82 FR 54353 - Medical Gas Regulation; Public Workshops; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 221 (November 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54353-54355 | |
| FR Document | 2017-24918 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Pages 54353-54355] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24918] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Medical Gas Regulation; Public Workshops; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshops; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing 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 first public workshop will be held on December 15, 2017, from 9 a.m. to 5 p.m. The second public workshop will be held on February 9, 2018, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the workshops may end early. FDA may announce additional public workshop dates in the future, if needed. Submit either electronic or written comments on these public workshops by March 15, 2018, for Workshop I, and by May 10, 2018, for Workshop II. See the SUPPLEMENTARY INFORMATION section for registration dates and information. ADDRESSES: The public workshops will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 B-C (sections B and C of 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. 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 should be submitted by or before March 15, 2018, for Workshop I, and May 10, 2018, for Workshop II). FDA will have one shared docket for all workshops. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 10, 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 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-2017-N-0001 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 [[Page 54354]] 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: [email protected]. SUPPLEMENTARY INFORMATION: I. Background On May 5, 2017, President Trump signed the Consolidated Appropriations Act, 2017 (Pub. L. 115-31). Section 756 of the Consolidated Appropriations Act, 2017 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 2012 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/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/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, 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 which, 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. If a stakeholder would like a comment to be discussed at a particular public workshop, it should be submitted with a discussion request by no later than 1 week before the date of the workshop. If a stakeholder would like a comment to be included in FDA's consideration of public comments presented and received for a particular workshop, it should be submitted no later than 90 days after the date of the workshop. As noted above, the https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 10, 2018. Late comments will not be considered. During Workshop I (December 2017), FDA intends to discuss the anticipated scope of the medical gas rulemaking, as well as three regulations to which stakeholders have previously requested changes: 21 CFR part 201 (labeling generally and labeling for medical air specifically), 21 CFR part 207 (registration and listing), and 21 CFR parts 210 and 211 (current good manufacturing practice). Depending on the number of speakers and time available, we may also consider comments on additional regulations. During Workshop II (February 2018), FDA intends to discuss 21 CFR part 314 (adverse event reporting) and the intersection of regulations for medical gases and regulations for medical devices and animal drugs. 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. FDA is considering whether to schedule one or more additional public workshops in 2018 to hear from stakeholders regarding any remaining topics. III. Participating in the Public Workshops Registration: The workshops are 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. If you need special accommodations because of a disability, please contact [email protected] (or see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of each workshop. 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 [email protected] (see FOR FURTHER INFORMATION CONTACT) by December 8, 2017, for Workshop I, or February 2, 2018, for Workshop II. 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 [[Page 54355]] 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. An agenda will be made available at least 3 days before each 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 each workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm. Streaming Webcast and Video of the Public Workshops: These public workshops will be webcast; the URL will be posted at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm at least 1 day before each workshop. A video record of the public workshops will be available at the same Web site address for 1 year. Dated: November 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-24918 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54353
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Type of interview responses per Total hours
respondents responses per response
respondent
Usability Testing Screener ................................. 2,028 1 2,028 0.083 (5 minutes) ........ 168
Total ............................................................ .......................... .......................... ........................ ..................................... 10,622
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be Submit either electronic or written confidential information that you or a
included in each new pretest may vary, comments on these public workshops third party may not wish to be posted,
depending on the nature of the material by March 15, 2018, for Workshop I, and such as medical information, your or
or message being tested and the target by May 10, 2018, for Workshop II. See anyone else’s Social Security number, or
audience. Table 1 provides examples of the SUPPLEMENTARY INFORMATION section confidential business information, such
the types of studies that may be for registration dates and information. as a manufacturing process. Please note
administered and estimated burden ADDRESSES: The public workshops will that if you include your name, contact
levels during the 3-year period. Time to be held at FDA’s White Oak Campus, information, or other information that
read, view, or listen to the message 10903 New Hampshire Ave., Bldg. 31 identifies you in the body of your
being tested is built into the ‘‘Hours per Conference Center, Rm. 1503 B–C comments, that information will be
Response’’ figures. (sections B and C of the ‘‘Great Room’’), posted on https://www.regulations.gov.
The burden for this collection has Silver Spring, MD 20993–0002. • If you want to submit a comment
decreased by 18,437 hours from 29,059 Entrance for public workshop with confidential information that you
to 10,622. FDA attributes this decrease participants (non-FDA employees) is do not wish to be made available to the
to assessing the planned studies for the through Building 1 where routine public, submit the comment as a
next 3 years. security-check procedures will be written/paper submission and in the
performed. For parking and security manner detailed (see ‘‘Written/Paper
Dated: November 9, 2017.
information, please refer to https:// Submissions’’ and ‘‘Instructions’’).
Anna K. Abram,
Deputy Commissioner for Policy, Planning, www.fda.gov/AboutFDA/ Written/Paper Submissions
Legislation, and Analysis. WorkingatFDA/BuildingsandFacilities/ Submit written/paper submissions as
[FR Doc. 2017–24924 Filed 11–16–17; 8:45 am] WhiteOakCampusInformation/ follows:
BILLING CODE 4164–01–P
ucm241740.htm. • Mail/Hand delivery/Courier (for
You may submit comments as written/paper submissions): Dockets
follows. Please note that late, untimely Management Staff (HFA–305), Food and
DEPARTMENT OF HEALTH AND filed comments may not be considered. Drug Administration, 5630 Fishers
HUMAN SERVICES For timely consideration, we request Lane, Rm. 1061, Rockville, MD 20852.
that electronic comments on workshop • For written/paper comments
Food and Drug Administration topics be submitted before or within 90 submitted to the Dockets Management
days after each workshop (i.e., Staff, FDA will post your comment, as
[Docket No. FDA–2017–N–0001]
comments should be submitted by or well as any attachments, except for
Medical Gas Regulation; Public before March 15, 2018, for Workshop I, information submitted, marked and
Workshops; Request for Comments and May 10, 2018, for Workshop II). identified, as confidential, if submitted
FDA will have one shared docket for all as detailed in ‘‘Instructions.’’
AGENCY: Food and Drug Administration, workshops. The https:// Instructions: All submissions received
HHS. www.regulations.gov electronic filing must include the Docket No. FDA–
ACTION: Notice of public workshops; system will accept comments until 2017–N–0001 for ‘‘Medical Gas
request for comments. midnight Eastern Time at the end of Regulation.’’ Received comments, those
May 10, 2018. Comments received by filed in a timely manner (see
SUMMARY: The Food and Drug mail/hand delivery/courier (for written/ ADDRESSES), will be placed in the docket
Administration (FDA, the Agency, or paper submissions) will be considered and, except for those submitted as
we) is announcing two public timely if they are postmarked or the ‘‘Confidential Submissions,’’ publicly
workshops entitled ‘‘Medical Gas delivery service acceptance receipt is on viewable at https://www.regulations.gov
Regulation: Workshop I’’ and ‘‘Medical or before the relevant date. or at the Dockets Management Staff
Gas Regulation: Workshop II.’’ The topic between 9 a.m. and 4 p.m., Monday
to be discussed is potential areas of Electronic Submissions
through Friday.
Federal drug regulation that should be Submit electronic comments in the • Confidential Submissions—To
revised with respect to medical gases. following way: submit a comment with confidential
DATES: The first public workshop will • Federal eRulemaking Portal: information that you do not wish to be
be held on December 15, 2017, from 9 https://www.regulations.gov. Follow the made publicly available, submit your
a.m. to 5 p.m. The second public instructions for submitting comments.
sradovich on DSK3GMQ082PROD with NOTICES
comments only as a written/paper
workshop will be held on February 9, Comments submitted electronically, submission. You should submit two
2018, from 9 a.m. to 5 p.m. However, including attachments, to https:// copies total. One copy will include the
depending on the level of public www.regulations.gov will be posted to information you claim to be confidential
participation, the workshops may end the docket unchanged. Because your with a heading or cover note that states
early. FDA may announce additional comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
public workshop dates in the future, if solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
needed. comment does not include any Agency will review this copy, including
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![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54355
scheduled presentation times. Persons information upon which it has based its identified, as confidential, if submitted
registered to speak should check in conclusion that a dietary supplement as detailed in ‘‘Instructions.’’
before the workshops and are containing the new dietary ingredient Instructions: All submissions received
encouraged to arrive early to ensure will reasonably be expected to be safe. must include the Docket No. FDA–
their designated order of presentation. DATES: Submit either electronic or 2013–N–0878 for ‘‘Premarket
Participants who are not present when written comments on the collection of Notification for a New Dietary
called may not be permitted to speak at information by January 16, 2018. Ingredient.’’ Received comments, those
a later time. An agenda will be made ADDRESSES: You may submit comments filed in a timely manner (see
available at least 3 days before each as follows. Please note that late, ADDRESSES), will be placed in the docket
workshop at https://www.fda.gov/ untimely filed comments will not be and, except for those submitted as
Drugs/NewsEvents/ucm582091.htm. considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly
FDA may also post specific questions be submitted on or before January 16, viewable at https://www.regulations.gov
for consideration at the meeting Web 2018. The https://www.regulations.gov or at the Dockets Management Staff
page; these will be made available at electronic filing system will accept between 9 a.m. and 4 p.m., Monday
least 3 days before each workshop at comments until midnight Eastern Time through Friday.
https://www.fda.gov/Drugs/NewsEvents/ at the end of January 16, 2018. • Confidential Submissions—To
ucm582091.htm. Comments received by mail/hand submit a comment with confidential
Streaming Webcast and Video of the delivery/courier (for written/paper information that you do not wish to be
Public Workshops: These public submissions) will be considered timely made publicly available, submit your
workshops will be webcast; the URL if they are postmarked or the delivery comments only as a written/paper
will be posted at https://www.fda.gov/ service acceptance receipt is on or submission. You should submit two
Drugs/NewsEvents/ucm582091.htm at before that date. copies total. One copy will include the
least 1 day before each workshop. A
Electronic Submissions information you claim to be confidential
video record of the public workshops
with a heading or cover note that states
will be available at the same Web site Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
address for 1 year. following way: CONFIDENTIAL INFORMATION.’’ The
Dated: November 13, 2017. • Federal eRulemaking Portal: Agency will review this copy, including
Leslie Kux, https://www.regulations.gov. Follow the the claimed confidential information, in
Associate Commissioner for Policy. instructions for submitting comments. its consideration of comments. The
[FR Doc. 2017–24918 Filed 11–16–17; 8:45 am] Comments submitted electronically, second copy, which will have the
BILLING CODE 4164–01–P
including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on
DEPARTMENT OF HEALTH AND comment will be made public, you are https://www.regulations.gov. Submit
HUMAN SERVICES solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
Food and Drug Administration confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
[Docket No. FDA–2013–N–0878]
such as medical information, your or information on the cover sheet and not
Agency Information Collection anyone else’s Social Security number, or in the body of your comments and you
Activities; Proposed Collection; confidential business information, such must identify this information as
Comment Request; Premarket as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Notification for a New Dietary that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Ingredient information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
AGENCY: Food and Drug Administration, comments, that information will be more information about FDA’s posting
HHS. posted on https://www.regulations.gov. of comments to public dockets, see 80
ACTION: Notice. • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
SUMMARY: The Food and Drug do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
Administration (FDA or Agency) is public, submit the comment as a 23389.pdf.
announcing an opportunity for public written/paper submission and in the Docket: For access to the docket to
comment on the proposed collection of manner detailed (see ‘‘Written/Paper read background documents or the
certain information by the Agency. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Under the Paperwork Reduction Act of
Written/Paper Submissions received, go to https://
1995 (PRA), Federal Agencies are
www.regulations.gov and insert the
required to publish notice in the Submit written/paper submissions as
docket number, found in brackets in the
Federal Register concerning each follows:
heading of this document, into the
proposed collection of information, • Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts
including each proposed extension of an written/paper submissions): Dockets
and/or go to the Dockets Management
existing collection of information, and Management Staff (HFA–305), Food and
sradovich on DSK3GMQ082PROD with NOTICES
Staff, 5630 Fishers Lane, Rm. 1061,
to allow 60 days for public comment in Drug Administration, 5630 Fishers
Rockville, MD 20852.
response to the notice. This notice Lane, Rm. 1061, Rockville, MD 20852.
solicits comments on the procedure by • For written/paper comments FOR FURTHER INFORMATION CONTACT: Ila
which a manufacturer or distributor of submitted to the Dockets Management Mizrachi, Office of Operations, Food
a new dietary ingredient or of a dietary Staff, FDA will post your comment, as and Drug Administration, Three White
supplement containing a new dietary well as any attachments, except for Flint North, 10A–12M, 11601
ingredient is to submit to FDA information submitted, marked and Landsdown St., North Bethesda, MD
VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1](https://thefederalregister.org/doc/82_FR_54574/page/3.svg)
Document Created: 2017-11-17 05:14:56
Document Modified: 2017-11-17 05:14:56
| 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 | Notices | |
| Action | Notice of public workshops; request for comments. | |
| Dates | The first public workshop will be held on December 15, 2017, from 9 a.m. to 5 p.m. The second public workshop will be held on February 9, 2018, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the workshops may end early. FDA may announce additional public workshop dates in the future, if needed. | |
| 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 | 82 FR 54353 |
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