[Federal Register: October 15, 2010 (Volume 75, Number 199)]
[Notices]
[Page 63534]
[DOCID:fr15oc10-156]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

International Standards on the Transport of Dangerous Goods;
Public Meeting

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

ACTION: Notice of public meeting.

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SUMMARY: This notice is to advise interested persons that PHMSA will
conduct a public meeting in preparation for the 38th session of the
United Nations Sub-Committee of Experts on the Transport of Dangerous
Goods (UNSCOE TDG) to be held November 29-December 7, 2010, in Geneva,
Switzerland. During this meeting, PHMSA is also soliciting comments
relative to potential new work items which may be considered for
inclusion in its international agenda.

Information Regarding the UNSCOE TDG Meeting

DATES: Wednesday, November 17, 2010; 1 p.m.-3:30 p.m.

ADDRESSES: The meeting will be held at the DOT Headquarters, West
Building, Conference Rooms 8, 9 and 10, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
    Notification: Any person wishing to participate in the public
meeting should send an e-mail to<EMAIL_ADDRESS>and include
their name and contact information (Organization/Address/Telephone
Number) no later than November 10, 2010. Providing this information
will facilitate the security screening process for entry into the
building on the day of the meeting.
    Conference Call Capability/Live Meeting Information: Conference
call-in and ``live meeting'' capability will be provided for this
meeting. Specific information on call-in and live meeting access will
be posted when available at http://www.phmsa.dot.gov/hazmat/regs/
international.

FOR FURTHER INFORMATION CONTACT: Mr. Duane Pfund, Acting Director,
Office of Hazardous Materials Technology or Mr. Shane Kelley,
International Transportation Specialist, Office of Hazardous Materials
Safety, Department of Transportation, Washington, DC 20590; (202) 366-
0656.

SUPPLEMENTARY INFORMATION: The primary purpose of this meeting will be
to prepare for the 38th session of the UNSCOE TDG. The 38th session of
the UNSCOE TDG is the last of four meetings scheduled for the current
2009-2010 biennium. The UNSCOE will consider proposals for the 17th
Revised Edition of the United Nations Recommendations on the Transport
of Dangerous Goods Model Regulations which will come into force in the
international regulations from January 1, 2013. Topics on the agenda
for the UNSCOE TDG meeting include:
     Recommendations made by the Sub-Committee at previous
sessions.
     Explosives and related matters.
     Listing, classification and packing.
     Electric storage systems.
     Electronic data interchange (EDI) for documentation
purposes.
     Cooperation with the International Atomic Energy Agency
(IAEA).
     Global harmonization of transport of dangerous goods
regulations.
     Guiding principles for the Model Regulations.
     Globally Harmonized System of Classification and Labeling
of Chemicals (GHS).
     Program of work for the biennium 2011-2012.
    In addition, PHMSA is soliciting comments on how to further enhance
harmonization for international transport of hazardous materials. PHMSA
has finalized a broad international strategic plan and welcomes input
on items which stakeholders believe should be included as specific
initiatives within this plan. PHMSA's Office of International Standards
Strategic Plan can be accessed at: http://www.phmsa.dot.gov/hazmat/
regs/international.
    The public is invited to attend without prior notification. Due to
the heightened security measures participants are encouraged to arrive
early to allow time for security checks necessary to obtain access to
the building. Following the 38th session of the UNSCOE TDG, PHMSA will
place a copy of the Sub-Committee's report and a summary of the results
on PHMSA's Hazardous Materials Safety Homepage at http://
www.phmsa.dot.gov/hazmat/regs/international.

Documents

    Copies of documents for the UNSCOE TDG meeting and the meeting
agenda may be obtained by downloading them from the United Nations
Transport Division's Web site at: http://www.unece.org/trans/main/dgdb/
dgsubc/c32010.html. PHMSA's site at http://www.phmsa.dot.gov/hazmat/
regs/international also provides additional information regarding the
UNSCOE TDG and related matters such as summaries of decisions taken at
previous sessions of the UNSCOE TDG.

    Issued in Washington, DC, on October 6, 2010.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 2010-25913 Filed 10-14-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Page 56976]
[FR Doc No: 2015-23582]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-102-000]

DCR Transmission, LLC; Notice of Petition for Declaratory Order

    Take notice that on September 14, 2015, pursuant to Rule 207(a)(2)
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a) and section 219 of the
Federal Power Act, 16 U.S.C. 824s (2012), DCR Transmission, LLC's
(Petitioner) filed a petition for declaratory order (petition)
requesting authorization for certain incentive rate treatments for the
Delaney Colorado River transmission line project (Project). The Project
consists of a new, single-circuit 500-kilovolt, alternating current
overhead transmission line approximately 114 miles in length,
connecting the Delaney Substation in Arizona (currently under
construction by Arizona Public Service Company) to the existing
Colorado River Substation in California (owned by Southern California
Edison), as more fully explained in its 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.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    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 October 14, 2015.

    Dated: September 15, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-23582 Filed 9-18-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41714-41715]
[FR Doc No: 2022-14871]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0750; FRL-9968-01-OCSPP]

Pesticide Registration Review; Proposed Interim Decisions for
Several Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
interim registration review decisions and opens a 60-day public comment
period on the proposed interim decisions for the following pesticides:
2-methyl-1-butanol, Calcium Acetate, Candida Oleophila, Cedarwood Oil,
Chlorflurenol Methyl Ester (CME), Citral, Heptyl butyrate, L-Carvone,
Sedaxane, Tebuconazole, Triadimefon and Triadimenol.

DATES: Comments must be received on or before September 12, 2022.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in Table 1 in Unit IV., through the Federal eRulemaking Portal
at https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information, contact: The Chemical Review
Manager for the pesticide of interest identified in Table 1 in Unit IV.
    For general information on the registration review program,
contact: Melanie Biscoe, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager for the pesticide of interest
identified in Table 1 in Unit IV.

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 on 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 preparing and submitting
your comments, see the commenting tips at: https://www.epa.gov/dockets/commenting-epa-dockets.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed proposed interim decisions for all pesticides
listed in Table 1 in Unit IV. Through this program, EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table 1 in Unit IV. pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
FIFRA section 3(g) provides, among other things, that the registrations
of pesticides are to be reviewed every 15 years. Under FIFRA, a
pesticide product may be registered or remain registered only if it
meets the statutory standard for registration given in FIFRA section
3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread
and commonly recognized practice, the pesticide product must perform
its intended function without unreasonable adverse effects on the
environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed interim registration review decisions for the
pesticides shown in Table 1 and opens a 60-day public comment period on
the proposed interim registration review decisions.

                                       Table 1--Proposed Interim Decisions
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical review manager
 Registration review case name and No.                   Docket ID No.                  and contact information
----------------------------------------------------------------------------------------------------------------
2-methyl-1-butanol, Case Number 6308...  EPA-HQ-OPP-2022-0303                          Jennifer Odom,
                                                                                [email protected],
<PHONE_NUMBER>.
Calcium Acetate, Case Number 6341......  EPA-HQ-OPP-2022-0304                          Jennifer Odom,
                                                                                [email protected],
<PHONE_NUMBER>.
Candida oleophila, Case Number 6019....  EPA-HQ-OPP-2022-0445                          Hannah Dean,
                                                                                [email protected],
<PHONE_NUMBER>.
Cedarwood Oil, Case Number 3150........  EPA-HQ-OPP-2022-0108                          Jennifer Odom,
                                                                                [email protected],
<PHONE_NUMBER>.
Chlorflurenol Methyl Ester (CME), Case   EPA-HQ-OPP-2016-0037                          Quinn Gavin,
 Number 2095.                                                                           [email protected],
<PHONE_NUMBER>.
Citral, Case Number 6314...............  EPA-HQ-OPP-2022-0301                          Susanne Cerrelli,
                                                                                [email protected]
                                                                                ,<PHONE_NUMBER>.
Heptyl butyrate, Case Number 6305......  EPA-HQ-OPP-2022-0402                          Hannah Dean,
                                                                                [email protected],
<PHONE_NUMBER>.
L-Carvone, Case Number 6306............  EPA-HQ-OPP-2022-0392                          Susanne Cerrelli,
                                                                                [email protected]
                                                                                ,<PHONE_NUMBER>.
Sedaxane, Case Number 7065.............  EPA-HQ-OPP-2022-0448                          Christian Bongard,
                                                                                [email protected],<PHONE_NUMBER>.
Tebuconazole, Case Number 7004.........  EPA-HQ-OPP-2015-0378                          Tiffany Green,
                                                                                [email protected],
<PHONE_NUMBER>.
Triadimefon and Triadimenol, Case        EPA-HQ-OPP-2016-0114                          Matthew B. Khan,
 Numbers 2700 and 7008.                                                                 [email protected],
<PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review case. For example, the
review opened with a Preliminary Work Plan, for public comment. A Final
Work Plan was placed in the docket following public comment on the
Preliminary Work Plan.
    The documents in the dockets describe EPA's rationales for
conducting additional risk assessments for the registration review of
the pesticides included in Table 1 in Unit IV., as well as the Agency's
subsequent risk findings and consideration of possible risk mitigation
measures. These proposed interim registration review decisions are
supported by the rationales included in those documents. Following
public comment, the Agency will issue interim or final registration
review decisions for the pesticides listed in Table 1 in Unit IV.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed interim
registration review decisions. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the proposed interim decision. All comments
should be submitted using the methods in ADDRESSES and must be received
by EPA on or before the closing date. These comments will become part
of the docket for the pesticides included in the Tables in Unit IV.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and may provide a ``Response to Comments Memorandum'' in
the docket. The interim registration review decision will explain the
effect that any comments had on the interim decision and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
https://www.epa.gov/pesticide-reevaluation.
    Authority: 7 U.S.C. 136 et seq.

    Dated: July 6, 2022.
Mary Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2022-14871 Filed 7-12-22; 8:45 am]
BILLING CODE 6560-50-P


December 20, 2007

Ms. Kay Prince

US Environmental Protection Agency

Region 4

61 Forsyth St. S.W.

Atlanta, GA 30303-8960

Dear Ms. Prince:

During the past several years, staff at the Western Piedmont Council of
Governments (WPCOG) has worked diligently with local governments and
other stakeholders on air quality issues in the Unifour Area related to
the formation of ground level ozone pollution and more recently PM 2.5
pollution. As part of the Early Action Compact (EAC) process, the
Unifour Air Quality Committee (UAQC) was formed. It is made up of
elected officials from the local members of the effected area and the
group oversees actions taken relevant to air quality. Since the UAQC’s
inception I have served as chair, and continued to serve as chair.

Along with other stakeholders, the group was instrumental in the
identification and implementation of the local control measures and in
the promotion of outreach and educational initiatives to improve both
air quality and air quality awareness throughout the region. On behalf
of the UAQC I certify that all agreed upon local control measures as
outlined in the EAC have been enacted.

We look forward to working with the USEPA and the NC Division of Air
Quality to address air quality issues in the Greater Hickory Metro Area.
 Thank you for all the support you provide in helping to make this
process successful.

Sincerely,

Kitty Barnes, Chair UAQC

cc:  Doug Taylor, Executive Director WPCOG

      John Tippett, Planning Director WPCOG

      Tony Gallegos, Water Quality Administrator WPCOG


[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Pages 22401-22404]
[FR Doc No: 2011-9651]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0231]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed extension of the
collection of information concerning requirements relating to FDA's
adverse experience reporting (AER) for licensed biological products,
and general records associated with the manufacture and distribution of
biological products.

DATES: Submit either written or electronic comments on the collection
of information by June 20, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>, Juanmanuel.vilela@
fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques when
appropriate, and other forms of information technology.

Adverse Experience Reporting for Licensed Biological Products; and
General Records--21 CFR Part 600 (OMB Control Number 0910-0308)--
Extension

    Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to insure its safe use. FDA issued the AER
requirements in part 600 (21 CFR part 600) to enable FDA to take
actions necessary for the protection of the public health in response
to reports of adverse experiences related to licensed biological
products. The primary purpose of FDA's AER system is to identify
potentially serious safety problems with licensed biological products.
Although premarket testing discloses a general safety profile of a
biological product's comparatively common adverse effects, the larger
and more diverse patient populations exposed to the licensed biological
product provides the opportunity to collect information on rare,
latent, and long-term effects. In addition, production and/or
distribution problems have contaminated biological products in the
past. AER reports are obtained from a variety of sources, including
manufacturers, patients, physicians, foreign regulatory agencies, and
clinical investigators. Identification of new and unexpected safety
issues through the analysis of the data in the AERS system contributes
directly to increased public health protection. For example, evaluation
of these safety issues enables FDA to take focused regulatory action.
Such action may include, but is not limited to, important changes to
the product's labeling (such as adding a new warning), coordination
with manufacturers to ensure adequate corrective action is taken, and
removal of a biological product from the market when necessary.
    Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires a
person who submits an adverse action report to the licensed
manufacturer rather than FDA to maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires licensed manufacturers to
report each adverse experience not reported in a postmarketing 15-day
alert report at quarterly intervals, for 3 years from the date of
issuance of the biologics license, and then at annual intervals. The
majority of these periodic reports are submitted annually since a large
percentage of currently licensed biological products have been licensed
longer than 3 years. Section 600.80(i) requires licensed manufacturers
to maintain for a period of 10 years records of all adverse experiences
known to the licensed manufacturer, including raw data and any
correspondence relating to the adverse experiences. Section 600.81
requires licensed manufacturers to submit, at an interval of every 6
months, information about the quantity of the product distributed under
the biologics license, including the quantity distributed to
distributors. These distribution reports provide FDA with important
information about products distributed under biologics licenses,
including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., fifty thousand per 10-
milliliter vials), and date of release. FDA may require the licensed
manufacturer to submit distribution reports under this section at times
other than every 6 months. Under Sec.  600.90, a licensed manufacturer
may submit a waiver request for any requirements that apply to the
licensed manufacturer under Sec. Sec.  600.80 and 600.81. A waiver
request submitted under Sec.  600.90 must include supporting
documentation.
    Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product
including any

recalls. These recordkeeping requirements serve preventative and
remedial purposes by establishing accountability and traceability in
the manufacture and distribution of products. These requirements also
enable FDA to perform meaningful inspections. Section 600.12 requires,
among other things, that records must be made, concurrently with the
performance of each step in the manufacture and distribution of
products. These records must be retained for no less than 5 years after
the records of manufacture have been completed or 6 months after the
latest expiration date for the individual product, whichever represents
a later date. In addition, under Sec.  600.12, manufacturers must
maintain records relating to the sterilization of equipment and
supplies, animal necropsy records, and records in cases of divided
manufacturing responsibility with respect to a product. Under Sec.
600.12(b)(2), manufacturers are also required to maintain complete
records pertaining to the recall from distribution of any product.
Furthermore, Sec.  610.18(b) requires, in part, that the results of all
periodic tests for verification of cultures and determination of
freedom from extraneous organisms be recorded and maintained.
    Respondents to this collection of information include manufacturers
of biological products and any person whose name appears on the label
of a licensed biological product. Under table 1 of this document, the
number of respondents is based on the estimated number of manufacturers
that are subject to those regulations or that submitted the required
information to the Center for Biologics Evaluation and Research and
Center for Drugs Evaluation and Research, FDA, in fiscal year (FY)
2010. Based on information obtained from the FDA's database system,
there were 108 licensed biologics manufacturers. This number excludes
those manufacturers who produce Whole Blood or components of Whole
Blood and in-vitro diagnostic licensed products, because of the
exemption under Sec.  600.80(k). The total annual responses are based
on the number of submissions received by FDA in FY 2010. There were an
estimated 86,583 15-day Alert reports, 57,300 periodic reports, and 349
lot distribution reports submitted to FDA. The number of 15-day alert
reports for postmarketing studies under Sec.  600.80(e) is included in
the total number of 15-day alert reports. FDA received 21 requests for
waivers under Sec.  600.90, of which 19 were granted. The hours per
response are based on FDA experience. The burden hours required to
complete the MedWatch Form for Sec.  600.80(c)(1), (e), and (f) are
reported under OMB Control No. 0910-0291.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of     responses per   Total annual    per  response    Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
600.80(c)(1) and 600.80(e)......             108          801.69          86,583               1          86,583
600.80(c)(2)....................             108          530.55          57,300              28       1,604,400
600.81..........................             108            3.23             349               1             349
600.90..........................              21               1              21               1              21
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,691,353
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Under table 2 of this document, the number of respondents is based
on the number of manufacturers subject to those regulations. Based on
information obtained from FDA's database system, there were 304
licensed manufacturers of biological products in FY 2010. However, the
number of recordkeepers listed for Sec.  600.12(a) through (e)
excluding (b)(2) is estimated to be 131. This number excludes
manufacturers of blood and blood components because their burden hours
for recordkeeping have been reported under Sec.  606.160 in OMB Control
No. 0910-0116. The total annual records is based on the annual average
of lots released in FY 2010 (6,752), number of recalls made (1,881),
and total number of adverse experience reports received (143,883) in FY
2010. The hours per record are based on FDA experience.
    FDA estimates the burden of this recordkeeping as follows:

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                     Number of       Number of     Total annual         per
         21 CFR section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
600.12 \2\......................             131           51.54           6,752              32         216,064
600.12 (b)(2)...................             304            6.19           1,881              24          45,144
600.80(c)(1) and 600.80(i)......             108        1,332.25         143,883               1         143,883
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         405,091
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The recordkeeping requirements in Sec.   610.18(b) are included in the estimate for Sec.   600.12.

    Dated: April 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9651 Filed 4-20-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Page 30951]
[FR Doc No: 2020-10968]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM93-11-000]

Revisions to Oil Pipeline Regulations, Pursuant to the Energy
Policy Act of 1992; Notice of Annual Change in the Producer Price Index
for Finished Goods

    The Commission's regulations include a methodology for oil
pipelines to change their rates through use of an index system that
establishes ceiling levels for such rates. The Commission bases the
index system, found at 18 CFR 342.3, on the annual change in the
Producer Price Index for Finished Goods (PPI-FG), plus one point two
three percent (PPI-FG + 1.23). The Commission determined in an Order
Establishing Index Level,\1\ issued December 17, 2015, that PPI-FG +
1.23 is the appropriate oil pricing index factor for pipelines to use
for the five-year period commencing July 1, 2016.
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    \1\ 153 FERC 61,312, at P 52 (2015).
---------------------------------------------------------------------------

    The regulations provide that the Commission will publish annually
an index figure reflecting the final change in the PPI-FG after the
Bureau of Labor Statistics publishes the final PPI-FG in May of each
calendar year. The annual average PPI-FG index figures were 204.1 for
2018 and 205.7 for 2019.\2\ Thus, the percent change (expressed as a
decimal) in the annual average PPI-FG from 2018 to 2019, plus 1.23
percent, is positive 0.020139.\3\ Oil pipelines must multiply their
July 1, 2019, through June 30, 2020, index ceiling levels by positive
1.020139 \4\ to compute their index ceiling levels for July 1, 2020,
through June 30, 2021, in accordance with 18 CFR 342.3(d). For guidance
in calculating the ceiling levels for each 12-month period beginning
January 1, l995,\5\ see Explorer Pipeline Company, 71 FERC 61,416, at
n.6 (1995).
---------------------------------------------------------------------------

    \2\ Bureau of Labor Statistics (BLS) publishes the final figure
in mid-May of each year. This figure is publicly available from the
Division of Industrial Prices and Price Indexes of the BLS, at 202-
691-7705, and in print in August in Table 1 of the annual data
supplement to the BLS publication Producer Price Indexes via the
internet at http://www.bls.gov/ppi/home.htm. To obtain the BLS data,
scroll down to PPI Databases and click on Top Picks of the Commodity
Data including headline FD-ID indexes (Producer Price Index--PPI).
At the next screen, under the heading PPI Commodity Data, select the
box, Finished goods--WPUFD49207, then scroll to the bottom of this
screen and click on Retrieve data.
    \3\ [205.7-204.1]/204.1 = .007839 + 0.0123 = +0.020139.
    \4\ 1 + 0.020139 = 1.020139.
    \5\ For a listing of all prior multipliers issued by the
Commission, see the Commission's website, http://www.ferc.gov/industries/oil/gen-info/pipeline-index.asp.
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    In addition to publishing the full text of this Notice in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print this Notice via the internet through
FERC's Home Page (http://www.ferc.gov) using the eLibrary link. To
access this document in eLibrary, type the docket number excluding the
last three digits of this document in the docket number field and
follow other directions on the search page. 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.
    User assistance is available for eLibrary and other aspects of
FERC's website during normal business hours. For assistance, please
contact the Commission's Online Support at 1-866-208-3676 (toll free)
or<PHONE_NUMBER> (email at FERCOnlineSupport@ferc.gov), or the Public
Reference Room at<PHONE_NUMBER>, TTY<PHONE_NUMBER>. E-Mail the Public
Reference Room at<EMAIL_ADDRESS>
    Dated: May 15, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-10968 Filed 5-20-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39781-39783]
[FR Doc No: 2012-16440]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67304; File No. SR-BATS-2012-023]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing of Proposed Rule Change To Amend BATS Rules 14.2 and 14.3 To
Adopt Additional Listing Requirements for Reverse Merger Companies and
To Align BATS Rules With the Rules of Other Self-Regulatory
Organizations

June 28, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or the ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on June 15, 2012, BATS Exchange, Inc. (the
``Exchange'' or ``BATS'') 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 is proposing to amend BATS Rules 14.2 and 14.3 to
adopt additional listing requirements for a company that has become an
Act reporting company by combining either directly or indirectly with a
public shell, whether through a Reverse Merger, exchange offer, or
otherwise (a ``Reverse Merger''). The text of the proposed rule
addition is available at the Exchange's Web site at http://www.batstrading.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 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 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 Exchange is proposing to adopt more stringent listing
requirements for operating companies that become Exchange Act reporting
companies through a Reverse Merger (``Reverse Merger Companies''). In a
Reverse Merger, an existing public shell company merges with a private
operating company in a transaction in which the shell company is the
surviving legal entity. While the public shell company survives the
merger, the shareholders of the private operating company typically
hold a large majority of the shares of the public company after the
merger and the management and board of the private company will assume
those roles in the post-merger public company. The assets and business
operations of the post-merger are primarily, if not solely, those of
the former private operating company. The Exchange understands that
private operating companies generally enter into Reverse Merger
transactions to enable the company and its shareholders to sell shares
in the public equity markets. By becoming a public reporting company
via a Reverse Merger, a private operating company can access the public
markets quickly and avoid the generally more expensive and lengthy
process of going public by way of an initial public offering. While the
public shell company is required to report the Reverse Merger in a Form
8-K filing with the Commission, generally there are no registration
requirements under the Securities Act of 1933 (the ``Securities Act'')
\3\ at that point in time, as there would be for an IPO.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 77a.
---------------------------------------------------------------------------

    Significant regulatory concerns, including accounting fraud
allegations, have arisen with respect to a number of Reverse Merger
Companies in recent times. The Commission has taken direct action
against Reverse Merger Companies. During 2011, the Commission suspended
trading in the securities of numerous Reverse Merger Companies.\4\ The
Commission also recently brought an enforcement proceeding against an
audit firm relating to its work for Reverse Merger Companies.\5\ In
addition, the Commission issued a bulletin on the risks of investing in
Reverse Merger Companies, noting potential market and regulatory risks
related to investing in Reverse Merger Companies.\6\
---------------------------------------------------------------------------

    \4\ See Letter from Mary L. Schapiro to Hon. Patrick T. McHenry,
dated April 27, 2011 (``Schapiro Letter''), at pages 3-4.
    \5\ See Schapiro Letter at page 4.
    \6\ See ``Investor Bulletin: Reverse Mergers'' 2011-123.
---------------------------------------------------------------------------

    BATS Rule 14.2 provides the exchange with ``broad discretionary
authority over the initial and continued listing of securities on the
Exchange in order to maintain the quality of and public confidence in
its market, to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, and to protect
investors and the public interest.'' BATS Rule 14.2 also provides that
the Exchange may use such discretion to ``deny initial listing, apply
additional or more stringent criteria for the initial or continued
listing of particular securities, or suspend or delist particular
securities based on any event, condition, or circumstance that exists
or occurs that makes initial or continued listing of the securities on
the Exchange inadvisable or unwarranted in the opinion of the Exchange,
even though the securities meet all enumerated criteria for initial or
continued listing on the Exchange.'' The Exchange may use this
discretionary authority to increase the stringency of its stated
listing criteria, but not to decrease their stringency.
    In light of the well-documented concerns related to some Reverse
Merger Companies described above, the Exchange believes that it is
appropriate to codify in its rules specific requirements with respect
to the initial listing qualification of Reverse Merger Companies. As
proposed, a Reverse Merger Company would not be eligible for listing
unless the combined entity had, immediately preceding the filing of the
initial listing application:
    (1) Traded for at least one year in the U.S. over-the-counter
market, on another national securities exchange, or on a regulated
foreign exchange following the consummation of the Reverse Merger and
(i) in the case of a domestic issuer, filed with the Commission a form
8-K including all of the information required by Item 2.01(f) of Form
8-K, including all required audited financial statements; or (ii) in
the case of a foreign private issuer, filed

the information described in (i) above on Form 20-F;
    (2) Maintained on both an absolute and an average basis for a
sustained period a minimum stock price of at least $4, but in no event
for less than 30 of the most recent 60 trading days prior to each of
the filing of the initial listing application and the date of the
Reverse Merger Company's listing on the Exchange, except that a Reverse
Merger Company that has satisfied the one-year trading requirement
described in (1) above and has filed at least four annual reports with
the Commission which each contain all required audited financial
statements for a full fiscal year commencing after filing the
information described in paragraph (1) above will not be subject to
this price requirement; and
    (3) Timely filed with the Commission all required reports since the
consummation of the Reverse Merger, including the filing of at least
one annual report containing audited financial statements for a full
fiscal year commencing on a date after the date of filing with the
Commission of the filing described in (1) above.
    In addition, a Reverse Merger Company would be required to maintain
on both an absolute and an average basis a minimum stock price of at
least $4 through listing.
    The Exchange believes that requiring a ``seasoning'' period prior
to listing for Reverse Merger Companies should provide great assurance
that the company's operations and financial reporting are reliable, and
will also provide time for its independent auditor to detect any
potential irregularities, as well as for the company to identify and
implement enhancements to address any internal control weaknesses. The
seasoning period will also provide time for regulatory and market
scrutiny of the company and for any concerns that would preclude
listing eligibility to be identified.
    In addition, the Exchange believes that the proposed rule change
will increase transparency to issuers and market participants with
respect to the factors considered by the Exchange in assessing Reverse
Merger Companies for listing and should generally reduce the risk of
regulatory concerns with respect to these companies being discovered
after listing. However, the Exchange notes that, while it believes that
the proposed requirements would be a meaningful additional safeguard,
it is not possible to guarantee that a Reverse Merger Company (or any
other listed company) is not engaged in undetected accounting fraud or
subject to other concealed and undisclosed legal or regulatory
problems.
    For purposes of the proposed amendment to BATS Rules 14.2(c) and
14.3(b)(9) (which will both be applicable to Reverse Merger Companies
which qualify to list under BATS Rules) and as defined above, a Reverse
Merger would mean any transaction whereby an operating company became
an Exchange Act reporting company by combining either directly or
indirectly with a shell company that was an Exchange Act reporting
company, whether through a Reverse Merger, exchange offer, or
otherwise. However, a Reverse Merger would not include the acquisition
of an operating company by a listed company that qualified for initial
listing under BATS Rule 14.2(b) (the Exchange's standard for companies
whose business plan is to complete one or more acquisitions). In
determining whether a company was a shell company, the Exchange would
consider, among other factors: Whether the company was considered a
``shell company'' as defined in Rule 12b-2 under the Exchange Act; what
percentage of the company's assets were active versus passive; whether
the company generates revenues, and if so, whether the revenues were
passively or actively generated; whether the company's expenses were
reasonably related to the revenues being generated; how many employees
worked in the company's revenue-generating business operations; how
long the company had been without material business operations; and
whether the company had publicly announced a plan to begin operating
activities or generate revenues, including through a near-term
acquisition or transaction.
    In order to qualify for initial listing, a Reverse Merger Company
would be required to comply with one of the initial listing standards
set forth in BATS Rule 14.4 or 14.5 and the stock price and market
value requirements of BATS Rule 14.8 or 14.9, as appropriate. Proposed
Rules 14.2(c)(3) and 14.3(b)(9) would supplement and not replace any
applicable requirements of Chapter XIV of BATS Rules. However, in
addition to the otherwise applicable requirements of BATS Rules, a
Reverse Merger Company would be eligible to submit an application for
an initial listing only if it meets the additional criteria specified
above.
    The Exchange would have the discretion to impose more stringent
requirements than those set forth above if the Exchange believed that
it was warranted in the case of a particular Reverse Merger Company,
based on, among other things, an inactive trading market in the Reverse
Merger Company's securities, the existence of a low number of publicly
held shares that were not subject to transfer restrictions, if the
Reverse Merger Company had not had a Securities Act registration
statement or other filing subjected to a comprehensive review by the
Commission, or if the Reverse Merger Company had disclosed that it had
material weaknesses in its internal controls which had been identified
by management and/or the Reverse Merger Company's independent auditor
and had not yet implemented an appropriate corrective action plan.
    The Exchange reiterates that any Reverse Merger Company would have
to comply with all listing standards set forth in BATS Rules, including
corporate governance standards. The Exchange also notes that it will
monitor the compliance with applicable BATS Rules by any Reverse Merger
Company and will investigate any issues that indicate that a Reverse
Merger Company is non-compliant with BATS Rules.
    A Reverse Merger Company would not be subject to the requirements
of proposed BATS Rules 14.2(c)(3) and 14.3(b)(9) if, in connection with
its listing, it completes a firm commitment underwritten public
offering where the gross proceeds to the Reverse Merger Company will be
at least $40 million.\7\ In that case, the Reverse Merger Company would
only need to meet the initial listing standards. The Exchange believes
that it is appropriate to exempt Reverse Merger Companies from the
proposed rule where they are listing in conjunction with a sizable
offering, as those companies would be subject to the same Commission
review and due diligence by underwriters as a company listing in
conjunction with its IPO or any other company listing in conjunction
with an initial firm commitment underwritten public offering, so it
would be inequitable to subject them to more stringent requirements.
---------------------------------------------------------------------------

    \7\ The prospectus and registration statement covering the
offering would thus need to relate to the combined financial
statements and operations of the Reverse Merger Company.
---------------------------------------------------------------------------

    The Exchange notes that the proposal is based on and consistent
with recent Commission approvals of analogous rules for the New York
Stock Exchange LLC (``NYSE''), NYSE Amex LLC (``AMEX'') and the NASDAQ
Stock Market LLC (``Nasdaq'').\8\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release Nos. 65709 (November 8,
2011), 76 FR 70795 (November 15, 2011) (File No. SR-NYSE-2011-38);
65710 (November 8, 2011), 76 FR 70790 (November 15, 2011) (File No.
SR-NYSEAmex-2011-55); 65708 (November 8, 2011), 76 FR 70799
(November 15, 2011) (File No. SR-NASDAQ-2011-073).

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

2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\9\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\10\
because it is designed to promote just and equitable principles of
trade, to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. The Exchange believes that the proposed rule change is
consistent with Section 6(b)(5) of the Act in that, as discussed above
under the heading ``Purpose'', its purpose is to apply more stringent
initial listing requirements to a category of companies that have
raised regulatory concerns, thereby furthering the goal of protection
of investors and the public interest. As set forth above, the proposal
is based on and consistent with recent Commission approvals of
analogous rules for NYSE, AMEX and Nasdaq.\11\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ See supra note 8.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition.

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

    The Exchange has neither solicited nor received written comments on
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 such 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-BATS-2012-023 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-BATS-2012-023. 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-BATS-2012-023, and should be submitted on or before July 26, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-16440 Filed 7-3-12; 8:45 am]
BILLING CODE 8011-01-P