[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48633-48634]
[FR Doc No: 2018-20902]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4318]

Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other
Entities; 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 or the Agency) is
announcing the availability of a guidance for industry entitled
``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.''
This guidance sets forth FDA's policy regarding compounding and
repackaging of radiopharmaceuticals for human use by State-licensed
nuclear pharmacies, Federal facilities, and other entities that hold a
radioactive materials (RAM) license for medical use issued by the
Nuclear Regulatory Commission (NRC) or by an Agreement State. Because
such radiopharmaceuticals are not eligible for exemptions from
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
related to the production of drugs, FDA is issuing this guidance to
describe the conditions under which it generally does not intend to
take action for violations of certain provisions of the FD&C Act when
these entities compound or repackage radiopharmaceuticals.

DATES: The announcement of the guidance is published in the Federal
Register on September 26, 2018.

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-2016-D-4318 for ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities.'' 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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-

0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Compounding and Repackaging of Radiopharmaceuticals by
State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain
Other Entities.'' Under current law, radiopharmaceuticals that are
compounded by entities that are not registered with FDA as outsourcing
facilities, and radiopharmaceuticals that are repackaged, are subject
to all applicable provisions of the FD&C Act related to the production
of drugs. Because Congress explicitly excluded radiopharmaceuticals
from section 503A of the FD&C Act (21 U.S.C. 353a) (see section
503A(d)(2)),\1\ compounded radiopharmaceuticals are not eligible for
the exemptions under section 503A from section 505 (21 U.S.C. 355)
(concerning new drug approval requirements), section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning labeling with adequate directions for
use), and section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice requirements). In addition, the
FD&C Act does not provide an exemption for repackaged
radiopharmaceuticals.
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    \1\ Section 503A of the FD&C Act describes the conditions that
must be met for drug products compounded by a licensed pharmacist in
a State-licensed pharmacy or Federal facility, or by a licensed
physician, to qualify for exemptions from sections 505, 502(f)(1),
and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act
states that ``this section shall not apply to . . .
radiopharmaceuticals.''
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    FDA is issuing this guidance to describe the conditions under which
the Agency generally does not intend to take action for violations of
sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a State-
licensed nuclear pharmacy, Federal facility, or other facility that is
not an outsourcing facility and that holds a RAM license for medical
use issued by the NRC or by an Agreement State compounds or repackages
radiopharmaceuticals for human use.
    Elsewhere in this issue of the Federal Register, FDA has announced
the availability of a separate guidance document concerning compounding
and repackaging of radiopharmaceuticals by outsourcing facilities
entitled ``Compounding and Repackaging of Radiopharmaceuticals by
Outsourcing Facilities.''
    In the Federal Register of December 29, 2016 (81 FR 96011), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on
February 27, 2017. FDA received comments on the draft guidance. In
response to received comments or on its own initiative, FDA made
several changes that are reflected in this final guidance. For example,
in response to requests in comments for clarification regarding the
beyond-use-date, FDA added a recommendation that sterile
radiopharmaceuticals should be compounded in compliance with USP
Chapter <797>. In addition, to address questions raised in comments,
FDA clarified the applicability of this guidance to various settings in
which radiopharmaceuticals are administered, such as nuclear medicine
departments and imaging centers, by clarifying that the policies in the
guidance apply to facilities that are not outsourcing facilities and
that hold a RAM license for medical use issued by the NRC or by an
Agreement State.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject
to review by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information have been approved under OMB control number 0910-0858.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20902 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 53 (Monday, March 19, 2018)]
[Notices]
[Pages 12054-12057]
[FR Doc No: 2018-05449]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82864; File No. SR-NYSEAMER-2018-07]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Amending the
NYSE American Company Guide To Require That Listed Companies Provide
Notice to the Exchange of Announcements of Dividends or Stock
Distributions at Least Ten Minutes in Advance of Public Release

March 13, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on March 1, 2018, NYSE American LLC (the ``Exchange'' or
``NYSE American'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE American Company Guide (the
``Company Guide'') to (i) require that listed companies provide notice
to the Exchange of announcements of dividends or stock distributions at
least 10 minutes in advance of public release, (ii) clarify the
application of the immediate release policy to dividends and stock
distributions, and (iii) adopt a provision specifying how listed
companies must provide required notifications to the Exchange.
    The proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text

of those statements may be examined at the places specified in Item IV
below. The Exchange has prepared summaries, set forth in sections A, B,
and C below, of the most significant parts of such statements.

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

1. Purpose
    NYSE American LLC (``NYSE American'' or the ``Exchange'') proposes
to amend the NYSE American Company Guide (the ``Company Guide'') to (i)
require that listed companies provide notice to the Exchange of
announcements of dividends and stock distributions at least 10 minutes
in advance of public release, (ii) clarify the application of the
immediate release policy to dividends and stock distributions, and
(iii) adopt a provision specifying how listed companies must provide
required notifications to the Exchange.
Advance Notice Requirements for Dividends and Stock Distributions
    Section 501 of the Company Guide currently requires listed
companies to publicize and notify the Exchange immediately of any
action taken in respect to the payment or non-payment of dividends. The
Exchange proposes to amend Section 501 to require listed companies to
provide notice to the Exchange at least 10 minutes before making any
public announcement with respect to a dividend or stock distribution
\4\ in all cases (including the omission or postponement of a dividend
action at the customary time as well as the declaration of a dividend),
including outside of the hours in which the Exchange's immediate
release policy is in operation.\5\ The rule as revised will provide
that such notice is in addition to immediate publicity, should be given
as soon as possible after declaration (but in any event at least ten
days in advance of the record date), and should be given to the
Exchange in accordance with proposed Section 405 (as described below).
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    \4\ The Exchange proposes to expand Section 501 to encompass
stock distributions as well as cash dividends. The Exchange believes
it is appropriate to treat stock distributions the same as cash
dividends for this purpose as they have a similar effect on the
economic interests of the shareholders and the trading market for
the shares. This approach mirrors the approach taken in the
comparable provision in the NYSE Listed Company Manual.
    \5\ Pursuant to Section 401(a) of the Company Guide, listed
companies must comply with the Exchange's immediate release policy
between 7:00 a.m. and 4:00 p.m., Eastern Time.
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    The principal effect of this amendment is to require listed
companies to provide 10 minutes advance notice to the Exchange with
respect to a dividend or stock distribution announcement made at any
time, rather than just during the hours of operation of the immediate
release policy, as is currently the case. The amended policy would take
effect as of April 1, 2018. A comparable amended dividend notification
policy recently adopted by the New York Stock Exchange (``NYSE'') was
implemented on February 1, 2018.\6\
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    \6\ See 82 FR 39485 (August 18, 2017); Securities Exchange Act
Release No. 81393 (August 14, 2017) (SR-NYSE-2017-17). See also 82
FR 42712 (September 11, 2017); Securities Exchange Act Release No.
81531 (September 5, 2017) (SR-NYSE-2017-43) (delaying implementation
of the amended NYSE dividend notice requirements).
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    The Exchange believes there are significant benefits to requiring
listed companies to provide all announcements of dividends and stock
distributions to the Exchange prior to their public dissemination. In
particular, if the Exchange is provided dividend and stock distribution
information prior to its public availability, Exchange staff will be
able to address any issues that may arise in relation to any
announcement of a dividend or stock distribution. The proposed advance
notice requirement will enable Exchange staff to ensure that a listed
company's proposed dividend or stock distribution schedule complies
with applicable Exchange requirements, including the requirement to
provide 10 days advanced notice of the record date, and that the
company's disclosure of the application of the Exchange's ``ex''-
dividend trading policy will be accurate. The Exchange intends to have
staff available at all times to review dividend and stock distribution
notifications immediately upon receipt, regardless of what time or day
of the week they are provided. The staff will contact a listed company
immediately if there is a problem with its notification. Addressing
problems with dividend and stock distribution notifications before they
are issued publicly will avoid any confusion in the marketplace
resulting from the dissemination of inaccurate information.
    The Exchange proposes amendments to Sections 503 and 504 to conform
to the proposed revisions to Section 501. The proposed amendments to
Section 503 would: (i) Specify that the company announcing a cash or
stock dividend should comply with the notification requirements set
forth in proposed Section 405 and proposed amended Section 501, as well
as the immediate release policy set forth in proposed amended Sections
401(a) and (b) (as described below); and (ii) delete the detailed
discussion in that rule of the methods by which companies comply with
the immediate release policy, as that discussion is made redundant by
the cross-reference to Sections 401(a) and (b). The proposed amendments
to Section 504 would specific that announcements with respect to non-
payment of dividends should be provided to the Exchange pursuant to
Section 501 and issued to the public pursuant to the immediate release
policy set forth in Sections 401 and 402 and that the notice and
announcement should be in the form specified in Section 503.
Application of Immediate Release Policy to Dividends
    Section 401(a) of the Company Guide provides that a listed company
is required to make immediate public disclosure of all material
information concerning its affairs, except in unusual circumstances
(referred to as the Exchange's ``immediate release policy''). When such
disclosure is to be made between 7:00 a.m. and 4:00 p.m., Eastern Time,
it is essential that the Exchange be notified at least ten minutes
prior to the announcement. The Exchange proposes to add commentary to
Section 401(a), to clarify that listed companies must comply with the
notification procedures in Sections 401(a) and (b) with respect to all
announcements relating to a dividend or stock distribution when such
disclosure is to be made between 7:00 a.m. and 4:00 p.m., Eastern Time.
The proposed commentary would also specify that listed companies must
also comply with the notification requirements of proposed amended
Section 501 with respect to all such announcements, including outside
of the hours of operation of the immediate release policy.
Uniform Method for Providing Notifications to the Exchange
    The Exchange proposes to adopt as new Section 405 of the Company
Guide a provision that will specify how listed companies must comply
with rules requiring them to provide notifications to the Exchange,
including under Section 501. This proposed provision is substantively
the same as Section 204.00(A) of the NYSE Listed Company

Manual.\7\ At the time of initial adoption, Section 405 would only
apply initially to notifications required under proposed amended
Section 501.
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    \7\ See Securities Exchange Act Release No. 68635 (January 11,
2013); 78 FR 3958 (January 17, 2013) (SR-NYSE-2012-54).
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    Under proposed Section 405, the company shall provide such notice
via a web portal or email address specified by the Exchange on its
website (and the Exchange shall promptly update and prominently display
the applicable information on its website in the event that it ever
changes), except in emergency situations, when notification may instead
be provided by telephone and confirmed by facsimile as specified by the
Exchange on its website. For purposes of Section 405, an emergency
situation will include lack of computer or internet access; a technical
problem on the systems of either the listed company or the Exchange; or
an incompatibility between the systems of the listed company and the
Exchange. Section 405 will remind listed companies that they must
continue to use the Exchange's telephone alert procedures when
notifying the Exchange of any material event or a statement dealing
with a rumor which calls for immediate release under Section 401. If a
rule containing a notification requirement does not specify that such
requirement must be met by complying with the notification procedures
set forth in Section 405, the company will be permitted to use the
methods provided by Section 405 or any other reasonable method. Section
405 will state that listed companies are encouraged to contact their
Exchange representative if they have any questions about the
appropriate method of providing notification under applicable Exchange
rules.
    The purpose of proposed Section 405 is to clarify the methods by
which listed companies must notify the Exchange when certain events
occur. By creating a uniform method of notification by web portal or
email for Exchange notification requirements, the Exchange may reduce
the likelihood that companies make a mistake when trying to notify the
Exchange of important events. In particular, timely notification with
respect to dividends and other distributions is critical to allow
investors time to make arrangements to be holders of a security by a
certain date for a distribution or shareholder meeting. In such cases,
it makes sense to require listed companies to give notice to the
Exchange using current, efficient electronic methods that more easily
lend themselves to accurate recordkeeping than manual or written
methods.
2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with Section 6(b) \8\ of the Act, in general, and further the
objectives of Section 6(b)(5) of the Act,\9\ in particular in that they
are designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest
and are not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed amendment to Section 501 of
the Company Guide and the conforming amendments to Sections 503 and 504
are consistent with the protection of investors and the public interest
in accordance with Section 6(b)(5) of the Act in that the changes
should allow Exchange staff to resolve any rule compliance issues with
a listed company's dividend or stock distribution action prior its
public announcement. By requiring listed companies to provide the
Exchange dividend or stock distribution notices at least ten minutes
prior to the public announcement of a distribution, irrespective of the
time of day (rather than limited to the hours of 7:00 a.m. and 4:00
p.m. as in the current rule), the Exchange should be able to address
any concerns with the content of such notifications (including the ten
day advance notice requirement), to ensure compliance with both
Exchange and Commission rules, consistent with investor protection and
the public interest. In addition, the proposed amendments are
reasonably designed to reduce the possibility for investor confusion in
the marketplace resulting from the dissemination of inaccurate or
misleading dividend or stock distribution information.
    The Exchange believes that the proposed amendments to Section
401(a) of the Company Guide are consistent with the Act in that they
will provide transparency and clarity to listed companies on the
application of the immediate news release policy to dividend or stock
distribution announcements.
    The Exchange believes that the adoption of proposed Section 405 of
the Company Guide is consistent with the protection of investors and
the public interest in accordance with Section 6(b)(5) of the Act
because it is intended to clarify the methods by which listed companies
must notify the Exchange when certain events occur. By creating a
uniform method of notification by web portal or email for Exchange
notification requirements, the Exchange may reduce the likelihood that
companies make a mistake when trying to notify the Exchange of
important events. In particular, timely notification with respect to
dividends and other distributions is critical to allow investors time
to make arrangements to ensure that they are holders of a security on
the record date for a distribution or shareholder meeting. In such
cases, it makes sense to require listed companies to give notice to the
Exchange using current, efficient electronic methods that more easily
lend themselves to accurate recordkeeping than manual or written
methods.

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

    The Exchange believes that the proposed amendments to the Company
Guide do not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
rule change does not affect competition in any way. Rather, the
proposed rule changes will (i) enable the Exchange to be aware of all
dividend announcements before they are made so that Exchange staff is
appropriately informed to enable it to address any rule compliance
problems with a listed company's dividend schedule before it is
publicly announced and (ii) specify a uniform approach to providing
notifications to the Exchange.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has

become effective pursuant to Section 19(b)(3)(A) of the Act \10\ and
Rule 19b-4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of such 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.

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 protected]. Please include
File Number SR-NYSEAMER-2018-07 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-NYSEAMER-2018-07. 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-NYSEAMER-2018-07, and should be
submitted on or before April 9, 2018.
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    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-05449 Filed 3-16-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59129-59131]
[FR Doc No: 2016-19925]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 100, 101, and 104

[Docket No. FDA-2016-N-0011]

Food Labeling; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food labeling regulations by redesignating a provision, updating any
references to that provision to reflect the redesignation, and revising
the section heading. The rule does not alter the content or application
of the redesignated provision in any substantive manner. This action is
editorial in nature and is intended to provide clarity and consistency
to our regulations.

DATES: This rule is effective August 29, 2016.

FOR FURTHER INFORMATION CONTACT: Carole Adler, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1451 et seq.)
requires certain consumer commodities sold in interstate commerce to be
honestly and informatively labeled to facilitate value comparisons and
enable consumers to make informed choices. FDA administers and enforces
the FPLA with respect to drugs, cosmetics, medical devices, and certain
foods. Pursuant to our authority under FPLA, FDA issued certain food
labeling regulations, including specifications regarding the statement
of identity and the net quantity of contents statement, which must be
present on the labels of most packaged foods. Our regulations affecting
the declaration of a food product's net quantity of contents are
currently located in Sec.  101.105 (21 CFR 101.105). Section 101.105
specifies how the net quantity of contents must be expressed on the
package, including the required units of measurement, wording,
typeface, and size to be used in the declaration, as well as the
location of the declaration on the label or package. Currently, Sec.
101.105 requires that the units of measurement be expressed using the
most appropriate units of the customary inch/pound (avoirdupois) system
carried out to not more than two decimal places, as applicable.
    In the Federal Register of May 21, 1993 (58 FR 29716), we proposed
to amend our food labeling regulations to require that the net quantity
of contents declaration be expressed using the most appropriate units
of both imperial units (inches/pounds) and the metric system
(International System of Units (SI)). The rule also proposed to provide
examples of the quantity of contents declaration, include the SI
equivalents to the avoirdupois terms used in the regulation, provide a
specific conversion chart for use in calculating the conversion between
the two systems of measurement, include SI terminology, provide
exemptions from SI labeling requirements, permit the expression of the
net quantity of contents to be carried out up to three decimal places,
and make the SI declaration of the net quantity of contents on random
weight packages optional. Additionally, the rule proposed certain
technical amendments, including redesignating Sec.  101.105 as new
Sec.  101.7, revising the section heading to correct the title of the
section, and making other editorial changes to the net quantity of
contents regulations. In the Federal Register of April 22, 2003 (68 FR
19766), we announced our intent to withdraw the proposed rule, along
with several other unrelated proposed actions that had been published
more than 5 years before the withdrawal, but never finalized. The
withdrawal was part of an overall regulatory reform initiative to
reduce our regulatory backlog and focus our resources on higher
priority regulations.
    Through this final rule, we are making some of the same technical
amendments to the declaration of net contents provision that were
proposed in 1993. However, we are not proposing at this time to
reinstitute rulemaking proceedings concerning the remaining amendments
proposed in 1993, such as those pertaining to the declaration of net
quantity in SI units or those modifying the expression of net quantity
in decimal fractions.

II. Provisions of Technical Amendments

    We are making technical amendments in our regulations at parts 1,
100, 101, and 104 (21 CFR parts 1, 100, 101, and 104) to redesignate
Sec.  101.105 as new Sec.  101.7, update references in other provisions
to reflect this redesignation, and revise the section heading of the
redesignated provision. Nothing in these technical amendments is to be
construed as modifying the applicability of the current regulations
affecting the declaration of net quantity of contents.

A. Redesignation

    FDA is amending the food labeling provisions in Sec.  101.105 by
redesignating Sec.  101.105 as new Sec.  101.7. Section 101.105 is
currently located in part 101, subpart G, which is entitled
``Exemptions From Food Labeling Requirements.'' However, Sec.  101.105
contains no information pertaining to when a food is exempt from a
declaration of the net quantity of contents. Instead, Sec.  101.105
establishes general provisions for the declaration of the statement of
net quantity of contents on the labels of most packaged foods. By
redesignating Sec.  101.105 as new Sec.  101.7, we are moving the
provision to subpart A, entitled ``General Provisions.'' Subpart A
provides general food labeling regulations and is a more appropriate
location for a provision regulating the declaration of net quantity of
contents.

B. Revising Section Heading

    We also are revising the section heading of new Sec.  101.7 to
read: ``Declaration of net quantity of contents'' instead of
``Declaration of net quantity of contents when exempt.'' The revised
heading, by removing any reference to exemptions, is more reflective of
the section's general provisions for the declaration of the statement
of net quantity of contents on all food labels. The revised heading
does not alter the substance of the provision.

C. Revising References

    Several existing regulations refer to Sec.  101.105. Therefore,
because we are redesignating Sec.  101.105 as a new Sec.  101.7, we are
making corresponding editorial changes to reflect the redesignation in
parts 1, 100, 101, and 104. These corresponding changes replace any
mention of Sec.  101.105 with Sec.  101.7.

III. Notice and Public Comment

    Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because these
amendments are nonsubstantive and provide only technical changes to
redesignate an existing regulation, make corresponding changes to other
regulations to reflect the redesignated section number, and make an
editorial change to the section heading. These technical amendments are
being made to improve the accuracy of our regulations.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 100

    Administrative practice and procedure, Food labeling, Food
packaging, Foods, Intergovernmental relations.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 104

    Food grades and standards, Frozen foods, Nutrition.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, the Food and
Drug Administration amends 21 CFR parts 1, 100, 101, and 104 as
follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343,
350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362,
371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241,
243, 262, 264.

Sec.  1.1 [Amended]

0
2. Amend Sec.  1.1(c) as follows:
0
a. Remove ``101.105(f)'' and add in its place ``101.7(f)''.
0
b. Remove ``101.105(i)'' and add in its place ``101.7(i)''.
0
c. Remove ``101.105(j)'' and add in its place ``101.7(j)''.
0
d. Remove ``101.105(o)'' and add in its place ``101.7(o)''.

Sec.  1.20   [Amended]

0
3. In Sec.  1.20, by removing ``Sec.  101.105(f)'' and adding in its
place ``Sec.  101.7(f)''.

Sec.  1.24   [Amended]

0
4. Amend Sec.  1.24 as follows:
0
a. Remove ``Sec.  101.105'' in paragraph (a)(2) and add in its place
``Sec.  101.7''.
0
b. Remove ``Sec.  101.105(b)(2)'' wherever it appears and add in its
place ``Sec.  101.7(b)(2)''.
0
c. Remove ``Sec.  101.105(f)'' wherever it appears and add in its place
``Sec.  101.7(f)''.
0
d. Remove ``Sec.  101.105(j)'' wherever it appears and add in its place
``Sec.  101.7(j)''.
0
e. Remove ``Sec.  101.105(j)(1)'' wherever it appears and add in its
place ``Sec.  101.7(j)(1)''.

PART 100--GENERAL

0
5. The authority citation for part 100 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 337, 342, 343, 348, 371.

Sec.  100.155  [Amended]

0
6. Amend Sec.  100.155 in paragraphs (a) and (b) by removing ``Sec.
101.105'' and adding in its place ``Sec.  101.7''.

PART 101--FOOD LABELING

0
7. The authority citation for part 101 continues to read as follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

Sec.  101.2 [Amended]

0
8. Amend Sec.  101.2 in paragraph (c) introductory text by removing
``Sec.  101.105(h)(1)'' and adding in its place ``Sec.  101.7(h)(1)''.

Sec.  101.105   [Redesignated as Sec.  101.7]

0
9. Redesignate Sec.  101.105 as Sec.  101.7.

0
10. Revise newly designated Sec.  101.7 section heading to read as
follows:

Sec.  101.7  Declaration of net quantity of contents.

* * * * *

Sec.  101.13   [Amended]

0
11. Amend paragraphs (d)(2), (h)(4)(i), and (i)(2) by removing ``Sec.
101.105(i)'' and adding in its place ``Sec.  101.7(i)''.

Sec.  101.30   [Amended]

0
12. Amend Sec.  101.30(g) by removing ``Sec.  101.105(i)'' and adding
in its place ``Sec.  101.7(i)''.

PART 104--NUTRITIONAL QUALITY GUIDELINES FOR FOODS

0
13. The authority citation for part 104 continues to read as follows:

    Authority:  21 U.S.C. 321, 343, 371(a).

Sec.  104.5   [Amended]

0
14. Amend Sec.  104.5(b) by removing ``Sec.  101.105'' and adding in
its place ``Sec.  101.7''.

    Dated: August 16, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19925 Filed 8-26-16; 8:45 am]
 BILLING CODE 4164-01-P