[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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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]
BILLING CODE 4164-01-P