[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Page 52547]
[FR Doc No: 2022-18423]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2689-000]

MTSun LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
MTSun LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 12, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: August 22, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-18423 Filed 8-25-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 749-751]
[FR Doc No: 2022-28603]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2022-N-3224]

Medical Devices; Neurological Devices; Classification of the
Brain Stimulation Programming Planning Software

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying brain stimulation programming planning software into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for the brain stimulation programming planning software's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective January 5, 2023. The classification was
applicable on August 23, 2021.

FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD, 20993-0002, 301-
796-6448, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the brain stimulation programming
planning software as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an

action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)).
We refer to these devices as ``postamendments devices'' because they
were not in commercial distribution prior to the date of enactment of
the Medical Device Amendments of 1976, which amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On February 3, 2021, FDA received Medtronic Neuromodulation's
request for De Novo classification of the SureTune4 Software. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on August 23, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.5855.\1\ We have named the generic type of device brain stimulation
programming planning software, and it is identified as a prescription
device intended to assist in planning stimulation programming for
implanted brain stimulators.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Brain Stimulation Programming Planning Software Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Suboptimal stimulation settings leading  Software verification,
 to temporary injury or impairment and/   validation, and hazard
 or ineffective stimulation.              analysis; Usability
                                          assessment; and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, brain stimulation programming
planning software is for prescription use only. 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 21 CFR 801.109 are met.

III. 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously

approved collections of information found in other FDA regulations and
guidance. 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 21 CFR
part 860, subpart D, regarding De Novo classification have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801and 809, regarding labeling, have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 882

    Medical devices.

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

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Add Sec.  882.5855 to subpart F to read as follows:

Sec.  882.5855  Brain stimulation programming planning software.

    (a) Identification. The brain stimulation programming planning
software is a prescription device intended to assist in planning
stimulation programming for implanted brain stimulators.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Software verification, validation, and hazard analysis must be
performed.
    (2) Usability assessment must demonstrate that the intended user(s)
can safely and correctly use the device.
    (3) Labeling must include:
    (i) The implanted brain stimulators for which the device is
compatible.
    (ii) Instructions for use.
    (iii) Instructions and explanations of all user-interface
components.
    (iv) A warning regarding use of the data with respect to not
replacing clinical judgment.

    Dated: December 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28603 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 6, 2008 (Volume 73, Number 194)]
[Rules and Regulations]
[Page 58032-58033]
[DOCID:fr06oc08-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2006-24825; Directorate Identifier 2006-NE-17-AD;
Amendment 39-15623; AD 2008-16-05]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(RRD) Dart 528, 529, 532, 535, 542, and 552 Series Turboprop Engines;
Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting airworthiness directive (AD) 2008-16-05.
That AD applies to RRD Dart 528, 529, 532, 535, 542, and 552 Series
turboprop engines. We published that AD in the Federal Register on July
31, 2008 (73 FR 44630). The superseded AD number in paragraph (b) in
the regulatory section is incorrect. This document corrects that
superseded AD number. In all other respects, the original document
remains the same.

DATES: Effective Date: Effective October 6, 2008.

FOR FURTHER INFORMATION CONTACT: Jason Yang, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On July 31, 2008 (73 FR 44630), we published
a final rule AD, FR Doc, E8-17423, in the Federal Register. That AD
applies to

RRD Dart 528, 529, 532, 535, 542, and 552 Series turboprop engines. We
need to make the following correction:

Sec.  39.13  [Corrected]

    On page 44631, in the second column, in paragraph (b) of the
regulatory section, ``2007-02-17'' is corrected to read ``2007-02-07''.

    Issued in Burlington, Massachusetts, on September 29, 2008.
Thomas A. Boudreau,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E8-23511 Filed 10-3-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Proposed Rules]
[Pages 20901-20906]
[FR Doc No: 2011-9044]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 7, and 16

[Docket No. FDA-2011-N-0121]
RIN 0910-AG60

Further Amendments to General Regulations of the Food and Drug
Administration To Incorporate Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
certain of its general regulations to include tobacco products, where
appropriate, in light of FDA's authority to regulate these products
under the Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act). With these amendments, tobacco products will be subject
to the same general requirements that apply to other FDA-regulated
products.

DATES: Submit either electronic or written comments on the proposed
rule by June 13, 2011. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 (the PRA) by May 16, 2011,
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0121 and/or Regulatory Information Number (RIN) number 0910-AG60, by
any of the following methods, except that comments on information
collection issues under the PRA must be submitted to the Office of
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0121 and RIN 0910-AG60 for this rulemaking.
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-CTP-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Tobacco Control Act was enacted on June 22, 2009, amending the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and providing FDA
with the authority to regulate tobacco products (Pub. L. 11-31; 123
Stat. 1776). In enacting the Tobacco Control Act, Congress sought to
ensure that FDA had authority to provide effective oversight and to
impose appropriate regulatory controls on the tobacco industry. In
order to effectuate these purposes, FDA is seeking to amend several
provisions of its general regulations to reflect the Agency's new
authority and mandate regarding tobacco products.

II. Legal Authority

    FDA is issuing this proposed rule under provisions of the FD&C Act,
as amended by the Tobacco Control Act (21 U.S.C. 321, 331, 333, 371,
381, 387, 387a, 387c, 387f, 387j and 387k); FDA is also issuing this
proposed rule under section 4 of the Federal Cigarette Labeling and
Advertising Act (FCLAA) (15 U.S.C. 1333) as amended by the Tobacco
Control Act and under section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402) as amended by the Tobacco
Control Act.

II. Description of Proposed Regulations

    FDA proposes to make the following amendments to title 21 of the
Code of Federal Regulations (CFR), reflecting the Agency's authority
over tobacco products under the Tobacco Control Act:
    1. Add ``tobacco products'' to the list of products covered by
Sec.  1.21(a) and (c)(1) (21 CFR 1.21(a) and (c)(1)) and Sec.  1.101(a)
and (b) (21 CFR 1.101(a) and (b));
    2. Revise the definition of ``product'' in Sec.  7.3(f) (21 CFR
7.3(f)) to include tobacco products; and
    3. Revise Sec.  16.1(b) (21 CFR 16.1(b)) to add provisions from the
Tobacco Control Act that allow for hearings.

A. Section 1.21--Failure To Reveal Material Facts

    Section 1.21(a) states that the labeling of FDA-regulated products
shall be deemed misleading if it fails to reveal facts that are: ``* *
* Material in light of other representations made or suggested by
statement, word, design, device or any combination thereof; or
[m]aterial with respect to consequences which may result from use of
the article under: The conditions prescribed in such labeling or such
conditions of use as are customary or usual.'' FDA is proposing to
amend Sec.  1.21(a) to provide that tobacco product labeling also would
be deemed misleading for similar failures to reveal material facts. See
section 903(a) of the Tobacco Control Act (21 U.S.C. 387c(a)) (stating
that a tobacco product shall be deemed to be misbranded if its labeling
is false or misleading). See also section 201(n) of the FD&C Act (21
U.S.C. 321(n)).
    Section 1.21(c) describes statements that are not permissible on
labeling for FDA-regulated products. For example, paragraph (c)(1)
explains that this regulation does not ``[p]ermit a statement of
differences of opinion with respect to warnings * * *'' on FDA-
regulated products. The proposed rule would amend this paragraph to
state that tobacco product labeling, like the labeling of other FDA-
regulated products, also may not have a statement of differences of
opinion regarding the warnings on tobacco packages or advertisements.
This change is in accordance with sections 201 and 204 of the Tobacco
Control Act, amending the FCLAA, and the CSTHEA, respectively, as well
as section 903(a) generally. FDA already has initiated a rulemaking
proceeding to implement section 201 of the Tobacco Control Act,
amending 15 U.S.C. 1333). See the Federal Register of November 12, 2010
(75 FR 69524).

B. Section 1.101--Notification and Recordkeeping

    Section 1.101 outlines the notification and recordkeeping
requirements for exports of FDA-regulated products.

Section 1.101(a) pertains to all notifications and records required for
FDA-regulated products that may be exported under section 801 or 802 of
the FD&C Act (21 U.S.C. 381 and 382) and section 351 of the Public
Health Service Act (42 U.S.C. 262). Because section 103(l) of the
Tobacco Control Act specifically amends section 801 of the FD&C Act to
include ``tobacco products'' on the list of FDA-regulated products that
may be exported under this section, the proposed rule would amend Sec.
1.101(a) and (b) to indicate that tobacco products exported under
section 801(e)(1) of the FD&C Act also would be subject to the
recordkeeping requirements of this regulation. Please note that this
revision to Sec.  1.101(b) does not alter the exercise of enforcement
discretion described in the advance notice of proposed rulemaking that
published in the Federal Register of June 1, 2004 (69 FR 30842).

C. Section 7.3--Definitions

    Section 7.3 defines the term ``product'' to include all the
specific items that are subject to FDA's jurisdiction. The proposed
change to Sec.  7.3 of the regulations would define ``product'' to also
include tobacco products.

D. Section 16.1--Scope

    Section 16.1(b) lists the statutory and regulatory provisions that
provide for the opportunity for a regulatory hearing. Sections
903(a)(8)(B)(ii), 906(e)(1)(B), 910(d)(1), and 911(j) of the Tobacco
Control Act all provide for the opportunity for a hearing. The proposed
rule would amend Sec.  16.1 to include certain instances in the Tobacco
Control Act where an opportunity for a hearing is provided.

IV. Analysis of Impacts

A. Introduction and Summary

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs Agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed requirements are likely to
impose a burden on a substantial number of affected small entities, the
Agency proposes to certify that the final rule will have a significant
economic impact on a substantial number of small entities and has
conducted an Initial Regulatory Flexibility Analysis as required under
the Regulatory Flexibility Act.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    FDA has not quantified the benefits of this proposed rule. This
proposed rule would impose compliance costs on producers of tobacco
products as they would have to comply with recordkeeping requirements
according to general regulations that apply to other products that FDA
regulates. The estimated annual costs of complying with these
requirements range from $71,438 to $376,242.

B. Need for the Proposed Rule

    The Tobacco Control Act grants FDA authority to regulate tobacco
products, thereby enabling FDA to assess the effects of tobacco
products on the public health.
    The proposed amendments would ensure tobacco manufacturers adhere
to the regulations that apply to other FDA-regulated products sold in
the United States, and exports of products that are not allowed for
sale in the United States. The proposed rule clarifies FDA's practices
and procedures with respect to voluntary recalls of tobacco products.
It also guarantees that tobacco product manufacturers have the same
rights as other FDA-regulated entities, where appropriate, such as the
right to regulatory hearings.

C. Benefits

    FDA is unable to quantify the benefits of the proposed amendments.
Benefits would derive from FDA's enhanced ability to carry out its
obligations, and from clarifying certain FDA practices and procedures
for tobacco product manufacturers.

D. Costs

    Section 7.3(f) clarifies and explains FDA's practices and
procedures with respect to recalls of tobacco products. FDA tentatively
concludes that tobacco product manufacturers follow recall procedures
consistent with current regulations and that the proposed amendment to
Sec.  7.3(f) would not impose additional burdens on tobacco product
manufacturers.\1\ The proposed revision to Sec.  16.1(b) allows for an
informal hearing when FDA is considering regulatory actions or
decisions related to misbranding, good manufacturing practice
requirements or withdrawal of a tobacco product. No additional costs
are expected to accrue from amendments to Sec. Sec.  1.21(c), 7.3(f),
and 16.1(b).
---------------------------------------------------------------------------

    \1\ In 1995, a major tobacco product manufacturer voluntarily
recalled a few tobacco product lines when it was found that the
products might be contaminated. After several investigations a
Centers for Disease Control and Prevention (CDC) report concluded
that it was the use of the tobacco product and not the contaminated
product that caused the health complaints (Ref. 1).
---------------------------------------------------------------------------

    Additional costs would derive from recordkeeping requirements as
they relate to some tobacco product exports (Sec. Sec.  1.101(a) and
(b)). The estimated annual costs range is between $0.07 million and
$0.37 million, as further explained in table 1 of this document.

                 Table 1--Total Estimated Costs of Rule
------------------------------------------------------------------------
                                                        Annual cost
                   Cost factor                   -----------------------
                                                      Low        High
------------------------------------------------------------------------
Exports of Tobacco Products.....................    $71,438    $376,242
------------------------------------------------------------------------

    Sections 1.101(a) and (b) pertain to recordkeeping of documentation
that demonstrates that tobacco products not allowed for sale in the
United States are exported in accordance with appropriate regulations.
In addition, recordkeeping documents must demonstrate that: (1) The
product meets the foreign purchaser's specifications; (2) the product
does not conflict with the laws of the foreign country; (3) correct
labeling is placed outside of the shipping package; and (4) the product
is not sold or offered in the United States. These documents are
required to be retained (Sec.  1.101(b)).
1. Number of Affected Entities
    The U.S. Department of Commerce International Trade Administration
(ITA) reports that the total number of

(manufacturing and nonmanufacturing) U.S. companies exporting tobacco
products (North American Industry Classification System or NAICS code
3122) to the world in 2007 was 158, which includes 30 manufacturers and
125 nonmanufacturers of tobacco products.\2\ Exporting manufacturers
represent approximately 38 percent of all manufacturing companies
reported by the 2007 Economic Census in this NAICS category (Ref. 3).
FDA takes the total number of exporting manufacturing companies as a
lower bound and the total number of exporting (manufacturing and
nonmanufacturing) companies as an upper bound for the total number of
respondents that would be affected by the proposed rule.
---------------------------------------------------------------------------

    \2\ As firms sometimes export multiple products, a single firm
can be represented in multiple products; thus, exporter counts may
not add up to the total (Ref. 2).
---------------------------------------------------------------------------

2. Estimated Economic Costs on Affected Entities
    In estimating the burden, FDA uses the number of responses per
respondent (3), and time per response (2 hours for recordkeeping) from
previously reported estimates relating to drugs and medical devices (73
FR 46007, August 7, 2008). In valuing the time cost, FDA uses the 2009
median hourly wage of $18.04 for Office and Administrative Support
Occupations (Standard Occupational Classification code 430000) in the
tobacco manufacturing industry (NAICS code 312200) as reported by the
Bureau of Labor Statistics (Ref. 4), plus benefits and overhead. Table
2 of this document shows that annual recordkeeping costs for all
respondents are estimated to be between $0.07 million and $0.37
million.

                                                   Table 2--Estimated Incremental Burden for Exporters
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Responses per                                Hours per
           Cost factor               Number of recordkeepers    recordkeeper      Total annual records     recordkeeper        Annual cost low--high
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping....................  30 to 158.................               3  90 to 474................               2  $71,438 to $376,242.
--------------------------------------------------------------------------------------------------------------------------------------------------------

E. Analysis of Alternatives

    The simplest alternative would be to exempt exporters of tobacco
products from the proposed recordkeeping requirements according to
general regulations that apply to other exports that FDA regulates.
Under this option, there would be no immediate compliance costs or
benefits. Compliance costs for exporters of tobacco products are
estimated to be between $0.07 million and $0.37 million. The proposed
recordkeeping requirements for exporters of tobacco products would have
the benefit of allowing FDA to carry out its obligations and to clarify
practices and procedures for tobacco product manufacturers.

F. Initial Regulatory Flexibility Act Analysis

    FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. This analysis serves as the Initial Regulatory Flexibility
Analysis as required under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
    The U.S. Small Business Administration (SBA) uses different
definitions of what a small entity is for different industries. Using
2009 SBA size standard definitions, a firm categorized in NAICS code
312229 (Other Tobacco Product Manufacturing) is considered small if it
hires fewer than 500 employees. On the other hand, firms classified in
NAICS code 312221 (Cigarette Manufacturing) are considered small if
they hire fewer than 1,000 employees (Ref. 5).
    The most current available data on the number of establishments by
employee size have not been released for the categories listed
previously; thus, FDA uses data from the 2002 Economic Census (Ref. 6)
to determine the number of small entities. FDA notes that the data are
available at the establishment level rather than at the firm level, and
assumes that the typical manufacturing establishment is roughly
equivalent to the typical small manufacturing firm. Statistics on the
classification of establishments by employment size show that in the
year 2002, 67 to 99 percent of tobacco manufacturing entities had fewer
than 1,000 employees and would be considered small by SBA. (See table 3
of this document.)

          Table 3--Estimated Number of Small Entities Affected
------------------------------------------------------------------------
                                                         Other tobacco
                                        Cigarette           product
                                      manufacturing      manufacturing
                                      (NAICS 312221)     (NAICS 312229)
------------------------------------------------------------------------
Size Standards in Number of                   < 1,000              < 500
 Employees........................
Total Number of Establishments....                 15                 83
Percent Considered Small..........                67%                99%
Estimated Number of Affected                        2                 12
 Entities.........................
------------------------------------------------------------------------

    FDA also estimates the percent of small to medium-sized \3\
exporting companies to be 15 percent, using industry trade data for
NAICS code 3122 (Tobacco Products) made available by ITA. The estimated
number of affected exporting entities is determined by multiplying 0.15
by the total number of establishments. The estimates indicate that the
estimated number of affected entities would range between 2 and 12
exporters. (See table 3 of this document.)
---------------------------------------------------------------------------

    \3\ ITA defines small firms as those with fewer than 100
employees and medium-sized firms as those that employ from 100 to
499 workers (Ref. 7).

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

2. Economic Effect on Small Entities
    FDA uses the total value of shipments data by employment size from
the 2002 Economic Census published by the U.S. Bureau of the Census to
determine the unit cost as a percent of the total value of shipment for
a typical manufacturer. The analysis of the effect on small versus
large entities is limited by the U.S. Bureau of the Census data
restrictions imposed to safeguard the confidentially of some
establishments in NAICS code 312221. Consequently, the average value of
shipments is presented for all establishments in NAICS code 312221 and
for establishments employing 1 to 19 and 20 to 99 employees,
separately. The average cost per entity is $2,814. It is estimated that
this average cost as a percent of average value of shipments for small
entities may be between 0.00 and 0.31 percent (see table 4). The Agency
tentatively concludes that this proposed rule would have a significant
economic impact on a substantial number of small entities, but the
impact is uncertain.

                    Table 4--Estimated Average Value of Shipments for a Typical Manufacturer
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
          Description                                                 NAICS
                               ---------------------------------------------------------------------------------
                                           31221                                    31229
----------------------------------------------------------------------------------------------------------------
Establishment Employee Size...  All.......................  1 to 19..................  20 to 99.
Value of Shipments ($1,000)...  $34,562,900...............  $35,979..................  $270,348.
Number of Establishments......  15........................  47.......................  20.
Average Value of Shipments      $2,304,193................  $766.....................  $13,517.
 ($1,000).
Unit Cost as Percent of         0.00%.....................  0.31%....................  0.02%.
 Average Value of Shipments.
----------------------------------------------------------------------------------------------------------------

3. Additional Flexibility Considered
    In this section, we discuss an alternative that would present
possible reductions in costs which would be channeled through small
entities. Exempting exporters of tobacco products from recordkeeping
requirements would result in an estimated annual savings of 0.02 to
0.31 percent of the cost of the value of shipments for small-sized
firms. However, these recordkeeping requirements would provide evidence
that tobacco product manufacturers export according to regulations that
apply to other FDA-regulated products.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A
description of these provisions is given in the following paragraphs
with an estimate of the annual recordkeeping burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Further Amendments to General Regulations of the Food and
Drug Administration to Incorporate Tobacco Product Issues--21 CFR
1.101.
    Description: On June 22, 2009, the President signed the Tobacco
Control Act into law. In this proposed rule, FDA is amending certain of
its general regulations to include tobacco products, where appropriate,
in light of FDA's authority to regulate these products under the
Tobacco Control Act. The amendments in this proposed rulemaking will
subject tobacco products to the same general requirements that apply to
other FDA-regulated products, where appropriate.
    This proposed rule would amend Sec.  1.101(b), among other
sections, to require persons who export human drugs, biologics,
devices, animal drugs, cosmetics, and tobacco products that may not be
sold in the United States to maintain records demonstrating their
compliance with the requirements in section 801(e)(1) of the FD&C Act.
Section 801(e)(1) requires exporters to keep records demonstrating that
the exported product: (1) Meets with the foreign purchaser's
specifications; (2) does not conflict with the laws of the foreign
country; (3) is labeled on the outside of the shipping package that is
intended for export; and (4) is not sold or offered for sale in the
United States. These criteria also could be met by maintaining other
documentation, such as letters from a foreign government Agency or
notarized certifications from a responsible company official in the
United States stating that the exported product does not conflict with
the laws of the foreign country.
    Description of Respondents: Manufacturers, distributors, and other
persons who export tobacco products not intended for sale in the United
States.

                                      Table 5--Estimated Annual Recordkeeping Burden Exporters of Tobacco Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                           21 CFR section                               Number of       frequency of     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records        recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(b)...........................................................             158                3              474               22           10,428
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Agency estimated the number of respondents and burden hours
associated with the recordkeeping requirements by reviewing Agency
records and using Agency expert resources, and conferring with another
Federal Agency with experience and information regarding tobacco
product exporters. FDA estimates that between

30 and 158 establishments could be involved in the exporting of tobacco
products and, based on previous recordkeeping estimates in OMB control
number 0910-0482, ``Export Notification and Recordkeeping
Requirements,'' each establishment may have to maintain records up to 3
times per year, at a total of 22 hours per recordkeeper. Therefore, the
Agency estimates between 1,980 and 10,428 burden hours will be needed
for tobacco product exporters to create and maintain records
demonstrating compliance with section 801(e)(1) of the FD&C Act.
Therefore, FDA estimates that 158 respondents will require
approximately 10,428 hours to comply with the requirements of section
801(e)(1) of the FD&C Act.

VI. Executive Order 13132: Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h), (i), and (k) 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.

VIII. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on public display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested parties between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to Web sites after this document publishes
in the Federal Register.

1. CDC, 1996, ``Recall of Philip Morris Cigarettes, May 1995-March
1996,'' Morbidity and Mortality Weekly Report, 45(12): pp. 251-254,
http://www.cdc.gov/mmwr/preview/mmwrhtml/00041035.htm, accessed
November 2010.
2. ITA, 2010, ``Industry Trade Data and Analysis,'' http://www.trade.gov/mas/ian/EDB/Reports/2007/table14_allmarkets_allcategories.html, last accessed November 2010.
3. U.S. Census Bureau American FactFinder, 2007, ``Sector 31:
EC0731I1: Manufacturing: Industry Series: Detailed Statistics by
Industry for the United States: 2007,'' http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0231I4&-_lang=en, accessed October 2010.
4. U.S. Bureau of Labor Statistics, 2009, ``Occupational Employment
Statistics,'' http://data.bls.gov/oes, accessed October 15, 2010.
5. SBA, 2010, ``Table of Small Business Size Standards Matched to
North American Industry Classification System Code,'' http://www.sba.gov/content/table-small-business-size-standards, accessed
March 2, 2011.
6. U.S. Census Bureau American FactFinder, 2002, ``2002 Economic
Census: Sector 31: Manufacturing: Industry Series: Industry
Statistics by Employment Size: 2002,'' http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0231I4&-_lang=en,
accessed October 2010.
7. ITA, http://www.trade.gov/mas/ian/smeoutlook/edbtechnicalnotes/tg_ian_001929.asp, last accessed November 2010.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 7

    Administrative practice and procedure, Consumer protection,
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 1, 7, and 16 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

    1. The authority citation for part 1 is revised to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d,
352, 355, 360b, 362, 371, 374, 381, 382, 387, 387a, 387c, 393; 42
U.S.C. 216, 241, 243, 262, 264.

    2. Amend Sec.  1.21 by revising paragraph (a) introductory text and
paragraph (c)(1) to read as follows:

Sec.  1.21  Failure to reveal material facts.

    (a) Labeling of a food, drug, device, cosmetic, or tobacco product
shall be deemed to be misleading if it fails to reveal facts that are:
* * * * *
    (c) * * *
    (1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling for food, drugs, devices, cosmetics, or tobacco products under
the Federal Food, Drug, and Cosmetic Act.
* * * * *
    3. Amend Sec.  1.101 by revising paragraph (a) and the heading of
paragraph (b) to read as follows:

Sec.  1.101  Notification and recordkeeping.

    (a) Scope. This section pertains to notifications and records
required for human drug, biological product, device, animal drug, food,
cosmetic, and tobacco product exports under sections 801 or 802 of the
Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or
section 351 of the Public Health Service Act (42 U.S.C. 262).
    (b) Recordkeeping requirements for human drugs, biological
products, devices, animal drugs, foods, cosmetics, and tobacco products
exported under or subject to section 801(e)(1) of the Federal Food,
Drug, and Cosmetic Act. * * *
* * * * *

PART 7--ENFORCEMENT POLICY

    4. The authority citation for part 7 continues to read as follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n,
264.

    5. Amend Sec.  7.3(f) by revising the first sentence to read as
follows:

Sec.  7.3  Definitions.

* * * * *
    (f) Product means an article subject to the jurisdiction of the
Food and Drug Administration, including any food,

drug, and device intended for human or animal use, any cosmetic and
biologic intended for human use, any tobacco product intended for human
use, and any item subject to a quarantine regulation under part 1240 of
this chapter. * * *
* * * * *

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    6. The authority citation for part 16 continues to read as follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

    7. Amend Sec.  16.1 by adding new statutory provisions to the end
of paragraph (b)(1) to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) * * *
    Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic
Act relating to the misbranding of tobacco products.
    Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act
relating to the establishment of good manufacturing practice
requirements for tobacco products.
    Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act
relating to the withdrawal of an order allowing a new tobacco product
to be introduced or delivered for introduction into interstate
commerce.
    Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating
to the withdrawal of an order allowing a modified risk tobacco product
to be introduced or delivered for introduction into interstate
commerce.
* * * * *

    Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9044 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 61 (Thursday, March 29, 2012)]
[Notices]
[Page 19011]
[FR Doc No: 2012-7504]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-47-000]

Southwest Power Pool, Inc.; Notice of Initiation of Proceeding
and Refund Effective Date

    On March 23, 2012, the Commission issued an order that initiated a
proceeding in Docket No. EL12-47-000, pursuant to section 206 of the
Federal Power Act (FPA), 16 U.S.C. 824e (2006), to determine the
justness and reasonableness of the proposed rate reduction by Southwest
Power Pool, Inc. Southwest Power Pool, Inc., 138 FERC ] 61,211 (2012).
    The refund effective date in Docket No. EL12-47-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Date issued: March 23, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-7504 Filed 3-28-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 17, 2006 (Volume 71, Number 52)]
[Notices]
[Page 13835-13836]
[DOCID:fr17mr06-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2692]

Duke Power; Notice of Authorization for Continued Project
Operation

March 9, 2006.
    On February 20, 2004, Duke Power, licensee for the Nantahala
Hydroelectric Project No. 2692, filed an application for a new or
subsequent license pursuant to the Federal Power Act (FPA) and the
Commission's regulations thereunder. Project No. 2692 is located on the
Nantahala River and its tributaries, in Macon and Clay Counties, North
Carolina.
    The license for Project No. 2692 was issued for a period ending
February 28, 2006. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year to year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of Section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2692 is issued to
Duke Power of Macon and Clay Counties, North Carolina for a period
effective March 1, 2006 through February 28, 2007, or until the
issuance of a new license for the project or other

disposition under the FPA, whichever comes first. If issuance of a new
license (or other disposition) does not take place on or before March
1, 2007, notice is hereby given that, pursuant to 18 CFR 16.18(c), an
annual license under Section 15(a)(1) of the FPA is renewed
automatically without further order or notice by the Commission, unless
the Commission orders otherwise.
    If the project is not subject to Section 15 of the FPA, notice is
hereby given that Duke Power of Macon and Clay Counties, North
Carolina, is authorized to continue operation of the Nantahala Project
No. 2692 until such time as the Commission acts on its application for
subsequent license.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3867 Filed 3-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50686-50687]
[FR Doc No: 2014-20150]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4188-DR; Docket ID FEMA-2014-0003]

Washington; 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 Washington (FEMA-4188-DR), dated August 11,
2014, and related determinations.

DATES: Effective date: August 11, 2014.

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 11, 2014, 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 Washington resulting from wildfires during the period of July 9
to August 5, 2014, 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 Washington.
    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. Direct
Federal assistance is authorized. Consistent with the requirement
that Federal assistance be supplemental, any Federal funds provided
under the Stafford Act for Hazard Mitigation will be limited to 75
percent of the total eligible costs. Federal funds provided under
the Stafford Act for Public Assistance also will be limited to 75
percent of the total eligible costs, with the exception of projects
that meet the eligibility criteria for a higher Federal cost-sharing
percentage under the Public Assistance Alternative Procedures Pilot
Program for Debris Removal implemented pursuant to section 428 of
the Stafford Act.
    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, Michael J. Hall, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Washington have been designated
as adversely affected by this major disaster:

    Okanogan County and the Confederated Tribes of the Colville
Reservation for Public Assistance, including direct federal
assistance.
    All areas within the State of Washington 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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-20150 Filed 8-22-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Notices]
[Page 15583-15584]
[DOCID:fr06ap09-151]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its denial of 112 applications from
individuals who requested an exemption from the Federal vision standard
applicable to interstate truck and bus drivers and the reasons for the
denials. FMCSA has statutory authority to exempt individuals from the
vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemptions does
not provide a level of safety that will be equivalent to, or greater
than, the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal vision standard for a renewable two-year period if it
finds ``such an exemption would likely achieve a level of safety that
is equivalent to, or greater than, the level that would be achieved
absent such an exemption.'' The procedures for requesting an exemption
are set out in 49 CFR part 381.
    Accordingly, FMCSA evaluated 112 individual exemption requests on
their merits and made a determination that these applicants do not
satisfy the criteria eligibility or meet the terms and conditions of
the Federal exemption program. Each applicant has, prior to this
notice, received a letter of final disposition on his/her exemption
request. Those decision letters fully outlined the basis for the denial
and constitute final Agency action. The list published today summarizes
the Agency's recent denials as required under 49 U.S.C. 31315(b)(4) by
periodically publishing names and reasons for denials.
    The following 14 applicants lacked sufficient driving experience
during the 3-year period prior to the date of their application:

Richard L. Bilby
Phillip J. Collova
Layne Coscorrosa
Craig D. Delph
Jerry L. Gray
Daniel Hill
Matthew B. Lairamoe
James F. McMahon, Jr.
Gary R. Morgan
Dale E. Schoettmer
Jack Skaw
Edward S. Stout
Kenneth D. Summers
George R. Van Gelder

    The following 11 applicants did not have any experience operating a
CMV.

Joey J. Abney
Amy J. Armstrong
Anthony W. Armstrong
James Bay
John H. Beenenga
Leo M. Lampinen
Rod Mosby
Andrea R. Piatz
Litter Rivera
Sirrane Traylor
Plato Watkins

    The following 22 applicants did not have 3 years of experience
driving a CMV on public highways with the vision deficiency.

Dylan T. Arndt
Fred R. Ballard, Jr.
Dwight A. Bennett
Walter Crean, III
James E. Creswell
Chris Croteau
Jerold D. Endress
Alvaro Esparza
James L. Gordon
Jerry N. Greear
Semir Husnic
Edward Kimpel
Daryl C. Lenz
Robert D. Lotz
Guy E. McCraw
Eric R. Mills
Rodney Richardson
Matthew N.D. Robbins
Temistocles E. Sanchez
Thomes L. Steinbach
Glenn R. Theis
Gary E. Valentine

    The following 7 applicants did not have 3 years of recent
experience driving a CMV with the vision deficiency.

Leonard C. Jackson
Larry S. Keith
Oliver A. Murphy
Herbert Recore, Jr.
William Rogers
Jeffery C. Stokes
Lyndon W. Williams

    The following 19 applicants did not have sufficient driving
experience over the past 3 years under normal highway operating
conditions.

Danny F. Ahlgren
Ronald Bishop
James W. Carpenter
Travis M. Christian
Sean Conorman
John Doyle
Herman Froehle
Steven H. Harris
Jason L. Hoovan
Jeffrey D. Huckle
Ronald L. Kitchens
Larry P. Magrath
Jame R. Salsgiver
Eric C. Sevier
Claude L. Snider, Sr.
Ronald C. Stringfellow
Douglas E. Weld
Scott Westphal
Casey Willis, Jr.

    Two applicants, Martin L. Bailey and Darrol W. Rippee, had more
than 2 commercial motor vehicle violations during the 3-year review
period and/or application process. Each applicant is only allowed 2
moving citations.
    One applicant, Joseph Ivey, did not have sufficient peripheral
vision in his better eye to qualify for an exemption.
    The following 7 applicants had commercial driver's license
suspensions during the 3-year review period in

relation to a moving violation. Applicants do not qualify for an
exemption with a suspension during the 3-year period.

Gary Alvarez
Giovanni Cerino
Robert O. Dolphin
Todd Gilliam
Paul H. Glowinski
Ranjodh Singh
Stephen Whitt

    One applicant, Robert D. Crumb, had 2 serious commercial motor
vehicle violations within a 3-year period. Each applicant is only
allowed a total of 2 moving violations, 1, which can be serious.
    One applicant, Charles H. Allen, did not have verifiable proof of
commercial driving experience over the past 3 years under normal
highway operating conditions that would serve as an adequate predictor
of future safe performance.
    One applicant, Justin M. Pool, did not hold a license which allowed
operation of vehicles over 10,000 pounds for all or part of the 3-year
period.
    The following 9 applicants were denied for miscellaneous/multiple
reasons.

John P. Atkinson
Randy S. Benitez
Kevin Byrd
Gary M. Eggers
Bradley C. Hansell
Randall E. Harnack
Owen E. Jackson
Valentino Parker
Dustin A. Wilson

    The following 4 applicants never submitted the required documents.

James R. Blair
Charles V. Fitzgerald
Herman Gray
Norman Patterson

    Finally, the following 13 applicants met the current federal vision
standards. Exemptions are not required for applicants that meet the
current regulations for vision.

Jose F. Armenta
Carlos R. Cordova
Frederick L. Feyen
Kenneth A. Keen
Diana L. Martin
Freddie B. Mills
James W. Mize, Sr.
James A. Shearin
Oliver Smith
Kenneth L. Sutphin
Kenneth C. Thornton
Edward Werling
Leroy C. Williams

    Issued on: March 27, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-7560 Filed 4-3-09; 8:45 am]

BILLING CODE 4910-EX-P