[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88083-88084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27967]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5020]
Notice to Public of Website Location of the Office of the Chief
Scientist Proposed Guidance Development List
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the website location where the Agency will post a list of
possible topics for future guidance document development or revision by
the Office of the Chief Scientist (OCS) during the next year. In
addition, FDA has established a docket where interested persons may
provide comments that could benefit the OCS guidance program and its
engagement with stakeholders, including comments on the priority of
topics for guidance. This feedback is critical to the OCS guidance
program as we consider feedback from stakeholders along with Agency
resources and priorities.
ADDRESSES: You may submit either electronic or written comments at any
time as follows:
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-2023-N-5020 for ``Notice to Public of Website Location of OCS
Proposed Guidance Development Agenda.'' 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: Jennifer Ross, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-4880 (this is
not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
FDA welcomes comments on any or all of the topics for guidance
documents on the list as explained in Sec. 10.115(f)(5) (21 CFR
10.115(f)(5)). FDA has established Docket No. FDA-2023-N-5020 where
comments on the list, drafts of proposed guidance documents on those or
other topics, suggestions for new or different guidances within OCS's
purview, and relative priority of listed guidance documents may be
submitted and shared with the public (see ADDRESSES). FDA believes this
docket is a valuable tool for receiving information from interested
persons. FDA anticipates that feedback from interested persons will
allow OCS to better prioritize and more efficiently draft guidances to
meet the needs of the Agency and our stakeholders.
Consistent with the Good Guidance Practices regulation at Sec.
10.115(f)(4), OCS would appreciate suggestions that OCS revise or
withdraw an already existing guidance document within OCS's purview. We
request that the suggestion clearly explain why the guidance document
should be revised or withdrawn and, if applicable, how it should be
revised.
II. Website Location of Guidance List
This notice announces the website location of the document that
provides
[[Page 88084]]
the list of possible topics for future guidance document development or
revision by OCS during the next year. The initial list covers calendar
year (CY) 2024. To access the list, visit FDA's website at https://www.fda.gov/about-fda/guidance-documents-office-chief-scientist/office-chief-scientist-guidance-documents-under-development. We note that the
topics on this list may be removed or modified based on current
priorities, as well as comments received regarding this list.
Furthermore, several factors may impact FDA's ability to issue a
guidance, including, for example, new Administration priorities,
emerging public health issues, or other extenuating circumstances. The
Agency is not required to publish every guidance on the list if, for
example, the resources needed would be to the detriment of meeting
other Agency priorities and statutory obligations. In addition, the
Agency is not precluded from issuing guidance documents that are not on
the list.
Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27967 Filed 12-19-23; 8:45 am]
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