[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29565-29567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13608]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0431]


Current Good Manufacturing Practice for Medical Gases; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a revised draft guidance for industry entitled 
``Current Good Manufacturing Practice for Medical Gases.'' This 
guidance is intended to assist manufacturers of medical gases in 
complying with applicable current good manufacturing practice (CGMP) 
regulations. Compliance with applicable CGMP requirements helps to 
ensure the safety, identity, strength, quality, and purity of medical 
gases. Medical gases that are not manufactured, produced, processed, 
packed, or held according to applicable CGMP requirements can cause 
serious injury or death. This guidance is expected to reduce the 
regulatory compliance burden for the medical gas industry by providing 
clear, up-to-date, detailed recommendations regarding CGMP issues that 
have been the subject of industry questions.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 28, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

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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 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-2003-D-0431 for ``Current Good Manufacturing Practice for Medical 
Gases.'' Received comments 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.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Frank Perrella, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4161, Silver Spring, MD 20993-0002, 301-
796-3265.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Current Good Manufacturing Practice for Medical 
Gases.'' When finalized, this guidance will represent FDA's current 
thinking on the manufacture, processing, packing, and holding of 
medical gases in compliance with applicable CGMP regulations (21 CFR 
parts 210 and 211). This guidance does not address every potentially 
applicable CGMP requirement. Instead, it addresses those requirements 
that are considered most critical to the safety of medical gases, that 
have been the subject of industry questions, or for which FDA has 
otherwise determined compliance recommendations are appropriate.
    FDA considered extensive input from the medical gas industry and 
other stakeholders regarding the appropriate application of CGMP 
requirements to medical gases in developing this revised draft 
guidance, which replaces the 2003 draft guidance of the same name (68 
FR 24005, May 6, 2003). FDA carefully reviewed and considered comments 
submitted on the 2003 draft guidance, information from meetings with 
stakeholders, and relevant information from a review of Federal drug 
regulations as applied to medical gases.\1\ FDA has changed draft 
recommendations regarding certain issues (e.g., expiration dating for 
medical gases). As mentioned previously, this guidance does not address 
every potentially applicable CGMP requirement, and we note that if a 
regulation was cited in the 2003 draft guidance without further 
discussion, and FDA is not aware of a need for guidance on the issue, 
discussion of the requirement was generally omitted from this revised 
draft guidance.
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    \1\ See section 1112(a)(2) of FDASIA(Pub. L. 112-144), requiring 
the review; see also FDA, 2015, ``Report to Congress, Review of 
Federal Drug Regulations With Regard to Medical Gases'', available 
at https://www.fda.gov/downloads/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/UCM453727.pdf.
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    We further note that this revised draft guidance is a key component 
of FDA's regulatory approach to medical gases. Section 1112 of the Food 
and Drug Administration Safety and Innovation Act (FDASIA) required 
that FDA determine whether any changes to Federal drug regulations were 
needed concerning medical gases, submit a report to Congress regarding 
any such changes, and undertake rulemaking to make any needed changes. 
In its report to Congress on this issue submitted in June 2015,\2\ FDA 
explained its determination that, although some regulation changes were 
necessary to implement the medical gas labeling provisions contained in 
FDASIA,\3\ the

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current regulatory framework is adequate and sufficiently flexible to 
appropriately regulate medical gases. FDA further explained that it can 
continue to work within this framework to appropriately regulate these 
products.
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    \2\ See FDA, 2015, ``Report to Congress, Review of Federal Drug 
Regulations With Regard to Medical Gases''.
    \3\ As amended by FDASIA, section 576(a)(3)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
360ddd-1(a)(3)(A)(ii)) provides that the requirements of sections 
503(b)(4) of the FD&C Act (21 U.S.C. 353(b)(4)) (regarding labeling 
of a drug as a prescription drug) and 502(f) of the FD&C Act (21 
U.S.C. 352(f)) (regarding inclusion of adequate directions for use 
and adequate warnings in drug labeling) are deemed to have been met 
for a designated medical gas if the labeling on the final use 
container for the medical gas bears: (1) The information required by 
section 503(b)(4); (2) a warning statement concerning the use of the 
medical gas as determined by the Secretary by regulation; and (3) 
appropriate directions and warnings concerning storage and handling.
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    FDA issued a final rule promulgating warning statements to be 
included in the labeling of designated medical gases on November 18, 
2016 (81 FR 81685). This final rule also imposes labeling, design, and 
color requirements on medical gas containers and closures to increase 
the likelihood that the contents of medical gas containers are 
accurately identified and reduce the likelihood of the wrong gas being 
connected to a gas supply system or container. FDA may undertake 
additional targeted rulemaking in the future on other specific issues 
if FDA determines that such issues cannot be adequately addressed by 
other means.
    In addition to the applicable regulations, FDA relies on guidance 
documents (such as this one), development of appropriate inspection 
practices and inspector training, and interaction with industry trade 
associations, State regulators, and other stakeholders on an as-needed 
basis in regulating medical gases.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on current good 
manufacturing practice for medical gases. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This revised draft guidance includes information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520). In accordance with the PRA, before publication of the final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any information collections recommended in this guidance 
that are new or that would represent material modifications to 
previously approved collections of information found in FDA 
regulations.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13608 Filed 6-28-17; 8:45 am]
 BILLING CODE 4164-01-P