Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability, 34679-34680 [2017-15654]
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Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
completing special studies, such as
Medicaid spending for special
education; collaborating with the
University of Massachusetts and the
University of Minnesota to show
targeted current year and longitudinal
data on the project Web site and
providing a create-a-chart option
allowing reports to be customized. The
comparative nationwide longitudinal
study of public financial commitments
and programmatic trends in
developmental disabilities services and
supports is a thirty-year body of work.
Agency Contact: For further
information or comments regarding this
supplemental action, contact KatherineCargill-Willis, U.S. Department of
Health and Human Services,
Administration for Community Living,
Administration on Intellectual and
Developmental Disabilities, 330 C Street
SW., Washington, DC 20201; telephone
202–795–7322; email katherine.cargillwillis@acl.hhs.gov.
Dated: July 17, 2017.
Mary Lazare,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–15662 Filed 7–25–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
Generic Drug User Fee Amendments of
2012: Questions and Answers Related
to Self-Identification of Facilities,
Review of Generic Drug Submissions,
and Inspections and Compliance;
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 the
guidance entitled ‘‘Generic Drug User
Fee Amendments of 2012: Questions
and Answers Related to SelfIdentification of Facilities, Review of
Generic Drug Submissions, and
Inspections and Compliance.’’ The
Generic Drug User Fee Amendments of
2012 (GDUFA) are designed to speed the
delivery of safe and effective generic
drugs to the public and to improve the
review process for abbreviated new drug
applications (ANDAs). This guidance is
intended to provide answers to common
questions from the generic drug
industry and other interested parties
involved in the development and/or
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:49 Jul 25, 2017
Jkt 241001
testing of generic drug products
regarding the requirements and
commitments of GDUFA. This guidance
finalizes the draft guidance originally
issued in August 2012 and issued in
revised draft form in September 2013.
DATES: Submit either electronic or
written comments on this guidance 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2012–D–0880 for ‘‘Generic Drug User
Fee Amendments of 2012: Questions
and Answers Related to SelfIdentification of Facilities, Review of
Generic Drug Submissions, and
Inspections and Compliance.’’ Received
comments will be placed in the docket
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
34679
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 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. 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:
Sonia Kim, Center for Drug Evaluation
and Research, Food and Drug
E:\FR\FM\26JYN1.SGM
26JYN1
34680
Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor,
Silver Spring, MD 20993–0002, 240–
402–5118.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK30JT082PROD with NOTICES
I. Background
GDUFA (Pub. L. 112–144, Title III)
was signed into law by the President on
July 9, 2012. GDUFA is designed to
speed the delivery of safe and effective
generic drugs to the public and to
improve the review process for ANDAs.
GDUFA enables FDA to assess user fees
to support critical and measurable
enhancements to FDA’s generic drugs
program.
On August 27, 2012, FDA announced
the availability of a draft guidance for
industry entitled ‘‘Generic Drug User
Fee Amendments of 2012: Questions
and Answers’’ (77 FR 51814). On
September 10, 2013, FDA announced
the availability of a revised version of
this guidance (78 FR 55261). The
comment period on the revised draft
guidance ended on December 11, 2013
(78 FR 70953). FDA received several
comments on the draft guidance, and
these comments as well as FDA’s
experience implementing GDUFA were
considered as the guidance was
finalized.
This guidance is intended to provide
answers to common questions from
generic drug industry participants and
other interested parties involved in the
development and/or testing of generic
drug products regarding FDA’s
implementation of GDUFA. This
guidance includes three categories of
questions and answers: Selfidentification of facilities, sites, and
organizations; review of generic drug
submissions; and inspections and
compliance. The draft versions of this
guidance also addressed the subject of
fees. The portion of the draft guidance
relating to fees was updated and
finalized in November 2016 (81 FR
81774, November 18, 2016).
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 ‘‘Generic Drug User
Fee Amendments of 2012: Questions
and Answers Related to SelfIdentification of Facilities, Review of
Generic Drug Submissions, and
Inspections and Compliance.’’ 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. This
guidance is not subject to Executive
Order 12866.
VerDate Sep<11>2014
17:49 Jul 25, 2017
Jkt 241001
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15654 Filed 7–25–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–3906]
Consumer Antiseptic Wash Final Rule
Questions and Answers; Guidance for
Industry; Small Entity Compliance
Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
guidance for industry entitled
‘‘Consumer Antiseptic Wash Final Rule
Questions and Answers.’’ We are
issuing this guidance in accordance
with the Small Business Regulatory
Enforcement Fairness Act to assist small
businesses in better understanding and
complying with the consumer antiseptic
wash final rule, which established that
certain active ingredients, including
triclosan, used in over-the-counter
(OTC) consumer antiseptic wash
products are not generally recognized as
safe and effective (GRASE). This
guidance explains the scope of the final
rule, how and when manufacturers must
comply with the final rule, and which
consumer antiseptic wash active
ingredients were deferred from the final
rule.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–D–3906 for ‘‘Consumer Antiseptic
Wash Final Rule Questions and
Answers; Guidance for Industry; Small
Entity Compliance Guide.’’ 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 Dockets Management Staff
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
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34679-34680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15654]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0880]
Generic Drug User Fee Amendments of 2012: Questions and Answers
Related to Self-Identification of Facilities, Review of Generic Drug
Submissions, and Inspections and Compliance; 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 the guidance entitled ``Generic Drug User Fee
Amendments of 2012: Questions and Answers Related to Self-
Identification of Facilities, Review of Generic Drug Submissions, and
Inspections and Compliance.'' The Generic Drug User Fee Amendments of
2012 (GDUFA) are designed to speed the delivery of safe and effective
generic drugs to the public and to improve the review process for
abbreviated new drug applications (ANDAs). This guidance is intended to
provide answers to common questions from the generic drug industry and
other interested parties involved in the development and/or testing of
generic drug products regarding the requirements and commitments of
GDUFA. This guidance finalizes the draft guidance originally issued in
August 2012 and issued in revised draft form in September 2013.
DATES: Submit either electronic or written comments on this guidance 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2012-D-0880 for ``Generic Drug User Fee Amendments of 2012:
Questions and Answers Related to Self- Identification of Facilities,
Review of Generic Drug Submissions, and Inspections and Compliance.''
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 Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 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. 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: Sonia Kim, Center for Drug Evaluation
and Research, Food and Drug
[[Page 34680]]
Administration, 10001 New Hampshire Ave., Hillandale Building, 4th
Floor, Silver Spring, MD 20993-0002, 240-402-5118.
SUPPLEMENTARY INFORMATION:
I. Background
GDUFA (Pub. L. 112-144, Title III) was signed into law by the
President on July 9, 2012. GDUFA is designed to speed the delivery of
safe and effective generic drugs to the public and to improve the
review process for ANDAs. GDUFA enables FDA to assess user fees to
support critical and measurable enhancements to FDA's generic drugs
program.
On August 27, 2012, FDA announced the availability of a draft
guidance for industry entitled ``Generic Drug User Fee Amendments of
2012: Questions and Answers'' (77 FR 51814). On September 10, 2013, FDA
announced the availability of a revised version of this guidance (78 FR
55261). The comment period on the revised draft guidance ended on
December 11, 2013 (78 FR 70953). FDA received several comments on the
draft guidance, and these comments as well as FDA's experience
implementing GDUFA were considered as the guidance was finalized.
This guidance is intended to provide answers to common questions
from generic drug industry participants and other interested parties
involved in the development and/or testing of generic drug products
regarding FDA's implementation of GDUFA. This guidance includes three
categories of questions and answers: Self-identification of facilities,
sites, and organizations; review of generic drug submissions; and
inspections and compliance. The draft versions of this guidance also
addressed the subject of fees. The portion of the draft guidance
relating to fees was updated and finalized in November 2016 (81 FR
81774, November 18, 2016).
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 ``Generic Drug User Fee Amendments of 2012:
Questions and Answers Related to Self- Identification of Facilities,
Review of Generic Drug Submissions, and Inspections and Compliance.''
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. This
guidance is not subject to Executive Order 12866.
II. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15654 Filed 7-25-17; 8:45 am]
BILLING CODE 4164-01-P
