Medical Gas Regulation Public Workshops

REMINDER: The public comment period for comments related to the third public workshop on medical gas regulation will close on August 9, 2018. Please submit comments by no later than August 9, 2018. Please follow the instructions in the Federal Register notice (83 FR 13440; March 29, 2018), accessible at https://www.federalregister.gov/documents/2018/03/29/2018-06251/medical-gas-regulation-public-workshop-request-for-comments . The docket number is FDA-2018-N-1214; accessible at www.regulations.gov .

Meeting Information:

Workshop I

Date:December 15, 2017,

Check-in/Registration: 8:15 a.m.

Time: 9:00 a.m. - 5:00 p.m.

Location: FDA’s White Oak campus
10903 New Hampshire Ave,
Building 31, Conference Center, The Great Room (Room 1503), Sections B-C
Silver Spring, MD 20903-0002.

Agenda : Agenda for December 15 Medical Gas Regulation Public Workshop

Stakeholders are invited to provide their thoughts on the attached questions during the workshop or via written comments submitted to the docket within 90 days after the workshop. For instructions on submitting comments, please see the Federal Register notice announcing the medical gas public workshops (82 FR 54353, Nov. 17, 2017)
FDA Questions for Consideration by Stakeholders

Workshop II

Date:February 9, 2018

Check-in/Registration: 8:15 a.m.

Time: 9:00 a.m. - 5:00 p.m.

Location: FDA’s White Oak campus
10903 New Hampshire Ave,
Building 31, Conference Center, The Great Room (Room 1503)
Silver Spring, MD 20903-0002.

Federal Register Notice : https://www.gpo.gov/fdsys/pkg/FR-2017-11-17/pdf/2017-24918.pdf

Agenda: Agenda for February 9, 2018 Medical Gas Regulation Public Workshop (updated 2/7/18)

Workshop III

Date: May 11, 2018

Check-in/Registration: 8:15 a.m.

Time: 9:00 a.m. - 5:00 p.m.

Location: FDA’s White Oak campus 10903 New Hampshire Ave, Building 31, Conference Center, The Great Room (Room 1503) Silver Spring, MD 20903-0002.

Federal Register Notice: https://www.federalregister.gov/documents/2018/03/29/2018-06251/medical-gas-regulation-public-workshop-request-for-comments

Docket Number Change: Please note that there is a new docket number beginning with this workshop announcement (FDA-2018-N-1214 rather than FDA-2017-N-0001).

Agenda: Final Agenda May 11, 2018

Questions for Stakeholder Consideration: No additional questions for this public workshop. Please see the Federal Register notice for topics of discussion.

Webcast Information: https://collaboration.fda.gov/mgrpw2018/

Background:

The U.S. Food and Drug Administration (FDA) has announced three public workshops on medical gas regulation as part of its implementation of section 756 of the Consolidated Appropriations Act of 2017 (Pub. L. 115-31).

Since the enactment of the Food and Drug Administration Safety and Innovation Act of 2012 (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; Nov. 16, 2016). Other activities include FDA’s June 2017 revised draft guidance for industry on current good manufacturing practice for medical gases; updated guidance for FDA inspectors regarding medical gases (March 2015); an extensive review of federal drug regulations related to medical gases from 2012 to 2014, including public comment and other stakeholder outreach (a report on the review was submitted to Congress in 2015); and implementation of FDASIA’s requirements regarding certification of medical gases (to date, over 70 certification requests have been granted).

In addition to the actions FDA has taken to date, FDA intends to engage in additional rulemaking in this area in accordance with section 756. To conduct rulemaking as efficiently as possible, FDA intends to build on the information and stakeholder input received since FDASIA’s enactment.

These public workshops are part of FDA’s ongoing outreach to stakeholders regarding medical gas regulation.

Goals and Objectives:

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 which, in their view, should be addressed by regulation change (rather than through other means, such as revisions to guidance or inspection practices). We are also interested in identifying remaining areas of industry or public confusion or concern.

FDA has addressed, or anticipates addressing the following issues at three public workshops:

Workshop I (December 15, 2017): During Workshop I, FDA and workshop participants discussed the anticipated scope of the medical gas rulemaking, as well as three regulation areas for which stakeholders have previously requested changes: 21 CFR 201 (labeling generally and labeling for medical air specifically), 21 CFR 207 (registration and listing), and 21 CFR 210-211 (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.
Workshop II (February 9, 2018): During Workshop II, FDA and workshop participants discussed 21 CFR parts 310, 314, and 514 (postmarket reporting of adverse drug experiences) and the intersection of regulations for medical gases and regulations for medical devices and animal drugs. A stakeholder 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.
Workshop III (May 11, 2018): During Workshop III, 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. Depending on the number of speakers and time available, we may also consider comments on additional regulations and medical gas issues not currently addressed in regulation.

Meeting Agendas

The agenda for each workshop will be posted by three days before that workshop.

Oral Presentations and Submission of Comments:

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 the contact person designated below by or before Friday, December 8, 2017. 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 workshops 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.

Submission of Written Comments: To submit written comments before or after the workshops, see the Federal Register notice (link above) for instructions regarding how to submit comments. The docket will be open for 90 days after each workshop, and will close 90 days after Workshop II.

Registration:

To register ahead of time to attend this public workshop either in-person or via webcast, please register by sending an e-mail to MedgasPublicWorkshops@fda.hhs.gov or contacting the designated contact person listed below.

Walk-in registration and attendance on the day of the event is also available, but walk-in participants may not be able to present due to time constraints (see information above regarding oral presentations).

Contact:
For any questions regarding the Medical Gas Regulation public workshops please contact: Christine Kirk via MedgasPublicWorkshops@fda.hhs.gov or 301-796-2465.

Parking Information:

Please see the Visitor Parking Map link below.
https://www.fda.gov/downloads/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/UCM242277.pdf

There is limited visitor parking available on the White Oak Campus. Public transit, taxi, and carpooling are highly encouraged. All visitors parking on campus are required to go through vehicle screening and to park in Northwest Surface Lot 1, 3, or 4.

Shuttle service is provided from the shuttle shelters located on Northwest Loop Road, near the visitor parking lot exit, to Building 1 for access to the CSU Building 2 Conference Center and Building 31 Great Room.

If driving to the White Oak campus, please allow for approximately 30 minutes to park and bring identification for vehicle screening.

Check-In Instructions:

For Great Room public meetings, please enter through the main entrance of Building 1. Brief security screenings are required for entry to the FDA White Oak campus. Visitors will then proceed to Building 31 from Building 1.

Meeting Materials Workshop I

Speaker Materials Presented at December Public Workshop

Slides presented by Michael Tiller, President and CEO, Compressed Gas Association (CGA)
- 21 CFR PROPOSED CHANGES CGA - GAWDA
Other materials presented are available in the public comment docket. Please see Docket No. FDA-2018-N-1214, accessible at www.regulations.gov. The proposed changes referenced during the stakeholder presentation are found in the attachments to Comment No. FDA-2018-N-1214-0005, submitted as a joint comment from CGA and the Gases and Welding Distributors Association GAWDA).

Webcast Recordings from the December Public Workshop:

Part 1: https://collaboration.fda.gov/p3okrea0rtz/

Part 2: https://collaboration.fda.gov/p89rcuab7ze/

Part 3: https://collaboration.fda.gov/p936iijdlmn/

Part 4: https://collaboration.fda.gov/p190t5vj2j1/

Meeting Materials Workshop II February 2018

Webcast Recordings from the February Public Workshop:

Part 1: https://collaboration.fda.gov/p1feifmxx81/
Part 2: https://collaboration.fda.gov/p7gc7cpme50/
Part 3: https://collaboration.fda.gov/p2usuij8vci/
Part 4: https://collaboration.fda.gov/p34de566bv8/

Meeting Materials Workshop III May 2018

Webcast Recordings from the May Public Workshop:

Part 1: https://collaboration.fda.gov/p7n2o5akhba/
Part 2: https://collaboration.fda.gov/p5150tspwde/
Part 3: https://collaboration.fda.gov/p8nl1oz9qn3/
Part 4: https://collaboration.fda.gov/p8rhf0va3ye/

Speaker Materials Presented at February Public Workshop

Slides presented by Michael Tiller, President and CEO, Compressed Gas Association (CGA)
Note: Other materials presented by Mr. Tiller may be added at a later date.