81_FR_8758 81 FR 8724 - Nonprescription Drugs Advisory Committee; Notice of Meeting

81 FR 8724 - Nonprescription Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 34 (February 22, 2016)

Page Range8724-8724
FR Document2016-03573

Federal Register, Volume 81 Issue 34 (Monday, February 22, 2016) 
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Page 8724]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Nonprescription Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Nonprescription Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 15, 2016, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number 
is 301-977-8900.
    Contact Person: 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, FAX: 301-847-
8533, [email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the 
Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The committee will discuss data submitted by Galderma 
Laboratories, L.P. to support supplemental new drug application (sNDA) 
20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The 
proposed OTC use is for the treatment of acne and to clear up acne 
pimples and acne blemishes. The applicant proposes to label the product 
for 12 years and older. The committee will be asked to consider whether 
data support an acceptable risk/benefit profile for the nonprescription 
use of adapalene gel 0.1% by OTC consumers.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
April 1, 2016. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before March 24, 2016. Time allotted for 
each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by March 25, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Moon Hee V. Choi at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 17, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03573 Filed 2-19-16; 8:45 am]
 BILLING CODE 4164-01-P

8724 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices may find a total coliform positive FDA Advisory Committee Information accommodated during the scheduled sample about three times per year in Line, 1–800–741–8138 (301–443–0572 open public hearing session, FDA may finished product testing, for a total of 23 in the Washington, DC area). A notice in conduct a lottery to determine the hours of recordkeeping. Upon finding a the Federal Register about last minute speakers for the scheduled open public total coliform sample, bottlers will then modifications that impact a previously hearing session. The contact person will have to conduct a followup test for E. announced advisory committee meeting notify interested persons regarding their coli. cannot always be published quickly request to speak by March 25, 2016. We expect that recordkeeping for the enough to provide timely notice. Persons attending FDA’s advisory followup test for E. coli will also take Therefore, you should always check the committee meetings are advised that the about 5 minutes per test. As shown in Agency’s Web site at http://www.fda. Agency is not responsible for providing table 1 of this document, we expect that gov/AdvisoryCommittees/default.htm access to electrical outlets. three bottlers per year will have to carry and scroll down to the appropriate FDA welcomes the attendance of the out the additional E. coli testing, with a advisory committee meeting link, or call public at its advisory committee burden of 1 hour. These bottlers will the advisory committee information line meetings and will make every effort to also have to keep records about to learn about possible modifications accommodate persons with disabilities. rectifying the source contamination, for before coming to the meeting. If you require accommodations due to a a burden of 2 hours. For all expected Agenda: The committee will discuss disability, please contact Moon Hee V. total coliform testing, E. coli testing, and data submitted by Galderma Choi at least 7 days in advance of the source rectification, we estimate a total Laboratories, L.P. to support meeting. burden of 179 hours. We base our supplemental new drug application FDA is committed to the orderly estimate on our experience with the (sNDA) 20–380, for over-the-counter conduct of its advisory committee current CGMP regulations. (OTC) marketing of adapalene gel 0.1%. meetings. Please visit our Web site at The proposed OTC use is for the http://www.fda.gov/Advisory Dated: February 16, 2016. treatment of acne and to clear up acne Leslie Kux, Committees/AboutAdvisoryCommittees/ pimples and acne blemishes. The ucm111462.htm for procedures on Associate Commissioner for Policy. applicant proposes to label the product public conduct during advisory [FR Doc. 2016–03549 Filed 2–19–16; 8:45 am] for 12 years and older. The committee committee meetings. BILLING CODE 4164–01–P will be asked to consider whether data Notice of this meeting is given under support an acceptable risk/benefit the Federal Advisory Committee Act (5 profile for the nonprescription use of U.S.C. app. 2). DEPARTMENT OF HEALTH AND adapalene gel 0.1% by OTC consumers. HUMAN SERVICES FDA intends to make background Dated: February 17, 2016. material available to the public no later Jill Hartzler Warner, Food and Drug Administration than 2 business days before the meeting. Associate Commissioner for Special Medical If FDA is unable to post the background Programs. [Docket No. FDA–2016–N–0001] material on its Web site prior to the [FR Doc. 2016–03573 Filed 2–19–16; 8:45 am] Nonprescription Drugs Advisory meeting, the background material will BILLING CODE 4164–01–P Committee; Notice of Meeting be made publicly available at the location of the advisory committee AGENCY: Food and Drug Administration, meeting, and the background material DEPARTMENT OF HEALTH AND HHS. will be posted on FDA’s Web site after HUMAN SERVICES ACTION: Notice. the meeting. Background material is available at http://www.fda.gov/ Food and Drug Administration This notice announces a forthcoming AdvisoryCommittees/Calendar/ [Docket No. FDA–2014–E–2346] meeting of a public advisory committee default.htm. Scroll down to the of the Food and Drug Administration appropriate advisory committee meeting Determination of Regulatory Review (FDA). The meeting will be open to the link. Period for Purposes of Patent public. Procedure: Interested persons may Extension; BREO ELLIPTA Name of Committee: Nonprescription present data, information, or views, Drugs Advisory Committee. orally or in writing, on issues pending AGENCY: Food and Drug Administration, General Function of the Committee: before the committee. Written HHS. To provide advice and submissions may be made to the contact ACTION: Notice. recommendations to the Agency on person on or before April 1, 2016. Oral FDA’s regulatory issues. presentations from the public will be SUMMARY: The Food and Drug Date and Time: The meeting will be scheduled between approximately 1 Administration (FDA) has determined held on April 15, 2016, from 8 a.m. to p.m. and 2 p.m. Those individuals the regulatory review period for BREO 5 p.m. interested in making formal oral ELLIPTA and is publishing this notice Location: Hilton Washington DC presentations should notify the contact of that determination as required by North/Gaithersburg, Grand Ballroom, person and submit a brief statement of law. FDA has made the determination 620 Perry Pkwy., Gaithersburg, MD the general nature of the evidence or because of the submission of an 20877. The hotel’s telephone number is arguments they wish to present, the application to the Director of the U.S. Patent and Trademark Office (USPTO), mstockstill on DSK4VPTVN1PROD with NOTICES 301–977–8900. names and addresses of proposed Contact Person: Moon Hee V. Choi, participants, and an indication of the Department of Commerce, for the Center for Drug Evaluation and approximate time requested to make extension of a patent which claims that Research, Food and Drug their presentation on or before March human drug product. Administration, 10903 New Hampshire 24, 2016. Time allotted for each DATES: Anyone with knowledge that any Ave., Bldg. 31, Rm. 2417, Silver Spring, presentation may be limited. If the of the dates as published (in the MD 20993–0002, 301–796–9001, FAX: number of registrants requesting to SUPPLEMENTARY INFORMATION section) are 301–847–8533, NDAC@fda.hhs.gov, or speak is greater than can be reasonably incorrect may submit either electronic VerDate Sep<11>2014 19:03 Feb 19, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1


Document Created: 2016-02-19 23:57:04
Document Modified: 2016-02-19 23:57:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation81 FR 8724 
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