[Federal Register Volume 83, Number 119 (Wednesday, June 20, 2018)]
[Notices]
[Pages 28651-28652]
[FR Doc No: 2018-13222]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1398]

Mitigation Strategies To Protect Food Against Intentional
Adulteration; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft guidance for industry entitled
``Mitigation Strategies to Protect Food Against Intentional
Adulteration: Guidance for Industry.'' This draft guidance document,
when finalized, will help food facilities that manufacture, process,
pack, or hold food, and that are required to register under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of
our regulation entitled ``Mitigation Strategies to Protect Food Against
Intentional Adulteration.''

DATES: Submit either electronic or written comments on the draft
guidance by December 17, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1398 for ``Mitigation Strategies to Protect Food Against
Intentional Adulteration: Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. FSMA enables FDA to focus more
on preventing food safety problems rather than relying primarily on
reacting to problems after they occur.
    FSMA added to the FD&C Act several new sections that reference
intentional adulteration. For example, section 418 of the FD&C Act (21
U.S.C. 350g) addresses intentional adulteration in the context of
facilities that manufacture, process, pack, or hold food, and that are
required to register under section 415 (21 U.S.C. 350d). Section 420 of
the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the
context of high-risk foods and exempts farms except for farms that
produce milk.
    We are announcing the availability of a draft guidance for industry
entitled ``Mitigation Strategies to Protect Food Against Intentional
Adulteration: Guidance for Industry.'' This multi-chapter draft
guidance for industry is intended to help food facilities required to
comply develop and implement some of the components of a food defense
plan, and meet other requirements under 21 CFR part 121. We are
announcing the availability of the following chapters:

 Introduction
 Chapter One--The Food Defense Plan
 Chapter Two--Vulnerability Assessment to Identify Significant

Vulnerabilities and Actionable Process Steps
 Chapter Three--Mitigation Strategies for Actionable Process
Steps
 Chapter Four--Mitigation Strategies Management Components:
Food Defense Monitoring
 Appendix--Food Defense Plan Worksheets
    We intend to announce the availability for public comment of
additional and expanded chapters of the draft guidance as we complete
them.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on food
defense measures against intentional adulteration for the regulation
``Mitigation Strategies to Protect Food Against Intentional
Adulteration.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 507 have been approved under
OMB control number 0910-0789.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Use the FDA website listed
in the previous sentence to find the most current version of the
guidance.

    Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13222 Filed 6-19-18; 8:45 am]
 BILLING CODE 4164-01-P


This appendix is only available from MassDEP as an electronic file
entitled “CMAQ Ozone Predictions versus 2002 Ozone Observations for
the OTR States”


[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]
[Page 36579-36581]
[DOCID:fr27jn08-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58004; File No. SR-FINRA-2008-009] Self-
Regulatory Organizations; Financial Industry Regulatory Authority,
Inc.; Order Approving Proposed Rule Change to the Code of Arbitration
Procedure for Customer Disputes and the Code of Arbitration Procedure
for Industry Disputes To Amend the Chairperson Eligibility Requirements

June 23, 2008.

I. Introduction

    On March 12, 2008, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') (f/k/a National Association of Securities Dealers,
Inc. (``NASD'')) filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') pursuant to section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change relating to amendments to NASD
Rule 12400(c) of the Code of Arbitration Procedure for Customer
Disputes (``Customer Code'') and NASD Rule 13400(c) of the Code of
Arbitration Procedure for Industry Disputes (``Industry Code''). The
proposed rule change was published for comment in the Federal Register
on March 25, 2008.\3\ The Commission received five comment letters in
response to the proposed rule change.\4\ This order approves the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 34-57529 (March 19,
2008); 73 FR 15817 (Mar. 25, 2008).
    \4\ See letter from Scot D. Bernstein, dated April 4, 2008
(``Bernstein letter''); letter from William A. Jacobson, Esq.,
Associate Clinical Professor, Director, Securities Law Clinic,
Cornell Law School, dated April 15, 2008 (``Cornell letter'');
letter from Lawrence S. Schultz, President, Public Investors
Arbitration Association, dated April 16, 2008 (``PIABA letter'');
letter from Karen Lockwood, dated May 12, 2008 (``Lockwood
letter''); and letter from Barry D. Estell, Esquire, dated May 22,
2008 (``Estell letter'').
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II. Description of the Proposed Rule Change

    The proposed rule change amends the chairperson eligibility
requirements under Rule 12400(c) of the Customer Code and Rule 13400(c)
of the Industry Code.
    On January 24, 2007, the SEC approved the Customer and Industry
Codes (collectively referred to as

``Codes'').\5\ The Codes reorganized the dispute resolution rules into
separate procedural codes, simplified the language of the old NASD Code
of Arbitration Procedure, codified current practices, and implemented
several substantive changes. One such substantive change involved
improving the arbitrator selection process by creating and maintaining
a new roster of arbitrators who are qualified to serve as chairpersons.
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    \5\ See Securities Exchange Act Release No. 55158 (January 24,
2007); 72 FR 4574 (January 31, 2007) (File Nos. SR-NASD-2003-158 and
SR-NASD-2004-011). The new Codes became effective on April 16, 2007.
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    Under the Codes, arbitrators are eligible for the chairperson
roster if they have completed chairperson training provided by FINRA
\6\ or have substantially equivalent training or experience, and
satisfy one of two remaining requirements of the rule.\7\ In the rule
filing proposing this change, FINRA explained that ``substantially
equivalent training or experience would include service as a judge or
administrative hearing officer, chairperson training offered by another
recognized dispute resolution forum, or the like. Decisions regarding
whether particular training or experience other than FINRA chairperson
training would qualify under this provision would be in the sole
discretion of the Director.'' \8\ In referring to the ``substantially
equivalent training or experience'' criterion (hereinafter,
``substantially equivalent''), the proposal also stated that FINRA
believed that the proposal would allow arbitrators of all professional
backgrounds to qualify as chairpersons.\9\ FINRA believed that this
criterion would help ensure that the forum could meet the demands of
the Codes concerning the new chairperson roster, while allowing FINRA
to continue to administer effectively the arbitrator selection process.
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    \6\ Although some of the events referenced in this rule filing
occurred prior to the formation of FINRA, the rule filing refers to
FINRA throughout for simplicity.
    \7\ Rule 12400(c) of the Customer Code and Rule 13400(c) of the
Industry Code.
    \8\ See Securities Exchange Act Release No. 51856 (June 15,
2005); 70 FR 36442, at 36446 (June 23, 2005).
    \9\ Id.
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    In the year since the Codes were approved, FINRA has determined
that the ``substantially equivalent'' criterion has not been essential
to creating and maintaining the chairperson roster, and therefore
proposed to remove this criterion from the rule. FINRA notes that all
arbitrators currently coded as chairpersons have completed the FINRA
Chairperson Training course (chair training),\10\ and the chair
training has never been waived for an arbitrator claiming to satisfy
the ``substantially equivalent'' criterion. FINRA believes that all
arbitrators wishing to serve as chairpersons would benefit from the
information contained in the chair training, which instructs
arbitrators on the added responsibilities of arbitrators assuming the
essential role of chairperson in the FINRA forum. Moreover, FINRA
believes that removing the ``substantially equivalent'' criterion would
make the chairperson eligibility standards more objective and uniform,
thereby eliminating any perception that large numbers of arbitrators
may be added to the chairperson roster without the benefit of the chair
training.
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    \10\ The online Chairperson training course costs $50 and is
available at http://www.finra.org/ArbitrationMediation/
ResourcesforArbitratorsandMediators/ArbitratorTraining/
ArbitratorTrainingPrograms/index.htm (last visited March 5, 2008).
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III. Comment Letters

    The Commission received five comment letters on the proposal.\11\
Three commenters opposed the proposal;\12\ one commenter urged the
Commission to postpone taking final action on the proposed rule change
pending further study;\13\ and one commenter offered no opinion on the
proposal.\14\
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    \11\ See supra, footnote 3.
    \12\ Bernstein, PIABA and Estell letters.
    \13\ Cornell letter.
    \14\ Lockwood letter.
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    Two commenters argued that the amendments would further reduce the
potential size of FINRA's pool of arbitrators who could be eligible to
serve as chair by removing the ``substantially equivalent'' criterion
from the rule.\15\
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    \15\ PIABA and Estell letters.
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    In a letter to the Commission, FINRA responded to these comments,
stating that the proposal will not narrow the pool of arbitrators who
could be eligible to serve as chair.\16\ FINRA explained that, in the
year since the Codes were approved, the substantially equivalent
criterion has proved irrelevant to creating and maintaining the
chairperson roster.\17\ Further, FINRA explained that all arbitrators
currently coded as chairpersons have completed the FINRA Chairperson
Training course (chair training) and that FINRA has never waived the
chair training for an arbitrator under the substantially equivalent
criterion.\18\ Finally, FINRA suggested that this criterion has had no
impact on its ability to maintain or expand the chairperson roster, and
is therefore not necessary.\19\
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    \16\ See letter from Mignon McLemore, Assistant Chief Counsel,
FINRA Dispute Resolution, dated June 2, 2008 (``FINRA letter'').
    \17\ FINRA letter.
    \18\ Id.
    \19\ Id.
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    Three commenters contended that by removing the substantially
equivalent criterion, FINRA would be, in effect, implementing a
mandatory arbitrator training requirement, which would give FINRA undue
control over the arbitrators who may serve as chairs.\20\
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    \20\ Bernstein, PIABA and Estell letters.
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    FINRA responded that the proposal would, instead, result in less
staff discretion because staff would not be assessing the arbitrator's
prior experience or training to determine whether it was substantially
equivalent to FINRA chair training.\21\ Under the proposal, arbitrators
would be required to take FINRA's online chair training to become chair
eligible. FINRA indicated that this requirement (which is easily
measured) would make chair eligibility determinations more objective,
because staff would not have to decide whether an arbitrator's
experience meets the substantially equivalent threshold.\22\ FINRA
stated that it believes the proposed amendments to the chair
eligibility standards are reasonable and, along with the rule's other
criteria, will provide investors with access to well-trained and well-
qualified arbitrators.\23\
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    \21\ FINRA letter.
    \22\ Id.
    \23\ Id.
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    One commenter suggested that chair training should not be a
prerequisite to appointment as chair. \24\ Rather, the commenter
suggested that FINRA could require that arbitrators, appointed as
chair, complete the training prior to the initial pre-hearing
conference (IPHC).\25\
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    \24\ Cornell letter at footnote 2.
    \25\ Cornell letter. See also FINRA letter, footnote 10, stating
that ``a pre-hearing conference is a hearing session that takes
place before the hearing on the merits. Rule 12100(t) of the
Customer Code and Rule 13100(t) of the Industry Code.''
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    FINRA responded by stating that it has considered this suggestion,
but concluded that it would be unworkable in its forum.\26\ FINRA
pointed out that there could be instances in which an arbitrator is
appointed as chair, but does not want to serve as the chair, refuses to
take the chair training, or delays taking the training and does not
complete it by the time of the IPHC.\27\ In such instances, FINRA
explained, the case would be delayed while either the arbitrator is
removed and another is appointed, or the IPHC is re-scheduled

to give the arbitrator additional time to take the training.\28\ FINRA
also stated that this suggestion would create a significant
administrative burden on staff, as staff would be required to monitor
continuously the arbitrators' training reports to ensure that they have
completed the chair training prior to IPHCs.\29\ For these reasons,
FINRA declined to amend the proposal to implement this suggestion.\30\
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    \26\ FINRA letter.
    \27\ Id.
    \28\ Id.
    \29\ Id.
    \30\ Id.
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    One commenter requested that FINRA make available arbitrator
selection records, beyond information publicly available from the
Arbitration Awards Online database, so that it could be analyzed to
determine whether arbitrators who award punitive or large compensatory
awards are appointed to cases with less frequency due to strikes from
industry parties, and whether the fragmentation of the random selection
process through a chair-qualified slot exacerbates the problem.\31\
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    \31\ Cornell letter.
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    FINRA responded that its arbitrator selection records are
proprietary and confidential.\32\ FINRA explained, that the arbitrator
selection records are generated during the resolution of a private
matter between parties and contain the parties' confidential
information, such as their striking and ranking choices.\33\ Further,
FINRA stated that it does not make this information available to the
public because it could inhibit the parties' decisions during the
arbitration process, which would compromise the integrity of the
arbitration process.\34\ For these reasons, FINRA declined to make this
information available.\35\
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    \32\ FINRA letter.
    \33\ Id.
    \34\ Id.
    \35\ Id.
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    Finally, four commenters objected to the existence of the separate
chair roster.\36\ FINRA stated that it is not proposing to amend the
structure of its arbitrator rosters in this rule filing.\37\ Further,
FINRA noted that these same concerns were addressed by FINRA in
connection with the proposal and adoption of the Codes,\38\ and the
changes to the arbitrator rosters were approved by the SEC.\39\ FINRA
stated that these comments are, therefore, outside the scope of the
rule filing.\40\
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    \36\ Bernstein, Cornell, PIABA, and Estell letters.
    \37\ FINRA letter.
    \38\ Id. citing Response to Comments and Amendment No. 5, May 4,
2006 (File No. SR-NASD-2003-158), at 21-22; see also Response to
Comments and Partial Amendment 7, August 15, 2006 (File No. SR-NASD-
2003-158), at 8.
    \39\ FINRA letter.
    \40\ Id.
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IV. Discussion and Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act, and the rules
and regulations thereunder that are applicable to a national securities
association.\41\ In particular, the Commission believes that the
proposed rule change is consistent with the provisions of section
15A(b)(6) of the Act,\42\ because it would enhance the fairness and
neutrality of FINRA's arbitration forum by making the chairperson
eligibility rules more objective and uniform.
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    \41\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition and capital
formation. See 15 U.S.C. 78c(f).
    \42\ 15 U.S.C. 78o-(b)(6).
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V. Conclusions

    It Is Therefore Ordered, pursuant to section 19(b)(2) of the
Act,\43\ that the proposed rule change (SR-FINRA-2008-009) be, and
hereby is, approved.
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    \43\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\44\
Florence E. Harmon,
Acting Secretary.
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    \44\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E8-14568 Filed 6-26-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26771-26772]
[FR Doc No: 2013-10947]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL13-60-000; QF13-402-001]

Otter Creek Solar LLC; Notice of Petition for Enforcement

    Take notice that on May 1, 2013, Otter Creek Solar LLC (Otter
Creek) filed a Petition for Enforcement, pursuant to section
210(h)(2)(B) of the Public Utility Regulatory Policies Act of 1978
(PURPA), requesting the Federal Energy Regulatory Commission
(Commission) to initiate enforcement action against the Vermont Public
Service Board (VPSB) to remedy the issuance of a series of orders by
the VPSB implementing a feed-in tariff program, called the Substainably
Priced Energy Enterprise Development or SPEED Program. Otter Creek
argues that the SPEED Program is contrary to the requirements of PURPA
and the Commission's regulations and in violation of the Federal Power
Act.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 15, 2013.

    Dated: May 1, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-10947 Filed 5-7-13; 8:45 am]
BILLING CODE 6717-01-P