[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32444-32445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1592]


Promoting Effective Drug Development: Identifying Opportunities 
and Priorities for the Food and Drug Administration's Office of 
Clinical Pharmacology; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket entitled ``Promoting Effective Drug 
Development: Identifying Opportunities and Priorities for the Food and 
Drug Administration's Office of Clinical Pharmacology.'' The purpose of 
this docket is to solicit input from interested parties on specific and 
actionable policy topics that could be prioritized, developed, and 
implemented by the staff of the Center for Drug Evaluation and 
Research's (CDER's) Office of Clinical Pharmacology (OCP) to support 
effective drug development programs.

DATES: Although you can comment at any time, to ensure that the Agency 
considers your comment, submit either electronic or written comments by 
June 25, 2024.

ADDRESSES: You may submit comments 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-2024-N-1592 for ``Promoting Effective Drug Development: Identifying 
Opportunities and Priorities for the Food and Drug Administration's 
Office of Clinical Pharmacology.'' Received comments 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.
     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.

FOR FURTHER INFORMATION CONTACT: Anuradha Ramamoorthy, Office of

[[Page 32445]]

Clinical Pharmacology, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002, 301-796-1688, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Clinical pharmacology impacts many important aspects of drug 
development including, but not limited to, dose selection and 
optimization, clinical trial inclusion and exclusion criteria, and 
evidence generation for safety and effectiveness determinations. 
Clinical pharmacology derived recommendations are also critical for 
optimizing pharmacotherapy in clinical practice (e.g., by informing 
patient-specific treatment strategies).
    Within CDER, OCP leverages clinical pharmacology information on 
drug disposition, disease biology, pharmacology, and determinants of 
response variability to support risk/benefit determinations and 
therapeutic individualization recommendations for patients and 
practitioners. OCP's mission is to advance the development of 
innovative new medicines by applying state-of-the-art scientific 
principles and promoting therapeutic optimization and 
individualization. OCP fulfills this mission through its core functions 
of regulatory review, regulatory research, and development and 
implementation of scientific guidances and policies.
    To facilitate effective and efficient drug development, FDA is 
engaged in multiple, high-priority policy initiatives. Consistent with 
FDA's broader initiatives and modernization efforts, OCP works 
collaboratively with stakeholders to develop and implement contemporary 
guidance and policy in the multidisciplinary field of clinical 
pharmacology to share the current regulatory thinking on a topic and 
promote effective drug development programs. FDA is establishing a 
public docket to solicit input from interested parties on specific and 
actionable clinical pharmacology-relevant policy topics that could be 
prioritized, developed, and implemented by OCP staff.

II. Request for Comments

    FDA is soliciting specific, actionable policy suggestions that 
could be prioritized, developed, and implemented in the near-term by 
OCP staff to promote effective drug development programs. We emphasize 
that the focus of this request is to seek input in the 
multidisciplinary field of clinical pharmacology. The Agency welcomes 
any relevant information that interested parties wish to share in a 
submission to the docket. We are particularly interested in seeking 
input on:
    1. Topics for development of new clinical pharmacology/
translational medicine guidances to improve clarity and promote 
effective drug development. Please provide a rationale to support your 
suggestion and highlight relevant aspects that could be considered in 
guidance development.
    2. Topics and concepts where further clarity on OCP's existing 
guidances may be warranted. Please provide a rationale to support your 
suggestions and actionable recommendations.
    3. Topics that promote patient centricity in drug development and 
regulatory assessment. For FDA, patient-centric drug development and 
providing patient-centered clinical recommendations are important 
priorities.

III. Electronic Access

    Persons with access to the internet may obtain relevant clinical 
pharmacology guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08956 Filed 4-25-24; 8:45 am]
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