Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments; Extension of Comment Period, 26566-26567 [2023-09169]
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Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices
The estimated annual third-party
disclosure burden for labeling is based
on data available to the Agency, our
knowledge of and experience with
cosmetics, and informal
communications with industry. The
hour burden is the additional or
incremental time that establishments
need to design and print labeling that
includes the following required
elements: a declaration of ingredients in
decreasing order of predominance, a
statement of the identity of the product,
a specification of the name and place of
business of the establishment, and a
declaration of the net quantity of
contents. These requirements increase
the time establishments needed to
design labels because they increase the
number of label elements that
establishments must consider when
designing labels. These requirements do
not generate any recurring burden per
label because establishments must
already print and affix labels to
cosmetic products as part of normal
business practices. Regarding the new
statutory labeling requirements for
products intended for professional use
only and contact information for
manufacturers to receive reports of
adverse events, we estimate that there
will be a capital cost of $94,080,000
associated with relabeling. This is the
cost of designing a revised label and
incorporating it into the manufacturing
process. We believe that this will be a
one-time cost. We estimate that the total
third-party disclosure burden is 178,806
hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
MoCRA citation; activity
Average
burden per
response
Total annual
responses
Total hours
Sec. 607(a)(1) of the FD&C Act; initial registrations ....
Sec. 607(a)(2) and (5) of the FD&C Act; biennial registration renewals.
Sec. 607(a)(4) of the FD&C Act; registration updates ..
Sec. 607(f) of the FD&C Act; post-hearing corrective
action plan.
Sec. 607(c)(1) and (2) of the FD&C Act; cosmetic
product listing.
Sec. 607(c)(3) of the FD&C Act; product listing renewals.
Sec. 607(c)(5) of the FD&C Act; product listing updates.
3,400
1,700
1
1
3,400
1,700
1 ...........................
0.25 (15 minutes)
3,400
425
100
5
1
1
100
5
0.25 (15 minutes)
10 .........................
25
50
3,400
5
17,000
0.50 (30 minutes)
8,500
3,400
5
17,000
0.25 (15 minutes)
4,250
200
1
200
0.25 (15 minutes)
50
Total .......................................................................
........................
........................
........................
1 There
..............................
16,700
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of reporting
burden hours on information from the
VCRP, because it provided the best
available data to FDA in terms of the
number of respondents and responses.
We believe that the VCRP reflected less
than half of cosmetic manufacturers and
processors because it was a voluntary
system. Accordingly, we doubled our
estimate for the number of respondents
registering and used this number to
estimate other activities related to
facility registration and cosmetic
product listing. Based on a review of the
information collection since our last
request for OMB approval, we have
increased our estimate to account for an
anticipated increase in respondents
resulting from new statutory
requirements.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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Number of
responses per
respondent
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1052]
Food and Drug Administration Data
and Technology Strategic Plan;
Request for Information and
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for information
and comments; extension of comment
period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice announcing a request for
information and comments that
appeared in the Federal Register of
April 13, 2023. In that notice, FDA
requested information and comments on
the FDA Data and Technology Strategic
Plan. The Agency is taking this action
to allow interested persons additional
time to submit comments.
DATES: FDA is extending the comment
period on the notice published April 13,
2023 (88 FR 22453). Either electronic or
SUMMARY:
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written comments must be submitted by
June 12, 2023, to ensure that the Agency
considers your comment on this request
for information and comments before it
begins work on the strategic plan.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 12, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received 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
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Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
2023–N–1052 for ‘‘FDA Data and
Technology Strategic Plan.’’ 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
VerDate Sep<11>2014
17:10 Apr 28, 2023
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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.
Casi
Alexander, Office of Digital
Transformation, Food and Drug
Administration, FDA Library, 5630
Fishers Lane, Rm. 1087, Rockville, MD
20857, 240–402–5171, Casi.Alexander@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of April 13, 2023, FDA
published a notice announcing a request
for information and comments entitled
‘‘FDA Data and Technology Strategic
Plan; Request for Information and
Comments.’’ Interested persons were
originally given until May 15, 2023, to
comment on the document. The Agency
has elected to extend the comment
period so that all interested parties are
able to more thoroughly consider the
request for input. FDA is extending the
comment period for 30 days, until June
12, 2023. The Agency believes that this
30-day extension allows adequate time
for interested persons to submit
comments.
SUPPLEMENTARY INFORMATION:
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09169 Filed 4–28–23; 8:45 am]
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26567
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1443]
Draft Pharmaceutical Quality/
Chemistry Manufacturing and Controls
Data Elements and Terminologies;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
requesting comment on the draft
Pharmaceutical Quality/Chemistry
Manufacturing and Controls (PQ/CMC)
Data Elements and Terminologies for
the electronic submission of PQ/CMC
data. Building on the Agency’s previous
Federal Register notices published on
July 11, 2017, and March 18, 2022,
requesting comments on PQ/CMC data
elements and controlled terminology,
the Agency is continuing to seek
comment on the accuracy, suitability,
and appropriateness of revised and/or
new data elements and terminologies for
submission of PQ/CMC data. In
addition, the progress toward the
establishment of standardized
pharmaceutical data elements and
terminologies will require further
interactions between the Agency and
interested parties and various
stakeholders, including industry.
Accordingly, FDA is planning to request
comment on additional PQ/CMC data
elements and terminologies over time.
FDA is establishing an open docket to
facilitate efficient receipt of comments
and public posting of updated draft
documents on PQ/CMC data elements
and terminologies.
DATES: Comments may be submitted to
this docket at any time.
ADDRESSES: You may submit comments
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,
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]]>Agencies
[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26566-26567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1052]
Food and Drug Administration Data and Technology Strategic Plan;
Request for Information and Comments; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information and comments; extension of
comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice announcing a request for
information and comments that appeared in the Federal Register of April
13, 2023. In that notice, FDA requested information and comments on the
FDA Data and Technology Strategic Plan. The Agency is taking this
action to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the notice published
April 13, 2023 (88 FR 22453). Either electronic or written comments
must be submitted by June 12, 2023, to ensure that the Agency considers
your comment on this request for information and comments before it
begins work on the strategic plan.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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
[[Page 26567]]
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-2023-N-1052 for ``FDA Data and Technology Strategic Plan.''
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: Casi Alexander, Office of Digital
Transformation, Food and Drug Administration, FDA Library, 5630 Fishers
Lane, Rm. 1087, Rockville, MD 20857, 240-402-5171,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of April 13, 2023,
FDA published a notice announcing a request for information and
comments entitled ``FDA Data and Technology Strategic Plan; Request for
Information and Comments.'' Interested persons were originally given
until May 15, 2023, to comment on the document. The Agency has elected
to extend the comment period so that all interested parties are able to
more thoroughly consider the request for input. FDA is extending the
comment period for 30 days, until June 12, 2023. The Agency believes
that this 30-day extension allows adequate time for interested persons
to submit comments.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09169 Filed 4-28-23; 8:45 am]
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