[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15953-15955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0010]
Cooperative Agreement To Support Regulatory Research Related to
Food and Drug Administration Commitments Under the 2012 Prescription
Drug User Fee Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) announces its intention
to accept and consider a single source application for award of a
cooperative agreement to the Brookings Institution's Engelberg Center
for Health Care Reform (ECHCR) in support of efforts to inform major
initiatives for process improvement and regulatory science related to
FDA commitments under the 2012 reauthorization of the Prescription Drug
User Fee Act (PDUFA V).
DATES: Important dates are as follows:
1. The application due date is April 15, 2013.
2. The anticipated start date is June 1, 2013.
3. The expiration date is April 16, 2013.
For Further Information and Additional Requirements Contact:
Adam Kroetsch, Office of Planning and Analysis, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver
Spring, MD 20993, 301-796-3842, [email protected];
or
Yemisi Akinneye, Office of Acquisitions and Grants Services, Food and
Drug Administration, 5630 Fishers Lane, HFA 500, Rm. 2037, Rockville,
MD 20857, 301-827-0079, [email protected].
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://grants2.nih.gov/grants/guide/and/or http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm093567.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-005; 93.103.
A. Background
The FDA Center for Drug Evaluation and Research (CDER) seeks to
support efforts to research, identify key issues, and convene
appropriate subject matter experts to help inform major initiatives for
process improvement and regulatory
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science related to FDA commitments under PDUFA V. PDUFA, first enacted
in 1992, has provided FDA with the resources and process enhancements
to enable a transformation of the human drug review process, increasing
the quality, number, and timely access to new drugs for U.S. patients.
The 2012 reauthorization of PDUFA initiated a set of performance
goals and procedures for FDA through fiscal year 2017. These
performance goals represent a series of commitments which were
established in consultation with drug industry representatives, patient
and consumer advocates, and health care professionals. Specific PDUFA
commitments include public meetings, staff training procedures, and
efficiency standards on a variety of issues. More information about
FDA's commitments under PDUFA V can be found at the following Web site:
http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
B. Research Objectives
In the most recent reauthorization of PDUFA, FDA has committed to
build on a record of continuing improvement through a wide range of new
innovative initiatives related to virtually every aspect of the new
drug life cycle, each of which represent specific areas of research
interest. These initiatives may include, but not be limited to, the
following:
Enhancing regulatory science and expediting drug
development;
Advancing metaanalysis methods;
Advancing the use of biomarkers and pharmacogenomics;
Developing and enhancing patient-reported outcomes to
support patient-focused drug development;
Facilitating rare disease drug development;
Structured approaches to enhancing FDA's assessment of
benefits and risks in human drugs;
Improving evaluation, standardization, and integration of
Risk Evaluation and Mitigation Strategies (REMS);
Exploring the use of Sentinel as a tool for evaluating
drug safety issues; and
Requiring electronic submissions and standardization of
electronic application data.
Several key areas of research interest are described in greater
detail below:
1. Developing and Enhancing Patient-Reported Outcomes To Support
Patient-Focused Drug Development
The advancement of patient-reported outcome measures (PROs) is
designed to promote patient engagement throughout the drug development
process. FDA has dedicated steps toward the development of these tools
by expanding clinical and statistical staff capacity, providing
qualification consultations, and promoting best practices for the use
of outcome assessment tools. FDA seeks to identify the challenges and
opportunities within the current review and qualification of PROs, to
address key issues with PRO evidentiary standards, develop new methods
for communication between the multiple stakeholders involved in PROs,
and identify best practices for evaluation and statistical analysis and
design of PROs.
2. Structured Approaches to Enhancing FDA's Assessment of Benefits and
Risks in Human Drugs
FDA recognizes that the Agency's efforts to develop a more
structured approach to benefit-risk assessment could be complemented by
further engagement of stakeholders and other parties. This engagement
seeks to focus on the current efforts and methods that have been
applied to structure and communicate regulatory decisions, including
the relevance to the work of a regulator and how well such approaches
integrate with how regulators think about their decisions. FDA expects
that these discussions would focus on the results of implementing
frameworks at regulatory agencies both in premarket application review
as well as post-market safety review, providing an opportunity to share
challenges and lessons learned in applying a more structured approach
to regulatory decision-making.
3. Improving Evaluation, Standardization, and Integration of REMS
FDA seeks stakeholder and expert feedback on approaches to
standardizing of REMS and integrating them into the health care
delivery system. Areas for research include the following:
A standardized methodology for selecting appropriate risk
management interventions when a REMS is deemed necessary. Such a
methodology should allow FDA and sponsors to proactively identify and
address the underlying causes of patient harm, and evaluate and
prioritize risk management interventions based on evidence of their
effectiveness and burden on the health care delivery system.
Standard approaches and best practices for implementing
REMS and integrating them into the existing health care delivery
system. These approaches may include the use of improved methods for
communicating with and training REMS stakeholders and the use of
information technology to facilitate REMS implementation.
Standard methods to evaluate REMS, including methods to
assess REMS effectiveness, impact on patient access, and burden on the
health care delivery system.
C. Approach
In order to achieve these research objectives as part of its PDUFA
V commitments, FDA has committed to seek input from relevant external
subject matter experts and other interested public stakeholders. In
addition, this input process should be conducted so as to be timely,
well-informed, candid, thoughtful, thorough, and well-documented.
FDA has a limited capacity to conduct the needed research to fully
inform and undertake these external expert engagements to ensure the
successful accomplishment of these PDUFA V commitments. FDA is
therefore seeking to establish a cooperative agreement with the
Brookings Institution's ECHCR for its unique qualifications and
experience in the conduct of the needed research, workshops and other
meetings, and related work.
The goal of this collaboration is to support the implementation of
PDUFA V performance goals by convening stakeholders with diverse
expertise. Through a series of meetings, workshops, webinars, and/or
workgroups, ECHCR would provide effective opportunities for engagement
of these stakeholders to inform implementation of the PDUFA V goals. In
addition to gathering input from selected stakeholder groups, ECHCR may
conduct background research prior to expert engagement, and to
communicate updates on the progress of PDUFA implementation to broader
audiences. Specific objectives of this collaboration would include:
Working collaboratively with FDA to identify and
prioritize pressing issues related to the implementation of PDUFA
reauthorization performance goals and procedures;
Conducting research and reviews of relevant literature to
plan the focus of sessions in which experts are convened to provide
critical input to FDA regulatory enhancement discussions;
Convening expert stakeholders in focused, substantive
discussions of these issues, and identify and explore potential
strategies for resolving them; and
Developing reports that summarize the background research
and discussion
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at each meeting and post these reports for public access.
D. Eligibility Information
The following organization is eligible to apply: ECHCR. Within the
Brookings Institution, the mission of the ECHCR is to provide practical
solutions to achieve high-quality, innovative, affordable health care
with particular emphasis on identifying opportunities on the national,
State, and local levels. Leveraging its status as a neutral, nonprofit,
research-focused institution with deep health care policy and technical
expertise, ECHCR frequently serves as a convener of discussions,
workshops, and symposia on complex policy and science topics. The
Center has developed a reputation as an ``honest broker'' with the
ability to identify practical solutions that reflect the best available
science and input from all stakeholders. The performance goals and
procedures outlined within PDUFA V will require a high degree of
leadership, research, outreach, and involvement from a broad range of
stakeholders across the health care system. ECHCR is uniquely qualified
to conduct the background research and act as a convener for engaging
critical stakeholders, raising awareness, and identifying practical
solutions that identify and overcome potential challenges and help
determine a clear path forward.
II. Award Information/Funds Available
A. Award Amount
FDA intends to fund one award, corresponding to a total of
$700,000, for fiscal year (FY) 2013. Future year amounts will depend on
annual appropriations. CDER anticipates providing in FY2013 up to
$700,000 (total costs include direct and indirect costs) for one award
subject to availability of funds in support of this project. The
possibility of four additional years of support is contingent upon
successful performance and the availability of funds, and would provide
funds up to following amounts:
FY 2014: $721,000
FY 2015: $743,000
FY 2016: $765,000
FY 2017: $788,000
B. Length of Support
The support will be 1 year with the possibility of an additional 4
years of noncompetitive support. Continuation beyond the first year
will be based on satisfactory performance during the preceding year,
receipt of a noncompeting continuation application and available
Federal FY appropriations.
III. Paper Application, Registration, and Submission Information
To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://grants2.nih.gov/grants/guide and/or http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm093567.htm. (FDA has verified the
Web site addresses throughout this document, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.) Persons interested in applying for
a grant may obtain an application at http://grants.nih.gov/grants/forms.htm. For all paper application submissions, the following steps
are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management
Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. After you have followed
these steps, submit paper applications to: Yemisi Akinneye, Grants
Management, 5630 Fishers Lane, HFA-500, rm. 2037, Rockville, MD.
Dated: March 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05726 Filed 3-12-13; 8:45 am]
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