[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Proposed Rules]
[Pages 65588-65589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26056]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2013-N-0001]
Medical Gas Regulation Review; Announcement of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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The Food and Drug Administration (FDA) is announcing a public
meeting on whether any changes to Federal drug regulations are
necessary for medical gases. The topic to be discussed is whether any
changes to the Federal drug regulations are necessary for medical gases
as part of the implementation of the Food and Drug Administration
Safety and Innovation Act (FDASIA).
Date and Time: The meeting will be held on December 6, 2013, from 9
a.m. to 5 p.m. However, depending on the level of public participation,
the meeting may be extended or may end early.
Location: The meeting will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993-0002. The FDA Conference Center at the
White Oak location is a Federal facility with security procedures and
limited seating (please note that all visitors to the White Oak Campus
must enter through Building 1). The meeting is free and seating will be
on a first-come, first-served basis. Attendees who do not wish to make
an oral presentation do not need to register.
Contact Persons: Mary Gross, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20903-0002, 301-796-3519, FAX: 301-847-8753, email:
[email protected]; or Christine Kirk, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20903-0002, 301-796-2465, FAX: 301-847-8440, email:
[email protected]; or Urvi Desai, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, email: [email protected].
Registration and Requests for Oral Presentations: If you wish to a
make an oral presentation, you must register by submitting your name,
title, firm name, address, telephone, email address, and FAX number, to
Mary Gross (see Contact Persons) by December 2, 2013. Please also
provide the type of organization you represent (e.g., industry,
consumer organization), and a brief summary of your remarks (including
the discussion topic(s) that will be addressed).
FDA will try to accommodate all persons who wish to make a
presentation; however, the duration of each speaker's presentation may
be limited by time constraints. FDA will notify registered presenters
of their scheduled presentation times. Persons registered to speak
should check in before the meeting and are encouraged to arrive early
to ensure their designated order of presentation. Participants who are
not present when called may not be permitted to speak at a later time.
An agenda of the meeting will be made available at least 3 days before
the meeting at http://www.fda.gov/Drugs/NewEvents/ucm370351.htm.
This public meeting will be Webcast and the URL will be posted at
http://www.fda.gov/Drugs/NewEvents/ucm370351.htm at least 1 day before
the meeting. A video record of the public meeting will be available at
the same Web site address for 1 year. If you need special
accommodations because of disability, please contact Mary Gross (see
Contact Persons) at least 7 days in advance.
[[Page 65589]]
Comments: Regardless of attendance at the public meeting,
interested persons may submit electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5600 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with Docket No. FDA-2013-N-0260, which has
previously been established to accept comments regarding this issue. In
order to receive consideration in advance of the delivery of the report
(discussed further in this document), comments must be received by
December 16, 2013. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Send written
requests to the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144)
into law. Section 1112(a) of FDASIA provides that not later than 18
months after its enactment, the Secretary, after obtaining input from
medical gas manufacturers and any other interested members of the
public, shall determine whether any changes to the Federal drug
regulations are necessary for medical gases and submit a report
regarding any such changes to the Committee on Health, Education,
Labor, and Pensions of the U.S. Senate and the Committee on Energy and
Commerce of the U.S. House of Representatives. Section 1112(c)(1)
defines ``Federal drug regulations'' to mean ``regulations in title 21
of the Code of Federal Regulations pertaining to drugs.'' Section
1112(b) provides that if the Secretary determines that changes to the
Federal drug regulations are necessary for medical gases, the Secretary
shall issue final regulations revising the Federal drug regulations
with respect to medical gases not later than 48 months after the
enactment of FDASIA.
On March 22, 2013, FDA issued a Federal Register notice (78 FR
17611), which established a public docket (Docket No. FDA-2013-N-0260)
to request comments from medical gas manufacturers and any other
interested members of the public on whether any changes to Federal drug
regulations are necessary for medical gases.
II. Purpose and Scope of the Meeting
We are holding this meeting to provide an additional opportunity
for medical gas manufacturers and any other interested members of the
public to provide input on whether any changes to Federal drug
regulations are needed for medical gases.
Dated: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26056 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P