[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Notices]
[Page 12431-12433]
[DOCID:fr24mr09-142]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59581; File No. SR-NYSE-2009-26]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC
Extending Until June 9, 2009, the Operation of Interim NYSE Rule 128
Which Permits the Exchange To Cancel or Adjust Clearly Erroneous
Executions if They Arise Out of the Use or Operation of Any Quotation,
Execution or Communication System Owned or Operated by the Exchange,
Including Those Executions That Occur in the Event of a System
Disruption or System Malfunction

 March 16, 2009.
    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 9, 2009, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') 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 extend until June 9, 2009, the operation
of interim NYSE Rule 128 (``Clearly Erroneous Executions for NYSE
Equities'') which permits the Exchange to cancel or adjust clearly
erroneous executions if they arise out of the use or operation of any
quotation, execution or communication system owned or operated by the
Exchange, including those executions that occur in the event of a
system disruption or system malfunction.

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
    The Exchange proposes to extend until June 9, 2009, the operation
of interim NYSE Rule 128 (``Clearly Erroneous Executions for NYSE
Equities'') which permits the Exchange to cancel or adjust clearly
erroneous executions if they arise out of the use or operation of any
quotation, execution or communication system owned or operated by the
Exchange, including those executions that occur in the event of a
system disruption or system malfunction.
    Prior to the implementation of NYSE Rule 128 on January 28,
2008,\4\ the NYSE did not have a rule providing the Exchange with the
authority to cancel or adjust clearly erroneous trades of securities
executed on or through the systems and facilities of the NYSE.
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    \4\ See Securities Exchange Act Release No. 57323 (February 13,
2008), 73 FR 9371 (February 20, 2008) (SR-NYSE-2008-09).
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    In order for the NYSE to be consistent with other national
securities exchanges which have some version of a clearly erroneous
execution rule, the Exchange is drafting an amended clearly erroneous
rule which will accommodate such other exchanges but will be
appropriate for the NYSE market model.
    The NYSE notes that the Commission approved an amended clearly
erroneous execution rule for Nasdaq in May 2008.\5\ On July 28, 2008,
the Exchange filed with the SEC a request to extend the operation of
interim Rule 128 until October 1, 2008 \6\ in order to review the
provisions of Nasdaq's clearly erroneous rule and to consider
integrating similar standards into its own amendment to Rule 128. On
October 1, 2008,\7\ the Exchange filed with the SEC a further request
to extend the operation of interim Rule 128 until January 9, 2009 in
order to consider integrating similar standards into the amendment to
Rule

128. On January 9, 2009,\8\ the Exchange filed with the SEC a request
to extend the operation of interim Rule 128 until March 9, 2009,
indicating that the Exchange was still in the process of reviewing the
Nasdaq rule with a view towards incorporating certain provisions into
the amendment of interim Rule 128.
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    \5\ See Securities Exchange Act Release No. 57826 (May 15,
2008), 73 FR 29802 (May 22, 2008) (SR-NASDAQ-2007-001).
    \6\ See Securities Exchange Act Release No. 58328 (August 8,
2008), 73 FR 47247 (August 13, 2008) (SR-NYSE-2008-63).
    \7\ See Securities Exchange Act Release No. 58732 (October 3,
2008), 73 FR 61183 (October 15, 2008) (SR-NYSE-2008-99).
    \8\ See Securities Exchange Act Release No. 59255 (January 15,
2009), 74 FR 4496 (January 26, 2009) (SR-NYSE-2009-02).
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    On February 10, 2009, NYSE Arca submitted a proposal to the
Commission to amend its clearly erroneous rule. The NYSE Arca proposed
rule differs in certain respects from the Nasdaq clearly erroneous
rule. Accordingly, the Exchange is presently in the process of
finalizing its review of NYSE Arca's proposed amended CEE [sic] rule,
which includes market wide CEE [sic] initiatives, to determine if it is
appropriate to incorporate such provisions into the Rule 128 amendment.
The Exchange is, therefore, requesting to extend the operation of
interim Rule 128 until June 9, 2009. Prior to June 9, 2009, the
Exchange intends to file a 19b-4 rule change amending interim Rule 128,
which, if approved by the SEC, will be effective after June 9, 2009.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (the ``Act'')
\9\ for this proposed rule change is the requirement under Section
6(b)(5)\10\ that an Exchange have rules that are designed to promote
just and equitable principles of trade, 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.
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    \9\ 15 U.S.C. 78f(a). [sic]
    \10\ 15 U.S.C. 78f(b)(5).
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    As articulated more fully above, the proposed rule would place the
NYSE on equal footing with other national securities exchanges. This
will promote the integrity of the market and protect the public
interest, since it would permit all exchanges to cancel or adjust
clearly erroneous trades when such trades occur, rather than canceling
them on all other markets, but leaving them standing on only one
market.

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 solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \11\ of the Act and Rule 19b-4(f)(6) \12\ thereunder. The
proposed rule change effects a change that (A) does not significantly
affect the protection of investors or the public interest; (B) does not
impose any significant burden on competition; and (C) by its terms,
does not become operative for 30 days after the date of the filing, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest; provided that the
self-regulatory organization has given 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.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
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    The Exchange believes that good cause, consistent with the
provisions of Rule 19b-4(f)(6), exists to justify making the rule
change immediately effective. Because the proposed rule is based on a
rule that has been previously approved by the Commission, and because
the proposed rule would in any event be operative only until a more
robust and market-appropriate rule was implemented, the NYSE believes
that the proposed rule is non-controversial. Moreover, the NYSE
believes that the absence of such a rule in an automated and fast-paced
trading environment poses a danger to the integrity of the markets and
the public interest, and that this exigency justifies filing the rule
for immediate effectiveness rather than using the regular Rule 19b-2
process, which would require the Exchange to continue without the
protection of the proposed rule until the expiration of the prescribed
time periods for notice, comment and approval. In contrast, immediate
effectiveness of the proposed rule will immediately and timely enable
the NYSE to cancel or adjust clearly erroneous trades that may present
a risk to the integrity of the equities markets and all related
markets. The proposed rule will also allow the Exchange to protect
customers and the public interest, and to continue to provide
economically efficient execution of securities transactions.
    The NYSE also requests that the Commission waive the five-day
period for notice of intent to file this proposed rule change, and the
30-day period before the rule becomes operative, both of which are
prescribed by Rule 19b-4(f)(6), but which may be waived pursuant to
Rule 19b-4(f)(6)(iii) \13\ if such action is consistent with the
protection of investors and public interest.\14\ The Exchange believes
that waiver of these time periods so that the rule may be immediately
operative are consistent with the protection of investors and the
public interest for the reasons described above.
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    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ In fact, the Commission notes, under Rule 19b-4(f)(6)(iii),
the ``consistent with the protection of investors and public
interest'' standard applies only to the Commission's waiver of the
30-day operative delay. 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 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.
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    The Commission believes that waiving the 30-day operative delay
will allow the Exchange to continue to immediately and timely cancel or
adjust trades that it determines to be clearly erroneous under Rule
128. The Commission believes that the extension of NYSE Rule 128 until
June 9, 2009 will allow the Exchange to continue to apply the rule
without interruption and is consistent with the protection of investors
and the public interest. The Commission hereby designates the proposal
as operative upon filing.\15\ The Commission has determined to waive
the five-day prefiling period in this case.
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    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate the 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2009-26 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-NYSE-2009-26. This
file number should be included on the subject line if e-mail 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 inspection
and copying 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 such filing also will be available for
inspection and copying at the principal office of the NYSE. 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-NYSE-2009-26 and should be
submitted on or before April 14, 2009.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-6397 Filed 3-23-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Notices]
[Pages 63333-63334]
[FR Doc No: 2020-22207]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Additional Public Comment Period--Notice of
Availability of a Draft Environmental Impact Statement (EIS) for the
Proposed LaGuardia Access Improvement Project at LaGuardia Airport
(LGA), New York City, Queens County, New York

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of additional 15-day public comment period for the Draft
Environmental Impact Statement for the proposed LaGuardia Access
Improvement Project at LaGuardia Airport (LGA), New York City, Queens
County, New York.

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SUMMARY: This notice provides an additional 15-day public comment
period for the Draft Environmental Impact Statement (EIS) for the
proposed LaGuardia Airport Access Improvement Project prepared to
disclose the potential environmental impacts resulting from the
Proposed Action, including real property transactions under the New
York State Eminent Domain Procedures Law. This notice announces the
extension of the public comment period to solicit public comments on
the Draft EIS.

DATES: The public comment period on the Draft EIS started on August 21,
2020 and has been extended to end on October 20, 2020. All comments
must be received by no later than 5:00 p.m. Eastern Daylight Time,
Tuesday, October 20, 2020.

ADDRESSES: Oral comments on the Draft EIS may be presented by leaving a
voicemail at (855) LGA-EIS9 or<PHONE_NUMBER>. Written comments on the
Draft EIS may be submitted via the following methods:
     Online on the project website at https://www.lgaaccesseis.com/formal-comment.
     Email to<EMAIL_ADDRESS>     U.S. Mail to Mr. Andrew Brooks, Environmental Program
Manager, Eastern Region Office, AEA-610, Federal Aviation
Administration, 1 Aviation Plaza, Jamaica, NY 11434.
    Comments on the Draft EIS will help FAA arrive at the best possible
informed decision about the proposal. If you choose to include your
name, address and telephone number, email, or other personal
identifying information in your comment, be advised that your entire
comment--including your personal identifying information--may be made
publicly available at any time. While you can ask us in your comment to
withhold your personal identifying information, FAA cannot guarantee
that we will be able to do so.

FOR FURTHER INFORMATION CONTACT: Mr. Andrew Brooks, Environmental
Program Manager, Eastern Region Office, AEA-610, Federal Aviation
Administration, 1 Aviation Plaza, Jamaica, NY 11434. Telephone: 718-
553-2511.

SUPPLEMENTARY INFORMATION: This notice continues the public comment
period on the Draft EIS for the LaGuardia Airport Access Improvement
Project announced in the Notice of Availability of a Draft
Environmental Impact Statement (EIS) and Notice of Public Workshops and
Hearings for the Proposed LaGuardia Access Improvement Project at
LaGuardia Airport (LGA), New York City, Queens County, New York, 85 FR
51142, August 19, 2020.
    The Draft EIS was prepared in response to a proposal presented by
the Port Authority of New York and New Jersey (Port Authority). The
Port Authority operates LGA under a lease agreement with the City of
New York. FAA must decide whether to approve, pursuant to 49 U.S.C.
47106 and 47107 relating to the eligibility of the Proposed Action for
federal funding under the Airport Improvement Program (AIP) and/or
under 49 U.S.C. 40117, as implemented by 14 CFR 158.25, to impose and
use passenger facility charge (PFC) revenue collected for the Proposed
Action to assist with construction of potentially eligible development
items shown on the Airport Layout Plan (ALP). FAA approval of the
eligibility for federal funding under AIP or to impose and use PFCs is
a Federal action that must

comply with NEPA requirements. FAA, as lead federal agency, invited the
U.S. Army Corps of Engineers, U.S. Environmental Protection Agency, New
York State Department of Environmental Conservation, New York State
Department of Transportation, and New York State Office of Parks,
Recreation and Historic Preservation to participate as cooperating
agencies, which they have accepted, as described under 40 CFR
1501.6(a)(1).
    The Draft EIS presents the purpose and need for the Proposed
Action, analysis of reasonable alternatives, discussion of impacts for
each reasonable alternative, and support appendices. Pursuant to 40 CFR
1502.14(d), the No Action Alternative is also assessed in the Draft EIS
as the baseline for comparison purposes. The Proposed Action includes:
     Construction of an above ground fixed guideway automated
people mover (APM) system approximately 2.3 miles in length that
extends from the future LGA Central Hall Building to the Metropolitan
Transportation Authority (MTA) Long Island Rail Road (LIRR) Mets-
Willets Point Station and the New York City Transit (NYCT) 7 Line Mets-
Willets Point Station;
     construction of two on-Airport APM stations (Central Hall
APM Station and East APM Station) and one off-Airport APM station at
Willets Point (Willets Point APM Station) that provides connections to
the Mets-Willets Point LIRR and NYCT 7 Line stations;
     construction of passenger walkway systems to connect the
APM stations to the passenger terminals, parking garages, and ground
transportation facilities;
     construction of a multi-level APM operations, maintenance,
and storage facility (OMSF) that includes up to 1,000 parking spaces
(500 for airport employees, 250 for MTA employees, 50 for APM
employees, and 200 for replacement Citi Field parking);
     construction of three traction power substations: One
located at the on-Airport East Station, another at-grade west of the
proposed Willets Point Station just south of Roosevelt Avenue, and the
third at the OMSF to provide power to the APM guideway;
     construction of a 27 kV main substation located adjacent
to the OMSF structure on MTA property;
     construction of utilities infrastructure, both new and
modified, as needed, to support the Proposed Action, including a
permanent stormwater outfall into Flushing Creek and a temporary
stormwater outfall into Flushing Creek; and
     acquisition of temporary and permanent easements.
    The Proposed Action also includes various connected actions,
including: Utility relocation and demolition of certain existing
facilities; a temporary MTA bus storage/parking facility; relocation of
up to 200 Citi Field parking spaces; demolition and replacement of the
Passerelle Bridge; temporary walkway to maintain access between the
transit stations and Flushing Meadows-Corona Park; modifications to the
MTA LIRR Mets-Willets Point Station, including service changes to the
LIRR Port Washington Line; and the relocation of a boat lift, finger
piers and connected timber floating dock, Marina office and boatyard
facility, boat storage and parking, and operations shed, part of the
World's Fair Marina.
    FAA provides the following notices:
     Pursuant to 36 CFR 800.8(c) that it is using the NEPA
process to notify the public of FAA's finding that the proposed
undertaking would adversely affect properties listed or eligible for
listing on the National Register of Historic Places and is seeking
public comment on the measures proposed to avoid, minimize, or mitigate
such effects disclosed in the Draft EIS. A Draft Memorandum of
Agreement to resolve adverse effects to historic properties is included
in Appendix K.11 of the Draft EIS.
     Pursuant to Section 4(f) of the DOT Act, FAA has prepared
a Draft Section 4(f) Evaluation (see Appendix I of the Draft EIS). The
Proposed Action would have a significant impact on Section 4(f)
resources and is seeking public comments on impacts and proposed
mitigation disclosed in Chapter 3.8 of the Draft EIS.
     Pursuant to DOT Order 5610.2(a), DOT Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations, the Proposed Action would have a significant impact on
minority environmental justice populations and is seeking public
comments on impacts and proposed mitigation disclosed in Chapter 3.14
of the Draft EIS.
     Pursuant to Executive Order 11990, Protection of Wetlands,
that the Proposed Action would temporarily affect less than 1 acre of
jurisdictional wetlands in Flushing Creek and less than 1 acre of
temporary and permanent impact in Flushing Bay. Impacts to these
aquatic resources are disclosed in Chapter 3.16 of the Draft EIS.
     Pursuant to Executive Order 11988, Floodplain Management
that the Proposed Action would not result in a significant encroachment
on floodplains. Impacts to floodplains are disclosed in Chapter 3.16 of
the Draft EIS.
    FAA encourages all interested parties to provide comments
concerning the scope and content of the Draft EIS. Comments should be
as specific as possible and address the analysis of potential
environmental impacts and the adequacy of the assessment of the
Proposed Action or merits of its alternatives and the mitigation being
considered. Reviewers should organize their participation so that it is
meaningful and makes the agency aware of the viewers' interests and
concerns using quotations and other specific references to the Draft
EIS and related documents. This commenting procedure is intended to
ensure that substantive comments and concerns are available to FAA in a
timely manner so that FAA has an opportunity to address them. Matters
that could have been raised with specificity during the comment period
on the Draft EIS may not be considered if they are raised for the first
time later in the decision process.
    Following the public comment period, FAA will prepare a Final EIS
and Record of Decision pursuant to 40 CFR 1503.4(c) [Council of
Environmental Quality regulations] and FAA Orders 1050.1F and 5050.4B.
The FAA may issue a single document that consists of the Final
Environmental Impact Statement and Record of Decision pursuant to 49
U.S.C. 304a(b) unless the FAA determines that statutory criteria or
practicability considerations preclude issuance of such a combined
document.

    Issued in Jamaica, New York, October 2, 2020.
Sukhbir Gill,
Assistant Manager, New York Airport District Office, Airports Division,
Eastern Region.
[FR Doc. 2020-22207 Filed 10-6-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5096-5100]
[FR Doc No: 2012-1923]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0993; FRL-9334-5]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Chemical
Substances Inventory (TSCA Inventory)) to notify EPA and comply with
the statutory provisions pertaining to the manufacture of new
chemicals. Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to
publish in the Federal Register a notice of receipt of a premanufacture
notice (PMN) or an application for a test marketing exemption (TME),
and to publish in the Federal Register periodic status reports on the
new chemicals under review and the receipt of notices of commencement
(NOC) to manufacture those chemicals. This document, which covers the
period from December 6, 2011 to December 16, 2011, and provides the
required notice and status report, consists of the PMNs, both pending
or expired, and the NOC to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period.

DATES: Comments identified by the specific PMN number or TME number,
must be received on or before March 2, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0993, and the specific PMN number or TME
number for the chemical related to your comment, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. The
DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the DCO is<PHONE_NUMBER>.
Such deliveries are only accepted during the DCO's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: EPA's policy is that all comments received will be
included in the docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity

or contact information unless you provide it in the body of your
comment. If you send an email comment directly to EPA without going
through regulations.gov, your email address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Bernice Mudd, Information Management Division (7407M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8951; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the PMNs addressed in this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Why is EPA taking this action?

    EPA classifies a chemical substance as either an ``existing''
chemical or a ``new'' chemical. Any chemical substance that is not on
EPA's TSCA Inventory is classified as a ``new chemical,'' while those
that are on the TSCA Inventory are classified as an ``existing
chemical.'' For more information about the TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm. Anyone who plans to
manufacture or import a new chemical substance for a non-exempt
commercial purpose is required by TSCA section 5 to provide EPA with a
PMN, before initiating the activity. Section 5(h)(1) of TSCA authorizes
EPA to allow persons, upon application, to manufacture (includes
import) or process a new chemical substance, or a chemical substance
subject to a significant new use rule (SNUR) issued under TSCA section
5(a), for ``test marketing'' purposes, which is referred to as a test
marketing exemption, or TME. For more information about the
requirements applicable to a new chemical go to: http://ww.epa.gov/opt/newchems.
    Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish
in the Federal Register a notice of receipt of a PMN or an application
for a TME and to publish in the Federal Register periodic status
reports on the new chemicals under review and the receipt of NOCs to
manufacture those chemicals. This status report, which covers the
period from December 6, 2011 to December 16, 2011, consists of the PMNs
and TMEs, both pending or expired, and the NOCs to manufacture a new
chemical that the Agency has received under TSCA section 5 during this
time period.

III. Receipt and Status Reports

    In Table I of this unit, EPA provides the following information (to
the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: The EPA case number assigned to the
PMN, the date the PMN was received by EPA, the projected end date for
EPA's review of the PMN, the submitting manufacturer/importer, the
potential uses identified by the manufacturer/importer in the PMN, and
the chemical identity.

                               Table I--22 PMNs Received From 12/06/11 to 12/16/11
----------------------------------------------------------------------------------------------------------------
                                                  Projected
           Case No.             Received date    notice end     Manufacturer/         Use            Chemical
                                                    date           Importer
----------------------------------------------------------------------------------------------------------------
P-12-0083....................      12/02/2011      02/29/2012  Georgia-Pacific  (G) Ore          (G) Amides,
                                                                Chemicals LLC.   beneficiation.   fatty acids,
                                                                                acetates.
P-12-0086....................      12/02/2011      02/29/2012  3M Company.....  (S) Moisture     (G)
                                                                                curing hot       Polyurethane
                                                                                melt adhesive.   prepolymer.
P-12-0087....................      12/06/2011      03/04/2012  Arkema Inc.....  (S) Used as a    (G) Acrylate
                                                                                viscosity        manufacture
                                                                                modifier/flow    byproduct
                                                                                enhancer for     distillation
                                                                                crude oil;       residues.
                                                                                used in boiler
                                                                                fuels as a
                                                                                burn promoter
                                                                                and for fuel
                                                                                value.
P-12-0088....................      12/06/2011      03/04/2012  CBI............  (G) Polymer for  (G)
                                                                                use in           Polylactide.
                                                                                producing
                                                                                packaging
                                                                                films.
P-12-0089....................      12/06/2011      03/04/2012  Brueggemann      (G) Zinc is a    (S) Process
                                                                Chemical U.S.,   natural,         regulators
                                                                Inc.             essential        other than
                                                                                element, which   polymerisation
                                                                                is needed for    or
                                                                                the optimal      vulcanisation
                                                                                growth and       processes
                                                                                development of   lubricants and
                                                                                all living       lubricant
                                                                                organisms,       additives,
                                                                                including man.   laboratory
                                                                                All living       chemicals, ph-
                                                                                organisms have   regulating
                                                                                homeostasis      agents.
                                                                                mechanisms
                                                                                that actively
                                                                                regulate zinc
                                                                                uptake and
                                                                                absorption/
                                                                                excretion from
                                                                                the body; due
                                                                                to this
                                                                                regulations,
                                                                                zinc and zinc
                                                                                compounds do
                                                                                not
                                                                                bioaccumulate
                                                                                or biomagnify.
                                                                                Most common
                                                                                technical
                                                                                function of
                                                                                substance
                                                                                (what it
                                                                                does): food/
                                                                                feedstuff
                                                                                additive.
P-12-0090....................      12/07/2011      03/05/2012  3M Company.....  (G) Textile      (G) Hydrocarbon
                                                                                treatment        urethane.
                                                                                additive.
P-12-0091....................      12/08/2011      03/06/2012  BASF             (G) Scale        (G)
                                                                Corporation.     inhibitor.       Alkylacrylic
                                                                                acid telomer
                                                                                with
                                                                                carboxylic
                                                                                acid,
                                                                                bisulfite,
                                                                                ester with
                                                                                .alpha.-alkyl-
                                                                                .omega.-
                                                                                hydroxypoly(ox
                                                                                yalkanediyl),
                                                                                alkali metal
                                                                                salt.
P-12-0092....................      12/08/2011      03/06/2012  CBI............  (G) Paint......  (G) Alkyl
                                                                                acrylate,
                                                                                polymer with
                                                                                alkyl
                                                                                acrylate,
                                                                                alkyl
                                                                                methacrylates,
                                                                                styrene and
                                                                                alkyl acid,
                                                                                peroxide-
                                                                                initiated.
P-12-0093....................      12/09/2011      03/07/2012  CBI............  (G) Component    (G) Modified
                                                                                of resin in      epoxy resin.
                                                                                two-part epoxy
                                                                                adhesive.
P-12-0094....................      12/09/2011      03/07/2012  CBI............  (G) Destructive  (G) Polyether
                                                                                use.             polyurethane
                                                                                dispersion.
P-12-0095....................      12/09/2011      03/07/2012  CBI............  (G) Open, non-   (G)
                                                                                dispersive use.  Polyacrylate.
P-12-0096....................      12/09/2011      03/07/2012  3M Company.....  (G) Protective   (G) Blocked
                                                                                treatment.       polyarylfluori
                                                                                nated
                                                                                polyacrylate
                                                                                urethane
                                                                                copolymer.
P-12-0097....................      12/12/2011      03/10/2012  CBI............  (G)              (G)
                                                                                Intermediate     Amidoalkoxysil
                                                                                for coatings.    ane.
P-12-0098....................      12/13/2011      03/11/2012  CBI............  (G) Component    (G) Modified
                                                                                of resin in a    epoxy resin.
                                                                                two-part epoxy
                                                                                adhesive.
P-12-0099....................      12/13/2011      03/11/2012  CBI............  (G) Component    (G) Modified
                                                                                resin in a two-  epoxy resin.
                                                                                part epoxy
                                                                                adhesive.
P-12-0100....................      12/14/2011      03/12/2012  CBI............  (S) Polymer      (G) Fatty
                                                                                modifier.        acids,
                                                                                diesters with
                                                                                dihydroxy
                                                                                bicyclic
                                                                                diether.

P-12-0101....................      12/15/2011      03/13/2012  CBI............  (G) Lens         (G) Substituted
                                                                                material for     carbomonocycli
                                                                                use in           c dicarboxylic
                                                                                electronic       acid, polymer
                                                                                applications.    with 1,2-
                                                                                ethanediol and
                                                                                2,2'-[9h-
                                                                                fluoren-9-
                                                                                ylidenebis(4,1-
                                                                                phenyleneoxy)]
                                                                                bis[ethanol].
P-12-0102....................      12/15/2011      03/13/2012  CBI............  (G) Lens         (G) Substituted
                                                                                material for     carbomonocycli
                                                                                use in           c dicarboxylic
                                                                                electronic       acid, dialkyl
                                                                                applications.    ester polymer
                                                                                with 1,2-
                                                                                ethanediol and
                                                                                2,2'-[9h-
                                                                                fluoren-9-
                                                                                ylidenebis(4,1-
                                                                                phenyleneoxy)]
                                                                                bis[ethanol].
P-12-0103....................      12/15/2011      03/13/2012  CBI............  (S) Ultraviolet  (G) Alkene-
                                                                                light            substituted
                                                                                stabilizer for   fatty acid
                                                                                use in           methyl ester
                                                                                polymers;        polymer
                                                                                flame
                                                                                retardant
                                                                                material for
                                                                                use in
                                                                                polymers..
P-12-0104....................      12/14/2011      03/12/2012  CBI............  (G) The product  (G) Mixture of
                                                                                can be used as   isomers of
                                                                                a dye for        condensation
                                                                                papers, wood.    products of
                                                                                substituted
                                                                                diazotized
                                                                                aminoanilines.
P-12-0105....................      12/15/2011      03/13/2012  Nanotech         (S) Flooring;    (S) Carbamic
                                                                Industries,      paints; top      acid, N-[3-
                                                                Inc.             coating.         [(carboxyamino
                                                                                )methyl]-3,5,5-
                                                                                trimethylcyclo
                                                                                hexyl]-, ester
                                                                                with 1,2-
                                                                                propanediol
                                                                                (1:2).
P-12-0106....................      12/15/2011      03/13/2012  BASF             (G) Paint......  (G) Alkyl
                                                                Corporation.                      acrylate
                                                                                polymer with
                                                                                styrene,
                                                                                triol,
                                                                                benzenedicarbo
                                                                                xylic acid
                                                                                anhydride and
                                                                                alkyl
                                                                                methacrylates,
                                                                                trialkylalkano
                                                                                ate, peroxide-
                                                                                initiated.
----------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC, the date the NOC was received by EPA, the projected end date for
EPA's review of the NOC, and chemical identity.

                              Table II--26 NOCs Received From 12/05/11 to 12/16/11
----------------------------------------------------------------------------------------------------------------
                                                         Commencement
               Case No.                  Received date    notice end                    Chemical
                                                             date
----------------------------------------------------------------------------------------------------------------
P-04-0563.............................      12/13/2011      11/18/2011  (G) Alkylated aryloxyaniline thiourea
P-04-0810.............................      12/13/2011      11/27/2011  (G) Alkylated aromatic isothiocyanate
P-09-0509.............................      12/06/2011      10/17/2011  (G) Aliphatic polyurethane dispersion
P-09-0517.............................      12/06/2011      10/13/2011  (G) Aliphatic polyurethane dispersion
P-10-0425.............................      12/02/2011      11/04/2011  (G) Silicon derivative
P-10-0556.............................      12/13/2011      11/20/2011  (S) Poly[oxy(methyl-1,2-ethanediyl)],
                                                                         .alpha.-[2-[[2,2-dimethyl-3-[(1-
                                                                         oxododecyl)oxy]propylidene]amino]methyl
                                                                         ethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-
                                                                         oxododecyl)oxy]propylidene]amino]methyl
                                                                         ethoxy]-
P-11-0049.............................      12/06/2011      12/01/2011  (G) Organic-N,P-compound
P-11-0090.............................      12/14/2011      12/01/2011  (G) Heteroaromatic compound
P-11-0128.............................      12/06/2011      11/11/2011  (S) 3H-indolium, 2-[2-[3-[2-(1,3-dihydro-
                                                                         1,3,3-trimethyl-2h-indol-2-
                                                                         ylidene)ethylidene]-2-[(1-phenyl-1H-
                                                                         tetrazol-5-yl)thio]-1-cyclohexen-1-
                                                                         yl]ethenyl]-1,3,3-trimethyl-, chloride
                                                                         (1:1)
P-11-0190.............................      12/14/2011      12/01/2011  (G) Dialdehyde, reaction products with
                                                                         hydrolyzed N-vinylamide homopolymer
                                                                         hydrohalides
P-11-0230.............................      12/15/2011      11/19/2011  (G) Alkyl amine salt
P-11-0264.............................      12/09/2011      11/22/2011  (G) Brominated aromatic oligomer
P-11-0342.............................      12/08/2011      11/07/2011  (G) Polyacrylate oligomer
P-11-0400.............................      12/09/2011      11/17/2011  (S) Poly(oxy-1,2-ethanediyl), .alpha.-(1-
                                                                         oxotetradecyl)-.omega.-methoxy-
P-11-0476.............................      12/12/2011      11/14/2011  (G) Dicarboxylic acid, compd. with 1,6-
                                                                         hexanediamine alkyldioate, homopolymer

P-11-0499.............................      12/14/2011      11/14/2011  (S) Phenol, 4,4'-(1-methylethylidene)bis-
                                                                         , polymer with 5-amino-1,3,3-
                                                                         trimethylcyclohexanemethanamine, N1,N2-
                                                                         bis(2-aminoethyl)-1,2-ethanediamine, 2-
                                                                         (chloromethyl) oxirane, .alpha.-hydro-
                                                                         .omega.-hydroxypoly[oxy(methyl-1,2-
                                                                         ethanediyl)], 2,2'-[(1-
                                                                         methylethylidene)bis(4,1-
                                                                         phenyleneoxymethylene)]bis[oxirane] and
                                                                         .alpha.-(2-oxiranylmethyl)-.omega.-(2-
                                                                         oxiranylmethoxy)poly[oxy(methyl-1,2-
                                                                         ethanediyl)], reaction products with 2-
                                                                         [[4-(1,1-
                                                                         dimethylethyl)phenoxy]methyl]oxira
                                                                         acetates (salts)''
P-11-0537.............................      12/12/2011      12/01/2011  (G) Pyrazole azo thiadiazole derivative
P-11-0539.............................      12/12/2011      12/09/2011  (G) Mixture of: Acrylic polymer with
                                                                         polymerized organic acid, compound with
                                                                         2-aminoethanol and organic acid, 2-
                                                                         aminoethanol salt
P-11-0544.............................      12/08/2011      12/01/2011  (G) Diazopyridine derivative
P-11-0554.............................      12/08/2011      11/11/2011  (G) Petroleum distillate lights
P-11-0578.............................      12/02/2011      11/10/2011  (S) Benzoic acid, 4-(1,1-dimethylethyl)-
                                                                         , hydrazide
P-11-0579.............................      12/02/2011      11/16/2011  (S) 1H-1,2,4-triazole-3-acetic acid, 5-
                                                                         [4-(1,1-dimethylethyl)phenyl]-
P-11-0580.............................      12/02/2011      11/28/2011  (S) Cyclohexanol, 2,6-bis(1,1-
                                                                         dimethylethyl)-4-methyl-
P-11-0584.............................      12/07/2011      12/01/2011  (G) Isocyanate crosslinker
P-11-0591.............................      12/02/2011      11/23/2011  (G) Ipdi modified polyester resin
P-11-0622.............................      12/16/2011      12/14/2011  (S) 4,5,6,7-tetrahydro-isobenzofuran-1,3-
                                                                         dione
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA as described in Unit II. to access
additional non-CBI information that may be available.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, Imports,
Notice of commencement, Premanufacturer, Reporting and recordkeeping
requirements, Test marketing exemptions.

    Dated: January 18, 2012.
Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2012-1923 Filed 1-31-12; 8:45 am]
BILLING CODE 6560-50-P


(c) The use of symbols in device labeling to provide the labeling
information referenced in paragraph (a) of this section which do not
meet the requirements of paragraph (b) of this section renders a device
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic
Act.
    (d) For purposes of paragraph (b) of this section:
    (1) An SDO is an organization that is nationally or internationally
recognized and that follows a process for standard development that is
transparent, (i.e., open to public scrutiny), where the participation
is balanced, where an appeals process is included, where the standard
is not in conflict with any statute, regulation, or policy under which
FDA operates, and where the standard is national or international in
scope.
    (2) The term ``symbols glossary'' means a compiled listing of:
    (i) Each SDO-established symbol used in the labeling for the
device;
    (ii) The title and designation number of the SDO-developed standard
containing the symbol;
    (iii) The title of the symbol and its reference number, if any, in
the standard; and
    (iv) The meaning or explanatory text for the symbol as provided in
the FDA recognition or, if FDA has not recognized the standard or
portion of the standard in which the symbol is located or the symbol is
not used according to the specifications for use of the symbol set
forth in FDA's section 514(c) recognition, the explanatory text as
provided in the standard.

0
7. Amend Sec.  660.50 by revising paragraph (a) to read as follows:

Sec.  660.50  Anti-Human Globulin.

    (a) Proper name and definition. The proper name of this product
shall be Anti-Human Globulin which shall consist of one or more
antiglobulin antibodies identified in Sec.  660.55(a)(4).
* * * * *

0
8. Revise Sec.  660.55 to read as follows:

Sec.  660.55  Labeling.

    (a) In addition to the applicable labeling requirements of
Sec. Sec.  610.62 through 610.65 and Sec.  809.10 of this chapter, and
in lieu of the requirements in Sec. Sec.  610.60 and 610.61 of this
chapter, the following requirements shall be met:
    (1) Final container label--(i) Color coding. The main panel of the
final container label of all Anti-IgG, -C3d (polyspecific) reagents
shall be white or colorless and printing shall be solid dark
contrasting lettering. The main panel of the final container label of
all other Anti-Human Globulin reagents shall be black with solid white
lettering. A logo or company name may be placed on the final container
label; however, the logo or company name shall be located along the
bottom or end of the label, outside of the main panel.
    (ii) Required information. The proper name ``Anti-Human Globulin''
need not appear on the final container label provided the final
container is distributed in a package and the package label bears the
proper name. The final container label shall bear the following
information:
    (A) Name of the antibody or antibodies present as set forth in
paragraph (a)(4) of this section. Anti-Human Globulin may contain one
or more antibodies to either immunoglobulins or complement components
but the name of each significant antibody must appear on the final
container label (e.g., anti-C3b,

-C3d, -C4d). The final container labels of polyspecific Anti-Human
Globulin are not required to identify antibody specificities other than
anti-IgG and anti-C3d but the reactivity of the Anti-Human Globulin
shall be accurately described in the package insert.
    (B) Name, address, and license number of the manufacturer.
    (C) Lot number, including any sublot designations.
    (D) Expiration date.
    (E) Source of the product.
    (F) Recommended storage temperature in degrees Celsius.
    (G) Volume of product.
    (H) Appropriate cautionary statement if the Anti-Human Globulin is
not polyspecific. For example, ``DOES NOT CONTAIN ANTIBODIES TO
IMMUNOGLOBULINS'' or ``DOES NOT CONTAIN ANTIBODIES TO COMPLEMENT
COMPONENTS.''
    (I) If the final container is not enclosed in a package, all items
required for a package label shall appear on the container label.
    (iii) Lettering size. The type size for the designation of the
specific antibody on the label of a final container shall be not less
than 12 point, unless otherwise approved by the Director, Center for
Biologics Evaluation and Research. The prefix anti- and other parts of
the name such as polyspecific may appear in smaller type.
    (iv) Visual inspection. When the label has been affixed to the
final container, a sufficient area of the container shall remain
uncovered for its full length or for no less than 5 millimeters of the
lower circumference to permit inspection of the contents.
    (2) Package label. The following items shall appear either on the
package label or on the final container label if see-through packaging
is used:
    (i) Proper name of the product, and the name of the antibody or
antibodies as listed in paragraph (a)(4) of this section.
    (ii) Name, address (including ZIP code), and license number of the
manufacturer.
    (iii) Lot number, including any sublot designations.
    (iv) Expiration date.
    (v) Preservative(s) used and its concentration.
    (vi) Number of containers, if more than one.
    (vii) Recommended storage temperature in degrees Celsius.
    (viii) Source of the product.
    (ix) Reference to enclosed package insert.
    (x) The statement: ``For In Vitro Diagnostic Use.''
    (xi) The statement: ``Meets FDA Potency Requirements.''
    (xii) A statement of an observable indication of an alteration of
the product, e.g., turbidity, color change, precipitate, that may
indicate possible deterioration of the product.
    (xiii) Appropriate cautions.
    (3) Package insert. Each final container of Anti-Human Globulin
shall be accompanied by a package insert meeting the requirements of
Sec.  809.10 of this chapter. If two or more final containers requiring
identical package inserts are placed in a single package, only one
package insert per package is required.
    (4) Names of antibodies. Anti-Human Globulin preparations may
contain one or more of the antibody specificities listed in this
paragraph as described in paragraph (a)(1)(ii)(A) of this section.

------------------------------------------------------------------------
   Antibody designation on
       container label                         Definition
------------------------------------------------------------------------
(1) Anti-IgG, -C3d;            Contains anti-IgG and anti-C3d (may
 Polyspecific.                  contain other anticomplement and anti-
                                immunoglobulin antibodies).
(2) Anti-IgG.................  Contains anti-IgG with no anti-complement
                                activity (not necessarily gamma chain
                                specific).
(3) Anti-IgG; heavy chains...  Contains only antibodies reactive against
                                human gamma chains.
(4) Anti-C3b.................  Contains only C3b antibodies with no anti-
                                immunoglobulin activity. Note: The
                                antibody produced in response to
                                immunization is usually directed against
                                the antigenic determinant which is
                                located in the C3c subunit; some persons
                                have called this antibody ``anti-C3c.''
                                In product labeling, this antibody
                                should be designated anti-C3b.
(5) Anti-C3d.................  Contains only C3d antibodies with no anti-
                                immunoglobulin activity.
(6) Anti-C4b.................  Contains only C4b antibodies with no anti-
                                immunoglobulin activity.
(7) Anti-C4d.................  Contains only C4d antibodies with no anti-
                                immunoglobulin activity.
------------------------------------------------------------------------

    (b) The applicant may provide the labeling information referenced
in this section in the form of:
    (1) A symbol accompanied by explanatory text adjacent to the
symbol;
    (2) A symbol not accompanied by adjacent explanatory text that:
    (i) Is contained in a standard that FDA recognizes under its
authority in section 514(c) of the Federal Food, Drug, and Cosmetic
Act;
    (ii) Is used according to the specifications for use of the symbol
set forth in FDA's section 514(c) recognition; and
    (iii) Is explained in a paper or electronic symbols glossary that
is included in the labeling for the device and the labeling on or
within the package containing the device bears a prominent and
conspicuous statement identifying the location of the symbols glossary
that is written in English or, in the case of articles distributed
solely in Puerto Rico or in a Territory where the predominant language
is one other than English, the predominant language may be used; or
    (3) A symbol not accompanied by adjacent explanatory text that:
    (i) Is established in a standard developed by a standards
development organization (SDO);
    (ii) Is not contained in a standard that is recognized by FDA under
its authority in section 514(c) or is contained in a standard that is
recognized by FDA but is not used according to the specifications for
use of the symbol set forth in FDA's section 514(c) recognition;
    (iii) Is determined by the manufacturer to be likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use in compliance with section 502(c) of the Federal Food,
Drug, and Cosmetic Act;
    (iv) Is used according to the specifications for use of the symbol
set forth in the SDO-developed standard; and
    (v) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in

Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used.
    (c) The use of symbols in device labeling to provide the labeling
information referenced in paragraph (a) of this section which do not
meet the requirements of paragraph (b) of this section renders a device
misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic
Act.
    (d) For purposes of paragraph (b) of this section:
    (1) An SDO is an organization that is nationally or internationally
recognized and that follows a process for standard development that is
transparent, (i.e., open to public scrutiny), where the participation
is balanced, where an appeals process is included, where the standard
is not in conflict with any statute, regulation, or policy under which
FDA operates, and where the standard is national or international in
scope.
    (2) The term ``symbols glossary'' means a compiled listing of:
    (i) Each SDO-established symbol used in the labeling for the
device;
    (ii) The title and designation number of the SDO-developed standard
containing the symbol;
    (iii) The title of the symbol and its reference number, if any, in
the standard; and
    (iv) The meaning or explanatory text for the symbol as provided in
the FDA recognition or, if FDA has not recognized the standard or
portion of the standard in which the symbol is located or the symbol is
not used according to the specifications for use of the symbol set
forth in FDA's section 514(c) recognition, the explanatory text as
provided in the standard.

PART 801--LABELING

0
9. The authority citation for part 801 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371,
374.

0
10. Amend Sec.  801.15 by revising the section heading and paragraph
(c)(1) to read as follows:

Sec.  801.15  Medical devices; prominence of required label statements;
use of symbols in labeling.

* * * * *
    (c)(1)(i) All words, statements, and other information required by
or under authority of the act to appear on the label or labeling for a
device shall appear thereon in one or more of the following formats:
    (A) The English language;
    (B) In the case of articles distributed solely in Puerto Rico or in
a Territory where the predominant language is one other than English,
the predominant language may be substituted for English;
    (C) A symbol accompanied by adjacent explanatory English text, or
text in the predominant language of the Territory, in the case of
articles distributed solely in Puerto Rico or in a Territory where the
predominant language is one other than English;
    (D) A symbol not accompanied by adjacent explanatory text that:
    (1) Is contained in a standard that FDA recognizes under its
authority in section 514(c) of the act;
    (2) Is used according to the specifications for use of the symbol
set forth in FDA's section 514(c) recognition; and
    (3) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used;
    (E) A symbol not accompanied by adjacent explanatory text that:
    (1) Is established in a standard developed by a standards
development organization (SDO);
    (2) Is not contained in a standard that is recognized by FDA under
its authority in section 514(c) of the act or is contained in a
standard that is recognized by FDA but is not used according to the
specifications for use of the symbol set forth in FDA's section 514(c)
recognition;
    (3) Is determined by the manufacturer to be likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use in compliance with section 502(c) of the act;
    (4) Is used according to the specifications for use of the symbol
set forth in the SDO-developed standard; and
    (5) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used;
    (F) The symbol statement ``Rx only'' or ``[rx] only'' may be used
as provided under Sec.  801.109(b)(1).
    (ii) The use of symbols in device labeling which do not meet the
requirements of paragraph (c)(1)(i) of this section renders a device
misbranded under section 502(c) of the act.
    (iii) For purposes of paragraph (c)(1)(i) of this section:
    (A) An SDO is an organization that is nationally or internationally
recognized and that follows a process for standard development that is
transparent, (i.e., open to public scrutiny), where the participation
is balanced, where an appeals process is included, where the standard
is not in conflict with any statute, regulation, or policy under which
FDA operates, and where the standard is national or international in
scope.
    (B) The term ``symbols glossary'' means a compiled listing of:
    (1) Each SDO-established symbol used in the labeling for the
device;
    (2) The title and designation number of the SDO-developed standard
containing the symbol;
    (3) The title of the symbol and its reference number, if any, in
the standard; and
    (4) The meaning or explanatory text for the symbol as provided in
the FDA recognition or, if FDA has not recognized the standard or
portion of the standard in which the symbol is located or the symbol is
not used according to the specifications for use of the symbol set
forth in FDA's section 514(c) recognition, the explanatory text as
provided in the standard.
* * * * *

0
11. Amend Sec.  801.109 by revising paragraph (b)(1) to read as
follows:

Sec.  801.109  Prescription devices.

* * * * *
    (b) * * *
    (1) The symbol statement ``Rx only'' or ``[rx] only'' or the
statement ``Caution: Federal law restricts this device to sale by or on
the order of a ___'', the blank to be filled with the word
``physician'', ``dentist'', ``veterinarian'', or with the descriptive
designation of any other practitioner licensed by the law of the State
in which the practitioner practices to use or order the use of the
device; and
* * * * *

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

0
12. The authority citation for part 809 continues to read as follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h,
360i, 360j, 371, 372, 374, 381.

0
13. In Sec.  809.10:
0
a. Add a last sentence to paragraph (a)(4),
0
b. Add a last sentence to paragraph (b)(5)(ii), and
0
c. Add paragraph (g).
    The additions read as follows:

Sec.  809.10  Labeling for in vitro diagnostic products.

    (a) * * *
    (4) * * * The limiting statement appropriate to the intended use of
a prescription in vitro diagnostic product shall bear the symbol
statement ``Rx only'' or ``[rx] only'' or the statement ``Caution:
Federal law restricts this device to sale by or on the order of a
___'', the blank to be filled with the word ``physician'', ``dentist'',
``veterinarian'', or with the descriptive designation of any other
practitioner licensed by the law of the State in which the practitioner
practices to use or order the use of the device.
* * * * *
    (b) * * *
    (5) * * *
    (ii) * * * The limiting statement appropriate to the intended use
of a prescription in vitro diagnostic product shall bear the symbol
statement ``Rx only'' or ``[rx] only'' or the statement ``Caution:
Federal law restricts this device to sale by or on the order of a
___'', the blank to be filled with the word ``physician'', ``dentist'',
``veterinarian'', or with the descriptive designation of any other
practitioner licensed by the law of the State in which the practitioner
practices to use or order the use of the device.
* * * * *
    (g)(1) The applicant may provide the labeling information
referenced in this section in the form of:
    (i) A symbol accompanied by explanatory text adjacent to the
symbol;
    (ii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is contained in a standard that FDA recognizes under its
authority in section 514(c) of the act;
    (B) Is used according to the specifications for use of the symbol
set forth in FDA's section 514(c) recognition; and
    (C) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used;
    (iii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is established in a standard developed by a standards
development organization (SDO);
    (B) Is not contained in a standard that is recognized by FDA under
its authority in section 514(c) of the act or is contained in a
standard that is recognized by FDA but is not used according to the
specifications for use of the symbol set forth in FDA's section 514(c)
recognition;
    (C) Is determined by the manufacturer to be likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use in compliance with section 502(c) of the act;
    (D) Is used according to the specifications for use of the symbol
set forth in the SDO-developed standard; and
    (E) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used; or
    (iv) The symbol statement ``Rx only'' or ``[rx] only'' used as
provided under paragraphs (a)(4) and (b)(5)(ii) of this section.
    (2) The use of symbols in device labeling which do not meet the
requirements of paragraph (g)(1) of this section renders a device
misbranded under section 502(c) of the act.
    (3) For purposes of paragraph (g)(1) of this section:
    (i) An SDO is an organization that is nationally or internationally
recognized and that follows a process for standard development that is
transparent, (i.e., open to public scrutiny), where the participation
is balanced, where an appeals process is included, where the standard
is not in conflict with any statute, regulation, or policy under which
FDA operates, and where the standard is national or international in
scope.
    (ii) The term ``symbols glossary'' means a compiled listing of:
    (A) Each SDO-established symbol used in the labeling for the
device;
    (B) The title and designation number of the SDO-developed standard
containing the symbol;
    (C) The title of the symbol and its reference number, if any, in
the standard; and
    (D) The meaning or explanatory text for the symbol as provided in
the FDA recognition or, if FDA has not recognized the standard or
portion of the standard in which the symbol is located or the symbol is
not used according to the specifications for use of the symbol set
forth in FDA's section 514(c) recognition, the explanatory text as
provided in the standard.

    Dated: June 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13989 Filed 6-14-16; 8:45 am]
BILLING CODE 4164-01-P