[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Page 37548]
[FR Doc No: 2023-12247]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-0120]

Determination That BUSPAR (Buspirone Hydrochloride) Capsules, 5
Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that BUSPAR (buspirone hydrochloride) capsules, 5 milligrams
(mg), 7.5 mg, 10 mg, and 15 mg, were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDA) for buspirone
hydrochloride capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, if all other
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Caitlin Callahan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 240-
402-4318, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and
15 mg, are the subject of NDA 021190, held by Bristol Myers Squibb Co.,
and initially approved on December 20, 2000. BUSPAR is indicated for
the management of anxiety disorders or the short-term relief of the
symptoms of anxiety.
    In correspondence dated December 28, 2012, Bristol Myers Squibb Co.
requested withdrawal of NDA 021190 for BUSPAR (buspirone
hydrochloride). In the Federal Register of December 5, 2014 (79 FR
72186), FDA announced that it was withdrawing approval of NDA 021190,
effective January 5, 2015.
    Epic Pharma, LLC submitted a citizen petition dated January 10,
2023 (Docket No. FDA-2023-P-0120), under 21 CFR 10.30, requesting that
the Agency determine whether BUSPAR (buspirone hydrochloride) capsules,
5 mg, 7.5 mg, 10 mg, and 15 mg, were withdrawn from sale for reasons of
safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that BUSPAR (buspirone hydrochloride) capsules, 5
mg, 7.5 mg, 10 mg, and 15 mg, were not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that BUSPAR (buspirone hydrochloride) capsules,
5 mg, 7.5 mg, 10 mg, and 15 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of BUSPAR (buspirone hydrochloride) capsules,
5 mg, 7.5 mg, 10 mg, and 15 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was not withdrawn from sale for reasons of
safety or effectiveness.\1\
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    \1\ FDA previously determined that BUSPAR (buspirone
hydrochloride) tablets, 5 mg, 10 mg, 15 mg, and 30 mg, approved
under NDA 018731 and held by Bristol Myers Squibb Co. Pharmaceutical
Research Institute, were not withdrawn from sale for reasons of
safety or effectiveness. See 75 FR 64310 (October 19, 2010), 81 FR
61220 (September 6, 2016).
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    Accordingly, the Agency will continue to list BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, may be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12247 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P


MEMORANDUM

Date:		June 6, 2013

Subject:	Report of May 30, 2013 Site Visit to Essroc, Logansport, IN

From:		Tanya Parise, EC/R Incorporated

To:		Mary Tom Kissell, U.S. Environmental Protection Agency

      This memo summarizes the site visit to the Essroc facility in Logansport, IN, which was conducted on May 30, 2013.  The purposes of this visit were to:

          * Enhance understanding of current processes and emission controls for the off-site waste and recovery operations (OSWRO) at the facility.
          * Gain an understanding of the other applicable Clean Air Act regulations for the facility, including 40 CFR 264, 265, 279 and 40 CFR Parts 60, 61 and 63.
          * Clarify any questions the U.S. EPA has regarding the response received from the recent information collection request for this facility.

	The participants in the site visit included the following:

      Essroc.
      David A. Constant  -  Senior Environmental Engineer
      Sara Leeman  -  Environmental Manager

      US EPA
      Mary Tom Kissell

      EC/R Incorporated
      Lesley Stobert
      Tanya Parise

This memo includes a brief overview of this project, an overview of the Essroc facility, and is followed by a description of the specific information gathered during the visit.

BACKGROUND

      Section 112 of the Clean Air Act (CAA) establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAP) from stationary sources. In the first stage, CAA section 112(d) requires us to promulgate technology-based national emission standards for each major source category listed under section 112(c).  These technology-based standards are often referred to as maximum achievable control technology, or MACT, standards.  The National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Off- Site Waste and Recovery Operations were promulgated on July 1, 1996 (61 FR 34140), and codified at 40 CFR part 63, subpart DD. The final rule was amended on July 20, 1999 (64 FR 38950).

      In the second stage of the regulatory process, the EPA is then required under CAA section 112(d)(6) to review these technology-based standards and revise them "as necessary (taking into account developments in practices, processes, and control technologies)" no less frequently than every eight years. In addition, within 8 years after promulgation of the MACT standards, CAA section 112(f)(2) requires the EPA to promulgate standards, if required, to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
This second stage in standard setting is referred to as the residual risk and technology review (RTR) for the standards.

      The EPA is in the process of conducting the RTR for the OSWRO MACT standards. As part of the RTR process, this Essroc production facility was selected for a site visit for three primary reasons: (1) it is one of several OSWRO facilities in or near the Chicago, IL area, which would enable the EPA to see several facilities in one trip, (2) based on available emissions data in the EPA's National Emissions Inventory (NEI), this facility had one of the higher emission rates of the OSWRO facilities identified in that database, and (3) visiting this facility would allow the EPA to view a facility that handles waste, but whose primary line of business is not waste management, and to learn how waste is utilized in the cement production industry.

PLANT SITE OVERVIEW

      The Essroc Cement Corporation facility is located at 3084 West County Road 225 South, Logansport, IN. The Logansport Essroc facility is a cement production company that has been in business for 75 years. This cement manufacturing facility acquires limestone on site, which is then crushed in various steps. The raw materials are then mixed and ground with water (i.e., wet process) to generate a slurry mixture which is then fed to a kiln. The kiln heats the material to extremely high temperatures and moves the material through the kiln. During the process some material separates out as gases and the remaining material develops into the product called clinker. The clinker is then ground and cooled and subsequently mixed with gypsum to produce Portland cement.

      The plant handles and integrates waste received from off-site sources into facility operations as a fuel source for the kiln. The kiln itself is the primary control device at the Essroc facility and the goal is to have the kiln running 90 percent of the time. According to Essroc representatives, the inside of the kiln is lined with a refractory shell to protect the metal from the high temperatures, and the kiln has to be shut down sometimes to protect the kiln shell. In the event the kiln is non-operational, the facility uses carbon beds as the backup control device for the non-kiln operations, including the OSWRO storage tanks. According to Essroc representatives, operations at Essroc are profitable and there are no plans to modernize the facility from the wet process to a dry process in the next 5-10 years.

      The operations are continuous, with operations occurring 24 hours a day, 7 days a week. The facility receives waste from several businesses (more than 80). This facility is subject to the OSWRO MACT (subpart DD), the Hazardous Waste Combustor MACT (subpart EEE), the Portland Cement MACT (subpart LLL), and also the Resource Conservation and Recovery Act (RCRA) regulations.

INFORMATION GATHERED DURING VISIT

	The following section describes the information gathered in relation to the three stated purposes of the visit.

   1. Enhance understanding of current processes and emission controls for the off-site waste and recovery operations (OSWRO) at the facility.

         * The facility uses diesel fuel to start up the kiln, but then switches to burning waste fuel in the kiln.
         * The facility receives waste in containers by trailer trucks, tanker trucks and by railcar.
         * Essroc receives waste in liquid, solid, and sludge form. The liquid waste is primarily waste solvents containing mostly organic liquids.
         * The solid and sludge waste the facility receives consists of gelled resins, paint pigments, rubber-based materials, wood, silica, clay, and solid still bottoms (i.e., tar).
         * Prior to being burned in the kiln, the facility tests the waste fuel for various properties. The fuel is analyzed to ensure it complies with the kiln fuel specifications.
         * The waste fuel heating value is the primary concern.
         * There are limits on the properties that cannot be fed to the kiln (e.g., high concentrations of metals).
         * The rotary kiln is the primary control device at the facility, with carbon beds as the backup.

   2. Gain an understanding of the other applicable Clean Air Act regulations for the facility, including 40 CFR 264, 265, 279 and 40 CFR Parts 60, 61 and 63.

         * The facility complies with the OSWRO MACT (subpart DD), the Hazardous Waste Combustor MACT (subpart EEE), the Portland Cement MACT (subpart LLL), and also the Resource Conservation and Recovery Act (RCRA) regulations.

   3. Clarify any questions the U.S. EPA has regarding the response received from the recent information collection request for this facility.

         * Ms. Leeman agreed to send information about storage tanks that was requested in the CAA section 114 information request but that was not provided in the response to that request.


[Federal Register: January 16, 2007 (Volume 72, Number 9)]
[Rules
and Regulations]
[Page 1668-1670]
[DOCID:fr16ja07-5]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[Docket No. EPA-R02-OAR-2006-0615, FRL-8268-9]

Approval and Promulgation of Plans for Designated Facilities; New
Jersey; Delegation of Authority

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
request from the New Jersey Department of

Environmental Protection (NJDEP) for delegation of authority to
implement and enforce the following three Federal plans: Municipal
Solid Waste Landfills (MSW Landfills); Hospital/Medical/Infectious
Waste Incinerators (HMIWI); and Small Municipal Waste Combustion Units
(Small MWC). On November 8, 1999, August 15, 2000 and January 31, 2003
respectively, EPA promulgated the Federal plans for MSW Landfills,
HMIWI and Small MWCs to fulfill the requirements of sections 111(d)/129
of the Clean Air Act (CAA). The Federal plans impose emission limits
and control requirements for existing affected facilities located in
areas not covered by an approved and currently effective State plan.
    On May 15, 2006, NJDEP signed Memorandums of Agreement (MOAs) which
act as the mechanism for the transfer of EPA authority to NJDEP. The
intended effect is to approve MOAs that define the policies,
responsibilities, and procedures by which the Federal plans for MSW
Landfills, HMIWI and Small MWCs will be administered on behalf of EPA
by NJDEP.
    EPA proposed approval of NJDEP's delegation request on August 31,
2006.

DATES: Effective Date:
     This rule will be effective February 15, 2007.

ADDRESSES: Copies of the state submittal(s) are available at the
following addresses for inspection during normal business hours:
    Environmental Protection Agency, Region 2 Office, Air Programs
Branch, 290 Broadway, 25th Floor, New York, New York 10007-1866.
    New Jersey Department of Environmental Protection, Office of
Energy, Bureau of Air Quality Planning, 401 East State Street, CN027,
Trenton, New Jersey 08625.

FOR FURTHER INFORMATION CONTACT: Anthony (Ted) Gardella
Gardella.Anthony@epa.gov), Air Programs Branch, Environmental
Protection Agency, 290 Broadway, 25th Floor, New York, New York 10007-
1866,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Environmental Protection Agency (EPA) is
approving the New Jersey Department of Environmental Protection's
(NJDEP's) request for delegation of authority of three Federal plans.
The following table of contents describes the format for this
SUPPLEMENTARY INFORMATION section.

I. What Action Is EPA Taking Today?
II. What Are the Details of EPA's Specific Action?
III. What Comments Were Received and How Has EPA Responded to Them?
IV. What Are EPA's Conclusions?
V. Statutory and Executive Order Reviews

I. What Action Is EPA Taking Today?

    EPA is approving NJDEP's request for delegation of authority to
implement and enforce three Federal plans and to adhere to the terms
and conditions prescribed in the Memorandums of Agreement (MOAs) signed
between EPA and NJDEP, as further explained below. NJDEP requested
delegation of authority of the following three Federal plans: Municipal
Solid Waste Landfills (MSW Landfills); Hospital/Medical/Infectious
Waste Incinerators (HMIWI); and Small Municipal Waste Combustion Units
(Small MWC). The Federal plans were promulgated by EPA to implement
emission guidelines pursuant to sections 111(d) and 129 of the Clean
Air Act, as amended, 42 U.S.C. 7401 et seq. (CAA). The purpose of this
delegation is to acknowledge NJDEP's ability to implement a program and
to transfer primary implementation and enforcement responsibility from
EPA to NJDEP for existing sources of MSW Landfills, HMIWI and Small
MWC. While NJDEP is delegated the authority to implement and enforce
the three Federal plans, nothing in the delegation agreement shall
prohibit EPA from implementing and enforcing the Federal plans for MSW
Landfills, HMIWI and Small MWC.

II. What Are the Details of EPA's Specific Action?

    On May 13, 2005, NJDEP submitted to EPA a request for delegation of
authority from EPA to implement and enforce the Federal plans for
existing MSW Landfills, HMIWI and Small MWC. EPA prepared the MOAs that
define the policies, responsibilities, and procedures by which the
Federal plans will be administered by both NJDEP and EPA, pursuant to
the following: ``Federal Plan Requirements for Municipal Solid Waste
Landfills That Commenced Construction Prior to May 30, 1991 and Have
Not Been Modified or Reconstructed Since May 30, 1991,'' 40 CFR part
62, subpart GGG, 40 CFR 62.14350-14356; ``Federal Plan Requirements for
Hospital/Medical/Infectious Waste Incinerators Constructed on or Before
June 20, 1996,'' 40 CFR part 62, subpart HHH, 40 CFR 62.14400-14495 and
``Federal Plan Requirements for Small Municipal Waste Combustion Units
Constructed on or Before August 30, 1999,'' 40 CFR part 62, subpart
JJJ, 40 CFR 62.15000-15410. The MOAs are the mechanism for the transfer
of responsibility between EPA and NJDEP.
    On April 24, 2006, Alan J. Steinberg, EPA Region 2 Administrator,
signed the three MOAs and forwarded them to NJDEP for signature. On May
15, 2006, Lisa P. Jackson, NJDEP Commissioner, signed the MOAs, thereby
agreeing to the terms and conditions of the MOAs and accepting
responsibility to implement and enforce the policies, responsibilities
and procedures of the Federal plans for MSW Landfills, HMIWI, and Small
MWC. The transfer of authority to NJDEP became effective on May 15,
2006. EPA proposed approval on August 31, 2006 (71 FR 51790).

III. What Comments Were Received and How Has EPA Responded to Them?

    There were no comments received on EPA's proposed approval of
NJDEP's request for delegation of the three Federal plans.

IV. What Are EPA's Conclusions?

    For reasons described in this action and in EPA's proposal action,
EPA is approving NJDEP's request for delegation of the three Federal
plans. For further details, the reader is referred to the proposal
action.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
approves state law as meeting Federal requirements and imposes no
additional requirements beyond those imposed by state law. Accordingly,
the Administrator certifies that this rule will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule
approves pre-existing requirements under state law and does not impose
any additional enforceable duty beyond that required by state law, it
does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This

action also does not have Federalism implications because it does not
have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action approves a state rule implementing a Federal standard, and
does not alter the relationship or the distribution of power and
responsibilities established in the Act. This rule also is not subject
to Executive Order 13045 ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because
it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Act. In this
context, in the absence of a prior existing requirement for the state
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove plan submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a plan
submission, to use VCS in place of a plan submission that otherwise
satisfies the provisions of the Act. Thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply. This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 19, 2007. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements, Waste treatment and disposal.

    Dated: January 4, 2007.
Alan J. Steinberg,
Regional Administrator, Region 2.

0
Part 62, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 62--[AMENDED]

0
1. The authority citation for part 62 continues to read as follows:

    Authority: 62 U.S.C. 7401-7671q.

Subpart FF--New Jersey

0
2. Part 62 is amended by adding new Sec.  62.7605 and an undesignated
heading to subpart FF to read as follows:
    Air Emissions from Existing Municipal Solid Waste Landfills, Small
Municipal Waste Combustion Units, and Hospital/Medical/Infectious Waste
Incinerators.

Sec.  62.7605  Identification of plan--delegation of authority.

    (a) Letter from the New Jersey Department of Environmental
Protection (NJDEP), submitted May 13, 2005, requesting delegation of
authority from EPA to implement and enforce the following three Federal
plans: Municipal Solid Waste Landfills (MSW Landfills), Hospital/
Medical/Infectious Waste Incinerators (HMIWI) and Small Municipal Waste
Combustion Units (Small MWCs). The Federal plans will be administered
by both NJDEP and EPA, pursuant to the following: ``Federal Plan
Requirements for Municipal Solid Waste Landfills That Commenced
Construction Prior to May 30, 1991 and Have Not Been Modified or
Reconstructed Since May 30, 1991,'' 40 CFR part 62, subpart GGG;
``Federal Plan Requirements for Hospital/Medical/Infectious Waste
Incinerators Constructed on or Before June 20, 1996,'' 40 CFR part 62,
subpart HHH; and ``Federal Plan Requirements for Small Municipal Waste
Combustion Units Constructed on or Before August 30, 1999,'' 40 CFR
part 62, subpart JJJ.
    (b) Identification of sources: The three Federal plans apply to
existing facilities as follows: MSW Landfills which commenced
construction, reconstruction, or modification before May 30, 1991 and a
MSW Landfill that has accepted waste at any time since November 8, 1987
or the landfill has additional capacity for future waste deposition;
HMIWIs that combust any amount of hospital, medical or infectious waste
and that commenced construction on or before June 20, 1996; and Small
MWCs with a capacity to combust at least 35 tons per day of municipal
solid waste or refuse-derived fuel but no more than 250 tons per day of
municipal solid waste or refuse-derived fuel and if the Small MWC
commenced construction on or before August 30, 1999.
    (c) On April 24, 2006, EPA prepared and signed Memorandums of
Agreement (MOAs) between EPA and NJDEP that define the policies,
responsibilities and procedures pursuant to the three Federal plans
identified in (a) above by which the Federal plans will be administered
by both NJDEP and EPA. On May 15, 2006, Lisa P. Jackson, NJDEP
Commissioner, signed the MOAs, therefore agreeing to the terms and
conditions of the MOAs and accepting responsibility to enforce and
implement the policies, responsibilities, and procedures for MSW
Landfills, HMIWIs and Small MWCs.
    (d) The delegation became fully effective on May 15, 2006, the date
the MOAs were signed by the NJDEP Commissioner.
 [FR Doc. E7-413 Filed 1-12-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Rules and Regulations]
[Pages 72033-72036]
[FR Doc No: 2013-28654]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0385; FRL-9903-23-Region 4]

Approval and Promulgation of Implementation Plans; Florida:
General Requirements and Gasoline Vapor Control; Correcting Amendment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendments.

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SUMMARY: On June 1, 2009, EPA published a final rule in the Federal
Register approving a Florida State Implementation Plan (SIP) revision,
submitted through the Florida

Department of Environmental Protection (FDEP), related to the State's
gasoline vapor recovery program. This correcting amendment corrects
errors in the regulatory language in paragraph (c) of EPA's June 1,
2009, final rule.

DATES: Effective on December 2, 2013.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Quality Modeling
and Transportation Section, Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The
telephone number is<PHONE_NUMBER>. Ms. Sheckler can be reached via
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This action corrects inadvertent errors in a
rulemaking related to Florida's gasoline vapor recovery program SIP
provision. In summary, this action corrects the effective date for the
Florida rules included in the regulatory text section of EPA's June 1,
2009, final rulemaking (74 FR 26103). Specifically, EPA is correcting
the June 1, 2009, final rule to provide the correct effective date for
Florida Code Annotated Sections 62-210.300, 62-210.310, 62-210.920, 62-
252.200, 62-252.300, 62-252.400, 62-252.500 and 62-296.418 related to
the State's gasoline vapor recovery program. In its May 31, 2007, SIP
revision, FDEP erroneously listed September 4, 2006, as the effective
date for the gasoline vapor recovery program rules. The correct
effective date of Florida's rules related to the gasoline vapor
recovery program, as provided by FDEP in a November 29, 2012, letter,
is May 9, 2007. This action corrects the regulatory text section of
EPA's June 1, 2009 final rule approving the Florida ``Gasoline Vapor
Recovery'' SIP revision to reflect a State effective date of May 9,
2007. See 74 FR 26103. Today's action also serves to update the State
effective dates of the relevant rules in the Table of EPA-Approved
Florida Regulations at 40 CFR 52.520.
    EPA has determined that today's actions fall under the ``good
cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedure Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation where public notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest. Public notice and comment for this action is
unnecessary because today's action to correct inadvertent regulatory
text errors included in EPA's June 1, 2009, final rule is consistent
with the substantive revision to the Florida SIP described therein
related to the gasoline vapor recovery program for the Florida SIP. In
addition, EPA can identify no particular reason why the public would be
interested in having the opportunity to comment on the correction prior
to this action being finalized, since this correction action does not
change EPA's analysis or overall action related to the approval of the
State's gasoline vapor recovery program into the Florida SIP.
    EPA also finds that there is good cause under APA section 553(d)(3)
for this correction to become effective on the date of publication of
this action. Section 553(d)(3) of the APA allows an effective date less
than 30 days after publication ``as otherwise provided by the agency
for good cause found and published with the rule.'' 5 U.S.C. 553(d)(3).
The purpose of the 30-day waiting period prescribed in APA section
553(d)(3) is to give affected parties a reasonable time to adjust their
behavior and prepare before the final rule takes effect. Today's rule,
however, does not create any new regulatory requirements such that
affected parties would need time to prepare before the rule takes
effect. Rather, today's action merely corrects inadvertent errors for
the regulatory text of EPA's prior rulemaking for the Florida SIP. For
these reasons, EPA finds good cause under APA section 553(d)(3) for
this correction to become effective on the date of publication of this
action.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely corrects an inadvertent error in the regulatory text of EPA's
June 1, 2009, final rule addressing the gasoline vapor recovery program
in the Florida SIP, and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this rule will not have a significant economic impact on a substantial
number of small entities under the Regulatory Flexibility Act (5 U.S.C.
601 et seq.). Because this rule merely corrects an inadvertent error
for the regulatory text of EPA's June 1, 2009, final rule addressing
the gasoline vapor recovery program in the Florida SIP, and does not
impose any additional enforceable duty beyond that required by state
law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This rule also does not have Federalism
implications because it does not have substantial direct effects on the
states, on the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This rule merely corrects inadvertent
errors in the regulatory text of EPA's June 1, 2009, final rule
addressing the gasoline vapor recovery program in the Florida SIP, and
does not alter the relationship or the distribution of power and
responsibilities established in the CAA. This rule also is not subject
to Executive Order 13045 ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because
it is not economically significant. In addition, this rule does not
involve technical standards, thus the requirements of section 12(d) of
the National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272 note) do not apply. This rule also does not impose an information
collection burden under the provisions of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: November 12, 2013.
Beverly H. Banister,
Acting Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52-APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart K--Florida

0
2. Section 52.520(c) is amended:
0
a. Under Chapter 62-210, by revising the entries for ``62-210.300,''
``62-210.310,'' and ``62-210.920;''
0
b. Under Chapter 62-252, by revising the entries for ``62-252.200,''
``62-252.300,'' ``62-252.400,'' and ``62-252.500;'' and
0
c. Under Chapter 62-296, by revising the entry for ``62-296.418'' to
read as follows:

Sec.  52.520  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Florida Regulations
----------------------------------------------------------------------------------------------------------------
                                                       State
         State citation            Title/subject     effective   EPA approval date           Explanation
                                                        date
----------------------------------------------------------------------------------------------------------------

                                                 * * * * * * *
                             Chapter 62-210 Stationary Sources-General Requirements

                                                  * * * * * * *
62-210.300.....................  Permits Required.     5/9/2007  6/1/2009.........  ............................
                                                                 63 FR 26103......
62-210.310.....................  Air General           5/9/2007  6/1/2009.........  ............................
                                  Permits.                       63 FR 26103......

                                                  * * * * * * *
62-210.920.....................  Air General           5/9/2007  6/1/2009.........  ............................
                                  Permit Forms.                  63 FR 26103......

                                                 * * * * * * *
                                     Chapter 62-252 Gasoline Vapor Control

                                                  * * * * * * *
62-252.200.....................  Definitions......     5/9/2007  6/1/2009.........  ............................
                                                                 63 FR 26103......
62-252.300.....................  Gasoline              5/9/2007  6/1/2009.........  ............................
                                  Dispensing                     63 FR 26103......
                                  Facilities-Stage
                                  I Vapor Recovery.
62-252.400.....................  Gasoline              5/9/2007  6/1/2009.........  ............................
                                  Dispensing                     63 FR 26103......
                                  Facilities Stage
                                  II Vapor
                                  Recovery.
62-252.500.....................  Gasoline Tanker       5/9/2007  6/1/2009.........  ............................
                                  Trucks.                        63 FR 26103......

                                                 * * * * * * *
                              Chapter 62-296 Stationary Sources-Emission Standards

                                                  * * * * * * *
62-296.418.....................  Bulk Gasoline         5/9/2007  6/1/2009.........  ............................
                                  Plants.                        63 FR 26103......

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-28654 Filed 11-29-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Proposed Rules]
[Pages 8129-8130]
[FR Doc No: 2014-02852]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0171; Airspace Docket No. 13-ANM-6]

Proposed Amendment of Class E Airspace; Redmond, OR.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify the Class E airspace areas at
Redmond, OR, to accommodate Area Navigation (RNAV) Global Positioning
System (GPS) standard instrument approach procedures for Instrument
Flight Rules (IFR) operations at Roberts Field. This action, initiated
by the biennial review of the Redmond, OR, airspace area, would enhance
the safety and management of IFR operations at the airport.

DATES: Comments must be received on or before March 28, 2014.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2013-
0171; Airspace Docket No. 13-ANM-6, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2013-0171 and Airspace Docket No. 13-ANM-6) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2013-0171 and Airspace Docket No. 13-ANM-6''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E surface airspace at
Roberts Field, Redmond, OR, to remove the segment extending from the
5.1 mile radius of the airport to .9 miles west of the VORTAC. After a
biennial review of the airspace, the FAA found this action necessary as
the airspace is no longer needed. Class E airspace extending 700 feet
above the surface would be modified with segments extending from the
7.6-mile radius of Roberts Field to 11.5 miles northeast and 15 miles
southeast of the airport. Class E airspace designated as an extension
to the Class D and Class E surface area would be modified by adding a
segment extending from the 5.1-mile radius of Roberts Field to 3.5
miles southeast of the airport, and removing the segment from the 5.1
mile radius of the airport to .9 miles west of the VORTAC to
accommodate RNAV (GPS) standard instrument approach procedures and for
the safety and management of IFR operations at the airport.
    Class E airspace designations are published in paragraph 6002, 6004
and 6005, respectively, of FAA Order 7400.9X, dated August 7, 2013, and
effective September 15, 2013, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) Is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) Does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for

the FAA Administrator. Subtitle VII, Aviation Programs, describes in
more detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of the airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
proposed regulation is within the scope of that authority as it would
modify controlled airspace at Roberts Field, Redmond, OR.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9X, Airspace Designations and
Reporting Points, dated August 7, 2013, and effective September 15,
2013 is amended as follows:

Paragraph 6002 Class E airspace Designated as Surface Areas

* * * * *

ANM OR E2 Redmond, OR [Modified]

Redmond, Roberts Field, OR
    (Lat. 44[deg]15'14'' N., long. 121[deg]09'00'' W.)

    That airspace within a 5.1 mile radius of Roberts Field. This
Class E airspace is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area

* * * * *

ANM OR E4 Redmond, OR [Modified]

Redmond, Roberts Field, OR
    (Lat. 44[deg]15'14'' N., long. 121[deg]09'00'' W.)

    That airspace extending upward from the surface within 1 mile
each side of the 122[deg] bearing of Roberts Field extending from
the 5.1 mile radius to 3.5 miles southeast of the airport. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth

* * * * *

ANM OR E5 Redmond, OR [Modified]

Redmond, Roberts Field, OR
    (Lat. 44[deg]15'14'' N., long. 121[deg]09'00'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.6 mile radius of Roberts Field, and within 3 miles either
side of the 87[deg] degree bearing of Roberts field extending from
the 7.6 mile radius to 11.5 miles northeast of the airport, and
within 3.5 miles either side of the 122[deg] bearing of the airport
extending from the 7.6 mile radius to 15 miles southeast of the
airport.

    Issued in Seattle, Washington, on February 3, 2014.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2014-02852 Filed 2-10-14; 8:45 am]
BILLING CODE 4910-13-P


John Silvasi/ RTP/ USEPA/ US 05/ 12/ 2005 02: 42 PM T o Amy Flynn c c S u b j e c t Revised deadline table Hi, Amy,

Some of our reviewers have found a few glitches so far with the table, so I'm sending you a revised version ( clean and redline/ strikeout versions that highlights the revisions from the previous version). I'll let you know if there are any additional revisions.

John J. Silvasi Environmental Engineer Ozone Policy and Strategies Group ( C539 02) Office of Air Quality Planning and Standards U. S. Environmental Protection Agency Research Triangle Park, NC 27711 919 541 5666 ( v); 919 541 0824 ( fax) silvasi. john@ epa. gov


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Pages 39835-39836]
[FR Doc No: 2015-16892]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015--0069]

School Bus Occupant Protection: Taking Safety to a New Level
Meeting

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of public meeting.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA) is
announcing a meeting that will be held in Washington, DC on July 23,
2015 to address the challenges and barriers that have prevented schools
from taking action to install three-point seat belt systems in school
buses. The workshop will include presentations and discussions on the
topic. Information on the date, time, location, and framework for this
public event is included in this notice. Attendance requires prior
registration; there will be no registration at the door. There are no
fees to register or to attend this event; however space is limited on a
first-come basis. The meeting will also be webcast live at
www.nhtsa.gov.

DATES: The workshop will be held on July 23, 2015, at the location
indicated in the ADDRESSES section below. The workshop will start at
9:00 a.m. and is scheduled to continue until 4:15 p.m., local time. If
you would like to register to attend the workshop, please contact the
person identified under FOR FURTHER INFORMATION CONTACT no later than
July 17, 2015.

ADDRESSES: The July 23, 2015 meeting will be held in the Media Center
of the U.S. Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: If you would like to attend the
workshop, please contact Pei Lee by the date specified under DATES
section above, at: Telephone<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>Please provide her with the following information:
Name, title, affiliation, address, email address, and telephone number,
and indicate whether you require accommodations such as a sign language
interpreter or translator. If you are not a U.S. citizen, also provide
your country of citizenship, date of birth, title or position, and
passport or diplomatic ID number, along with expiration date.

SUPPLEMENTARY INFORMATION: NHTSA is hosting a meeting to address the
challenges and barriers that have prevented schools from taking action
to install three-point seat belt systems in school buses.
    This meeting will update the current state of knowledge regarding
occupant protection technology on school buses, identify operational
challenges, and explore new approaches for funding mechanisms. The
meeting will explore topics such as seating capacity loss, which in the
past has prevented many States and school districts from considering
three-point belt systems as an option, communication strategies to
reach parents and children, and new training programs that may be
needed for bus drivers and students. Additionally, the National
Transportation Safety Board has been invited to present on their
findings and recommendations from investigations of school bus crashes.
    Workshop Procedures. NHTSA will conduct the meeting informally.
Thus, technical rules of evidence will not apply. The workshop will
include brief presentations and breakout group discussions with
representatives from NHTSA and school transportation officials. There
will be opportunities for attendees to ask NHTSA and the speakers
questions.
    To attend this workshop, please register with NHTSA by the date
specified under the DATES section above by sending the required
information to the person listed in the FOR FURTHER INFORMATION CONTACT
section. Registration is necessary for security and space limitation
reasons. After registration, NHTSA will send attendees follow-up
information regarding workshop day logistics (i.e., directions

to the building, parking accommodations, etc.).
    For security purposes, photo identification is required to enter
the Department of Transportation building. To allow sufficient time to
clear security and enter the building, NHTSA recommends that workshop
participants arrive 30 to 60 minutes prior to the start of the event.

    Authority: 49 U.S.C. 30182.

    Issued on: July 1, 2015.
Mark R. Rosekind,
Administrator.
[FR Doc. 2015-16892 Filed 7-9-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Proposed Rules]
[Pages 78702-78704]
[FR Doc No: 2015-31537]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-7524; Directorate Identifier 2014-NM-231-AD]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly
Known as Saab AB, Saab Aerosystems)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2014-15-
04 for certain Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. AD
2014-15-04 currently requires deactivating the potable water system, or
alternatively filling and activating the potable water system. Since we
issued AD 2014-15-04, the manufacturer developed a modification that
would address the unsafe condition. This proposed AD would also require
inspecting the in-line heater for correct brazing and corrective action
if needed, and installing a shrinkable tube on the water line and a
spray shield on the in-line heater. We are proposing this AD to prevent
rudder pedal restriction due to the pitch control mechanism becoming
frozen as the result of water spray, which could prevent disconnection
and normal pitch control, and consequently result in reduced
controllability of the airplane.

DATES: We must receive comments on this proposed AD by February 1,
2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Saab AB, Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone
+46 13 18 5591; fax +46 13 18 4874; email
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
    You may view this referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
7524; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-7524;
Directorate Identifier 2014-NM-231-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On July 13, 2014, we issued AD 2014-15-04, Amendment 39-17906 (79
FR 45337, August 5, 2014). AD 2014-15-04 requires actions intended to
address an unsafe condition on Saab AB, Saab Aeronautics Model SAAB
2000 airplanes.
    Since we issued AD 2014-15-04, Amendment 39-17906 (79 FR 45337,
August 5, 2014), a modification has been developed that would address
the unsafe condition and allow reactivation of the potable water
system.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0255, dated November 25, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition on certain Saab AB, Saab
Aeronautics Model SAAB 2000 airplanes. The MCAI states:

    One occurrence of rudder pedal restriction was reported on a
SAAB 2000 aeroplane. Subsequent investigation showed that this was
the result of water leakage at the inlet tubing for the in-line
heater (25HY) in the lower part of the forward fuselage (Zone 116).
The in-line heater attachment was found ruptured, which resulted in
water spraying in the area. Frozen water on the rudder control
mechanism in Zone 116 then led to the rudder pedal restriction.
    Analysis after the reported event indicated that the pitch
control mechanism (including pitch disconnect/spring unit) may also
be frozen as a result of water spray, which would prevent
disconnection and normal pitch control.
    This condition, if not corrected, could result in further
occurrences of reduced control of an aeroplane. To address this
potential unsafe condition, SAAB issued Service Bulletin (SB) 2000-
38-10 to provide instructions to deactivate the Potable Water
System. Consequently, EASA issued [EASA] [an] Emergency AD * * * to
require that action. That [EASA] Emergency AD was revised and
republished as EASA AD 2013-0172R1 [(http://ad.easa.europa.eu/ad/2013-0172R1), which corresponds to FAA AD 2014-15-041, Amendment 39-
17906 (79 FR 45337, August 5, 2014)], introducing a temporary
alternative procedure for filling, which would allow reactivation
and operation of the Potable Water System.
    Since that [EASA] AD was issued, SAAB developed an in-line
heater spray shield and a water line shrink tube to eliminate the
consequences of a water spray leak in case of rupture of the in-line
heater. SAAB also issued a SB 2000-38-011, providing instructions
for inspection of the in-line heater and installation of a shrink
tube and a spray shield.
    For reasons described above, this [EASA] AD retains the
requirements of EASA AD 2013-0172R1, which is superseded, and
requires inspection [for correct brazing] of the in-line heater [and
corrective action if needed] and installation of shrink tube [on
water line] and spray shield [on in-line heater].

    Corrective actions include repairing or replacing the in-line
heater. You may examine the MCAI in the AD docket on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2015-7524.

Related Service Information Under 1 CFR Part 51

    Saab issued Service Bulletin 2000-38-011, dated October 22, 2014.
The service information describes procedures for inspecting for correct
brazing of the in-line heater, repairing or replacing the in-line
heater, and installing a shrinkable tube on the water line and a spray
shield on the in-line heater. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section of this NPRM.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 1 airplane of U.S.
registry.
    The actions required by AD 2014-15-04, Amendment 39-17906 (79 FR
45337, August 5, 2014), and retained in this proposed AD take about 1
work-hour per product, at an average labor rate of $85 per work-hour.
Required parts cost $0 per product. Based on these figures, the
estimated cost of the actions that are required by AD 2014-15-04 is $85
per product.
    We also estimate that it would take about 6 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $3,650
per product. Based on these figures, we estimate the cost of this
proposed AD on U.S. operators to be $4,160.

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 determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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)
2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014), and
adding the following new AD:

Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab
Aerosystems): Docket No. FAA-2015-7524; Directorate Identifier 2014-
NM-231-AD.

(a) Comments Due Date

    We must receive comments by February 1, 2016.

(b) Affected ADs

    This AD replaces AD 2014-15-04, Amendment 39-17906 (79 FR 45337,
August 5, 2014).

(c) Applicability

    This AD applies to Saab AB, Saab Aeronautics (formerly known as
Saab AB, Saab Aerosystems) Model SAAB 2000 airplanes, certificated
in any category, serial numbers 004 through 016 inclusive, 018, 022,
023, 024, 026, 029, 031, 032, 033, 035 through 039 inclusive, 041
through 044 inclusive, 046, 047, 048, 051, and 053 through 063
inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 38, Water/Waste.

(e) Reason

    This AD was prompted by a report of rudder pedal restriction
which was the result of water leakage at the inlet tubing of an in-
line heater in the lower part of the forward fuselage. This AD was
also prompted by the development of a modification that would
address the unsafe condition. We are issuing this AD to prevent
rudder pedal restriction due to the pitch control mechanism becoming
frozen as the result of water spray, which could prevent
disconnection and normal pitch control, and consequently result in
reduced controllability of the airplane.

(f) Compliance

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

(g) Retained Deactivation of Potable Water System With New Exception

    This paragraph restates the requirements of paragraph (g) of AD
2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014), with a
new exception. Except as provided by paragraph (l) of this AD,
within 30 days after September 9, 2014 (the effective date of AD
2014-15-04), deactivate the potable water system, in accordance with
the Accomplishment Instructions of Saab Service Bulletin 2000-38-
010, dated July 12, 2013, which is incorporated by reference in AD
2014-15-04.

(h) Retained Alternative To Deactivation of Potable Water System With
No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014), with
no changes. As an alternative, or subsequent, to the action required
by paragraph (g) of this AD, during each filling of the potable
water system after September 9, 2014, (the effective date of AD
2014-15-04), accomplish the temporary filling procedure, in
accordance with the instructions in Saab Service Newsletter SN 2000-
1304, Revision 01, dated September 10, 2013, including Attachment 1
Engineering Statement to Operator 2000PBS034334, Issue

A, dated September 9, 2013, which is incorporated by reference in AD
2014-15-04.

(i) New Inspection and Installation

    At the applicable compliance times specified in paragraphs
(j)(1) and (j)(2) of this AD, concurrently accomplish the actions
specified in paragraphs (i)(1) and (i)(2) of this AD, in accordance
with the Accomplishment Instructions of Saab Service Bulletin 2000-
38-011, dated October 22, 2014.
    (1) Do a detailed inspection for correct brazing of the in-line
heater, and if any discrepancy is found, before further flight, and
before accomplishment of the modification required by paragraph
(i)(2) of this AD, accomplish all applicable corrective actions.
    (2) Install a shrink tube on the water line and a spray shield
on the in-line heater.

(j) Compliance Times for Inspection and Installation

    Do the actions specified in paragraph (i) of this AD at the
applicable times specified in paragraphs (j)(1) and (j)(2) of this
AD.
    (1) For airplanes having had the potable water system
reactivated and operated using the alternative filling procedure
specified in Saab Service Newsletter SN 2000-1304, Revision 01,
dated September 10, 2013, including Attachment 1 Engineering
Statement to Operator 2000PBS034334, Issue A, dated September 9,
2013, which is incorporated by reference in AD 2014-15-04, within 6
months after the effective date of this AD.
    (2) For airplanes having the potable water system deactivated
using procedures specified in the Accomplishment Instructions of
Saab Service Bulletin 2000-38-010, dated July 12, 2013: Before
further flight after the reactivation of the potable water system.

(k) Terminating Actions for the Deactivation of the Potable Water
System

    Accomplishing the actions required by paragraph (i) of this AD
terminates the requirements of paragraphs (g) and (h) of this AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, ANM-
116, International Branch, Transport Airplane Directorate, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (ii) AMOCs approved previously in accordance with AD 2014-15-04,
Amendment 39-17906 (79 FR 45337, August 5, 2014), are approved as
AMOCs for the corresponding provisions of paragraphs (g) and (h) of
this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Saab AB, Saab Aeronautics' EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency Airworthiness Directive 2014-
0255, dated November 25, 2014, for related information. This MCAI
may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2015-7524.
    (2) For service information identified in this AD, contact Saab
AB, Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone
+46 13 18 5591; fax +46 13 18 4874; email
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
You may view this service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on December 8, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-31537 Filed 12-16-15; 8:45 am]
 BILLING CODE 4910-13-P


MEMORANDUM FOR SIP-IV DOCKET
DATE: August 23, 2017
SUBJECT: Conference call with representatives from Caterpillar regarding proposed revisions to § 1926.800(k)(10)(ii)
PARTICIPANTS: 	Blake Skogland, OSHA
			Garvin Branch, OSHA
			Lisa Wilson, Office of the Solicitor of Labor  -  OSH Division
			George Lin, Caterpillar
			Craig Hodges, Caterpillar
			Charles Crowell, Caterpillar

      OSHA received a comment from Caterpillar (OSHA-2012-0007-0762) that supported the proposed changes regarding the substitution of 30 CFR 57.5067 for former Part 32, but recommended that OSHA not require compliance with sections 75.1909, 75.1910, and 75.1911(a) through (i) of part 30.  The comment explained that requiring compliance with sections 75.1909, 75.1910, and 75.1911(a) through (i) of part 30, "would create some conflict or, at the least, confusion...and inappropriately add underground coal-mining equipment requirements to equipment used in non-coal environments."  The Agency felt that clarification from Caterpillar was necessary as to why it felt requiring compliance with sections 75.1909, 75.1910, and 75.1911(a) through (i) of part 30 was inappropriate.
      To obtain clarification, OSHA hosted a conference call on August 23, 2017, with Caterpillar representatives.  They stated that all engines used in underground coal mines must be approved by MSHA, but that for metal/non-metal mines, the engines can be approved by MSHA or be EPA compliant.  They explained that sections 75.1909, 75.1910, and 75.1911(a) through (i) of part 30 apply to equipment used in coal mines, with their unique hazards, but that 30 CFR 57.5067 applies to equipment used in underground metal and nonmetal mines.  They stated that the use of diesel engines for underground construction is much more like use in a metal/non-metal mine than in a coal mine.  Caterpillar participants also recommended that OSHA look at alternative standards related to equipment used in underground metal and nonmetal mines such as 30 CFR 57.14100-14162  -  Safety Devices and Maintenance Requirements or 30 CFR 57.5060-5075  -  Diesel Particulate Matter  -  Underground Only.


[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Rules and Regulations]
[Page 24248]
[FR Doc No: 2017-10899]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0449]

Drawbridge Operation Regulation; Lake Champlain, North Hero
Island, VT

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the US2 Bridge across Lake Champlain,
mile 91.8, between North Hero and South Hero Island, Vermont. This
deviation is necessary to extend the operating life of the drawbridge
until a replacement bridge is constructed. This deviation allows the
bridge to open only on the hour during the day for the 2017 boating
season.

DATES: This deviation is effective without actual notice from May 26,
2017 through 8 p.m. on October 15, 2016. For the purposes of
enforcement, actual notice will be used from May 18, 2017, until May
26, 2017.

ADDRESSES: The docket for this deviation, USCG-2017-0449, is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Jeffrey Stieb; Bridge Management
Specialist, First Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The bridge owner, Vermont Agency of
Transportation, requested a temporary deviation from the normal
operating schedule of the US2 Bridge, mile 91.8, across Lake Champlain
at North Hero Island, Vermont. The drawbridge navigation span has a
vertical clearance of 18 feet at ordinary high water in the closed
position. The existing bridge operating regulations are found at 33 CFR
117.993(b). The waterway is transited by seasonal recreational vessels
of various sizes. Several marina facilities are in the area of the
bridge.
    In response to the request, the Coast Guard's First District has
approved a deviation from 8 a.m. on May 18, 2017 to 8 p.m. on October
15, 2017, to conduct repairs to extend the life of the machinery which
operates the drawbridge. During this deviation, the US2 Bridge shall
open on signal only on the hour from 8 a.m. to 8 p.m.
    Vessels that are able to pass under the bridge in the closed
position may do so at anytime. The bridge will be able to open for
emergencies, and for vessels unable to pass through the bridge in the
closed position there is an alternate route to the north under the
Alburg Passage US2 fixed bridge. The Alburg Passage US2 Bridge has a
vertical clearance of 26 feet at ordinary high water. The Coast Guard
will inform the users of the waterway through our Local Notice and
Broadcast Notice to Mariners of the change in operating schedule so
that vessel operators can arrange their transits to minimize any impact
caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this deviation. This deviation from the operating regulations
is authorized under 33 CFR 117.35.

    Dated: May 23, 2017.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2017-10899 Filed 5-25-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Notices]
[Page 66197]
[DOCID:fr14de09-115]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket Nos. FMCSA-1999-5578; FMCSA-1999-6480; FMCSA-2001-9561; FMCSA-
2003-15892; FMCSA-2007-27897; FMCSA-2007-28695]

Qualification of Drivers; Exemption Renewals; Vision

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA previously announced its decision to renew the
exemptions from the vision requirement in the Federal Motor Carrier
Safety Regulations for 19 individuals. FMCSA has statutory authority to
exempt individuals from the vision requirement if the exemptions
granted will not compromise safety. The Agency has concluded that
granting these exemptions will provide a level of safety that will be
equivalent to, or greater than, the level of safety maintained without
the exemptions for these commercial motor vehicle (CMV) drivers.

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

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period. The comment
period ended on November 18, 2009 (74 FR 53581).

Discussion of Comments

    FMCSA received no comments in this proceeding.

Conclusion

    The Agency has not received any adverse evidence on any of these
drivers that indicates that safety is being compromised. Based upon its
evaluation of the 19 renewal applications, FMCSA renews the Federal
vision exemptions for Lauren C. Allen, Tracey A. Ammons, David N.
Cleveland, Randy B. Combs, Robert L. Cross, Jr., James D. Davis, Thomas
E. Dixon, Edward J. Genovese, Dewayne E. Harms, Mark D. Kraft, David F.
LeClerc, Charles D. Oestreich, Carson E. Rohrbaugh, Donald J. Snider,
John A. Sortman, Jesse L. Townsend, James A. Welch, Edward W. Yeates,
Jr., and Michael E. Yount.
    In accordance with 49 U.S.C. 31136(e) and 31315, each renewal
exemption will be valid for 2 years unless revoked earlier by FMCSA.
The exemption will be revoked if: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136 and 31315.

    Issued on: December 4, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-29701 Filed 12-11-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55438-55440]
[FR Doc No: 2022-19500]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1837]

Statement of Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug Products; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Statement
of Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products.'' This draft guidance provides
recommendations for the content and format of the required statement of
identity on the labeling of human nonprescription drug products. This
draft guidance also provides recommendations on the inclusion of the
drug product's strength on the labeling. The recommendations in this
draft guidance are intended to help manufacturers, packers,
distributors, applicants, relabelers, and sponsors ensure consistent
content and format of the statement of identity and strength for all
human nonprescription drug products. Consistent content and format

of the statement of identity and strength may aid consumers in
comparing nonprescription drug products and assist consumers in
appropriate self-selection.

DATES: Submit either electronic or written comments on the draft
guidance by November 8, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2022-D-1837 for ``Statement of Identity and Strength--Content and
Format of Labeling for Human Nonprescription Drug Products.'' 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 the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5493, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Statement of Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug Products.'' This draft guidance
provides recommendations for the content and format of the required
statement of identity on the labeling of human nonprescription drug
products. This draft guidance also provides recommendations on the
inclusion of the drug product's strength on the labeling.
    Labeling for nonprescription drug products is intended to enable
consumers to self-select appropriately and use the nonprescription drug
product safely and effectively without the supervision of a healthcare
practitioner. Nonprescription drug products must comply with applicable
labeling requirements for over-the-counter (OTC) products under 21 CFR
part 201, including, but not limited to, the statement of identity
under Sec.  201.61 (21 CFR 201.61). The statement of identity is one of
the principal features on nonprescription drug product labeling and
consists of the established name for the nonprescription drug product,
if one exists, followed by an accurate statement of the general
pharmacological category(ies) or the principal intended action(s) of
the drug. The labeling of all nonprescription drug products must
display the statement of identity on the product's principal display
panel (Sec.  201.61(a)).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Statement of
Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products.'' 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 draft guidance refers to proposed collections of information
described in FDA's 60-day notice requesting public comment on the
proposed collection of information entitled ``Agency

Information Collection Activities; Proposed Collection; Comment
Request; General Drug Labeling Provisions and Over-the-Counter
Monograph Drug User Fee Submissions.'' The proposed collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521). As required by the PRA, FDA has published an analysis of
these information collection provisions elsewhere in this edition of
the Federal Register and will submit them for OMB approval following
the period for public comment. This draft guidance also refers to
previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR part 314 have
been approved under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19500 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Notices]
[Page 6460]
[DOCID:fr08fe06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-383-074]

Dominion Transmission, Inc.; Notice of Negotiated Rate

February 2, 2006.
    Take notice that on January 31, 2006, Dominion Transmission, Inc.
(DTI) tendered for filing as part of its FERC Gas Tariff, Third Revised
Volume No. 1, Third Revised Sheet No. 1405, to become effective
February 1, 2006.
    DTI states that the purpose of this filing is to amend the
Appalachian Pool Operators negotiated rate customer and contract list.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-1707 Filed 2-7-06; 8:45 am]

BILLING CODE 6717-01-P