83 FR 3736 - Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 18 (January 26, 2018)

Page Range		3736-3737
FR Document		2018-01377

The Food and Drug Administration (FDA) 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 January 22, 2020.

Federal Register, Volume 83 Issue 18 (Friday, January 26, 2018)

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3736-3737]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01377]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6903]

Advisory Committee; Pharmaceutical Science and Clinical
Pharmacology Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Pharmaceutical Science

[[Page 3737]]

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 January 22, 2020.

DATES: Authority for the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee will expire on January 22, 2020, unless
the Commissioner formally determines that renewal is in the public
interest.

FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, 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 20993-0002, 301-796-9001, Fax: 301-847-
8533, email: PSCP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
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 which 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.
The Committee shall consist of a core of 14 voting members
including two 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, 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. Almost
all non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who 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 members who are identified with industry
interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/default.htm 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 document 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: January 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01377 Filed 1-25-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3737

and Clinical Pharmacology Advisory Commissioner or designee from among DEPARTMENT OF HEALTH AND
Committee by the Commissioner of authorities knowledgeable in the fields HUMAN SERVICES
Food and Drugs (the Commissioner). of pharmaceutical sciences
The Commissioner has determined that (pharmaceutical manufacturing, Food and Drug Administration
it is in the public interest to renew the bioequivalence research, laboratory [Docket Nos. FDA–2016–E–2443 and FDA–
Pharmaceutical Science and Clinical analytical techniques, pharmaceutical 2016–E–2444]
Pharmacology Advisory Committee for chemistry, physiochemistry,
an additional 2 years beyond the charter biochemistry, molecular biology, Determination of Regulatory Review
expiration date. The new charter will be immunology, microbiology) and clinical Period for Purposes of Patent
in effect until January 22, 2020. pharmacology (dose-response, Extension; VRAYLAR
DATES: Authority for the Pharmaceutical pharmacokinetics-pharmacodynamics,
Science and Clinical Pharmacology AGENCY: Food and Drug Administration,
modeling and simulation, HHS.
Advisory Committee will expire on pharmacogenomics, clinical trial design,
January 22, 2020, unless the ACTION: Notice.
pediatrics, and special populations and
Commissioner formally determines that innovative methods in drug
renewal is in the public interest. SUMMARY: The Food and Drug
development), biostatistics, related Administration (FDA or the Agency) has
FOR FURTHER INFORMATION CONTACT: Jay
biomedical and pharmacological determined the regulatory review period
Fajiculay, Division of Advisory specialties, current good manufacturing for VRAYLAR and is publishing this
Committee and Consultant
practices, and quality systems notice of that determination as required
Management, Center for Drug
implementation. Members will be by law. FDA has made the
Evaluation and Research, Food and
invited to serve for overlapping terms of determination because of the
Drug Administration, 10903 New
up to 4 years. Almost all non-Federal submission of applications to the
Hampshire Ave., Bldg. 31, Rm. 2417,
members of this committee serve as Director of the U.S. Patent and
Silver Spring, MD 20993–0002, 301–
Special Government Employees. The Trademark Office (USPTO), Department
796–9001, Fax: 301–847–8533, email:
core of voting members may include one of Commerce, for the extension of a
PSCP@fda.hhs.gov.
technically qualified member, selected patent which claims that human drug
SUPPLEMENTARY INFORMATION: Pursuant product.
to 41 CFR 102–3.65 and approval by the by the Commissioner or designee, who
Department of Health and Human is identified with consumer interests DATES: Anyone with knowledge that any
Services pursuant to 45 CFR part 11 and and is recommended by either a of the dates as published (see the
by the General Services Administration, consortium of consumer-oriented SUPPLEMENTARY INFORMATION section) are
FDA is announcing the renewal of the organizations or other interested incorrect may submit either electronic
Pharmaceutical Science and Clinical persons. In addition to the voting or written comments and ask for a
Pharmacology Advisory Committee (the members, the Committee may include redetermination by March 27, 2018.
Committee). The Committee is a up to three non-voting members who are Furthermore, any interested person may
discretionary Federal advisory identified with industry interests. petition FDA for a determination
committee established to provide advice regarding whether the applicant for
Further information regarding the extension acted with due diligence
to the Commissioner. The Committee most recent charter and other
advises the Commissioner or designee during the regulatory review period by
information can be found at https:// July 25, 2018. See ‘‘Petitions’’ in the
in discharging responsibilities as they
www.fda.gov/AdvisoryCommittees/ SUPPLEMENTARY INFORMATION section for
relate to helping to ensure safe and
CommitteesMeetingMaterials/Drugs/ more information.
effective drugs for human use and, as
AdvisoryCommitteeforPharmaceutical ADDRESSES: You may submit comments
required, any other product for which
FDA has regulatory responsibility. ScienceandClinicalPharmacology/ as follows. Please note that late,
The Committee reviews and evaluates default.htm or by contacting the untimely filed comments will not be
scientific, clinical, and technical issues Designated Federal Officer (see FOR considered. Electronic comments must
related to the safety and effectiveness of FURTHER INFORMATION CONTACT). In light be submitted on or before March 27,
drug products for use in the treatment of the fact that no change has been made 2018. The https://www.regulations.gov
of a broad spectrum of human diseases, to the committee name or description of electronic filing system will accept
the quality characteristics which such duties, no amendment will be made to comments until midnight Eastern Time
drugs purport or are represented to 21 CFR 14.100. at the end of March 27, 2018. Comments
have, and as required, any other product This document is issued under the received by mail/hand delivery/courier
for which FDA has regulatory Federal Advisory Committee Act (5 (for written/paper submissions) will be
responsibility, and makes appropriate U.S.C. app.). For general information considered timely if they are
recommendations to the Commissioner. related to FDA advisory committees, postmarked or the delivery service
The Committee may also review Agency please visit us at https://www.fda.gov/ acceptance receipt is on or before that
sponsored intramural and extramural AdvisoryCommittees/default.htm. date.
biomedical research programs in
Dated: January 19, 2018. Electronic Submissions
support of FDA’s drug regulatory
responsibilities and its critical path Leslie Kux, Submit electronic comments in the
initiatives related to improving the Associate Commissioner for Policy. following way:
daltland on DSKBBV9HB2PROD with NOTICES

efficacy and safety of drugs and [FR Doc. 2018–01377 Filed 1–25–18; 8:45 am]
• Federal eRulemaking Portal:
improving the efficiency of drug https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P
development. instructions for submitting comments.
The Committee shall consist of a core Comments submitted electronically,
of 14 voting members including two including attachments, to https://
Chairpersons. Members and www.regulations.gov will be posted to
Chairpersons are selected by the the docket unchanged. Because your

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Document Created: 2018-10-26 10:05:03
Document Modified: 2018-10-26 10:05:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
Dates		Authority for the Pharmaceutical Science and Clinical Pharmacology Advisory Committee will expire on January 22, 2020, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Jay Fajiculay, 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 20993-0002, 301-796-9001, Fax: 301-847- 8533, email: [email protected]
FR Citation		83 FR 3736

83 FR 3736 - Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 18 (January 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration