[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89109-89110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29589]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4096]


Final 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 final 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 final 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 of the document 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 final assessment of the Program.

DATES: The public meeting will be held on March 27, 2017, from 10 a.m. 
to 1 p.m. Public comments will be accepted through April 3, 2017. See 
the ADDRESSES section for information about submitting comments to the 
public docket. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 2, Conference Room 2047 E, Silver 
Spring, MD 20993-0002. Entrance for the public meeting participants 
(non-FDA employees) is through Building 1 where routine security check 
procedures will be performed. For more information on parking and 
security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-4096. Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

[[Page 89110]]

    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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 improve the timeliness and predictability of new drug 
review while maintaining FDA's rigorous standards for drug quality, 
safety and efficacy. With the availability of these additional fee 
resources, FDA was able to agree to certain review performance goals, 
including a complete review of NDAs and BLAs and taking regulatory 
action within specified timeframes. The managed review processes put in 
place to accomplish this, and the process enhancements including 
investments in modernized post-market safety and regulatory science 
over subsequent reauthorizations of PDUFA, have revolutionized the new 
drug review process, helping to bring critical products to market for 
patients. The PDUFA program has been reauthorized every 5 years, with 
the most recent and fifth authorization occurring in 2012. The PDUFA V 
Performance Goals and Procedures for Fiscal Years 2013 through 2017 can 
be accessed 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 to understand the 
Program's effect on the review of these applications. The interim 
assessment was published March 31, 2015, and can be accessed at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf. The PDUFA V performance commitments also call for a 
final assessment of the Program to be published by December 31, 2016, 
for public comment. The final assessment can be accessed at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm. 
A public meeting will be held on March 27, 2017, where the final 
assessment will be discussed and public stakeholders may present their 
views on the Program.

II. PDUFA V NME NDA and Original BLA Review Program

    FDA's performance goals for review of priority and standard new 
drug 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 and transparency 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 without compromising FDA's standards for approval.

III. Meeting Attendance and Participation

    FDA is holding the public meeting on March 27, 2017, from 10 a.m. 
to 1 p.m. If you wish to attend this public meeting, visit: https://nmemeeting.eventbrite.com. Please register by March 20, 2017. If you 
are unable to attend the public meeting in person, you can register to 
view a live Webcast of the public meeting. You will be asked to 
indicate in your registration if you plan to attend in person or via 
the Webcast. Seating will be limited, so early registration is 
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from 
each organization based on space limitations. Registrants will receive 
confirmation once they have been accepted. Onsite registration on the 
day of the public meeting will not be possible. If you need special 
accommodations because of a disability, please contact Graham Thompson 
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the public 
meeting.
    FDA will hold an open public comment period to give the public an 
opportunity to comment during the public meeting. Registration for open 
public comment will occur at the registration desk on the day of the 
public meeting on a first-come, first-served basis.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets 
Management (see ADDRESSES). A link to the transcript will also be 
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm.

    Dated: December 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29589 Filed 12-8-16; 8:45 am]
BILLING CODE 4164-01-P