80 FR 27323 - Prescription Drug User Fee Act; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 92 (May 13, 2015)

Page Range		27323-27325
FR Document		2015-11537

The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA authorizes FDA to collect user fees for the process for the review of human drugs. The current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2018-2022.

Federal Register, Volume 80 Issue 92 (Wednesday, May 13, 2015)

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27323-27325]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]


Prescription Drug User Fee Act; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a public meeting on the reauthorization of the Prescription Drug User 
Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA 
authorizes FDA to collect user fees for the process for the review of 
human drugs. The current legislative authority for PDUFA expires in 
September 2017. At that time, new legislation will be required for FDA 
to continue collecting user fees in future fiscal years. The Federal 
Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA begin the 
PDUFA reauthorization process by publishing a notice in the Federal 
Register requesting public input and holding a public meeting where the 
public may present its views on the reauthorization. FDA invites public 
comment as the Agency begins the

[[Page 27324]]

process to reauthorize the program in FYs 2018-2022.

DATES: The public meeting will be held on July 15, 2015, from 9 a.m. to 
2 p.m. Registration to attend the meeting must be received by June 30, 
2015. See section III.B for information on how to register for the 
meeting. Submit either electronic or written comments by August 15, 
2015.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31 Conference Center, Sections B and C of the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://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. All comments should be identified with the docket number found 
in brackets in the heading of this document.
    Transcripts of the meeting will be available on the FDA Web site 
(http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM2005475.htm) approximately 30 days after the meeting.

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.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a public meeting to begin the reauthorization 
process of PDUFA, the legislation that authorizes FDA to collect user 
fees for the process for the review of human drugs by various 
components in FDA including the Center for Drug Evaluation and 
Research, the Center for Biologics Evaluation and Research, the Office 
of the Commissioner, and the Office of Regulatory Affairs. The current 
authorization of the program (PDUFA V) expires in September 2017. 
Without new legislation, FDA will no longer be able to collect user 
fees for future fiscal years to fund the human drug review process. 
Section 736B(d)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires 
that before FDA begins negotiations with the regulated industry on 
PDUFA reauthorization, we do the following: (1) Publish a notice in the 
Federal Register requesting public input on the reauthorization, (2) 
hold a public meeting where the public may present its views on the 
reauthorization, (3) provide a period of 30 days after the public 
meeting to obtain written comments from the public, and (4) publish the 
comments on the FDA Web site at http://www.regulations.gov. This 
notice, the public meeting, the 30-day comment period after the 
meeting, and the posting of the comments on the FDA Web site will 
satisfy these requirements. The purpose of the meeting is to hear 
stakeholder views on PDUFA as we consider the features to propose, 
update, and discontinue in the next PDUFA. FDA is interested in 
responses to the following three questions and welcomes any other 
pertinent information stakeholders would like to share:
     What is your assessment of the overall performance of 
PDUFA V thus far?
     What current features of PDUFA should be reduced or 
discontinued to ensure the continued efficiency and effectiveness of 
the human drug review process?
     What new features should FDA consider adding to the 
program to enhance the efficiency and effectiveness of the human drug 
review process?
    The following information is provided to help potential meeting 
participants better understand the history and evolution of PDUFA and 
its current status.

II. What is PDUFA? What does it do?

    PDUFA is a law that authorizes FDA to collect fees from drug 
companies that submit marketing applications for certain human drug and 
biological products. PDUFA was originally enacted in 1992 as the 
Prescription Drug User Fee Act (Pub. L. 102-571) for a period of 5 
years. In 1997, Congress passed the FDA Modernization Act of 1997 
(FDAMA, Pub. L. 105-115) which reauthorized the program (PDUFA II) for 
an additional 5 years. In 2002, Congress extended PDUFA again through 
FY 2007 (PDUFA III) in the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Pub. L. 107-188). In 2007, Title 
I of the Food and Drug Administration Amendments Act of 2007 (FDAAA, 
Pub. L. 110-85) reauthorized PDUFA through FY 2012 (PDUFA IV). Most 
recently, PDUFA was reauthorized through FY 2017 (PDUFA V) as Title I 
of the Food and Drug Administration Safety and Innovation Act (FDASIA, 
Pub. L. 112-144).
    PDUFA's intent is to provide additional revenues so that FDA can 
hire more staff, improve systems, and establish a better managed human 
drug review process to make important therapies available to patients 
sooner without compromising review quality or FDA's high standards for 
safety, efficacy, and quality. As part of FDA's agreement with industry 
during each reauthorization, the Agency agrees to certain performance 
goals. These goals apply to the process for the review of original new 
human drug and biological product applications, resubmissions of 
original applications, and supplements to approved applications. During 
the first few years of PDUFA I, the additional funding enabled FDA to 
eliminate backlogs of original applications and supplements. Phased in 
over the 5 years of PDUFA I, the goals were to review and act on 90 
percent of priority new drug applications (NDAs), biologics license 
applications (BLAs), and efficacy supplements within 6 months of 
submission of a complete application; to review and act on 90 percent 
of standard original NDAs, BLAs, and efficacy supplements within 12 
months, and to review and act on resubmissions and manufacturing 
supplements within 6 months. Over the course of PDUFA I, FDA exceeded 
all of these performance goals and significantly reduced median review 
times of both priority and standard NDAs and BLAs.
    Under PDUFA II, the review performance goals were shortened and new 
procedural goals were added to improve FDA's interactions with industry 
sponsors and to help facilitate the drug development process. The 
procedural goals, for example, articulated timeframes for scheduling 
sponsor-requested meetings intended to address issues or questions 
regarding specific drug development programs, as well as timeframes for 
the timely response to industry-submitted questions on special study 
protocols. FDA met or exceeded nearly all of the review and procedural 
goals under PDUFA II. However, concerns grew that overworked review 
teams often had to return applications as ``approvable'' because they 
did not have the resources and sufficient staff time to work with the 
sponsors to resolve issues so that applications could be approved in 
the first review cycle.
    A sound financial footing and support for limited postmarket risk 
management were key themes of PDUFA III. Base user fee resources were 
significantly increased and a mechanism to account for changes in human 
drug review workload was adopted. PDUFA III also

[[Page 27325]]

expanded the scope of user fee activities to include postmarket 
surveillance of new therapies for up to 3 years after marketing 
approval. FDA committed to the development of guidance for industry on 
risk assessment, risk management, and pharmacovigilance as well as 
guidance to review staff and industry on Good Review Management 
Principles and Practices (GRMPs). Initiatives to improve application 
submission and Agency-sponsor interactions during the drug development 
and application review processes were also adopted.
    With PDUFA's reauthorization under FDAAA Title I (PDUFA IV), FDA 
obtained a significant increase in base fee funding and committed to 
full implementation of GRMPs, which includes providing a planned review 
timeline for premarket review, development of new guidance for industry 
on innovative clinical trials, modernization of postmarket safety, and 
elimination of the 3-year limitation on fee support for postmarket 
surveillance. Additional provisions in FDAAA (Titles IV, V, and IX) 
gave FDA additional statutory authority that increased the pre- and 
postmarket review process requirements, added new deadlines, and 
effectively increased review workload. Specifically, the new provisions 
expanded FDA's drug safety authorities such as the authority to require 
risk evaluation mitigation strategies (REMS), order safety labeling 
changes, and require postmarket studies.
    With the current authorization of PDUFA under Title I of FDASIA, 
FDA implemented a new review program (``the Program'') to promote 
greater transparency and increase communication between the FDA review 
team and the applicant on the most innovative products reviewed by the 
Agency. The Program applies to all new molecular entity (NME) NDAs and 
original BLAs received by the Agency from October 1, 2012 through 
September 30, 2017. The Program adds new opportunities for 
communication between the FDA review team and the applicant during 
review of a marketing application, including mid-cycle communications 
and late-cycle meetings, while adding 60 days to the review clock to 
provide for this increased interaction and to address review issues for 
these complex applications. PDUFA V also required two assessments of 
the impact of the Program. The first of these, the interim assessment, 
is available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf.
    In addition to continued commitment to a significant set of review, 
processing, and procedural goals, PDUFA V also included commitments 
related to enhancing regulatory science and expediting drug 
development, enhancing benefit-risk assessment in regulatory 
decisionmaking, modernizing the FDA drug safety system, and improving 
the efficiency of human drug review by requiring electronic submissions 
and standardization of electronic drug application data. The PDUFA V 
Commitment Letter (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf) requires 
that FDA report on the progress in satisfying these commitments in the 
annual PDUFA performance report. The FY 2014 report can be found at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm440180.htm. More information about FDA's 
implementation of PDUFA V can also be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm. Key Federal 
Register documents, PDUFA-related guidances, performance reports, and 
financial reports can also be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.

III. Public Meeting Information

A. Purpose and Scope of the Meeting

    Through this notice, FDA is announcing a public meeting to hear 
stakeholder views on what features the Agency should propose in the 
reauthorization of PDUFA for FYs 2018-2022. In general, the meeting 
format most likely will include presentations by FDA and a series of 
panels representing different stakeholder groups. We will also provide 
an opportunity for other stakeholders to provide public comment at the 
meeting. FDA policy issues are beyond the scope of these 
reauthorization discussions. Accordingly, the presentations should 
focus on process enhancements and funding issues, and not focus on 
policy issues.
    Please consider the following questions for this meeting:
     What is your assessment of the overall performance of 
PDUFA V thus far?
     What new features should FDA consider adding to the 
program to enhance the efficiency and effectiveness of the human drug 
review process?
     What current features of PDUFA should be reduced or 
discontinued to ensure the continued efficiency and effectiveness of 
the human drug review process?

B. Meeting Attendance and Participation

    We will conduct the meeting on July 15, 2015, at Building 31 of the 
FDA White Oak Campus (see ADDRESSES). If you wish to attend this 
meeting, visit http://pdufapublicmeeting.eventbrite.com. Please 
register by June 30, 2015. If you are unable to attend the meeting in 
person, you can register to view a live Web cast of the meeting. You 
will be asked to indicate in your registration if you plan to attend in 
person or via the Web cast. Your registration must also contain your 
complete contact information, including name, title, affiliation, 
address, email address, and phone number. 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 their registrations have 
been accepted. Onsite registration on the day of the meeting will be 
based on space availability. If you need special accommodations because 
of a disability, please contact Graham Thompson (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days before the meeting.
    In addition, any person may submit either electronic comments 
regarding this document to http://www.regulations.gov or written 
comments to the Division of Dockets Management (see ADDRESSES). It is 
only necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov. To ensure consideration, all 
comments must be received by August 15, 2015.
    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM2005475.htm.

    Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11537 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27323

international harmonization of Genotoxicity Testing’’ (VICH GL23(R)) IV. Comments
regulatory requirements. FDA has giving interested persons until May 6, Interested persons may submit either
participated in efforts to enhance 2013, to comment on the draft revised electronic comments regarding this
harmonization and has expressed its guidance. FDA received one comment document to http://www.regulations.gov
commitment to seek scientifically based, on the draft revised guidance, and that or written comments to the Division of
harmonized technical procedures for the comment, as well as those received by Dockets Management (see ADDRESSES). It
development of pharmaceutical other VICH member regulatory agencies, is only necessary to send one set of
products. One of the goals of were considered as the guidance was comments. Identify comments with the
harmonization is to identify, and then finalized. The guidance announced in docket number found in brackets in the
reduce, differences in technical this document finalizes the draft revised heading of this document. Received
requirements for drug development guidance dated March 5, 2013. The comments may be seen in the Division
among regulatory agencies in different revised guidance is a product of the of Dockets Management between 9 a.m.
countries.
FDA has actively participated in the Safety Expert Working Group of the and 4 p.m., Monday through Friday, and
International Conference on VICH. will be posted to the docket at http://
Harmonisation of Technical This revised VICH guidance www.regulations.gov.
Requirements for Registration of document recommends a second test to VI. Electronic Access
Pharmaceuticals for Human Use (ICH) evaluate the potential of a chemical to
Persons with access to the Internet
for several years to develop harmonized produce chromosomal effects. The
technical requirements for the approval may obtain the revised guidance at
revised VICH guidance indicates that
of human pharmaceutical and biological either http://www.fda.gov/
the potential of a chemical to produce
products among the European Union, AnimalVeterinary/
chromosomal effects can be evaluated
Japan, and the United States. The VICH GuidanceComplianceEnforcement/
using one of the following three tests:
is a parallel initiative for veterinary GuidanceforIndustry/default.htm or
(1) An in vitro chromosomal aberrations http://www.regulations.gov.
medicinal products. The VICH is test using metaphase analysis, which
concerned with developing harmonized detects both clastogenicity and Dated: May 7, 2015.
technical requirements for the approval aneugenicity; (2) an in vitro mammalian Leslie Kux,
of veterinary medicinal products in the cell micronucleus test, which detects Associate Commissioner for Policy.
European Union, Japan, and the United the activity of clastogenicity and [FR Doc. 2015–11527 Filed 5–12–15; 8:45 am]
States, and includes input from both aneugenicity; or (3) a mouse lymphoma BILLING CODE 4164–01–P
regulatory and industry representatives. test, which, with modification, can
The VICH Steering Committee is
detect both gene mutation and
composed of member representatives DEPARTMENT OF HEALTH AND
chromosomal damage. This revised
from the European Commission, HUMAN SERVICES
VICH guidance is intended to facilitate
European Medicines Evaluation Agency,
European Federation of Animal Health, the mutual acceptance of safety data
Food and Drug Administration
Committee on Veterinary Medicinal necessary for the establishment of
Products, FDA, the U.S. Department of acceptable daily intakes for veterinary
drug residues in human food by the [Docket No. FDA–2010–N–0128]
Agriculture, the Animal Health
Institute, the Japanese Veterinary relevant regulatory authorities. The
Prescription Drug User Fee Act; Public
Pharmaceutical Association, the objective of this revised VICH guidance
Meeting; Request for Comments
Japanese Association of Veterinary is to ensure international harmonization
Biologics, and the Japanese Ministry of of genotoxicity testing. AGENCY: Food and Drug Administration,
Agriculture, Forestry, and Fisheries. HHS.
II. Significance of Guidance
Six observers are eligible to ACTION: Notice of public meeting;
participate in the VICH Steering This guidance, developed under the request for comments
Committee: One representative from the VICH process, is being issued consistent
government of Australia/New Zealand, with FDA’s good guidance practices SUMMARY: The Food and Drug
one representative from the industry in regulation (21 CFR 10.115). This Administration (FDA or Agency) is
Australia/New Zealand, one guidance represents the current thinking announcing a public meeting on the
representative from the government of of FDA on this topic. It does not reauthorization of the Prescription Drug
Canada, one representative from the establish any rights for any person and User Fee Act (PDUFA) for fiscal years
industry of Canada, one representative is not binding on FDA or the public. (FYs) 2018 through 2022. PDUFA
from the government of South Africa, authorizes FDA to collect user fees for
You can use an alternative approach if
and one representative from the the process for the review of human
it satisfies the requirements of the
industry of South Africa. The VICH drugs. The current legislative authority
applicable statutes and regulations.
Secretariat, which coordinates the for PDUFA expires in September 2017.
preparation of documentation, is III. Paperwork Reduction Act of 1995 At that time, new legislation will be
provided by the International required for FDA to continue collecting
Federation for Animal Health (IFAH). This guidance refers to previously user fees in future fiscal years. The
An IFAH representative also approved collections of information Federal Food, Drug, and Cosmetic Act
asabaliauskas on DSK5VPTVN1PROD with NOTICES

participates in the VICH Steering found in FDA regulations. These (FD&C Act) requires that FDA begin the
Committee meetings. collections of information are subject to PDUFA reauthorization process by
In the Federal Register of March 5, review by the Office of Management and publishing a notice in the Federal
2013 (78 FR 14306), FDA published a Budget (OMB) under the Paperwork Register requesting public input and
notice of availability for a draft revised Reduction Act of 1995 (44 U.S.C. 3501– holding a public meeting where the
guidance document entitled ‘‘Studies to 3520). The collections of information in public may present its views on the
Evaluate the Safety of Residues of 21 CFR part 514 have been approved reauthorization. FDA invites public
Veterinary Drugs in Human Food: under OMB control number 0910–0032. comment as the Agency begins the

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public meeting; request for comments
Dates		The public meeting will be held on July 15, 2015, from 9 a.m. to 2 p.m. Registration to attend the meeting must be received by June 30, 2015. See section III.B for information on how to register for the meeting. Submit either electronic or written comments by August 15, 2015.
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.
FR Citation		80 FR 27323

80 FR 27323 - Prescription Drug User Fee Act; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 92 (May 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration