83 FR 13440 - Medical Gas Regulation; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 61 (March 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 61 (March 29, 2018)
| Page Range | 13440-13442 | |
| FR Document | 2018-06251 |
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)] [Proposed Rules] [Pages 13440-13442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06251] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2018-N-1214] Medical Gas Regulation; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments; public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing an additional public workshop on medical gas regulation entitled ``Medical Gas Regulation: Workshop III.'' FDA has previously held two public workshops entitled ``Medical Gas Regulation: Workshop I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases. DATES: The public workshop will be held on May 11, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by August 9, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the ``Great Room''), Silver Spring, MD 20993-0002. Entrance for public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The workshop is free and seating will be on a first- come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register. You may submit comments as follows. Please note that late, untimely filed comments may not be considered. For timely consideration, we request that electronic comments on workshop topics be submitted before or within 90 days after each workshop (i.e., comments submitted by or before March 15, 2018, for Workshop I; May 10, 2018, for Workshop II; and August 9, 2018, for Workshop III). FDA has one shared docket for all workshops. However, with this notice, the docket number will change from FDA-2017-N-0001 to FDA-2018-N-1214. All comments submitted on the previous docket number will be transferred to the new docket number. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 9, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before the relevant date. 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 [[Page 13441]] 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-2018-N-1214 for ``Medical Gas Regulation.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.thefederalregister.org/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. FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2465, Fax: 301- 847-8440, email: MedgasPublicWorkshops@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On May 5, 2017, President Trump signed the Consolidated Appropriations Act of 2017 (Pub. L. 115-31). Section 756 of the Consolidated Appropriations Act requires FDA to issue final regulations revising Federal drug regulations with respect to medical gases. These public workshops are being held as part of FDA's implementation of the requirements of section 756. Since the enactment of the Food and Drug Administration Safety and Innovation Act (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; November 18, 2016). Other activities include FDA's June 2017 revised draft guidance for industry on current good manufacturing practice for medical gases,\1\ updated guidance for FDA inspectors regarding medical gases (March 2015),\2\ an extensive review of Federal drug regulations related to medical gases from 2012 to 2014 (a report on the review was submitted to Congress in 2015),\3\ and implementation of FDASIA's requirements regarding certification of medical gases (to date, over 70 certifications have been granted). --------------------------------------------------------------------------- \1\ Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070270.pdf. \2\ Available at: https://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125417.pdf. \3\ Available at: https://www.fda.gov/downloads/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm453727.pdf. --------------------------------------------------------------------------- FDA intends to engage in additional rulemaking in this area in accordance with section 756 of the Consolidated Appropriations Act of 2017. To conduct rulemaking as efficiently as possible, FDA intends to build on the information and stakeholder input received since FDASIA's enactment. As noted in more detail below, FDA invites comments from stakeholders on specific medical gas issues that could or should be addressed in regulation. II. Topics for Discussion at the Public Workshops 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 that, in their view, should be addressed by regulation change (rather than through other means, such as revisions to guidance or inspection practices). Commenters should include concrete and specific reasons that rulemaking is preferable to other options. Commenters' views regarding the prioritization of particular rulemaking proposals would also be helpful. As noted above, the https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 9, 2018. Late comments may not be considered. During Workshop I (December 2017), FDA and workshop participants discussed the anticipated scope of the medical gas rulemaking, as well as three regulations to which stakeholders have previously requested changes: Part 201 (21 CFR part 201) (labeling generally and labeling for medical air specifically), part 207 (21 CFR part 207) (registration and listing), and parts 210 and 211 (21 CFR parts 210 and 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. During Workshop II (February 2018), FDA and workshop participants discussed parts 310, 314, and 514 (21 CFR parts 310, 314, and 514) (postmarket reporting of adverse drug experiences, including adverse reactions and medication errors) and the intersection of regulations for medical gases and regulations for medical devices and animal drugs. A stakeholder [[Page 13442]] 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. The Agency has determined that we will hold a third workshop to hear additional comments from stakeholders regarding the issues discussed at Workshops I and II, as well as any additional topics related to medical gas regulation that stakeholders may wish to discuss, as time allows. This workshop is primarily intended to build on the discussion from the previous workshops, as well as written comments submitted to the docket. During Workshop III (May 11, 2018), 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. III. Participating in the Public Workshop 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 MedgasPublicWorkshops@fda.hhs.gov (see FOR FURTHER INFORMATION CONTACT) by May 4, 2018, for Workshop III. 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 workshop 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. An agenda will be made available at least 3 days before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm. FDA may also post specific questions for consideration at the meeting web page; these will be made available at least 3 days before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm. Streaming Webcast of the Public Workshops: This public workshop will be webcast; the URL will be posted at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm at least 1 day before the workshop. A video record of the public workshops will be available at the same website address for 1 year. If you need special accommodations because of a disability, please contact MedgasPublicWorkshops@fda.hhs.gov (or see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the workshop. Dated: March 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06251 Filed 3-28-18; 8:45 am] BILLING CODE 4164-01-P
![13440 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Proposed Rules
entities under the criteria of the Paragraph 6005 Class E Airspace Areas Room’’), Silver Spring, MD 20993–0002.
Regulatory Flexibility Act. Extending Upward From 700 Feet or More Entrance for public workshop
Above the Surface of the Earth. participants (non-FDA employees) is
Environmental Review * * * * * through Building 1 where routine
This proposal will be subject to an ACE NE E5 Columbus, NE [Amended] security check procedures will be
environmental analysis in accordance performed. For parking and security
Columbus Municipal Airport, NE
with FAA Order 1050.1F, information, please refer to https://
(Lat. 41°26′55″ N, long. 97°20′34″ W)
‘‘Environmental Impacts: Policies and Columbus VOR/DME www.fda.gov/AboutFDA/
Procedures’’ prior to any FAA final (Lat. 41°27′00″ N, long. 97°20′27″ W) WorkingatFDA/BuildingsandFacilities/
regulatory action. That airspace extending upward from 700 WhiteOakCampusInformation/
feet above the surface within a 6.7-mile ucm241740.htm. The workshop is free
List of Subjects in 14 CFR Part 71 and seating will be on a first-come, first-
radius of Columbus Municipal Airport and
Airspace, Incorporation by reference, within 2.4 miles each side of the Columbus served basis. Attendees who do not
Navigation (air). VOR/DME 150° radial extending from the wish to make an oral presentation do
6.7-mile radius to 7.0 miles southeast of the not need to register.
The Proposed Amendment airport and within 2.4 miles each side of the You may submit comments as
Columbus VOR/DME 309°radial extending follows. Please note that late, untimely
Accordingly, pursuant to the from the 6.7-mile radius to 7.7 miles filed comments may not be considered.
authority delegated to me, the Federal northwest of the airport. For timely consideration, we request
Aviation Administration proposes to Issued in Fort Worth, Texas, on March 21, that electronic comments on workshop
amend 14 CFR part 71 as follows: 2018. topics be submitted before or within 90
Christopher L. Southerland, days after each workshop (i.e.,
PART 71—DESIGNATION OF CLASS A,
Acting Manager, Operations Support Group, comments submitted by or before March
B, C, D, AND E AIRSPACE AREAS; AIR
ATO Central Service Center. 15, 2018, for Workshop I; May 10, 2018,
TRAFFIC SERVICE ROUTES; AND
[FR Doc. 2018–06246 Filed 3–28–18; 8:45 am] for Workshop II; and August 9, 2018, for
REPORTING POINTS
BILLING CODE 4910–13–P Workshop III). FDA has one shared
docket for all workshops. However, with
■ 1. The authority citation for 14 CFR this notice, the docket number will
part 71 continues to read as follows: change from FDA–2017–N–0001 to
Authority: 49 U.S.C. 106(f), 106(g); 40103,
DEPARTMENT OF HEALTH AND
FDA–2018–N–1214. All comments
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, HUMAN SERVICES
submitted on the previous docket
1959–1963 Comp., p. 389. number will be transferred to the new
Food and Drug Administration
§ 71.1 [Amended] docket number. The https://
21 CFR Chapter I www.regulations.gov electronic filing
■ 2. The incorporation by reference in system will accept comments until
14 CFR 71.1 of FAA Order 7400.11B, [Docket No. FDA–2018–N–1214] midnight Eastern Time at the end of
Airspace Designations and Reporting August 9, 2018. Comments received by
Points, dated August 3, 2017, and Medical Gas Regulation; Public mail/hand delivery/courier (for written/
effective September 15, 2017, is Workshop; Request for Comments paper submissions) will be considered
amended as follows: timely if they are postmarked or the
AGENCY: Food and Drug Administration,
HHS. delivery service acceptance receipt is on
or before the relevant date.
Paragraph 6002 Class E Airspace Areas ACTION:Request for comments; public
Designated as Surface Areas. workshop. Electronic Submissions
* * * * * Submit electronic comments in the
SUMMARY: The Food and Drug
ACE NE E2 Columbus, NE [Amended] Administration (FDA, the Agency, or following way:
• Federal eRulemaking Portal:
Columbus Municipal Airport, NE we) is announcing an additional public
https://www.regulations.gov. Follow the
(Lat. 41°26′55″ N, long. 97°20′34″ W) workshop on medical gas regulation
instructions for submitting comments.
Within a 4.7 mile radius of Columbus entitled ‘‘Medical Gas Regulation:
Comments submitted electronically,
Municipal Airport. Workshop III.’’ FDA has previously held
Paragraph 6004. Class E Airspace Areas
including attachments, to https://
two public workshops entitled ‘‘Medical
Designated as an Extension to a Class D or www.regulations.gov will be posted to
Gas Regulation: Workshop I’’ and
Class E Surface Area. the docket unchanged. Because your
‘‘Medical Gas Regulation: Workshop II.’’
* * * * * comment will be made public, you are
The topic to be discussed is potential
solely responsible for ensuring that your
ACE MO E4 Columbus, NE [New] areas of Federal drug regulation that
comment does not include any
should be revised with respect to
Columbus Municipal Airport, NE confidential information that you or a
(Lat. 41°26′55″ N, long. 97°20′34″ W)
medical gases.
third party may not wish to be posted,
Columbus VOR/DME DATES: The public workshop will be such as medical information, your or
(Lat. 41°27′00″ N, long. 97°20′27″ W) held on May 11, 2018, from 9 a.m. to 5 anyone else’s Social Security number, or
That airspace extending upward from the p.m. Submit either electronic or written confidential business information, such
rmajette on DSKBCKNHB2PROD with PROPOSALS
surface within 2.4 miles each side of the comments on this public workshop by as a manufacturing process. Please note
Columbus VOR/DME 150° radial extending August 9, 2018. See the SUPPLEMENTARY that if you include your name, contact
from the 4.2-mile radius of Columbus INFORMATION section for registration date
Municipal Airport to 7.0 miles southeast of
information, or other information that
and information. identifies you in the body of your
the airport, and within 2.4 miles each side of
the Columbus VOR/DME 309° radial ADDRESSES: The public workshop will comments, that information will be
extending from the 4.2-mile radius of be held at FDA’s White Oak Campus, posted on https://www.regulations.gov.
Columbus Municipal Airport to 7.7 miles 10903 New Hampshire Ave., Bldg. 31 • If you want to submit a comment
northwest of the airport. Conference Center, Rm. 1503 (the ‘‘Great with confidential information that you
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![13442 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Proposed Rules
presentation also addressed, among you represent (e.g., industry, consumer that ‘‘bump fire’’ stocks, slide-fire
other things, followup information organization) and a brief summary of devices, and devices with certain
related to Workshop I topics, including your remarks (including the discussion similar characteristics (bump-stock-type
part 207 (registration and listing) and topic(s) that you would like to address). devices) are ‘‘machineguns’’ as defined
parts 210 and 211 (current good FDA will try to accommodate all by the National Firearms Act of 1934
manufacturing practice), including the persons who wish to make a (NFA) and the Gun Control Act of 1968
possibility of one or more separate CFR presentation; however, the duration of (GCA), because such devices allow a
sections for designated medical gases, as each speaker’s presentation may be shooter of a semiautomatic firearm to
well as additional topics including the limited by time constraints. FDA will initiate a continuous firing cycle with a
certification process for designated notify registered presenters of their single pull of the trigger. Specifically,
medical gases and issues related to the scheduled presentation times. Persons these devices convert an otherwise
filling of oxygen containers by registered to speak should check in semiautomatic firearm into a
emergency medical service (EMS) before the workshop and are encouraged machinegun by functioning as a self-
providers and health care facilities. FDA to arrive early to ensure their designated acting or self-regulating mechanism that
also heard comments on additional order of presentation. Participants who harnesses the recoil energy of the
regulations and medical gas issues as are not present when called may not be semiautomatic firearm in a manner that
time allowed. permitted to speak at a later time. An allows the trigger to reset and continue
The Agency has determined that we agenda will be made available at least 3 firing without additional physical
will hold a third workshop to hear days before the workshop at https:// manipulation of the trigger by the
additional comments from stakeholders www.fda.gov/Drugs/NewsEvents/ shooter. Hence, a semiautomatic firearm
regarding the issues discussed at ucm582091.htm. FDA may also post to which a bump-stock-type device is
Workshops I and II, as well as any specific questions for consideration at attached is able to produce automatic
additional topics related to medical gas the meeting web page; these will be fire with a single pull of the trigger.
regulation that stakeholders may wish to made available at least 3 days before the With limited exceptions, primarily as to
discuss, as time allows. This workshop workshop at https://www.fda.gov/ government agencies, the GCA makes it
is primarily intended to build on the Drugs/NewsEvents/ucm582091.htm. unlawful for any person to transfer or
discussion from the previous Streaming Webcast of the Public possess a machinegun unless it was
workshops, as well as written comments Workshops: This public workshop will lawfully possessed prior to the effective
submitted to the docket. be webcast; the URL will be posted at date of the statute. The bump-stock-type
During Workshop III (May 11, 2018), https://www.fda.gov/Drugs/NewsEvents/ devices covered by this proposed rule
FDA intends to provide designated ucm582091.htm at least 1 day before the were not in existence prior to the GCA’s
panel time for followup discussion of workshop. A video record of the public effective date, and therefore would fall
several topics raised at previous workshops will be available at the same within the prohibition on machineguns
workshops, and for an open panel to website address for 1 year. If you need if this Notice of Proposed Rulemaking
discuss any additional issues related to special accommodations because of a (NPRM) is implemented. Consequently,
medical gas regulation that are of disability, please contact current possessors of these devices
interest to FDA or other workshop MedgasPublicWorkshops@fda.hhs.gov would be required to surrender them,
participants. The topics for designated (or see FOR FURTHER INFORMATION destroy them, or otherwise render them
panel time include further consideration CONTACT) at least 7 days in advance of permanently inoperable upon the
of potential changes to: Part 201 the workshop. effective date of the final rule.
(labeling); parts 210 and 211 (current
good manufacturing practice); part 207 Dated: March 21, 2018. DATES: Written comments must be
(registration and listing); and parts 310, Leslie Kux, postmarked and electronic comments
314, and 514 (postmarket reporting of Associate Commissioner for Policy. must be submitted on or before June 27,
adverse drug experiences, including [FR Doc. 2018–06251 Filed 3–28–18; 8:45 am] 2018. Commenters should be aware that
adverse reactions and medication BILLING CODE 4164–01–P
the electronic Federal Docket
errors); including the possibility of one Management System will not accept
or more separate CFR sections for comments after midnight Eastern
designated medical gases. Potential DEPARTMENT OF JUSTICE Daylight Time on the last day of the
topics for open panel time include, but comment period.
are not limited to: The certification Bureau of Alcohol, Tobacco, Firearms, ADDRESSES: You may submit comments,
process for designated medical gases; and Explosives identified by docket number ATF
issues related to the filling of oxygen 2017R–22, by any of the following
containers by EMS providers and health 27 CFR Parts 447, 478, and 479 methods:
care facilities; or other topics of interest • Federal eRulemaking Portal: http://
[Docket No. 2017R–22; AG Order No. 4132–
to stakeholders. 2018] www.regulations.gov. Follow the
directions for submitting comments.
III. Participating in the Public RIN 1140–AA52 • Fax: (202) 648–9741.
Workshop • Mail: Vivian Chu, Mailstop 6N–518,
Registration and Requests for Oral Bump-Stock-Type Devices Office of Regulatory Affairs,
Presentations: If you wish to a make an AGENCY: Bureau of Alcohol, Tobacco, Enforcement Programs and Services,
rmajette on DSKBCKNHB2PROD with PROPOSALS
oral presentation, you must register by Firearms, and Explosives (ATF), Bureau of Alcohol, Tobacco, Firearms,
submitting your name, title, firm name, Department of Justice. and Explosives, 99 New York Ave. NE,
address, telephone, email address, and ACTION: Notice of proposed rulemaking. Washington DC 20226. ATTN: 2017R–
Fax number to 22.
MedgasPublicWorkshops@fda.hhs.gov SUMMARY: The Department of Justice Instructions: All submissions received
(see FOR FURTHER INFORMATION CONTACT) (Department) proposes to amend the must include the agency name and
by May 4, 2018, for Workshop III. Please Bureau of Alcohol, Tobacco, Firearms, docket number for this notice of
also indicate the type of organization and Explosives regulations to clarify proposed rulemaking. All properly
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Document Created: 2018-03-29 00:25:27
Document Modified: 2018-03-29 00:25:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Request for comments; public workshop. | |
| Dates | The public workshop will be held on May 11, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by August 9, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Christine Kirk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2465, Fax: 301- 847-8440, email: [email protected] | |
| FR Citation | 83 FR 13440 |
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