83 FR 31399 - Abbreviated New Drug Application Submissions-Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 129 (July 5, 2018)

Page Range		31399-31400
FR Document		2018-14429

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance finalizes the October 2017 draft guidance for industry ``ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.

Federal Register, Volume 83 Issue 129 (Thursday, July 5, 2018)

[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31399-31400]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14429]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5670]

Abbreviated New Drug Application Submissions--Amendments to
Abbreviated New Drug Applications Under the Generic Drug User Fee Act;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' This guidance finalizes the October 2017 draft guidance for
industry ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance is intended to explain to
applicants how the review goals established as part of the Generic Drug
User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to
amendments to either abbreviated new drug applications (ANDAs) or prior
approval supplements (PASs) submitted to FDA under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment
classifications and categories and explains how amendment submissions
may affect an application's review goal dates. The guidance also
describes how FDA will review amendments submitted to ANDAs and PASs
received prior to October 1, 2017, the effective date to implement the
GDUFA II review goals.

DATES: The announcement of the guidance is published in the Federal
Register on July 5, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-2017-D-5670 for ``ANDA Submissions--Amendments to Abbreviated New
Drug Applications 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 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.thefederalregister.org/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002,
240-

[[Page 31400]]

402-7930, elizabeth.giaquinto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance finalizes the October 2017
draft guidance for industry ``ANDA Submissions--Amendments to
Abbreviated New Drug Applications Under GDUFA.'' This guidance is
intended to assist applicants preparing to submit amendments to ANDAs
or to PASs to FDA under section 505(j) of the FD&C Act (21 U.S.C.
355(j)) by explaining how the review goals established as part of GDUFA
II apply to these submissions. In accordance with the GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022 (GDUFA II Commitment Letter: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/ucm525234.pdf), FDA agreed to
certain review goals and procedures for the review of amendments
pending as of or received on or after the GDUFA II effective date.
The GDUFA II Commitment Letter reflects significant changes in the
classification of and review goals for amendments to ANDAs and PASs
under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under
GDUFA I, amendments were classified into a complex Tier system based on
the following factors: (1) Whether the amendment was solicited
(submitted in response to a complete response letter) or unsolicited
(submitted on the applicant's own initiative); (2) whether the
amendment was major or minor; the number of amendments submitted to the
ANDA or PAS; and (3) whether an inspection was necessary to support the
information contained in the amendment.
GDUFA II simplified the amendment review goals and no longer
subjects them to a Tier system; however, review goals are still
dependent on several factors. In general, under GDUFA II, amendments
will be designated as either standard or priority; will be classified
as major or minor, and will receive a goal date based on the factors
discussed in the draft guidance, including whether a preapproval
inspection is needed. This guidance supersedes the December 2001
guidance for industry ``Major, Minor, and Telephone Amendments to
Abbreviated New Drug Applications'' and the July 2014 draft guidance
for industry ``ANDA Submissions--Amendments and Easily Correctable
Deficiencies Under GDUFA,'' both of which will be withdrawn. This
guidance finalizes the October 2017 draft guidance for industry ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' The final guidance contains clarifications to the draft
guidance of the same title that published in October 2017.
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--Amendments to
Abbreviated New Drug Applications 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. This guidance is not subject to
Executive Order 12866.

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 in 21 CFR 314.96 have been approved under
OMB control number 0910-0001.

III. 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: June 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14429 Filed 7-3-18; 8:45 am]
BILLING CODE 4164-01-P

31400 Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices

402–7930, elizabeth.giaquinto@ ‘‘ANDA Submissions—Amendments burden of Alzheimer’s disease and
fda.hhs.gov. and Easily Correctable Deficiencies related dementias on people with the
SUPPLEMENTARY INFORMATION:
Under GDUFA,’’ both of which will be disease and their caregivers. The
withdrawn. This guidance finalizes the Advisory Council will spend the
I. Background October 2017 draft guidance for majority of the July meeting considering
FDA is announcing the availability of industry ‘‘ANDA Submissions— recommendations made by each of the
a guidance for industry entitled ‘‘ANDA Amendments to Abbreviated New Drug three subcommittees to present to the
Submissions—Amendments to Applications Under GDUFA.’’ The final Secretary of HHS and Congress.
Abbreviated New Drug Applications guidance contains clarifications to the Additional presentations in the
Under GDUFA.’’ This guidance finalizes draft guidance of the same title that afternoon will include a presentation on
the October 2017 draft guidance for published in October 2017. a recent study by RAND on the health
industry ‘‘ANDA Submissions— This guidance is being issued care infrastructure, the CDC/
Amendments to Abbreviated New Drug consistent with FDA’s good guidance Alzheimer’s Association’s joint Healthy
Applications Under GDUFA.’’ This practices regulation (21 CFR 10.115). Brain Initiative Roadmap, federal
guidance is intended to assist applicants The guidance represents the current workgroup updates, and updates on
preparing to submit amendments to thinking of FDA on ‘‘ANDA work by the non-federal members.
ANDAs or to PASs to FDA under Submissions—Amendments to DATES: The meeting will be held on July
section 505(j) of the FD&C Act (21 Abbreviated New Drug Applications 30, 2018 from 9:00 a.m. to 5:00 p.m.
U.S.C. 355(j)) by explaining how the Under GDUFA.’’ It does not establish EDT.
review goals established as part of any rights for any person and is not ADDRESSES: The meeting will be held in
GDUFA II apply to these submissions. binding on FDA or the public. You can Room 800 in the Hubert H. Humphrey
In accordance with the GDUFA use an alternative approach if it satisfies Building, 200 Independence Avenue
Reauthorization Performance Goals and the requirements of the applicable SW, Washington, DC 20201.
Program Enhancements Fiscal Years statutes and regulations. This guidance Comments: Time is allocated in the
2018–2022 (GDUFA II Commitment is not subject to Executive Order 12866. afternoon on the agenda to hear public
Letter: https://www.fda.gov/downloads/ II. Paperwork Reduction Act of 1995 comments. The time for oral comments
ForIndustry/UserFees/GenericDrug will be limited to two (2) minutes per
This guidance refers to previously individual. In lieu of oral comments,
UserFees/ucm525234.pdf), FDA agreed
approved collections of information formal written comments may be
to certain review goals and procedures
found in FDA regulations. These submitted for the record to Rohini
for the review of amendments pending
collections of information are subject to Khillan, OASPE, 200 Independence
as of or received on or after the GDUFA
review by the Office of Management and Avenue SW, Room 424E, Washington,
II effective date.
Budget (OMB) under the Paperwork DC 20201. Comments may also be sent
The GDUFA II Commitment Letter
Reduction Act of 1995 (44 U.S.C. 3501– to napa@hhs.gov. Those submitting
reflects significant changes in the
3520). The collections of information in written comments should identify
classification of and review goals for
21 CFR 314.96 have been approved themselves and any relevant
amendments to ANDAs and PASs under
under OMB control number 0910–0001. organizational affiliations. Those
the Generic Drug User Fee Amendments
of 2012 (GDUFA I). Under GDUFA I, III. Electronic Access intending to make public comments at
amendments were classified into a the meeting must submit their
Persons with access to the internet comments either by mail or email ahead
complex Tier system based on the may obtain the guidance at either
following factors: (1) Whether the of time for the record. Comments are
https://www.fda.gov/Drugs/Guidance due no later than Monday, July 23,
amendment was solicited (submitted in ComplianceRegulatoryInformation/
response to a complete response letter) 2018.
Guidances/default.htm or https://
or unsolicited (submitted on the www.regulations.gov. FOR FURTHER INFORMATION CONTACT:
applicant’s own initiative); (2) whether Rohini Khillan (202) 690–5932,
the amendment was major or minor; the Dated: June 29, 2018.
rohini.khillan@hhs.gov. Note: Seating
number of amendments submitted to the Leslie Kux, may be limited. Those wishing to attend
ANDA or PAS; and (3) whether an Associate Commissioner for Policy. the meeting must send an email to
inspection was necessary to support the [FR Doc. 2018–14429 Filed 7–3–18; 8:45 am] napa@hhs.gov and put ‘‘July 30 Meeting
information contained in the BILLING CODE 4164–01–P Attendance’’ in the Subject line by
amendment. Friday, July 20, so that their names may
GDUFA II simplified the amendment be put on a list of expected attendees
review goals and no longer subjects DEPARTMENT OF HEALTH AND and forwarded to the security officers at
them to a Tier system; however, review HUMAN SERVICES the Department of Health and Human
goals are still dependent on several Services. Any interested member of the
factors. In general, under GDUFA II, Advisory Council on Alzheimer’s public who is a non-U.S. citizen should
amendments will be designated as Research, Care, and Services; Meeting include this information at the time of
either standard or priority; will be AGENCY: Assistant Secretary for registration to ensure that the
classified as major or minor, and will Planning and Evaluation, HHS. appropriate security procedure to gain
receive a goal date based on the factors ACTION: Notice of meeting.
entry to the building is carried out.
discussed in the draft guidance, Although the meeting is open to the
amozie on DSK3GDR082PROD with NOTICES1

including whether a preapproval SUMMARY: This notice announces the public, procedures governing security
inspection is needed. This guidance public meeting of the Advisory Council and the entrance to Federal buildings
supersedes the December 2001 guidance on Alzheimer’s Research, Care, and may change without notice. If you wish
for industry ‘‘Major, Minor, and Services (Advisory Council). The to make a public comment, you must
Telephone Amendments to Abbreviated Advisory Council on Alzheimer’s note that within your email.
New Drug Applications’’ and the July Research, Care, and Services provides SUPPLEMENTARY INFORMATION: Notice of
2014 draft guidance for industry advice on how to prevent or reduce the these meetings is given under the

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Document Created: 2018-07-03 23:40:28
Document Modified: 2018-07-03 23:40:28

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		The announcement of the guidance is published in the Federal Register on July 5, 2018.
Contact		Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240- 402-7930, [email protected]
FR Citation		83 FR 31399

83 FR 31399 - Abbreviated New Drug Application Submissions-Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 129 (July 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration