82 FR 43388 - Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 178 (September 15, 2017)

Page Range		43388-43388
FR Document		2017-19670

The Food and Drug Administration (FDA) is announcing the renewal of the Nonprescription Drugs 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 Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2019.

Federal Register, Volume 82 Issue 178 (Friday, September 15, 2017)

[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Page 43388]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19670]



[[Page 43388]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3137]


Advisory Committee; Nonprescription Drugs Advisory Committee, 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Nonprescription Drugs 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 
Nonprescription Drugs Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until August 27, 2019.

DATES: Authority for the Nonprescription Drugs Advisory Committee will 
expire on August 27, 2017, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee Choi, 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, email: [email protected].

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 Nonprescription Drugs Advisory Committee (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 data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug 
products, or any other FDA-regulated product, for use in the treatment 
of a broad spectrum of human symptoms and diseases and advises the 
Commissioner either on the issuance of monographs establishing 
conditions under which these drugs are generally recognized as safe and 
effective and not misbranded or on the approval of new drug 
applications for such drugs. The Committee serves as a forum for the 
exchange of views regarding the prescription and nonprescription 
status, including switches from one status to another, of these various 
drug products and combinations thereof. The Committee may also conduct 
peer review of Agency sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.
    The Committee shall consist of a core of 10 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of internal medicine, family practice, clinical toxicology, 
clinical pharmacology, pharmacy, dentistry, and related specialties. 
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 one non-voting member who is identified with industry 
interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/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 http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: September 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19670 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P

43388 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices

DEPARTMENT OF HEALTH AND approval of new drug applications for DEPARTMENT OF HEALTH AND
HUMAN SERVICES such drugs. The Committee serves as a HUMAN SERVICES
forum for the exchange of views
Food and Drug Administration regarding the prescription and Food and Drug Administration
[Docket No. FDA–2015–N–3137] nonprescription status, including [Docket No. FDA–2017–N–4758]
switches from one status to another, of
Advisory Committee; Nonprescription these various drug products and Determination That CORTONE
Drugs Advisory Committee, Renewal combinations thereof. The Committee (Cortisone Acetate) Tablets and Other
may also conduct peer review of Agency Drug Products Were Not Withdrawn
AGENCY: Food and Drug Administration, From Sale for Reasons of Safety or
HHS. sponsored intramural and extramural
scientific biomedical programs in Effectiveness
ACTION:Notice; renewal of advisory
support of FDA’s mission and regulatory AGENCY: Food and Drug Administration,
committee.
responsibilities. HHS.
SUMMARY: The Food and Drug The Committee shall consist of a core ACTION: Notice.
Administration (FDA) is announcing the of 10 voting members including the
renewal of the Nonprescription Drugs Chair. Members and the Chair are SUMMARY: The Food and Drug
Advisory Committee by the selected by the Commissioner or Administration (FDA or Agency) has
Commissioner of Food and Drugs (the designee from among authorities determined that the drug products listed
Commissioner). The Commissioner has knowledgeable in the fields of internal in this document were not withdrawn
determined that it is in the public medicine, family practice, clinical from sale for reasons of safety or
interest to renew the Nonprescription effectiveness. This determination means
toxicology, clinical pharmacology,
Drugs Advisory Committee for an that FDA will not begin procedures to
pharmacy, dentistry, and related
additional 2 years beyond the charter withdraw approval of abbreviated new
specialties. Members will be invited to
expiration date. The new charter will be drug applications (ANDAs) that refer to
in effect until August 27, 2019. serve for overlapping terms of up to 4 these drug products, and it will allow
years. Almost all non-Federal members FDA to continue to approve ANDAs that
DATES: Authority for the
of this committee serve as Special refer to the products as long as they
Nonprescription Drugs Advisory
Government Employees. The core of meet relevant legal and regulatory
Committee will expire on August 27,
voting members may include one requirements.
2017, unless the Commissioner formally
determines that renewal is in the public technically qualified member, selected
FOR FURTHER INFORMATION CONTACT:
interest. by the Commissioner or designee, who
Stacy Kane, Center for Drug Evaluation
is identified with consumer interests
FOR FURTHER INFORMATION CONTACT: and Research, Food and Drug
and is recommended by either a
Moon Hee Choi, Center for Drug Administration, 10903 New Hampshire
consortium of consumer-oriented
Evaluation and Research, Food and Ave., Bldg. 51, Rm. 6236, Silver Spring,
Drug Administration, 10903 New organizations or other interested MD 20993–0002, 301–796–8363,
Hampshire Ave., Bldg. 31, Rm. 2417, persons. In addition to the voting Stacy.Kane@fda.hhs.gov.
Silver Spring, MD 20993–0002, 301– members, the Committee may include
SUPPLEMENTARY INFORMATION: In 1984,
796–9001, email: NDAC@fda.hhs.gov. one non-voting member who is
Congress enacted the Drug Price
SUPPLEMENTARY INFORMATION: Pursuant
identified with industry interests. Competition and Patent Term
to 41 CFR 102–3.65 and approval by the Further information regarding the Restoration Act of 1984 (Pub. L. 98–417)
Department of Health and Human most recent charter and other (the 1984 amendments), which
Services pursuant to 45 CFR part 11 and information can be found at http:// authorized the approval of duplicate
by the General Services Administration, www.fda.gov/AdvisoryCommittees/ versions of drug products approved
FDA is announcing the renewal of the CommitteesMeetingMaterials/ under an ANDA procedure. ANDA
Nonprescription Drugs Advisory Drugs/Nonprescription applicants must, with certain
Committee (Committee). The Committee DrugsAdvisoryCommittee/default.htm exceptions, show that the drug for
is a discretionary Federal advisory or by contacting the Designated Federal which they are seeking approval
committee established to provide advice Officer (see FOR FURTHER INFORMATION contains the same active ingredient in
to the Commissioner. The Committee CONTACT). In light of the fact that no the same strength and dosage form as
advises the Commissioner or designee change has been made to the committee the ‘‘listed drug,’’ which is a version of
in discharging responsibilities as they name or description of duties, no the drug that was previously approved.
relate to helping to ensure safe and amendment will be made to 21 CFR ANDA applicants do not have to repeat
effective drugs for human use and, as 14.100. the extensive clinical testing otherwise
required, any other product for which necessary to gain approval of a new
FDA has regulatory responsibility. This document is issued under the drug application (NDA).
The Committee reviews and evaluates Federal Advisory Committee Act (5 The 1984 amendments include what
data concerning the safety and U.S.C. app.). For general information is now section 505(j)(7) of the Federal
effectiveness of over-the-counter related to FDA advisory committees, Food, Drug, and Cosmetic Act (21 U.S.C.
(nonprescription) human drug products, please visit us at http://www.fda.gov/ 355(j)(7)), which requires FDA to
or any other FDA-regulated product, for AdvisoryCommittees/default.htm. publish a list of all approved drugs.
mstockstill on DSK30JT082PROD with NOTICES

use in the treatment of a broad spectrum Dated: September 11, 2017. FDA publishes this list as part of the
of human symptoms and diseases and ‘‘Approved Drug Products With
Anna K. Abram,
advises the Commissioner either on the Therapeutic Equivalence Evaluations,’’
issuance of monographs establishing Deputy Commissioner for Policy, Planning, which is generally known as the
conditions under which these drugs are Legislation, and Analysis. ‘‘Orange Book.’’ Under FDA regulations,
generally recognized as safe and [FR Doc. 2017–19670 Filed 9–14–17; 8:45 am] a drug is removed from the list if the
effective and not misbranded or on the BILLING CODE 4164–01–P Agency withdraws or suspends

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Document Created: 2017-09-15 00:18:28
Document Modified: 2017-09-15 00:18:28

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 Nonprescription Drugs Advisory Committee will expire on August 27, 2017, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Moon Hee Choi, 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, email: [email protected]
FR Citation		82 FR 43388

82 FR 43388 - Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 178 (September 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration