[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Rules and Regulations]
[Pages 3545-3548]
[FR Doc No: 2020-00494]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2018-N-1553]

Radiology Devices; Reclassification of Medical Image Analyzers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to reclassify medical image analyzers applied to
mammography breast cancer, ultrasound breast lesions, radiograph lung
nodules, and radiograph dental caries detection, postamendments class
III devices (regulated under product code MYN), into class II (special
controls), subject to premarket notification. These devices are
intended to direct the clinician's attention to portions of an image
that may reveal abnormalities during interpretation of patient
radiology images by the clinician. FDA is also identifying the special
controls that the Agency believes are necessary to provide a reasonable
assurance of safety and effectiveness of the device type.

DATES: This order is effective February 21, 2020.

FOR FURTHER INFORMATION CONTACT: Robert Ochs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3680, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until, the device
is reclassified into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or II under section 513(f)(3). Section 513(f)(3) of the FD&C
Act provides that FDA acting by order can reclassify the device into
class I or II on its own initiative, or in response to a petition from
the manufacturer or importer of the device. To change the
classification of the device, the proposed new class must have
sufficient regulatory controls to provide a reasonable assurance of the
safety and effectiveness of the device for its intended use.
    On June 4, 2018 (83 FR 25598), FDA published in the Federal
Register a proposed order to reclassify the device type from class III
to class II, subject to premarket notification. The comment period on
the proposed order closed on August 3, 2018.

II. Comments on the Proposed Order

    In response to the June 4, 2018, proposed order (83 FR 25598), FDA
received two comments including from

a healthcare professional in the medical device industry and a
professional society by the close of the comment period, each
containing one or more comments on one or more issues. We describe and
respond to the comments in this section of the document. The order of
response to the commenters is purely for organizational purposes and
does not signify the comment's value or importance nor the order in
which comments were received.
    (Comment 1) One commenter supported the proposed reclassification
and requested that the Agency provide examples to further clarify what
devices may fall within the scope of the proposed reclassification
action. The commenter offered three use cases as examples: (1) A
concurrent-read software device that shows computer assisted or aided
detection (CADe) marks (on the regions of interest) intended to draw
the clinicians' attention during their standard review workflow, (2) a
software device that provides quantitative measures of disease risk,
and (3) a software device that suggests prioritization of the cases in
a review list/worklist for a clinician's reading session.
    (Response 1) FDA agrees that providing examples as part of the
preamble would provide further clarity in the scope of the
reclassification order. FDA stated in Section II of the proposed order
(83 FR 25598) that, if finalized, the reclassification would cover
medical image analyzers including CADe devices for mammography breast
cancer, ultrasound breast lesions, radiograph lung nodules, and
radiograph dental caries detection that are assigned product code MYN.
Therefore, if example number 1 from the commenter above provided is a
CADe device intended for use in the clinical applications noted above,
it likely falls within the scope of this reclassification order. FDA
believes that examples number 2 and number 3 identified in Comment 1
would not be appropriately classified as medical image analyzers or
CADe devices. Therefore, these two examples are device types not
covered by this reclassification. Specifically, FDA believes that
example number 2 is likely a computer-aided diagnosis device, which FDA
has classified separately under 21 CFR 892.2060 Radiological computer-
assisted diagnostic (CADx) software for lesions suspicious for cancer,
and example number 3 is likely a computer-aided triage device, which
FDA has classified separately under 21 CFR 892.2080, Radiological
Computer Aided Triage and Notification Software.
    FDA believes that the identification language in Sec.  892.2070(a)
(21 CFR 892.2070) of the classification regulation as described in the
proposed order adequately identifies the types of devices that would be
affected by this reclassification action and declines to further modify
the identification language for medical image analyzers.
    (Comment 2) The commenter generally supported the proposed
reclassification and proposed special controls but recommended the
following additional special controls to ensure the safety and
effectiveness of the devices:
     Collect postmarket data: The commenter recommends that FDA
consider adding special controls that require the collection of
postmarket data when necessary to ensure that the device performance is
acceptable in clinical use and to allow for a comparison to premarket
data submitted for 510(k) clearance.
     Employ periodic retraining: The commenter recommends that
FDA consider adding special controls for periodic retraining of
clinicians to ensure that they understand the use of the device
according to device labeling and the appropriate reading protocol to
follow.
     Implement quality assurance requirements: The commenter
notes that there are no quality assurance requirements in the proposed
special controls to assure the medical image analyzer does not fail or
to ensure that it operates at its expected performance level.
Accordingly, the commenter asks FDA to consider adding special controls
for a well-defined device-specific quality assurance process.
    (Response 2) FDA disagrees with this comment. The Agency believes
that the special controls, as identified in the proposed order,
together with general controls, are sufficient to provide reasonable
assurance of safety and effectiveness of medical image analyzers. FDA
does not believe that a requirement for collecting postmarket data as a
special control is necessary to provide reasonable assurance of the
safety and effectiveness for medical image analyzers devices. FDA has
nearly 20 years of experience regulating medical image analyzers as
class III devices considered within the scope of this reclassification,
and postmarket studies have not been required during this period.
Additionally, there have not been signals observed during this time
that would suggest postmarket studies were necessary. As stated in the
proposed order, in the past 10 years, there have been no medical device
reports related to these CADe devices. FDA has only classified one
recall for these CADe devices due to distribution of the CADe device
without prior premarket application approval. Further, FDA still
maintains the authority to require manufacturers to conduct postmarket
surveillance of class II devices under section 522 of the FD&C Act (21
U.S.C. 360l) when certain conditions are met.
    FDA does not believe that an additional special control regarding
user retraining is necessary to provide reasonable assurance of the
safety and effectiveness of medical image analyzers. The Agency
believes that it has identified the risk of misuse by a physician and
that the measures described in this final order will be effective in
mitigating this probable risk to health, mainly Sec.  892.2070(b)(2)
that requires the labeling of these devices to include a detailed
description of the intended user and user training that addresses
appropriate reading protocols for the device.
    While FDA agrees that appropriate quality assurance (QA) approaches
are helpful in ensuring that a medical image analyzer consistently
operates at its expected performance level, FDA disagrees with the need
to write specific QA requirements for the end-users into the special
controls. FDA believes specifying end-user QA requirements may be
redundant with the special controls already identified in this final
order (see specifically Sec.  892.2070(b)(1) and (2)), in combination
with general controls, including especially the Quality System (QS)
Regulations under part 820 (21 CFR part 820). In addition, because many
different approaches to address QA exist, coupled with the general and
special controls requirements that are already applicable to this
device type, FDA does not believe that defining specific QA
requirements in the special controls is necessary to reasonably assure
safety, and FDA believes manufacturers should consider the need for,
and most appropriate methods, to evaluate potential changes in CADe
performance over time. This information should address the general
controls as well as special controls (see specifically Sec.
892.2070(b)(2)), including providing user training, identifying
compatible hardware, identifying limitations, and providing operating
instructions.

III. The Final Order

    Based on the information discussed in the preamble to the proposed
order (83 FR 25598, June 4, 2018), the comments received for the
proposed order, prior panel discussions, and FDA's experiences over the
years in reviewing

these device types, FDA concludes that special controls, in conjunction
with general controls, will provide reasonable assurance of the safety
and effectiveness of medical image analyzers. FDA is adopting its
findings under section 513(f)(3) of the FD&C Act, as published in the
preamble to the proposed order (83 FR 25598). FDA is issuing this final
order to reclassify medical image analyzers, including CADe devices,
for mammography breast cancer, ultrasound breast lesions, radiograph
lung nodules, and radiograph dental caries detection from class III to
class II, and establishing special controls by revising 21 CFR part
892.\1\ In this final order, the Agency has identified the special
controls under section 513(a)(1)(B) of the FD&C Act that, together with
general controls, provide reasonable assurance of the safety and
effectiveness of these devices.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of medical image analyzers, and therefore, this device
type is not exempt from premarket notification requirements. Persons
who intend to market a new CADe device must obtain clearance of a
premarket notification and demonstrate compliance with the special
controls included in this final order, prior to marketing the device.
    The device is assigned the generic name medical image analyzer, and
identified as a medical image analyzers, including CADe devices, for
mammography breast cancer, ultrasound breast lesions, radiograph lung
nodules, and radiograph dental caries detection, is a prescription
device that is intended to identify, mark, highlight, or in any other
manner direct the clinicians' attention to portions of a radiology
image that may reveal abnormalities during interpretation of patient
radiology images by the clinicians. This device incorporates pattern
recognition and data analysis capabilities and operates on previously
acquired medical images. This device is not intended to replace the
review by a qualified radiologist and is not intended to be used for
triage or to recommend diagnosis.
    Under this final order, the medical image analyzer is a
prescription use only device under Sec.  801.109 (21 CFR 801.109).
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of Sec.  801.109 are met (referring to 21 U.S.C. 352(f)(1)).
Under 21 CFR 807.81, the device continues to be subject to 510(k)
requirements.

IV. Codification of Orders

    Prior to the amendments in the Food and Drug Administration Safety
and Innovation Act (FDASIA), section 513(e) of the FD&C Act provided
for FDA to issue regulations to reclassify devices. Although section
513(e) as amended requires FDA to issue final orders rather than
regulations, it also provides for FDA to revoke previously issued
regulations by order. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as changes to
codified classification determinations or as newly codified orders.
Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this
final order, we are proposing to codify the classification of medical
image analyzers, applied to CADe devices for mammography breast cancer,
ultrasound breast lesions, radiograph lung nodules, and radiograph
dental caries detection in the new Sec.  892.2070, under which medical
image analyzers would be reclassified into class II.

V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved FDA collections. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in part 807, subpart E have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 801 have been approved under OMB control number 0910-0485;
and the collections of information in part 820 have been approved under
OMB control number 0910-0073.

List of Subjects in 21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
892 is amended as follows:

PART 892--RADIOLOGY DEVICES

0
1. The authority citation for part 892 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  892.2070 to subpart B to read as follows:

Sec.  892.2070  Medical image analyzer.

    (a) Identification. Medical image analyzers, including computer-
assisted/aided detection (CADe) devices for mammography breast cancer,
ultrasound breast lesions, radiograph lung nodules, and radiograph
dental caries detection, is a prescription device that is intended to
identify, mark, highlight, or in any other manner direct the
clinicians' attention to portions of a radiology image that may reveal
abnormalities during interpretation of patient radiology images by the
clinicians. This device incorporates pattern recognition and data
analysis capabilities and operates on previously acquired medical
images. This device is not intended to replace the review by a
qualified radiologist, and is not intended to be used for triage, or to
recommend diagnosis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Design verification and validation must include:
    (i) A detailed description of the image analysis algorithms
including a description of the algorithm inputs and outputs, each major
component or block, and algorithm limitations.
    (ii) A detailed description of pre-specified performance testing
methods and dataset(s) used to assess whether the device will improve
reader performance as intended and to characterize the standalone
device performance. Performance testing includes one or more standalone
tests, side-by-side comparisons, or a reader study, as applicable.
    (iii) Results from performance testing that demonstrate that the
device improves reader performance in the intended use population when
used in accordance with the instructions for use. The performance
assessment must be based on appropriate diagnostic accuracy measures
(e.g., receiver operator characteristic plot, sensitivity, specificity,
predictive value, and diagnostic likelihood ratio). The test dataset
must contain a sufficient number of cases from important cohorts (e.g.,
subsets defined by clinically relevant confounders, effect modifiers,
concomitant diseases, and subsets defined by image acquisition
characteristics) such that the performance estimates and confidence
intervals of the device for these individual subsets can be
characterized for the intended use population and imaging equipment.
    (iv) Appropriate software documentation (e.g., device hazard
analysis; software requirements specification document; software design
specification document; traceability analysis; description of
verification and validation activities including system level test
protocol, pass/fail criteria, and results; and cybersecurity).
    (2) Labeling must include the following:
    (i) A detailed description of the patient population for which the
device is indicated for use.
    (ii) A detailed description of the intended reading protocol.
    (iii) A detailed description of the intended user and user training
that addresses appropriate reading protocols for the device.
    (iv) A detailed description of the device inputs and outputs.
    (v) A detailed description of compatible imaging hardware and
imaging protocols.
    (vi) Discussion of warnings, precautions, and limitations must
include situations in which the device may fail or may not operate at
its expected performance level (e.g., poor image quality or for certain
subpopulations), as applicable.
    (vii) Device operating instructions.
    (viii) A detailed summary of the performance testing, including:
test methods, dataset characteristics, results, and a summary of sub-
analyses on case distributions stratified by relevant confounders, such
as lesion and organ characteristics, disease stages, and imaging
equipment.

    Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00494 Filed 1-21-20; 8:45 am]
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[Federal Register: December 30, 2008 (Volume 73, Number 250)]
[Notices]
[Page 79876-79877]
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL09-21-000]

PacifiCorp; Notice of Filing

December 19, 2008.
    Take notice that on December 16, 2008, PacifiCorp filed a petition
for declaratory order (petition), pursuant to Rule 207 of the
Commission's Rules of Practice and Procedures, 18 CFR 385.207,
requesting that the Commission disclaim jurisdiction over agreements
listed in the index of the petition, pursuant to section 205 of the
Federal Power Act.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    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 14 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 14, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-30926 Filed 12-29-08; 8:45 am]

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[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17472-17473]
[FR Doc No: 2012-7149]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-56-000]

Texas Eastern Transmission, LP, Algonquin Gas Transmission, LLC;
Notice of Availability of the Final Environmental Impact Statement for
the Proposed New Jersey-New York Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the New Jersey-New York Expansion Project (NJ-NY Project or
Project), proposed by Texas Eastern Transmission, LP (Texas Eastern)
and Algonquin Gas Transmission, LLC (Algonquin), both Spectra Energy
Corporation natural gas pipeline companies, in the above-referenced
docket. Texas Eastern and Algonquin request authorization to expand
their natural gas pipeline systems in New Jersey, New York, and
Connecticut, to deliver up to 800,000 dekatherms per day of natural gas
from multiple receipt points on the Texas Eastern and Algonquin
pipeline systems to new delivery points in New Jersey and New York.
    The final EIS assesses the potential environmental effects of the
construction and operation of the NJ-NY Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed Project would have some
adverse environmental impact; however, these impacts would be reduced
to less-than-significant levels with the implementation of Texas
Eastern's and Algonquin's proposed

mitigation and the additional measures we recommend in the EIS.
    The U.S. Environmental Protection Agency (EPA), U.S. Department of
Transportation, U.S. Army Corps of Engineers, New York City Mayor's
Office, and New York City Department of Environmental Protection
participated as cooperating agencies in the preparation of the EIS.
Cooperating agencies have jurisdiction by law or special expertise with
respect to resources potentially affected by the proposal and
participate in the NEPA analysis. Although the cooperating agencies
provided input to the conclusions and recommendations presented in the
EIS, the agencies will present their own conclusions and
recommendations in their respective Records of Decision for the
project.
    The final EIS addresses the potential environmental effects of the
following project facilities:
     Construction and operation of approximately 15.2 miles of
new 30-inch-diameter pipeline and 4.8 miles of 42-inch-diameter
pipeline;
     Abandonment of 8.95 miles of existing 12-, 20-, and 24-
inch-diameter pipeline;
     Installation of seven new metering and regulating (M&R)
stations;
     Modifications to four existing compressor stations and one
existing M&R station; and
     Modifications and installations of associated valves and
piping.
    The FERC staff mailed copies of the EIS to federal, state, and
local government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes; local
newspapers and libraries in the Project area; intervenors to the FERC's
proceeding; and potentially affected landowners and other interested
individuals and groups. Paper copy versions of the EIS were mailed to
those specifically requesting them; all others received a CD version.
In addition, the EIS is available for public viewing on the FERC's Web
site (www.ferc.gov) using the eLibrary link. A limited number of copies
are available for distribution and public inspection at: Federal Energy
Regulatory Commission, Public Reference Room, 888 First Street NE.,
Room 2A, Washington, DC 20426.<PHONE_NUMBER>.
    In accordance with the Council on Environmental Quality's (CEQ)
regulations implementing NEPA, no agency decision on a proposed action
may be made until 30 days after the EPA publishes a notice of
availability of the final EIS in the Federal Register. However, the CEQ
regulations provide an exception to this rule when an agency decision
is subject to a formal internal appeal process that allows other
agencies or the public to make their views known. In such cases, the
agency decision may be made at the same time the notice of the final
EIS is published, allowing both periods to run concurrently. The
Commission decision for this proposed action is subject to a 30-day
rehearing period.

Questions

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP11-
56). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>; for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/esubscribenow.htm.

    Dated: March 16, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-7149 Filed 3-23-12; 8:45 am]
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[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Notices]
[Page 56581-56583]
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8722-2; Docket ID No. EPA-HQ-OAR-2008-0699]

Notice of Workshop and Call for Information on Integrated Science
Assessment for Ozone

AGENCY: Environmental Protection Agency.

ACTION: Notice; call for information.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
that the Office of Research and Development's National Center for
Environmental Assessment (NCEA) is preparing an Integrated Science
Assessment (ISA) as part of the review of the National Ambient Air
Quality Standards (NAAQS) for ozone (O3). This is intended
to update the scientific assessment presented in the ``Air Quality
Criteria for Ozone and Related Photochemical Oxidants'' (EPA 600/P-05/
004aF-cF), published in February 2006. Interested parties are invited
to assist the EPA in developing and refining the scientific information
base for the review of the O3 NAAQS by submitting research
studies that have been published, accepted for publication, or
presented at a public scientific meeting.
    The EPA is also announcing that a workshop entitled, ``Workshop to
Discuss Policy-Relevant Science to Inform EPA's Integrated Plan for the
Ozone NAAQS,'' is being organized by NCEA and the EPA Office of Air and
Radiation's Office of Air Quality Planning and Standards (OAQPS). The
workshop will be held October 29-30, 2008, in Research Triangle Park,
North Carolina. The workshop will be open to attendance by interested
public observers on a first-come, first-served basis up to the limits
of available space.

DATES: The workshop will be held on October 29 and 30, 2008. The pre-
registration deadline is October 17, 2008. In response to the call for
information, all communications and information should be received by
EPA by November 3, 2008.

ADDRESSES: The workshop will be held at U.S. EPA, 109 T.W. Alexander
Drive, Research Triangle Park, North Carolina. An EPA contractor, E.H.
Pechan & Associates, Inc., is providing logistical support for the
workshop. To register, please use the on-line registration form at:
http://projects.pechan.com/epa/o3review/. Please direct questions
regarding workshop registration or logistics to E. H. Pechan &
Associates at<PHONE_NUMBER>, ext. 119, or Tricia Crabtree at 919-541-
5688, or e-mail<EMAIL_ADDRESS>For specific questions
regarding technical aspects of the workshop see the section of this
notice entitled FOR FURTHER INFORMATION CONTACT.
    Information in response to the call for information may be
submitted electronically, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions as provided in the
section of this notice entitled SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For details on the period for
submission of research information from the public, contact the Office
of Air and Radiation (OAR) Docket, telephone:<PHONE_NUMBER>, facsimile:
202-566-9744, or e-mail<EMAIL_ADDRESS>    For technical information, contact James Brown, NCEA, telephone:
919-541-0765, facsimile:<PHONE_NUMBER>, or e-mail<EMAIL_ADDRESS>
or contact David McKee, OAQPS, telephone:<PHONE_NUMBER>, or e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Project

    Section 108 (a) of the Clean Air Act directs the Administrator to
issue ``air quality criteria'' for certain air pollutants. These air
quality criteria are to ``accurately reflect the latest scientific
knowledge useful in indicating the kind and extent of all identifiable
effects on public health or welfare which may be expected from the
presence of such pollutants in the ambient air. * * *'' Under section
109 of the Act, EPA is then to establish National Ambient Air Quality
Standards (NAAQS) for each pollutant for which EPA has issued criteria.
Section 109 (d) of the Act subsequently requires periodic review and,
if appropriate, revision of existing air quality criteria to reflect
advances in scientific knowledge on the effects of the pollutant on
public health and welfare. EPA is also to revise the NAAQS, if
appropriate, based on the revised air quality criteria.
    Ozone (O3) is one of six principal (or ``criteria'')
pollutants for which EPA has

established NAAQS. Periodically, EPA reviews the scientific basis for
these standards by preparing an Integrated Science Assessment (ISA),
formerly called an Air Quality Criteria Document (AQCD). The ISA and
supplementary annexes are the scientific basis for the additional
technical and policy assessments that form the basis for EPA decisions
on the adequacy of a current NAAQS and the appropriateness of new or
revised standards. Early steps in this process include announcing the
beginning of this periodic NAAQS review and the development of the ISA,
and NCEA requesting that the public submit scientific literature that
they want to bring to the attention of the Agency as it begins this
process. The Clean Air Scientific Advisory Committee (CASAC), an
independent science advisory committee mandated by the Clean Air Act
and part of the EPA's Science Advisory Board (SAB), is charged with
independent/expert scientific review of EPA's draft ISAs. As the
process proceeds, the public will have opportunities to review and
comment on draft O3 ISAs. These opportunities will also be
announced in the Federal Register.
    The Agency is interested in obtaining additional information,
particularly concerning toxicological studies of effects of controlled
exposure to O3 on laboratory animals, humans, and in vitro
systems, as well as epidemiologic (observational) studies of health
effects associated with ambient exposures of human populations to
O3. EPA also seeks recent information in other areas of
O3 research such as chemistry and physics, sources and
emissions, analytical methodology, transport and transformation in the
environment, ambient concentrations, and effects on public welfare or
the environment. This and other selected literature relevant to a
review of the NAAQS for O3 will be assessed in the
forthcoming O3 ISA.
    As part of this review of the O3 NAAQS, EPA intends to
sponsor a workshop on October 29-30, 2008, to highlight significant new
and emerging O3 research, and to make recommendations to the
Agency regarding the design and scope of the review for the primary
(health-based) and secondary (welfare) O3 standards to
ensure that it addresses key policy-relevant issues and considers the
new science that is relevant to informing our understanding of these
issues. In addition, other opportunities for submission of new peer-
reviewed, published (or in-press) papers will be possible as part of
public comment on the draft ISAs that will be reviewed by CASAC. The
workshop will provide an opportunity for internal and external experts
to highlight significant new and emerging O3 research, and
to make recommendations to the Agency regarding the design and scope of
the review for the O3 standards to ensure that it addresses
key policy-relevant issues and considers the new science relevant to
informing our understanding of these issues. We intend that workshop
discussions will build upon three prior publications or events:
    1. National Ambient Air Quality Standards for Ozone: Final Rule (73
FR 16436, March 27, 2008). The preamble to the final rule included
detailed discussions of policy-relevant issues central to the last
review.
    2. Air Quality Criteria for Ozone and Related Photochemical
Oxidants (EPA 600/P-05/004aF-cF, February 2006). Please see http://
www.epa.gov/ttn/naaqs/standards/o3/s_o3_index.html to obtain a copy
of the 2006 Air Quality Criteria Document, the notice of final
rulemaking from 2008, and other related documents.
    3. December 2006 workshop sponsored by NCEA, entitled
``Interpretation of Epidemiologic Studies of Multi-pollutant Exposure
and Health Effects.'' The workshop dealt with important issues relevant
to this review, such as the interpretation and understanding of
criteria air pollutant health effects analyses in population-level
epidemiologic studies, with a focus on multi-pollutant exposures (71 FR
67566, November 22, 2006). Workshop participants are encouraged to
review each of these documents and/or supporting materials thoroughly
before the meeting begins, as they provide important insights into new
scientific advances and key policy-relevant questions.
    Based in large part on the input received during this workshop, EPA
will develop a draft integrated O3 NAAQS review plan that
will outline the schedule, process, and approaches for evaluating the
relevant scientific information and addressing the key policy-relevant
issues to be considered in this review. The CASAC will be asked to
conduct a consultation with the Agency on the draft integrated plan
early next year, and the public will have the opportunity to comment on
it as well. The final integrated plan will be used to frame each of the
major elements of the O3 review under the new NAAQS process:
an integrated science assessment document, a risk/exposure assessment
report, and a policy assessment to be published as an advance notice of
proposed rulemaking (ANPR).

II. How To Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2008-
0699 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2008-0699. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your e-mail address will be automatically captured and included as part
of the

comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the OEI Docket in the EPA
Headquarters Docket Center.

    Dated: September 23, 2008.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E8-22799 Filed 9-26-08; 8:45 am]

BILLING CODE 6560-50-P


The background papers on the candidate national program priorities are intended to initiate further discussion. When priorities are selected, more detailed strategies with in depth background information, numerical targets, schedules, milestones and performance measures will be developed.

_____________________________________________________________________________

December, 2003 Page 1 of 3 Proposed Priority: Environmental Management Systems at Federal Facilities Universe and Types of Facilities Federal facilities, like all other regulated facilities, are responsible for complying with environmental regulations and requirements. Federal agencies and facilities are likewise accountable to the public for general environmental stewardship. In addition, Federal agencies are responsible for implementation of a variety of environmental Executive Orders designed to promote environmental leadership, stewardship and sustainability across the Federal government.

The Federal government owns and leases vast amounts of property in the United States. According to the General Services Administration, as of September 30, 2002, the total amount of Federally owned or leased property is approximately 670 million acres. This represents approximately 30 percent of all land in the United States. The total area of Federally owned or leased buildings amounts to approximately 3 billion square feet.

According to EPA, there are approximately 8,000 Federal facilities across the United States that engage in some type of activity where the Federal government is formally accountable under environmental regulation. The Federal government covers a broad array of unique facility types from industrial facilities occupied by Department of Defense, Department of Energy and NASA operations to land management " facilities" that are managed by agencies such as the Forest Service and National Park Service and cover thousands of acres. Federal facilities also include operations such as hospitals and laboratories as well as administrative offices. In addition, Federal facilities may be operated by contractors or may include concessioners or other entities where activities are not directly managed by the Federal facility operators.

Environmental Risks Federal facilities are responsible for a number of environmental challenges, including compliance with various environmental statutes and implementing regulations established under those statutes as well as basic operational stewardship and management of lands where contractors, concessioners and permit holders operate. In addition, as previously mentioned, there are a number of Executive Orders from current and previous Administrations that call for enhanced environmental stewardship across the Federal government. These initiatives cover a range of operational, procurement and management policy directives that are required of the Federal community. Below is a brief summary of environmental challenges faced by some types of Federal Facilities:

DOD is charged with defending the interests of the United States anywhere in the world. As such, DOD maintains thousands of installations in the United States to provide the necessary The background papers on the candidate national program priorities are intended to initiate further discussion. When priorities are selected, more detailed strategies with in depth background information, numerical targets, schedules, milestones and performance measures will be developed.

_____________________________________________________________________________

December, 2003 Page 2 of 3 infrastructure for the armed services to meet this mission. Installations range in size from a few acres to thousands of square miles; their missions range from logistics and training to manufacturing and rebuilding aircraft and ships. Many of these installations are the equivalent of small cities, and thus they possess all of the infrastructure ( e. g., hospitals, sewage treatment plants, roads, airports) associated with city environments. Much of the support activity associated with DOD's mission is industrial involving maintenance and repair of complex and frequently large systems and equipment. As such, facilities use a broad array of processes involving chemicals such as paints and solvents. Therefore, DOD installations face compliance issues relating to air and water pollution and solid/ hazardous waste generation.

DOE is involved in electric power generation and transmission, fuel research, petroleum storage, and nuclear weapons research and production. Many of DOE's approximately 350 installations are dedicated to laboratory research. DOE laboratories work on a variety of issues including solar energy, battery development, energy transmission methods, atomic energy, fossil fuels, and nuclear weapons. Some laboratories are located on large compounds such as Savannah River, SC, Los Alamos, NM, and Oak Ridge, TN, while others are part of university systems such as the Fermi Lab in Chicago. Like DOD, the large scale manufacturing and industrial nature of many DOE activities presents DOE with a broad range of environmental compliance issues.

Civilian Federal Agency ( CFA) facilities range in size and scope from single purpose buildings to extensive multipurpose compounds. Regulated activities may include vehicle fleet management, construction, facility operation, scientific and medical research, materials storage and shipment, and many others. Because of the diversity of CFA activities, as a group, they face environmental compliance issues as extensive as those faced by many industrial Federal facilities. In addition, in the case of land management agencies, facilities must understand and respond to environmental management issues such as natural resource protection and preservation as well as potential impacts from operations such as mining and timber harvesting and visitors using the facility for recreation.

For more information on environmental regulations associated with common activities at Federal facilities go to www. epa. gov/ fedsite/.

Noncompliance Information In recent years, the Federal facility compliance rate with the Resource Conservation and Recovery Act ( RCRA) has increased steadily. In contrast, the compliance rate for Clean Water Act, National Pollutant Discharge Elimination System ( CWA/ NPDES) has decreased overall with a slight increase in compliance in the most recent reporting year. The compliance rates for The background papers on the candidate national program priorities are intended to initiate further discussion. When priorities are selected, more detailed strategies with in depth background information, numerical targets, schedules, milestones and performance measures will be developed.

_____________________________________________________________________________

December, 2003 Page 3 of 3 the Clean Air Act ( CAA) fluctuated in recent years, increasing slightly during the last reporting year. The compliance rate for Safe Drinking Water Act ( SDWA) has declined slightly in recent years.

To enhance and better maintain regulatory compliance and environmental stewardship, EPA plans to foster a more effective implementation of environmental management systems ( EMS) by Federal facilities. An EMS is a tool that can accomplish or facilitate the implementation of many environmental requirements and expectations facing Federal agencies. An EMS is a process and framework used by an organization to manage its environmental affairs and issues, most notably those areas where the entity interacts with or affects the environment, as well as where legal requirements exist. The key to success is understanding the relationships and linkages among the various issues and requirements, and being cognizant of how they all fit into the EMS framework. The type of EMS currently being envisioned by most Federal agencies is generally modeled using the Plan, Do, Check, Act management concept. The private sector experience in applying management system principles to environment regulatory and stewardship issues has shown that this organized approach is both prudent and effective and can improve efficiency as well as regulatory compliance.

In the past Federal environmental programs have focused on regulatory compliance as the goal and accepted standard for environmental management. This reactive approach has limited the ability of organizations to implement a process or plan to address and prevent environmental impacts. The EMS concept represents a fundamental change from a traditional, reactive, compliance based, stand alone environmental management programs to a proactive, impactpredicting management system that is focused on the mission and embedded in everyday business processes and mission activities. The EMS approach suggests that " stovepiped" environmental programs do not sufficiently integrate mission activities and business processes to identify and mitigate potential environmental impacts during the planning stages and to ensure environmental excellence.


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Notices]
[Page 26719]
[FR Doc No: 2011-11235]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-2256-000]

California Independent System Operator Corporation; Notice
Establishing Comment Periods

    This notice establishes the comment periods for the technical
conference which was held on April 28, 2011, to discuss issues related
to California Independent System Operator Corporation's (CAISO)
Capacity Procurement Mechanism (CPM) compensation methodology and
exceptional dispatch mitigation provisions.\1\ All parties are invited
to submit initial comments on or before Friday, May 27, 2011, and
initial comments are requested to be no longer than 25 pages. Reply
comments are due on or before Wednesday, June 15, 2011, and are
requested to be no longer than 15 pages.
---------------------------------------------------------------------------

    \1\ Cal. Indep. Sys. Operator Corp., 134 FERC ] 61,211, at P2
(2011).
---------------------------------------------------------------------------

    For more information, please contact Katheryn Hoke at
<EMAIL_ADDRESS>or<PHONE_NUMBER>, or Colleen Farrell at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.

    Dated: May 3, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-11235 Filed 5-6-11; 8:45 am]
BILLING CODE 6717-01-P


1.  COMMENT: The commentor indicated that he is opposed to the extension
of the new vehicle inspection exemption from four (4) years to five (5)
years but willing to work with the Motor Vehicle Commission (MVC) on a
smooth transition and further changes that will benefit the State
budget, the public and small businesses.  The commentor believes that if
the new vehicle inspection exemption period is extended, the time period
when the motorist will ignore an illuminated Check Engine light will be
extended from 4 to 5 years, polluting the air for an additional year.

RESPONSE:   The Department evaluated the emission reduction impacts of
the proposed extension of the new vehicle inspection exemption period
using the protocol set forth in the USEPA’s final rule on I/M
requirements.  The USEPA protocol requires a demonstration, using the
most current version of USEPA’s mobile source emission model, that the
equivalency of the emission levels achieved by the State’s proposed
enhanced I/M program design be compared to those of the performance
standard.  Using this protocol, the results of the model indicate that
there is no difference between emission factors for New Jersey’s
existing and proposed enhanced I/M programs for ozone precursors (VOCs
and NOx). For these pollutants the magnitude of the increase in
emissions due to the increased new vehicle exemption period from 4 years
to 5 years is completely offset by the reduction in emissions due to the
increased effectiveness of New Jersey’s Private Inspection Facilities
(PIFs).

The new enhanced I/M program design results in an insignificantly small
increase in the

predicted carbon monoxide emission factor relative to the existing
enhanced I/M

program. The increase is well below the USEPA margin of error of +/-
0.02 grams per mile (gpm).  When stated to 4 significant figures, the
carbon monoxide emission factors are the same.

 This demonstrates that the proposed changes to the enhanced I/M program
do not compromise the State’s efforts to meet and/or maintain National
Ambient Air Quality Standards (NAAQSs) for ozone or carbon monoxide.
Also, the State's new enhanced I/M program meets the USEPA low enhanced
performance standard.

The Department appreciates the commentor’s willingness to work with
the State on making a smooth transition into the new I/M program.  The
Department is also committed to working with the PIFs, the MVC and other
State agencies to ensure that changes to the inspection program continue
to protect the health of New Jersey’s citizens and its environment.

2.  COMMENT: The commentor supports upgrading the Private Inspection
Facility (PIF) inspection effectiveness. However, he notes that PIFs
should receive 100% equivalency, and not limit it to 96% as proposed in
the SIP revision. The basis for the commentor’s claim is that it is in
the best interest of PIF inspectors to identify and point out vehicle
defects to their customers.

RESPONSE: The Department commissioned a study to reevaluate the level of
PIF effectiveness.  The study arrived at a factor of 96% PIF inspection
equivalency for emissions testing. The study compared Centralized
Inspection Facility (CIF) and PIF inspections, assigning a default of
100% credit to CIF inspections. Among the factors examined, the study
looked at emission inspection failure rates and suspected incorrect
emission testing rates for both on-board diagnostics (OBD) and tailpipe
tests. The study’s findings support the commentor’s assertions that
the PIF OBD tests should receive 100% credit. Results from tailpipe
testing, however, are less conclusive and the Department agrees with the
study’s conclusions that it is prudent to retain the previous estimate
of 80% effectiveness. The overall 96% PIF credit results from a weighted
blending of 100% PIF credit for OBD and 80% PIF credit for tailpipe
tests. Since an increasing percentage of tests are now OBD and not
tailpipe, the OBD effectiveness dominates the weighting.

3.  COMMENT: The commentor feels that the use of OBD effectiveness in
supporting lower rates of in-use deterioration in emissions performance
may be flawed. The commentor further contends that motorists do not
always respond to the OBD malfunction light and may refuse needed
emission repairs if their vehicle is not exhibiting driveability issues
and is not due for an I/M test.  The commentor goes on to state that the
problem of ignoring needed repairs may have become even worse in recent
years as a result of economic concerns reducing money available to
motorists for repairs. The commentor believes that the State is missing
this effect but has no way of calculating it.

RESPONSE: The rate of motorist response to an illuminated Check Engine
light in between inspection cycles (off-cycle), is a basic function
built into the USEPA emission factor model.  The Department used the
most current version of the model to estimate the emissions impact of
the proposed changes to the I/M program.  The USEPA will make changes to
the model if key assumptions, such as the motorist’s response rate to
an illuminated MIL change over time.

4.  COMMENT:  The commentor stated that, although aware that the hearing
was not addressing safety-related inspection issues, the same issue
regarding lack of motorist response to a Check Engine light applies to
safety-related defects.  The commenter stated that his association
members continue to document instances where motorists bring their cars
in for maintenance and are advised of serious safety issues, and now,
without a safety-inspection program and the need to have the
safety-related item corrected in order to pass inspection, they are more
frequently ignored by the motorist.

RESPONSE:  Legislation signed into law on June 28, 2010, directed the
Motor Vehicle Commission to end mechanical inspections on August 1, 2010
for non-commercial vehicles.  The commentor is correct that the
NJDEP’s SIP hearing covered only the emissions-test related aspects of
the I/M program and did not address the mechanical inspection program.
As such, comments on the mechanical inspection program will not be
addressed in this document.  However, the Department has forwarded the
transcripts from the SIP hearing to the MVC for their information.


[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Page 72519]
[FR Doc No: 2023-23197]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4729-DR; Docket ID FEMA-2023-0001]

Tennessee; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Tennessee (FEMA-4729-DR), dated August 17,
2023, and related determinations.

DATES: The declaration was issued August 17, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 17, 2023, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Tennessee resulting from severe storms and straight-line winds
during the period of June 25 to June 26, 2023, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of Tennessee.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Andrew D. Friend, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Tennessee have been designated
as adversely affected by this major disaster:

    Fayette, Shelby, and Tipton Counties for Public Assistance.
    All areas within the State of Tennessee are eligible for
assistance under the Hazard Mitigation Grant Program.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-23197 Filed 10-19-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Page 14421]
[FR Doc No: 2021-05383]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15059-000]

Kinet, Inc.; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

    On December 3, 2020, Kinet, Inc., filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of a conventional hydropower
project located in Anderson, Woodford, and Mercer Counties, Kentucky.
The sole purpose of a preliminary permit, if issued, is to grant the
permit holder priority to file a license application during the permit
term. A preliminary permit does not authorize the permit holder to
perform any land-disturbing activities or otherwise enter upon lands or
waters owned by others without the owners' express permission.
    The proposed Kentucky River Lock and Dam No. 5 Hydroelectric
Project would consist of the following: (1) An existing 594-foot-long,
36-foot-high, timber crib dam with concrete overlay connected to a 390-
foot-long, and 38-foot-wide abandoned navigation lock, which are owned
by the Kentucky River Authority; (2) a reservoir with a surface area of
448 acres and a storage capacity of 7,500 acre-feet; (3) five,
proposed, 32-foot-long, 9-foot-diameter penstocks connected to five
generating units with a combined capacity of 2.4 megawatts, within the
existing lock; (4) a proposed powerhouse/control room adjacent to the
lock; (5) a 30-foot-long by 63-foot-wide tailrace; and (6) a 175-foot-
long, 12.47 kilo-Volt transmission line. The proposed project would
have an estimated annual generation of 16,243 megawatt-hours.
    Applicant Contact: Dan Panko, Kinet, Inc., 2401 Monarch Street,
Alameda, CA 9401; phone:<PHONE_NUMBER>.
    FERC Contact: Joshua Dub; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's website at https://elibrary.ferc.gov/eLibrary/search.
Enter the docket number (P-15059) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: March 10, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-05383 Filed 3-15-21; 8:45 am]
BILLING CODE 6717-01-P


Marjorie Jones/RTP/USEPA/US

07/17/2007 02:59 PM

To

"Johansson, Robert"<EMAIL_ADDRESS> cc

Ron Evans/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA

Subject

Call tomorrow 330-430pm

Rob -- we've scheduled a call for tomorrow (Wed, July 18) from 3:30 - 4:30p.m.

Call-in number:<PHONE_NUMBER>.

If you have an idea of issues before then, please let us know.  I've asked everyone to be on the call because right now we're not sure what's going to come up.

Thanks, Margie

Marjorie C. Jones

Office of Air Quality Planning & Standards

Air Benefit and Cost Group, Mail Code C439-02

Health and Environmental Impacts Division

RTP, NC 27711

voice:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

Shipping/receiving: 4930 Old Page Rd.

Durham, NC 27709


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26046-26047]
[FR Doc No: 2021-09968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0074]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Submit written comments (including recommendations) on the
collection of information by June 11, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0275. Also include the FDA docket
number found in brackets in the heading of this document.

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

State Enforcement Notifications--21 CFR 100.2(d)

OMB Control Number 0910-0275--Extension

    This information collection supports Agency regulations.
Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain
sections of the FD&C Act in its own name and within its own
jurisdiction. However, before doing so, a State must provide notice to
FDA according to Sec.  100.2 (21 CFR 100.2). The information required
in a letter of notification under Sec.  100.2(d) enables us to identify
the food against which a State intends to take action and to advise
that State whether Federal enforcement action against the food has been
taken or is in process. With certain narrow exceptions, Federal
enforcement action precludes State action under the FD&C Act.
    In the Federal Register of December 17, 2020 (85 FR 81932), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d)...........................................................               1                1                1               10               10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
    The estimated reporting burden for Sec.  100.2(d) is minimal
because

enforcement notifications are seldom used by States. During the last 3
years, we have not received any new enforcement notifications;
therefore, we estimate that one or fewer notifications will be
submitted annually. Although we have not received any new enforcement
notifications in the last 3 years, we believe these information
collection provisions should be extended to provide for the potential
future need of a State government to submit enforcement notifications
informing us when it intends to take enforcement action under the FD&C
Act against a particular food located in the State.

    Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09968 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 220 (Thursday, November 14, 2019)]
[Notices]
[Pages 61946-61947]
[FR Doc No: 2019-24697]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87489; File No. SR-Phlx-2019-47]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rule
3304(a)

November 7, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 29, 2019, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Rule 3304(a), as described below.
While these amendments are effective upon filing, the Exchange has
designated the proposed amendments to be operative on November 4, 2019.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend Rule 3304(a), which lists the
proprietary and network processor feeds that the Exchange utilizes for
the handling, routing, and execution of orders, as well as for the
regulatory compliance processes related to those functions. Presently,
the Exchange's trading system utilizes proprietary market data as the
Primary Source of quotation data for the following markets that provide
a reliable direct feed: NYSE American, Nasdaq BX, CBOE EDGA, CBOE EDGX,
CHX, NYSE, NYSE Arca, Nasdaq, Nasdaq PSX, CBOE BYX, and CBOE BZX. For
each of these markets, the Exchange uses SIP data as the Secondary
Source of quotation data.\3\ For other markets, namely NYSE National,
FINRA ADF, and IEX, the Exchange utilizes SIP data as the Primary
Source; there is no Secondary Source for those markets. The Exchange
proposes to amend Rule 3304(a) to state that going forward, the
Exchange will utilize SIP data, rather than a direct feed, as its
Primary Source of data for CHX (now known as NYSE Chicago \4\), with no
Secondary Source utilized for that data. The Exchange proposes this
amendment to reflect the fact that NYSE Chicago is migrating to a new
technology platform and that, after November 1, 2019, it has announced
that it will cease offering the NYSE Chicago Book Feed that currently
serves as its direct feed to the Exchange.\5\ Although the Exchange
understands that NYSE Chicago plans to offer new data feeds to replace
the NYSE Chicago Book Feed, the Exchange has yet to decide whether it
will utilize them.\6\
---------------------------------------------------------------------------

    \3\ Pursuant to Rule 3304(a), the Primary Source of data is used
unless it is delayed by a configurable amount compared to the
Secondary Source of data. The Exchange reverts to the Primary Source
of data once the delay has been resolved.
    \4\ The Exchange also proposes to update the Rule to reflect the
fact that the Chicago Stock Exchange is now known as NYSE Chicago.
    \5\ See https://www.nyse.com/market-data/real-time#chicago.
    \6\ See id. If and when the Exchange decides to subscribe to
these replacement NYSE Chicago direct data feed products, the
Exchange will file a proposal to amend Rule 4759 [sic] accordingly.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that it is necessary to amend its Rules to
account for the fact that, after November 1, 2019, NYSE Chicago will no
longer offer the direct feed to which the Exchange currently
subscribes. The Exchange notes that it already utilizes the SIP as its
sole source of quote data for NYSE National and IEX--as well as the
FINRA ADF, without issue. In the event that the Exchange determines
that its proposal to utilize SIP data is inadequate for its purposes,
then the Exchange may choose to subscribe to one or more of the
replacement proprietary data feeds that NYSE Chicago plans to offer
beginning on November 4, 2019.
    Lastly, the Exchange believes that it is consistent with the public
interest and the protection of investors to update the names of the
exchanges listed in Rule 3304(a) as this change will make it easier for
market participants to identify

the exchanges for which the Exchange uses the direct feed and/or SIP
for the purposes described in the Rule.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change is not
designed to address any competitive issue; instead, it is merely
intended to reflect the fact that the Exchange will no longer consume
the NYSE Chicago Book Feed, which NYSE Chicago plans to discontinue
after November 1, 2019. The Exchange does not expect that its decision
to utilize the SIP, going forward, to obtain NYSE Chicago quote data
will have any competitive impacts. As noted above, the Exchange
presently utilizes the SIP as its sole source of quote data for several
other exchanges, including NYSE National and IEX.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has requested that the Commission waive the pre-filing
requirement. The Commission hereby waives that requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative for 30 days from the date of filing. However,
Rule 19b-4(f)(6)(iii) \12\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay so that the Exchange can
amend Rule 3304(a) prior to the discontinuation of the NYSE Chicago
Book Feed. The Exchange states that waiver of the operative delay would
prevent Rule 3304(a) from being inaccurate and causing confusion among
investors and the public. For these reasons, the Commission believes
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission hereby waives the 30-day operative delay and designates the
proposed rule change operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2019-47 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2019-47. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2019-47 and should be submitted on
or before December 5, 2019.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-24697 Filed 11-13-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Pages 66698-66699]
[FR Doc No: 2018-28042]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-441-001.
    Applicants: WTG Hugoton, LP.
    Description: WTG Hugoton LP submits tariff filing per 260.402
Corrected FERC Form 501-G Filing to be effective N/A.
    Filed Date: 12/11/18.
    Accession Number: 20181211-5116.
    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: RP19-442-001.
    Applicants: West Texas Gas, Inc.

    Description: West Texas Gas submits tariff filing per 260.402
Corrected FERC Form 501-G Filing to be effective N/A.
    Filed Date: 12/11/18.
    Accession Number: 20181211-5145.
    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: RP19-443-001.
    Applicants: Western Gas Interstate Company.
    Description: Western Gas Interstate Company submits tariff filing
per 260.402 Corrected FERC Form 501-G Filing to be effective N/A.
    Filed Date: 12/11/18.
    Accession Number: 20181211-5147.
    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: RP19-468-000.
    Applicants: Anadarko Energy Services Company, Pacific Summit Energy
LLC.
    Description: Joint Petition for Temporary Waivers of Capacity
Release Regulations and Policies, et al. of Anadarko Energy Services
Company, et al. under RP19-468.
    Filed Date: 12/17/18.
    Accession Number: 20181217-5095.
    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: RP19-469-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing-
December 2018 pilgrims Pride 1010887 to be effective 12/17/2018.
    Filed Date: 12/17/18.
    Accession Number: 20181217-5373.
    Comments Due: 5 p.m. ET 12/31/18.

    Docket Numbers: RP19-470-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 121818 Negotiated Rates--
Mercuria Energy America, Inc. R-7540-02 to be effective 1/1/2019.
    Filed Date: 12/18/18.
    Accession Number: 20181218-5009.
    Comments Due: 5 p.m. ET 12/31/18.

    Docket Numbers: RP19-471-000.
    Applicants: American Midstream (AlaTenn), LLC.
    Description: Sec.  4(d) Rate Filing: General Terms and Conditions
Section 37, Version 3.0.0. to be effective 1/1/2019.
    Filed Date: 12/18/18.
    Accession Number: 20181218-5287.
    Comments Due: 5 p.m. ET 12/31/18.

    Docket Numbers: RP19-472-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: NC Contract 2018-12-18
Colorado Springs Utilities to be effective 12/1/2018.
    Filed Date: 12/18/18.
    Accession Number: 20181218-5415.
    Comments Due: 5 p.m. ET 12/31/18.

    Docket Numbers: RP19-76-001.
    Applicants: Kern River Gas Transmission Company.
    Description: Compliance filing 2018 Tax Reform Settlement Filing to
be effective 11/15/2018.
    Filed Date: 12/18/18.
    Accession Number: 20181218-5375.
    Comments Due: 5 p.m. ET 12/26/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-28042 Filed 12-26-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 18, 2008 (Volume 73, Number 53)]
[Notices]
[Page 14471-14472]
[DOCID:fr18mr08-83]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0162]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Product Labeling: Medication Guide
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 regulations requiring the
distribution of patient labeling, called Medications Guides, for
certain products that pose a serious and significant public health
concern requiring distribution of FDA-approved patient medication.

DATES: Submit written or electronic comments on the collection of
information by May 19, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to 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: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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 assumption 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.

Prescription Drug Product Labeling: Medication Guide Requirements (OMB
Control Number 0910-0393)--Extension

    FDA regulations require the distribution of patient labeling,
called Medication Guides, for certain prescription human drug and
biological products used primarily on an outpatient basis that pose a
serious and significant public health concern requiring distribution of
FDA-approved patient medication information. These Medication Guides
inform patients about the most important information they should know
about these products in order to use them safely and effectively.
Included is information such as the drug's approved uses,
contraindications, adverse drug reactions, and cautions for specific
populations, with a focus on why the particular product requires a
Medication Guide. These regulations are intended to improve the public
health by providing information necessary for patients to use certain
medications safely and effectively.
    The regulations contain the following reporting requirements that
are subject to the PRA. The estimates for the burden hours imposed by
the following regulations are listed in table 1 of this document:
     21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA

approval according to the prescribed content and format.
     21 CFR 208.24(e)--Each authorized dispenser of a
prescription drug product for which a Medication Guide is required,
when dispensing the product to a patient or to a patient's agent, must
provide a Medication Guide directly to each patient unless an exemption
applies under Sec.  208.26 (21 CFR 208.26).
     Section 208.26(a)--Requests may be submitted for exemption
or deferral from particular Medication Guide content or format
requirements.
     21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application
holders must submit changes to Medication Guides to FDA for prior
approval as supplements to their applications.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours Per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
208.20                                                                 10                     1                 10                320              3,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
208.24(e)                                                          59,000                 5,000        295 million              .0014            413,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
208.26(a)                                                               1                     1                  1                  4                  4
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.70(b)(3)(ii) and 601.12(f)                                          5                     1                  5                 72                360
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                416,564
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

    Dated: March 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5384 Filed 3-17-08; 8:45 am]

BILLING CODE 4160-01-S