[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]
[Page 31311-31312]
[DOCID:fr06jn07-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-65-000]

Bonneville Power Administration Complainant, v. Puget Sound
Energy, Inc., Hermiston Power Partnership, Chehalis Power Generating,
L.P., PPM Energy, Inc. TransAlta Centralia Generation, L.L.C.,
Respondents.; Notice of Complaint

May 31, 2007.
    Take notice that on May 30, 2007, the Bonneville Power
Administration (Bonneville) filed a formal complaint against Puget
Sound Energy, Inc., Hermiston Power Partnership, Chehalis Power
Generating, L.P., PPM Energy, Inc., and TransAlta Centralia Generation,
L.L.C. (Respondents) pursuant to section 206 of the Federal Power Act
and Rule 206 of the Rules of Practice and Procedure of the Federal
Energy Regulatory Commission, 18 CFR 385.206 (2006), requesting that
the Commission issue an order reducing to zero the rates Respondents
may charge Bonneville for Reactive Power Service, effective October 1,
2007.
    Bonneville certified that copies of the complaint were served on
the contacts for Respondents as listed on the Commission's list of
Corporate Officials.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 14
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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 19, 2007.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-10834 Filed 6-5-07; 8:45 am]

BILLING CODE 6717-01-P


WORKSHOP ON LNG AND RELATED FACILITIES LIST OF CONTACT PEOPLE NAME AGENCY AFILIATION PHONE E MAIL ADDRESS Karen Abrams NOAA/ HQ/ Habitat Conservation ( 301) 713 4300 Karen. Abrams@ noaa. gov Mi Ae Kim NOAA/ HQ/ Protected Resources ( 301) 713 1401 Mi. Ae. Kim@ noaa. gov David Kaiser NOAA/ NOS/ Ocean and Coastal Resource Management ( 301) 713 3155 David. Kaiser@ noaa. gov John Armor NOAA/ NOS/ National Marine Sanctuaries ( 301) 713 3125 John. Armor@ noaa. gov Rickey Ruebsamen NOAA/ Southeast Region ( 850) 234 5061 Ric. Ruebsamen@ noaa. gov Tom Minello NOAA/ Southeast Fisheries Science Center ( 409) 766 3506 Tom. Minello@ noaa. gov Mark Helvey NOAA/ Southwest Region ( 562) 980 4046 Mark. Helvey@ noaa. gov Lou Chiarella ( 978) 281 9277 Lou. Chiarella@ noaa. gov Christopher Boelke NOAA/ Northeast Region ( 978) 281 9131 Christopher. Boelke@ noaa. gov James Martin Federal Energy Regulatory Commission ( 202) 502 8045 James. Martin@ ferc. gov James Bennett Minerals Management Service ( 703) 787 1660 JFBennett@ mms. gov Ashley Allen ( 202) 566 1012 Allen. Ashley@ epa. gov Carey Johnston Environmental Protection Agency ( 202) 566 1014 Johnston. Carey@ epa. gov Mark Prescott U. S. Coast Guard ( 202) 267 0225 MPrescott@ comdt. uscg. mil


[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Notices]
[Pages 2583-2585]
[FR Doc No: 2012-779]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66139; File No. SR-CHX-2012-01]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend its Fee Schedule To Assess Fees for Derivative Securities
Products

January 11, 2012.
    Pursuant to 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 January 6, 2012, the Chicago Stock Exchange, Inc. (``CHX'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the CHX. CHX has filed
the proposal pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule
19b-4(f)(2) thereunder,\4\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CHX proposes to amend its Fee Schedule, effective January 9, 2012,
to create a separate fee and rebate structure for Derivative Securities
Products and to remove certain references to Tape A, B and C securities
throughout the Fee Schedule.
    The text of this proposed rule change is available on the
Exchange's Web site at (www.chx.com) and in 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 CHX included statements
concerning the purpose of and basis for the

proposed rule changes and discussed any comments it received regarding
the proposal. The text of these statements may be examined at the
places specified in Item IV below. The CHX 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Through this filing, the Exchange proposes to amend its Schedule of
Fees and Assessments (the ``Fee Schedule''), effective January 9, 2012,
to create a separate fee and rebate structure for Derivative Securities
Products \5\ and to remove references to Tape A, B and C securities
throughout our Fee Schedule.
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    \5\ ``Derivative Securities Product'' is defined under Rule 19b-
4(e) as any type of option, warrant, hybrid securities product or
any other security, other than a single equity option or a security
futures product, whose value is based, in whole or in part, upon the
performance of, or interest in, an underlying instrument. See, 17
CFR 240.19b-4(e).
---------------------------------------------------------------------------

    Pursuant to this proposal, the Exchange would eliminate the
distinction in the fee and rebate structure for Tape A, B and C
securities and replace it with a structure based on Derivative
Securities Products.\6\ Currently, the Exchange offers a provide credit
of $0.0022/share under Section E.1. of the Fee Schedule only for
transactions in Tape B securities.\7\ Many, but not all, Tape B
securities are Derivative Securities Products and some Tape A and C
securities are Derivative Securities Products. For securities priced
$1/share or more and which are executed in the Regular Trading Session,
the Exchange seeks to eliminate the payment of provide credits pursuant
to Section E.1. of the Fee Schedule for all non-Derivative Securities
Products priced $1/share or more and simultaneously extend the provide
credit to transactions in Derivative Securities Products priced $1/
share or more. Thus, some Tape B securities which are not Derivative
Securities Products would no longer be eligible for a provide credit in
the Regular Trading Session and certain Derivative Securities Products
which are Tape A and C securities would be eligible for a provide
credit. As a category, Derivative Securities Products are heavily
traded in the National Market System. By this proposal, the Exchange
seeks to pay a provide credit for transactions in such securities in
order to incent additional order flow in these issues to the Exchange.
---------------------------------------------------------------------------

    \6\ Tape A securities are those equity securities for which the
New York Stock Exchange, Inc. is the primary listing market. Tape C
securities are those issues for which the Nasdaq Stock Exchange,
Inc. is the primary listing center. Tape B securities are those
issues for which some other national securities exchange is the
primary listing market.
    \7\ Among other things, the Exchange proposes to correct a
typographical error in its Fee Schedule to clarify that the provide
credit paid pursuant to Section E.1. for issues priced $1/share or
more is $.00022 per share.
---------------------------------------------------------------------------

    Pursuant to the Exchange's proposed new fee and rebate structure,
Participants would be charged a fee of $0.003/share to take liquidity
and given a rebate of $0.0022/share for providing liquidity in the
Regular Trading Session for securities priced $1.00/share or more which
are Derivative Securities Products. For transactions in non- Derivative
Securities Products priced $1/share or more which were executed in the
Regular Trading Session, the Exchange proposes to charge a fee of
$0.003/share to take liquidity while giving no rebate for providing
liquidity. A liquidity removal fee of $0.003/share and a provide credit
of $0.0022/share would be assessed for transactions in securities
priced $1/share or more in the Exchange's Early and Late Trading
Sessions. Participants would be assessed a liquidity removal fee of
0.30% of trade value and given a provide credit of $0.00009/share in
all issues priced less than $1/share in all trading sessions.
    The Exchange proposes similar changes to the fee and rebate
structure for single-sided orders executed in the Matching System which
were submitted through an Exchange-registered Institutional Broker.
These changes in essence substitute the term ``Derivatives Securities
Products'' for ``Tape B securities'' within the applicable section of
the Exchange's Fee Schedule (Section E.1.). Thus, a provide credit of
$0.0022/share in transactions involving Derivatives Securities products
executed in the Regular Trading Session would be paid to the
Institutional Broker representing the Participant which originated the
order.\8\ The Exchange proposes to replace references to ``Tape A, B
and C'' securities with an all-inclusive reference to ``any'' or
``all'' securities in the text governing the provide credit paid to
Institutional Brokers for transactions in the Early and Late Trading
Sessions and in securities priced under $1/share in any trading
session.
---------------------------------------------------------------------------

    \8\ Currently, the same amount is paid to the Institutional
Broker for transactions in Tape B securities.
---------------------------------------------------------------------------

    The Exchange proposes to add the definition of a Derivative
Securities Product, taken from Rule 19b-4(e) of the Exchange Act, to
the Fee Schedule for purposes of clarity.\9\ The Exchange also proposes
to replace all references in Section E. of the Fee Schedule to the term
``issue'' with that to [sic] ``securities,'' which is a more accurate
and well-defined term.\10\ The Exchange proposes to remove all other
references in various sections of the Fee Schedule to Tape A, B and C
securities, since those categories would no longer be relevant in
assessing fees to CHX Participants. Finally, the Exchange proposes to
replace the references to Exchange Traded Funds (``ETFs''), Exchange
Traded Notes (``ETNs'') or Exchange Traded Vehicles (``ETVs'') in
Section E.8. (Order Cancellation Fee (Regular Trading Session only))
with a reference to Derivative Securities Products.\11\ The Exchange
believes that these references are functionally equivalent as applied
to trading on the Exchange and use of a common term throughout the Fee
Schedule should provide additional clarity to Exchange Participants.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(e).
    \10\ The Exchange also proposes to replace the references to the
term ``issue'' in Section I (Listing Fees) to the different types of
securities ``listed on the Exchange'' in order to be consistent.
    \11\ The Exchange also proposes to delete the reference to the
effective date of the Cancellation Fees, since that date is now a
number of months in the past.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \12\ in general, and furthers the
objectives of Section 6(b)(4) of the Act \13\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and other persons using any facility or
system which the Exchange operates or controls. Because the proposed
structure will apply to all single sided orders executed in the CHX
Matching System, with the limited exception of take fees for
Institutional Brokers, which have their own, previously approved, fee
structure, the Exchange believes the proposed fee and rebate structure
will equitably allocate the same reasonable rebate rates among
Participants in a non-discriminatory nature. Furthermore, because
quoting and trading activity is different among certain categories of
securities, such as Derivative Securities Products, the Exchange
believes that it is fair and reasonable to create different fee and
rebate structures for Derivative Securities Products and all other
securities in order to better incent activity by Participants on the

Exchange's trading facilities in those particular categories.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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.

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

    No written comments were either solicited or received.

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

    The proposed rule change is to take effect pursuant to Section
19(b)(3)(A)(ii) of the Act \14\ and subparagraph (f)(2) of Rule 19b-4
thereunder \15\ because it establishes or changes a due, fee or other
charge applicable to the Exchange's members and non-members, which
renders the proposed rule change effective upon filing.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \15\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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.
    As more fully discussed above, the Exchange believes that the
proposed changes represent a fair and reasonable structure designed to
create different fee and rebate amounts to incent activity among all
Participants within the Exchange's trading facilities.

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-CHX-2012-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CHX-2012-01. 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
a.m. and 3 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-CHX-2012-01 and should be
submitted on or before February 8, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-779 Filed 1-17-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Notices]
[Pages 52114-52115]
[FR Doc No: 2020-18509]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-507-000]

Transcontinental Gas Pipe Line Company, LLC; Sea Robin Pipeline
Company, LLC; Florida Gas Transmission Company, LLC; Notice of
Application

    Take notice that on August 6, 2020, Transcontinental Gas Pipe Line
Company, LLC (Transco), P.O. Box 1396, Houston, Texas 77251, Sea Robin
Pipeline Company, LLC (Sea Robin), 1300 Main Street. Houston, Texas
77002, and Florida Gas Transmission Company, LLC (FGT), 1300 Main
Street. Houston, Texas 77002, jointly filed an application in the above
referenced docket pursuant to section 7(b) of the Natural Gas Act (NGA)
and part 157 of the Commission's regulations requesting authorization
to abandon approximately 12.6 miles of 24-inch-diameter lateral
pipeline extending from offshore Vermilion Parish, Louisiana, at the
Vermilion Area Block 22 subsea tie-in to a point of connection with
Transco's Central Louisiana Gathering System onshore in the Pecan
Island area, Vermilion Parish, Louisiana, and related metering
facilities, all as more fully set forth in the application which is on
file with the Commission and open to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application may be directed to Nick
Baumann, Regulatory Analyst, Transcontinental Gas Pipe Line Company,
P.O. Box 1396, Houston, Texas 77251,<PHONE_NUMBER>; Deborah A.
Bradbury, Sr. Director, Regulatory Tariffs & Reporting, Sea Robin
Pipeline Company, 1300 Main Street, Houston, Texas 77002, (713) 989-
7571; or Blair Lichtenwalter, Senior Director, Certificates, Florida
Gas Transmission Company, 1300 Main Street, Houston, Texas 77002, (713)
989-2605.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit five copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new NGA section 3 or
section 7 proceeding.\1\ Persons desiring to become a party to a
certificate proceeding are to intervene in a timely manner. If seeking
to intervene out-of-time, the movant is required to ``show good cause
why the time limitation should be waived,'' and should provide
justification by reference to factors set forth in Rule 214(d)(1) of
the Commission's Rules and Regulations.\2\
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC ] 61,167 at
] 50 (2018).
    \2\ 18 CFR 385.214(d)(1).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov.

In lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Comment Date: 5:00 p.m. Eastern Time on September 7, 2020.

    Dated: August 17, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-18509 Filed 8-21-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Rules and Regulations]
[Pages 29054-29055]
[FR Doc No: 2019-13223]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 117 and 507

[Docket No. FDA-2018-D-0671]

Determining the Number of Employees for Purposes of the ``Small
Business'' Definition (Current Good Manufacturing Practices and
Preventive Controls Regulations for Human and Animal Food): Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry describing the
Agency's current thinking on how to determine the number of employees
for purposes of the ``small business'' definition in the current good
manufacturing practice (CGMP), hazard analysis, and risk-based
preventive controls for human and animal food rules. The guidance will
help industry subject to these rules determine the number of employees
for purposes of the ``small business'' definition.

DATES: The announcement of the guidance is published in the Federal
Register on June 21, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-0671 for ``Determining the Number of Employees for Purposes
of the `Small Business' Definition in Parts 117 and 507 (CGMP and
Preventive Controls Regulations for Human and Animal Food): 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
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT:
    For questions relating to CGMP, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.
    For questions relating to CGMP, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals: Jeanette Murphy, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Determining the Number of Employees for Purposes of the
`Small Business' Definition in Parts 117 and 507 (CGMP and Preventive
Controls Regulations for Human and Animal Food): Guidance for
Industry.'' We are issuing the guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on this topic. 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.
    This guidance concerns two regulations that we have established in

Title 21 of the Code of Federal Regulations (21 CFR) as part of our
implementation of the FDA Food Safety Modernization Act (FSMA) (Pub. L.
111-353). These two regulations are part 117 (21 CFR part 117)
(September 17, 2015, 80 FR 55907) and part 507 (21 CFR part 507)
(September 17, 2015, 80 FR 51670). Under parts 117 and 507, whether a
business is a ``small business'' has two main implications. First,
certain small businesses are exempt from the human food preventive
controls requirements and the animal food preventive controls
requirements if they are engaged only in specified low-risk activity/
food combinations. Second, small businesses have later compliance dates
for parts 117 and 507 than larger businesses. This guidance provides
additional information to assist businesses in determining their status
as a ``small business.''
    In the Federal Register of March 20, 2018 (83 FR 12143), we made
available a draft guidance for industry entitled ``Determining the
Number of Employees for Purposes of the `Small Business' Definition in
Parts 117 and 507: Guidance for Industry'' and gave interested parties
an opportunity to submit comments by May 21, 2018, for us to consider
before beginning work on the final version of the guidance. We received
no substantive comments on the draft guidance and are issuing the
guidance with editorial changes to improve clarity and revision of one
example to improve usefulness. The guidance announced in this notice
finalizes the draft guidance dated March 2018.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances 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 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13223 Filed 6-20-19; 8:45 am]
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