[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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