[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Pages 46087-46089]
[FR Doc No: 2012-18858]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14066-002]

Inside Passage Electric Cooperative; Notice of Application
Accepted for Filing With the Commision, Soliciting Motions To Intervene
and Protests, Ready for Environmental Analysis, Intent To Waive
Scoping, Soliciting Comments, Terms and Conditions, Recommendations,
and Prescriptions, and Establishing an Expedited Schedule for
Processing

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Minor License.
    b. Project No.: 14066-002.
    c. Date filed: May 25, 2012.
    d. Applicant: Inside Passage Electric Cooperative.
    e. Name of Project: Gartina Falls Hydropower Project.
    f. Location: On Gartina Creek, near the Town of Hoonah, Alaska. The
project would not occupy any federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r)
(2006).
    h. Applicant Contact: Mr. Peter A. Bibb, Operations Manager, Inside
Passage Electric Cooperative, P.O. Box 210149, 12480 Mendenhall Loop
Road, Auke Bay, AK 99821,<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Ryan Hansen,<PHONE_NUMBER>, or email at
<EMAIL_ADDRESS>    j. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document (P-14066). For assistance,
contact FERC Online Support at<EMAIL_ADDRESS>or toll free
at 1-866-208-3676, or for TTY<PHONE_NUMBER>.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The proposed Gartina Falls project would consist of: (1) A 56-
foot-long, 14-foot-high concrete diversion structure at the head of
Gartina Falls; (2) a sluiceway constructed on the left side of the
center diversion section to convey flow to an intake chamber; (3) an
approximately 54-inch-diameter, 225-foot-long steel penstock that would
convey water from the intake chamber to the powerhouse; (4) a
powerhouse containing a single 445-kilowatt cross-flow turbine/
generator unit, discharging flows directly to Gartina Creek; (5) an
approximately 3.8-mile-long, 12.5-

kilovolt transmission line; (6) an approximately 0.5-mile-long access
road; and (7) appurtenant facilities. The estimated annual generation
output for the project is 1.81 gigawatt-hours.
    m. Due to the small size and remote location of this project, the
applicant's close coordination with tribal, state, and federal agencies
during the preparation of the application, and the lack of any study
requests submitted during pre-filing consultation and in response to
the Commission's tendering notice, we intend to waive scoping and
shorten the filing and comment date on final terms and conditions,
recommendations, and prescriptions. Based on a review of the
application, resource agency consultation letters, and comments filed
to date, Commission staff intends to prepare a single environmental
assessment (EA). The issues that need to be addressed in its EA have
been adequately identified during the pre-filing period for the
application, which included a public meeting and site visit, and no new
issues are likely to be identified through additional scoping.
    n. Deadline for filing motions to intervene and protests, comments,
terms and conditions, recommendations, and prescriptions: Due to the
small size and remote location of this project, as well as the
applicant's close coordination with the National Marine Fisheries
Service, U.S. Fish and Wildlife Service, City of Hoonah, Huna Totem
Corporation, Sealaska Corporation, Hoonah Indian Association, Alaska
Department of Fish and Game, Alaska Department of Natural Resources,
and the Alaska State Historic Preservation Office in the preparation of
the application, the 60-day timeframe specified in 18 CFR 4.34(b) for
filing motions to intervene and protests, comments, terms and
conditions, recommendations, and prescriptions is shortened to 30 days
from the issuance date of this notice. All reply comments must be filed
with the Commission within 45 days from the date of this notice.
    All documents may be filed electronically via the Internet in lieu
of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site (http://www.ferc.gov/docs-filing/ferconline.asp)
under the ``eFiling'' link. For a simpler method of submitting text
only comments, click on ``Quick Comment.'' For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>call toll-
free at<PHONE_NUMBER>; or, for TTY, contact<PHONE_NUMBER>. Although
the Commission strongly encourages electronic filing, documents may
also be paper-filed. To paper-file, mail an original and eight copies
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    o. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.
    Anyone may submit comments, a protest, or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, and .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) Bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' ``COMPETING APPLICATION,'' ``COMMENTS,''
``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or
``PRESCRIPTIONS;'' (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application. A copy of all
other filings in reference to this application must be accompanied by
proof of service on all persons listed in the service list prepared by
the Commission in this proceeding, in accordance with 18 CFR 4.34(b)
and 385.2010.
    p. Procedural schedule and final amendments: We intend to accept
the consultation that has occurred on this project during the pre-
filing period as satisfying our requirements for the standard 3-stage
consultation process under 18 CFR 4.38 and for National Environmental
Policy Act scoping and the application will be processed according to
the following procedural schedule. Revisions to the schedule may be
made as appropriate.

------------------------------------------------------------------------
            Milestone                           Target date
------------------------------------------------------------------------
Comments, recommendations, and     August 27, 2012.
 terms and conditions due.
Reply comments due...............  September 11, 2012.
Notice of the availability of the  November 14, 2012.
 EA.
------------------------------------------------------------------------

    Dated: July 27, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-18858 Filed 8-1-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Pages 54270-54272]
[FR Doc No: 2022-18966]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95622; File No. SR-CboeBZX-2022-031]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order
Instituting Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change To List and Trade Shares of the ARK 21Shares
Bitcoin ETF Under BZX Rule 14.11(e)(4), Commodity-Based Trust Shares

August 29, 2022.
    On May 13, 2022, Cboe BZX Exchange, Inc. (``BZX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``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 to list and trade shares (``Shares'') of the ARK
21Shares Bitcoin ETF (``Trust'') under BZX Rule 14.11(e)(4), Commodity-
Based Trust Shares. The proposed rule change was published for comment
in the Federal Register on June 1, 2022.\3\ The Commission has received
no comments on 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. 94982 (May 25,
2022), 87 FR 33250 (``Notice'').
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    On July 12, 2022, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ This order institutes proceedings under Section 19(b)(2)(B)
of the Act \6\ to determine whether to approve or disapprove the
proposed rule change.
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    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 95257, 87 FR 42530
(July 15, 2022). The Commission designated August 30, 2022, as the
date by which it should approve, disapprove, or institute
proceedings to determine whether to disapprove the proposed rule
change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
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I. Summary of the Proposal

    As described in more detail in the Notice,\7\ the Exchange proposes
to list and trade the Shares of the Trust under BZX Rule 14.11(e)(4),
which governs the listing and trading of Commodity-Based Trust Shares
on the Exchange.
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    \7\ See Notice, supra note 3.
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    The investment objective of the Trust is to seek to track the
performance of bitcoin, as measured by the performance of the S&P
Bitcoin Index (``Index''), adjusted for the Trust's expenses and other
liabilities.\8\ Each Share will represent a fractional undivided
beneficial interest in the bitcoin held by the Trust. The Trust's
assets will consist of bitcoin held by the Custodian on behalf of the
Trust. The Trust generally does not intend to hold cash or cash
equivalents. However, there may be situations where the Trust will
unexpectedly hold cash on a temporary basis.\9\
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    \8\ See id. at 33269. 21Shares US LLC (``Sponsor'') is the
sponsor of the Trust, Delaware Trust Company is the trustee, and The
Bank of New York Mellon will be the administrator
(``Administrator'') and transfer agent. Foreside Global Services,
LLC will be the marketing agent in connection with the creation and
redemption of Shares. ARK Investment Management LLC will provide
assistance in the marketing of the Shares. Coinbase Custody Trust
Company, LLC (``Custodian''), will be responsible for custody of the
Trust's bitcoin. See id. at 33250, 33268.
    \9\ See id. at 33268-69.
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    In seeking to achieve its investment objective, the Trust will hold
bitcoin and will value the Shares daily based on the Index. The Index
is a U.S. dollar-denominated composite reference rate for the price of
bitcoin. The Index price is currently sourced from the following
platforms: Binance, Bitfinex, Bitflyer, Bittrex, Bitstamp, Coinbase
Pro, Gemini, HitBTC, Huobi, Kraken, KuCoin, and Poloniex.\10\ The Index
methodology is intended to determine the fair market value for bitcoin
by determining the principal market for bitcoin as of 4:00 p.m. E.T.
daily.\11\
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    \10\ The underlying platforms are sourced by Lukka Inc. (``Data
Provider''), an independent third-party digital asset data company
engaged by the Sponsor, based on a combination of qualitative and
quantitative metrics to analyze a comprehensive data set and
evaluate factors including legal/regulation, Know-Your-Customer/
transaction risk, data provision, security, team/exchange, asset
quality/diversity, market quality, and negative events. As the
digital ecosystem continues to evolve, the Data Provider can add or
remove platforms based on the processes established by Lukka's
Pricing Integrity Oversight Board. See id. at 33269 and n.72.
    \11\ The Index methodology uses a ranking approach that
considers several characteristics of the trading platforms,
including oversight and intra-day trading volume. Specifically, to
rank the credibility and quality of each trading platform, the Data
Provider dynamically assigns a Base Exchange Score (``BES'') to the
key characteristics for each platform. The BES reflects the
fundamentals of a platform and determines which platform should be
designated as the principal market at a given point of time. This
score is determined by computing a weighted average of the values
assigned to four different trading platform characteristics: (i)
oversight; (ii) microstructure efficiency; (iii) data transparency;
and (iv) data integrity. The methodology then applies a five-step
weighting process for identifying a principal trading platform and
the last price on that platform. Following this weighting process,
an executed trading platform price is assigned for bitcoin as of
4:00 p.m. E.T. See id. at 33269.
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    The Net Asset Value (``NAV'') of the Trust means the total assets
of the Trust including, but not limited to, all bitcoin and cash, if
any, less total liabilities of the Trust, each determined on the basis
of generally accepted accounting principles. The NAV of the Trust is
the aggregate value of the Trust's assets less its estimated accrued
but unpaid liabilities (which include accrued expenses). In determining
the Trust's NAV, the Administrator values the bitcoin held by the Trust
based on the price set by the Index as of 4:00 p.m. E.T. The
Administrator determines the NAV of the Trust on each day that the
Exchange is open for regular trading, as promptly as practical after
4:00 p.m. E.T.\12\
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    \12\ See id. at 33271.
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    The Trust will provide information regarding the Trust's bitcoin
holdings, as well as an Intraday Indicative Value (``IIV'') per Share
updated every 15 seconds, as calculated by the Exchange or a third-
party financial data provider during the Exchange's Regular Trading
Hours (9:30 a.m. E.T. to 4:00 p.m. E.T.). The IIV will be calculated by
using the prior day's closing NAV per Share as a base and updating that
value during Regular Trading Hours to reflect changes in the value of
the Trust's bitcoin holdings during the trading day.\13\
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    \13\ See id. at 33270.
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    When the Trust sells or redeems its Shares, it will do so in ``in-
kind'' transactions in blocks of 5,000 Shares. Authorized participants
will deliver, or facilitate the delivery of, bitcoin to the Trust's
account with the Custodian in exchange for Shares when they purchase
Shares, and the Trust, through the Custodian, will deliver bitcoin to
such authorized participants when they redeem Shares with the
Trust.\14\
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    \14\ See id. at 33269.
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II. Proceedings To Determine Whether To Approve or Disapprove SR-
CboeBZX-2022-031 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \15\ to determine whether the proposed rule
change should be approved or disapproved. Institution of proceedings is
appropriate at this time in view of the legal and policy issues raised
by the proposed rule change, as discussed below. Institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, as
described below, the Commission seeks and encourages interested persons
to provide comments on the proposed rule change.
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    \15\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\16\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices'' and ``to protect investors and the
public interest.'' \17\
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    \16\ Id.
    \17\ 15 U.S.C. 78f(b)(5).
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    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of

the proposal, which are set forth in the Notice,\18\ in addition to any
other comments they may wish to submit about the proposed rule change.
In particular, the Commission seeks comment on the following questions
and asks commenters to submit data where appropriate to support their
views:
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    \18\ See Notice, supra note 3.
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    1. What are commenters' views on whether the proposed Trust and
Shares would be susceptible to manipulation? What are commenters' views
generally on whether the Exchange's proposal is designed to prevent
fraudulent and manipulative acts and practices? What are commenters'
views generally with respect to the liquidity and transparency of the
bitcoin markets, the bitcoin markets' susceptibility to manipulation,
and thus the suitability of bitcoin as an underlying asset for an
exchange-traded product?
    2. Based on data and analysis provided and the academic research
cited by the Exchange,\19\ do commenters agree with the Exchange that
the Chicago Mercantile Exchange (``CME'') on which bitcoin futures
contracts trade (``CME Bitcoin Futures'') represents a regulated market
of significant size related to spot bitcoin? \20\ What are commenters'
views on whether there is a reasonable likelihood that a person
attempting to manipulate the Shares would also have to trade on the CME
to manipulate the Shares? Do commenters agree with the Exchange's
assertion that the combination of (a) CME Bitcoin Futures leading price
discovery; (b) the overall size of the bitcoin market; and (c) the
ability for market participants to buy or sell large amounts of bitcoin
without significant market impact, helps to prevent the Shares from
becoming the predominant force on pricing in either the spot bitcoin or
CME Bitcoin Futures markets? \21\
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    \19\ See id. at 33256-61, 33261 n.59.
    \20\ See id. at 33262.
    \21\ See id.
---------------------------------------------------------------------------

    3. The Exchange states that bitcoin is resistant to price
manipulation and that other means to prevent fraudulent and
manipulative acts and practices exist to justify dispensing with the
requirement to enter into a comprehensive surveillance-sharing
agreement with a regulated market of significant size related to spot
bitcoin.\22\ In support of its assertion, the Exchange provides data
and analysis \23\ to indicate that the spot bitcoin market is
``increasingly efficient,'' with ``higher liquidity'' and a ``higher
degree of consensus among investors regarding the price of [b]itcoin,''
making it ``less susceptible to manipulation.'' \24\ Do commenters
believe the Exchange has shown that the bitcoin market is resistant to
price manipulation?
---------------------------------------------------------------------------

    \22\ See id. at 33261 n.62.
    \23\ See id. at 33262-68.
    \24\ See id. at 33264-66.
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III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, and
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\25\
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    \25\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by September 23, 2022. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
October 7, 2022.
    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 protected]. Please include
File Number SR-CboeBZX-2022-031 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-CboeBZX-2022-031. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2022-031 and should be submitted
by September 23, 2022. Rebuttal comments should be submitted by October
7, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
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    \26\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-18966 Filed 9-1-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14538-14539]
[FR Doc No: 2022-05476]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0367]

Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-
Forming Fish and Fishery Products--Decomposition and Histamine;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the draft Compliance Policy Guide entitled
``Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming
Fish and Fishery Products--Decomposition and Histamine'' that published
in the Federal Register of December 27, 2021. We are taking this action
in response to a request from stakeholders to extend the comment period
to allow additional time for interested parties to develop and submit
data, other information, and comments before FDA begins work on the
final guidance.

DATES: FDA is reopening the comment period for the draft Compliance
Policy Guide announced in the Federal Register on December 27, 2021 (86
FR 73295). Submit either electronic or written comments on the draft
guidance by April 14, 2022, to ensure that we consider your comments
before we begin work on the final 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-2021-D-0367 for ``Compliance Policy Guide Sec. 540.525 Scombrotoxin
(Histamine)-forming Fish and Fishery Products--Decomposition and
Histamine.'' 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,<PHONE_NUMBER>.
     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.'' We will review
this copy, including the claimed confidential information, in our
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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Division of Seafood
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316, email: [email protected]; or Jessica Larkin,
Center for Food Safety and Applied Nutrition, Office of Regulations and
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 27, 2021
(86 FR 73295), we published a notice announcing the availability of a
draft Compliance Policy Guide (CPG) entitled ``Sec. 540.525
Scombrotoxin (Histamine)-forming Fish and Fishery Products--
Decomposition and

Histamine (CPG 7108.24).'' This draft CPG would update and replace
existing guidance for FDA staff on adulteration associated with
decomposition and histamine identified during surveillance sampling and
testing of fish and fishery products susceptible to histamine
formation. We gave interested parties until February 25, 2022, to
submit comments before we began work on the final guidance.
    FDA has received a request for a 30-day extension for this comment
period to allow additional time for interested parties to develop and
submit data, other information, and comments for this draft Compliance
Policy Guide before we begin work on the final version of the guidance.
We have considered this request and are reopening the comment period
for 30 days. FDA believes that this additional 30 days will allow
adequate time for any interested parties to submit data, other
information, and comments before we begin work on the final guidance.

    Dated: March 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05476 Filed 3-14-22; 8:45 am]
BILLING CODE 4164-01-P