Document ID: FDA-2012-D-1197-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Certification of Designated Medical Gases; Availability
Posted Date: 2012-12-18T05:00Z

[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Notices]
[Pages 74852-74854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1197]

Draft Guidance for Industry on Certification of Designated 
Medical Gases; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Certification 
Process for Designated Medical Gases.'' This draft guidance describes 
the new certification process created by the Food and Drug 
Administration Safety and Innovation Act (FDASIA) for certain medical 
gases and explains how FDA plans to implement that process.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 19, 2013. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance and attached Form 3864 by February 19, 2013.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: 

Michael Folkendt, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-1900; or
Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8331.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Certification Process for Designated Medical Gases.'' This 
guidance is intended to help persons or entities interested in 
requesting a certification for a designated medical gas under the new 
approval process for designated medical gases created by FDASIA (Pub. 
L. 112-144, 126 Stat. 993).
    Title XI, subtitle B, of FDASIA added sections 575 and 576 to the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act), which created a 
certification process for designated medical gases. Specifically, 
section 575 provides that oxygen, nitrogen, nitrous oxide, carbon 
dioxide, helium, carbon monoxide, and medical air are designated 
medical gases. Section 576 permits any person, beginning on January 5, 
2013, to request a certification of a medical gas for certain 
indications and describes when FDA will grant or deny these requests.
    This draft guidance explains how FDA plans to implement this new 
certification process. Specifically, the draft guidance describes the 
medical gases that are eligible for certification, who should submit a 
certification request, what information should be submitted, and how 
FDA will evaluate and act on the request. The draft guidance also 
describes how the new certification requirement will be enforced and 
describes FDA's intent to exercise enforcement discretion in certain 
instances.
    FDA has also developed a form to help requestors submit their 
certification requests. FDA recommends that requestors use this form. 
The form

[[Page 74853]]

and an instructions page for use in completing the form are attached to 
this draft guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the Agency's current thinking on the 
certification process for designated medical gases. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if that approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), 
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 collection of information associated with this 
draft guidance, FDA invites 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 
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.
    Title: Request for Certification Process for Designated Medical 
Gas.
    Description of Respondents: Respondents to this collection of 
information are manufacturers and/or marketers of certain medical gas 
drug products.
    Burden Estimate: Under section 576 of the FD&C Act and the draft 
guidance, the following information would be submitted to FDA by a 
person requesting certification of a designated medical gas product: 
The requestor's name, address, and other contact information; the name, 
address, and other contact information of the manufacturing facilities 
involved in the production of the gas; and certain affirmations that 
the gas meets applicable compendial standards and that the product is 
manufactured in accordance with current good manufacturing practice. 
Requestors will make certification requests using FDA Form 3864 and 
will include a cover letter explaining the nature of the submission (as 
explained in the Instructions page to the form). In certain 
circumstances FDA may ask followup questions if additional information 
is needed from the requestor to determine whether a medical gas 
qualifies for certification as a designated medical gas.
    Based on our knowledge of the medical gas marketplace, we estimate 
that a total of approximately 50 requestors (``number of respondents'' 
in table 1) will submit certification requests for designated medical 
gases in 2013. We expect that a small number (we estimate five) of 
these requestors will need to resubmit their certification requests, 
which we also expect to occur in 2013. Thus, for 2013, we estimate 
approximately 55 ``total responses'' in table 1. In 2014 and beyond we 
expect to receive only a small number of submissions. We estimate 5 per 
year, and estimate 1 out of 10 such submissions will require 
resubmission, for a total of 5.5 annualized responses (as reflected in 
table 2). Those submissions would consist of new certification 
requests, resubmissions, and postapproval submissions to provide FDA 
with updated information (e.g., a change of ownership or closure of a 
particular manufacturing facility). In every case the requestor should 
submit a new Form 3864 together with a cover letter explaining the 
nature of the submission. For all submissions, we estimate that 
preparing and submitting the form and cover letter to FDA will take 
approximately 2 hours per requestor (``average burden per response'' in 
the tables in this document). This estimate includes the time that some 
requestors may need to reply to followup questions by FDA.

                                                      Table 1--Estimated 2013 Reporting Burden \1\
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                                                                                         Number of                       Average burden
                                                                        Number of      responses per   Total responses    per response     Total hours
                                                                       respondents       respondent                        (in hours)
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Form FDA 3864 and other requested information......................              50              1.1               55                2              110
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                       Table 2--Estimated Annual Reporting Burden in 2014 and Subsequent Years \1\
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                                                                                         Number of                       Average burden
                                                                        Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
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Form FDA 3864 and other requested information......................               5              1.1              5.5                2               11
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit either written comments regarding 
this document 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

[[Page 74854]]

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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov. Always access an FDA guidance document 
by using FDA's Web site listed in the previous sentence to find the 
most current version of the guidance.

    Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30382 Filed 12-17-12; 8:45 am]
BILLING CODE 4160-01-P