Notice2022-10702
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 18, 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 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 This guidance is finalizing FDA's draft guidance for industry "Assessing User Fees Under the Generic Drug User Fee Amendments of 2017," published in November 2019.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 96 (Wednesday, May 18, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30229-30230]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10702]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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FDA's draft guidance for industry ``Assessing User Fees Under the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:
<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-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 <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
[[Page 30230]]
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 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,
<a href="/cdn-cgi/l/email-protection#1a595e5f48597576767f796e737574695a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="2063646572634f4c4c454354494f4e53604644410e4848530e474f56">[email protected]</span></a>.
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
<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: 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.