Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal, 63662-63663 [2019-24917]
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Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
Kimberly S. Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81). The NDA
holders listed in table 1 have failed to
submit the required annual reports and
have not responded to the Agency’s
request for submission of the reports.
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
NDA holder
NDA 014217 ..........
MAOLATE (chlorphenesin carbamate) Tablet, 400 milligrams (mg).
CHYMODIACTIN (chymopapain) for Injection, 4,000 Units/
vial and 10,000 Units/vial.
IONTOCAINE (epinephrine and lidocaine hydrochloride
(HCl)) Topical Solution, 0.01 mg/milliliter; 2%.
LIDOSITE TOPICAL SYSTEM: LidoSite Patch (lidocaine
HCl and epinephrine topical iontophoretic patch) 10%/
0.1% and LidoSite Controller.
Pan American Laboratories, LLC, 4099 Highway 190, Covington, LA 70433.
Chart Medical, Inc., c/o Renascent Medical, Inc., 9600
Great Hills Trail, Suite 150 West, Austin, TX 78759.
Iomed, Inc., 2441 South 3850 West, Suite A, Salt Lake City,
UT 84120–9941.
Vyteris, Inc., 13–01 Pollitt Dr., Fair Lawn, NJ 07410.
NDA 018663 ..........
NDA 020530 ..........
NDA 021504 ..........
Therefore, notice is given to the NDA
holders listed in table 1 and to all other
interested persons that the Director of
CDER proposes to issue an order under
section 505(e) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(e)), withdrawing approval of the
applications and all amendments and
supplements thereto on the grounds that
the NDA holders have failed to submit
reports required under § 314.81.
In accordance with section 505 of the
FD&C Act and 21 CFR part 314, the
NDA holders are hereby provided an
opportunity for a hearing to show why
the approval of the applications listed
previously should not be withdrawn
and an opportunity to raise, for
administrative determination, all issues
relating to the legal status of the drug
products covered by these applications.
An NDA holder who decides to seek
a hearing must file the following: (1) A
written notice of participation and
request for a hearing (see DATES and
ADDRESSES) and (2) the data,
information, and analyses relied on to
demonstrate that there is a genuine and
substantial issue of fact that requires a
hearing (see DATES and ADDRESSES). Any
other interested person may also submit
comments on this notice. The
procedures and requirements governing
this notice of opportunity for a hearing,
notice of participation and request for a
hearing, information and analyses to
justify a hearing, other comments, and
a grant or denial of a hearing are
contained in § 314.200 (21 CFR 314.200)
and in 21 CFR part 12.
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17:41 Nov 15, 2019
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The failure of an NDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
NDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the applications and constitutes a
waiver of any contentions concerning
the legal status of the drug products.
FDA will then withdraw approval of the
applications, and the drug products may
not thereafter be lawfully introduced or
delivered for introduction into interstate
commerce. Any new drug product
introduced or delivered for introduction
into interstate commerce without an
approved application is subject to
regulatory action at any time.
A request for a hearing may not rest
upon mere allegations or denials, but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. If a
request for a hearing is not complete or
is not supported, the Commissioner of
Food and Drugs will enter summary
judgment against the person who
requests the hearing, making findings
and conclusions, and denying a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in four copies. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen at the Dockets Management Staff
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday, and will
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Fmt 4703
Sfmt 4703
be posted to the docket at https://
www.regulations.gov.
This notice is issued under section
505(e) of the FD&C Act and under
authority delegated to the Director of
CDER by the Commissioner of Food and
Drugs.
Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24921 Filed 11–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2649]
Advisory Committee; Nonprescription
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
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, 2021.
SUMMARY:
E:\FR\FM\18NON1.SGM
18NON1
Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
Authority for the
Nonprescription Drugs Advisory
Committee will expire on August 27,
2021, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. 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: NDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3, FDA is announcing
the renewal of the Nonprescription
Drugs 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
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
promulgation 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.
Pursuant to its charter, the Committee
consists 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 are 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
DATES:
VerDate Sep<11>2014
17:41 Nov 15, 2019
Jkt 250001
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented 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 https://
www.fda.gov/advisory-committees/
nonprescription-drugs-advisorycommittee/nonprescription-drugsadvisory-committee-charter 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 check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24917 Filed 11–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Ryan White HIV/AIDS
Program Parts A and B Unobligated
Balances and Rebate Addendum
Tables, OMB No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than December 18,
2019.
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
63663
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
paperwork@hrsa.gov or by fax to (202)
395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Ryan White HIV/AIDS Program Parts A
and B Unobligated Balances and Rebate
Addendum Tables, OMB No. 0906–
xxxx—NEW.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states,
territories, and local clinics/communitybased organizations to deliver efficient
and effective HIV care, treatment, and
support to low-income people
diagnosed with HIV. Nearly two-thirds
of RWHAP clients (patients) live at or
below 100 percent of the federal poverty
level and approximately three-quarters
of RWHAP clients are racial and ethnic
minorities. Since 1990, the RWHAP has
developed a comprehensive system of
HIV service providers who deliver high
quality direct health care and support
services to over half a million people
diagnosed with HIV—more than 50
percent of all people diagnosed with
HIV in the United States.
Grant recipients funded under Parts
A, B, C, and D of the RWHAP (codified
under Title XXVI of the Public Health
Service Act) are required to report
financial data to HRSA at the beginning
(Allocations Report) and at the end of
each grant budget period (Expenditures
Report) using the HRSA Electronic
Handbooks (EHBs).i HRSA RWHAP
Parts A and B collect unobligated
balances (UOB) of federal funds and
rebate addendum information by
subprogram from their grant recipients.
Parts A and B use the UOB and rebate
addendum financial information to
determine formula funding as directed
by the RWHAP statute. These data were
collected when grant recipients
submitted their annual Federal
Financial Report (FFR SF–425) in hard
copy only, and were submitted to the
individual HHS Operating Divisions.
HRSA added UOB and rebate
addendum tables after the FFR SF–425,
using a suggested format through the
HRSA EHBs. This financial information
is collected in the same location to
ADDRESSES:
i The Allocations Report and the Expenditures
Report were approved by OMB under the 0915–
0318 control number.
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63662-63663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24917]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2649]
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, 2021.
[[Page 63663]]
DATES: Authority for the Nonprescription Drugs Advisory Committee will
expire on August 27, 2021, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Moon Hee V. 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, FDA is announcing
the renewal of the Nonprescription Drugs 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 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 promulgation 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.
Pursuant to its charter, the Committee consists 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 are 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 https://www.fda.gov/advisory-committees/nonprescription-drugs-advisory-committee/nonprescription-drugs-advisory-committee-charter 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 check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24917 Filed 11-15-19; 8:45 am]
BILLING CODE 4164-01-P
