[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30229-30230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]


Assessing User Fees Under the Generic Drug User Fee Amendments of 
2017; 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 ``Assessing 
User Fees Under the Generic Drug User Fee Amendments of 2017.'' This 
guidance provides stakeholders information regarding the implementation 
of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies 
and procedures surrounding its application. This guidance is finalizing 
FDA's draft guidance for industry ``Assessing User Fees Under the 
Generic Drug User Fee Amendments of 2017,'' published in November 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on May 18, 2022.

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-2012-D-0880 for ``Assessing User Fees Under the Generic Drug User 
Fee Amendments of 2017.'' 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

[[Page 30230]]

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 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: Keith F. Verrett Jr., Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Rm. 2179, Silver Spring, MD 20993-0002, 301-796-7900, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Assessing User Fees Under the Generic Drug User Fee 
Amendments of 2017.'' GDUFA II (Pub. L. 115-52, Title III), was signed 
into law on August 18, 2017. GDUFA II extends FDA's authority to assess 
and collect generic drug user fees from fiscal year (FY) 2018 through 
FY 2022. The extension of this user fee authority under GDUFA II 
continues FDA's and industry's ability to meet the goals of improving 
public access to safe and effective generic drugs and enhancing the 
predictability of the review process.
    The guidance announced in this notice replaces the draft guidance 
for industry on ``Assessing User Fees Under the Generic Drug User Fee 
Amendments of 2017,'' dated October 2019 and published in November 
2019. This guidance addresses changes in user fee assessments from 
GDUFA I, user fees incurred by industry under GDUFA II, payment 
procedures, reconsideration and appeals, and other additional 
information to assist industry in complying with GDUFA II. This 
guidance also describes how FDA determines affiliation for purposes of 
assessing generic drug user fees.
    FDA has reviewed the comments submitted to the docket and 
determined that the comments do not require substantive changes from 
the draft guidance. Clarifying language was, however, added to this 
final guidance largely based on the public comments and to update the 
Agency's treatment of sponsor requests for ``transfer'' of certain user 
fee payments eligible for refund toward applicable user fee 
liabilities.
    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 ``Assessing User Fees Under the Generic Drug 
User Fee Amendments of 2017.'' 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 Form FDA 3913 (User Fee Payment Refund Request) have 
been approved under OMB control number 0910-0805 and the collections of 
information in Form FDA 3914 (User Fee Payment Transfer Request) have 
been approved under OMB control number 0910-0805.

III. Electronic Access

    Persons with access to the internet may obtain the 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: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10702 Filed 5-17-22; 8:45 am]
BILLING CODE 4164-01-P