[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Proposed Rules]
[Pages 41372-41373]
[FR Doc No: 2011-17489]

Vol. 76

Wednesday,

No. 134

July 13, 2011

Part IV

Department of Commerce

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Bureau of Industry and Security

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15 CFR Part 714

Impact of Reducing the Mixture Concentration Threshold for Commercial
Schedule 3 Chemical Activities Under the Chemical Weapons Convention
Regulations; Proposed Rule

Federal Register / Vol. 76 , No. 134 / Wednesday, July 13, 2011 /
Proposed Rules

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 714

[Docket No. 100817371-0505-01]

Impact of Reducing the Mixture Concentration Threshold for
Commercial Schedule 3 Chemical Activities Under the Chemical Weapons
Convention Regulations

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Notice of inquiry.

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SUMMARY: The Bureau of Industry and Security (BIS) is seeking public
comments on the impact of amending the Chemical Weapons Convention
Regulations (CWCR) to reduce the concentration level at which the CWCR
exempt certain mixtures containing Schedule 3 chemicals from the
declaration requirements that apply to Schedule 3 chemical production
and the reporting requirements that apply to exports and imports of
Schedule 3 chemicals under the Chemical Weapons Convention (CWC).
    BIS is considering amending the CWCR declaration requirements that
apply to the production of Schedule 3 chemicals to conform with the low
concentration exemption adopted by the Organization for the Prohibition
of Chemical Weapons (OPCW) in 2003, which applies when the
concentration of any single Schedule 3 chemical in a mixture is ``30%
or less,'' by weight or volume (whichever yields the lesser percent).
Currently, the CWCR do not require the quantity of a Schedule 3
chemical contained in a mixture to be counted for declaration or
reporting purposes if the concentration of the Schedule 3 chemical in
the mixture is ``less than 80%'' by volume or weight (whichever yields
the lesser percent). The current low concentration level was
implemented in accordance with requirements set forth in the Chemical
Weapons Convention Implementation Act (CWCIA). Accordingly, publication
and implementation of regulatory changes affecting this low
concentration exemption level would be contingent upon amendment of the
CWCIA by the Congress.
    In addition, consistent with U.S. national discretion, BIS is
considering amending the CWCR reporting requirements for exports and
imports of Schedule 3 chemicals by reducing the low concentration
exemption that applies to certain mixtures containing Schedule 3
chemicals from the current low concentration level of ``less than 80%''
of a Schedule 3 chemical by volume or weight (whichever yields the
lesser percent) to a concentration of ``30% or less.''

DATES: Comments are due August 12, 2011.

ADDRESSES: You may submit comments by any of the following methods:
     E-mail<EMAIL_ADDRESS>Include the phrase ``Schedule
3 Notice of Inquiry'' in the subject line of the message.
     Fax:<PHONE_NUMBER> (Attn: Willard Fisher). Please alert
the Regulatory Policy Division, by calling<PHONE_NUMBER>, if you are
faxing comments.
     Mail or Hand Delivery/Courier: Willard Fisher, U.S.
Department of Commerce, Bureau of Industry and Security, Regulatory
Policy Division, 14th Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230.

Send comments regarding the collection of information identified in
this notice of inquiry, including suggestions for reducing the burden,
to Jasmeet Seehra, Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to
the Regulatory Policy Division, Bureau of Industry and Security,
Department of Commerce, 14th Street & Pennsylvania Avenue, NW., Room
2705, Washington, DC 20230. Comments on this collection of information
should be submitted separately from comments on the notice of inquiry--
all comments on the latter should be submitted by one of the three
methods outlined above.

FOR FURTHER INFORMATION CONTACT: For questions on the CWC requirements
for Schedule 3 chemicals, contact Douglas Brown, Treaty Compliance
Division, Office of Nonproliferation and Treaty Compliance, Bureau of
Industry and Security, U.S. Department of Commerce, Phone: (202) 482-
2163. For questions on the submission of comments, contact Willard
Fisher, Regulatory Policy Division, Office of Exporter Services, Bureau
of Industry and Security, U.S. Department of Commerce, Phone: (202)
482-2440.

SUPPLEMENTARY INFORMATION:

Background

    The Convention on the Prohibition of the Development, Production,
Stockpiling, and Use of Chemical Weapons and Their Destruction,
commonly called the Chemical Weapons Convention (CWC or ``the
Convention''), is an international arms control and nonproliferation
treaty that established the Organization for the Prohibition of
Chemical Weapons (OPCW) to implement the verification provisions of the
treaty. The CWC imposes a number of obligations on countries that have
ratified the Convention (States Parties), including enactment of
legislation to prohibit the production, storage, and use of chemical
weapons, and establishment of a National Authority to liaison with the
OPCW and other States Parties. The CWC also requires States Parties to
implement a comprehensive data declaration and inspection regime to
provide transparency and to verify that both the public and private
sectors of States Parties are not engaged in activities prohibited
under the CWC.
    Part VIII, paragraph 5 of the Verification Annex to the CWC
(Schedule 3 Regime) provides that declarations ``are generally not
required for mixtures containing a low concentration of a Schedule 3
chemical'' and that the Conference of the States Parties to the
Convention would consider and approve guidelines to establish the
appropriate ``low concentration'' exemption level. Schedule 3
chemicals, as set forth in the Convention's ``Annex on Chemicals,''
include those chemicals and precursors identified in the Convention as
posing a risk to the object and purpose of the Convention, but less
than the ``high'' or ``significant'' risk identified in the Convention
with regard to Schedule 1 and Schedule 2 chemicals, respectively.
    The Department of Commerce, Bureau of Industry and Security (BIS)
administers the Chemical Weapons Convention Regulations (CWCR) (15 CFR
parts 710-722), which implement provisions of the Chemical Weapons
Implementation Act of 1998 (CWCIA) (22 U.S.C. 6701 et seq.). At the
time that the CWCIA was enacted, the OPCW had not yet established
guidelines concerning low concentration limits for declarations of
Schedule 3 chemicals. In section 402(a)(2) of the CWCIA (22 U.S.C.
6742(a)(2)), Congress set 80% as the concentration of any Schedule 3
chemical in a mixture, below which the CWC's declaration, reporting and
inspection requirements do not apply. Consistent with the CWCIA, the
CWCR do not require that the quantity of a Schedule 3 chemical
contained in a mixture be counted for declaration or reporting purposes
if the concentration of the Schedule 3 chemical in the mixture is
``less than 80%'' by volume or weight, whichever yields the lesser
percent.
    The declaration and reporting requirements in the CWC that affect
commercial activities involving Schedule 3 chemicals are described in

part 714 of the CWCR. These CWCR provisions:
    (1) Require annual declarations by certain facilities (i.e.,
``declared'' Schedule 3 ``plant sites'') that were engaged in the
production of a Schedule 3 chemical in excess of 30 metric tons during
the previous calendar year, or which anticipate engaging in such
production in the next calendar year (15 CFR 714.1(a)(1));
    (2) Require that the calculation of the quantity of any Schedule 3
chemical that is produced must include the quantities produced in
mixtures, if the concentration of the Schedule 3 chemical in the
mixture is equal to or greater than 80% by volume or by weight,
whichever yields the lesser percent (15 CFR 714.1(a)(3));
    (3) Define Schedule 3 chemical production to include all steps in
the production of a Schedule 3 chemical in any units within the same
plant through chemical reaction, including any associated processes
(e.g., purification, separation, extraction, distillation, or refining)
in which the chemical is not converted into another chemical (15 CFR
714.1(a)(2));
    (4) Provide that all ``declared Schedule 3'' plant sites are
subject to routine inspection by the OPCW (15 CFR 714.1(e)); and
    (5) Require persons, plant sites, and trading companies to submit
annual reports of exports and imports of any Schedule 3 chemical to, or
from, other destinations if the total quantity that was exported or
imported exceeded 30 metric tons of a Schedule 3 chemical (15 CFR
714.2(a)).
    During the OPCW's Fifth Session of the Conference of the States
Parties to the Convention, which was held in The Hague, Netherlands, on
May 19, 2000, the States Parties established guidelines concerning low
concentration limits for declarations of Schedule 3 chemicals.
Specifically, the States Parties agreed that the Convention's
declaration and reporting requirements would not apply to a chemical
mixture in which the concentration of any single Schedule 3 chemical is
``30% or less'' by volume or weight, whichever yields the lesser
percent. This agreement is documented in OPCW decision C-V/DEC.19 and
can be obtained from the OPCW Web site (www.opcw.org). Accordingly, if
U.S. requirements are to mirror the low concentration exemption level
adopted by the OPCW after the enactment of the CWCIA, both statutory
and regulatory changes must be implemented.

Discussion and Request for Comments

    BIS is seeking public comments on the potential effects of amending
the CWCR declaration requirements that apply to the production of
Schedule 3 chemicals by reducing the exemption for mixtures containing
low concentrations of Schedule 3 chemicals from the current level of
``less than 80%'' by volume or weight (whichever yields the lesser
percent) to a concentration of ``30% or less'' by volume or weight
(whichever yields the lesser percent). These comments will assist BIS
in assessing the impact of this change on U.S. persons involved in the
production of Schedule 3 chemicals.
    Additionally, BIS is seeking public comments on the potential
effects of amending the CWCR reporting requirements that apply to
certain exports and imports of Schedule 3 chemicals by reducing the
exemption for mixtures containing low concentrations of Schedule 3
chemicals from the current level of ``less than 80%'' by volume or
weight (whichever yields the lesser percent) to a concentration of
``30% or less'' by volume or weight (whichever yields the lesser
percent).
    In particular, BIS seeks comments on the potential impact of these
changes on costs, operations, and trade.
    Furthermore, BIS is seeking public comments on the anticipated
impact of these changes with respect to an existing collection of
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.) (PRA). Notwithstanding any other provision of law, no
person is required to respond to, nor shall any person be subject to a
penalty for failure to comply with, a collection of information subject
to the PRA, unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. The changes
that are being considered by BIS would revise an existing collection of
information subject to the requirements of the PRA. This collection has
been approved by OMB under Control Number 0694-0091 (Chemical Weapons
Convention--Declaration and Report Forms), which carries burden hour
estimates of 10.6 hours for Schedule 1 Chemicals, 11.9 hours for
Schedule 2 chemicals, 2.5 hours for Schedule 3 chemicals, 5.3/5.1/5.1
hours for unscheduled discrete organic chemicals (includes Annual
Declaration on Past Activities, No Changes Authorization Form, and
Change in Inspection Status Form, respectively), and 0.17 hours for
Schedule 1 notifications.
    Specifically, these changes would affect this approved information
collection with respect to information collection activities (e.g.,
declarations, reports, recordkeeping) involving CWC Schedule 3
chemicals that are subject to declaration and/or reporting requirements
under the CWCR. In this regard, BIS is seeking comments that address
the anticipated impact of the changes being considered by BIS on the
burden hours and costs associated with Schedule 3 chemical activities
under this approved information collection.
    Send comments regarding this collection of information, including
suggestions for reducing the burden, to Jasmeet Seehra, Office of
Management and Budget (OMB), and to the Regulatory Policy Division,
Bureau of Industry and Security, Department of Commerce, as indicated
in the ADDRESSES section of this notice.

Submission of Comments

    All comments must be submitted to the address indicated in this
notice. The Department requires that all comments be submitted in
written form.
    The Department encourages interested persons who wish to comment to
do so at the earliest possible time. The period for submission of
comments will close on August 12, 2011. The Department will consider
all comments received before the close of the comment period. Comments
received after the end of the comment period will be considered, if
possible, but their consideration cannot be assured. The Department
will not accept comments accompanied by a request that a part or all of
the material be treated confidentially because of its business
proprietary nature or for any other reason. The Department will return
such comments and materials to the persons submitting the comments and
will not consider them. All comments submitted in response to this
notice will be a matter of public record and will be available for
public inspection and copying.
    The Office of Administration, Bureau of Industry and Security, U.S.
Department of Commerce, displays public comments on the BIS Freedom of
Information Act (FOIA) Web site at http://www.bis.doc.gov/foia. This
office does not maintain a separate public inspection facility. If you
have technical difficulties accessing this Web site, please call BIS's
Office of Administration, at<PHONE_NUMBER>, for assistance.

    Dated: July 1, 2011.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2011-17489 Filed 7-12-11; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41596-41597]
[FR Doc No: 2020-14796]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0598]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Type A Medicated Articles

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by August 10, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0154. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice Regulations for Type A Medicated
Articles, 21 CFR part 226

OMB Control Number 0910-0154--Extension

    Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351), FDA has the statutory authority to issue current
good manufacturing practice (cGMP) regulations for drugs, including
Type A medicated articles. A Type A medicated article is a feed product
containing a concentrated drug diluted with a feed carrier substance. A
Type A medicated article is intended solely for use in the manufacture
of another Type A medicated article or a Type B or Type C medicated
feed. Medicated feeds are administered to animals for the prevention,
cure, mitigation, or treatment of disease or for growth promotion and
feed efficiency.
    Statutory requirements for cGMPs for Type A medicated articles have
been codified in part 226 (21 CFR part 226). Type A medicated articles
that are not manufactured in accordance with these regulations are
considered adulterated under section 501(a)(2)(B) of the FD&C Act.
Under part 226, a manufacturer is required to establish, maintain, and
retain records for Type A medicated articles, including records to
document procedures required under the manufacturing process to assure
that proper quality control is maintained. Such records would, for
example, contain information concerning receipt and inventory of drug
components, batch production, laboratory assay results (i.e., batch and
stability testing), and product distribution.
    The required records are used by both the respondents and FDA. The
records are used by manufacturers of Type A medicated articles to
verify that appropriate control measures have been maintained, or that
appropriate corrective actions were taken if the control measures were
not maintained. Such verification activities are essential to ensure
that the cGMP system is working as planned. We review the records
during the conduct of periodic plant inspections. This information is
needed so that we can monitor drug usage and possible misformulation of
Type A medicated articles. The information could also prove useful to
us in investigating product defects when a drug is recalled. In
addition, we will use the cGMP criteria in part 226 to determine
whether or not the systems used by manufacturers of Type A medicated
articles are adequate to ensure that their medicated articles meet the
requirements of the FD&C Act as to safety and also meet the article's
claimed identity, strength, quality, and purity, as required by section
501(a)(2)(B) of the FD&C Act.
    In the Federal Register of February 21, 2020 (85 FR 10170), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
226.42; requires records be                 65             260          16,900  0.75 (45                  12,675
 prepared and maintained for 2                                                   minutes).
 years with respect to
 components (drug and nondrug)
 used in the manufacture of
 the medicated premixes.
226.58; requires recordkeeping              65             260          16,900  1.75............          29,575
 for establishment of
 laboratory controls to ensure
 that adequate specifications
 and test procedures for the
 drug components and Type A
 medicated articles conform to
 appropriate standards of
 identity, strength, quality,
 and purity.
226.80; requires maintenance                65             260          16,900  0.75 (45                  12,675
 of records for packaging and                                                    minutes).
 labeling of Type A medicated
 articles.
226.102; requires maintenance               65             260          16,900  1.75............          29,575
 of master-formula and batch-
 production records for Type A
 medicated articles.
226.110; requires maintenance               65             260          16,900  0.25 (15                   4,225
 of distribution records (for                                                    minutes).
 2 years) for each shipment of
 Type A medicated articles for
 recall purposes.
226.115; requires maintenance               65              10             650  0.5 (30 minutes)             325
 of complaint files for Type A
 medicated articles for 2
 years.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          89,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14796 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17569-17570]
[FR Doc No: 2012-7193]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2012-0058; Notice No. 12-4]

United States-Canada Regulatory Cooperation Council (RCC)--
Transportation--Dangerous Goods Working Group

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation.

ACTION: Notice of request for stakeholder input.

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SUMMARY: This notice is a request for comments and suggestions relative
to the draft work plan of the Transportation--Dangerous Goods Working
Group, of the United States-Canada Regulatory Cooperation Council
(RCC). Comments will be accepted from all interested stakeholders.

DATES: Comments must be received by April 25, 2012.

ADDRESSES: Comments: It is requested that comments be submitted via
email to<EMAIL_ADDRESS>as well as by any one of the following methods
(please identify comments by the docket number PHMSA-2012-0058):
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: To Docket Operations, Room W12-140 on the
ground floor of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Instructions: All submissions must include the agency name and
docket number for this notice at the beginning of the comment. Note
that all comments received will be posted without change to the Federal
eRulemaking Portal, including any personal information provided.
    Privacy Act: Anyone is able to search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (Volume 65, Number 70;
Pages 19477-78), which may also be found at http://www.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or DOT's Docket
Operations Office (see ADDRESSES).

FOR FURTHER INFORMATION CONTACT: Mr. Shane Kelley or Mr. Vincent
Babich, Office of Hazardous Materials Safety, Department of
Transportation, Washington, DC 20590;<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: President Barack Obama and Prime Minister
Stephen Harper created the U.S.-Canada Regulatory Cooperation Council
(RCC) on February 4, 2011. After private sector consultations and
bilateral negotiations, the RCC released the Joint Action Plan on
Regulatory Cooperation on December 7, 2011. The Joint Action Plan is a
practical first step to increased regulatory cooperation between the
United States and Canada.
    In order to address the dangerous goods (hazardous materials)
transportation opportunities identified in the Joint Action Plan, the
Transportation--Dangerous Goods Working Group led by senior officials
of regulatory agencies from both countries has developed a work plan
with concrete objectives, deliverables and milestones for tangible
progress within the RCC's two-year mandate. When available, the work
plan will be posted at http://www.trade.gov/rcc/.
    The purpose of this request is to invite all interested
stakeholders to provide comments relative to the plan and the RCC. The
draft work plan has also been posted and is available for viewing under
this docket number. All stakeholders including those who may not have
participated in the United States-Canada Regulatory Cooperation Council
(RCC) stakeholder engagement session on January 31, 2012 in Washington,
DC are welcome to submit additional comments. Comments that were
submitted prior to the publication date of this notice will be posted
to this docket and do not need to be resubmitted.
    PHMSA is particularly soliciting comments and suggestions in the
following areas:
     The development of ongoing cooperation frameworks and
alignment mechanisms in the work plan.
     Technical input relevant to issues identified in the work
plan or otherwise in relation to the transportation of hazardous
materials between the U.S. and Canada.
     Your preferred method and frequency of stakeholder
engagement for the working group.
     Overall United States-Canada regulatory cooperation and
the RCC process with respect to the transportation of hazardous
materials.

Additional information concerning the RCC and the Joint Action Plan is
available at http://www.trade.gov/rcc/.

    Issued in Washington, DC on March 13, 2012.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 2012-7193 Filed 3-23-12; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14366-14367]
[FR Doc No: 2017-05417]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Identification and Characterization of the Infectious Disease
Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products;
Public Workshop; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Thursday, December 29, 2016.
The document announced a

public workshop entitled ``Identification and Characterization of the
Infectious Disease Risks of Human Cells, Tissues, and Cellular and
Tissue-based Products.'' The document was published with an error in
the Web site address to access the transcript of the workshop. This
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Monica Kapoor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3111C, Silver Spring, MD 20993,
<EMAIL_ADDRESS>or Staci Revette, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3109B, Silver Spring, MD 20993,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday,
December 29, 2016, in FR Doc. 2016-31628, on page 96008, the following
correction is made:
    On page 96008, in the second column under the Transcripts caption
of section III, Participating in the Public Workshop, the third
sentence in the fourth paragraph is corrected to read, ``Please be
advised that as soon as a transcript of the public workshop is
available, it will be accessible at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm525001.htm.''

    Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05417 Filed 3-17-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Rules and Regulations]
[Pages 32235-32239]
[FR Doc No: 2016-11963]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2012-0289; FRL-9946-69-Region 1]

Air Plan Approval; New Hampshire; Ozone Maintenance Plan

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of New
Hampshire that contains an ozone maintenance plan for New Hampshire's
former 1-hour ozone nonattainment areas. The Clean Air Act requires
that areas that are designated attainment for the 1997 8-hour ozone
standard, and also had been previously designated either nonattainment
or maintenance for the 1-hour ozone standard, develop a plan showing
how the state will maintain the ozone standard for the area. The
intended effect of this action is to approve New Hampshire's
maintenance plan. This action is being taken in accordance with the
Clean Air Act.

DATES: This direct final rule will be effective July 22, 2016, unless
EPA receives adverse comments by June 22, 2016. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2012-0289 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Anne Arnold, Air Quality Planning
Unit, U.S. Environmental Protection Agency, Suite 100, Mail Code OEP05-
02, Boston, MA 02109-3912, telephone number<PHONE_NUMBER>, fax number
(617) 918-0047, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. What is the background for this action?
II. What action is EPA taking?

III. What is a Section 110(a)(1) maintenance plan?
IV. How has New Hampshire addressed the components of a Section
110(a)(1) maintenance plan?
V. Final Action
VI. Statutory and Executive Order Reviews

I. What is the background for this action?

    This action addresses requirements associated with the transition
from the 1-hour National Ambient Air Quality Standards (NAAQS) for
ground-level ozone to the 1997 8-hour ozone NAAQS.
    EPA has established, and periodically reviews and revises, the
NAAQS for ground-level ozone. On July 18, 1997 (62 FR 38855), EPA
published a final rule for a new 8-hour ozone standard of 0.08 parts
per million (ppm). On April 30, 1994 (69 FR 23858), EPA designated and
classified areas for the 1997 8-hour ozone NAAQS. Also, on April 30,
2004 (69 FR 23951), EPA published the Phase 1 rule for implementation
of the 1997 8-hour ozone NAAQS. Among other requirements, this rule set
forth requirements for anti-back sliding purposes for areas designated
attainment for the 1997 8-hour ozone standard.
    Subsequently, in 2008, and in 2015, EPA again revised the ozone
NAAQS to 0.075 ppm and 0.070 ppm, respectively.

II. What action is EPA taking?

    EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of New Hampshire on March 2, 2012. The SIP
revision consists of the Clean Air Act (CAA or Act) section 110(a)(1)
ozone maintenance plan for the 1997 8-hour ozone standard for New
Hampshire. The maintenance plan demonstrates how the state intends to
maintain the 1997 8-hour National Ambient Air Quality Standard for
ozone.
    The CAA section 110(a)(1) maintenance plan requirement applies to
areas that are designated as attainment/unclassifiable for the 1997 8-
hour ozone standard and also had a designation of either nonattainment
or attainment with an approved maintenance plan for the 1-hour ozone
standard as of June 15, 2004, the effective date of the 1997 8-hour
ozone standard designation for these areas (See 69 FR 23857). In New
Hampshire, this area consists of the cities and towns listed in Table
1.

    Table 1--1-Hour Ozone Nonattainment/Maintenance Areas Designated
  Unclassifiable/Attainment for the 8-Hour Standard as of June 15, 2004
               [= New Hampshire maintenance planning area]
------------------------------------------------------------------------
            Area                   County      Cities and towns included
------------------------------------------------------------------------
Boston-Lawrence-Worcester     Hillsborough     Mont Vernon, Wilton.
 Area.                         (part).
Manchester Area.............  Hillsborough     Antrim, Bennington,
                               (part).          Deering, Francestown,
                                                Greenfield, Greenville,
                                                Hancock, Hillsborough,
                                                Lyndeborough, Mason, New
                                                Boston, New Ipswich,
                                                Peterborough, Sharon,
                                                Temple, Weare, Windsor.
                              Merrimack        Allenstown, Andover,
                               (part).          Boscawen, Bow, Bradford,
                                                Canterbury, Chichester,
                                                Concord, Danbury,
                                                Dunbarton, Epsom,
                                                Franklin, Henniker,
                                                Hill, Hopkinton, Loudon,
                                                New London, Newbury,
                                                Northfield, Pembroke,
                                                Pittsfield, Salisbury,
                                                Sutton, Warner, Webster,
                                                Wilmot.
Rockingham County...........  Rockingham       Deerfield, Northwood,
                               (part).          Nottingham.
Strafford County............  Strafford        Barrington, Farmington,
                               (part).          Lee, Madbury, Middleton,
                                                Milton, New Durham,
                                                Strafford.
Cheshire County.............  Cheshire (all).  Alstead, Chesterfield,
                                                Dublin, Fitzwilliam,
                                                Gilsum, Harrisville,
                                                Hinsdale, Jaffrey,
                                                Keene, Marlborough,
                                                Marlow, Nelson,
                                                Richmond, Rindge,
                                                Roxbury, Stoddard,
                                                Sullivan, Surry,
                                                Swanzey, Troy, Walpole,
                                                Westmoreland,
                                                Winchester.
------------------------------------------------------------------------

III. What is a Section 110(a)(1) maintenance plan?

    Pursuant to section 110(a)(1) of the Clean Air Act, the
implementation rule for the 1997 ozone standard requires that areas
that were either nonattainment or maintenance areas for the 1-hour
ozone NAAQS, but attainment for the 1997 8-hour ozone NAAQS, submit a
plan to demonstrate the continued maintenance of the 1997 8-hour ozone
NAAQS. EPA established June 15, 2007, three years after the effective
date of the initial 1997 8-hour ozone designations, as the deadline for
submission of plans for these areas. See 40 CFR 51.905.
    On May 20, 2005, EPA issued guidance \1\ that applies, in part, to
areas that are designated attainment/unclassifiable for the 1997 8-hour
ozone standard and either have an approved 1-hour ozone maintenance
plan or were designated nonattainment of the 1-hour ozone standard. The
purpose of the guidance is to assist the states in the development of a
section 110(a)(1) maintenance plan SIP. There are five components of a
section 110(a)(1) maintenance plan which are: (1) An attainment
inventory, which is based on actual typical summer day emissions of
volatile organic compounds (VOCs) and oxides of nitrogen
(NOX) for a ten-year period from a base year as chosen by
the state; (2) a maintenance demonstration which shows how the area
will remain in compliance with the 1997 8-hour ozone standard for 10
years after the effective date of designations (June 15, 2004); (3) a
commitment to continue to operate air quality monitors; (4) a
contingency plan that will ensure that a violation of the 1997 8-hour
ozone NAAQS is promptly addressed; and (5) an explanation of how the
state will track the progress of the maintenance plan.
---------------------------------------------------------------------------

    \1\ ``Maintenance Plan Guidance Document for Certain 8-hour
Ozone Areas Under Section 110(a)(1) of Clean Air Act,'' EPA
memorandum dated May 20, 2005, from Lydia Wegman to Air Division
Directors.
---------------------------------------------------------------------------

    Subsequently, in the implementation rule for the 2008 ozone NAAQS
(80 FR 12264; March 6, 2015), EPA revoked the 1997 8-hour ozone
standard. Nevertheless, New Hampshire's March 2, 2012 SIP revision of a
Section 110(a)(1) ozone maintenance plan for the 1997 8-hour ozone
standard is pending before us, so we are taking action on it at this
time.

IV. How has New Hampshire addressed the components of a Section
110(a)(1) maintenance plan?

    EPA has determined that the New Hampshire Department of

Environmental Services (NHDES) 1997 8-hour ozone maintenance plan
addresses all of the necessary components of a Section 110(a)(1) 1997
8-hour ozone maintenance plan as discussed below.

A. Emissions Inventory

    An emissions inventory is an itemized list of emission estimates
for sources of air pollution in a given area for a specified time
period. NHDES has provided a comprehensive emissions inventory for
ozone precursors (NOX and VOCs) in the area. NHDES uses 2002
as the base year from which it projects emissions. The submittal also
includes an explanation of the methodology used for determining the
anthropogenic emissions (point, area, and mobile sources) in the
maintenance area. The inventory is based on emissions for a ``typical
summer day.''

B. Maintenance Demonstration

    With regard to demonstrating continued maintenance of the 1997 8-
hour ozone standard, NHDES projects that the total emissions from the
maintenance area will decrease during the ten-year maintenance period.
NHDES has projected emissions from 2002 until 2014. The projected trend
in emissions is downward. This clearly demonstrates that the 1997 8-
hour ozone standard will be maintained for the ten year period between
2004 and 2014, which is the required test.
    Table 2 shows the total VOC and NOx emissions for the maintenance
area in New Hampshire for the base year (2002), an interim year (2012),
and a final year (2014).\2\ More detailed emissions tables can be found
in the NHDES submittal. The trend in emissions is downward, for each
pollutant in the area. As such, the plan demonstrates that, from an
emissions projections standpoint, emissions are projected to decrease.
---------------------------------------------------------------------------

    \2\ It should be noted that the emissions shown in this table
are for the entire five counties named, rather than the somewhat
smaller maintenance area, due to the difficulty of parsing out
inventory data to a sub-county basis. This difference is not
considered significant, and does not affect the downward trend shown
in the emissions.

              Table 2--2002, 2012, and 2014 VOC and NOX Emissions for Cheshire, Hillsborough, Merrimack, Rockingham, and Strafford Counties
                                                                    [Pounds per day]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                VOC                                             NOX
                     Source category                     -----------------------------------------------------------------------------------------------
                                                               2002            2012            2014            2002            2012            2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Point...................................................          15,898           6,696           7,005          67,347          48,358          50,739
Area....................................................          93,778          85,443          91,068          10,516           9,091           9,134
Non-Road Mobile.........................................          68,223          40,210          35,121          49,787          36,131          31,215
On-Road Mobile..........................................          87,161          36,904          34,245         261,303          75,202          62,347
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................         265,060         169,253         167,439         388,953         168,782         153,435
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Ambient Monitoring

    With regard to the ambient air monitoring component of a
maintenance plan, New Hampshire's submittal describes the ozone
monitoring network in the maintenance area and New Hampshire commits to
the continuing operation of an effective air quality monitoring network
to verify the area's attainment status in accordance with the Code of
Federal Regulations (CFR), specifically, 40 CFR part 58. New
Hampshire's SIP revision was submitted on March 2, 2012 and includes
ozone design values \3\ for 2010 and 2011 which demonstrate that the
maintenance area is meeting the 0.08 ppm 1997 8-hour ozone standard. In
addition, based on more recent ozone data from 2014, all of New
Hampshire meets the 1997 8-hour ozone standard. Furthermore,
preliminary ozone data for 2015 shows that all of New Hampshire
continues to meet the 1997 8-hour ozone standard. Table 3 shows the
ozone design values for each monitor in the five county area listed in
Table 2. As noted in Table 1, portions of these counties make up New
Hampshire's maintenance area.
---------------------------------------------------------------------------

    \3\ The design value at an ozone monitor is the 3-year average
annual fourth-highest daily maximum 8-hour average ozone
concentration measured at that monitor. The design value for an area
is the highest design value recorded at any monitor in the area.

              Table 3--Ozone Design Values (ppm) for Monitors in the New Hampshire Maintenance Area
----------------------------------------------------------------------------------------------------------------
                                                                                Design Value
                        Monitor location                            AQS \4\ No.  -------------------------------
                                                                                2014          2015 \5\
----------------------------------------------------------------------------------------------------------------
Keene...........................................................       330050007           0.062           0.060
Peterborough....................................................       330115001           0.070           0.067
Nashua..........................................................       330111011           0.066           0.064
Concord.........................................................       330131007           0.063           0.062
Portsmouth......................................................       330150014           0.068           0.066
Rye.............................................................       330150016           0.068           0.068
Londonderry.....................................................       330150018           0.067           0.065
----------------------------------------------------------------------------------------------------------------

D. Contingency Measures

    EPA interprets section 110(a)(1) of the CAA to require that the
state develop a contingency plan that will ensure that any violation of
a NAAQS is promptly corrected. Therefore, as required by section
110(a)(1) of the Act, New Hampshire has listed in its submittal
possible contingency measures, as well as a protocol the state will
follow, in the event of a future ozone air quality problem. As noted in
New Hampshire's

SIP revision, at the conclusion of each ozone season, NHDES will
evaluate whether the design value for any ozone monitor in the
maintenance area meets the 1997 8-hour ozone standard. If the design
value is above the standard, NHDES will evaluate the potential causes
of this design value increase, specifically, whether this increase is
due to an increase in local in-state emissions, an increase in upwind
out-of-state emissions, or an exceptional event as defined in 40 CFR
50.1. If an increase in in-state emissions is determined to be a
contributing factor to the design value increase, NHDES will evaluate
the projected in-state emissions for the maintenance area for the ozone
season in the following year. If in-state emissions are not expected to
satisfactorily decrease in the following ozone season in order to
mitigate the violation, New Hampshire will implement one or more of the
contingency measures listed in the submittal, or substitute other VOC
or NOx control measures to achieve additional in-state emission
reductions. The contingency measure(s) will be selected by the
Governor, or the Governor's designee, within six months of the end of
the ozone season for which contingency measures have been determined
necessary. Further details on the types of possible control measures to
be used as contingencies can be found in the New Hampshire submittal.
New Hampshire's submittal satisfies EPA's contingency measure
requirements.
---------------------------------------------------------------------------

    \4\ AQS is EPA's Air Quality System. States submit ozone
monitoring data to AQS.
    \5\ Ozone design values for 2015 are based on preliminary data.
---------------------------------------------------------------------------

E. Tracking Progress

    New Hampshire's SIP revision notes that the State will track the
maintenance of attainment by analyzing air quality trends at local
monitors and annually updating the state's emissions inventories. NHDES
produces comprehensive emission inventories on a three-year cycle and
revises the inventories annually using updated emissions data for the
largest sources.
    Finally, as a practical matter, at this point in time, the 10 year
maintenance period (2004-2014) has ended and, as noted by the ozone
design values in Table 3 above, the area has maintained the 1997 8-hour
ozone standard.

V. Final Action

    EPA is approving into the New Hampshire SIP the Clean Air Act
Section 110(a)(1) 1997 8-hour ozone maintenance plan for the New
Hampshire area that is required to have such a plan. This area includes
the cities and towns listed in Table 1 above.
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
relevant adverse comments be filed. This rule will be effective July
22, 2016 without further notice unless the Agency receives relevant
adverse comments by June 22, 2016.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on July 22, 2016 and no further action will be
taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 22, 2016. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for

the purposes of judicial review nor does it extend the time within
which a petition for judicial review may be filed, and shall not
postpone the effectiveness of such rule or action. Parties with
objections to this direct final rule are encouraged to file a comment
in response to the parallel notice of proposed rulemaking for this
action published in the proposed rules section of today's Federal
Register, rather than file an immediate petition for judicial review of
this direct final rule, so that EPA can withdraw this direct final rule
and address the comment in the proposed rulemaking. This action may not
be challenged later in proceedings to enforce its requirements. (See
section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: May 4, 2016.
H. Curtis Spalding,
Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

     Authority: 42 U.S.C. 7401 et seq.

Subpart EE--New Hampshire

0
2. Section 52.1534 is amended by adding paragraph (j) to read as
follows:

Sec.  52.1534  Control strategy: Ozone.

* * * * *
    (j) Approval--EPA is approving the Clean Air Act section 110(a)(1)
maintenance plan for the 1997 8-hour ozone National Ambient Air Quality
Standard in the area of the New Hampshire required to have such a plan.
This area includes portions of Hillsborough, Merrimack, Rockingham, and
Strafford Counties, and all of Cheshire County. This maintenance plan
was submitted to EPA on March 2, 2012.

[FR Doc. 2016-11963 Filed 5-20-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Proposed Rules]
[Page 33145]
[FR Doc No: 2014-13484]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 77

[Docket No. FAA-2014-0134]
RIN 2120-AF90

Proposal To Consider the Impact of One Engine Inoperative
Procedures in Obstruction Evaluation Aeronautical Studies

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Proposed policy; notice of public meeting and extension of
comment period.

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

SUMMARY: The FAA will hold a public meeting to discuss its proposal to
consider the impact of one engine inoperative procedures during
aeronautical studies. This proposal was published in the Federal
Register on April 28, 2014. During the meeting, the FAA will explain
the proposal and respond to questions seeking clarification of the
proposed policy. In addition, the FAA is extending the time period for
which the public may submit written comments for an additional 30 days.

DATES: The comment period for the proposed policy published April 28,
2014 (79 FR 23300), is extended. The meeting will be held online with a
teleconference on Wednesday, June 25, 2014, from 2:00 p.m. to 4:00 p.m.
eastern time. Written public comments regarding this FAA proposed
policy should be submitted by July 28, 2014.

FOR FURTHER INFORMATION CONTACT: John Speckin, Airport Obstruction
Standards Committee, Region and Center Operations, Office of Finance
and Management, Federal Aviation Administration, 800 Independence
Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 28, 2014, the FAA published for
public comment a proposal to amend its policy concerning the impacts of
certain structures during aeronautical studies conducted under Title 14
of the Code of Federal Regulations Part 77. Specifically, the FAA
proposed to consider the impact of one engine out procedures when
studying new structures or modifications to existing structures at
certain airports that have a defined departure area for each runway end
supporting commercial service operations. FAA is proposing to factor
these impacts into the aeronautical study process because the
encroachment of airspace by structures surrounding certain airports
appears to be significantly limiting options available to airlines to
establish OEI procedures. Registration for the meeting is required by
June 23, 2014. To register, email<EMAIL_ADDRESS>with your name and the company or organization you are representing. In
a response email, the attendees will be provided with instructions on
how to connect to the online meeting and the teleconference. In the
public meeting, the FAA will provide a slide presentation to further
explain the proposed policy. Participants will be able to submit
questions utilizing the instant message application of the online tool.
In addition, the FAA is extending the time period for which the public
may submit written comments for an additional 30 days.

    Issued in Washington, DC, on June 3, 2014.
Raymond Towles,
Deputy Assistant Administrator for Regions and Center Operations,
Office of Finance and Management, Federal Aviation Administration.
[FR Doc. 2014-13484 Filed 6-5-14; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40282-40283]
[FR Doc No: 2020-14423]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-482-000]

Enable Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on June 17, 2020, Enable Gas Transmission, LLC.
(EGT), 910 Louisiana Street, Suite 48040, Houston, Texas 77002, filed
in Docket No. CP20-482-000 a prior notice request pursuant to sections
157.205, 157.208, 157.210, and 157.216 of the Commission's regulations
under the Natural Gas Act (NGA), and EGT's blanket certificate issued
in Docket Nos. CP82-384-000 and CP82-384-001, to: (i) install a new
1.5-mile pipeline that will provide transportation service from EGT's
existing Delhi Compressor Station to a tap on EGT's existing Line CP;
(ii) modify the existing Delhi Compressor Station including abandonment
of existing compressor units and installation of a new compressor unit
package; (iii) permanently remove and relocate an existing compressor
unit from EGT's White River Compressor Station to its existing Byars
Lake Compressor Station; (iv) install auxiliary facilities at EGT's
existing FM-63 and FM-65 receiver site; (v) install auxiliary
facilities at EGT's existing Amber Junction Compressor Station; and
(vi) install auxiliary facilities at EGT's existing Beirne Compressor
Station.
    All project work will be conducted within Clark and Jackson
Counties,

Arkansas; Richland Parish, Louisiana; and Grady and McClain Counties,
Oklahoma, all as more fully set forth in the application which is on
file with the Commission and open to public inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the eLibrary link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Lisa
Yoho, Senior Director, Regulatory & FERC Compliance, Enable Gas
Transmission, LLC, 910 Louisiana Street, Suite 48040, Houston, Texas
77002, by telephone at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters, will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and two copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE,
    Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.

    Dated: June 29, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-14423 Filed 7-2-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60429-60430]
[FR Doc No: 2017-27348]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82327; File No. SR-NASDAQ-2017-129]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 4120 (Limit Up-Limit Down Plan and Trading Halts) To Reduce
the Length of the ``Display-Only Period'' for the Initial Pricing on
Nasdaq of a Security That Is the Subject of an Initial Public Offering

December 14, 2017.
    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 December 8, 2017, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') 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 Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 4120 (Limit Up-Limit Down Plan
and Trading Halts) \3\ to reduce the length of the ``Display-Only
Period'' for the initial pricing on Nasdaq of a security that is the
subject of an initial public offering (``IPO'').
---------------------------------------------------------------------------

    \3\ References to rules are to Nasdaq rules, unless otherwise
noted.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    The purpose of this proposal is to amend Rule 4120 (Limit Up-Limit
Down Plan and Trading Halts) to reduce the length of the Display-Only
Period for the initial pricing on Nasdaq of a security that is the
subject of an IPO from 15 minutes to 10 minutes. In all other respects,
the process for conducting the initial pricing of an IPO security will
remain unchanged.
    Initial pricing of an IPO security on Nasdaq occurs by means of the
IPO Halt Cross provided for in Rule 4753. Prior to the IPO Halt Cross,
trading in the security is halted, pursuant to Rule 4120(a)(7), until
such time as the conditions in Rule 4120(c)(8) are satisfied and Nasdaq
releases the security for trading. Market participants may enter orders
in the security for participation in the IPO Halt Cross beginning at
4:00 a.m. As the scheduled time for the IPO Halt Cross approaches, the
security enters a Display-Only Period during which indicative
information about the potential outcome of the IPO Halt Cross is
displayed to market participants and during which market participants
may continue to enter orders.
    After the conclusion of the Display-Only Period, the security
enters a ``Pre-Launch Period'' of indeterminate duration, during which
indicative information continues to be disseminated.\4\ The Pre-Launch
Period ends and the security is released for trading by Nasdaq when the
conditions described in paragraphs (c)(8)(A)(i), (ii), and (iii) of
Rule 4120 are all met:
---------------------------------------------------------------------------

    \4\ Nasdaq Rule 4753(b)(1).
---------------------------------------------------------------------------

     Nasdaq receives notice from the underwriter of the IPO
that the security is ready to trade. The Nasdaq system then calculates
the Current Reference Price at that time (the ``Expected Price'') and
displays it to the underwriter. If the underwriter then approves
proceeding, the Nasdaq system will conduct two pricing validation
checks.
     First, the Nasdaq system must determine that all market
orders will be executed in the IPO Halt Cross; and
     Second, if the actual price calculated by the IPO Halt
Cross differs from the Expected Price by an amount in excess of a price
band previously selected by the underwriter, the security will not be
released for trading and the Pre-Launch Period will continue.

The failure to satisfy these conditions during the process to release
the security for trading will result in a delay of the release for
trading of the IPO security, and a continuation of the Pre-Launch
Period, until all conditions have been satisfied. Market participants
may continue to enter orders and order cancellations for participation
in the IPO Halt Cross during the Pre-Launch Period up to the point that
the IPO Halt Cross auction process commences.
    Based on feedback from underwriters participating in the IPO
process, Nasdaq is proposing to reduce the time of the Display-Only
Period from 15 minutes to 10 minutes. As discussed above, market
participants may begin entering orders in an IPO security at 4:00 a.m.,
while the initial pricing of IPOs occurs no

earlier than 10 a.m. Thus, market participants have ample opportunity
to enter order for participation in the IPO Halt Cross. Moreover, the
IPO Halt Cross does not actually occur until the conditions described
above, including a decision from the underwriter that the security is
ready to commence trading, have been satisfied. The underwriter
generally bases this decision upon a determination that expected
trading interest with respect to the IPO Halt Cross has been entered
and that the IPO Halt Cross will occur at a stable price and quantity
consistent with the underwriter's expectations. In some IPOs,
particularly smaller ones, this determination can be made relatively
quickly after the commencement of the Display-Only Period, but Rule
4120 does not allow the IPO Halt Cross to occur until after the end of
the 15-minute Display-Only Period. Thus, shortening the Display-Only
Period to 10 minutes will provide the underwriter with greater
flexibility to initiate trading more quickly where circumstances
warrant. On the other hand, since the IPO Halt Cross will not occur
until all of the conditions provided for by the rule (including
underwriter approval) are satisfied, the change will not prevent the
continuation of a longer pre-IPO Halt Cross period if more time is
needed to allow further order entry and greater price stability.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
In particular, Nasdaq believes that the change will facilitate the
commencement of orderly trading in securities that are the subject of
an IPO, by providing the underwriter with greater flexibility to allow
an earlier commencement of trading in cases, such as smaller IPOs,
where an extended pre-Cross period is not required to allow order entry
and the development of price stability. At the same time, the change
will not constrain the underwriter from requiring a longer pre-Cross
period in cases where extensive order entry is still occurring or where
price stability has not yet developed.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 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 not necessary or appropriate in
furtherance of the purposes of the Act. In particular, the Exchange
believes that the change will enhance the competitiveness of its
process for initial pricing of IPO securities without imposing any
burdens on the ability of underwriters or other market participants to
participate in that process.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\7\ and subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and the text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule change should be approved or 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 protected]. Please include
File Number SR-NASDAQ-2017-129 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2017-129. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2017-129 and should be submitted
on or before January 10, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27348 Filed 12-19-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Page 79467]
[FR Doc No: 2016-27291]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Notice of Petition for Enforcement

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Otter Creek Solar LLC..................  EL17-16-000
Allco Finance Limited PLH LLC..........
Otter Creek Solar LLC..................  QF13-402-006
Otter Creek Solar LLC..................  QF16-353-001
Otter Creek Solar LLC..................  QF16-354-001
Otter Creek Solar LLC..................  QF16-355-001
Otter Creek Solar LLC..................  QF16-356-001
------------------------------------------------------------------------

    Take notice that on November 4, 2016, pursuant to section
210(h)(2)(B) of the Public Utility Regulatory Policies Act of 1978
(PURPA), Otter Creek Solar LLC, Allco Finance Limited, and PLH LLC
(Petitioners) filed a Petition for Enforcement, requesting the Federal
Energy Regulatory Commission (Commission) to exercise its authority and
initiate enforcement action against the Vermont Public Service Board to
remedy their alleged improper implementation of PURPA, all as more
fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Petitioners.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 25, 2016.

    Dated: November 7, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-27291 Filed 11-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19524]
[DOCID:fr10ap08-80]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1746-DR]

Kentucky; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-1746-DR), dated February 21,
2008, and related determinations.

DATES: Effective Date: April 1, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the catastrophe declared a major disaster by the President
in his declaration of February 21, 2008.

    The counties of Harrison and Nicholas for Public Assistance
(already designated for Individual Assistance.)

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050 Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-7595 Filed 4-9-08; 8:45 am]

BILLING CODE 9110-10-P