[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Proposed Rules]
[Pages 13440-13442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2018-N-1214]


Medical Gas Regulation; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments; public workshop.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing an additional public workshop on medical gas regulation 
entitled ``Medical Gas Regulation: Workshop III.'' FDA has previously 
held two public workshops entitled ``Medical Gas Regulation: Workshop 
I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be 
discussed is potential areas of Federal drug regulation that should be 
revised with respect to medical gases.

DATES: The public workshop will be held on May 11, 2018, from 9 a.m. to 
5 p.m. Submit either electronic or written comments on this public 
workshop by August 9, 2018. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the 
``Great Room''), Silver Spring, MD 20993-0002. Entrance for public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The workshop 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.
    You may submit comments as follows. Please note that late, untimely 
filed comments may not be considered. For timely consideration, we 
request that electronic comments on workshop topics be submitted before 
or within 90 days after each workshop (i.e., comments submitted by or 
before March 15, 2018, for Workshop I; May 10, 2018, for Workshop II; 
and August 9, 2018, for Workshop III). FDA has one shared docket for 
all workshops. However, with this notice, the docket number will change 
from FDA-2017-N-0001 to FDA-2018-N-1214. All comments submitted on the 
previous docket number will be transferred to the new docket number. 
The https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of August 9, 2018. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before the relevant date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you

[[Page 13441]]

do not wish to be made available to the public, submit the comment as a 
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-1214 for ``Medical Gas Regulation.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked 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/2015-23389.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: Christine Kirk, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2465, Fax: 301-
847-8440, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On May 5, 2017, President Trump signed the Consolidated 
Appropriations Act of 2017 (Pub. L. 115-31). Section 756 of the 
Consolidated Appropriations Act requires FDA to issue final regulations 
revising Federal drug regulations with respect to medical gases. These 
public workshops are being held as part of FDA's implementation of the 
requirements of section 756.
    Since the enactment of the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144), FDA has engaged in multiple 
activities related to medical gases, including rulemaking. For example, 
in 2016, FDA issued the final rule ``Medical Gas Containers and 
Closures: Current Good Manufacturing Practice Requirements'' (81 FR 
81685; November 18, 2016). Other activities include FDA's June 2017 
revised draft guidance for industry on current good manufacturing 
practice for medical gases,\1\ updated guidance for FDA inspectors 
regarding medical gases (March 2015),\2\ an extensive review of Federal 
drug regulations related to medical gases from 2012 to 2014 (a report 
on the review was submitted to Congress in 2015),\3\ and implementation 
of FDASIA's requirements regarding certification of medical gases (to 
date, over 70 certifications have been granted).
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    \1\ Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070270.pdf.
    \2\ Available at: https://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125417.pdf.
    \3\ Available at: https://www.fda.gov/downloads/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm453727.pdf.
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    FDA intends to engage in additional rulemaking in this area in 
accordance with section 756 of the Consolidated Appropriations Act of 
2017. To conduct rulemaking as efficiently as possible, FDA intends to 
build on the information and stakeholder input received since FDASIA's 
enactment. As noted in more detail below, FDA invites comments from 
stakeholders on specific medical gas issues that could or should be 
addressed in regulation.

II. Topics for Discussion at the Public Workshops

    We are holding these workshops to provide an opportunity for 
medical gas manufacturers and any other interested members of the 
public to provide input on potential areas of Federal drug regulation 
that should be revised with respect to medical gases.
    We are asking stakeholders to comment on existing medical gas 
issues that, in their view, should be addressed by regulation change 
(rather than through other means, such as revisions to guidance or 
inspection practices). Commenters should include concrete and specific 
reasons that rulemaking is preferable to other options. Commenters' 
views regarding the prioritization of particular rulemaking proposals 
would also be helpful. As noted above, the https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of August 9, 2018. Late comments may not be considered.
    During Workshop I (December 2017), FDA and workshop participants 
discussed the anticipated scope of the medical gas rulemaking, as well 
as three regulations to which stakeholders have previously requested 
changes: Part 201 (21 CFR part 201) (labeling generally and labeling 
for medical air specifically), part 207 (21 CFR part 207) (registration 
and listing), and parts 210 and 211 (21 CFR parts 210 and 211) (current 
good manufacturing practice). A stakeholder presentation addressed 
parts 201, 210, and 211, among other things, including initial 
stakeholder views on the possibility of having one or more separate CFR 
sections for designated medical gases. FDA also heard comments on 
additional regulations and medical gas issues as time allowed.
    During Workshop II (February 2018), FDA and workshop participants 
discussed parts 310, 314, and 514 (21 CFR parts 310, 314, and 514) 
(postmarket reporting of adverse drug experiences, including adverse 
reactions and medication errors) and the intersection of regulations 
for medical gases and regulations for medical devices and animal drugs. 
A stakeholder

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presentation also addressed, among other things, followup information 
related to Workshop I topics, including part 207 (registration and 
listing) and parts 210 and 211 (current good manufacturing practice), 
including the possibility of one or more separate CFR sections for 
designated medical gases, as well as additional topics including the 
certification process for designated medical gases and issues related 
to the filling of oxygen containers by emergency medical service (EMS) 
providers and health care facilities. FDA also heard comments on 
additional regulations and medical gas issues as time allowed.
    The Agency has determined that we will hold a third workshop to 
hear additional comments from stakeholders regarding the issues 
discussed at Workshops I and II, as well as any additional topics 
related to medical gas regulation that stakeholders may wish to 
discuss, as time allows. This workshop is primarily intended to build 
on the discussion from the previous workshops, as well as written 
comments submitted to the docket.
    During Workshop III (May 11, 2018), FDA intends to provide 
designated panel time for followup discussion of several topics raised 
at previous workshops, and for an open panel to discuss any additional 
issues related to medical gas regulation that are of interest to FDA or 
other workshop participants. The topics for designated panel time 
include further consideration of potential changes to: Part 201 
(labeling); parts 210 and 211 (current good manufacturing practice); 
part 207 (registration and listing); and parts 310, 314, and 514 
(postmarket reporting of adverse drug experiences, including adverse 
reactions and medication errors); including the possibility of one or 
more separate CFR sections for designated medical gases. Potential 
topics for open panel time include, but are not limited to: The 
certification process for designated medical gases; issues related to 
the filling of oxygen containers by EMS providers and health care 
facilities; or other topics of interest to stakeholders.

III. Participating in the Public Workshop

    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 
[email protected] (see FOR FURTHER INFORMATION CONTACT) 
by May 4, 2018, for Workshop III. Please also indicate the type of 
organization you represent (e.g., industry, consumer organization) and 
a brief summary of your remarks (including the discussion topic(s) that 
you would like to address).
    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 workshop 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 will be made available at least 3 days before the workshop at 
https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm. FDA may also post 
specific questions for consideration at the meeting web page; these 
will be made available at least 3 days before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm.
    Streaming Webcast of the Public Workshops: This public workshop 
will be webcast; the URL will be posted at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm at least 1 day before the workshop. A video 
record of the public workshops will be available at the same website 
address for 1 year. If you need special accommodations because of a 
disability, please contact [email protected] (or see 
FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the 
workshop.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06251 Filed 3-28-18; 8:45 am]
 BILLING CODE 4164-01-P