitioners to 
access, read, and use, thereby facilitating use of the package insert 
to make prescribing decisions. The final rule has a phased-in 
implementation schedule that initially targets new and recently 
approved drugs. These new requirements have been in effect for 4 years, 
and many drugs on the market have package inserts in the new format.
    Because complying with these new requirements is essential for 
meeting the objective of better risk communication, FDA is interested 
in obtaining feedback from health care practitioners on whether the new 
package insert format is being implemented in a manner that meets the 
needs of the practicing physician and other health care practitioners 
or whether there are areas in which FDA could improve implementation.
 Risk Evaluation and Mitigation Strategies (REMS)
    With the additional regulatory authority granted to FDA in the FDA 
Amendments Act of 2007, FDA has begun requiring REMS, with the 
components of each individual strategy varying by the risks involved 
and patient populations eligible.
    Based on existing FDA guidance, REMS components have included 
medication guides (``MedGuides''); patient package inserts; 
communication plan(s) for health care practitioners (e.g. ``Dear 
Provider'' letters); and elements to assure safe use (ETASU), including 
requirements for those who prescribe, dispense, or use the drug. In 
some cases, MedGuides have been the only component required; in other 
cases, FDA has required ETASU of varying designs, such as those 
requiring that a drug be dispensed to patients with evidence (e.g., 
restricted distribution) or other documentation of safe-use conditions 
(e.g., certain laboratory test result outcomes required before a drug 
may be dispensed).
    The current REMS requirement process has led to the implementation 
of more than 100 new strategies, with varying elements based on the 
severity

[[Page 74065]]

of risk projected and different approaches taken by manufacturers 
seeking to meet those requirements. FDA would like to convene sessions 
of experts and hold focused meetings over the next 3 years to discuss 
REMS implementation to date, and explore practical policy approaches 
relevant to restricted distribution processes and quality care 
counseling.

C. Eligibility Information

    This supplement is available only to the existing grant recipient, 
Brookings.

D. Requirements of the Supplemental Application

    1. The application clearly demonstrates an understanding of the 
purpose and objectives of the program expansion as described in section 
B of this document.
    2. The application clearly describes the steps involved in a 
proposed schedule for planning, implementing, and accomplishing the 
activities to be carried out under the program expansion.
    3. The application establishes Brookings ability to perform the 
responsibilities under the program expansion including the availability 
of appropriate staff and sufficient funding.
    4. The application describes Brookings ability to act as a neutral, 
independent third party to convene a wide group of diverse stakeholders 
with relevant expertise related to selected topics.
    5. The application specifies the manner in which interaction with 
FDA will be maintained throughout the lifetime of the project.
    6. The application specifies how Brookings will monitor progress of 
the work under the program expansion and how progress will be reported 
to FDA.
    7. The application shall include a detailed budget that shows: (1) 
Anticipated costs for personnel, travel, communications and postage, 
and supplies and (2) the sources of funds to meet those needs, if other 
than FDA.

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates supplementing this program expansion by providing 
approximate total cost of $501,534 (direct costs only) in each budget 
period beginning in 2010, and the remaining budget periods (years: 
2011, 2012, and 2013).

B. Length of Support

    The initial supplemental award will be awarded to correspond with 
the 2010 budget period, and the remaining budget periods (2011, 2012, 
and 2013) will be dependant on the grantee's successful performance, 
and financial management.

III. Paper Application and Submission Information

    To submit a paper application in response to this supplemental 
notice, applicants should download the PHS-398 form at http://grants.nih.gov/grants/funding/phs398/phs398.html. (FDA has verified the 
Web site address, but FDA is not responsible for any subsequent changes 
to the Web site after this document publishes in the Federal Register.)
    For all paper application submissions, the following steps are 
required:
    Submit paper via Express mail to (see the For Further Information 
and Additional Requirements Contact section of this document).

    Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30054 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P
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