[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \1\ This document is available on the Internet at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
---------------------------------------------------------------------------

    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\
----------------------------------------------------------------------------------------------------------------
                                    Dates       Electronic addresses        Addresses         Other information
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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