[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Proposed Rules]
[Pages 17611-17612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06526]



Food and Drug Administration

21 CFR Part Chapter 1

[Docket No. FDA-2013-N-0260]

Provisions of the Food and Drug Administration Safety and 
Innovation Act Related to Medical Gases; Request for Comments Regarding 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is inviting comments 
from the public on whether any potential changes to the Federal drug 
regulations are necessary for medical gases.

DATES: Submit electronic or written comments by May 21, 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.

Christine Kirk, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6280, Silver 
Spring, MD 20993-0002, 301-796-2465, [email protected]; or
Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and 
Drug Administration, 7500 Standish Pl., MPN2, Rockville, MD 20855, 240-
276-8331, [email protected].


I. Background

    On July 9, 2012, President Obama signed the Food and Drug Safety 
and Innovation Act (FDASIA) (Pub. L. 112-144) into law. Section 1112(a) 
of FDASIA provides that not later than 18 months after its enactment, 
the Secretary of Health and Human Services, 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)(l) 
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. FDA is opening this docket to provide 
the public with an opportunity to submit comments on whether any 
potential changes to Federal drug regulations are necessary for medical 

II. Opportunities for Comment on Other Medical Gas Dockets

    FDASIA also added new sections regarding medical gases to the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (see Title XI, 
Subtitle B, section 1111 of FDASIA, adding new sections 575, 576, and 
577 to the FD&C Act). FDA has previously issued two other Federal 
Register notices related to these new sections.
    On November 23, 2012 (77 FR 70166), FDA issued a Federal Register 

[[Page 17612]]

establishing a public docket (Docket No. FDA-2012-N-1090) for 
information pertaining to FDA's implementation of the provisions of 
FDASIA related to medical gases. Interested persons may submit comments 
relevant to that Federal Register notice (see ADDRESSES) under Docket 
No. FDA-2012-N-1090.
    On December 18, 2012 (77 FR 74852), FDA issued a notice of 
availability announcing publication of a draft guidance for industry 
entitled ``Certification Process for Designated Medical Gases'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332136.pdf) (Docket No. FDA-2012-D-1197). The draft 
guidance describes the new certification process created by FDASIA for 
certain medical gases and explains how FDA plans to implement that 
process. Interested persons may submit comments regarding the draft 
guidance (see ADDRESSES) under Docket No. FDA-2012-D-1197. Please note 
that although comments on draft guidance may be submitted at any time, 
FDA requested that comments be submitted by February 19, 2013, in order 
to allow adequate time for the comments to be considered while the 
Agency is preparing final guidance.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: March 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06526 Filed 3-21-13; 8:45 am]