Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability, 71511-71513 [2016-25037]
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jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
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performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Audrey Thomas, Office of Regulatory
Science and Innovation, Office of the
Chief Scientist, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4220, Silver Spring,
MD 20993–0002, 301–796–3520,
Audrey.Thomas@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
purpose of this public workshop is to
provide an opportunity for stakeholders,
including scientists from government,
academia, and industry, patient
advocacy groups, clinicians,
pharmacists, and the general public to
discuss marketed generic drugs. Generic
drugs account for 88 percent of
prescriptions in the United States. In
light of the significant contributions of
generic drugs to public health, it is
important that tools are developed to
monitor marketed generic drugs to
ensure that they have the same safety
and effectiveness as their reference
listed drug. Specifically, this workshop
will include presentations on: (1)
Current generic drug surveillance
practices at FDA and in industry, (2)
public perception of generic drug
quality and effectiveness, (3) generic
drug substitution studies in patients,
and (4) development of methods and
tools to conduct postmarket surveillance
of generic drugs. The workshop will
include four panel sessions for
interaction and discussion among the
speakers and attendees.
Agenda: The agenda is available at
https://www.fda.gov/scienceresearch/
specialtopics/regulatoryscience/
ucm521545.htm.
Registration: There is no registration
fee to attend this public workshop. Seats
are limited and registration will be on
a first-come, first-served basis. Advance
registration is required and is online
only at https://www.fda.gov/
scienceresearch/specialtopics/
regulatoryscience/ucm521545.htm.
There will be no day-of, onsite
registration.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. There is no registration
fee for access to the workshop via the
Webcast, but registration is still
required. Information regarding
registration and access to the Webcast
link is available at https://www.fda.gov/
scienceresearch/specialtopics/
regulatoryscience/ucm521545.htm. If
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Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25004 Filed 10–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0229]
Food and Drug Administration,
HHS.
ACTION:
Dated: October 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–24947 Filed 10–14–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Notice.
[Docket No. FDA–2014–D–0901]
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
rare pediatric disease product
applications that meet certain criteria.
FDA has determined that EXONDYS 51
(eteplirsen), manufactured by Sarepta
Therapeutics, meets the criteria for a
priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4842, FAX: 301–796–9858,
email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of a rare
pediatric disease product application.
SUMMARY:
PO 00000
Under section 529 of the FD&C Act (21
U.S.C. 360ff), which was added by
FDASIA, FDA will award priority
review vouchers to sponsors of rare
pediatric disease product applications
that meet certain criteria. FDA has
determined that EXONDYS 51
(eteplirsen), manufactured by Sarepta
Therapeutics, meets the criteria for a
priority review voucher. EXONDYS 51
(eteplirsen) is indicated for the
treatment of Duchenne muscular
dystrophy (DMD) in patients who have
a confirmed mutation of the DMD gene
that is amenable to exon 51 skipping.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about EXONDYS 51
(eteplirsen) go to the ‘‘Drugs@FDA’’ Web
site at https://www.accessdata.fda.gov/
scripts/cder/drugsatfda/index.cfm.
BILLING CODE 4164–01–P
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
71511
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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.
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
SUMMARY:
E:\FR\FM\17OCN1.SGM
17OCN1
71512
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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’’).
jstallworth on DSK7TPTVN1PROD with NOTICES
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 https://www.regulations.gov
or at the Division of Dockets
VerDate Sep<11>2014
14:22 Oct 14, 2016
Jkt 241001
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 https://
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: https://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 https://
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.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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
E:\FR\FM\17OCN1.SGM
17OCN1
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
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.
jstallworth on DSK7TPTVN1PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
information/Guidances/default.htm, or
https://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
VerDate Sep<11>2014
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Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0598]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the recordkeeping requirements for
manufacturers of Type A medicated
articles.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by December 16, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
71513
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–
2010–N–0598] for ‘‘[Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice
Regulations for Type A Medicated
Articles].’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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 https://
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: https://www.fda.gov/
E:\FR\FM\17OCN1.SGM
17OCN1
Agencies
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71511-71513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25037]
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm, or
https://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