[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54112-54113]
[FR Doc No: 2018-23437]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6904 and FDA-2017-E-6909]

Determination of Regulatory Review Period for Purposes of Patent
Extension; REBINYN

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for REBINYN and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 26, 2018. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by April 24,
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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 Nos.
FDA-2017-E-6904 and FDA-2017-E-6909--for ''Determination of Regulatory
Review Period for Purposes of Patent Extension; REBINYN.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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 Sec.  10.20 (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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product REBINYN
(Coagulation Factor IX (Recombinant) GlycoPEGylated). REBINYN is
indicated for use in adults and children with hemophilia B for: (1) On-
demand treatment and control of bleeding episodes, and (2)
Perioperative management of bleeding. Subsequent to this approval, the
USPTO received a patent term restoration application for REBINYN (U.S.
Patent Nos. 7,138,371 and 7,179,617) from Novo Nordisk A/S, and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated February 6,
2018, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of REBINYN
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
REBINYN is 2,793 days. Of this time, 2,412 days occurred during the
testing phase of the regulatory review period, while 381 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 9,
2009. The applicant claims May 16, 2009, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 9, 2009,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): May 16, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
REBINYN (BLA 125611/0) was initially submitted on May 16, 2016.
    3. The date the application was approved: May 31, 2017. FDA has
verified the applicant's claim that BLA 125611/0 was approved on May
31, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,660 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23437 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32157-32159]
[FR Doc No: 2012-13148]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67057; File No. SR-NYSEAmex-2012-31]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of
Proposed Rule Change Defining a Primary Specialist in Each Options
Class and Modifying the Specialist Entitlement Accordingly

May 24, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 11, 2012, NYSE Amex LLC (the ``Exchange'' or ``NYSE Amex'')
filed with the Securities and Exchange Commission (``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\ 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 define a Primary Specialist in each
options class and modify the Specialist entitlement accordingly. The
text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and www.nyse.com.

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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rules 964NY and 964.2NY to define
Primary Specialists, and to modify the order allocation entitlement
amongst Specialist Pool participants so as to enhance competition
between the Specialist and e-Specialists.
    Rule 964NY sets forth the priority for the allocation of incoming
orders to resting interest at a particular price in the NYSE Amex
System. Under the rule, resting Customer orders have first priority.
After that, Directed Order Market Makers have second priority, provided
they satisfy the criteria to be eligible to receive a Directed Order.
If an order is not allocated to a Directed Order Market Maker, the
Specialist Pool has next priority. As currently provided in Rule
964NY(b)(2)(C) and Rule 964.2NY, the Specialist and e-Specialists in
each class compete in the Specialist Pool on a size pro-rata basis, and
do not compete at all for the allocation of non-Directed Orders of five
contracts or fewer.\3\ For orders of five contracts or fewer, they are
allocated on a rotating basis (i.e., a round robin) to a Specialist or
e-Specialist in the

Specialist Pool. After the Specialist Pool, non-Customer interest has
next priority on a size pro-rata basis.
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    \3\ Under the rule, the Specialist's pro-rata allocation may
receive additional weighting as determined by the Exchange.
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    The Exchange proposes to enhance competition amongst the Specialist
Pool participants by designating one of the participants to be the
Primary Specialist. The Primary Specialist will be determined using
objective evaluation of the relative quote performance of each
Specialist and e-Specialist. The evaluation will be conducted on a
quarterly basis and would include one or more of the following factors:
time and size at the NBBO, average quote width, average quote size, and
the relative share of electronic volume in a given class of options.\4\
The Exchange will issue a Regulatory Bulletin at least five business
days prior to each evaluation period with the evaluation criteria,
including the relative weighting of each factor.
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    \4\ Notwithstanding the quarterly evaluation timeframe noted
above, the first evaluation period may be longer or shorter than a
calendar quarter, depending on the approval date of this filing. As
noted above, the Exchange will announce the evaluation criteria and
relative weighting of each factor at least 5 business days prior to
that period and subsequent quarterly periods.
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    The Exchange believes that providing for a Primary Specialist to be
designated based on competitive quote performance will encourage
tighter and more liquid markets, and thus provide better markets for
all investors. The Exchange notes that the Primary Specialist, like all
Specialists on the Exchange today, would continue to be eligible to
receive Directed Orders under Rule 964NY(b)(2)(B), but would continue
to be subject to the restrictions in that provision, including the
limitation on receiving no more than 40% of a Directed Order. Moreover,
as is currently the case today, if the Primary Specialist were to
receive a Directed Order under Rule 964NY(b)(2)(B), the Specialist
Pool, including the Primary Specialist, would be ineligible to receive
an allocation from that order and the NYSE Amex System would move to
the next step in the allocation process--size pro rata allocation
pursuant to Rule 964NY(b)(2)(D).
    Under the proposed rule change, the Primary Specialist (instead of
the Specialist) would receive any additional weighting in the size pro
rata allocation amongst Specialist Pool participants. This additional
weighting would be determined by the Exchange, as is currently the case
now. Additionally, under the proposal, rather than a round robin
allocation of non-Directed Orders for five contracts or fewer, all such
orders would be allocated to the Primary Specialist after any
allocation to Customers, not to exceed the size of their quote,
provided the Primary Specialist is quoting at the NBBO.\5\ If the
Primary Specialist's quote size is less than the order of five
contracts or fewer, any remaining contracts after the Primary
Specialist receives its allocation will be allocated in accordance with
Rule 964NY(b)(2)(D) (i.e., size pro rata).
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    \5\ The Exchange proposes to eliminate the round robin for such
orders.
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    In addition, as is the case under the current rule for the
Specialist Pool, if the Primary Specialist is not quoting at the NBBO
at the time the order for five or fewer contracts arrives, then the
order will be executed in accordance with the provision of Rule
964NY(b)(2)(D).
    Finally, the Exchange proposes to correct a typographical error in
Rule 964.2NY(b)(3)(A) by changing the word ``on'' to ``one''.
    NYSE Amex will not implement this rule change until such time that
ATP Holders have been notified via Regulatory Bulletin.

Compliance Date

    The Exchange plans to issue a notice announcing the compliance date
of the rule change within 90 days from the effective date of the rule
change.
2. Statutory Basis
    The Exchange believes that this proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (``Act''),\6\
in general, and furthers the objectives of Section 6(b)(5) of the Act
\7\ in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, promote just and equitable principles
of trade, 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. In particular, the proposed rule
change seeks to enhance quote competition amongst Specialist Pool
participants. Increasing quote competition should lead to narrower
spreads and more liquid markets and thus benefit investors. Narrower
spreads and more liquid markets should attract more order flow to the
Exchange, enhancing price discovery and generally benefiting all
participants on the Exchange. The Exchange further believes that the
proposed rule change would be not be unfairly discriminatory in
allocating orders of 5 contracts or fewer to the Primary Specialist
because it uses objective standards to determine the Primary
Specialist, and re-evaluates Specialist performance on a quarterly
basis. In this respect, all Specialists compete on a quarterly basis to
be designated the Primary Specialist based on objective standards that
are published prior to each quarter in which Specialist performance is
measured, and accordingly, all Specialists have the opportunity to be
designated the Primary Specialist.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2012-31 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-NYSEAmex-2012-31. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. The text of the proposed rule change is available on
the Commission's Web site at http://www.sec.gov. Copies of such filing
also will be available for inspection and copying at the principal
office of the Exchange. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-NYSEAmex-2012-31 and should be submitted on or before June 21, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-13148 Filed 5-30-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Proposed Rules]
[Pages 23184-23192]
[FR Doc No: 2013-09155]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2012-0740; FRL-9377-8]
RIN 2070-AB27

Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for eight chemical substances which
were the subject of premanufacture notices (PMNs) P-11-327, P-11-328,
P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299. This
action would require persons who intend to manufacture, import, or
process any of the chemical substances for an activity that is
designated as a significant new use by this proposed rule to notify EPA
at least 90 days before commencing that activity. The required
notification would provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit the activity
before it occurs.

DATES: Comments must be received on or before May 20, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0740, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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. ATTN:
Docket ID Number EPA-HQ-OPPT-2012-0740. 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: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0740. EPA's policy is that all comments received will be included
in the docket without change and may be made available online 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:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; 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; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed rule. The following list of North American Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
     Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. Importers of chemicals subject to a final SNUR
must certify their compliance with the SNUR requirements. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. In addition, any persons who export or intend to export a
chemical substance that is the subject of a proposed or final SNUR are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec.  [emsp14]721.20) and must comply with the
export notification requirements in 40 CFR part 707, subpart D.

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 email. 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. Background

A. What action is the agency taking?

    EPA is proposing these SNURs under section 5(a)(2) of TSCA for
eight chemical substances which were the subject of PMNs P-11-327, P-
11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299.
These SNURs would require persons who intend to manufacture, import, or
process any of these chemical substances for an activity that is
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
    In the Federal Register of November 2, 2012 (77 FR 66149) (FRL-
9366-7), EPA issued direct final SNURs on these eight chemical
substances in accordance with the procedures at Sec.  721.160(c)(3)(i).
EPA received notices of intent to submit adverse comments on these
SNURs. Therefore, as required by Sec.  721.160(c)(3)(ii), EPA removed
the direct final SNURs in a separate document, published in the Federal
Register of December 21, 2012 (77 FR 75566) (FRL 9373-8), and is now
issuing this proposed rule on the eight chemical substances. The record
for the direct final SNURs on these chemical substances was established
as docket number EPA-HQ-OPPT-2012-0740. That record includes
information considered by the Agency in developing the direct final
rule and the notice of intent to submit adverse comments.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec.  [emsp14]721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  [emsp14]721.1(c), persons subject to these SNURs must comply
with the same notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the

activities for which it has received the SNUN. If EPA does not take
action, EPA is required under TSCA section 5(g) to explain in the
Federal Register its reasons for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the
eight chemical substances that are the subject of this proposed rule,
EPA considered relevant information about the toxicity of the chemical
substances, likely human exposures and environmental releases
associated with possible uses, and the four bulleted TSCA section
5(a)(2) factors listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements
for eight chemical substances in 40 CFR part 721, subpart E. In this
unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) number (if assigned for
non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
     CFR citation assigned in the regulatory text section of
this proposed rule.
    The regulatory text section of this proposed rule specifies the
activities designated as significant new uses.
    This proposed rule includes PMN substances P-11-327, P-11-328, P-
11-329, P-11-330, P-11-331, and P-11-332, that are subject to a ``risk-
based'' consent order under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. This
consent order requires protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``section 5(e) SNURs'' on these PMN substances are proposed pursuant to
Sec.  [emsp14]721.160, and are based on and consistent with the
provisions in the underlying consent order. The section 5(e) SNURs
designate as a ``significant new use'' the absence of the protective
measures required in the corresponding consent order.
    This proposed rule also includes a SNUR on PMN substances P-12-298
and P-12-299 that were not subject to a consent order under TSCA
section 5(e). In this case, EPA did not find that the use scenario
described in the PMNs triggered the determinations set forth under TSCA
section 5(e). However, EPA does believe that certain changes from the
use scenario described in the PMNs could result in increased exposures,
thereby constituting a ``significant new use.'' This so-called ``non-
section 5(e) SNUR'' is proposed pursuant to Sec.  [emsp14]721.170. EPA
has determined that every activity designated as a ``significant new
use'' in all non-section 5(e) SNURs issued under Sec.  [emsp14]721.170
satisfies the two requirements stipulated in Sec.  721.170(c)(2), i.e.,
these significant new use activities, ``(i) are different from those
described in the premanufacture notice for the substance, including any
amendments, deletions, and additions of activities to the
premanufacture notice, and (ii) may be accompanied by changes in
exposure or release levels that are significant in relation to the
health or environmental concerns identified'' for the PMN substance.

PMN Numbers P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, and P-11-
332

Chemical names: Distillates (lignocellulosic), C5-40 (P-11-327);
Paraffin waxes
(lignocellulosic) hydrotreated, C5-40- branched, cyclic and linear (P-
11-328); Naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (P-
11-329); Kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (P-
11-330); Distillates
(lignocellulosic), hydrotreated, C8-26--branched, cyclic, and linear
(P-11-331); and
Residual oils (lignocellulosic), hydrotreated, C20-40- branched,
cyclic, and linear (P-11-332).

    CAS numbers: 1267611-99-3 (P-11-327), 1267611-06-2 (P-11-328),
1267611-35-7 (P-11-329), 1267611-14-2 (P-11-330), 1267611-11-9 (P-11-
331), and 1267611-71-1 (P-11-332).
    Effective date of TSCA section 5(e) consent order: July 21, 2012.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) uses of the PMN substances will be as a
distillation feedstock after hydrotreatment (P-11-327), as a feedstock
(P-11-328), as a blend-stock for conventional fossil fuels (P-11-329,
P-11-330, and P-11-331), and use in a manner comparable to gas oil as
it is currently used in industry (P-11-332). These PMNs are complex
mixtures and have been assessed based on the toxic components within
their mixture. The most important and primary component present is
benzene. Based on this analysis, EPA identified concerns for
oncogenicity, immunosuppression, and skin sensitization (defatting of
the skin tissue) to workers exposed to the PMN substances. The EPA
Maximum Contaminant Level for benzene in drinking water is 5 parts per
billion (ppb). The PMNs' New Chemical Exposure Limit (NCEL) is 0.32
milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted average. In
addition, based on ecological structure activity relationship (EcoSAR)
analysis of test data on analogous neutral organics, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
82 ppb for each of the following: P-11-329 and P-11-331, and 180 ppb
for each of the following: P-11-327, P-11-328, P-11-330, and P-11-332.
However, EPA does not expect risk to aquatic organisms at the expected
levels and duration of exposure as described in the PMNs. The consent
order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that these substances may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the consent order requires:
    1. Use of personal protective equipment including dermal protection
when there is potential dermal exposure and a National Institute for
Occupational Safety and Health

(NIOSH)-certified respirator with an assigned protection factor (APF)
of at least 10,000, or compliance with a NCEL of 0.32 mg/m\3\ as an 8-
hour time-weighted average when there is potential inhalation exposure.
    2. No use of the substances resulting in surface water
concentrations exceeding 5 ppb of the combination of these PMN
substances.
    3. Establishment and use of a hazard communication program. The
SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that a combined chronic
toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would
help characterize the human health and environmental effects of the PMN
substances. The order does not require submission of the testing at any
specified time or production volume. However, the order's restrictions
on manufacture, import, processing, distribution in commerce, use, and
disposal will remain in effect until the order is modified or revoked
by EPA based on submission of that or other relevant information.
    CFR citations: 40 CFR 721.10612 (P-11-327); 721.10613 (P-11-328);
721.10614 (P-11-329); 721.10615 (P-11-330); 721.10616 (P-11-331); and
721.10617 (P-11-332).

PMN Numbers P-12-298 and P-12-299

    Chemical name: Vinylidene ester (generic).
    CAS number: Not available.
    Basis for action: The PMNs state that the generic uses of the
substances will be adhesives. Based on EcoSAR analysis of test data on
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 7 ppb of the PMN substances in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substances to surface water exceed releases from the use described
in the PMNs. For the described use in the PMNs, significant
environmental releases are not expected because environmental releases
did not result in surface water concentrations exceeding 7 ppb for more
than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that
combined production volume of the two PMN substances exceeding 20,000
kilograms per year could result in exposures which may cause
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guidelines
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guidelines 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10623.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the eight chemical
substances that are subject to these proposed SNURs, EPA concluded that
for six of the substances, regulation was warranted under TSCA section
5(e), pending the development of information sufficient to make
reasoned evaluations of the health and environmental effects of the
chemical substances. For two of the eight substances, where the uses
are not regulated under a TSCA section 5(e) consent order, EPA
determined that one or more of the criteria of concern established at
Sec.  721.170 were met. The basis for these findings is outlined in
Unit IV.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances that
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this proposed rule:
     EPA would receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
     EPA would be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
     EPA would ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the final rule is
issued, other persons might engage in a use that has been identified as
a significant new use. However, TSCA section 5(e) consent orders have
been issued for six of the eight chemical substances, and the PMN
submitters are prohibited by the TSCA section 5(e) consent orders from
undertaking activities which would be designated as significant new
uses. The other two chemical substances contained in this proposed rule
are not regulated with TSCA section 5(e) consent orders. The identities
of these two chemical substances have been claimed as confidential, and
EPA has received no post-PMN bona fide submissions (per Sec.  720.25
and Sec.  721.11). Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses described in the
regulatory text of this proposed rule are ongoing.
    If uses begun after the direct final rule was published on November
2, 2012, were considered ongoing rather than new, any person could
defeat the SNUR by initiating the significant new use

before the final rule was issued. Therefore EPA designates November 2,
2012 as the cutoff date for determining whether the new use is ongoing.
Persons who begin commercial manufacture, import, or processing of the
chemical substances for a significant new use identified as of that
date would have to cease any such activity upon the effective date of
the final rule. To resume their activities, these persons would have to
first comply with all applicable SNUR notification requirements and
wait until the notice review period, including any extensions, expires.
If such a person met the conditions of advance compliance under Sec.
721.45(h), the person would be considered exempt from the requirements
of the SNUR. Consult the Federal Register document of April 24, 1990
(55 FR 17376) for a more detailed discussion of the cutoff date for
ongoing uses.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
    1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
    The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply
with the same notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in Sec.  720.50. SNUNs must be
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
Sec. Sec.  720.40 and 721.25. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances during the development of the direct final
rule. EPA's complete economic analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2012-0740.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for eight chemical
substances that were the subject of PMNs, and in six cases, a TSCA
section 5(e) consent order. The Office of Management and Budget (OMB)
has exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA would amend the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this proposed rule, if the SNUR is subsequently issued as a final
rule. This listing of the OMB control numbers and their subsequent
codification in the CFR satisfies the display requirements of PRA and
OMB's implementing regulations at 5 CFR part 1320. This Information
Collection Request (ICR) was previously subject to public notice and
comment prior to OMB approval, and given the technical nature of the
table, EPA finds that further notice and comment to amend it is
unnecessary. As a result, EPA finds that there is ``good cause'' under
section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C.
553(b)(3)(B), to amend this table without further notice and comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial

number of small entities where the following are true:
    1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost
significantly more than $8,300. A copy of that certification is
available in the docket for this proposed rule.
    This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity
significantly more than $8,300.
    Therefore, the promulgation of these SNURs would not have a
significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this proposed rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action would not involve any technical
standards the National Technology Transfer and Advancement Act (NTTAA),
section 12(d) (15 U.S.C. 272 note), would not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: April 12, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  721.10612 to subpart E to read as follows:

Sec.  721.10612  Distillates (lignocellulosic), C5-40.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec.  721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec.  721.63 respirator requirements may request to
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  721.90
(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases
for the following substances: Distillates (lignocellulosic), C5-40 (PMN
P-11-327; CAS No. 1267611-99-3); paraffin waxes (lignocellulosic)
hydrotreated, C5-40-branched, cyclic

and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic),
hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No.
1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-
branched, cyclic, and linear (PMNP-11-331; CAS No. 1267611-11-9); and
residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic,
and linear (PMN P-11-332; CAS No. 1267611-71-1)).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
3. Add Sec.  721.10613 to subpart E to read as follows:

Sec.  721.10613  Paraffin waxes (lignocellulosic) hydrotreated, C5-40-
branched, cyclic and linear.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec.  721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec.  721.63 respirator requirements may request to
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic,
and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1)).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
4. Add Sec.  721.10614 to subpart E to read as follows:

Sec.  721.10614  Naphtha (lignocellulosic), hydrotreated, C5-12-
branched, cyclic and linear.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329; CAS No. 1267611-35-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63 (a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec.  721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec.  721.63 respirator requirements may request to
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), and (g).
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic)

hydrotreated, C5-40-branched, cyclic and linear (PMN P-11-328; CAS No.
1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12-branched,
cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN
P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic),
hydrotreated, C8-26-branched, cyclic, and linear (PMN P-11-331; CAS No.
1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-
40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
5. Add Sec.  721.10615 to subpart E to read as follows:

Sec.  721.10615  Kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN
P-11-330; CAS No. 1267611-14-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec.  721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec.  721.63 respirator requirements may request to
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12- branched, cyclic and linear (PMN P-11-329; CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic,
and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1)).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
6. Add Sec.  721.10616 to subpart E to read as follows:

Sec.  721.10616  Distillates (lignocellulosic), hydrotreated, C8-26-
branched, cyclic, and linear.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear
(PMN P-11-331; CAS No. 1267611-11-9) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec.  721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec.  721.63 respirator requirements may request to
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  721.90
(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases
for the following substances: Distillates (lignocellulosic), C5-40 (PMN
P-11-327; CAS No. 1267611-99-

3); paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched,
cyclic and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic),
hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No.
1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-
branched, cyclic, and linear (PMN P-11-331; CAS No. 1267611-11-9); and
residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic,
and linear (PMN P-11-332; CAS No. 1267611-71-1)).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
7. Add Sec.  721.10617 to subpart E to read as follows:

Sec.  721.10617  Residual oils (lignocellulosic), hydrotreated, C20-40-
branched, cyclic, and linear.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec.  721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec.  721.63 respirator requirements may request to
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic,
and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1)).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
8. Add Sec.  721.10623 to subpart E to read as follows:

Sec.  721.10623  Vinylidene ester (generic).

    (a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
vinylidene ester (PMNs P-12-298 and P-12-299) are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(s) (20,000 kilograms of the aggregate of
the two chemical substances).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2013-09155 Filed 4-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Rules and Regulations]
[Pages 31835-31836]
[FR Doc No: 2013-12534]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-0148; Special Conditions No. 25-490-SC]

Special Conditions: Embraer S.A., Model EMB-550 Airplane; Landing
Pitchover Condition

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for the Embraer S.A. Model
EMB-550 airplane. This airplane will have a novel or unusual design
feature associated with landing loads due to the automatic braking
system. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: Effective Date: June 27, 2013.

FOR FURTHER INFORMATION CONTACT: Todd Martin, FAA, Airframe and Cabin
Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On May 14, 2009, Embraer S.A. applied for a type certificate for
their new Model EMB-550 airplane. The Model EMB-550 airplane is the
first of a new family of jet airplanes designed for corporate flight,
fractional, charter, and private owner operations. The aircraft has a
conventional configuration with low wing and T-tail empennage. The
primary structure is metal with composite empennage and control
surfaces. The Model EMB-550 airplane is designed for 8 passengers, with
a maximum of 12 passengers. It is equipped with two Honeywell HTF7500-E
medium bypass ratio turbofan engines mounted on aft fuselage pylons.
Each engine produces approximately 6,540 pounds of thrust for normal
takeoff. The primary flight controls consist of hydraulically powered
fly-by-wire elevators, aileron and rudder, controlled by the pilot or
copilot sidestick.
    The Model EMB-550 airplane is equipped with an automatic braking
system. This feature is a pilot-selectable function that allows earlier
braking at landing without pilot pedal input. When the autobrake system
is armed before landing, it automatically commands a pre-defined
braking action after the main wheels touch down. This might cause a
high nose gear sink rate, and potentially higher gear and airframe
loads than would occur with a traditional braking system. Therefore,
the FAA has determined special conditions are necessary.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, Embraer S.A. must show that
the Model EMB-550 airplane meets the applicable provisions of part 25,
as amended by Amendments 25-1 through 25-127 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model EMB-550 airplane because of
a novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special

conditions, the Embraer S.A. Model EMB-550 airplane must comply with
the fuel vent and exhaust emission requirements of 14 CFR part 34 and
the noise certification requirements of 14 CFR part 36 and the FAA must
issue a finding of regulatory adequacy under Sec.  611 of Public Law
92-574, the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Embraer S.A. Model EMB-550 airplane is equipped with an
automatic braking system, which is a pilot-selectable function that
allows earlier maximum braking at landing without pilot pedal input.
When the autobrake system is armed before landing, it automatically
commands maximum braking at main wheels touchdown. This will cause a
high nose gear sink rate, and potentially higher gear and airframe
loads than would occur with a traditional braking system.

Discussion

    These special conditions define a landing pitchover condition that
accounts for the effects of the automatic braking system. The special
conditions define the airplane configuration, speeds, and other
parameters necessary to develop airframe and nose gear loads for this
condition. The special conditions require that the airplane be designed
to support the resulting limit and ultimate loads as defined in Sec.
25.305.

Discussion of Comments

    Notice of proposed special conditions No. 25-13-01-SC for the
Embraer S.A. Model EMB-550 airplanes was published in the Federal
Register on February 19, 2013 (78 FR 11609). No comments were received,
and the special conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions are applicable to the
Embraer S.A. Model EMB-550 airplane. Should Embraer S.A. apply at a
later date for a change to the type certificate to include another
model incorporating the same novel or unusual design feature, the
special conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplanes. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Embraer S.A. Model EMB-550 airplanes.

Landing Pitchover Condition

    A landing pitchover condition must be addressed that takes into
account the effect of the autobrake system. The airplane is assumed to
be at the design maximum landing weight, or at the maximum weight
allowed with the autobrake system on. The airplane is assumed to land
in a tail-down attitude and at the speeds defined in Sec.  25.481.
Following main gear contact, the airplane is assumed to rotate about
the main gear wheels at the highest pitch rate allowed by the autobrake
system. This is considered a limit load condition from which ultimate
loads must also be determined. Loads must be determined for critical
fuel and payload distributions and centers of gravity. Nose gear loads,
as well as airframe loads, must be determined. The airplane must
support these loads as described in Sec.  25.305.

    Issued in Renton, Washington, on May 21, 2013.
Jeff Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-12534 Filed 5-24-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Page 55782]
[FR Doc No: 2014-22099]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 405-000]

Exelon Generation Company, LLC; Notice of Authorization for
Continued Project Operation

    On August 31, 2012 the Exelon Generation Company, LLC, licensee for
the Conowingo Hydroelectric Project, filed an Application for a New
License pursuant to the Federal Power Act (FPA) and the Commission's
regulations thereunder. The Conowingo Hydroelectric Project is located
on the Susquehanna River, in Hartford and Cecil Counties, Maryland and
Lancaster and York Counties, Pennsylvania.
    The license for Project No. 405 was issued for a period ending
September 1, 2014. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 405 is issued to
the licensee for a period effective September 2, 2014 through September
1, 2015 or until the issuance of a new license for the project or other
disposition under the FPA, whichever comes first. If issuance of a new
license (or other disposition) does not take place on or before
September 1, 2015, notice is hereby given that, pursuant to 18 CFR
16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, Exelon Generation Company, LLC, is
authorized to continue operation of the Conowingo Hydroelectric
Project, until such time as the Commission acts on its application for
a subsequent license.

    Dated: September 10, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-22099 Filed 9-16-14; 8:45 am]
BILLING CODE 6717-01-P