[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22532-22534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09300]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0093]
Interim Assessment of the Program for Enhanced Review
Transparency and Communication; Public Meeting and Establishment of
Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and establishment of docket; request
for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to obtain comments on the interim assessment
of the Program for Enhanced Review Transparency and Communication for
New Molecular Entity (NME) New Drug Applications (NDAs) and Original
Biologics License Applications (BLAs) (the Program). FDA is also
announcing a public meeting where the interim assessment will be
discussed and public stakeholders may present their views on the
Program to date.
The Program is part of the FDA performance commitments under the
fifth authorization of the Prescription Drug User Fee Act (PDUFA),
which enables FDA to collect user fees for the review of human drug and
biologics applications for fiscal years (FYs) 2013-2017. The Program is
described in detail in section II.B entitled ``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013 through 2017.'' The
Program is being evaluated by an independent contractor with expertise
in assessing the quality and efficiency of pharmaceutical and
biopharmaceutical development and regulatory review programs. As part
of FDA's performance commitments, FDA is providing a period for public
comment on the interim assessment of the Program.
DATES: See Section III, ``How to Participate in the Public Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document for dates and
times of the public meeting, closing dates for advance registration,
requesting special accommodations due to disability, and information on
deadlines for submitting either electronic or written comments to FDA's
Division of Dockets Management.
ADDRESSES: See Section III, ``How to Participate in the Public
Meeting'' in the SUPPLEMENTARY INFORMATION section of this document.
[[Page 22533]]
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The timely review of the safety and efficacy of new drugs and
biologics is central to FDA's mission to protect and promote the public
health. Since the implementation of PDUFA I in 1993, FDA has used PDUFA
resources to significantly reduce the time it takes to evaluate new
drugs without compromising FDA's rigorous standards for drug safety and
efficacy. In return for these additional resources, FDA agreed to
certain review performance goals, such as completing reviews of NDAs
and BLAs and taking regulatory actions on them within predictable
timeframes. These changes revolutionized the review process and enabled
FDA to improve the efficiency of the application review process for new
drugs and biologics without compromising the Agency's high standards
for demonstration of safety, efficacy, and quality of new drugs and
biologics prior to approval.
PDUFA provides FDA with a source of stable, consistent funding that
has made possible our efforts to focus on promoting innovative
therapies and helping to bring to market critical products for
patients. The PDUFA program has been reauthorized every 5 years, with
the most recent reauthorization occurring in 2012 for FYs 2013-2017
(PDUFA V).\1\
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\1\ This document is available on the Internet at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
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PDUFA V introduced a new review program for NME NDAs and original
BLAs to enhance review transparency and communication between FDA and
applicants on these complex applications. FDA committed to engaging an
independent contractor to evaluate the Program. The PDUFA V performance
commitments call for an interim assessment of the Program to be
published by March 31, 2015, for public comment. The interim assessment
can be accessed at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf.
II. PDUFA V NME NDA and Original BLA Review Program
FDA's review performance goals for priority and standard
applications, 6 and 10 months respectively, have been in place since
the late 1990s. Since that time, additional requirements in the review
process and scientific advances in product development have made those
goals increasingly challenging to meet, particularly for more complex
applications like NME NDAs and original BLAs. FDA further recognizes
that increasing communication between the Agency and applicants during
FDA's review has the potential to increase efficiency in the review
process.
To promote greater transparency and improve communication between
the FDA review team and the applicant, FDA implemented a new review
model for NME NDAs and original BLAs in PDUFA V. The Program provides
opportunities for increased communication between FDA and applicants,
including mid-cycle and late-cycle meetings. To accommodate the
increased interaction during regulatory review and to address the need
for additional time to review these complex applications, FDA's review
clock begins after the 60-day administrative filing review period for
applications reviewed under the Program.
The goal of the Program is to improve the efficiency and
effectiveness of the first-cycle review process by increasing
communications during application review. This will provide sponsors
with the opportunity to clarify previous submissions and provide
additional data and analyses that are readily available, potentially
avoiding the need for an additional review cycle when concerns can be
promptly resolved but without compromising FDA' standards for approval.
To understand the Program's effect on the review of these
applications, the Program is being evaluated by an independent
contractor. In addition to publishing an interim assessment and opening
a docket for public comments, a public meeting will be held on May 20,
2015, where the interim assessment will be discussed and public
stakeholders may present their views on the Program to date. The final
assessment of the Program will be published for public comment by
December 31, 2016, and will be followed by a public meeting by March
30, 2017.
III. How To Participate in the Public Meeting
FDA is holding the public meeting on May 20, 2015, from 10 a.m. to
1 p.m. Due to limited space and time, we encourage all persons who wish
to attend the meeting to register in advance. There is no fee to
register for the public meeting, and registration will be on a first-
come, first-served basis.
Table 1 of this document provides information on participation in
the public meeting.
Table 1--Information on Participating in the Meeting and on Submitting Comments to the Docket \1\
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Dates Electronic addresses Addresses Other information
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Attend public meeting........ May 20, 2015, Please preregister FDA White Oak Participants must
from 10 a.m. at https:// Campus, 10903 New enter through
to 1 p.m. www.nmepdufa.eventb Hampshire Ave., Building 1 and
rite.com. Bldg. 31 Conference undergo security
Center, Section A screening. For more
of the Great Room information on
(Rm. 1503) Silver parking and
Spring, MD 20993. security
procedures, please
visit http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Preregister.................. Register by May Individuals who wish We encourage the use There is no
13, 2015. to participate in of electronic registration fee
person are asked to registration, if for the public
preregister at possible.\1\ meeting.
https://www.nmepdufa.eventbrite.com.
[[Page 22534]]
View Web cast................ May 20, 2015, Individuals who are .................... The Web cast will
from 10 a.m. unable to attend have closed
to 1 p.m. the meeting in captioning.
person, can
register to view a
live Web cast. You
will be asked to
indicate in your
registration
whether you plan to
attend in person or
via the Web cast.
Request special Request at Graham Thompson, See FOR FURTHER
accommodations due to least 7 days email: INFORMATION CONTACT.
disability. before the Graham.Thompson@fda
meeting. .hhs.gov.
Submit electronic or written Submit comments Federal eRulemaking Mail/Hand delivery/ Identify your
comments. by June 30, Portal: http:// Courier (for paper comments with the
2015. www.regulations.gov submissions): docket number
. Follow the Division of Dockets listed in brackets
instructions for Management (HFA- in the heading of
submitting comments. 305), Food and Drug this document. We
Administration, encourage you to
5630 Fishers Lane, submit electronic
Rm. 1061, comments by using
Rockville, MD 20852. the Federal
eRulemaking Portal.
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\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and
phone and fax numbers in your registration information and send to: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver
Spring, MD 20993, 301-796-5003, FAX: 301-847-8443, [email protected].
IV. Comments and Transcripts
Regardless of attendance at the public meeting, interested persons
may submit to FDA's Division of Dockets Management (see Addresses in
table 1) either electronic or written comments on the interim
assessment of the Program for Enhanced Review Transparency and
Communication for NME NDAs and Original BLAs. You only need to send one
set of comments. Identify the comments with the docket number provided
in brackets in the heading of this document.
With respect to transcripts, please be advised that as soon as a
transcript is available, it will be accessible at www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09300 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P