82 FR 46066 - Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46066-46068 | |
| FR Document | 2017-21175 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46066-46068] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21175] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5670] Abbreviated New Drug Applications Submissions--Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA.'' This draft guidance is intended to explain to applicants how [[Page 46067]] the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The draft guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II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 DATES: Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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: 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 the draft 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 draft 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, 240-402-7930, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance is intended to assist applicants preparing to submit amendments to ANDAs or 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, available at: 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: Whether the amendment was solicited (submitted in response to a complete response letter) or unsolicited (submitted on the applicant's own initiative). Whether the amendment was major or minor. The number of amendments submitted to the ANDA or PAS. 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 [[Page 46068]] 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. When finalized, this draft guidance will replace the December 2001 guidance for industry ``Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications.'' This draft guidance supersedes the July 2014 draft guidance for industry ``ANDA Submissions--Amendments and Easily Correctable Deficiencies Under GDUFA.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 draft 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 draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21175 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
![46066 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
its consideration of comments. The reproducible. FDA believes that these selected for presentation, any
second copy, which will have the BE approaches would benefit from presentation materials must be emailed
claimed confidential information public discussion. to GDUFARegulatoryScience@
redacted/blacked out, will be available fda.hhs.gov no later than October 13,
II. Topics for Discussion at the Public
for public viewing and posted on 2017. No commercial or promotional
Workshop
https://www.regulations.gov. Submit material will be permitted to be
both copies to the Dockets Management This public workshop will focus on a presented or distributed at the public
Staff. If you do not wish your name and discussion of current regulatory science workshop.
contact information to be made publicly initiatives intended to foster the Streaming webcast of the public
available, you can provide this development of topical dermatological workshop: This public workshop will
information on the cover sheet and not generic drug products, examining also be webcast. A live webcast of this
in the body of your comments and you alternative BE approaches that may be workshop will be viewable at https://
must identify this information as more efficient and less risky than collaboration.fda.gov/ogddermaldrug/
‘‘confidential.’’ Any information marked traditional approaches. FDA is also on the day of the workshop.
as ‘‘confidential’’ will not be disclosed interested in receiving public input If you have never attended a Connect
except in accordance with 21 CFR 10.20 about any barriers that may limit the use Pro event before, test your connection at
and other applicable disclosure law. For of such alternative BE approaches in the https://collaboration.fda.gov/common/
more information about FDA’s posting development of topical dermatological help/en/support/meeting_test.htm. To
of comments to public dockets, see 80 generic drug products. Public input is get a quick overview of the Connect Pro
FR 56469, September 18, 2015, or access also sought about strategies to overcome program, visit https://www.adobe.com/
the information at: https://www.gpo.gov/ these barriers. go/connectpro_overview. FDA has
fdsys/pkg/FR-2015-09-18/pdf/2015- III. Participating in the Public verified the Web site addresses in this
23389.pdf. Workshop document, as of the date this document
Docket: For access to the docket to publishes in the Federal Register, but
Registration: Persons interested in Web sites are subject to change over
read background documents or the
attending this public workshop must time.
electronic and written/paper comments
register online at https:// Transcripts: Please be advised that as
received, go to https://
survey.co1.qualtrics.com/jfe/form/SV_ soon as a transcript of the public
www.regulations.gov and insert the
9YQDLZJRjXtYiXz. Please provide workshop is available, it will be
docket number, found in brackets in the
complete contact information for each accessible at https://
heading of this document, into the
attendee, including name, title, www.regulations.gov. It may be viewed
‘‘Search’’ box and follow the prompts
affiliation, address, email, and at the Dockets Management Staff (see
and/or go to the Dockets Management
telephone. ADDRESSES). A link to the transcript will
Staff, 5630 Fishers Lane, Rm. 1061, Registration is free and based on
Rockville, MD 20852. also be available on the internet at
space availability, with priority given to https://www.fda.gov/Drugs/NewsEvents/
FOR FURTHER INFORMATION CONTACT: Sam early registrants. Persons interested in
Raney, Center for Drug Evaluation and ucm557252.htm.
attending this public workshop must
Research, Food and Drug Dated: September 28, 2017.
register by October 13, 2017, midnight,
Administration, 10903 New Hampshire Eastern Time. Early registration is Anna K. Abram,
Ave., Bldg. 75, Rm. 4706, Silver Spring, recommended because seating is Deputy Commissioner for Policy, Planning,
MD 20993, 240–402–7967, email: Legislation, and Analysis.
limited; therefore, FDA may limit the
Sameersingh.Raney@fda.hhs.gov; or number of participants from each [FR Doc. 2017–21186 Filed 10–2–17; 8:45 am]
Markham Luke, Center for Drug organization. BILLING CODE 4164–01–P
Evaluation and Research, Food and If you need special accommodations
Drug Administration, 10903 New due to a disability, please contact Sam
Hampshire Ave., Bldg. 75, Rm. 4712, Raney (see FOR FURTHER INFORMATION DEPARTMENT OF HEALTH AND
Silver Spring, MD 20993, 301–796– CONTACT) no later than October 13, 2017. HUMAN SERVICES
5556, email: Markham.Luke@ Requests for Oral Presentations:
fda.hhs.gov. Food and Drug Administration
During online registration you may
SUPPLEMENTARY INFORMATION: indicate if you wish to present during a [Docket No. FDA–2017–D–5670]
public comment session, and which
I. Background topic(s) you wish to address. We will do Abbreviated New Drug Applications
The conventional approach to our best to accommodate requests to Submissions—Amendments To
establish bioequivalence (BE) for most make public comments. Individuals and Abbreviated New Drug Applications
topical dermatological generic drug organizations with common interests are Under the Generic Drug User Fee Act;
products relies upon clinical endpoint urged to consolidate or coordinate their Draft Guidance for Industry;
BE studies. The risk of failing to presentations, and to request time for a Availability
demonstrate BE due to the relative joint presentation, or to submit requests AGENCY: Food and Drug Administration,
insensitivity of these clinical endpoint for designated representatives to HHS.
studies, combined with their burden participate in the focused sessions. ACTION: Notice of availability.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and length, may represent a barrier to Following the close of registration, we
generic drug development and may will determine the amount of time SUMMARY: The Food and Drug
adversely impact patient access to some allotted to each presenter and the Administration (FDA or Agency) is
topical dermatological generic drug approximate time each oral presentation announcing the availability of a draft
products. FDA is evaluating alternative is to begin, and will select and notify guidance for industry entitled ‘‘ANDA
BE approaches for topical participants by October 16, 2017. All Submissions—Amendments to
dermatological generic drug products, requests to make oral presentations Abbreviated New Drug Applications
using methods that are more efficient, must be received by the close of Under GDUFA.’’ This draft guidance is
and also more sensitive and registration on October 9, 2017. If intended to explain to applicants how
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![46068 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
goals are still dependent on several DEPARTMENT OF HEALTH AND that date will be taken into
factors. In general, under GDUFA II, HUMAN SERVICES consideration by the Agency. You may
amendments will be designated as submit comments as follows:
either standard or priority, will be Food and Drug Administration
Electronic Submissions
classified as major or minor, and will [Docket No. FDA–2017–N–5891]
receive a goal date based on the factors Submit electronic comments in the
discussed in the draft guidance, following way:
Endocrinologic and Metabolic Drugs
• Federal eRulemaking Portal:
including whether a preapproval Advisory Committee; Notice of
https://www.regulations.gov. Follow the
inspection is needed. When finalized, Meeting; Establishment of a Public
instructions for submitting comments.
this draft guidance will replace the Docket; Request for Comments
Comments submitted electronically,
December 2001 guidance for industry including attachments, to https://
AGENCY: Food and Drug Administration,
‘‘Major, Minor, and Telephone HHS. www.regulations.gov will be posted to
Amendments to Abbreviated New Drug the docket unchanged. Because your
ACTION: Notice; establishment of a
Applications.’’ This draft guidance comment will be made public, you are
public docket; request for comments.
supersedes the July 2014 draft guidance solely responsible for ensuring that your
for industry ‘‘ANDA Submissions— SUMMARY: The Food and Drug comment does not include any
Amendments and Easily Correctable Administration (FDA or Agency) confidential information that you or a
Deficiencies Under GDUFA.’’ announces a forthcoming public third party may not wish to be posted,
This draft guidance is being issued advisory committee meeting of the such as medical information, your or
consistent with FDA’s good guidance Endocrinologic and Metabolic Drugs anyone else’s Social Security number, or
practices regulation (21 CFR 10.115). Advisory Committee. The general confidential business information, such
The draft guidance, when finalized, will function of the committee is to provide as a manufacturing process. Please note
represent the current thinking of FDA advice and recommendations to the that if you include your name, contact
Agency on FDA’s regulatory issues. The information, or other information that
on ‘‘ANDA Submissions—Amendments
meeting will be open to the public. FDA identifies you in the body of your
to Abbreviated New Drug Applications
is establishing a docket for public comments, that information will be
Under GDUFA.’’ It does not establish posted on https://www.regulations.gov.
comment on this document.
any rights for any person and is not • If you want to submit a comment
binding on FDA or the public. You can DATES: The public meeting will be held
on October 18, 2017, from 8 a.m. to 5 with confidential information that you
use an alternative approach if it satisfies do not wish to be made available to the
p.m.
the requirements of the applicable public, submit the comment as a
statutes and regulations. This guidance ADDRESSES: Tommy Douglas Conference
written/paper submission and in the
is not subject to Executive Order 12866. Center, the Ballroom, 10000 New
manner detailed (see ‘‘Written/Paper
Hampshire Ave., Silver Spring, MD
Submissions’’ and ‘‘Instructions’’).
II. Paperwork Reduction Act of 1995 20903. The conference center’s
telephone number is 240–645–4000. Written/Paper Submissions
This draft guidance refers to Answers to commonly asked questions
previously approved collections of Submit written/paper submissions as
about FDA Advisory Committee follows:
information found in FDA regulations. meetings may be accessed at https:// • Mail/Hand delivery/Courier (for
These collections of information are www.fda.gov/AdvisoryCommittees/ written/paper submissions): Dockets
subject to review by the Office of AboutAdvisoryCommittees/ Management Staff (HFA–305), Food and
Management and Budget (OMB) under ucm408555.htm. Information about the Drug Administration, 5630 Fishers
the Paperwork Reduction Act of 1995 Tommy Douglas Conference Center can Lane, Rm. 1061, Rockville, MD 20852.
(44 U.S.C. 3501–3520). The collections be accessed at: http:// • For written/paper comments
of information in 21 CFR 314.96 have www.tommydouglascenter.com/. submitted to the Dockets Management
been approved under OMB control FDA is establishing a docket for Staff, FDA will post your comment, as
number 0910–0001. public comment on this meeting. The well as any attachments, except for
docket number is FDA–2017–N–5891. information submitted, marked and
III. Electronic Access The docket will close on October 17, identified, as confidential, if submitted
Persons with access to the Internet 2017. Submit either electronic or as detailed in ‘‘Instructions.’’
may obtain the draft guidance at either written comments on this public Instructions: All submissions received
https://www.fda.gov/Drugs/Guidance meeting by October 17, 2017. Late, must include the Docket No. FDA–
untimely filed comments will not be 2017–N–5891for ‘‘Endocrinologic and
ComplianceRegulatoryInformation/
considered. Electronic comments must Metabolic Drugs Advisory Committee;
Guidances/default.htm or https://
be submitted on or before October 17, Notice of Meeting; Establishment of a
www.regulations.gov.
2017. The https://www.regulations.gov Public Docket; Request for Comments.’’
Dated: September 27, 2017. electronic filing system will accept Received comments, those filed in a
Anna K. Abram, comments until midnight Eastern Time timely manner (see ADDRESSES), will be
Deputy Commissioner for Policy, Planning, at the end of October 17, 2017. placed in the docket and, except for
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Legislation, and Analysis. Comments received by mail/hand those submitted as ‘‘Confidential
[FR Doc. 2017–21175 Filed 10–2–17; 8:45 am] delivery/courier (for written/paper Submissions,’’ publicly viewable at
submissions) will be considered timely https://www.regulations.gov or at the
BILLING CODE 4164–01–P
if they are postmarked or the delivery Dockets Management Staff between 9
service acceptance receipt is on or a.m. and 4 p.m., Monday through
before that date. Friday.
Comments received on or before • Confidential Submissions—To
October 11, 2017, will be provided to submit a comment with confidential
the committee. Comments received after information that you do not wish to be
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Document Created: 2017-10-03 01:01:10
Document Modified: 2017-10-03 01:01:10
| 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 the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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 | 82 FR 46066 |
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