[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Rules and Regulations]
[Pages 32551-32553]
[FR Doc No: 2013-12696]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0024; Directorate Identifier 2000-NE-12-AD;
Amendment 39-17469; AD 2013-11-09]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for Turbomeca S.A. Arrius 2B, 2B1, and 2F turboshaft engines. That AD
currently requires replacement of injector manifolds and borescope-
inspection of the flame tube and the high-pressure (HP) turbine area
for possible damage. This new AD requires, depending on the engine
model, repetitive replacements of fuel injection manifolds and the
privilege injector, or, repetitive replacements of the privilege
injector. This AD was prompted by a report that the corrective actions
of the existing AD were insufficient to eliminate the unsafe condition.
We are issuing this AD to prevent an uncommanded in-flight shutdown of
Arrius 2B1 and 2F turboshaft engines and damage to the helicopter.

DATES: This AD is effective July 5, 2013.

ADDRESSES: For service information identified in this AD, contact
Turbomeca, 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; telex: 570
042; fax: 33 (0)5 59 74 45 15. You may view this service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M 30, West
Building Ground Floor, Room W12 140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2001-08-14R1, Amendment 39 14423 (71 FR 2993,
January 19, 2006). That AD applies to Turbomeca S.A. Arrius 2B, 2B1,
and 2F turboshaft engines. The Arrius 2B engine model is no longer
listed because it is no longer in service and has been removed from the
engine Type Certificate Data Sheet No. E34NE, as requested by the
manufacturer. The NPRM published in the Federal Register on February 7,
2013 (78 FR 9007). That NPRM proposed to require, depending on the
engine model, repetitive replacements of fuel injection manifolds and
the privilege injector, or, repetitive replacements of the privilege
injector.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Request To Change Paragraphs (f)(1) and (g)(1)

    Turbomeca USA requested that we change compliance paragraph (f)(1)
by deleting ``or since last inspection of the fuel injection manifolds
and privilege injector, whichever comes first.'' The commenter also
requested that we change paragraph (g)(1) by deleting ``or since last
inspection of the privilege injector, whichever comes first.'' The
commenter stated that paragraphs (f)(1) and (g)(1) speak to initial
replacement where subsequent replacements are addressed in paragraphs
(f)(3) and (g)(3). There is no required inspection for this reason
prior to reaching the allocated hours of operation time-since-new (TSN)
so there will be no ``last inspection'' at this point. The fuel
injection manifolds and privilege injector (Arrius 2B1 engines) and,
the privilege injector (Arrius 2F engines) will not have been in
service long enough to have an inspection performed. Also, an
inspection (unless leading to a replacement) if done for whatever
reason, will not ``reset'' the allocated hours (200 or 400) of
operation TSN counter. Only a replacement will, which is why the
commenter thinks the allocated hours (200 or 400) of operation TSN
limit is sufficient.
    We agree. Because there is no specific inspection requirement, fuel
injection manifolds and privilege injectors (Arrius 2B1 enignes) and,
privilege injectors (Arrius 2F engines) can be removed from one Arrius
2B1 engine and installed in another Arrius 2B1engine or from one Arrius
2F engine and installed in another Arrius 2F engine as noted in their
respective service bulletins (SBs). We anticipated that those used
components would undergo an inspection and flow check, prior to
reinstallation. However, the fuel injection manifolds and privilege
injectors are limited to the allocated hours (200 or 400) of operation
TSN regardless of reuse. We changed paragraphs (f)(1) and (g)(1) of the
AD as requested above.

Request To Change Compliance Paragraphs (f)(2) and (g)(2)

    Turbomeca USA requested that we change compliance paragraph (f)(2)
by adding ``when replacing the fuel injection manifolds and privilege
injector for the first time.'' The commenter also requested that we
change paragraph (g)(2) by adding ``when replacing the privilege
injector for the first time.'' The commenter stated that without adding
these words, these paragraphs would require a borescope inspection each
time the

manifolds and privilege injector (Arrius 2B1 engines) and, privilege
injectors (Arrius 2F engines) are replaced. Turbomeca SB No. A319 73
2012 (Arrius 2B1) and SB No. A319 73 4001 (Arrius 2F) specifically
state to perform the borescope inspection when the components are
replaced for the first time.
    The commenter also stated that the purpose of borescope inspection
is to identify the internal condition before initial replacement and to
verify there is no distress caused by a partially blocked or totally
blocked condition. It is intended to verify there was no collateral
damage downstream (flame tube, HP turbine). The replacement interval is
an interval that would prevent any distress being created, should a
blocked condition occur, thus eliminating the need for borescope checks
at each replacement. Also, borescope inspection of the combustion
chamber and the gas generator turbine is called for at certain
intervals by the engine maintenance manual, which will allow sufficient
periodic monitoring for collateral damage.
    We agree with the commenter's technical explanation and rationale.
We changed paragraphs (f)(2) and (g)(2) of the AD as requested above.

Request To Change Compliance Paragraphs (f)(3)

    Turbomeca USA requested that we change compliance paragraph (f)(3)
which states, ``Thereafter, within every 200 operating hours time-in-
service (TIS) since last fuel injector manifolds and privilege injector
replacement, replace the fuel injector manifolds and the privilege
injector with parts eligible for installation'' to ``Thereafter, within
every 200 operating hours TIS since last fuel injector manifolds and
privilege injector replacement, or sooner if a power check performed
per flight manual EC T135-T1 indicates a negative T45 margin, replace
the fuel injector manifolds and the privilege injector with parts
eligible for installation.'' The commenter stated that T45 margin is
monitored as part of existing scheduled maintenance and, as it is known
as being a possible consequence of manifolds or privilege injector
blockage, it is inserted as an additional ``trigger'' point for
replacement prior to the hard hours TSN replacement limit. The engine
is not serviceable with a negative T45 margin and engine repair is
needed before further flight. The need for borescope inspection only
with first replacement is not modified in case of an early replacement
triggered by detection of negative T45 margin.
    We agree with the commenter's technical explanation and rationale,
which applies only to the Arrius 2B1 engines. We changed paragraph
(f)(3) of the AD as requested above.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects about 38 Arrius 2B1 engines and
about 93 Arrius 2F engines installed on helicopters of U.S. registry.
We also estimate that it will take about two hours per engine to
replace the injector manifolds and about one hour per engine to replace
the privilege injector. The average labor rate is $85 per hour. Based
on these figures, we estimate the cost of the AD on U.S. operators to
be $663,615.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2001-08-14R1, Amendment 39 14423 (71 FR 2993, January 19, 2006), and
adding the following new AD:
* * * * *
2013-11-09 Turbomeca S.A.: Amendment 39 17469; Docket No. FAA-2013-
0024; Directorate Identifier 2000-NE-12-AD.

(a) Effective Date

    This AD is effective July 5, 2013.

(b) Affected ADs

    This AD supersedes AD 2001-08-14R1, Amendment 39 14423 (71 FR
2993, January 19, 2006).

(c) Applicability

    This AD applies to all Turbomeca S.A. Arrius 2B1 and 2F
turboshaft engines.

(d) Unsafe Condition

    This AD was prompted by a report that the corrective actions of
AD 2001-08-14R1, Amendment 39 14423 (71 FR 2993, January 19, 2006)
were insufficient to eliminate the unsafe condition. We are issuing
this AD to prevent an uncommanded in-flight shutdown of Arrius 2B1
and 2F turboshaft engines and damage to the helicopter.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(f) Arrius 2B1 Turboshaft Engines

    (1) Replace the fuel injector manifolds and privilege injector
with parts eligible for

installation before exceeding 200 operating hours, time-since-new
(TSN).
    (2) Borescope-inspect the flame tube and the high-pressure
turbine area for turbine distress, when replacing the fuel injection
manifolds and privilege injector for the first time.
    (3) Thereafter, within every 200 operating hours, time-in-
service (TIS) since last fuel injector manifolds and privilege
injector replacement, or sooner if a power check performed per
flight manual EC T135-T1 indicates a negative T45 margin, replace
the fuel injector manifolds and the privilege injector with parts
eligible for installation.

(g) Arrius 2F Turboshaft Engines

    (1) Replace the privilege injector with a privilege injector
eligible for installation before exceeding 400 operating hours TSN.
    (2) Borescope-inspect the flame tube and the high-pressure
turbine area for turbine distress, when replacing the privilege
injector for the first time.
    (3) Thereafter, within every 400 operating hours TIS since last
privilege injector replacement, replace the privilege injector with
parts eligible for installation.

(h) Definition

    For the purposes of this AD, TIS is defined as:
    (1) The number of engine operating hours on the manifolds since
the manifolds were new or since the manifolds were last cleaned,
whichever is more.
    (2) The number of engine operating hours on the privilege
injector since the privilege injector was new or since the privilege
injector was last cleaned, whichever is more.

(i) Installation Prohibitions

    (1) For Arrius 2B1 turboshaft engines, after the effective date
of this AD, do not install fuel injector manifolds or a privilege
injector on an engine, or an engine on a helicopter, unless the fuel
injection manifold and privilege injector have accumulated fewer
than 200 operating hours since new, or since last inspection.
    (2) For Arrius 2F turboshaft engines, after the effective date
of this AD, do not install a privilege injector on an engine, or an
engine on a helicopter, unless the privilege injector has
accumulated fewer than 400 operating hours since new, or since last
inspection.

(j) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(k) Related Information

    (1) For more information about this AD, contact James Lawrence,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) See European Aviation Safety Agency AD 2012-0150, dated
August 8, 2012, and AD 2012-0249, dated November 21, 2012, Turbomeca
S.A. Alert Mandatory Service Bulletin (MSB) No. A319 73 2012,
Version I, dated November 12, 2012, and Turbomeca S.A. Alert MSB No.
A319 73 4001, Version L, dated January 17, 2013, for related
information.
    (3) For service information identified in this AD, contact
Turbomeca, 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; telex:
570 042; fax: 33 (0)5 59 74 45 15. You may view this service
information at the FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on May 23, 2013.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2013-12696 Filed 5-30-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60951-60953]
[FR Doc No: 2023-19182]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1981]

Drug Supply Chain Security Act Standards for the Interoperable
Exchange of Information for Tracing of Certain Human, Finished,
Prescription Drugs; Guidance for Industry; 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 a final guidance for industry entitled ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs.'' This guidance identifies
the standards necessary to facilitate adoption of secure,
interoperable, electronic data exchange among the pharmaceutical
distribution supply chain, and clarifies the trading partners,
products, and transactions subject to such standards. This guidance
finalizes the revised draft guidance of the same title, ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs,'' issued in July 2022, as
required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal
Register on September 6, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2014-D-1981 for ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain

Human, Finished, Prescription Drugs.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription
Drugs.'' The FD&C Act, as amended by the Drug Supply Chain Security Act
(DSCSA), outlines requirements for enhanced drug distribution security,
which include the steps to achieve interoperable, electronic tracing of
products at the package level. Section 582(g)(1) of the FD&C Act (21
U.S.C. 360eee-1(g)(1)) sets forth enhanced drug distribution security
requirements for trading partners, including adherence to standards
established by FDA for the exchange of transaction information and
transaction statements in a secure, interoperable, electronic manner
and the verification of product at the package level. Section 582(g)(1)
of the FD&C Act states that these enhanced drug distribution security
requirements go into effect on November 27, 2023. Additionally, section
582(h)(4)(A) of the FD&C Act specifies that FDA issue a guidance to
identify and make recommendations with respect to the standards
necessary for adoption in order to support the secure, interoperable,
electronic data exchange among the pharmaceutical distribution supply
chain that comply with a form and format developed by a widely
recognized international standards development organization.
    In this guidance, FDA considered the standards established pursuant
to sections 505D of the FD&C Act (21 U.S.C. 355e). FDA also considered
the standards established pursuant to section 582(a)(2) of the FD&C Act
and described in the July 2022 revised draft guidance entitled ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs.'' The pilot projects
conducted per section 582(j) of the FD&C Act also informed this
guidance.
    In November 2014, FDA issued a draft guidance for industry,
entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription Drugs:
How to Exchange Product Tracing Information.'' In July 2022, FDA issued
a revised draft guidance, entitled ``DSCSA Standards for the
Interoperable Exchange of Information for Tracing of Certain Human,
Finished, Prescription Drugs'' (87 FR 40258), that updated the policies
articulated in the 2014 draft guidance. This guidance finalizes the
July 2022 revised draft guidance. FDA considered comments received on
the revised draft guidance as the guidance was finalized. Changes were
made to the guidance to improve clarity. This guidance finalizes the
policy articulated in the July 2022 revised draft guidance to reflect
the enhanced drug distribution security requirements in section
582(g)(1) of the FD&C Act that will go into effect on November 27,
2023, including that only electronic methods of product tracing will be
permitted and verification of product at the package level will be
required, unless a waiver, exception, or exemption applies. This
guidance is intended to also facilitate the creation of a uniform
methodology for product tracing while ensuring the protection of
confidential commercial information and trade secrets. FDA also
published other guidances describing recommendations for enhanced drug
distribution security, including the attributes necessary for enhanced
product tracing and verification, which should be read in conjunction
with this guidance (see FDA's Drug Supply Chain Security Law and
Policies web page at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies).
    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 ``DSCSA Standards for the Interoperable
Exchange of Information for Tracing of Certain Human, Finished,
Prescription Drugs.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance includes information collection provisions that 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). FDA intends
to solicit public comment and obtain OMB approval for any information
collections recommended in this guidance that are new or that would
represent substantive or material modifications to those previously
approved collections of information found in FDA regulations or
guidance.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19182 Filed 9-5-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Page 54515]
[FR Doc No: 2022-19155]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes FDA to award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that VOXZOGO (vosoritide) manufactured by BioMarin Pharmaceutical,
Inc., meets the criteria for receipt of a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff) FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that VOXZOGO (vosoritide) manufactured by BioMarin
Pharmaceutical, Inc., meets the criteria for a priority review voucher.
VOXZOGO (vosoritide) is indicated to increase linear growth in
pediatric patients with achondroplasia who are 5 years of age and older
with open epiphyses.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about VOXZOGO (vosoritide), go to the ``[email protected]'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19155 Filed 9-2-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Notices]
[Page 16000-16001]
[DOCID:fr26mr08-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

March 20, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP96-312-180.
    Applicants: Tennessee Gas Pipeline Company.
    Description: Tennessee Gas Pipeline Co submits a Gas Transportation
Agreement with Statoil Natural Gas, LLC.
    Filed Date: 03/18/2008.
    Accession Number: 20080319-0223.
    Comment Date: 5 p.m. Eastern Time on Monday, March 31, 2008.

    Docket Numbers: RP99-176-157.
    Applicants: Natural Gas Pipeline Co Of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
Original Sheet 26Q.02 & Original Sheet

26Q.03 to its FERC Gas Tariff, Sixth Revised Volume 1, to be effective
April 1, 2008.
    Filed Date: 03/19/2008.
    Accession Number: 20080320-0026.
    Comment Date: 5 p.m. Eastern Time on Monday, March 31, 2008.

    Docket Numbers: RP08-274-000.
    Applicants: Gas Transmission Northwest Corporation.
    Description: Gas Transmission Northwest Corporation submits Second
Revised Sheet 127 et al part of its FERC Gas Tariff, Third Revised
Volume 1-A, to become effective April 14, 2008.
    Filed Date: 03/17/2008.
    Accession Number: 20080317-0223.
    Comment Date: 5 p.m. Eastern Time on Monday, March 31, 2008.

    Docket Numbers: RP08-275-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits Original Sheet 10
et al to FERC Gas Tariff, Second Revised Volume 1, to be effective
April 1, 2008.
    Filed Date: 03/18/2008.
    Accession Number: 20080319-0041.
    Comment Date: 5 p.m. Eastern Time on Monday, March 31, 2008.

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

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-6136 Filed 3-25-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Notices]
[Page 30785]
[FR Doc No: 2020-10882]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-20]

Petition for Exemption; Summary of Petition Received; Embry
Riddle Aeronautical University

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before June 9, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0191
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: 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 http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Linda Lane<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 15, 2020.
Brandon Roberts,
Acting Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-0191.
    Petitioner: Embry-Riddle Aeronautical University (ERAU).
    Section(s) of 14 CFR Affected: Appendix C, paragraph 4(c)(1) to
Part 141 and/or Sec.  61.65(d)(2)(ii)(C).
    Description of Relief Sought: The petitioner seeks relief from the
Instrument rating flight training requirements of Appendix C, paragraph
4(c)(1) to Part 141 and/or Sec.  61.65(d)(2)(ii)(C), which requires an
applicant to complete three different kinds of approaches with the use
of navigation systems on a 250 nautical mile cross country flight.

[FR Doc. 2020-10882 Filed 5-19-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46791-46793]
[FR Doc No: 2014-18948]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-498-000]

Rockies Express Pipeline, LLC; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Zone 3 East-To-West Project
and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Zone 3 East-to-West Project
(Project) involving construction and operation of facilities by Rockies
Express Pipeline, LLC (Rockies Express) in Illinois, Indiana, and Ohio.
The Commission will use this EA in its decision-making process to
determine whether the project is in the public convenience and
necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the Project. Your input will help the Commission staff
determine what issues they need to evaluate in the EA. Please note that
the scoping period will close on September 4, 2014. Further details on
how to submit written comments are in the Public Participation section
of this notice.
    This notice is being sent to the Commission's current environmental
mailing list for this Project. State and local government
representatives should notify their constituents of this proposed
Project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the Project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    Rockies Express provided landowners with a fact sheet prepared by
the FERC entitled ``An Interstate Natural Gas Facility On My Land? What
Do I Need To Know?'' This fact sheet addresses a number of typically-
asked questions, including the use of eminent domain and how to
participate in the Commission's proceedings. It is also available for
viewing on the FERC Web site (www.ferc.gov).

Summary of the Proposed Project

    The purpose of the Project is to enable bi-directional flow
capability within Rockies Express Zone 3, thereby allowing the existing
42'' Rockies Express Pipeline to offer an additional 1,200,000
dekatherms per day (Dth/d) of east-to-west firm transportation of
Appalachian Basin gas production to Midwestern gas markets, while
maintaining existing firm transportation commitments stations, over
pressure protection addition to Zone 3 delivery interconnects, and
modifications to four existing delivery interconnects.

Modifications to Existing Compressor Stations

     Station piping to provide bi-directional flow at the
existing Chandlersville, Hamilton, and Bainbridge Compressor Stations
in Muskingum County and Warren County, Ohio; and Putnam County,
Indiana; and
     mainline pressure regulation facilities at the existing
Blue Mound

Compressor Station in Christian County, Illinois.

Over Pressure Protection Addition to Zone 3 Delivery Interconnects

     Over pressure protection facilities at the Clarington Hub
encompassing three delivery interconnects (Dominion Transmission,
Dominion East Ohio, and Texas Eastern Transmission) in Monroe County,
Ohio; and
     over pressure protection facilities at the Panhandle
Eastern Pipeline Company (PEPL) Putnam delivery interconnect in Putnam
County, Indiana.

Modifications to Existing Delivery Interconnects

     Facility modifications at existing delivery interconnect
at PEPL Putnam in Putnam County, Indiana; Midwestern Edgar in Edgar
County, Illinois; Trunkline Douglas in Douglas County, Illinois; and
NGPL Moultrie in Moultrie County, Illinois. The general location of the
project facilities is shown in appendix 1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    The total land requirement for construction of the Project is about
10.2 acres, of which 6.1 acres would be permanently affected by the
facilities operation.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. The NEPA also requires
us \2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \2\ ``We'', ``us'', and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed Project under these
general headings:
     Geology and soils;
     land use;
     water bodies, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species; and
     public safety
    We will also evaluate reasonable alternatives to the proposed
Project or portions of the Project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure your comments are considered, please
carefully follow the instructions in the Public Participation section
of this notice.
    With this notice, we are asking agencies with jurisdiction and/or
special expertise with respect to environmental issues to formally
cooperate with us in the preparation of the EA. Agencies that would
like to request cooperating agency status should follow the
instructions for filing comments provided under the Public
Participation section of this notice.

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for Section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with applicable State Historic Preservation Office (s) (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the Project's potential effects on
historic properties.\3\ We will define the Project-specific Area of
Potential Effects (APE) in consultation with the SHPOs as the project
develops. On natural gas projects, the APE at a minimum encompasses all
areas subject to ground disturbance (examples include construction
right-of-way, contractor/pipe storage yards, compressor stations, and
access roads). Our EA for this Project will document our findings on
the impacts on historic properties and summarize the status on
consultations under Section 106.
---------------------------------------------------------------------------

    \3\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Historic
properties are defined in those regulations as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register for Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send in your comments
so that they will be received in Washington, DC on or before September
4, 2014.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the Project docket number (CP14-498-000) with your
submission. The Commission encourages electronic filing of comments and
has expert eFiling staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at www.ferc.gov
under the link to Documents and Filings. An eComment is an easy method
for interested persons to submit brief, text-only comments on a
project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at www.ferc.gov
under the link to Documents and Filings. With eFiling you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making. A comment on a particular project is considered a ``Comment
on a Filing;'' or
    (3) You may file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental groups and non-

governmental organizations; interested Indian tribes; other interested
parties; and local libraries and newspapers. This list also includes
all affected landowners (as defined in the Commission's regulations)
who are potential right-of-way grantors, whose property may be used
temporarily for Project purposes, or who own homes within certain
distances of aboveground facilities, and anyone who submits comments on
the Project. We will update the environmental mailing list as the
analysis proceeds to ensure that we send the information related to
this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If the EA is published for distribution, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the compact
disc version or would like to remove your name from the mailing list,
please return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are
included in the User's Guide under the ``e-filing'' link on the
Commission's Web site.

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits, in the Docket Number field (i.e.,
CP14-498). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets.
    This can reduce the amount of time you spend researching
proceedings by automatically providing you with notification of these
filings, document summaries and direct links to the documents. Go to
http://www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: August 5, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-18948 Filed 8-8-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12623-12624]
[FR Doc No: 2019-06385]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1215]

Post-Marketing Pediatric-Focused Product Safety Reviews;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to collect comments related to the post-marketing
pediatric-focused safety reviews of products posted between October 12,
2018, and April 1, 2019, on FDA's website but not presented at the
April 8, 2019, Pediatric Advisory Committee (PAC) meeting. These
reviews are intended to be available for review and comment by members
of the PAC, interested parties (such as academic researchers, regulated
industries, consortia, and patient groups), and the general public.

DATES: Submit either electronic or written comments by April 15, 2019.

ADDRESSES: FDA is establishing a docket for public comment on this
document. The docket number is FDA-2019-N-1215. The docket will close
on April 15, 2019. Submit either electronic or written comments by that
date. Please note that late, untimely comments will not be considered.
Electronic comments must be submitted on or before April 15, 2019. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of April 15, 2019.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions
    for submitting comments. Comments submitted electronically,
including attachments, to https://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 https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to make 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): Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2019-N-1215 for ``Post-Marketing Pediatric-Focused Product Safety
Reviews; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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.'' FDA 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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. 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:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Odegaard, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5151, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation. FDA also has
responsibility for regulating the manufacturing, marketing, and
distribution of tobacco products to protect the public health and to
reduce tobacco use by minors.
    FDA has established a public docket, Docket No. FDA-2019-N-1215, to
receive input on post-marketing pediatric-focused safety reviews of
products posted between October 12, 2018, and April 1, 2019, available
on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but
not presented at the April 8, 2019, PAC meeting. FDA welcomes comments
by members of the PAC, as mandated by the Best Pharmaceuticals for
Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of
2003 (Pub. L. 108-155), interested parties (such as academic
researchers, regulated industries, consortia, and patient groups), and
the general public. The docket number is FDA-2019-N-1215. The docket
will open on April 2, 2019, and remain open until April 15, 2019. The
post-marketing pediatric-focused safety reviews are for the following
products from the following centers at FDA:

Center for Biologics Evaluation and Research

1. ADYNOVATE (Antihemophilic Factor [recombinant])
2. IXINITY (Coagulation Factor IX [Recombinant])
3. EPICEL (cultured epidermal autografts) (Humanitarian Device
Exemption [HDE])

Center for Drug Evaluation and Research

1. ACZONE GEL (dapsone)
2. AIRDUO RESPICLICK (fluticasone propionate and salmeterol) and
ARMONAIR RESPICLICK (fluticasone propionate)
3. AVELOX (moxifloxacin hydrochloride)
4. CALDOLOR INJECTION (ibuprofen)
5. CUBICIN INJECTION (daptomycin)
6. DEXILANT (dexlansoprazole)
7. EUCRISA OINTMENT (crisaborole)
8. LILETTA (levonorgestrel-releasing intrauterine system)
9. LYRICA (pregabalin)
10. NARCAN NASAL SPRAY (naloxone hydrochloride)
11. OFIRMEV (acetaminophen)
12. SELZENTRY (maraviroc)
13. SPIRIVA RESPIMAT (tiotropium bromide)
14. SYMBICORT INHALATION AEROSOL (budesonide/formoterol fumarate
dehydrate)
15. TARCEVA (erlotinib hydrochloride)
16. VELCADE (bortezomib)

Center for Devices and Radiological Health

1. FLOURISHTM PEDIATRIC ESOPHAGEAL ATRESIA DEVICE (HDE)
2. LIPOSORBER LA-15 SYSTEM (HDE)
3. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)

    Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06385 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 24, 2008 (Volume 73, Number 207)]
[Notices]
[Page 63469]
[DOCID:fr24oc08-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12948-002]

Clementine Dam Hydro, LLC; Notice of Surrender of Preliminary
Permit

October 17, 2008.
    Take notice that Clementine Dam Hydro, LLC, permittee for the
proposed Clementine Dam Hydroelectric Project, has requested that its
preliminary permit be terminated. The permit was issued on April 16,
2008, and would have expired on March 31, 2011.\1\ The project would
have been located on the American River in Placer County, California.
---------------------------------------------------------------------------

    \1\ 123 FERC ] 62,053.
---------------------------------------------------------------------------

    The permittee filed the request on October 15, 2008, and the
preliminary permit for Project No. 12948 shall remain in effect through
the thirtieth day after issuance of this notice unless that day is a
Saturday, Sunday, part-day holiday that affects the Commission, or
legal holiday as described in section 18 CFR 385.2007, in which case
the effective date is the first business day following that day. New
applications involving this project site, to the extent provided for
under 18 CFR Part 4, may be filed on the next business day.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-25343 Filed 10-23-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 54 (Monday, March 21, 2016)]
[Notices]
[Pages 15103-15104]
[FR Doc No: 2016-06215]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0337; FRL-9943-92-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Portland Cement Plants (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NESHAP for Portland Cement
Plants (40 CFR part 63, subpart LLL) (Renewal)'' (EPA ICR No. 1801.12,
OMB Control No. 2060-0416), to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of
the ICR, which is currently approved through March 31, 2016. Public
comments were previously requested via the Federal Register (80 FR
32116) on June 5, 2015 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may not conduct or sponsor and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 20,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0337, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the

Docket Center is<PHONE_NUMBER>. For additional information about EPA's
public docket, visit: http://www.epa.gov/dockets.
    Abstract: Owners and operators of affected facilities are required
to comply with reporting and record keeping requirements for the
general provisions of 40 CFR part 63, subpart A, as well as the
applicable standards at 40 CFR part 63, subpart LLL. This includes
submitting initial notification reports, performance tests and periodic
reports and results, and maintaining records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility, or any period during which the monitoring system
is inoperative. These reports are used by EPA to determine compliance
with the standards.
    Form Numbers: None.
    Respondents/affected entities: Portland cement plants.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart LLL).
    Estimated number of respondents: 87 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 59,600 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $25,800,000 (per year), which includes
$19,800,000 in annualized capital/startup and/or operation &
maintenance costs.
    Changes in the Estimates: There is an overall decrease in burden as
currently identified in the OMB Inventory of Approved Burdens. This
decrease is not due to any program changes. The change in the burden
and cost estimates occurred because the standard has been in effect for
more than three years and the requirements are different during initial
compliance (new facilities) as compared to on-going compliance
(existing facilities). The previous ICR reflected those burdens and
costs associated with the initial activities for subject facilities.
This includes purchasing monitoring equipment, conducting performance
tests and establishing recordkeeping systems. This ICR, by in large,
reflects the on-going burden and costs for existing facilities.
Activities for existing source include continuously monitoring of
pollutants and the submission of semiannual reports. In addition, we
have updated the number of respondents from 100 to 87 using the most
recent data available. The overall result is a decrease in the number
of responses, labor hours, and costs (including capital and O&M cost).

Courtney Kerwin,
Acting-Director, Collection Strategies Division.
[FR Doc. 2016-06215 Filed 3-18-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Notices]
[Page 28674-28677]
[DOCID:fr21my10-156]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0182]

Mercedes-Benz, U.S.A. LLC; Denial of Application for Renewal of
Temporary Exemption From Federal Motor Vehicle Safety Standard No. 108

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Denial of application for renewal of temporary exemption.

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SUMMARY: This document responds to an application from Mercedes-Benz,
U.S.A. LLC (``MBUSA''), on behalf of itself and its parent corporation
Daimler AG (``Daimler''), dated December 3, 2007, for the renewal of a
temporary exemption from S5.5.10 of Federal Motor Vehicle Safety
Standard (FMVSS) No. 108; Lamps, reflective devices, and associated
equipment. The National Highway Traffic Safety Administration (NHTSA)
granted MBUSA's original petition for a temporary exemption on January
30, 2006. Based on the agency's evaluation, NHTSA is denying the
application from MBUSA for the renewal of the temporary exemption.

DATES: The exemption from S5.5.10 of FMVSS No. 108 terminates on July
20, 2010.

FOR FURTHER INFORMATION CONTACT: David Hines, Office of Crash Avoidance
Standards, NHTSA, 1200 New Jersey Avenue, SE., W45-338, Washington, DC
20590, telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a petition dated June 5, 2005, Mercedes-Benz, U.S.A. LLC (MBUSA)
petitioned the National Highway Traffic Safety Administration (NHTSA),
for a two-year temporary exemption from S5.5.10 of Federal Motor
Vehicle Safety Standard (FMVSS) No. 108; Lamps, reflective devices, and
associated equipment. S5.5.10 specifies that with certain exceptions
(not applicable to this MBUSA application) all lamps, including stop
lamps, must be wired to be steady-burning.\1\ In order to evaluate a
flashing stop lamp signaling system in the United States, MBUSA sought
a temporary exemption from the ``steady-burning'' requirement as it
applies to stop lamps. MBUSA stated that its flashing stop lamp system
was currently available in Europe on a number of Mercedes vehicles.
---------------------------------------------------------------------------

    \1\ See S5.5.10 of 49 CFR 571.108. Turn signal lamps, hazard
warning signal lamps, and school bus warning lamps shall be wired to
flash. Headlamps and side marker lamps may be wired to flash for
signaling purposes. Motorcycle headlamps may be wired to allow
either its upper beam or its lower beam, but not both, to modulate
from a higher intensity to a lower intensity in accordance with
section S7.9.
---------------------------------------------------------------------------

    On January 30, 2006, NHTSA published in the Federal Register a
notice granting the MBUSA application for a temporary exemption, until
January 23, 2008, from the requirements of S5.5.10 of FMVSS No. 108. In
granting MBUSA's request in the original grant, NHTSA made several
determinations. The agency stated that MBUSA had met the requirements
to receive an exemption under 49 CFR Part 555(b), which permits
exemptions from the FMVSS on the basis that the exemption would make
easier the development of field evaluation of safety equipment.
Specifically, the agency stated that based on information provided by
MBUSA, it appeared the proposed lighting equipment provided at least an
equivalent level of safety to the lighting equipment required by FMVSS
No. 108. Furthermore, NHTSA decided that granting the request would be
in the public interest, because the new field data obtained by MBUSA
through the temporary exemption would enable the agency to make more
informed decisions regarding the effect of the flashing stop lamp
signaling systems on motor vehicle safety. In accordance with 49 CFR
555.6(b)(5), MBUSA was permitted to sell up to 2,500 exempted vehicles
in any twelve-month period within the two-year exemption period.

II. MBUSA Application Requesting Renewal of Temporary Exemption

    In a petition dated December 3, 2007, MBUSA petitioned NHTSA, on
behalf of itself and its parent corporation Daimler AG (``Daimler''),
for a renewal of the temporary exemption from S5.5.10 of FMVSS No. 108.
According to MBUSA, the basis of the renewal was to further evaluate
whether safety benefits could be identified through the allowance of
flashing stop lamps on passenger vehicles in the United States. MBUSA
stated that the preliminary results from the United States and Europe
were positive and while limited, constituted a trend which could
continue to be monitored.
    In its request for a renewal, MBUSA indicated that the company has
``sold a total of approximately 2,870 12 cylinder S and CL class
passenger vehicles in the United States between February 2006 and
August 2007,'' and this number would slightly increase through the
remainder of the exemption period, but remain below the maximum 5,000
vehicle limit over 2 years.
    MBUSA's application stated, ``Daimler's plan for monitoring the
experience of these vehicles focused on both dealer inputs and
insurance claims.'' Daimler received only one dealer input, but in
early November 2007 received input from an insurance company that
insures about 20 percent of the vehicles that have been sold in the
United States with the flashing stop lamp feature. MBUSA stated that
the data collected from the insurance company at the time of the MBUSA
application was promising. The company reported that with respect to
416 vehicles equipped with the flashing stop lamp feature, there were a
total of 5 reported crashes and of these only one involved activation
of the feature. It said there were a total of 94 reported crashes in a
group of 4,507 vehicles without the flashing stop lamp feature. This,
the company said, translates into a ``crash ratio per month'' for
vehicles with the flashing stop lamp feature of 11.44688645 as compared
to a ratio of 19.86328146 for vehicles without the feature.
    MBUSA also indicated that ``data from Germany has also been
promising.'' While intending to monitor a German database with the
acronym GIDAS and data from Germany's Federal Statistical Office,
MBUSA, in its application, indicated that there have thus far been no
GIDAS investigations involving vehicles equipped with flashing stop
lamps among the approximately 1,000 in depth crash investigations
performed for GIDAS every year. The company indicated it examined
Federal Statistical Office crash statistics for 2005 and 2006. MBUSA
stated, ``Although subject to a significant degree of statistical
scatter, data from the Federal Statistical Office for 2005 shows a
decrease of rear impact compared to other Mercedes-Benz passenger cars,
and an experience for 2006 that shows a slight increase in rear impacts
but which is also comparable to the experience with the control group
without the feature.''

III. Comments and Response Regarding the MBUSA Petition for Renewal of
the Temporary Exemption

    NHTSA published a notice of receipt of the petition on November 25,
2008, and provided an opportunity for comment.\2\ The agency received
five comments, one each from Nissan North America, Inc., Porsche Cars
North America, Inc., American Honda Motors Co., Inc., Toyota Motor
North America, Inc., and Ms. Barbara Sachau. The four motor vehicle
manufacturers all supported the MBUSA application for renewal of the
temporary exemption. Toyota Motor North America, Inc., also indicated
that it has recently introduced its flashing stop lamp signaling system
on Toyota and Lexus models in the European and Japanese markets.
However, we note that none of the vehicle manufacturers presented data
indicating that the use of the flashing stop lamp systems provided
traffic safety benefits. A fifth comment from Ms. Barbara Sachau
opposed the granting of the petition by stating that vehicle
manufacturers should not determine regulatory policy involving vehicle
safety.
---------------------------------------------------------------------------

    \2\ We note that under 49 CFR 555.8(e), if an application for
renewal of a temporary exemption that meets the requirements of
Sec.  555.5 has been filed not later than 60 days before the
termination date of an exemption, the exemption does not terminate
until the Administrator grants or denies the application for
renewal.
---------------------------------------------------------------------------

    In January 2009, Daimler, through a submission by Hogan & Hartson
LLP, supplied additional information related to the experience of
flashing stop lamps in Germany. This submission referenced data samples
representing half of police-reported crashes in Germany for several
years and characterized a preliminary positive safety trend, which was
not able to be considered a stable result due to the low number of rear
end crashes for Mercedes vehicles. In April 2010, MBUSA submitted an
additional comment in support of its petition. It indicated that, to
date, MBUSA/Daimler has sold approximately 4,700 vehicles with flashing
stop lamps in the United States during the pendency of the exemption.
It stated, however, that the

limited volume of vehicles permitted to be sold each year in the United
States under this type of exemption creates a fundamental impediment to
being able to use statistical analysis to show the impact of a crash
avoidance feature controlled for other influences on the results. MBUSA
stated that the data available in the United States cannot, due to the
limited numbers of vehicles sold, statistically support in just a few
years an analysis showing the number of crashes avoided because drivers
were alerted to an emergency situation through flashing stop lamps.
    MBUSA claimed that it is clear that flashing stop lamps do not
otherwise impair any of the important benefits of other rear lamps. It
also claimed that data being developed in other markets does support
the safety benefits of flashing stop lamps.
    In its April 2010 submission, MBUSA provided a further update to
the information it had previously submitted concerning data from
Germany. It stated that the data from Germany continues to indicate a
positive trend, with crash rates for vehicles equipped with flashing
stop lamps slightly lower than those for comparable vehicles without
the feature. It also stated that since this feature is now available on
all Mercedes vehicles sold in Germany and other markets, the trend is
expected to be more defined and easier to interpret in the coming
years. In addition, MBUSA noted that the exposure of vehicles with
flashing stop lamps remains too low to derive statistical conclusions
from the data.
    In addition, MBUSA stated that the United States should contribute
to the growing body of international data on flashing stop lamps to the
extent permitted by the regulation. It stated that a number of
manufacturers are offering this feature in other markets in increasing
numbers. MBUSA argued that the agency's decision should not be based on
whether the exemption would create a database that can conclusively
demonstrate a statistical benefit, but should instead base its decision
on being able to contribute to the growing body of international data
with experience from the United States. It stated that while the data
set will be necessarily small because of the regulatory limitations,
the experience is necessary to show that the limited exposure in the
United States remains consistent with the more robust experience found
in other markets. MBUSA also argued that flashing stop lamps can
contribute to the reduction of crashes associated with distracted
driving, and that continuing the exemption would contribute to this
objective.

IV. Agency Analysis and Decision

    After carefully considering the MBUSA application for renewal of
the temporary exemption from S5.5.10 of FMVSS No. 108 and the public
comments, we have decided to deny the petition. The reasons for this
decision are explained below.
    We note that prior to the submission of MBUSA's original petition
for temporary exemption, NHTSA had denied that company's petition for
rulemaking to permanently amend FMVSS No. 108 to allow flashing brake
signaling systems. Among the reasons for the denial was the need for
additional data on safety benefits of flashing brake lamps.
    In granting the original petition for temporary exemption in
January 2006, we stated that we believed a temporary exemption was in
the public interest because the new field data obtained through the
temporary exemption would enable the agency to make more informed
decisions regarding the effect of flashing brake signaling systems on
motor vehicle safety. We also noted that the agency was conducting
research concerning enhanced rear signaling.
    We noted, however, that some of the benefits associated with signal
lamps relate to standardization. We stated that we had not made any
determination as to whether it would be appropriate to permit flashing
stop lamps more generally.
    In considering MBUSA's application for renewal of the temporary
exemption, we have evaluated whether a renewal would be in the public
interest. As part of this, we have considered whether the additional
field data that would be obtained as a result of a renewed exemption
would enhance, in a meaningful way, the agency's ability to make more
informed decisions in this area. Based on the available information, we
have concluded that the answer is no.
    First, after reviewing the material in the renewal request, we are
concerned that MBUSA has not established a rigorous crash evaluation
and data collection program in the U.S. for its flashing stop lamp
system. As such, we believe that a continuation of the current efforts
would not yield additional insight into the anticipated benefits of
such a rear signaling system.
    In its application for renewal, the petitioner included the
following paragraph:
    ``Daimler's plan for monitoring the experience of these vehicles
focused on both dealer inputs and insurance claims. MBUSA received only
one dealer input, but in early November 2007 received input from an
insurance company that insures about 20% of the vehicles that have been
sold in the United States with the flashing stop lamp feature. The data
collected to date from the insurance company is promising. The crash
ratio per month of these vehicles with the flashing stop lamp feature
is 11.44688645; whereas the crash ratio per month of the same vehicles
without the feature was 19.86328146.''
    A footnote to this paragraph provided by MBUSA in its application
explained, ``There were a total of 5 reported crashes with regard to
vehicles with the emergency braking feature, of 416 vehicles, and a
total of 94 reported crashes with regard to the 4507 vehicles without
emergency brake assist. Daimler has since learned, based on more
detailed information, that at least 4 of the 5 vehicles involved in the
crashes with the feature did not involve activation of the feature,
indicating an even lower crash per month ratio.''
    NHTSA made the following determinations regarding the data and
information presented. First, the agency is struck by the low level of
participation by what would seem to be critical players in a research
crash data collection effort, specifically insurance carriers and
dealers. The agency is concerned about the level of effort devoted to
the research plan on which the original 2-year temporary exemption from
S5.5.10 of FMVSS No. 108 was based. Beyond this, there is no indication
in the data presented, based on only 20 percent of the vehicles in the
U.S. equipped with the flashing stop signaling system, as to the nature
of the crashes involved. It is suggested from the information provided
by MBUSA that four of the five crashes discussed earlier were not rear
end collisions and that one of the crashes occurred because it was the
only case in which the flashing stop lamp signaling system was
activated. In any event, there is not enough information presented in
MBUSA's request for renewal of its exemption to know. The nature of all
the crashes involved is important information to know in assessing the
data presented.
    It does not appear, based upon the data provided by MBUSA, that
there is a robust program to evaluate acceptance of the flashing stop
lamps among the American public or whether risk might be transferred to
vehicles without the flashing stop lamps by acting as a distraction
from other on-road events. The agency notes that MBUSA indicated that
it had, on the date of its application

for extension, received input from only one dealer.
    Also, MBUSA did not make it possible for NHTSA to evaluate its
suggested claims of potential safety benefits of its flashing stop lamp
system because its application for renewal and the data provided to
NHTSA to date does not clearly identify how it will appropriately track
applicable rear end collisions in the United States, and does not
include an explanation of the comparisons cited in its application.
Without definitions of the comparison groups, raw data, and a
description of the calculations made, the MBUSA claim of potential
safety benefits is not supported.
    Moreover, even if MBUSA were to develop a more robust evaluation
program, it is not clear how the additional vehicles produced as a
result of an extended exemption would provide significant additional
data on safety benefits of flashing stop lamps. As indicated above,
MBUSA stated in its recent comments that the data available in the
United States cannot, due to the limited numbers of vehicles that can
be sold under a temporary exemption, statistically support in just a
few years an analysis showing the number of crashes avoided because
drivers were alerted to an emergency situation through flashing stop
lamps.
    The petitioner argued that the agency's decision should not be
based on whether the exemption would create a database that can
conclusively demonstrate a statistical benefit, but NHTSA should
instead base its decision on being able to contribute to the growing
body of international data with experience from the United States. It
stated that while the data set will be necessarily small because of the
regulatory limitations, the experience is necessary to show that the
limited exposure in the United States remains consistent with the more
robust experience found in other markets.
    However, MBUSA has already sold approximately 4700 vehicles with
flashing stop lamps in the United States during the pendency of the
existing exemption, and it has not provided any specific explanation as
to how a two year extension resulting in potentially up to 5000
additional vehicles in this country would result in significant
additional meaningful data concerning safety benefits of flashing brake
lamps. Also, it is unclear how extending the exemption in this country
would facilitate the analysis of the German data, especially given the
difference in the sizes of the relevant vehicle populations.
    MBUSA also mentioned the fact that the flashing stop lamp signaling
system is permitted in Europe in support of an extension of its
temporary exemption from S5.5.10 of FMVSS No. 108. While NHTSA is
always interested in actions taken in other parts of the world, there
is nothing presented in MBUSA's request for renewal relating to safety
benefits and crash reduction data provided to the European regulatory
authorities. We note the data from Germany referenced in MBUSA's
renewal request is not any more effective in shedding light on the
effectiveness of the flashing stop lamp signaling system in preventing
rear end collisions. The request notes that the ``GIDAS database'',
which includes ``about 1,000 in depth crash investigations each year''
thus far has not included investigations of vehicles equipped with the
flashing stop lamp signaling system. No conclusion can be drawn from
this fact. The request indicated that crash statistics have been
received for 2005 and 2006 from the Federal Statistical Office. The
crash data is ``subject to a significant degree of statistical
scatter,'' MBUSA says, but maintains the data ``shows a decrease of
rear impacts compared to other Mercedes-Benz passenger cars, and an
experience for 2006 that shows a slight increase in rear impacts but
which is also comparable to the experience with the control group
without the feature.''
    Again, this information is inconclusive. There is no indication of
the sample size involved and the number of crashes on which MBUSA makes
its assertions as to the impact of the flashing stop lamp signaling
system. The agency does not know what MBUSA means when it says the
crash data is subject to a ``significant degree of statistical
scatter'' and the impact it has on the conclusion suggested by MBUSA or
the likelihood that the larger sample will be enough for statistically
significant conclusions.
    MBUSA also argued that flashing stop lamps can contribute to the
reduction of crashes associated with distracted driving, and that
continuing the exemption would contribute to this objective. However,
while NHTSA is interested in potential safety benefits of enhanced rear
signaling, MBUSA has not shown how extending the exemption would result
in significant meaningful data concerning safety benefits of flashing
stop lamps.
    After considering the available information, we have concluded that
MBUSA has not provided adequate justification for renewal of the
exemption. It has not shown that the additional field data that would
be obtained as a result of a renewed exemption would enhance, in a
meaningful way, NHTSA's ability to make more informed decisions
concerning anticipated benefits of flashing brake lamps. Moreover, as
noted earlier, some of the benefits associated with signal lamps relate
to standardization. We have therefore concluded that it would not be in
public interest to renew this exemption, and we are denying the
application.
    In order to allow MBUSA adequate time to make the necessary
production changes, we are making this decision to deny the request
effective 60 days after publication of this notice.

    Issued: May 17, 2010.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. 2010-12190 Filed 5-20-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Notices]
[Page 75522-75523]
[DOCID:fr15de06-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC07-6-000; FERC Form 6]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Extension

December 8, 2006.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice.

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

SUMMARY: In compliance with the requirements of section 3506(c)(2)(a)
of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Federal
Energy Regulatory Commission (Commission) is soliciting public comment
on the specific aspects of the information collection described below.

DATES: Comments on the collection of information are due February 16,
2007.

ADDRESSES: Copies of sample filings of the proposed collection of
information can be obtained from the Commission's Web site (http://www.ferc.gov/docs-filings/elibrary.asp
) or from the Federal Energy

Regulatory Commission, Attn: Michael Miller, Office of the Executive
Director, ED-34, 888 First Street, NE., Washington, DC 20426. Comments
may be filed either in paper format or electronically. Those parties
filing electronically do not need to make a paper filing. For paper
filing, the original and 14 copies of such comments should be submitted
to the Secretary of the Commission, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426 and refer to
Docket No. IC07-6-000.
    Documents filed electronically via the Internet must be prepared in
WordPerfect, MS Word, Portable Document Format, or ASCII format. To
file the document, access the Commission's Web site at http://www.ferc.gov
 and click on ``Make an E-filing'', and then follow the

instructions for each screen. First time users will have to establish a
user name and password. The Commission will send an automatic
acknowledgement to the sender's e-mail address upon receipt of
comments.
    All comments may be viewed, printed or downloaded remotely via the
Internet through FERC's homepage using the eLibrary link. For user
assistance, contact<EMAIL_ADDRESS>or toll-free at (866)
208-3676. or for TTY, contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC Form 6 ``Annual Report of Oil Pipeline Companies''
(OMB No. 1902-0022) is used by the Commission to carry out its
responsibilities in implementing the statutory provisions of the
Interstate Commerce Act (ICA), (49 U.S.C.). The ICA authorizes the
Commission to make investigations and to collect and record data and to
prescribe rules and regulations concerning accounts, records and
memoranda as necessary or appropriate for purposes of administering the
ICA. The Commission may prescribe a system of accounts for
jurisdictional companies and, after notice and opportunity for hearing
may determine the accounts in which particular outlays and receipts
will be entered, charged or credited. Every pipeline carrier subject to
the provisions of Section 20 of the ICA must electronically file with
the Commission through Commission-provided software.
    The Commission's Office of Enforcement uses the FERC Form 6 data
collected to assist in the implementation of its financial audits and
investigation programs, in the continuous review of the financial
condition of regulated companies and in the assessment of energy
markets. The Office of Energy Markets and Reliability (OEMR) uses the
data collected for its various rate proceedings and economic analyses.
The Office of Administrative Litigation (OAL) uses the data collected
for background research for use in litigation. The Office of General
Counsel uses the data in its programs relating to the administration of
the ICA. Additionally, the Office of the Executive Director (OED) uses
the data contained on certain schedules of the FERC Form 6 to compute
annual charges which are then assessed against oil pipeline companies
to recover the Commission's annual costs. These annual charges are
required by Section 3401 of the Budget Act.
    Most notably, the ICA mandates the collection of information needed
by the Commission to perform it regulatory responsibilities in the
setting of the just and reasonable rates. The Commission could be held
in violation of the ICA if the information was not collected.
    The Commission implements these filing requirements in the Code of
Federal Regulations (CFR) under 18 CFR Section 357.1 and 357.2.
    Action: The Commission is requesting a three-year extension of the
current

expiration date, with no changes to the existing collection of data.
    Burden Statement: Public reporting burden for this collection is
estimated as:

----------------------------------------------------------------------------------------------------------------
                                                                                Average  burden
                                                                  Number of        hours per       Total annual
             Number of respondents annually  (1)                responses per    response  (3)     burden hours
                                                               respondent  (2)                   (1) x (2) x (3)
----------------------------------------------------------------------------------------------------------------
156..........................................................               1              186           29,016
----------------------------------------------------------------------------------------------------------------

    Estimated cost burden to respondents is $1,703,811. (29,016 hours/
2080 hours per year times $122,137 per year average per employee =
$1,703,811). The cost per respondent is $10,922).
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting, or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities, which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency'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 those who are
to respond, including the use of or other technological collection
techniques or other forms of information technology.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21384 Filed 12-14-06; 8:45 am]

BILLING CODE 6717-01-P