[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46658-46659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1576]


Assessing the Resource Needs of the Generic Drug User Fee 
Amendments; Publication of Report; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of report publication; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the publication of a report, entitled ``Independent Evaluation of the 
GDUFA Resource Capacity Planning Adjustment Methodology,'' providing 
options and recommendations for a new methodology to assess accurately 
changes in the resource needs of the generic drug review program. FDA, 
in the Generic Drug User Fee Amendments of 2017 (GDUFA II), committed 
to obtaining this report through a contract with an independent third 
party and publishing it before September 30, 2020. FDA is announcing 
publication of this report and the opening of a docket to receive 
public comment on this report.

DATES: Submit either electronic or written comments on the report by 
September 2, 2020 to ensure that the Agency considers your comment on 
this report.

ADDRESSES: You may submit comments on this report at any time prior to 
September 2, 2020 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-2020-N-1576 for ``Assessing the Resource Needs of the Generic Drug 
User Fee Amendments, Publication of Report; Request for Comments.'' 
Comments filed in a timely manner (see ADDRESSES), 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://

[[Page 46659]]

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.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the publication of a 
report, entitled ``Independent Evaluation of the GDUFA Resource 
Capacity Planning Adjustment Methodology,'' providing options and 
recommendations for a methodology to accurately assess changes in the 
resource needs of the generic drug review program. FDA, in the GDUFA II 
Commitment Letter \1\ (entitled GDUFA Reauthorization Performance Goals 
and Program Enhancements Fiscal Years 2018-2022), committed to 
obtaining this report and publishing it before September 30, 2020.
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    \1\ Available at: https://www.fda.gov/media/101052/download.
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    The third authorization of the Prescription Drug User Fee Act 
(PDUFA III), which began in fiscal year 2003, introduced the concept of 
a Workload Adjuster. This was a mechanism to ensure that the annual 
revenue for the program could be adjusted based on workload levels to 
ensure adequate staffing levels. Since its introduction, several 
updates have been made to the methodology, including its renaming as 
the Capacity Planning Adjustment (CPA).
    GDUFA does not currently have a methodology analogous to the CPA to 
enable adjustment of the annual target revenue. The study announced by 
this notice posits options and recommendations to consider regarding 
the potential application of an adjustment methodology for the GDUFA 
program.
    FDA commissioned Booz Allen Hamilton to produce this report. The 
report is publicly available on FDA's website at: https://www.fda.gov/industry/fda-user-fee-programs/resource-capacity-planning-and-modernized-time-reporting. FDA will review the public comments on the 
report.

    Dated: July 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16794 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P