[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Pages 50884-50885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6129]


Assessment of Food and Drug Administration Hiring and Retention; 
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 
announcing the following public meeting entitled ``Assessment of FDA 
Hiring and Retention''. The purpose of the public meeting is to share 
high-level findings from a recently completed diagnostic assessment of 
FDA's hiring process conducted by a qualified, independent contractor 
with expertise in assessing human resources operations and 
transformation. The purpose also is to outline a set of near-term 
actions FDA will or can take to improve the hiring process, provide an 
update on FDA's progress toward Prescription Drug User Fee Act (PDUFA) 
and Biosimilar User Fee Act (BsUFA) user fee hiring and retention 
commitments, and solicit input on actions FDA is taking and any further 
recommendations or priorities FDA should pursue with regard to the 
hiring process.

DATES: The public meeting will be held on November 30, 2017, from 9 
a.m. to 12 noon. Submit either electronic or written comments on this 
public workshop by January 15, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at the FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Section A, Silver Spring, MD 20993. Entrance for the 
public meeting participants (non-FDA employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    A summary report of evaluation findings related to the hiring 
process, conducted by an independent third party contractor, will be 
published in the docket by November 15, 2017, and will be titled 
``Initial Assessment of FDA Hiring and Retention.''
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before January 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 15, 2018. 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-2017-N-6129 for ``Assessment of FDA Hiring and Retention; 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Daniel Brounstein, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1312, Silver 
Spring,

[[Page 50885]]

MD 20993, 301-796-0674, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is responsible for protecting and promoting the public health 
by helping to ensure the safety, efficacy, and security of human and 
veterinary drugs, biological products, and medical devices; and by 
helping to ensure the safety of the nation's food supply, cosmetics, 
and products that emit radiation. FDA also has responsibility for 
regulating the manufacturing, marketing, and distribution of tobacco 
products to protect the public health and to reduce tobacco use by 
minors.
    Included in this is a mandate to advance the public health mission 
by helping to speed innovations that make medical products more 
effective, safer, and more affordable, and helping the public access 
accurate science-based information for FDA-regulated products. Just as 
the science and technology underlying new medical products is 
advancing, the science of development and evaluation of medical 
products and clinical care is also dramatically improving. To enable 
FDA to continue to effectively evaluate these innovative developments, 
a specialized workforce is required to support the Agency's regulatory 
science and operations initiatives.
    Over the past 5 years, the Agency has struggled with challenges 
related to its hiring processes, including challenges in managing the 
hiring process and bringing the right skills to the Agency. FDA has 
demonstrated that diagnosing the current state and drastically 
reimagining the hiring process is a top priority and is committed to 
implementing new, bold, consistent, and high quality hiring processes 
to tackle these challenges. The criticality of these priorities is 
consistent with the PDUFA VI and BsUFA II user-fee commitments. These 
commitments include the use of a qualified, independent contractor with 
expertise in assessing human resources operations and transformation to 
perform an initial baseline assessment no later than December 31, 2017, 
and a public meeting no later than December 31, 2017, to present and 
discuss report findings.1 2
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    \1\ PDUFA Reauthorization Performance Goals and Procedures 
Fiscal Years 2018 Through 2022, https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    \2\ Biosimilar Biological Product Reauthorization Performance 
Goals and Procedures Fiscal Years 2018 Through 2022, https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf.
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II. Topics for Discussion at the Assessment of FDA Hiring and Retention 
Public Meeting

    The agenda will be posted prior to the meeting at: https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm577055.htm, and 
will involve a plenary presentation related to the assessment findings 
summarized in the ``Initial Assessment of FDA's Hiring and Retention'' 
report and an open public comment period.
    Registration: The FDA Conference Center at the White Oak location 
is a Federal facility with security procedures and limited seating. 
Attendance will be free and on a first-come, first-served basis. If you 
wish to attend (either in person or by webcast) (see Streaming Webcast 
of the Public Meeting), please register online by 12 noon on Friday, 
November 24, Eastern Time at the following Web site: https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm577055.htm. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone. You 
will receive confirmation of your registration.
    If you need special accommodations due to a disability, please 
contact [email protected] no later than Friday, November 24, at 
12 noon Eastern Time.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be live webcast. To join the meeting via the webcast, please go to 
https://collaboration.fda.gov/fdahiringretention. 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 Web site addresses in this 
document, as of the date this document publishes in the Federal 
Register, but Web sites 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). A link to the transcript will also be available on the 
internet at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm577055.htm.

    Dated: October 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23899 Filed 11-1-17; 8:45 am]
 BILLING CODE 4164-01-P