Food and Drug Administration Hiring and Retention Final Assessment; Public Meeting; Request for Comments, 8262-8264 [2022-03097]
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<![CDATA[
8262
Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Performance Progress and Monitoring
Report (PPMR) (OMB Control No. 0920–
1132, Exp. 10/31/2022)—Extension—
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Each year, approximately 80% of the
CDC’s budget is distributed via
contracts, grants and cooperative
agreements, from the Office of Financial
Resources (OFR) to partners (Awardees)
throughout the world in an effort to
promote health, prevent disease, injury
and disability and prepare for new
health threats. OFR is responsible for
the stewardship of these funds while
providing excellent, professional
outlined for each of the CDC Awardees.
Collection and reporting of the
information will occur in an efficient,
standardized, and user-friendly manner
that will generate a variety of routine
and customizable reports. The PPMR
will allow each Awardee to summarize
activities and progress towards meeting
performance measures and goals over a
specified time period specific to each
award. CDC will also have the capacity
to generate reports that describe
activities across multiple Awardees. In
addition, CDC will use the information
collection to respond to inquiries from
HHS, Congress and other stakeholder
inquiries about program activities and
their impact. The current submission
process allows Awardees to submit a
completed PDF version of the PPMR by
uploading it to www.grants.gov, or
directly to the programs at CDC that will
be performing the evaluation.
This Extension request is being
submitted to allow CDC to continue
collection of this valuable information
from Awardees for an additional three
years. There are no anticipated changes
to the information collection
instruments or associated burden at this
time. CDC requests OMB approval for an
estimated 13,014 annual burden hours.
There is no cost to respondents other
than their time.
services to our partners and
stakeholders.
Currently, CDC uses the Performance
Progress and Monitoring Report (PPMR,
OMB Control No. 0920–1132,
Expiration: 10/31/2022), a set of
progress reporting forms for NonResearch awards to collect information
semi-annually from Awardees regarding
the progress made over specified time
periods on CDC funded projects. The
PPMR was originally modified from SF–
PPR (OMB Control No. 0970–0406,
Expiration: 10/31/2015), a similar
progress report that was owned by the
Administration for Children and
Families (ACF) within the Department
of Health and Human Services (HHS).
The PPMR was created by CDC to
provide an agency-wide collection tool
that would be able to obtain data on the
progress of CDC Awardees for the
purposes of evaluation, and to bring the
Awardee reporting procedure into
compliance with the Paperwork
Reduction Act (PRA).
The information collected enables the
accurate, reliable, uniform, and timely
submission to CDC of each Awardee’s
work plans and progress reports,
including strategies, activities and
performance measures. The information
collected by the PPMR is designed to
align with, and support the goals
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
CDC Award Recipients .....................
Performance Progress and Monitoring Report (PPMR—Att. A–F).
Performance Progress and Monitoring Report (PPMR—Att. G).
Performance Progress and Monitoring Report (PPMR—Att. A–F).
CDC Award Recipients .....................
NHSS Award Recipients ...................
Total ...........................................
Number of
responses per
respondent
Number of
respondents
Type of respondent
...........................................................
1
2
10,400
1,632
1
5/60
136
60
1
41
2,478
........................
........................
........................
13,014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–03080 Filed 2–11–22; 8:45 am]
[Docket No. FDA–2022–N–0083]
Food and Drug Administration
BILLING CODE 4163–18–P
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Food and Drug Administration Hiring
and Retention Final Assessment;
Public Meeting; Request for Comments
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is holding a virtual meeting entitled
SUMMARY:
VerDate Sep<11>2014
17:54 Feb 11, 2022
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Total burden
(in hours)
5,200
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
AGENCY:
Average
burden per
response
(in hours)
Sfmt 4703
‘‘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.
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
DATES:
E:\FR\FM\14FEN1.SGM
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Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices
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.
jspears on DSK121TN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:54 Feb 11, 2022
Jkt 256001
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-201509-18/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, patricia.stewart@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is holding a public meeting to
share high-level findings from a recently
PO 00000
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8263
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
E:\FR\FM\14FEN1.SGM
14FEN1
8264
Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES1
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-hrassessment.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://pdufahr-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
VerDate Sep<11>2014
17:54 Feb 11, 2022
Jkt 256001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0304]
Brian Michael Parks: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Brian Michael Parks for a period of 5
years from importing or offering for
import any article of food (including
dietary supplements) or drug into the
United States. FDA bases this order on
a finding that Mr. Parks was convicted
of one felony count under Federal law
for distribution of an unapproved new
drug with the intent to defraud and
mislead. The factual basis supporting
Mr. Parks’ conviction, as described
below, is conduct relating to the
importation into the United States of
any food and of any drug or controlled
substance. Mr. Parks was given notice of
the proposed debarment and was given
an opportunity to request a hearing to
show why he should not be debarred.
As of November 17, 2021 (30 days after
receipt of the notice), Mr. Parks had not
responded. Mr. Parks’ failure to respond
and request a hearing constitutes a
waiver of his right to a hearing
concerning this matter.
DATES: This order is applicable February
14, 2022.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food. Section 306(b)(1)(D) of the
FD&C Act permits debarment of an
individual from importing or offering
for import any drug into the United
States if the FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act
that the individual has been convicted
of a felony for conduct relating to the
importation into the United States of
any drug or controlled substance.
On February 16, 2021, Mr. Parks was
convicted, as defined in section
306(l)(1) of the FD&C Act in the U.S.
District Court for the Western District of
Virginia, after his plea of guilty, when
the court entered judgment against him
for the offense of distribution of an
unapproved new drug with the intent to
defraud and mislead, in violation of
sections 301(d) and 303(a)(2) of the
FD&C Act 21 U.S.C. 331(d) and
333(a)(2). The FDA’s finding that
debarment is appropriate is based on the
felony conviction referenced herein.
The factual basis for this conviction is
as follows:
As contained in the information in
Mr. Parks’ case, filed on November 23,
2020, he was the owner and operator of
MedFitRX Inc., later known as MedFit
Sarmacuticals Inc. (collectively referred
to as MedFitRX herein), a purported
sport supplement company based in
North Carolina. MedFitRX imported
Selective Androgen Receptor
Modulators (SARMs) in order to use
them in MedFitRx products. SARMs are
synthetic chemicals designed to mimic
the effects of testosterone and other
anabolic steroids. From approximately
March 2016 to September 2019, Mr.
Parks imported SARMs and other drug
active ingredients from China on
multiple occasions. The drug active
ingredients he imported included MK–
677, S–4, MK–2866, GW–501516, LGD–
4033, and RAD140, among others. In
addition, on or about May 17, 2018, Mr.
Parks sold two MedFitRX products to
undercover FDA Office of Criminal
Investigation agents posing as
consumers. The first product Mr. Parks
sold to these undercover agents, Lucky
SARMS Magical AF, contained the
drugs S–23 and SR9009, which he had
caused to be imported into the United
States. The second product, Estrovert,
E:\FR\FM\14FEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
