Document ID: FDA-2012-N-1090-0001
Agency: fda
Document Type: Notice
Title: Docket Establishment for Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases
Posted Date: 2012-11-23T05:00Z

[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70166-70167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28431]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1090]

Provisions of the Food and Drug Administration Safety and 
Innovation Act Related to Medical Gases; Establishment of a Public 
Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket for information pertaining to FDA's implementation of the 
provisions of the Food and Drug Administration Safety and Innovation 
Act (FDASIA) related to medical gases. This action is intended to 
ensure that information submitted to FDA on the implementation of the 
medical gas provisions of FDASIA is available to all interested persons 
in a timely fashion.

DATES: Submit electronic or written comments by November 25, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522, patrick.raulerson@fda.hhs.gov; or Germaine Connolly, Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., MPN2, Rockville, MD 20855, 240-276-8331, 
germaine.connolly@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, President Obama signed into law FDASIA (Pub. L. 
112-144, 126 Stat. 993). Title XI, Subtitle B, section 1111 of FDASIA 
added new sections 575, 576, and 577 to the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) regarding medical gases. Among other 
things, these new sections define the terms ``designated medical gas'' 
and ``medical gas'' and establish the process for the certification of 
a medical gas as a designated medical gas. (See sections 575(1) and (2) 
of the FD&C Act.) The sections describe the process for filing a 
request for certification and describe the information that should be 
included in the request for certification. (See section 576(a) of the 
FD&C Act.) Under section 576(a)(3) of the FD&C Act, if a certification 
is granted for a designated medical gas, the designated medical gas 
will be deemed to have in effect an approved new human drug application 
under section 505 (21 U.S.C. 355) or an approved new animal drug 
application under section 512 (21 U.S.C. 360b) of the FD&C Act for 
certain specified indications and subject to all applicable 
postapproval requirements. Under section 576(a)(1) of the FD&C Act, 
requests for certification may be submitted to FDA beginning 180 days 
after the enactment of FDASIA, or January 5, 2013.
    FDA is establishing a public docket for information pertaining to 
FDA's implementation of these new medical gas provisions. This action 
is intended to ensure that information submitted to FDA on the 
implementation of the medical gas provisions of FDASIA is available to 
all interested persons in a timely fashion. The Compressed Gas

[[Page 70167]]

Association and the Gases and Welding Distributors Association 
voluntarily submitted to the Agency its views on implementation of the 
medical gas provisions of FDASIA. FDA plans to place these comments in 
the public docket so they are readily available to all interested 
members of the public. FDA expects to place all additional submissions 
containing recommendations on how the Agency should implement the 
medical gas provisions of FDASIA in this docket, and directs the public 
to submit all comments related to these provisions to this docket. This 
docket will be open for comments for 1 year from the date of 
publication of this notice. In addition, as FDA implements the medical 
gas provisions of FDASIA, FDA plans to open other dockets. For example, 
we plan to issue a separate Federal Register notice in the future to 
provide the public with an opportunity to submit comments on section 
1112 of FDASIA. Section 1112(a)(1) of FDASIA provides that not later 
than 18 months after the date of the enactment of FDASIA, the 
Secretary, after obtaining input from medical gas manufacturers and any 
other interested members of the public, must determine whether any 
changes to the Federal drug regulations are necessary for medical 
gases.

II. Comments

    Interested persons may submit either written comments to the 
Division of Dockets Management (see ADDRESSES) or electronic comments 
to http://www.regulations.gov. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. 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.

    Dated: November 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28431 Filed 11-21-12; 8:45 am]
BILLING CODE 4160-01-P