[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30327-30328]
[FR Doc No: 2022-10661]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0154]

Agency Information Collection Activities; Approval of a Renewal
of a Currently-Approved Information Collection: Annual Report of Class
I and Class II For-Hire Motor Carriers

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

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. FMCSA requests approval
to renew the previously approved ICR

titled, ``Annual Report of Class I and Class II For-Hire Motor
Carriers,'' OMB Control No. 2126-0032. This ICR is necessary to comply
with FMCSA's financial and operating statistics requirements at chapter
III of title 49 CFR part 369 titled, ``Reports of Motor Carriers.''

DATES: Comments on this notice must be received on or before June 17,
2022.

ADDRESSES: Written comments and recommendations for the information
collection should be sent within 30 days of publication of this notice
to www.reginfo.gov/public/do/PRAMain. Find this information collection
by selecting ``Currently under 30-day Review--Open for Public
Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Secrist, Office of
Registration and Safety Information, DOT, FMCSA, West Building 6th
Floor, 1200 New Jersey Avenue SE, Washington, DC 20590-0001. Telephone:
202-385-2367; email [email protected] .

SUPPLEMENTARY INFORMATION:
    Title: Annual Report of Class I and Class II For-Hire Motor
Carriers.
    OMB Control Number: 2126-0032.
    Type of Request: Renewal of a currently-approved information
collection.
    Respondents: Class I and Class II For-Hire Motor Carriers of
Property and Class I For-Hire Motor Carriers of Passengers.
    Estimated Number of Respondents: 102 total (34 per year).
    Estimated Time per Response: 9 hours for Form M and 0.3 hours for
Form MP-1.
    Expiration Date: May 31, 2022.
    Frequency of Response: Annually.
    Estimated Total Annual Burden: 306 hours [306 hours (Form M) + 0
hours (Form MP-1)].
    Estimated annual respondents for Form M decreased from 43 in the
previously approved Information Collection Requirement (ICR) to 34 in
the current ICR. Estimated annual burden hours for Form M decreased by
78 hours [306 proposed hours-384 currently approved hours = -78 hours].
Estimated annual respondents for Form MP-1 stayed the same. The
previously approved ICR had 0 annual hours. The current ICR has 0
annual hours. This estimate is based off the number of Form M and Form
MP-1 submissions received by the Agency between 2018 and 2020, which
results in these estimates of annual respondents/responses for the
upcoming information collection period.
    Labor costs to industry have decreased by $2,276 annually [$14,494
in proposed costs - $16,770 currently approved costs = -$2,276]. This
is due to the decreased estimates of annual respondents/responses.
Other annual costs to respondents (i.e., associated with mailing
completed forms to FMCSA) have decreased by $9 [($34 in proposed
mailing costs for Form M + $0 in proposed mailing costs for Form MP-
1)--($43 in previously approved mailing costs for Form M + $0 in
previously approved mailing costs for Form MP-1) = $-9]. This change is
also due to the decreased estimates of annual respondents/responses.
    For the Federal Government, annual costs have increased by $6 [$79
in proposed costs - $73 in previously approved costs = $6]. This
increase is due to a revision in the federal government employee load
rate, which was revised to be consistent with other FMCSA ICRs.

Background

    Section 14123 of title 49 of the United States Code (U.S.C.)
requires certain for-hire motor carriers of property, passengers, and
household goods to file annual financial reports. The annual reporting
program was implemented on December 24, 1938 (3 FR 3158), and it was
subsequently transferred from the Interstate Commerce Commission (ICC)
to the U.S. Department of Transportation's (DOT) Bureau of
Transportation Statistics (BTS) on January 1, 1996. The Secretary of
Transportation delegated to BTS the responsibility for the program on
December 17, 1996 (61 FR 68162). Responsibility for collection of the
reports was transferred from BTS to FMCSA on August 17, 2004 (69 FR
51009), and the regulations were redesignated as 49 CFR part 369 on
August 10, 2006 (71 FR 45740). FMCSA collects carriers' annual reports
and furnishes copies of the reports when requested under the Freedom of
Information Act (FOIA). Annual financial reports are filed on Form M
(Class I and II for-hire property carriers, including household goods
carriers) and Form MP-1 (Class I for-hire passenger carriers). For-hire
motor carriers (including interstate and intrastate) subject to the
Federal Motor Carrier Safety Regulations are classified on the basis of
their gross carrier operating revenues.\1\
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    \1\ For purposes of the Financial and Operating Statistics
(F&OS) program, carriers are classified into the following three
groups: (1) Class I carriers are those having annual carrier
operating revenues (including interstate and intrastate) of $10
million or more after applying the revenue deflator formula as set
forth in Note A of 49 CFR 369.2; and (2) Class II carriers are those
having annual carrier operating revenues (including interstate and
intrastate) of at least $3 million, but less than $10 million after
applying the revenue deflator formula as set forth in 49 CFR 369.2.
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    The data and information collected is publicly available through
FOIA requests. FMCSA has created electronic forms that may be prepared,
signed electronically, and submitted to FMCSA via https://ask.fmcsa.dot.gov/app/ask/. FMCSA revised Form M to ensure that it
solicits only that information required by statute, and also added an
option to allow filers to upload their own document in lieu of filling
out either Form M or MP-1 (as applicable), so long as the document
includes all of the information listed on the form.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.
    Issued under the authority of 49 CFR 1.87.

Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2022-10661 Filed 5-17-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Pages 59848-59850]
[FR Doc No: 2020-20963]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0049]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt five individuals from
the requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) that interstate commercial

motor vehicle (CMV) drivers have ``no established medical history or
clinical diagnosis of epilepsy or any other condition which is likely
to cause loss of consciousness or any loss of ability to control a
CMV.'' The exemptions enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on September 8, 2020. The
exemptions expire on September 8, 2022.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<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.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2020-0049 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting Docket Operations in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays. To be sure someone is there to help you, please call (202)
366-9317 or<PHONE_NUMBER> before visiting Docket Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On August 7, 2020, FMCSA published a notice announcing receipt of
applications from five individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (85 FR 48063). The public comment
period ended on September 8, 2020, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on the 2007 recommendations of the Agency's Medical Expert Panel
(MEP). The Agency conducted an individualized assessment of each
applicant's medical information, including the root cause of the
respective seizure(s) and medical information about the applicant's
seizure history, the length of time that has elapsed since the
individual's last seizure, the stability of each individual's treatment
regimen and the duration of time on or off of anti-seizure medication.
In addition, the Agency reviewed the treating clinician's medical
opinion related to the ability of the driver to safely operate a CMV
with a history of seizure and each applicant's driving record found in
the Commercial Driver's License Information System for commercial
driver's license (CDL) holders, and interstate and intrastate
inspections recorded in the Motor Carrier Management Information
System. For non-CDL holders, the Agency reviewed the driving records
from the State Driver's Licensing Agency (SDLA). A summary of each
applicant's seizure history was discussed in the August 7, 2020,
Federal Register notice (85 FR 48063) and will not be repeated in this
notice.
    These five applicants have been seizure-free over a range of nine
to 35 years while taking anti-seizure medication and maintained a
stable medication treatment regimen for the last 2 years. In each case,
the applicant's treating physician verified his or her seizure history
and supports the ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in Sec.
391.41(b)(8) is likely to achieve a level of safety equal to that
existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must remain seizure-free and maintain a stable treatment
during the 2-year exemption period; (2) each driver must submit annual
reports from their treating physicians attesting to the stability of
treatment and that the driver has remained seizure-free; (3) each
driver must undergo an annual medical examination by a certified ME, as
defined by Sec.  390.5; and (4) each driver must provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy of his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the five exemption applications, FMCSA
exempts the following drivers from the epilepsy and seizure disorder
prohibition, Sec.  391.41(b)(8), subject to the requirements cited
above:

Diego Dasilva (MA)
Brian Duncan (IL)
Clint Honea (AL)
Daryl James (NY)
Michael Shorty (NM)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-20963 Filed 9-22-20; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Notices]
[Page 5174]
[FR Doc No: 2013-01370]

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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: RP13-443-000.
    Applicants: Millennium Pipeline Company, L.L.C.
    Description: Millennium Pipeline Company, L.L.C. submits Penalty
Revenue Crediting Report.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5038.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: RP13-444-000.
    Applicants: Cheyenne Plains Gas Pipeline Company LLC.
    Description: Request for Waiver of Cheyenne Plains Gas Pipeline
Company, L.L.C.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5184.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: RP13-445-000.
    Applicants: Gas Transmission Northwest LLC.
    Description: Gas Transmission Northwest LLC submits Coyote Springs
Lateral Refund Report.
    Filed Date: 1/14/13.
    Accession Number: 20130114-5030.
    Comments Due: 5 p.m. ET 1/28/13.
    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.

Filings in Existing Proceedings

    Docket Numbers: RP12-1067-002.
    Applicants: Leaf River Energy Center LLC.
    Description: Leaf River Energy Center LLC--Revised Compliance
Filing to be effective 12/1/2012.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5100.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: RP12-1068-002.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Tres Palacios Gas Storage LLC--Revised Compliance
Filing to be effective 12/1/2012.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5045.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: RP12-1075-002.
    Applicants: Arlington Storage Company, LLC.
    Description: Arlington Storage Company, LLC--Revised Compliance
Filing to be effective 12/1/2012.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5052.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: RP13-169-002.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Atmos Energy Corporation Non-Conforming TSA to be
effective 10/25/2012.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5153.
    Comments Due: 5 p.m. ET 1/23/13.

    Docket Numbers: RP13-389-001.
    Applicants: Equitrans, L.P.
    Description: Refile Negotiated Rate Service Agreement--Stone Energy
Corp to be effective 12/17/2012.
    Filed Date: 1/14/13.
    Accession Number: 20130114-5027.
    Comments Due: 5 p.m. ET 1/28/13.
    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service 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 (202) 502-
8659.

    Dated: January 14, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-01370 Filed 1-23-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Notices]
[Pages 90365-90367]
[FR Doc No: 2016-29989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4803]

Public Notification of Emerging Postmarket Medical Device Signals
(``Emerging Signals''); Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Public Notification of
Emerging Postmarket Medical Device Signals (`Emerging Signals').'' FDA
is issuing this guidance to describe the Center for Devices and
Radiological Health's (CDRH) policy for notifying the public about
medical device ``emerging signals.'' This guidance describes the

factors CDRH intends to consider in deciding whether to notify the
public about an emerging signal and the processes and timelines it
intends to follow in issuing and updating the notification. Timely
notification about those emerging signals based on the factors
described in this guidance document is intended to provide health care
providers, patients, and consumers with access to the most current
information concerning the performance and potential benefits and risks
of marketed medical devices so that they can make informed patient
management decisions about their treatment and diagnostic options.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-4803 for ``Public Notification of Emerging Postmarket
Medical Device Signals ('Emerging Signals').'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Public Notification of Emerging Postmarket Medical Device Signals
('Emerging Signals')'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    All medical devices have benefits and risks. FDA weighs probable
benefit to health from the use of the device against any probable risk
of injury or illness from such use in determining the safety and
effectiveness of a device.\1\ Once FDA has made its determination,
health care providers, patients, and consumers must weigh these
benefits and risks when making patient management decisions. However,
not all information regarding benefits and risks for a given device may
be known before the device reaches the market. New information about a
device's safety and/or effectiveness, including unanticipated adverse
events, may become available once the device is more widely distributed
and used under real-world conditions and in broader patient populations
than may have been studied in support of a marketing application. Also,
subsequent changes made to the device, its manufacturing process, or
supply chain might lead to new safety problems.
---------------------------------------------------------------------------

    \1\ See 21 U.S.C. 360c(a)(2) and 21 CFR 860.7.
---------------------------------------------------------------------------

    FDA is issuing this guidance to describe CDRH policy for notifying
the public about medical device ``emerging signals.'' For the purposes
of this guidance, an emerging signal is new information about a
marketed medical device: (1) That supports a new causal association or
a new aspect of a known association between a device and an adverse
event or set of adverse events and (2) for which the Agency has
conducted an initial evaluation and determined that the information has
the potential to impact patient management decisions and/or the known
benefit-risk profile of the device. Information that is

unconfirmed, unreliable, or lacks sufficient strength of evidence is
not an emerging signal.
    This guidance describes the factors CDRH intends to consider in
deciding whether to notify the public about emerging signals and the
processes and timelines it intends to follow in issuing and updating
the notification. Timely notification about those emerging signals
based on the factors described in this guidance document is intended to
provide health care providers, patients, and consumers with access to
the most current information concerning the performance and potential
benefits and risks of marketed medical devices so that they can make
informed patient management decisions about their treatment and
diagnostic options.
    In the Federal Register of December 31, 2015 (80 FR 81829), FDA
announced the availability of the draft of this guidance. Interested
persons were invited to comment by February 29, 2016. In the Federal
Register of January 27, 2016 (81 FR 4632), FDA extended the comment
period to March 29, 2016. FDA received and considered 21 sets of public
comments and revised the guidance as appropriate. CDRH also intends to
provide periodic public updates on the implementation of this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Public Notification of Emerging Postmarket
Medical Device Signals ('Emerging Signals').'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Public Notification of
Emerging Postmarket Medical Device Signals ('Emerging Signals')'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 1500027
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collections of information in 21 CFR parts 801, regarding labeling,
have been approved under OMB control number 0910-0485 and the
collections of information in 21 CFR part 803, regarding medical device
reporting, have been approved under OMB control numbers 0910-0291,
0910-0437, and 0910-0471.

    Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29989 Filed 12-13-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Notices]
[Pages 35550-35558]
[FR Doc No: 2014-14547]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0670]

Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Novel Influenza A (H7N9) Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for detection of the novel influenza
A (H7N9) virus (detected in China in 2013). FDA is issuing this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by Arbor Vita Corporation. The Authorization
contains, among other things, conditions on the emergency use of the
authorized in vitro diagnostic device. The Authorization follows the
April 19, 2013, determination by the Secretary of Health and Human
Services (HHS) that there is a significant potential for a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves the novel influenza A (H7N9) virus. On the basis of such
determination, the Secretary of HHS also declared on April 19, 2013,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection of the novel influenza A (H7N9)
virus subject to the terms of any authorization issued under the FD&C
Act. The Authorization, which includes an explanation of the reasons
for issuance, is reprinted in this document.

DATES: The Authorization is effective as of April 25, 2014.

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

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Assistant Commissioner
for Counterterrorism Policy, Office of Counterterrorism and Emerging
Threats, and Acting Deputy Chief Scientist, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver
Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
\1\ or (4) the identification of a material threat by the Secretary of
Homeland Security pursuant to section 319F-2 of the Public Health
Service Act (PHS Act) (42 U.S.C. 247d-6b) sufficient to affect national
security or the health and security of U.S. citizens living abroad.
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    \1\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013 (Public Law 113-5), the Secretary of HHS
may make a determination of a public health emergency, or a
significant potential for a public health emergency, under section
564 of the FD&C Act. The Secretary of HHS is no longer required to
make a determination of a public health emergency under section 319
of the PHS Act (42 U.S.C. 247d) to support a determination made
under section 564 of the FD&C Act.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances),

FDA \2\ concludes: (1) That an agent referred to in a declaration of
emergency or threat can cause a serious or life-threatening disease or
condition; (2) that, based on the totality of scientific evidence
available to FDA, including data from adequate and well-controlled
clinical trials, if available, it is reasonable to believe that: (A)
The product may be effective in diagnosing, treating, or preventing (i)
such disease or condition; or (ii) a serious or life-threatening
disease or condition caused by a product authorized under section 564
of the FD&C Act, approved or cleared under the FD&C Act, or licensed
under section 351 of the PHS Act, for diagnosing, treating, or
preventing such a disease or condition caused by such an agent; and (B)
the known and potential benefits of the product, when used to diagnose,
prevent, or treat such disease or condition, outweigh the known and
potential risks of the product, taking into consideration the material
threat posed by the agent or agents identified in a declaration under
section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is
no adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
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    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of the
Novel Influenza A (H7N9) Virus

    On April 19, 2013, under section 564(b)(1)(C) of the FD&C Act, the
Secretary of HHS determined that there is a significant potential for a
public health emergency that has a significant potential to affect
national security or the health and security of U.S. citizens living
abroad and that involves the novel influenza A (H7N9) virus. Also on
April 19, 2013, under section 564(b)(1) of the FD&C Act, and on the
basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection of the novel influenza A (H7N9) virus,
subject to the terms of any authorization issued under section 564 of
the FD&C Act. The Secretary of HHS also specified that this declaration
is a declaration of an emergency with respect to in vitro diagnostics
as defined under the Public Readiness and Emergency Preparedness (PREP)
Act Declaration for Pandemic Influenza Diagnostics, Personal
Respiratory Protection Devices, and Respiratory Support Devices signed
by then Secretary Michael Leavitt on December 17, 2008 (73 FR 78362,
December 22, 2008). Notice of the determination and the declaration of
the Secretary were published in the Federal Register on April 30, 2013
(78 FR 25273). On April 9, 2014, Arbor Vita Corporation submitted a
complete request for, and on April 25, 2014, FDA issued, an EUA for the
A/H7N9 Influenza Rapid Test subject to the terms of this authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of the novel influenza A (H7N9) virus (detected in China in
2013) subject to the terms of the Authorization. The Authorization in
its entirety (not including the authorized versions of the fact sheets
and other written materials) follows and provides an explanation of the
reasons for its issuance, as required by section 564(h)(1) of the FD&C
Act.
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    Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14547 Filed 6-20-14; 8:45 am]
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[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Proposed Rules]
[Page 68119-68121]
[DOCID:fr04de07-27]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2007-0717; FRL-8501-6]

Approval and Promulgation of Air Quality Implementation Plans;
Wisconsin; Approval of Construction Permit Waiver

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Wisconsin State
Implementation Plan (SIP) submitted by the Wisconsin Department of
Natural Resources (WDNR) on May 1, 2007. The WDNR has submitted for
approval into its SIP a revision which allows the State to issue a
waiver to a source allowing it to commence construction prior to a
construction permit being issued, in certain cases. This provision is
only allowed for minor sources which meet specific criteria, and WDNR
must follow established procedures to grant a waiver. In addition, the
revision also contains changes to Wisconsin's fee provisions to allow a
fee to be charged for the waiver. EPA is proposing to approve this
revision because it is consistent with Federal regulations governing
state permit programs.

DATES: Comments must be received on or before January 3, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2007-0717, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Air Permits Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Air Permits Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only
accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2007-0717. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes 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 http://www.regulations.gov or e-mail. The http://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 http://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 instructions on submitting
comments, go to Section I of the SUPPLEMENTARY INFORMATION section of
this document.
    Docket: All documents in the docket are listed in the http://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 material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental Protection

Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This

facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. We recommend that you telephone Susan
Siepkowski, Environmental Engineer, at<PHONE_NUMBER> before visiting
the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Susan Siepkowski, Environmental
Engineer, Air Permits Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What Should I Consider as I Prepare My Comments for EPA?
II. What Has Wisconsin Submitted?
III. Does This Submittal Comply With Federal Regulations?
IV. What Action Is EPA Taking Today?
V. Statutory and Executive Order Reviews.

I. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. What Has Wisconsin Submitted?

    On May 1, 2007, WDNR submitted a SIP revision request to EPA for
approval. The submittal requests that EPA approve the following
revisions to WDNR's SIP: to renumber and amend NR 406.03, to amend NR
410.03(intro.) and to create NR 406.03(2) and NR 410.03(l)(bm). These
changes would allow WDNR to issue a waiver to a source allowing it to
commence construction prior to a construction permit being issued.
These revisions also contain changes to Wisconsin's fee provisions to
allow a fee to be charged for the waiver.
    The WDNR held two public hearings in August 2006 and the comment
period for this rule closed on August 18, 2006. The WDNR proposed this
rule revision to the Wisconsin Natural Resources Board for adoption,
and the Board approved the final rule on March 22, 2007.
    Wisconsin Rule NR 406 contains the requirements and procedures for
construction permits. The revisions to NR 406.03 require the following
conditions to be satisfied before the State may grant a source a
waiver: (1) A complete construction permit application has been
submitted for the source; (2) the source and the proposed project will
result in the source remaining a true minor source (no synthetic minor
or netting permits); (3) the waiver requests must demonstrate that
undue hardship will result if the waiver is not granted. Undue hardship
may result from adverse weather conditions, catastrophic damage of
existing equipment, a substantial financial hardship that may preclude
the project in its entirety, and other unique conditions; (4) the
source is not located or to be located within 10 kilometers of a Class
I area.
    The rule further states that a waiver does not obligate the WDNR to
ultimately approve the project, or relieve the source from compliance
with any applicable regulation. Finally, if a waiver is granted and the
source proceeds with construction, the rule specifies that it is doing
so at its own risk, and the source may not operate until the permit is
issued. WDNR may rescind a waiver if the owner or operator does not
diligently respond to inquiries on the construction permit application
or if WDNR preliminarily determines that the source will not meet the
criteria for permit approval.
    Additional changes are being made to NR 410, Wisconsin's air permit
fee rules, to include fees for waivers. NR 10.03(1)(a)(5), related to
the fees for a construction permit revision, is amended to exempt the
fee if the requested revision is to make the source eligible for a
registration operation permit.

III. Does This Submittal Comply With Federal Regulations?

    EPA reviewed Wisconsin's May 1, 2007, SIP revision submittal to
determine completeness, in accordance with the completeness criteria
set out at 40 CFR part 51, appendix V (1991), as amended by 57 FR 42216
(August 26, 1991). We found the submittal to be complete.
    EPA evaluated Wisconsin's waiver rule with respect to the SIP
approval criteria established in EPA's June 28, 1989, rulemaking
``Requirements for the Preparation, Adoption, and Submittal of
Implementation Plans,'' (EPA's 1989 rulemaking); Approval and
Promulgation of Implementation Plans, 54 FR 27274. In addition, EPA has
evaluated WDNR's rule with respect to relevant Federal rules and
guidance documents, as discussed in more detail below.
    Section 165 of the Clean Air Act (Act) sets forth preconstruction
requirements for the Prevention of Significant Deterioration (PSD)
program. Specifically, ``(a) No major emitting facility on which
construction is commenced after the date of the enactment of this part,
may be constructed in any area to which this part applies unless (1) a
permit has been issued for such proposed facility in accordance with
this part setting forth emission limitations for such facility which
conform to the requirements of this part.''
    However, this requirement only applies to major sources, and no
such restriction is specified under the minor New Source Review (NSR)
program requirements, which are set forth in 40 CFR 51.160. In
addition, EPA has made determinations which further support that
construction may begin before a permit is issued for minor sources. For
example, EPA's October 10, 1978, memorandum from Edward E. Reich to
Thomas W. Devine in Region 1 discusses preconstruction activities
allowed at a site with both PSD and non-PSD sources. This memo states
that construction may begin on PSD-exempt projects before the permit is
issued.
    Furthermore, EPA approved a rule for Idaho's permit program which
allowed construction to commence prior to a permit being issued. (See
68 FR 2217, final rule.) The August 13, 2002, Federal Register proposed
approval of Idaho's rule, Section 213, regarding construction prior to
final permit issuance, states:

    Section 213, entitled ``Pre-Permit Construction'' allows
construction to commence on certain non-major sources and non-major
modifications prior to receiving a final permit to construct,
provided certain conditions are met. EPA believes that this
provision is consistent with the requirements of section
110(a)(2)(C) of the CAA and 40 CFR 51.160, including 40 CFR
51.160(b), which requires States to have legally

enforceable procedures to prevent construction or modification of a
source if it would violate any SIP control strategies or interfere
with attainment or maintenance of the NAAQS. (See 67 FR 52666).

    WDNR's rule revision provides that waivers can only be granted for
minor sources, and the rule complies with EPA's minor source NSR rules
set forth at 40 CFR 51.160. The minor source NSR rules require a state
to have a program: (1) To determine ``whether construction or
modification'' of a source will interfere with the SIP or attainment or
maintenance of the National Ambient Air Quality Standards (NAAQS); and,
(2) that includes procedures to ``prevent the construction or
modification'' of the source if it would interfere with the SIP or
attainment or maintenance of the NAAQS. WDNR will have enforceable
procedures to prevent construction or modification of a source if it
would violate any SIP requirement, or interfere with attainment or
maintenance of the NAAQS. Additionally, WDNR can rescind a waiver if
the source does not meet the criteria in Wis. Statute 285.63(1), which
contain the criteria for permit application approval, including that
the source will not cause or exacerbate a violation of any NAAQS or
ambient air increment, and that the source will meet all applicable
emission limitations and other requirements promulgated under the
chapter.
    Finally, the rule contains the following additional safeguards.
First, granting a waiver does not obligate the WDNR to ultimately
approve the proposed project, or relieve the source from compliance
with any applicable regulation. Second, if a waiver is granted and the
source proceeds with construction, the rule specifies that it is doing
so at its own risk, and the source may not operate until the permit is
issued.
    Based on EPA's regulations and guidance, and the reasons set forth
above, we believe that WDNR's SIP revision is approvable.

IV. What Action Is EPA Taking Today?

    EPA is proposing to approve revisions to Wisconsin SIP rules NR 406
and 410 submitted by the State on May 1, 2007. EPA also is soliciting
comment on this proposed approval.

V. Statutory and Executive Order Reviews

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, September 30, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget.

Paperwork Reduction Act

    This proposed rule does not impose an information collection burden
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.).

Regulatory Flexibility Act

    This proposed action merely proposes to approve state law as
meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law. Accordingly, the Administrator
certifies that this proposed rule will not have a significant economic
impact on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.).

Unfunded Mandates Reform Act

    Because this rule proposes to approve pre-existing requirements
under state law and does not impose any additional enforceable duty
beyond that required by state law, it does not contain any unfunded
mandate or significantly or uniquely affect small governments, as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely proposes to approve a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Act.

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    This proposed rule also does not have tribal implications because
it will not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000).

Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks

    This proposed rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it proposes approval of
a state rule implementing a Federal standard.

Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant regulatory action,'' this
action is also not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001).

National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272, requires Federal agencies to use
technical standards that are developed or adopted by voluntary
consensus to carry out policy objectives, so long as such standards are
not inconsistent with applicable law or otherwise impractical. In
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the Act. Absent a prior
existing requirement for the state to use voluntary consensus
standards, EPA has no authority to disapprove a SIP submission for
failure to use such standards, and it would thus be inconsistent with
applicable law for EPA to use voluntary consensus standards in place of
a program submission that otherwise satisfies the provisions of the
Act. Therefore, the requirements of section 12(d) of the NTTAA do not
apply.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: November 23, 2007.
Gary Gulezian,
Acting Regional Administrator, Region 5.
[FR Doc. E7-23482 Filed 12-3-07; 8:45 am]

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