Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology; Request for Comments, 32444-32445 [2024-08956]
Download as PDF
<![CDATA[
32444
Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
likely to use the drug in clinical
practice.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Cancer Clinical Trial Eligibility
Criteria: Performance Status.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014;
the collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09037 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[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.
VerDate Sep<11>2014
20:31 Apr 25, 2024
Jkt 262001
Notice; establishment of a
public docket; request for comments.
ACTION:
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:
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,
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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-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.
FOR FURTHER INFORMATION CONTACT:
Anuradha Ramamoorthy, Office of
E:\FR\FM\26APN1.SGM
26APN1
Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
Clinical Pharmacology, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1688,
anuradha.ramamoorthy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
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 patientspecific 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
VerDate Sep<11>2014
20:31 Apr 25, 2024
Jkt 262001
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, patientcentric 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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1382]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic User
Fee Payment Request Forms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
32445
solicits comments on electronic user fee
payment request forms.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
25, 2024.
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 25, 2024. 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
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–
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
