Current Good Manufacturing Practice for Medical Gases; Draft Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice for Medical Gases.”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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 28, 2017.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. 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. 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.

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, FDA explained its determination that, although some regulation changes were necessary to implement the medical gas labeling provisions contained in FDASIA, the 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.

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.