Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration Commitments Under the 2012 Prescription Drug User Fee Act, 15953-15955 [2013-05726]
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Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, but there is sufficient
information to establish special controls
to provide such assurance. The statute
permits FDA to establish as special
controls many different things,
including postmarket surveillance,
development and dissemination of
guidance recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (section 513(a)(1)(B)
of the FD&C Act). This information
collection is a measure that FDA
determined to be necessary to provide
reasonable assurance of safety and
effectiveness of reagents for detection of
specific novel influenza A viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on February 3, 2006,
establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification was
codified in 21 CFR 866.3332, a
regulation that describes the new
classification for reagents for detection
of specific novel influenza A viruses
and sets forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation refers to the special controls
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Reagents for Detection of Specific Novel
Influenza A Viruses,’’ which provides
recommendations for measures to help
provide a reasonable assurance of safety
and effectiveness for these reagents. The
guidance document recommends that
sponsors obtain and analyze postmarket
data to ensure the continued reliability
of their device in detecting the specific
novel influenza A virus that it is
intended to detect, particularly given
the propensity for influenza viruses to
mutate and the potential for changes in
disease prevalence over time. As
updated sequences for novel influenza
A viruses become available from the
World Health Organization, National
Institutes of Health, and other public
health entities, sponsors of reagents for
detection of specific novel influenza A
viruses will collect this information,
compare them with the primer/probe
sequences in their devices, and
incorporate the result of these analyses
into their quality management system,
as required by 21 CFR 820.100(a)(1).
15953
These analyses will be evaluated against
the device design validation and risk
analysis required by 21 CFR 820.30(g),
to determine if any design changes may
be necessary.
FDA estimates that 10 respondents
will be affected annually. Each
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 300
hours. The guidance also refers to
previously approved information
collections found in FDA regulations.
The collections of information in 21
CFR part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807 subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
In the Federal Register of September
25, 2012 (77 FR 58997), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
FD&C Act section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
513(g) ...................................................................................
10
2
20
15
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05722 Filed 3–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0010]
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
source application for award of a
SUMMARY:
VerDate Mar<15>2010
17:11 Mar 12, 2013
Jkt 229001
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, Adam.Kroetsch@fda.hhs.gov;
or
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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,
Oluyemisi.Akinneye@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
grants2.nih.gov/grants/guide/and/or
https://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
E:\FR\FM\13MRN1.SGM
13MRN1
15954
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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: https://
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 patientreported outcomes to support patientfocused 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 PatientReported Outcomes To Support PatientFocused Drug Development
The advancement of patient-reported
outcome measures (PROs) is designed to
VerDate Mar<15>2010
17:11 Mar 12, 2013
Jkt 229001
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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, wellinformed, 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
E:\FR\FM\13MRN1.SGM
13MRN1
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
at each meeting and post these reports
for public access.
and available Federal FY
appropriations.
D. Eligibility Information
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 https://grants2.nih.gov/grants/
guide and/or https://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 https://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 https://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.
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
Dated: March 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05726 Filed 3–12–13; 8:45 am]
BILLING CODE 4160–01–P
A. Award Amount
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
17:11 Mar 12, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0221]
Draft Guidance for Industry and
Review Staff on Formal Dispute
Resolution: Appeals Above the
Division Level; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry and review staff entitled
‘‘Formal Dispute Resolution: Appeals
Above the Division Level.’’ This
guidance is intended to provide
recommendations for industry on the
procedures in the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) for resolving scientific
and procedural disputes that cannot be
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
15955
resolved at the division level. This
guidance describes procedures for
formally appealing such disputes to the
office or center level and providing
information to assist FDA officials in
resolving the issue(s) presented. This
guidance revises the guidance of the
same name issued in February 2000.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by June 11, 2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. The
draft guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amy Bertha, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6469, Silver Spring,
MD 20993–0002, 301–796–0700; or,
Sheryl Lard-Whiteford, Center for
Biologics Evaluation and Research
(HFM–4), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448, 301–827–
0379.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and review
staff entitled ‘‘Formal Dispute
Resolution: Appeals Above the Division
Level.’’ In the course of drug review,
CDER and CBER make a wide variety of
scientific and procedural decisions that
are critical to a sponsor’s drug
development program. Sometimes, a
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15953-15955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05726]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, Adam.Kroetsch@fda.hhs.gov;
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, Oluyemisi.Akinneye@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at https://grants2.nih.gov/grants/guide/and/or https://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
[[Page 15954]]
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:
https://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
[[Page 15955]]
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 https://grants2.nih.gov/grants/guide and/or https://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 https://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 https://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]
BILLING CODE 4160-01-P
