Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments, 4254-4255 [2022-01570]
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Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices
updates, information describing the type
of submission that should be made to
FDA, as well as other considerations for
submitting a labeling update to FDA.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Revising ANDA Labeling Following
Revision of the RLD Labeling.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA.
• The collections of information in
part 314 for the submission of ANDAs
(including the content and format of
ANDAs and supplements and
amendments) have been approved
under OMB control number 0910–0001
and in part 314 (included under the 21
CFR parts 10 through 16 hearing
regulations) for OMB control number
0910–0191.
• The collections of information
pertaining to the electronic submission
of labeling changes have been approved
under OMB control number 0910–0045.
• The collections of information
pertaining to the content and format
requirements for human prescription
drugs and biological products and the
submission of such labeling have been
approved under OMB control number
0910–0572.
lotter on DSK11XQN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01577 Filed 1–26–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:53 Jan 26, 2022
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4337]
Prescription Drug User Fee Act of
2017; Electronic Submissions and Data
Standards; Public Meeting; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the following virtual public
meeting entitled ‘‘Prescription Drug
User Fee Act of 2017; Electronic
Submissions and Data Standards.’’ The
purpose of the virtual public meeting
and the request for comments is to
fulfill FDA’s commitment to seek
stakeholder input related to data
standards and the electronic submission
system’s past performance, future
targets, emerging industry needs, and
technology initiatives. FDA will use the
information from the public meeting as
well as from comments submitted to the
docket to provide input into data
standards and electronic submissions
initiatives.
DATES: The public meeting will be held
on April 12, 2022, from 9 a.m. to 1 p.m.
Eastern Time, and will take place
virtually, held by webcast only. Submit
either electronic or written comments
on this public meeting by March 22,
2022. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: Registration to attend the
meeting and other information can be
found at https://www.fda.gov/industry/
prescription-drug-user-fee-amendments/
pdufa-vi-information-technology-goalsand-progress.
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 March 22, 2022. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of March 22, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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• 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–
2018–N–4337 for ‘‘Prescription Drug
User Fee Act of 2017; Electronic
Submissions and Data Standards.’’
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
E:\FR\FM\27JAN1.SGM
27JAN1
Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices
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 laws.
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:
Bryan Spells, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1117, Silver Spring,
MD 20993–0002, Bryan.Spells@
fda.hhs.gov, 240–402–6511; or Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911, Stephen.Ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
I. Background
FDA is committed to achieve the longterm goal of improving the
predictability and consistency of the
electronic submission process and
enhancing transparency and
accountability of FDA information
technology-related activities. In the
document containing the performance
goals and procedures for the
Prescription Drug User Fee Act
(PDUFA) reauthorization for fiscal years
2018 through 2022 (the PDUFA VI
commitment letter), FDA agreed to hold
annual public meetings to seek
stakeholder input related to electronic
submissions and data standards to
inform the FDA Information Technology
VerDate Sep<11>2014
17:53 Jan 26, 2022
Jkt 256001
Strategic Plan and published targets.
The PDUFA VI commitment letter
outlines FDA’s performance goals and
procedures under the PDUFA program
for the years 2018 through 2022. The
PDUFA VI commitment letter can be
found at https://www.fda.gov/media/
99140/download.
FDA will consider all comments made
at this meeting or received through the
docket (see ADDRESSES).
II. Participating in the Public Meeting
Registration: To register to attend
‘‘Prescription Drug User Fee Act of
2017; Electronic Submissions and Data
Standards,’’ please visit the following
website: https://www.eventbrite.com/e/
pdufa-vi-data-standards-publicmeeting-2022-tickets-215684276477?
ref=estw. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone. A draft
agenda will be posted approximately 1
month prior to the meeting.
Opportunity for Public Comment:
Those who register online by March 22,
2022, will receive a notification about
an opportunity to participate in the
public comment session of the meeting.
If you wish to speak during the public
comment session, follow the
instructions in the notification and
identify 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
comments and request time jointly. All
requests to make a public comment
during the meeting must be received by
March 22, 2022, 11:59 p.m. Eastern
Time. We will determine the amount of
time allotted to each commenter and the
approximate time each comment is to
begin, and we will select and notify
participants by April 1, 2022. No
commercial or promotional material
will be permitted to be presented or
distributed at the public meeting.
Streaming Webcast of the Public
Meeting: This public meeting will be
held via Zoom (https://fda.zoom
gov.com/j/1606221249).
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/
forindustry/userfees/prescription
druguserfee/ucm446608.htm.
PO 00000
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4255
Dated: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01570 Filed 1–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6854]
Good Abbreviated New Drug
Applications Submission Practices;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Good
ANDA Submission Practices.’’ This
guidance is intended to assist applicants
preparing to submit to FDA abbreviated
new drug applications (ANDAs). This
guidance highlights common, recurring
deficiencies that may lead to a delay in
the approval of an ANDA. It also makes
recommendations to applicants on how
to avoid these deficiencies with the goal
of minimizing the number of review
cycles necessary for approval. This
guidance finalizes the draft guidance
entitled ‘‘Good ANDA Submission
Practices’’ issued on January 4, 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on January 27, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
E:\FR\FM\27JAN1.SGM
27JAN1
]]>Agencies
[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4254-4255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01570]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4337]
Prescription Drug User Fee Act of 2017; Electronic Submissions
and Data Standards; 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, Agency, or we) is
announcing the following virtual public meeting entitled ``Prescription
Drug User Fee Act of 2017; Electronic Submissions and Data Standards.''
The purpose of the virtual public meeting and the request for comments
is to fulfill FDA's commitment to seek stakeholder input related to
data standards and the electronic submission system's past performance,
future targets, emerging industry needs, and technology initiatives.
FDA will use the information from the public meeting as well as from
comments submitted to the docket to provide input into data standards
and electronic submissions initiatives.
DATES: The public meeting will be held on April 12, 2022, from 9 a.m.
to 1 p.m. Eastern Time, and will take place virtually, held by webcast
only. Submit either electronic or written comments on this public
meeting by March 22, 2022. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: Registration to attend the meeting and other information can
be found at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-information-technology-goals-and-progress.
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 March 22, 2022. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of March 22, 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-2018-N-4337 for ``Prescription Drug User Fee Act of 2017;
Electronic Submissions and Data Standards.'' 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
[[Page 4255]]
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 laws. 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: Bryan Spells, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002,
[email protected], 240-402-6511; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is committed to achieve the long-term goal of improving the
predictability and consistency of the electronic submission process and
enhancing transparency and accountability of FDA information
technology-related activities. In the document containing the
performance goals and procedures for the Prescription Drug User Fee Act
(PDUFA) reauthorization for fiscal years 2018 through 2022 (the PDUFA
VI commitment letter), FDA agreed to hold annual public meetings to
seek stakeholder input related to electronic submissions and data
standards to inform the FDA Information Technology Strategic Plan and
published targets. The PDUFA VI commitment letter outlines FDA's
performance goals and procedures under the PDUFA program for the years
2018 through 2022. The PDUFA VI commitment letter can be found at
https://www.fda.gov/media/99140/download.
FDA will consider all comments made at this meeting or received
through the docket (see ADDRESSES).
II. Participating in the Public Meeting
Registration: To register to attend ``Prescription Drug User Fee
Act of 2017; Electronic Submissions and Data Standards,'' please visit
the following website: https://www.eventbrite.com/e/pdufa-vi-data-standards-public-meeting-2022-tickets-215684276477?ref=estw. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone. A draft agenda will
be posted approximately 1 month prior to the meeting.
Opportunity for Public Comment: Those who register online by March
22, 2022, will receive a notification about an opportunity to
participate in the public comment session of the meeting. If you wish
to speak during the public comment session, follow the instructions in
the notification and identify 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 comments and request time jointly. All
requests to make a public comment during the meeting must be received
by March 22, 2022, 11:59 p.m. Eastern Time. We will determine the
amount of time allotted to each commenter and the approximate time each
comment is to begin, and we will select and notify participants by
April 1, 2022. No commercial or promotional material will be permitted
to be presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: This public meeting will
be held via Zoom (https://fda.zoomgov.com/j/1606221249).
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/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.
Dated: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01570 Filed 1-26-22; 8:45 am]
BILLING CODE 4164-01-P
