Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Renewal, 17851-17852 [2024-05218]
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Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
FOR FURTHER INFORMATION CONTACT:
III. Electronic Access
Teresa Buracchio, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4212,
Silver Spring, MD 20993–0002, 240–
402–4274; or James Myers, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
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may obtain the draft guidance at https://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.
SUPPLEMENTARY INFORMATION:
Dated: March 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Early Alzheimer’s Disease:
Developing Drugs for Treatment.’’ This
draft guidance is intended to assist
sponsors in the clinical development of
drugs for the treatment of the stages of
sporadic AD that occur before the onset
of overt dementia. This draft guidance
revises the draft guidance for industry
entitled ‘‘Early Alzheimer’s Disease:
Developing Drugs for Treatment’’ issued
February 16, 2018 (83 FR 7060), and
reflects FDA’s consideration of public
comments on the draft guidance. This
revision describes FDA’s current
thinking regarding the use of biomarkers
for the selection of participants with
early stages of AD for enrollment in
clinical trials, the selection of outcome
measures for clinical trials in early AD,
and the use of effects on characteristic
pathophysiological changes of AD to
support approval in these populations.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Early Alzheimer’s Disease:
Developing Drugs for Treatment.’’ 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.
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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 the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014.
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BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0869]
Advisory Committee; Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until the January 22, 2026, expiration
date.
SUMMARY:
Authority for the Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee will expire on
January 22, 2026, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Yvette Waples, Division of Advisory
Committee and Consultant
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993, 301–796–
9001, ACPS-CP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
DATES:
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17851
Services and by the General Services
Administration, FDA is announcing the
renewal of the Pharmaceutical Science
and Clinical Pharmacology Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
scientific, clinical, and technical issues
related to the safety and effectiveness of
drug products for use in the treatment
of a broad spectrum of human diseases,
the quality characteristics that such
drugs purport or are represented to
have, and as required, any other product
for which FDA has regulatory
responsibility, and makes appropriate
recommendations to the Commissioner.
The Committee may also review
Agency-sponsored intramural and
extramural biomedical research
programs in support of FDA’s drug
regulatory responsibilities and its
critical path initiatives related to
improving the efficacy and safety of
drugs and improving the efficiency of
drug development.
Pursuant to its charter, the Committee
shall consist of a core of 14 voting
members including 2 Chairpersons.
Members and Chairpersons are selected
by the Commissioner or designee from
among authorities knowledgeable in the
fields of pharmaceutical sciences
(pharmaceutical manufacturing,
bioequivalence research, laboratory
analytical techniques, pharmaceutical
chemistry, physiochemistry,
biochemistry, molecular biology,
immunology, and microbiology) and
clinical pharmacology (dose-response,
pharmacokinetics-pharmacodynamics,
modeling and simulation,
pharmacogenomics, clinical trial design,
pediatrics and special populations, and
innovative methods in drug
development), biostatistics, related
biomedical and pharmacological
specialties, current good manufacturing
practices, and quality systems
implementation. Members will be
invited to serve for overlapping terms of
up to 4 years. Non-Federal members of
this Committee will serve either as
Special Government Employees or nonvoting representatives. Federal members
will serve as Regular Government
Employees or Ex-Officios. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
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17852
Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
up to three non-voting representative
members who are identified with
industry interests. There may also be an
alternate industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
pharmaceutical-science-and-clinicalpharmacology-advisory-committee or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
VerDate Sep<11>2014
19:36 Mar 11, 2024
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Dated: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05218 Filed 3–11–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–5847 and FDA–
2019–E–5855]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Light Adjustable Lens
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for LIGHT ADJUSTABLE LENS and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by May 13, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 9, 2024. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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
May 13, 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.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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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 Nos. FDA–
2019–E–5847 and FDA–2019–E–5855
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; LIGHT ADJUSTABLE
LENS.’’ 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
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]]>Agencies
[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17851-17852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0869]
Advisory Committee; Pharmaceutical Science and Clinical
Pharmacology Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee by the Commissioner of Food and Drugs
(the Commissioner). The Commissioner has determined that it is in the
public interest to renew the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
January 22, 2026, expiration date.
DATES: Authority for the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee will expire on January 22, 2026, unless
the Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Yvette Waples, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993, 301-796-9001, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Pharmaceutical
Science and Clinical Pharmacology Advisory Committee (the Committee).
The Committee is a discretionary Federal advisory committee established
to provide advice to the Commissioner. The Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee reviews and evaluates scientific, clinical, and
technical issues related to the safety and effectiveness of drug
products for use in the treatment of a broad spectrum of human
diseases, the quality characteristics that such drugs purport or are
represented to have, and as required, any other product for which FDA
has regulatory responsibility, and makes appropriate recommendations to
the Commissioner. The Committee may also review Agency-sponsored
intramural and extramural biomedical research programs in support of
FDA's drug regulatory responsibilities and its critical path
initiatives related to improving the efficacy and safety of drugs and
improving the efficiency of drug development.
Pursuant to its charter, the Committee shall consist of a core of
14 voting members including 2 Chairpersons. Members and Chairpersons
are selected by the Commissioner or designee from among authorities
knowledgeable in the fields of pharmaceutical sciences (pharmaceutical
manufacturing, bioequivalence research, laboratory analytical
techniques, pharmaceutical chemistry, physiochemistry, biochemistry,
molecular biology, immunology, and microbiology) and clinical
pharmacology (dose-response, pharmacokinetics-pharmacodynamics,
modeling and simulation, pharmacogenomics, clinical trial design,
pediatrics and special populations, and innovative methods in drug
development), biostatistics, related biomedical and pharmacological
specialties, current good manufacturing practices, and quality systems
implementation. Members will be invited to serve for overlapping terms
of up to 4 years. Non-Federal members of this Committee will serve
either as Special Government Employees or non-voting representatives.
Federal members will serve as Regular Government Employees or Ex-
Officios. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who
[[Page 17852]]
is identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
up to three non-voting representative members who are identified with
industry interests. There may also be an alternate industry
representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact
that no change has been made to the committee name or description of
duties, no amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05218 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
