[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