[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Notices]
[Pages 35896-35897]
[FR Doc No: 2011-15141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0447]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Dispute Resolution:
Scientific and Technical Issues Related to Pharmaceutical Current Good
Manufacturing Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information resulting from the guidance to manufacturers of veterinary
and human drugs, including human biological drug products, on how to
resolve disputes of scientific and technical issues relating to current
good manufacturing practice (CGMP).

DATES: Submit either electronic or written comments on the collection
of information by August 19, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, including
each proposed extension of an existing 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 following collection of information, FDA
invites comment 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.

Guidance for Industry on Formal Dispute Resolution: Scientific and
Technical Issues Related to Pharmaceutical Current Good Manufacturing
Practice--(OMB Control Number 0910-0563)--Extension

    The guidance is intended to provide information to manufacturers of
veterinary and human drugs, including human biological drug products,
on how to resolve disputes of scientific and technical issues relating
to CGMP. Disputes related to scientific and technical issues may arise
during FDA inspections of pharmaceutical manufacturers to determine
compliance with CGMP requirements or during FDA's assessment of
corrective actions undertaken as a result of such inspections. The
guidance provides procedures that encourage open and prompt discussion
of disputes and lead to their resolution. The guidance describes
procedures for raising such disputes to the Office of Regulatory
Affairs (ORA) and center levels and for requesting review by the
dispute resolution (DR) panel.
    When a scientific or technical issue arises during an FDA
inspection, the manufacturer should initially attempt to reach
agreement on the issue informally with the investigator. Certain
scientific or technical issues may be too complex or time consuming to
resolve during the inspection. If resolution of a scientific or
technical issue is not accomplished through informal mechanisms prior
to the issuance of the FDA Form 483, the manufacturer can formally
request DR and can use the formal two-tiered DR process described in
the guidance.
    Tier one of the formal DR process involves scientific or technical
issues raised by a manufacturer to the ORA and center levels. If a
manufacturer disagrees with the tier one decision, tier two of the
formal DR process would then be available for appealing that decision
to the DR panel.
    The written request for formal DR to the appropriate ORA unit
should be made within 30 days of the completion of an inspection and
should include all supporting documentation and arguments for review,
as described in this document. The written request for formal DR to the
DR panel should be made within 60 days of receipt of the tier one
decision and should include all supporting documentation and arguments,
as described in the following paragraphs.
    All requests for formal DR should be in writing and include
adequate information to explain the nature of the dispute and to allow
FDA to act quickly and efficiently. Each request should be

sent to the appropriate address listed in the guidance and include the
following:
     Cover sheet that clearly identifies the submission as
either a request for tier one DR or a request for tier two DR;
     Name and address of manufacturer inspected (as listed on
FDA Form 483);
     Date of inspection (as listed on FDA Form 483);
     Date the FDA Form 483 was issued (from FDA Form 483);
     Facility Establishment Identifier (FEI) Number, if
available (from FDA Form 483);
     FDA employee names and titles that conducted inspection
(from FDA Form 483);
     Office responsible for the inspection (e.g., district
office, as listed on the FDA Form 483);
     Application number, if the inspection was a preapproval
inspection;
     Comprehensive statement of each issue to be resolved;
     Identify the observation in dispute:
    [cir] Clearly present the manufacturer's scientific position or
rationale concerning the issue under dispute with any supporting data.
    [cir] State the steps that have been taken to resolve the dispute,
including any informal DR that may have occurred before the issuance of
the FDA Form 483.
    [cir] Identify possible solutions.
    [cir] State expected outcome.
     Name, title, telephone and FAX number, and e-mail address
(as available) of manufacturer contact.
    The guidance was part of the FDA initiative ``Pharmaceutical CGMPs
for the 21st Century: A Risk-Based Approach,'' which was announced in
August 2002. The initiative focuses on FDA's current CGMP program and
covers the manufacture of veterinary and human drugs, including human
biological drug products. The Agency formed the Dispute Resolution
Working Group comprising representatives from ORA, the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation and
Research, and the Center for Veterinary Medicine. The working group met
weekly on issues related to the DR process and met with stakeholders in
December 2002 to seek their input.
    The guidance was initiated in response to industry's request for a
formal DR process to resolve differences related to scientific and
technical issues that arise between investigators and pharmaceutical
manufacturers during FDA inspections of foreign and domestic
manufacturers. In addition to encouraging manufacturers to use
currently available DR processes, the guidance describes the formal
two-tiered DR process explained earlier in this document. The guidance
also covers the following topics:
     The suitability of certain issues for the formal DR
process, including examples of some issues with a discussion of their
appropriateness for the DR process.
     Instructions on how to submit requests for formal DR and a
list of the supporting information that should accompany these
requests.
     Public availability of decisions reached during the DR
process to promote consistent application and interpretation of drug
quality-related regulations.
    Description of Respondents: Pharmaceutical manufacturers of
veterinary and human drug products and human biological drug products.
    Burden Estimate: Based on the number of requests for tier one and
tier two DRs received by FDA since the guidance published in January
2006, FDA estimates that approximately two manufacturers will submit
approximately two requests annually for a tier one DR and that there
will be one appeal of these requests to the DR panel (request for tier
two DR). FDA estimates that it will take manufacturers approximately 30
hours to prepare and submit each request for a tier one DR and
approximately 8 hours to prepare and submit each request for a tier two
DR. Table 1 of this document provides an estimate of the annual
reporting burden for requests for tier one and tier two DRs.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of                        Average burden
                           Activity                                 Number of       responses per     Total annual      per response       Total hours
                                                                   respondents       respondent         responses        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Tier One DR......................................                 2                 1                 2                30                60
Requests for Tier Two DR......................................                 1                 1                 1                 8                 8
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................                68
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15141 Filed 6-17-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32737-32739]
[FR Doc No: 2017-14889]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81119; File No. SR-PEARL-2017-31]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend MIAX
PEARL Rule 524, Reporting of Matched Trades to Clearing Corporation

July 11, 2017.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that, on June 28, 2017, MIAX PEARL, LLC (``MIAX PEARL''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s (b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 524,
Reporting of Matched Trades to Clearing Corporation.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/rule-filings/pearl at MIAX
PEARL's principal office, and at the Commission's Public Reference
Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Exchange Rule 524, Reporting of
Matched Trades to Clearing Corporation, to adopt Interpretations and
Policies .01, to state that post-trade adjustments that do not affect
the contractual terms of a trade are to be performed by the Exchange
Member \3\ via an Exchange approved electronic interface. The Exchange
will notify Members of the approved electronic interface via Regulatory
Circular. The Exchange notes that an identical filing has been
submitted by its affiliate, MIAX Options. In order to ensure consistent
operation of both MIAX PEARL and MIAX Options through having consistent
rules, the Exchange proposes to amend MIAX PEARL Rule 524 as described
below.
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    \3\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associate with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.

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    The Exchange staffs a Help Desk \4\ to provide customer service and
support to its Members. One of the support functions the Help Desk
currently provides is to make certain post-trade adjustments to a
Member's matched trades at the Member's request and on its behalf. The
Exchange has also developed functionality that it makes available to
all Members that enables Members to electronically and independently
perform post-trade adjustments that do not affect the contractual terms
of the transaction to their side of the matched trade. Examples of
post-trade adjustments that do not affect the contractual terms of a
trade include: Changing the position indicator (e.g., from Open to
Close or Close to Open); adding or removing Clearing Member Trade
Agreement (``CMTA'') information; changing the clearing account type
(e.g., Customer or Firm); and modifying the optional data field, which
may be used by Members for their own internal back-office processing.
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    \4\ The term ``Help Desk'' means the Exchange's control room
consisting of Exchange staff authorized to make certain trading
determinations on behalf of the Exchange. The Help Desk shall report
to and be supervised by a senior executive officer of the Exchange.
See Exchange Rule 100.
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    Despite the availability of functionality for Members to perform
these straightforward post-trade adjustments on their own, the Help
Desk still receives a significant number of requests on a daily basis
to manually perform these adjustments. Processing these requests is a
time consuming exercise for Exchange staff and is an inefficient use of
Exchange time and resources given that Members have the ability to
perform these adjustments themselves electronically via an Exchange
provided interface. Accordingly, the Exchange proposes to mandate that
Members perform their own post-trade adjustments which do not affect
the contractual terms of a trade as discussed above, using the
functionality provided by the Exchange. The Exchange notes that use of
the functionality provided by the Exchange does not relieve Members of
their obligations to abide by the rules of the Exchange.\5\ The
Exchange also represents that it has an adequate surveillance program
in place to review post-trade adjustments made by its Members.
Additionally, the Exchange has a Regulatory Services Agreement in place
with the Financial Industry Regulatory Authority to monitor adjustments
done directly at the Options Clearing Corporation (``OCC'') to ensure
compliance with applicable Exchange rules and such Securities and
Exchange Commission Trading rules related to options trading. Further,
the Exchange notes that Members may make post-trade adjustments to
trades executed on the Exchange directly at the OCC, as the OCC
provides functionality for Members to update certain non-critical trade
information with respect to the transaction, provided such changes are
not in contravention of any rule of the Exchange on which a confirmed
trade was executed.\6\
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    \5\ Specifically, the Exchange notes that Members have an
obligation to adhere to Exchange Rule 507, Must Give Up Clearing
Member.
    \6\ See OCC Rules, Chapter IV, Rule 401, Reporting of Confirmed
Trades Effected on Exchanges.
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    The Exchange notes that other exchanges offer similar functionality
to their members for post-trade adjustments.\7\ However, these
Exchanges incentivize their members to perform their own post-trade
adjustments by charging a fee when the member elects to have the
exchange perform the adjustment on their behalf, as opposed to
mandating usage of an interface to perform post-trade adjustments such
as the Exchange is proposing.
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    \7\ See Securities Exchange Act Release Nos. 73585 (November 13,
2014), 79 FR 68927 (November 19, 2014) (SR-NYSEArca-2014-116); and
73542 (November 6, 2014), 79 FR 67496 (November 13, 2014) (SR-
NYSEMKT-2014-87).
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2. Statutory Basis
    MIAX PEARL believes that its proposed rule change is consistent
with Section 6(b) of the Act \8\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \9\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that its proposal would promote just and
equitable principles of trade and not unfairly discriminate between
Members because the functionality to make post-trade adjustments is
available to all Members. Further, the Exchange believes that its
proposal would promote a fair and orderly market and protect investors
and the public interest because its proposal would result in a more
efficient use of Exchange resources, which would benefit all market
participants.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not designed to address any competitive issues but rather to make more
efficient use of the Exchange's employee time and resources, which may
ultimately benefit Members.
    The Exchange does not believe that the proposed rule change will
impose any burden on intra-market competition as the Rules apply
equally to all Exchange Members.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6) \11\
thereunder.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-PEARL-2017-31 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-PEARL-2017-31. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-PEARL-2017-31, and should be
submitted on or before August 7, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-14889 Filed 7-14-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54353-54355]
[FR Doc No: 2017-24918]

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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.

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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

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.

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,<PHONE_NUMBER>, 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<EMAIL_ADDRESS>    \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

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