Notice2026-02789
Certification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Primary source
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Published
February 12, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Certification Process for Designated Medical Gases." This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, the guidance discusses what products qualify as DMGs, who must submit a certification request, what information must be submitted, and how FDA will evaluate and act on the request. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.
Full Text
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<title>Federal Register, Volume 91 Issue 29 (Thursday, February 12, 2026)</title>
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[Federal Register Volume 91, Number 29 (Thursday, February 12, 2026)]
[Notices]
[Pages 6645-6647]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02789]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1197]
Certification Process for Designated Medical Gases; Draft
Guidance for Industry; Availability; Agency Information Collection
Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Certification Process for Designated Medical Gases.'' This guidance
explains how FDA administers the certification process and describes
the annual reporting requirements for designated medical gases (DMGs).
Specifically, the guidance discusses what products qualify as DMGs, who
must submit a certification request, what information must be
submitted, and how FDA will evaluate and act on the request. This draft
guidance is being issued to reflect new and revised regulations in
several areas to reduce the regulatory burden, as appropriate, for the
medical gas industry. This draft guidance revises and replaces the
draft guidance of the same name issued in November 2015, which was
withdrawn on December 18, 2025.
DATES: Submit either electronic or written comments on the draft
guidance by April 13, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by April 13,
2026.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2012-D-1197 for ``Certification Process for Designated Medical
Gases.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
[[Page 6646]]
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 or Policy
and Regulations Staff, Center for Veterinary Medicine, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. 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:
With regard to the draft guidance: Ashley Boam, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993-0002, 301-
796-6341, <a href="/cdn-cgi/l/email-protection#3a797e7f68176b4f5b56534e43176a55565359437a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="ffbcbbbaadd2ae8a9e93968b86d2af9093969c86bf999b9ed197978cd1989089">[email protected]</span></a> or Scott Fontana, Center for
Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-0656, <a href="/cdn-cgi/l/email-protection#5d1c2e361e0b101d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="4706342c04110a07212326692f2f3469202831">[email protected]</span></a>.
With regard to the proposed collection of information: Anne Taylor,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-
5683, <a href="/cdn-cgi/l/email-protection#2b7b796a785f4a4d4d6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="643436253710050202240200054a0c0c174a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Certification Process for Designated Medical Gases.'' This
guidance revises and replaces the draft guidance of the same name (80
FR 73771, November 25, 2015) which made recommendations intended to
help persons interested in requesting certification of a DMG under the
process established by the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144). The 2015 draft guidance was
withdrawn on December 18, 2025.
FDASIA added sections 575, 576, and 577 to the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360ddd, 360ddd-1, and 360ddd-2),
which created a certification process for DMGs. Specifically, section
575 of the FD&C Act provides that oxygen, nitrogen, nitrous oxide,
carbon dioxide, helium, medical air, and carbon monoxide are DMGs.
Section 576 of the FD&C Act permits any person to request certification
of a medical gas for certain indications and describes when FDA will
grant or deny these requests.
On June 18, 2024, FDA issued a final rule (89 FR 51738) that
established requirements more specifically tailored to medical gases to
better address the unique characteristics of these drugs. The final
rule was intended to reduce the regulatory burden, as appropriate, for
the medical gas industry. This deregulatory effort addressed several
areas in which either new regulations were needed or existing
regulations required revision because they were not well-suited for
medical gases. One area where new regulations were established was the
certification of DMGs. Regulations that implement and clarify the
certification process for DMGs described in section 576 of the FD&C Act
are set forth in 21 CFR part 230.
FDA is issuing this revised draft guidance to align with the
regulations for certification of DMGs that became effective on December
18, 2025, in accordance with the final rule. Revisions to the guidance
include adding additional sections related to what information must be
submitted, changes to a granted certification, annual reports, and
withdrawal or revocation of approval. We also revised the discussion on
labeling to align with the revised regulations in 21 CFR 201.161 and
made editorial revisions to improve readability. We removed the
attached certification request form; Form FDA 3864 and instructions for
completing the form are now located at <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>.
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
``Certification Process for Designated 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the
[[Page 6647]]
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Cover Letter for Certification Requests; OMB Control Number 0910-0906--
Revision
This information collection helps support implementation of
regulatory requirements that govern certification of DMGs. We have
issued regulations in 21 CFR part 230, Certification and Postmarketing
Reporting for Designated Medical Gases, setting forth applicable
standards and procedures that include associated reporting and
recordkeeping requirements.
We are revising the information collection to support the use of
cover letters in connection with the certification process for
certification requests, amendments, and supplements. As we noted in our
May 23, 2022, proposed rule regarding certification of DMGs (87 FR
31302), we recommend that the applicant include a cover letter
describing the purpose of the certification request submission (e.g.,
original certification, amendment to supply additional information
requested by FDA). The draft guidance for industry entitled
``Certification Process for Designated Medical Gases'' describes the
recommended use of a cover letter when submitting certification
requests. The draft guidance document is available for download at
<a href="https://www.regulations.gov/search?filter=FDA-2012-D-1197">https://www.regulations.gov/search?filter=FDA-2012-D-1197</a>.
All Agency guidance documents are issued in accordance with our
good guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable guidance database
on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that utilizes topic-specific search terms. We
intend to finalize the guidance document upon OMB approval of the
attendant information collection.
The use of cover letters can assist stakeholders in more
efficiently communicating requests for certification, amendments, or
supplements. For example, in accordance with 21 CFR 230.70(a), if the
original information submitted in connection with a certification
request becomes incomplete or inaccurate at any time after the request
has been deemed granted, the applicant must submit a supplement that
includes a new certification request with updated information. As
explained in section VII of the draft guidance, Changes to a Granted
Certification, we recommend that an applicant also submit a cover
letter with a new Form FDA 3864 clearly explaining the purpose of the
submission and highlighting the updated information. We will use the
context and information provided in the cover letters as we process
certification requests.
Description of Respondents: Respondents to this information
collection are entities who manufacture, process, pack, label, or
distribute certain medical gases.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Certification process for designated Number of Total Average
medical gases draft guidance for industry; Number of responses per annual burden per Total
activity respondents respondent responses response hours
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Cover letter for certification request, 9 1 9 1 9
amendment, or supplement..................
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
We base our estimates on the number of certification request,
amendment, and supplement respondents estimated in table 5 of the final
rule entitled ``Current Good Manufacturing Practice, Certification,
Postmarketing Safety Reporting, and Labeling Requirements for Certain
Medical Gases'' published June 18, 2024 (89 FR 51738 at 51764). We
assume all respondents submitting certification requests, amendments,
or supplements will also submit a cover letter. We anticipate that
respondents will be able to leverage information across the
certification request, amendment, or supplement for use in the cover
letter and estimate that it will take a respondent one hour to prepare
and submit a cover letter.
This draft guidance also refers to previously approved FDA
collections of information found in FDA regulations. The collections of
information in 21 CFR part 230 relating to DMG certification
requirements, certification requests using Form FDA 3864, and annual
reporting using Form FDA 5025, as well as the collections of
information in 21 CFR part 213 relating to current good manufacturing
practice requirements for medical gases, including recordkeeping under
21 CFR 213.82 associated with receipt and storage of incoming DMGs,
have been approved under OMB control number 0910-0906. The collections
of information in 21 CFR 201.161 and 201.328 relating to labeling
requirements for medical gas containers have been approved under OMB
control number 0910-0572. The collections of information in 21 CFR part
207 relating to registration of producers of drugs and listing of drugs
in commercial distribution have been approved under OMB control number
0910-0045. The collections of information in 21 CFR part 314 relating
to new drug applications, including hearing procedures under 21 CFR
314.200, have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 514 relating to new animal
drug applications, including hearing procedures under 21 CFR 514.200,
have been approved under OMB control number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-02789 Filed 2-11-26; 8:45 am]
BILLING CODE 4164-01-P
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