[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41995-41996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No.FDA-2020-N-1500]


Food and Drug Administration Hiring and Retention Interim 
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 Interim 
Assessment'' and an opportunity for public comment. The topic to be 
discussed is FDA's hiring and retention interim assessment which was an 
independent assessment performed by Booz Allen Hamilton, published on 
June 5, 2020. 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 July 30, 2020, from 9 a.m. to 
noon. Submit either electronic or written comments on this public 
meeting by September 30, 2020. See the 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 September 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 30, 2020. 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-2020-N-1500 ``FDA Hiring and Retention Interim 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

[[Page 41996]]

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, 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, patricia.stewart@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is holding a public meeting to share high-level findings from a 
recently-completed interim assessment of FDA's hiring process, 
conducted by a qualified, independent contractor with expertise in 
assessing transformation of human resources operations. FDA recognizes 
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 fulfil its strategic 
mission, it is imperative that the Agency 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 PDUFA (Prescription Drug User Fee 
Act) and BsUFA (Biosimilar User Fee Act) user fee hiring and retention 
commitments and solicit input on actions with regards to the hiring 
process. To view the evaluation assessment report, please visit here: 
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-interim-hiring-and-retention-assessment-report.
    This public meeting is intended to meet performance commitments 
included in PDUFA VI and BsUFA II. These user fee programs were 
reauthorized as part of the FDA Reauthorization Act of 2017 (FDARA) 
(Pub. L. 115-52) signed by the President on August 18, 2017. The 
complete set of performance goals for each program are available at:
     PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf and
     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 Interim Hiring and Retention 
Assessment report and FDA will provide an update on the Agency's 
progress in addressing the findings from the independent third-party 
evaluation that was published June 5, 2020. To view the evaluation 
assessment report, please visit here: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-interim-hiring-and-retention-assessment-report

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website to register: https://www.eventbrite.com/e/fda-hiring-and-retention-interim-assessment-public-meeting-registration-106125275556. Please provide complete contact information for each 
attendee, including name, title, affiliation, address, email, and 
telephone.
    Persons interested in attending this public meeting must register 
by July 28, 2020, 11:59 p.m. Eastern Time.
    If you need special accommodations due to a disability (e.g. Closed 
Captioning), please contact Patricia Stewart (see FOR FURTHER 
INFORMATION CONTACT) no later than July 22, 2020.
    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 July 27, 2020. All 
requests to make oral presentations must be received by July 22, 2020, 
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 July 28, 2020. 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 at https://collaboration.fda.gov/fdapublicmeeting073020/.
    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: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14980 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P


