[Federal Register Volume 78, Number 146 (Tuesday, July 30, 2013)]
[Notices]
[Pages 45924-45925]
[FR Doc No: 2013-18198]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2005-0161; FRL 9534-4]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Renewable Fuel Standard (RFS 2) Program
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Renewable Fuel Standard (RFS 2)
Program (Renewal)'' (EPA ICR No. 2333.03, OMB Control No. 2060-0640) to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
This is a proposed extension of the ICR, which is currently approved
through July 31, 2013. Public comments were previously requested via
the Federal Register (78 FR 11870) on February 20, 2013 during a 60-day
comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before August 29,
2013.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2005-0161 to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Geanetta Heard, Fuel Compliance
Center, 6406J, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone

number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: EPA would like to continue to collect annual compliance
reports from obligated parties, quarterly reports for all EPA Moderated
Transaction System (EMTS) users, generation and assignment of Renewable
Identification Numbers (RINs) quarterly reports from biofuels producers
and importers, and third party disclosure reports from biofuel
feedstock producers by way of the Agency's Central Data Exchange (CDX).
The recordkeeping and reporting will allow EPA to monitor compliance
with the RFS program. EPA informs respondents that they may assert
claims of business confidentially for information they submit in
accordance with 40 CFR 2.203.
    Form Numbers: 5900-275 (RFSA101--RFS2 2011 Activity Report); 5900-
276 (RFS0101--RFS2 2010 Activity Report); 5900-277 (RFG 1300--VOC
Average Report); 5900-278 (RFS0901--RFS2 Production Outlook Report);
5900-279 (RFS0100 RFS Activity Report); 5900-280 (EMTS: RFS2 RIN
Generation Report (Equivalent to RSF0400)); 5900-281 (RFS0201--RFS 1
Transaction Report); 5900-282 (RFS0301--RFS2 2010 Annual Compliance
Report); 5900-283 (RFS0900--RFS2 Production Outlook Report); 5900-284
(RFS0200--RIN Transaction Report); 5900-285 (RFS0700--RFS2 Renewable
Fuel Producer Co-Products); 5900-286 (RFS2 EMTS RIN Transaction
Report); 5900-287 (RFS0103--RFS 2012 Q1 Activity Report); 5900-288
(RFS0104--RFS2 Activity Report); 5900-289 (RFS0701--RFS2 Renewable Fuel
Producer Co-Producer); 5900-290 (RFS0601--RFS2 Renewable Fuel Producer
Supplemental); 5900-291 (RFS0300--RFS2 Obligated Party Annual
Compliance Report); 5900-292 (RFS0800--RFS2 Renewable Biomass Report);
5900-293 (RFS0801--RFS2 Renewable Biomass Report); 5900-294 (RFS0102--
RFS2 2011 Activity Report); 5900-295 (RFS2 EPA Cellulosic Biofuel
Waiver Credit Form); 5900-296 (RFS0303--RFS2 Annual Compliance Report).
    Respondents/affected entities: Producers of renewable fuels,
Importers, Obligated party, Parties who own RINs and Foreign Refiners.
    Respondent's obligation to respond: Mandatory (42 U.S.C. 7414 and
7542).
    Estimated number of respondents: 2,092,731 (total).
    Frequency of response: Annually, Quarterly & Daily.
    Total estimated burden: 608,220 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $69,337,137 (per year), which includes no
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 812,913 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to adjustments to the estimates.
At the onset of the RFS2 program, EMTS for RINs were not a feature of
RFS1. For the new EMTS system, all parties who owned RINs were required
to re-submit their application, disclose feedstock sources, prepare
quarterly reports on RIN activity and submit annual compliance reports
(obligated party only). Re-submittal provisions are no longer required,
which will cause a decrease in total responses for this ICR. EMTS users
will not be burdened to submit more reports in this information
collection, unlike the previous. The total responses for industry
decreased now that the final rule is no longer requiring re-submissions
or quarterly reports for certain party members. To date, biofuels
producers and importers are required to submit quarterly reports along
with their third party disclosure on feedstock producers to EPA. All
users of the EMTS system are required to submit quarterly RIN reports.
    The number of respondents or users of the EMTS system has more than
doubled due to the additional response burden for mapping foreign and
domestic plantation/forest land owners and foreign biofuels feedstock
producers, which was not reflected in the previous ICR reporting
period. With an increase of respondents, total burden hours have
decreased from 1,421,133 to 608,220 hours. The reduction is due to the
fact that the EMTS system's automation structure helps users to prepare
reports instantly, lessening the amount of time and cost needed to
respond, even with more than a million added users.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-18198 Filed 7-29-13; 8:45 am]
BILLING CODE 6560-50-P


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[Federal Register: March 20, 2009 (Volume 74, Number 53)]
[Notices]
[Page 11961-11963]
[DOCID:fr20mr09-75]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0641]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Hazard
Analysis and Critical Control Point Manuals for Operators and
Regulators of Retail and Food Service Establishments

AGENCY: Food and Drug Administration, 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: Fax written comments on the collection of information by April
20, 2009.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0578.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

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.

Voluntary Hazard Analysis and Critical Control Point Manuals for
Operators and Regulators of Retail and Food Service Establishments--
(OMB Control Number 0910-0578--Extension)

    The Operator's Manual contains information and recommendations for
operators of retail and foodservice establishments who wish to develop
and implement a voluntary food safety management system based on Hazard
Analysis and Critical Control Point (HACCP) principles. Operators may
decide to incorporate some or all of the principles presented in the
manual into their existing food safety management systems. The
recordkeeping practices discussed in the manual are voluntary and may
include documenting certain activities, such as monitoring and
verification, which the operator may or may not deem necessary to
ensure food safety. The manual includes optional worksheets to assist
operators in developing and validating a voluntary food safety
management system.
    The Regulator's Manual contains recommendations for State, local,
and tribal regulators on conducting risk-based inspections of retail
and foodservice establishments, including recommendations about
recordkeeping practices that can assist operators in preventing
foodborne illness. These recommendations may lead to voluntary actions
by operators based on consultation with regulators. For example, an
operator may develop a risk control plan as an intervention strategy
for controlling specific out-of-control foodborne illness risk factors
identified during an inspection. Further, the manual contains
recommendations to assist regulators when evaluating voluntary food
safety management systems in retail and foodservice establishments.
Such evaluations typically consist of the following two components: (1)
Validation (assessing whether the establishment's voluntary food safety
management system is adequate to control food safety hazards) and (2)
verification (assessing whether the establishment is following its
voluntary food safety management system). The manual includes a sample
entitled ``Verification Inspection Checklist'' to assist regulators
when conducting verification inspections of establishments with
voluntary food safety management systems.
    Types of operator records discussed in the manuals and listed in
the following burden estimates include: (1) Food safety management
systems (plans that delineate the formal procedures to follow to
control all food safety hazards in an operation); (2) risk control
plans (HACCP-based, goal-oriented plans for achieving active managerial
control over specific out-of-control foodborne illness risk factors);
(3) hazard analysis (written assessment of the significant food safety
hazards associated with foods prepared in the establishment); (4)
prerequisite programs (written policies or procedures, including but
not limited to, standard operating procedures, training protocols, and
buyer specifications that address maintenance of basic operational and
sanitation conditions); (5) monitoring (records showing the
observations or measurements that are made to help determine if
critical limits are being met and maintained); (6) corrective action
(records indicating the activities that are completed whenever a
critical limit is not met); (7) ongoing verification (records showing
the procedures that are followed to ensure that monitoring and other
functions of the food safety management system are being implemented
properly); and (8) validation (records indicating that scientific and
technical information is collected and evaluated to determine if the
food safety management system, when properly implemented, effectively
controls the hazards).
    All recommendations in both manuals are voluntary. For simplicity
and to avoid duplicate estimates for operator recordkeeping practices
that are discussed in both manuals, the burden for all collection of
information recommendations for retail and foodservice operators are
estimated together in table 1 of this document, regardless of the
manual in which they appear. Collection of information recommendations
for regulators in the Regulator's Manual are listed separately in table
2 of this document.
    Description of Respondents: The likely respondents to this
collection of information are operators and regulators of retail and
foodservice establishments.
    In the Federal Register of December 19, 2008 (73 FR 77721), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                        Table 1.--Estimated Annual Recordkeeping Burden for Operators\1\
----------------------------------------------------------------------------------------------------------------
   Types of           No. of       Annual Frequency  of     Total Annual        Hours per
    Records       Recordkeepers        Recordkeeping          Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
Prerequisite           100,000\2\                   365         36,500,000                0.1          3,650,000
 Program
 Records
----------------------------------------------------------------------------------------------------------------
Monitoring             100,000\2\                   365         36,500,000                0.3         10,950,000
 Records
----------------------------------------------------------------------------------------------------------------
Corrective             100,000\2\                   365         36,500,000                0.1          3,650,000
 Action
 Records
----------------------------------------------------------------------------------------------------------------
Ongoing                100,000\2\                   365         36,500,000                0.1          3,650,000
 Verification
 Records
 (includes
 calibration
 records)
----------------------------------------------------------------------------------------------------------------
Validation              50,000\2\                     1             50,000                4              200,000
 Records
----------------------------------------------------------------------------------------------------------------
Annual Burden\3\:                                                                                22,100,000
----------------------------------------------------------------------------------------------
Risk Control               50,000                     1             50,000                2              100,000
 Plan
----------------------------------------------------------------------------------------------------------------
Monitoring                100,000                    90          9,000,000                0.3          2,700,000
 Records
----------------------------------------------------------------------------------------------------------------
Corrective                100,000                    90          9,000,000                0.1            900,000
 Action
 Records
----------------------------------------------------------------------------------------------------------------
Ongoing                   100,000                    90          9,000,000                0.1            900,000
 Verification
 Records
 (includes
 calibration
 records)
----------------------------------------------------------------------------------------------------------------
Annual Burden\4\                                                                                4,600,000
----------------------------------------------------------------------------------------------
Total Annual Burden for Operators                                                                     26,700,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Annual burden.
\3\ Burden for developing and implementing a food safety management system based on the Operator's Manual.
\4\ Annual burden for developing and implementing a risk control plan based on the Regulator's Manual.

    The burden for these activities may vary among retail and
foodservice operators depending on the type and number of products
involved, the complexity of an establishment's operation, the nature of
the equipment or instruments required to monitor critical control
points, and the extent to which an operator uses the Operator's Manual
and/or the Regulator's Manual. The estimate does not include
collections of information that are a usual and customary part of an
operator's normal activities. FDA has established as a goal to have
50,000 (0.05 percent) of the approximately 1 million U.S. retail and
foodservice operators implement the recommendations outlined in the 2
manuals. This target figure is used in calculating the burden in tables
1 and 2 of this document because the agency lacks data on how to base
an estimate of how many retail and foodservice establishments are
likely to use one or more of the manuals to voluntarily implement a
comprehensive food safety management system based on HACCP principles
or a risk control plan for out-of-control processes identified during
an inspection. FDA's estimate of the total number of retail and
foodservice establishments is based on numbers obtained from the two
major trade organizations representing these industries, the Food
Marketing Institute, and the National Restaurant Association,
respectively.
    The hour burden estimates in table 1 of this document for operators
who follow the HACCP-based recommendations in the Operator's Manual are
based on the estimated average annual information collection burden for
mandatory HACCP rules, including seafood HACCP (60 FR 65096 at 65178;
December 18, 1995) and juice HACCP (66 FR 6138 at 6202; January 19,
2001). FDA estimates that once the system is in place, the annual
frequency of records is based on 365 operating days per year. Assuming
there is one recordkeeper per shift of operation, the agency estimates
that two recordkeepers per day would be needed to conduct monitoring,
corrective action, recordkeeping, and verification outlined in the
system. The agency further estimates that validation will be conducted
once per year, based on menu or food list changes, changes in
distributors, or changes in food preparation processes used. The
validation will require a total of 4 labor hours.
    The second set of estimates in table 1 of this document shows the
annual burden for developing and implementing a risk control plan to
control specific out-of-control foodborne illness risk factors
identified during an inspection by a State, local, or tribal regulatory
authority. If an operator decides to use a risk control plan as
recommended in the Regulator's Manual, one person from the
establishment is needed to work with the regulator to develop the
written plan. FDA estimates that two recordkeepers per day (one
recordkeeper for each shift) would be needed to conduct monitoring,
corrective action, recordkeeping, and verification outlined in the risk
control plan. The estimated duration of implementation for a risk
control plan is 90 days, which is the minimum recommended time to
achieve long-term behavior change.

                                            Table 2.--Estimated Annual Recordkeeping Burden for Regulators\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency  of     Total Annual        Hours per
                   Types of Records                       Recordkeepers        Recordkeeping          Records          Recordkeeper       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Food Safety Management System Evaluation                 50,000                     1             50,000                 16            800,000
 (includes validation, verification, and completion of
 verification inspection checklist)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Annual Burden for Regulators                                                                                800,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    It is difficult to predict the number of State, local, and tribal
regulatory jurisdictions that will use the Regulator's Manual. But, FDA
anticipates that retail and foodservice establishments which
voluntarily develop and implement a food safety management system based
on the Operator's Manual will request their regulatory authorities to
conduct an evaluation of their system. The estimates in table 2 of this
document for the annual burden to State, local, and tribal regulators
that follow the recommendations in the Regulator's Manual were
calculated based on the usual time needed for one person to evaluate a
voluntarily-implemented food safety management system and record the
findings. The number of times an inspector may be asked by an operator
to evaluate a voluntarily-implemented system is not expected to exceed
once per year.

    Dated: March 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6168 Filed 3-19-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22900-22906]
[FR Doc No: 2022-08230]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0049]

Revocation of Five Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to BillionToOne, Inc. for the qSanger-COVID-19
Assay, RTA Laboratories Biological Products Pharmaceutical and
Machinery Industry (RTA) for the Diagnovital SARS-CoV-2 Real-Time PCR
Kit, DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, and
CENTOGENE US, LLC for both the CentoFast-SARS-CoV-2 RT-PCR Assay and
CentoSure SARS-CoV-2 RT-PCR Assay. FDA revoked these Authorizations
under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The
revocations, which include an explanation of the reasons for each
revocation, are reprinted in this document.

DATES: The Authorization for the qSanger-COVID-19 Assay is revoked as
of March 10, 2022. The Authorization for the Diagnovital SARS-CoV-2
Real-Time PCR Kit is revoked as of March 14, 2022. The Authorization
for the DiaSorin LIAISON SARS-CoV-2 IgM Assay is revoked as of March
15, 2022. The Authorizations for the CentoFast-SARS-CoV-2 RT-PCR Assay
and CentoSure SARS-CoV-2 RT-PCR Assay are revoked as of March 17, 2022.

ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On September 4, 2020, FDA issued
an EUA to BillionToOne, Inc. for the qSanger-COVID-19 Assay, subject to
the terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on November 20,
2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act.
On June 12, 2020, FDA issued an EUA to RTA for the Diagnovital SARS-
CoV-2 Real-Time PCR Kit, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on November 20, 2020 (85 FR 74346), as required by
section 564(h)(1) of the FD&C Act. On September 29, 2020, FDA issued an
EUA to DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on April 23,
2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act.
On July 1, 2020, FDA issued an EUA to CENTOGENE US, LLC for the
CentoFast-SARS-CoV-2 RT-PCR Assay, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on November 20, 2020 (85 FR 74346),
as required by section 564(h)(1) of the FD&C Act. On September 29,
2020, FDA issued an EUA to CENTOGENE US, LLC for the CentoSure SARS-
CoV-2 RT-PCR Assay, subject to the terms of the Authorization. Notice
of the issuance of this Authorization was published in the Federal
Register on April 23, 2021 (86 FR 21749), as required by section
564(h)(1) of the FD&C Act. Subsequent changes to the Authorizations
were made available on FDA's website. The authorization of a device for
emergency use under section 564 of the FD&C Act may, pursuant to
section 564(g)(2) of the

FD&C Act, be revoked when the criteria under section 564(c) of the FD&C
Act for issuance of such authorization are no longer met (section
564(g)(2)(B) of the FD&C Act), or other circumstances make such
revocation appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Requests

    On February 25, 2022, BillionToOne, Inc. requested revocation of,
and on March 10, 2022, FDA revoked, the Authorization for the qSanger-
COVID-19 Assay. Because BillionToOne, Inc. notified FDA that it has
decided to discontinue distribution of the qSanger-COVID-19 Assay and
requested FDA revoke the EUA for the qSanger-COVID-19 Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization. FDA received a request dated
February 15, 2022, from RTA for the revocation of, and on March 14,
2022, FDA revoked, the Authorization for the Diagnovital SARS-CoV-2
Real-Time PCR Kit. Because RTA notified FDA that the EUA for the
Diagnovital SARS-CoV-2 Real-Time PCR Kit is no longer required and
requested that FDA revoke the EUA for the Diagnovital SARS-CoV-2 Real-
Time PCR Kit, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization. On March 10,
2022, FDA received a request from DiaSorin Inc. for the revocation of,
and on March 15, 2022, FDA revoked, the Authorization for the DiaSorin
LIAISON SARS-CoV-2 IgM Assay. Because DiaSorin Inc. notified FDA that
DiaSorin Inc. has decided to discontinue commercial distribution and
support of the DiaSorin LIAISON SARS-CoV-2 IgM Assay and requested FDA
revoke the EUA for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On March 14, 2022, FDA received a
request from CENTOGENE US, LLC. for the revocation of, and on March 17,
2022, FDA revoked, the Authorization for the CentoFast-SARS-CoV-2 RT-
PCR Assay. Because CENTOGENE US, LLC. notified FDA that it does not
offer the CentoFast-SARS-CoV-2 RT-PCR Assay anymore and requested FDA
revoke the EUA for the CentoFast-SARS-CoV-2 RT-PCR Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On March 14, 2022, FDA received a
request from CENTOGENE US, LLC. for the revocation of, and on March 17,
2022, FDA revoked, the Authorization for the CentoSure SARS-CoV-2 RT-
PCR Assay. Because CENTOGENE US, LLC. notified FDA that it does not
offer the CentoSure SARS-CoV-2 RT-PCR Assay anymore and requested FDA
revoke the EUA for the CentoSure SARS-CoV-2 RT-PCR Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUAs for BillionToOne, Inc.'s qSanger-COVID-19 Assay,
RTA's Diagnovital SARS-CoV-2 Real-Time PCR Kit, DiaSorin Inc.'s
DiaSorin LIAISON SARS-CoV-2 IgM Assay, and CENTOGENE US, LLC's
CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR
Assay. The revocations in their entirety follow and provide an
explanation of the reasons for each revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

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[GRAPHIC] [TIFF OMITTED] TN18AP22.027

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    Dated: April 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08230 Filed 4-15-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Notices]
[Page 12348-12350]
[DOCID:fr24mr09-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings1

March 16, 2009.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER06-787-008.
    Applicants: Idaho Power Company.
    Description: Compliance filing of Idaho Power Company.
    Filed Date: 03/11/2009.
    Accession Number: 20090311-5198.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER07-1356-009; ER07-1358-008; ER07-1112-007; ER07-
1113-007; ER07-1115-008; ER07-1116-006; ER07-1117-008; ER07-1118-008;
ER07-1120-008; ER07-1122-008; ER00-2885-023; ER01-2765-022; ER08-148-
008; ER02-1582-020; ER05-1232-017; ER03-1283-017; ER02-2102-022; ER09-
335-003.
    Applicants: J.P. Morgan Ventures Energy Corporation, BE Allegheny
LLC, BE CA LLC, BE Colquitt LLC, BE Ironwood LLC, BE KJ LLC, BE Rayle
LLC, BE Satilla LLC, BE Walton LLC, BE Alabama LLC, BE Louisiana LLC,
Central Power & Lime, Inc., Cedar Brakes I, L.L.C., Mohawk River
Funding IV, L.L.C., Utility Contract Funding, L.L.C., Vineland Energy
LLC, Cedar Brakes II, L.L.C.
    Description: Notice of non-material changes of status of J.P.
Morgan Ventures Energy Corporation, et al.
    Filed Date: 03/11/2009.
    Accession Number: 20090311-5227.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER08-54-011.
    Applicants: ISO New England Inc.
    Description: Report of ISO New England Inc. Regarding Report of ISO
New England Regarding Implementation of Market Rule Changes to Permit
Non-Generating Resources to Participate in the Regulation Market.
    Filed Date: 12/19/2008.
    Accession Number: 20081219-5158.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 26, 2009.

    Docket Numbers: ER08-354-003.
    Applicants: Wells Fargo Energy Markets, LLC.
    Description: Wells Fargo Energy Markets, LLC notifies FERC of a
non-material change in status in connection with the acquisition of
Wachovia Corp etc.
    Filed Date: 03/11/2009.
    Accession Number: 20090312-0275.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER08-1237-002.
    Applicants: Shiloh Wind Project 2, LLC.
    Description: Notice of Non-Material Change in Status of Shiloh Wind
Project 2, LLC.
    Filed Date: 03/11/2009.
    Accession Number: 20090311-5181.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-411-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits response to FERC's 2/9/09 request for additional information.
    Filed Date: 03/11/2009.
    Accession Number: 20090316-0064.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-621-003.
    Applicants: TAQA Gen X LLC.
    Description: TAQA Gen X, LLC submits a clean and blacklined version
of its FERC Electric Tariff, Original Volume 1.
    Filed Date: 03/11/2009.
    Accession Number: 20090312-0280.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-805-000.
    Applicants: Quntum Energy LLC.
    Description: Quntum Energy, LLC submits Petition for Acceptance of
Initial Tariff, Waivers and Blanket Authority & requests acceptance of
FERC Electric Tariff, Original Volume 1.
    Filed Date: 03/13/2009.
    Accession Number: 20090316-0223.
    Comment Date: 5 p.m. Eastern Time on Friday, April 3, 2009.

    Docket Numbers: ER09-826-000.
    Applicants: Michigan Waste Energy, Inc.
    Description: Michigan Waste Energy, Inc submits FERC Electric
Tariff, Original Volume 1.
    Filed Date: 03/12/2009.
    Accession Number: 20090313-0116.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Docket Numbers: ER09-832-000; ER09-544-001.
    Applicants: NextEra Energy Power Marketing, LLC, FPL Energy Power
Marketing, LLC.

    Description: NextEra Energy submits Notice of Succession, Revisions
to Market-Based Rate Tariff, and Notice of Non-Material Change in
Status to reflect the name change.
    Filed Date: 03/11/2009.
    Accession Number: 20090312-0274.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-833-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies resubmits an amendment to
Service Schedule MSS-3 of the Entergy System Agreement.
    Filed Date: 03/10/2009.
    Accession Number: 20090312-0273.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 31, 2009.

    Docket Numbers: ER09-834-000.
    Applicants: Wyoming Colorado Intertie, LLC.
    Description: Wyoming Colorado Intertie, LLC submits an Application
for Authority To Sell Transmission Rights at Negotiated Rates, to be
effective 3/12/09.
    Filed Date: 03/11/2009.
    Accession Number: 20090312-0282.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-835-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits a Transmission Interconnection
Agreement etc with Desert Power et al.
    Filed Date: 03/11/2009
    Accession Number: 20090312-0276.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-836-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
proposed revisions to its Market Administration and Control Area
Services Tariff.
    Filed Date: 03/11/2009.
    Accession Number: 20090312-0277.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-837-000.
    Applicants: Southern Company Services, Inc.
    Description: Southern Companies submits a Service Agreement for the
Resale, Reassignment of transfer of Point-to-Point Transmission Service
with CER Generation, LLC.
    Filed Date: 03/11/2009.
    Accession Number: 20090312-0278.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: ER09-838-000.
    Applicants: Entegra Power Services LLC.
    Description: Entergra Power Services LLC Request for Acceptance of
Initial Market-Based Rate Tariff, Waivers and Blanket Authority.
    Filed Date: 03/13/2009.
    Accession Number: 20090316-0224.
    Comment Date: 5 p.m. Eastern Time on Friday, April 3, 2009.

    Docket Numbers: ER09-839-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest ISO submits Facilities Construction Agreement
among Wapsipinicon Power Partners, LLC, et al.
    Filed Date: 03/12/2009.
    Accession Number: 20090313-0128.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Docket Numbers: ER09-840-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits revised
tariff sheets for the Interconnection Facilities Agreement between SCE
and WM Energy Solutions, Inc, etc.
    Filed Date: 03/12/2009.
    Accession Number: 20090313-0127.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Docket Numbers: ER09-841-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits Engineering and Procurement
Agreement dated 2/10/09 between PacifiCorp and Three Buttes Windpower,
LLC, etc.
    Filed Date: 03/12/2009.
    Accession Number: 20090313-0126.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Docket Numbers: ER09-842-000.
    Applicants: PJM Interconnection L.L.C.
    Description: PJM Interconnection, LLC submits executed
interconnection service agreement among PJM, Stony Creek Wind Farm,
LLC, et al.
    Filed Date: 03/12/2009.
    Accession Number: 20090313-0125.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Docket Numbers: ER09-843-000.
    Applicants: Maine Public Service Company.
    Description: Maine Public Service Company submits informational
filing setting forth the changed loss factor eff. 3/1/09 along with
back up materials.
    Filed Date: 03/12/2009.
    Accession Number: 20090313-0123.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-12-005; OA08-113-002.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation's
Order 890 Non-Generation Compliance Filing.
    Filed Date: 03/11/2009.
    Accession Number: 20090311-5201.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 1, 2009.

    Docket Numbers: OA08-14-005; OA08-106-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Compliance filing of Midwest Independent Transmission
System Operator, Inc.
    Filed Date: 03/12/2009.
    Accession Number: 20090312-5106.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 2, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance with any FERC Online
service, please e-mail<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-6351 Filed 3-23-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16007-16008]
[FR Doc No: 2014-06365]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0493]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Additional Criteria and Procedures for Classifying
Over-the-Counter Drugs as Generally Recognized as Safe and Effective
and Not Misbranded

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 collection of information
associated with the criteria and procedures for classifying over-the-
counter (OTC) drugs as generally recognized as safe and effective and
not misbranded, in accordance with regulations and discussed in the
Guidance for Industry ``Time and Extent Applications for
Nonprescription Drug Products.''

DATES: Submit either electronic or written comments on the collection
of information by May 23, 2014.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
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.

Additional Criteria and Procedures for Classifying OTC Drugs as
Generally Recognized as Safe and Effective and Not Misbranded--21 CFR
330.14 (OMB Control Number 0910-0688)--Extension

    In the Federal Register of January 23, 2002 (67 FR 3060), we
established regulations in Sec.  330.14 (21 CFR 330.14) providing
additional criteria and procedures for classifying OTC drugs as
generally recognized as safe and effective and not misbranded (2002
time and extent application (TEA) final rule). These regulations state
that OTC drug products introduced into the U.S. market after the OTC
drug review began and OTC drug products without any marketing
experience in the United States can be evaluated under the monograph
process if the conditions (e.g., active ingredients) meet certain
``time and extent'' criteria outlined in Sec.  330.14(b). The
regulations allow a TEA to be submitted to us by any party for our
consideration to include new conditions in the OTC drug monograph
system. TEAs must provide evidence described in Sec.  330.14(c)
demonstrating that the condition is eligible for inclusion in the
monograph system. (Section 330.14(d) specifies the number of copies and
address for submission of a TEA.) If a condition is found eligible, any
interested parties can submit safety and effectiveness information as
explained in Sec.  330.14(f). Safety and effectiveness data includes
the data and information listed in 21 CFR 330.10(a)(2), a listing of
all serious adverse drug experiences that may have occurred, and an
official or proposed compendial monograph. We published the Guidance
for Industry ``Time and Extent Applications for Nonprescription Drug
Products'' in September 2011.
    In the Federal Register of February 8, 2011 (76 FR 6801), we
published a 60-day notice requesting public comment on the proposed
collection of information. In that notice, we stated that, based on the
number of submissions we had received in the 8 years following
publication of the TEA final rule, we expected to receive an average of
two TEAs and two submissions of safety and effectiveness data each
year. In the same document, we stated our estimate that approximately
1,525 hours are required to prepare a TEA and approximately 2,350 hours
to prepare a safety and effectiveness submission. This estimate is
based on a comment from a manufacturer that filed two TEAs that was
submitted to the Agency in response to the 60-day notice requesting
public comment on this proposed collection of information in the
Federal Register of October 8, 2010, (75 FR 62404). The commenter
included, as part of the estimated burden of safety and effectiveness
data submission, an estimate to submit environmental data to conduct an
environmental assessment, as required by the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) (see 21 CFR 25.1),
or the application of any categorical exclusion that may be warranted
(21 CFR 25.20(f)). Because the information provided in the submission
is based on actual experience by a TEA applicant and included an
estimated burden to comply with NEPA, we agreed with the submission and
adjusted our estimates accordingly. Based on our experience since the
February 8, 2011, Federal Register notice, we continue to estimate that
we will receive two TEAs and two safety and effectiveness submissions
each year, and that it will take

approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a
comprehensive safety and effectiveness submission, to include
environmental data.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
330.14(c)--Time & Extent                       2               1               2           1,525           3,050
 Application and (d)\2\--
 submission of information;
 confidentiality................
330.14(f)--Request for data and                2               1               2           2,350           4,700
 views and (i)\3\--compendial
 monograph......................
���������������������������������
    Total.......................  ..............  ..............  ..............  ..............           7,750
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ TEA.
\3\ Safety and effectiveness submission, including environmental data in accordance with 21 CFR 25.1.

    Dated: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06365 Filed 3-21-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 27, 2008 (Volume 73, Number 60)]
[Notices]
[Page 16405-16407]
[DOCID:fr27mr08-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57543; File No. SR-OCC-2008-03]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Cross-Margining

March 20, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on January 29, 2008, The
Options Clearing Corporation (``OCC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I, II, and III below, which items have been prepared
primarily by OCC. OCC filed the proposed rule change pursuant to
Section 19(b)(3)(A)(iii) of the Act \2\ and Rule 19b-4(f)(4) \3\
thereunder so that the proposal was effective upon filing with the
Commission. 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 \ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3 \ 17 CFR 240.19b-4(f)(4).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change amends Article VI, Clearance of Exchange

Transactions, Section 24, Cross-Margining With Participating CCOs,
paragraph (c) of OCC's By-Laws so that additional OCC-cleared products
may be more easily added in the future by amending only the relevant
Cross-Margining Agreement and not the By-Law provision.

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of such
statements.\4\
---------------------------------------------------------------------------

    \4 \ The Commission has modified parts of these statements.
---------------------------------------------------------------------------

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

    Existing cross-margining programs between OCC and certain other
commodity clearing organizations (each a ``CCO'') permit positions in
index futures and options on such futures cleared by the CCO to be
cleared in a special proprietary or non-proprietary cross-margining
account (``X-M Account'') at the CCO which is paired with a
corresponding X-M account (proprietary or non-proprietary, as the case
may be) at OCC in which securities options are cleared. A non-
proprietary X-M account is limited to options market-makers and other
``market professionals.'' The non-proprietary cross-margining accounts
are treated as futures customer accounts in that they are carried
subject to the segregation provisions of Section 4d of the Commodity
Exchange Act rather than as securities accounts subject to the
Commission's Rule 15c3-3 and other customer protection rules under the
Act. Paired X-M Accounts may be established by a ``joint clearing
member'' of OCC and the CCO or by a ``pair of affiliated clearing
members,'' one of which is a clearing member of OCC and the other of
which is a clearing member of the CCO. The paired X-M Accounts are
treated for margin purposes as if they were a single account, making it
possible to margin the paired X-M Accounts based on the net risk of the
potentially offsetting positions within them.
    In referring to the types of cleared contracts that may be carried
in an X-M Account at OCC, paragraph (c) of Section 24 of Article VI of
OCC's By-Laws presently refers only to options. The purpose of the
proposed rule change is to expand this reference to include security
futures, as defined in the Act and in the CEA, on exchange-traded funds
(``ETFs'') based on broad-based securities indices and any other
cleared contract, as defined in OCC's By-Laws, that has been approved
for cross-margining by OCC's Board of Directors.\5\ The precise types
of contracts that can be included in X-M Accounts in any particular
cross-margining program are identified in a Cross-Margining Agreement
between OCC and the CCO. The existing cross-margining programs are
limited to index options and OCC-cleared options on ETFs and index
futures cleared by a CCO. The immediate reason for expanding the types
of cleared products that may be included in X-M Accounts at OCC is to
permit security futures on ETFs based on broad-based securities indices
to be included.\6\ However, OCC has determined to amend Article VI,
Section 24(c) to make it as broad as possible so that additional OCC-
cleared products may be added in the future by amending only the
relevant Cross-Margining Agreement and not this By-Law provision.
---------------------------------------------------------------------------

    \5 \ ``Cleared contract'' is defined in Article I of OCC's By-
Laws to mean ``a cleared security or a commodity future or futures
option that is cleared by the Corporation.'' The term ``cleared
security'' is defined as ``an option contract (other than a futures
option), a security future or a BOUND.'' In effect, therefore, the
term ``cleared contract'' includes any derivative contract cleared
by OCC.
    \6 \ The Chicago Mercantile Exchange Inc. (``CME'') also clears
security futures contracts, which are reported to OCC under the
terms of the Associated Clearinghouse Agreement between the
organizations. Securities Exchange Act Release No. 46653 (October
11, 2002), 67 FR 64689 (October 21, 2002) (File No. SR-OCC-2002-07).
Under the terms of the OCC-CME cross-margining agreement, such CME-
cleared security futures are eligible contracts for purposes of
cross-margining. However, OCC will not treat security futures on
broad-based indices as eligible contracts until the CFTC issues an
order providing relief from certain provisions of Section 4d(a) of
the Commodity Exchange Act to permit the inclusion of such contracts
as eligible contracts for purposes the OCC-CME cross-margining
program.
---------------------------------------------------------------------------

    The inclusion of security futures in cross-margining is not novel.
Under Article VI, Section 25 of the By-Laws, OCC's own internal cross-
margining program for non-proprietary accounts already includes OCC-
cleared security futures along with all other cleared securities that
may be cross-margined against any OCC-cleared futures products that are
cleared by OCC in its capacity as a derivatives clearing organization
regulated by the CFTC. Unlike the other cross-margining accounts, the
internal cross-margining accounts are not limited to index options,
index futures, and OCC-cleared ETF options. OCC has broad authority to
designate any cleared contract as eligible for these accounts provided
the contract has sufficient price correlation with other eligible
contracts to provide significant risk reduction when positions are on
opposite sides of the market. As a result, no rule change is needed to
allow OCC to include futures on ETFs in these accounts. Moreover,
cross-margining of all OCC-cleared securities with OCC-cleared futures
and futures options occurs automatically in the firm account and other
proprietary accounts because OCC's By-Laws permit any OCC-cleared
contract to be carried in these accounts.
    The proposed rule change is consistent with the purposes and
requirements of Section 17A of the Act because it enhances the utility
of existing cross-margining programs by permitting the inclusion of
products that did not exist at the time the cross-margining programs
were established. Cross-margining enhances the safety of the clearing
system while providing lower clearing margin costs to participants.
Therefore, expanding the positions that may be included in X-M Accounts
is beneficial to the clearing system and its participants. The proposed
rule change is not inconsistent with the other rules of OCC, including
any rules proposed to be amended.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition.

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

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change, and none have been received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(4) \8\ promulgated
thereunder because the proposal effects a change in an existing service
of OCC that (A) does not adversely affect the safeguarding of
securities or funds in the custody or

control of OCC or for which it is responsible and (B) does not
significantly affect the respective rights or obligations of OCC or
persons using the service. At any time within sixty days of the filing
of the proposed rule change, the Commission could summarily abrogate
such rule change if it appears to the Commission that such action was
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2008-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2008-03. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of OCC. 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-OCC-2008-03 and should be
submitted on or before April 17, 2008.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-6252 Filed 3-26-08; 8:45 am]

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[Federal Register: May 19, 2009 (Volume 74, Number 95)]
[Proposed Rules]
[Page 23372-23373]
[DOCID:fr19my09-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 61

[EPA-R09-OAR-2008-0860; FRL-8905-9]

Delegation of New Source Performance Standards and National
Emission Standards for Hazardous Air Pollutants for the States of
Arizona, California, Hawaii, and Nevada

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve updates for delegation of certain
federal standards to state and local agencies in Region IX for
delegation of New Source Performance Standards (NSPS) and National
Emission Standards for Hazardous Air Pollutants (NESHAP).

DATES: Any comments on this proposal must arrive by June 18, 2009.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2008-0860, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    E-mail<EMAIL_ADDRESS>    2. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://
www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected

should be clearly identified as such and should not be submitted
through  http://www.regulations.gov or e-mail. http://
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Cynthia Allen, EPA Region IX, (415)
947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal updates the delegation tables
in 40 CFR parts 60 and 61, to allow easier access by the public to the
status of local jurisdictions. In the Rules and Regulations section of
this Federal Register, we are updating these delegation tables in a
direct final action without prior proposal because we believe these
delegations are not controversial. If we receive adverse comments,
however, we will publish a timely withdrawal of the direct final rule
and address the comments in subsequent action based on this proposed
rule.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: April 17, 2009.
Allyn Stern,
Acting Director, Air Division, Region IX.
[FR Doc. E9-11523 Filed 5-18-09; 8:45 am]

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[Federal Register Volume 82, Number 158 (Thursday, August 17, 2017)]
[Proposed Rules]
[Pages 39065-39067]
[FR Doc No: 2017-17259]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-2891; Airspace Docket No. 15-ANE-1]

Proposed Establishment of Class E Airspace; Deblois, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface in Deblois, ME, to accommodate
new area navigation (RNAV) global positioning system (GPS) standard
instrument approach procedures (SIAPs) serving Deblois Flight Strip.
Controlled airspace is necessary for the safety and management of
instrument flight rules (IFR) operations at the airport.

DATES: Comments must be received on or before October 2, 2017.

ADDRESSES: Send comments on this rule to: U. S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg Ground Floor Rm W12-140, Washington, DC 20590; Telephone: 1-800-
647-5527, or<PHONE_NUMBER>.You must identify the Docket No. FAA-2015-
2891; Airspace Docket No. 15-ANE-1, at the beginning of your comments.
You may also submit and review received comments through the Internet
at http://www.regulations.gov. You may review the public docket
containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC, 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would establish Class E airspace extending upward from
700 feet above the surface at Deblois Flight Strip, Deblois, ME, to
support IFR operations in standard instrument approach procedures at
the airport.

Comments Invited

    Interested persons are invited to comment on this proposed rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2015-2891 and Airspace Docket No. 15-ANE-1) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for address
and phone number). You may also submit comments through the Internet at
http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2015-2891; Airspace Docket No. 15-ANE-1.'' The postcard will be
date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this notice may be changed in light of
the comments received. A report summarizing each substantive public
contact with FAA personnel concerned with this rulemaking will be filed
in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, room
350, 1701 Columbia Avenue, College Park, Georgia 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace extending
upward from 700 feet above the surface within a 7-mile radius of
Deblois Flight Strip, Deblois, ME, providing the controlled airspace
required to support the new RNAV (GPS) standard instrument approach
procedures for IFR operations at the airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant preparation of a regulatory
evaluation as the anticipated impact is so minimal. Since this is a
routine matter that will only affect air traffic procedures and air
navigation, it is certified that this proposed rule, when promulgated,
will not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016,
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE ME E5 Deblois Flight Strip, Deblois, ME [New]

Deblois Flight Strip, ME
    (Lat. 44[deg]43'35'' N., long. 67[deg]59'27'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Deblois Flight Strip, and within 1-mile
either side of a 135[deg] bearing from the airport, extending from
the 7-mile radius to 10.5 miles southeast of the airport.

    Issued in College Park, Georgia, on August 8, 2017
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2017-17259 Filed 8-16-17; 8:45 am]
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