81 FR 71511 - Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

Page Range		71511-71513
FR Document		2016-25037

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to fund critical and measurable improvements to FDA's generic drugs program. This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA's performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to GDUFA performance metric goals. This guidance finalizes the draft guidance issued on July 11, 2014.

Federal Register, Volume 81 Issue 200 (Monday, October 17, 2016)

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71511-71513]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-25037]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0901]

Abbreviated New Drug Application Submissions--Prior Approval
Supplements Under Generic Drug User Fee Amendments; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``ANDA
Submissions--Prior Approval Supplements Under GDUFA.'' The Generic Drug
User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to
fund critical and measurable improvements to FDA's generic drugs
program. This guidance is intended to assist applicants preparing to
submit to FDA prior approval supplements (PASs) and amendments to PASs
for abbreviated new drug applications (ANDAs). It describes FDA's
performance metric goals for PASs and clarifies how FDA will handle a
PAS

[[Page 71512]]

and amendments to a PAS for an ANDA subject to GDUFA performance metric
goals. This guidance finalizes the draft guidance issued on July 11,
2014.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: 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-2014-D-0901 for ``ANDA Submissions--Prior Approval Supplements
Under GDUFA.'' 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.
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.
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tamara R. Coley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903, 240-402-6903 or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.''
On July 9, 2012, the President signed GDUFA (Pub. L. 112-144, Title
III) into law. GDUFA is based on an agreement negotiated by FDA and
representatives of the generic drug industry to address a growing
number of regulatory challenges. GDUFA aims to ensure timely access to
safe, high-quality, affordable generic drugs. GDUFA enables FDA to
assess user fees to fund critical and measurable improvements to FDA's
generic drugs program and to bring greater predictability and
timeliness to the review of generic drug applications.
GDUFA requires that FDA and human generic drug manufacturers meet
certain commitments. In the GDUFA Commitment Letter, FDA committed to
review and act on a certain percentage of PASs within a specified
period from the date of submission for receipts in fiscal years 2015 to
2017. The percentage of PASs that FDA has committed to review and act
on increases with each fiscal year, and the deadlines for review depend
on whether a PAS requires an inspection.
This guidance describes the performance metric goals to which FDA
agreed in the Commitment Letter and clarifies how FDA will review a PAS
and amendments to a PAS for an ANDA subject to the GDUFA performance
metric goals. The GDUFA performance metrics described in this guidance
only apply to ANDA applicants who electronically submit a PAS on or
after October 1, 2014. These performance metrics do not apply to new
drug applications (NDAs), biologics license applications (BLAs),
supplements filed for NDAs or BLAs, or changes being effected
supplements and annual report filings to NDAs, BLAs, or ANDAs.
This guidance finalizes the draft guidance that was issued under
the same title on July 11, 2014 (79 FR 40112), and reflects FDA's
consideration of public comments on the draft guidance. Generally, FDA
revised the

[[Page 71513]]

draft guidance to provide clarifying and explanatory information that
will assist human generic drug manufacturers with PAS submissions.
Changes from the draft guidance include clarification on the point at
which a PAS is deemed submitted to FDA and a description of the process
through which applicants may request FDA reconsider its supplement
reporting category determination. The draft guidance and related public
comments are publicly available in Docket No. FDA-2014-D-0901.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``ANDA Submissions--Prior Approval
Supplements Under GDUFA.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information for supplements and amendments in 21 CFR
part 314 have been approved under OMB control number 0910-0001. The
collection of information for manufacturer registration in 21 CFR part
207 has been approved under OMB control number 0910-0045. The
collection of information for manufacturer compliance with current good
manufacturing practices in 21 CFR part 211 has been approved under OMB
control number 0910-0139.

III. Electronic Access

Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm, or
http://www.regulations.gov.

Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25037 Filed 10-14-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71511

security check procedures will be you have never attended a Connect Pro Under section 529 of the FD&C Act (21
performed. For parking and security event before, test your connection at U.S.C. 360ff), which was added by
information, please refer to http:// https://collaboration.fda.gov/common/ FDASIA, FDA will award priority
www.fda.gov/AboutFDA/ help/en/support/meeting_test.htm. To review vouchers to sponsors of rare
WorkingatFDA/BuildingsandFacilities/ get a quick overview of the Connect Pro pediatric disease product applications
WhiteOakCampusInformation/ program, visit http://www.adobe.com/ that meet certain criteria. FDA has
ucm241740.htm. go/connectpro_overview. (FDA has determined that EXONDYS 51
FOR FURTHER INFORMATION CONTACT: verified these Web site addresses, but (eteplirsen), manufactured by Sarepta
Audrey Thomas, Office of Regulatory FDA is not responsible for any Therapeutics, meets the criteria for a
Science and Innovation, Office of the subsequent changes to the Web sites priority review voucher. EXONDYS 51
Chief Scientist, Food and Drug after this document publishes in the (eteplirsen) is indicated for the
Administration, 10903 New Hampshire Federal Register.) treatment of Duchenne muscular
Ave., Bldg. 1, Rm. 4220, Silver Spring, Accommodations: Attendees are dystrophy (DMD) in patients who have
MD 20993–0002, 301–796–3520, responsible for their own hotel a confirmed mutation of the DMD gene
Audrey.Thomas@fda.hhs.gov. accommodations. If you need special that is amenable to exon 51 skipping.
accommodations while at FDA’s White For further information about the Rare
SUPPLEMENTARY INFORMATION: The
Oak Campus due to a disability, please Pediatric Disease Priority Review
purpose of this public workshop is to
contact Shari Solomon at Voucher Program and for a link to the
provide an opportunity for stakeholders,
Shari.Solomon@fda.hhs.gov at least 7 full text of section 529 of the FD&C Act,
including scientists from government,
days in advance. go to http://www.fda.gov/ForIndustry/
academia, and industry, patient
advocacy groups, clinicians, Dated: October 11, 2016. DevelopingProductsforRareDiseases
pharmacists, and the general public to Leslie Kux, Conditions/RarePediatricDiseasePriority
discuss marketed generic drugs. Generic VoucherProgram/default.htm. For
Associate Commissioner for Policy.
drugs account for 88 percent of further information about EXONDYS 51
[FR Doc. 2016–25004 Filed 10–14–16; 8:45 am]
prescriptions in the United States. In (eteplirsen) go to the ‘‘Drugs@FDA’’ Web
BILLING CODE 4164–01–P
light of the significant contributions of site at http://www.accessdata.fda.gov/
generic drugs to public health, it is scripts/cder/drugsatfda/index.cfm.
important that tools are developed to DEPARTMENT OF HEALTH AND Dated: October 6, 2016.
monitor marketed generic drugs to HUMAN SERVICES Leslie Kux,
ensure that they have the same safety Associate Commissioner for Policy.
and effectiveness as their reference Food and Drug Administration [FR Doc. 2016–24947 Filed 10–14–16; 8:45 am]
listed drug. Specifically, this workshop [Docket No. FDA–2014–N–0229] BILLING CODE 4164–01–P
will include presentations on: (1)
Current generic drug surveillance Issuance of Priority Review Voucher;
practices at FDA and in industry, (2) Rare Pediatric Disease Product DEPARTMENT OF HEALTH AND
public perception of generic drug HUMAN SERVICES
quality and effectiveness, (3) generic AGENCY: Food and Drug Administration,
drug substitution studies in patients, HHS. Food and Drug Administration
and (4) development of methods and ACTION: Notice.
[Docket No. FDA–2014–D–0901]
tools to conduct postmarket surveillance
SUMMARY: The Food and Drug
of generic drugs. The workshop will Abbreviated New Drug Application
Administration (FDA) is announcing the
include four panel sessions for Submissions—Prior Approval
issuance of a priority review voucher to
interaction and discussion among the Supplements Under Generic Drug User
the sponsor of a rare pediatric disease
speakers and attendees. Fee Amendments; Guidance for
product application. The Federal Food,
Agenda: The agenda is available at Industry; Availability
Drug, and Cosmetic Act (the FD&C Act),
http://www.fda.gov/scienceresearch/
as amended by the Food and Drug AGENCY: Food and Drug Administration,
specialtopics/regulatoryscience/
Administration Safety and Innovation HHS.
ucm521545.htm.
Registration: There is no registration Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of ACTION: Notice of availability.
fee to attend this public workshop. Seats
are limited and registration will be on rare pediatric disease product SUMMARY: The Food and Drug
a first-come, first-served basis. Advance applications that meet certain criteria. Administration (FDA or Agency) is
registration is required and is online FDA has determined that EXONDYS 51 announcing the availability of a
only at http://www.fda.gov/ (eteplirsen), manufactured by Sarepta guidance for industry entitled ‘‘ANDA
scienceresearch/specialtopics/ Therapeutics, meets the criteria for a Submissions—Prior Approval
regulatoryscience/ucm521545.htm. priority review voucher. Supplements Under GDUFA.’’ The
There will be no day-of, onsite FOR FURTHER INFORMATION CONTACT: Generic Drug User Fee Amendments of
registration. Larry Bauer, Rare Diseases Program, 2012 (GDUFA) enables FDA to assess
Streaming Webcast of the Public Center for Drug Evaluation and user fees to fund critical and measurable
Workshop: This public workshop will Research, Food and Drug improvements to FDA’s generic drugs
also be Webcast. There is no registration Administration, 10903 New Hampshire program. This guidance is intended to
jstallworth on DSK7TPTVN1PROD with NOTICES

fee for access to the workshop via the Ave., Silver Spring, MD 20993–0002, assist applicants preparing to submit to
Webcast, but registration is still 301–796–4842, FAX: 301–796–9858, FDA prior approval supplements (PASs)
required. Information regarding email: larry.bauer@fda.hhs.gov. and amendments to PASs for
registration and access to the Webcast SUPPLEMENTARY INFORMATION: FDA is abbreviated new drug applications
link is available at http://www.fda.gov/ announcing the issuance of a priority (ANDAs). It describes FDA’s
scienceresearch/specialtopics/ review voucher to the sponsor of a rare performance metric goals for PASs and
regulatoryscience/ucm521545.htm. If pediatric disease product application. clarifies how FDA will handle a PAS

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Document Created: 2016-10-15 01:52:17
Document Modified: 2016-10-15 01:52:17

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 availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Tamara R. Coley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 240-402-6903 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 240-402-7911.
FR Citation		81 FR 71511

81 FR 71511 - Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration