[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8262-8264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0083]


Food and Drug Administration Hiring and Retention Final 
Assessment; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
holding a virtual meeting entitled ``FDA Hiring and Retention Final 
Assessment'' and an opportunity for public comment. The topic to be 
discussed is the FDA Hiring and Retention Final Assessment, which was 
an independent assessment performed by Booz Allen Hamilton, published 
on December 10, 2021. This public meeting will take place virtually due 
to extenuating circumstances and will be held by webcast only.

DATES: The public meeting will be held on March 15, 2022, from 9 a.m. 
to 12 noon Eastern Time. Submit either electronic or written comments 
on this public meeting by May 16, 2022. See the

[[Page 8263]]

SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or by May 16, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 16, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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-N-0083 for ``FDA Hiring and Retention Final Assessment; Public 
Meeting; Request for Comments.'' Received comments, those 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://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: Patricia Stewart, Office of 
Operations, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-4735, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is holding a public meeting to share high-level findings from a 
recently completed final assessment of FDA's hiring and retention 
processes, conducted by a qualified, independent contractor with 
expertise in assessing transformation of Human Resource operations. We 
recognize that the critical work to protect public health is made 
possible in part by the Agency's ability to attract and retain a 
talented, diverse, and dedicated workforce. As FDA continues to fulfill 
its strategic mission, it is imperative that we identify and leverage 
the talent, skills, and diversity within--and outside of--the Agency.
    These priorities are reflected in FDA's plan to enhance its hiring 
and retention programs; recruit qualified candidates with diverse 
backgrounds, experiences, and talents; provide internal development 
opportunities; and further enhance the Agency's ability to nurture a 
supportive and fair work environment. The public meeting will provide 
an update on FDA's progress toward the Prescription Drug User Fee Act 
(PDUFA VI) and the Biosimilar User Fee Amendments Act of 2017 (BsUFA 
II) hiring and retention commitments and solicit input on actions 
regarding the hiring process. To view the evaluation assessment report, 
please visit https://www.fda.gov/media/154873/download.
    This public meeting is intended to meet performance commitments 
included in PDUFA VI and BsUFA II. These user fee programs were 
reauthorized, for fiscal years 2018--2022, as part of the FDA 
Reauthorization Act of 2017 (Pub. L. 115-52) signed by the President on 
August 18, 2017. The complete set of performance goals for each program 
is available at:
     PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.
     BsUFA II program: https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf.

II. Topics for Discussion at the Public Meeting

    This public meeting will provide FDA the opportunity to update 
interested public stakeholders on topics related to the FDA hiring and 
retention programs. Booz Allen Hamilton will present their findings and 
recommendations that are outlined in the Hiring and Retention Final 
Assessment Report and we will provide an update on the Agency's 
progress in addressing the findings from the independent third-party 
evaluation that was published December 10, 2021. To view the evaluation 
assessment

[[Page 8264]]

report, please visit https://www.fda.gov/media/154873/download.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://pdufa-hr-assessment.eventbrite.com. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by March 14, 2022, 11:59 p.m. Eastern Time. We 
will let registrants know if registration closes before the day of the 
public meeting.
    If you need special accommodations due to a disability, please 
contact Patricia Stewart (see FOR FURTHER INFORMATION CONTACT) no later 
than March 8, 2022.
    Requests for Oral Presentations: During online registration, you 
may indicate if you wish to present during a public comment session, 
and which topic(s) you wish to address. We will do our best to 
accommodate requests to make public comments. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their presentations and request time for a joint 
presentation. Following the close of registration, we will determine 
the amount of time allotted to each presenter and the approximate time 
each oral presentation is to begin, and will select and notify 
participants by March 11, 2022. All requests to make oral presentations 
must be received by March 8, 2022, 11:59 p.m. Eastern Time. If selected 
for presentation, any presentation materials must be emailed to 
Patricia Stewart (see FOR FURTHER INFORMATION CONTACT) no later than 
March 11, 2022. No commercial or promotional material will be permitted 
to be presented at the public meeting.
    Streaming Webcast of the public meeting: The webcast for this 
public meeting is accessible at https://pdufa-hr-assessment.eventbrite.com.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES).

    Dated: February 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03097 Filed 2-11-22; 8:45 am]
BILLING CODE 4164-01-P