[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61039-61040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Fee Amendments; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Facility 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 This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by December 6, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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