Notice2022-21811
Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability
Primary source
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Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Facility Readiness: Goal Date Decisions Under GDUFA." This draft guidance provides information to applicants on how FDA will use information related to a facility's readiness for inspection as certified on Form FDA 356h to set a goal date for an original abbreviated new drug application (ANDA) submitted under the Federal Food, Drug, and Cosmetic Act. This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter).
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61039-61040]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1981]
Facility Readiness: Goal Date Decisions Under Generic Drug User
Fee Amendments; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Facility
Readiness: Goal Date Decisions Under GDUFA.'' This draft guidance
provides information to applicants on how FDA will use information
related to a facility's readiness for inspection as certified on Form
FDA 356h to set a goal date for an original abbreviated new drug
application (ANDA) submitted under the Federal Food, Drug, and Cosmetic
Act. This guidance incorporates a program enhancement agreed upon by
the Agency and industry as part of the negotiations relating to
reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as
described in ``GDUFA Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2023-2027'' (GDUFA III commitment letter).
DATES: Submit either electronic or written comments on the draft
guidance by December 6, 2022 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-1981 for ``Facility Readiness: Goal Date Decisions Under
GDUFA.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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: Karen Takahashi, Center for Drug
Evaluation and Research (HFD-320), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 6686, Silver Spring, MD 20993-0002,
301-796-3191.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Facility Readiness: Goal Date Decisions Under GDUFA.'' This
draft guidance provides information to applicants on how FDA intends to
assign a goal date based on a facility's readiness for inspection as
certified on Form FDA 356h submitted as part of an original ANDA under
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)). This guidance explains how FDA incorporates a performance
enhancement in the
[[Page 61040]]
GDUFA III commitment letter as part of its goal date assignments.
Under the commitment letter related to the GDUFA authorization for
fiscal years 2018 through 2022 (under the Generic Drug User Fee
Amendments of 2017), a goal date was assigned without regard to
facility readiness for inspection. In contrast, under the GDUFA III
commitment letter, FDA agreed to assign a longer goal date if a
facility is not ready for an inspection at the time of application
submission. An application containing a facility not ready for
inspection is more likely to require multiple assessment cycles,
extending the time required for possible approval and potentially
delaying patient access to quality generic drugs. This change in goal
date assignment will help FDA to focus resources on applications with
facilities ready for inspection.
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 ``Facility
Readiness: Goal Date Decisions 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001. Currently, manufacturing establishment information is
submitted as part of the existing application form, Form FDA 356h, and
is approved by OMB under control number 0910-0338. The collections of
information in 21 CFR parts 210 and 211 (current good manufacturing
practice) and part 11 (electronic records and signatures) have been
approved under OMB control numbers 0910-0139 and 0910-0303,
respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21811 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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