Notice2022-03097
Food and Drug Administration Hiring and Retention Final Assessment; Public Meeting; Request for Comments
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
February 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 30 (Monday, February 14, 2022)</title>
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[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8262-8264]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<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-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 <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 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.
FOR FURTHER INFORMATION CONTACT: Patricia Stewart, Office of
Operations, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-796-4735, <a href="/cdn-cgi/l/email-protection#17677663657e747e76396463726076656357717376397f7f6439707861"><span class="__cf_email__" data-cfemail="bacadbcec8d3d9d3db94c9cedfcddbc8cefadcdedb94d2d2c994ddd5cc">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/154873/download">https://www.fda.gov/media/154873/download</a>.
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:
<bullet> PDUFA VI program: <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf</a>.
<bullet> BsUFA II program: <a href="https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf">https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf</a>.
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 <a href="https://www.fda.gov/media/154873/download">https://www.fda.gov/media/154873/download</a>.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: <a href="https://pdufa-hr-assessment.eventbrite.com">https://pdufa-hr-assessment.eventbrite.com</a>. 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 <a href="https://pdufa-hr-assessment.eventbrite.com">https://pdufa-hr-assessment.eventbrite.com</a>.
If you have never attended a Connect Pro event before, test your
connection at <a href="https://collaboration.fda.gov/common/help/en/support/meeting_test.htm">https://collaboration.fda.gov/common/help/en/support/meeting_test.htm</a>. To get a quick overview of the Connect Pro program,
visit <a href="https://www.adobe.com/go/connectpro_overview">https://www.adobe.com/go/connectpro_overview</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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