1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STANDARDS OF PERFORMANCE NESHAP, Subpart GGG, Pharmaceuticals Production 1. Identification of the Information Collection 1( a) Title of the Information Collection ICR for NESHAP, Subpart GGG  Pharmaceuticals Production; OMB Control Number 2060 0358; EPA ICR Number 1781.02 1( b) Short Characterization/ Abstract In general all NESHAP require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance; and are required, in general, of all sources subject to NESHAP. This information is used by the Agency to identify sources subject to the standards to insure that the maximum achievable control technologies are being applied.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least 5 years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or Local authority and are entered into the AIRS database. In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office.

The National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Pharmaceuticals Production were proposed on April 2, 1997 and promulgated on September 21, 1998. These standards apply to the facilities in Pharmaceuticals Production that are major sources of hazardous air pollutants ( HAP). The affected facility is all pharmaceutical manufacturing operations including process vents, storage tanks, equipment components, and wastewater systems commencing construction or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR Part 63 Subpart GGG..

Approximately 100 sources are currently subject to the standard, and it is estimated that there will be no new growth in the industry; with the exception of one reconstruction in the industry. By definition of affected facility in Subpart GGG, there is one affected facility per plant. These estimates were obtained through the course of the regulation development through consultations with industry and trade associations, such as the Pharmaceutical Research and Manufacturers Association ( PhRMA). 2 2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction.

In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

. . . ( A) establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, HAP emissions ( predominantly methanol, methylene chloride, and toluene) from Pharmaceuticals Production cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore NESHAP were promulgated for this source category at 40 CFR Part 63 Subpart GGG.

2( b) PRACTICAL UTILITY/ USERS OF THE DATA The control of emissions of hazardous air pollutants ( HAP) from Pharmaceuticals Production requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of HAP from Pharmaceuticals Production are the result of operation of the pharmaceuticals manufacturing operations. These standards rely on the reduction of HAP emissions by air pollution control devices, suppression and control of HAP in liquids, and leak detection and repair procedures. The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and leaks are being detected and repaired and the standard is being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

The information generated by the monitoring, recordkeeping and reporting requirements 3 described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP continue to operate the control equipment and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 63 Subpart GGG.

3( a) Nonduplication If the standard has not been delegated the information is sent to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or Local Agency. If a State or Local Agency has adopted their own similar regulation to implement the Federal Regulation, a copy of the report submitted to the State or Local agency can be sent to the Administrator in lieu of the report required by the Federal Standard. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on March 31, 2000.

3( c) Consultations No comments were received on the burden published in the Federal Register.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB in 5 CFR 1320.6. 4 3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping and reporting requirements are producers of material described by Standard Industrial Classification ( SIC) codes 2833 and 2834 and are producers of material whose manufacturing process is described by North American Industrial Classification System ( NAICS) codes 325411 and 325412.

4( b) INFORMATION REQUESTED ( i) Data Items All data in this ICR that is recorded and/ or reported is required by 40 CFR Part 63 Subpart GGG. A source must make the following reports and keep the following records.

Reports for NESHAP  SUBPART GGG Change in area source status ( as applicable) 63.1( c)( 5)

Construction/ reconstruction 63.5( b)( 4), 63.5( d), 63.1260( c)

Applicability 63.9( a)

Initial notifications ( and implementation plans for facilities using emissions averging) 63.9( b) or ( d), 63.1260( b)

Notification of performance test or delay, alternative test methods or waivers 63.7( b)( 1) & ( 2), 63.7( f), 63.7( h) 63.9( e) Reports for NESHAP  SUBPART GGG 5 Notification for CMS performance evaluation & results 63.8( e)( 2), 63.9( g)( 1), 63.9( e)( 5), 63.10( e)( 2), 63.1260( d)

Notification that criterion to continue use of alternative to relative accuracy testing has been exceeded 63.9( g)( 3)

Notification of Compliance Status 63.9( h), 63.1260( f)

Initial performance test results 63.10( d)( 2)

Progress Reports for Compliance Extensions ( as applicable) 63.10( d)( 4)

Startup, shutdown, malfunction reports 63.10( d)( 5)

Initial performance test ( notification, test plan, and emission profile) 63.7( b)( 1) and ( c), 63.9( e), 63.1257( b)( 8) 63.1260( l)

Rescheduled initial performance test 63.7( b)( 2)

Precompliance report 63.1260( e)

Notification of Compliance status Report ( NOCSR) 63.9( f)

Physical or operational change 63.1260( g)( 2)( vii), 63.1260( h)( 1)

Periodic Reports 63.1260( g)

Excess emissions reports 63.10( e)( 3) 63.1260( g)( 2)

Reports on monitoring data with days when average values are outside established ranges ( including operating logs) 63.1260( g)( 2)

Reports of periods when monitoring data is not collected due to excursions 63.1260( g)( 2)

Reports of leaks of vapor suppression equipment 63.1260( g)( 2)

Reports of vapor collection systems equipped with a bypass line 63.1260( g)( 2) Reports for NESHAP  SUBPART GGG 6 Periods of Planned Routine Maintenance 63.1260( g)( 2)

New Operating Scenarios 63.1260( g)( 2)

Notice of change in activity since Precompliance report or change in control device status 63.1260( h)( 2)

LDAR reporting requirements 63.1260( j)

Reports of startup, shutdown, and malfunction 63.1260( i)

Reports of emissions averaging 63.1260( k)

Source status report 63.1260( g) and ( h)

Recordkeeping for NESHAP  SUBPART GGG Recordkeeping requirements 63.10( a)

Data retention 63.10( b)( 1), 63.1259( a)( 1)

Applicability 63.10( b)( 3), 63.1259( a)( 2)

Startup, shutdown, and malfunction plan 63.1259( a)( 3)

CMS 63.10( c)( 1)( 14), 63.1259( a)( 4)

Construction/ Reconstruction 63.1259( a)( 5)

Records of equipment operation 63.1259( b)

Operating Parameters 63.1259( b)( 1)

Pollution Prevention ( as applicable) 63.1259( b)( 2)

CMS Checks ( as applicable) 63.1259( b)( 3)

Rolling Annual Total Emissions ( as applicable) 63.1259( b)( 4)

Number of batches per year, operating hours per year, uncontrolled and controlled emissions per batch ( as appropriate) 63.1259( b)( 5), ( b)( 6)

WW concentration per POD or process 63.1259( b)( 7) Recordkeeping for NESHAP  SUBPART GGG 7 Number of storage tank turnovers per year ( as applicable) 63.1259( b)( 8)

Daily schedule or log of operating scenarios 63.1259( b)( 9)

Description of worst case operating scenarios for control devices 63.1259( b)( 10)

Periods of planned routine maintenance for storage tanks 63.1259( b)( 11)

Records of operating scenarios 63.1259( c)

Records of leak detection and repair programs 63.1259( d)

Records of emissions averaging 63.1259( e)

Records of delay of repairs 63.1259( f)

Records of wastewater stream and residual transfer 63.1259( g)

Records of extensions 63.1259( h)

Records of inspections 63.1259( i)

( ii) Respondent Activities Respondent Activities for NESHAP  SUBPART GGG Read instructions.

Plan compliance strategy ( includes preparing implementation plans)

Train personnel Perform initial testing and establish operating range parameters Information gathering ( includes equipment inspections and monitoring data collection)

Compile and review collected information to demonstrate compliance Prepare formal reports Manage and record information It is estimated that 20 percent of the information will be collected and recorded electronically.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 8 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Aerometric Information Retrieval System ( AIRS) database.

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard and note the operating conditions under which compliance was achieved. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Information contained in the reports is entered into AIRS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AIRS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AIRS for tracking air pollution compliance and enforcement by Local and State regulatory agencies, and EPA Regional Offices and Headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data. The records required by this regulation must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility The recordkeeping and reporting requirements were selected within the context of this specific subpart and the specific process equipment and pollutants. The impact on small businesses was accounted for in the regulation development. The requirements reflect the burden on small businesses. Even though, the recordkeeping and reporting requirements are the same for small and larger businesses. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced. The Agency considers these requirements 9 the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Industry Burden..

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for each of the subparts included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory. The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated at 161,326 person hours. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates: $ 73.93 per hour for Executive, Administrative, and Managerial, $ 54.94 per hour for Technical, and $ 34.42 per hour for Clerical. These rates are from the United States Department of Commerce Bureau of Labor Statistics, March 1999, Table 10: Employment Costs for Private Industry by Occupational and Industry Group. The rates are from column 1: Total compensation. The wage rates have been loaded by adding 110% overhead.

( ii) Estimating Capital and Operations and Maintenance Costs The capital start up costs are one time costs when a facility becomes subject to the standard. For this industry the only capital cost anticipated are the purchase of customized software estimated at $ 1400 and the purchase of a datalogger and thermocouple estimated at $ 3000 ( an average of 2.31 per facility based on the number of control devices found during 10 regulation development ( 231) at the 100 major sources). Neither of these are capitalized so the annual cost is the total cost divided by the period of the ICR, or $ 3388/ year ($ 4400* 2.31/ 3). This cost is shown on the OMB 83 I form in block 14 letter a: Total annualized capital/ startup costs. The numbers in block 14 of the OMB 83 I form are truncated to show the cost in thousands of dollars.

The only O& M that is associated with this effort is the O& M on the thermocouple and datalogger, estimated at $ 1800/ year, based on experience with this type of equipment in other industries. The total O& M is therefore $ 4158/ year ($ 1800* 2.31). This cost is shown on the OMB 83 I form in block 14 letter b: Total annual costs ( O& M). The numbers in block 14 of the OMB 83 I form are truncated to show the cost in thousands of dollars.

The total respondent costs have been calculated on the addition of the capital start up costs and the annual operations and maintenance costs. The average annual cost for capital and operations and maintenance costs to industry over the next three years of the ICR is estimated to be $ 7546 . This cost is shown on the OMB 83 I form in block 14 letter c: Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are truncated to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information. Publication and distribution of the information are part of the AIRS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Federal Government cost during the 3 years of the ICR is estimated to be $ 112,996 ( from Table 1). This cost is based on an average wage of a GS 10 step 1 employee rate, $ 35.89/ hour ( 17.09 hr + 110% overhead = $ 35.89). This rate is from OPM's 2000 General Schedule, excluding locality pay, basic rates and travel associated with compliance activities. Details upon which this estimate is based appear in Table 1.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondant Universe Regulation Title ( A) # new sources per year ( B) # of initial reports for new sources ( C) # existing sources ( D) # of reports for existing sources ( E) total annual responses ( AXB)+( CXD)

Subpart GGG 1 reconstructed 3 103 2 209 11 The number of total respondents is 103. This number is in column A of the Respondant Universe table. It is shown on the OMB 83 I form in block 13 a. This is the number of existing sources plus the number of new sources anticipated in one year. The total annual responses is 209. This number is in column E of the Respondant Universe table. It is shown on the OMB 83 I form in block 13 b. The total annual labor costs are $ 8,708,620. Details upon which this estimate is based appear in Table 2.

6( e) Bottom Line Burden Hours And Cost Tables See attachments for burden hours and costs tables.

6( f) Reasons for Change in Burden The change in burden from the most recently approved ICR is due to an adjustment. The labor costs have been updated. Also, several first year requirements, such as the initial notification, are no longer required.

6( g) Burden Statement Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, Office of Environmental Information ( OEI), U. S. Environmental Protection Agency, Mail Code 2822, 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1781.02 and OMB control 2060 0358 number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Rules and Regulations]
[Pages 32639-32640]
[FR Doc No: 2014-13243]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-1038; Special Conditions No. 25-549-SC]

Special Conditions: Bombardier Aerospace, Models BD-500-1A10 and
BD-500-1A11 Series Airplanes; Flight Envelope Protection: High-Speed
Limiting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final Special Conditions.

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SUMMARY: These special conditions are issued for the Bombardier
Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes. These
airplanes will have a novel or unusual design feature associated with
an electronic flight control system that contains fly-by-wire control
laws, including envelope protections, for the overspeed protection and
roll-limiting function. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: Effective Date: July 7, 2014.

FOR FURTHER INFORMATION CONTACT: Joe Jacobsen, FAA, Airplane and Flight
Crew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On December 10, 2009, Bombardier Aerospace applied for a type
certificate for their new Models BD-500-1A10 and BD-500-1A11 series
airplanes (hereafter collectively referred to as ``CSeries''). The
CSeries airplanes are swept-wing monoplanes with an aluminum alloy
fuselage sized for 5-abreast seating. Passenger capacity is designated
as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11.
Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and
144,000 pounds for the Model BD-500-1A11.
    The longitudinal control law design of the Bombardier CSeries
airplanes incorporates an overspeed protection system in the normal
mode. This mode prevents the pilot from inadvertently or intentionally
exceeding a speed approximately equivalent to the maximum speed for
stability characteristics (VFC) or attaining demonstrated
flight diving speed (VDF). Current Title 14, Code of Federal
Regulations (14 CFR) part 25 standards did not envision a high-speed
limiter that might preclude or modify flying qualities assessments in
the overspeed region.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, Bombardier Aerospace must
show that the CSeries airplanes meet the applicable provisions of part
25 as amended by Amendments 25-1 through 25-129 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the CSeries airplanes because of a
novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the CSeries airplanes must comply with the fuel vent and
exhaust emission requirements of 14 CFR part 34 and the noise
certification requirements of 14 CFR part 36, and the FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The CSeries airplanes will incorporate the following novel or
unusual design features: An electronic flight control system that
contains fly-by-wire control laws, including envelope protections, for
the overspeed protection and roll-limiting function. Current part 25
requirements do not contain appropriate standards for high-speed
protection systems.

Discussion

    The overspeed protection functionality includes multifunction
spoilers (MFS) that will automatically deploy as speed brakes once the
airspeed exceeds a small tolerance above maximum operating limit speed
(Vmo/Mmo); the MFS will retract automatically
when speed is subsequently reduced. Special conditions are necessary in
addition to the requirements of Sec.  25.143 for the operation of the
high-speed protection. The general intent is that the overspeed
protection does not impede normal maneuvering and speed control, and
that the overspeed protection does not restrict or prevent emergency
maneuvering.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Discussion of Comments

    Notice of proposed special conditions No. 25-13-38-SC for the
Bombardier CSeries airplanes was published in the Federal Register on
December 11, 2013 (78 FR 75284). We received one comment in favor of
the proposed special conditions as written.

Applicability

    As discussed above, these special conditions are applicable to the
Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier
Aerospace apply at a later date for a change to the type certificate to
include another model incorporating the same novel or unusual design
feature, the special conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on two model series of airplanes. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type

certification basis for the Bombardier Aerospace Models BD-500-1A10 and
BD-500-1A11 series airplanes.

Flight Envelope Protection--High-Speed Limiting

0
1. In addition to Sec.  25.143, the following requirements apply:
Operation of the high-speed limiter during all routine and descent
procedure flight must not impede normal attainment of speeds up to
overspeed warning.

    Issued in Renton, Washington, on April 22, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-13243 Filed 6-5-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 76 (Thursday, April 19, 2012)]
[Proposed Rules]
[Pages 23420-23425]
[FR Doc No: 2012-9477]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0420; Directorate Identifier 2011-NM-284-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede an existing airworthiness directive
(AD) that applies to certain Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes. The existing AD currently
requires revising certain sections of a certain airplane flight manual,
deactivating certain hydraulic accumulators, removing certain hydraulic
accumulators, ultrasonic inspections for cracks on accumulators and
screw caps and replacement if necessary, and replacing certain
accumulators. Since we issued that AD, we have determined that, for
certain airplanes, reducing the compliance time for a certain
replacement is necessary to ensure that the identified unsafe condition
is addressed. This proposed AD would continue to require the existing
actions from the existing AD. We are proposing this AD to detect and
correct hydraulic accumulator screw cap/end cap failure, which could
result in the loss of the associated hydraulic

system and high-energy impact damage to adjacent systems and structure,
and consequent loss of control of the airplane.

DATES: We must receive comments on this proposed AD by June 4, 2012.

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
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this 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: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue Suite 410, Westbury,
New York 11590; 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-2012-0420;
Directorate Identifier 2011-NM-284-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 October 20, 2011, we issued AD 2011-23-08, Amendment 39-16859
(76 FR 71241, November 17, 2011). That AD required actions intended to
address an unsafe condition on certain Bombardier, Inc. Model CL-600-
2B19 (Regional Jet Series 100 & 440) Airplanes.
    Since we issued AD 2011-23-08, Amendment 39-16859 (76 FR 71241,
November 17, 2011), we have determined that the compliance time
specified in paragraph (n) of this proposed AD (referred to as
paragraph (q) in AD 2011-23-08) must be clarified. We are including the
phrase, ``whichever occurs first,'' in paragraph (n)(1) of this AD,
which requires operators to perform the action at the earlier of the
times. We have determined that the proposed reduced compliance time is
necessary to address the identified unsafe condition in a timely
manner. This compliance time also matches the compliance time given in
Canadian Airworthiness Directive CF-2010-24, dated August 3, 2010.
    We have also determined that certain phrases need to be added and
certain phrases need to be removed from certain credit paragraphs of
this AD. We have revised paragraphs (o)(4) and (o)(5) of this proposed
AD to specify ``before December 22, 2011 (the effective date of AD
2011-23-08, Amendment 39-16859 (76 FR 71241, November 17, 2011)),''
instead of ``before November 4, 2010.'' We have revised paragraph
(o)(2) of this AD by removing ``hydraulic system No. 1'' because the
service information in paragraph (o)(2) does not specify to remove the
hydraulic system No. 1 accumulator. We have also revised paragraph
(o)(2) of this proposed AD by removing Bombardier Service Bulletin
601R-32-107, Revision A, dated June 17, 2010, because credit for that
service bulletin is already given in paragraph (m) of this proposed AD.
You may obtain further information by examining the MCAI in the AD
docket.

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.

Changes to Existing AD

    This proposed AD would retain all requirements of AD 2011-23-08,
Amendment 39-16859 (76 FR 71241, November 17, 2011). Since AD 2011-23-
08 was issued, the AD format has been revised, and certain paragraphs
have been rearranged. As a result, the corresponding paragraph
identifiers have changed in this proposed AD, as listed in the
following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                                         Corresponding
Requirement in AD 2011-23-08, Amendment 39-16859 (76    requirement in
            FR 71241, November 17, 2011)               this  proposed AD
------------------------------------------------------------------------
paragraph (l).......................................   paragraph (p)(1)
paragraph (m).......................................   paragraph (p)(2)
paragraph (n).......................................   paragraph (p)(3)
paragraph (o).......................................      paragraph (l)
paragraph (p).......................................      paragraph (m)
paragraph (q).......................................      paragraph (n)
paragraph (r).......................................   paragraph (o)(4)
paragraph (s).......................................   paragraph (o)(5)
------------------------------------------------------------------------

    We have also revised paragraph (j) (paragraph (j) of AD 2011-23-08,
Amendment 39-16859 (76 FR 71241, November 17, 2011)) of this proposed
AD to refer to paragraph (k) of this AD instead of paragraph (l)(1)
(paragraph (l) of AD 2011-23-08) for the applicable compliance times.

Differences Between This AD and the MCAI or Service Information

    The actions specified in Canadian Airworthiness Directive CF-2010-
24, dated August 3, 2010, apply only to Tactair accumulators. The
actions required by paragraphs (h), (i), and (m) of this proposed AD
apply to all accumulators in the positions specified in paragraphs (h),
(i), and (l) of this proposed AD.
    While Canadian Airworthiness Directive CF-2010-24, dated August 3,
2010, does not require replacement of the reducer of the hydraulic
system No.

1 with a new reducer, paragraph (n) of this proposed AD does.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 605 products of U.S. registry.
    The actions that are required by AD 2011-23-08, Amendment 39-16859
(76 FR 71241, November 17, 2011), and retained in this proposed AD take
about 33 work-hours per product, at an average labor rate of $85 per
work hour. Required parts cost about $3,054 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, the estimated cost of the currently required actions is $5,859
per product.
    The new requirements of this proposed AD add no additional economic
burden.

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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by removing airworthiness directive
(AD) 2011-23-08, Amendment 39-16859 (76 FR 71241, November 17, 2011),
and adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2012-0420; Directorate Identifier
2011-NM-284-AD.

(a) Comments Due Date

    We must receive comments by June 4, 2012.

(b) Affected ADs

    This AD supersedes AD 2011-23-08, Amendment 39-16859 (76 FR
71241, November 17, 2011).

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category,
serial numbers 7003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic
Power; 32, Landing Gear.

(e) Reason

    This AD was prompted by reports of on-ground hydraulic
accumulator screw cap/end cap failure. We are issuing this AD to
detect and correct hydraulic accumulator screw cap/end cap failure,
which could result in the loss of the associated hydraulic system
and high-energy impact damage to adjacent systems and structure, and
consequent loss of control of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Retained Airplane Flight Manual (AFM) Revision, With Revised
Service Information

    This paragraph restates the revision required by paragraph (g)
of AD 2010-22-02, Amendment 39-16481 (75 FR 64636, October 20,
2010), with revised service information. Within 30 days after
November 4, 2010 (the effective date of AD 2010-22-02, Amendment 39-
16481 (75 FR 64636, October 20, 2010)), revise the Limitations
section, Normal Procedures section, and Abnormal Procedures section
of the Canadair Regional Jet AFM, CSP A-012, by incorporating
Canadair Regional Jet Temporary Revision (TR) RJ/186-1, dated August
24, 2010, into the applicable section of Canadair Regional Jet AFM,
CSP A-012. Thereafter, except as provided by paragraph (p) of this
AD, no alternative actions specified in Canadair Regional Jet TR RJ/
186-1, dated August 24, 2010, may be approved.

    Note 1 to paragraph (g) of this AD:  The actions required by
paragraph (g) of this AD may be done by inserting a copy of Canadair
Regional Jet TR RJ/186-1, dated August 24, 2010, into the applicable
section of the Canadair Regional Jet AFM, CSP A-012. When this TR
has been included in the general revisions of this AFM, the general
revisions may be inserted into this AFM, and this TR removed,
provided that the relevant information in the general revision is
identical to that in Canadair Regional Jet TR RJ/186-1, dated August
24, 2010.

(h) Retained Deactivation of the Hydraulic System No. 3 Accumulator,
With Revised Service Information

    This paragraph restates the deactivation required by paragraph
(h) of AD 2010-22-02, Amendment 39-16481 (75 FR 64636, October 20,
2010), with revised service information. Within 250 flight cycles
after November 4, 2010 (the effective date of AD 2010-22-02),
deactivate the hydraulic system No. 3 accumulator, in accordance
with Part A of the Accomplishment Instructions of Bombardier Alert
Service Bulletin A601R-29-031, Revision A, dated March 26, 2009.
Doing the removal of the hydraulic system No. 3 accumulator in
paragraph (l) of this AD terminates the requirements of this
paragraph. The actions in this paragraph apply to all accumulators
in hydraulic system No. 3.

(i) Retained Removal of the Hydraulic System No. 2 Accumulator, With
Revised Service Information

    This paragraph restates the removal required by paragraph (i) of
AD 2010-22-02, Amendment 39-16481 (75 FR 64636, October 20, 2010),
with revised service information. Within 500 flight cycles after
November 4, 2010 (the effective date of AD 2010-22-02), remove the
hydraulic system No. 2 accumulator, in accordance with the

Accomplishment Instructions of Bombardier Service Bulletin 601R-29-
032, Revision A, dated January 26, 2010. The actions in this
paragraph apply to all accumulators in hydraulic system No. 2.

(j) Retained Initial and Repetitive Ultrasonic Inspections of Hydraulic
System No. 1, Inboard Brake and Outboard Brake Accumulators, With
Revised Service Information

    This paragraph restates the initial and repetitive ultrasonic
inspections required by paragraph (k) of AD 2010-22-02, Amendment
39-16481 (75 FR 64636, October 20, 2010), with revised service
information. For hydraulic system No. 1, inboard brake and outboard
brake accumulators having part number (P/N) 601R75138-1 (08-60163-
001 or 08-60163-002): At the applicable compliance times specified
in paragraph (k) of this AD, do the inspections required by
paragraphs (j)(1) and (j)(2) of this AD. Repeat the inspections for
each accumulator having P/N 601R75138-1 (08-60163-001 or 08-60163-
002) thereafter at intervals not to exceed 500 flight cycles until
the replacement specified in this paragraph is done or the
replacement specified in paragraph (m) of this AD is done. If any
crack is found, before further flight, replace the accumulator with
a new accumulator having P/N 601R75138-1 (08-60163-001 or 08-60163-
002) and having the letter ``T'' after the serial number on the
identification plate, in accordance with the Accomplishment
Instructions of the applicable service bulletin identified in table
1 or table 2 of this AD.
    (1) Do an ultrasonic inspection for cracks on each accumulator,
in accordance with Part B of the Accomplishment Instructions of the
applicable service bulletin identified in table 1 of this AD.

                       Table 1--Bombardier Service Information for Accumulator Inspection
----------------------------------------------------------------------------------------------------------------
         Accumulator                     Document                   Revision                    Date
----------------------------------------------------------------------------------------------------------------
Hydraulic System No. 1......  Bombardier Alert Service        B...................  May 11, 2010.
                               Bulletin A601R-29-029,
                               including Appendix A, dated
                               October 18, 2007.
Inboard and Outboard Brake..  Bombardier Alert Service        D...................  May 11, 2010.
                               Bulletin A601R-32-103,
                               including Appendix A,
                               Revision A, dated October 18,
                               2007.
----------------------------------------------------------------------------------------------------------------

    (2) Do an ultrasonic inspection for cracks on the screw cap, in
accordance with the Accomplishment Instructions of the applicable
service bulletin identified in table 2 of this AD.

                        Table 2--Bombardier Service Information for Screw Cap Inspection
----------------------------------------------------------------------------------------------------------------
         Accumulator                     Document                   Revision                    Date
----------------------------------------------------------------------------------------------------------------
Hydraulic System No. 1......  Bombardier Service Bulletin     A...................  May 11, 2010.
                               601R-29-033, including
                               Appendix A, dated May 5, 2009.
Inboard and Outboard Brake..  Bombardier Service Bulletin     A...................  May 11, 2010.
                               601R-32-106, including
                               Appendix A.
----------------------------------------------------------------------------------------------------------------

(k) Retained Initial and Repetitive Ultrasonic Inspections of Hydraulic
System No. 1, Inboard Brake and Outboard Brake Accumulators, With
Revised Service Information

    This paragraph restates the initial and repetitive ultrasonic
inspections required by paragraph (l) of AD 2010-22-02, Amendment
39-16481 (75 FR 64636, October 20, 2010), with revised service
information. For hydraulic system No. 1 inboard brake, and outboard
brake accumulators having P/N 601R75138-1 (08-60163-001 or 08-60163-
002): Do the inspections specified in paragraph (j) of this AD at
the applicable time in paragraph (k)(1), (k)(2), and (k)(3) of this
AD.
    (1) For any accumulator not having the letter ``T'' after the
serial number on the identification plate and with more than 4,500
flight cycles on the accumulator as of November 4, 2010 (the
effective date of AD 2010-22-02, Amendment 39-16481 (75 FR 64636,
October 20, 2010)): Inspect within 500 flight cycles after November
4, 2010 (the effective date of AD 2010-22-02).
    (2) For any accumulator not having the letter ``T'' after the
serial number on the identification plate and with 4,500 flight
cycles or less on the accumulator as of November 4, 2010 (the
effective date of AD 2010-22-02, Amendment 39-16481 (75 FR 64636,
October 20, 2010)): Inspect prior to the accumulation of 5,000
flight cycles on the accumulator.
    (3) If it is not possible to determine the flight cycles
accumulated for any accumulator not having the letter ``T'' after
the serial number on the identification plate: Inspect within 500
flight cycles after November 4, 2010 (the effective date of AD 2010-
22-02, Amendment 39-16481 (75 FR 64636, October 20, 2010)).

    Note 2 to paragraph (j) of this AD:  For any accumulator having
P/N 601R75138-1 (08-60163-001 or 08-60163-002) and the letter ``T''
after the serial number on the identification plate, or if the
accumulator part number is not listed in paragraph (j) of this AD,
the inspection specified in paragraph (j) of this AD is not
required.

                    Table 3--Bombardier Credit Service Information for Accumulator Inspection
----------------------------------------------------------------------------------------------------------------
                Document                             Revision                              Date
----------------------------------------------------------------------------------------------------------------
Bombardier Alert Service Bulletin A601R- ...............................  October 18, 2007.
 29-029.
Bombardier Alert Service Bulletin A601R- A..............................  November 12, 2009.
 29-029.
Bombardier Alert Service Bulletin A601R- ...............................  November 21, 2006.
 32-103.
Bombardier Alert Service Bulletin A601R- A..............................  March 7, 2007.
 32-103.
Bombardier Alert Service Bulletin A601R- B..............................  October 18, 2007.
 32-103.
Bombardier Alert Service Bulletin A601R- C..............................  February 26, 2009.
 32-103.
----------------------------------------------------------------------------------------------------------------

 Table 4--Bombardier Credit Service Information for Screw Cap Inspection
------------------------------------------------------------------------
                 Document                               Date
------------------------------------------------------------------------
Bombardier Service Bulletin 601R-29-033..  May 5, 2009.
Bombardier Service Bulletin 601R-32-106..  May 5, 2009.
------------------------------------------------------------------------

(l) Retained Removal of the Hydraulic System No. 3 Accumulator, With No
New Service Information

    This paragraph restates the removal required by paragraph (o) of
AD 2011-23-08, Amendment 39-16859 (76 FR 71241, November 17, 2011),
with reduced compliance time for paragraph (n) of this AD, and no
new service information. Within 1,000 flight cycles after December
22, 2011 (the effective date of AD 2011-23-08), remove the hydraulic
system No. 3 accumulator, in accordance with Part B of the
Accomplishment Instructions of Bombardier Alert Service Bulletin
A601R-29-031, Revision A, dated March 26, 2009. Doing the action in
this paragraph terminates the requirements of paragraph (h) of this
AD.

(m) Retained Replacement of the Hydraulic System No. 1, Inboard Brake
and Outboard Brake Accumulators, With No New Service Information

    This paragraph restates the replacement required by paragraph
(p) of AD 2011-23-08, Amendment 39-16859 (76 FR 71241, November 17,
2011), with reduced compliance time for paragraph (o) of this AD,
and no new service information. Within 4,000 flight cycles or 24
months after December 22, 2011 (the effective date of AD 2011-23-
08), whichever occurs first, replace any hydraulic system No. 1,
inboard brake or outboard brake accumulator having P/N 601R75138-1
(08-60163-001 or 08-60163-002), with a new accumulator having P/N
601R75139-1 (11093-4), in accordance with the Accomplishment
Instructions of the applicable service bulletin identified in table
5 of this AD. Doing the action in this paragraph terminates the
requirement for the inspections in paragraph (j) of this AD for that
accumulator. As of December 22, 2011 (the effective date of AD 2011-
23-08), use only Bombardier Service Bulletin 601R-29-035, Revision
A, dated December 8, 2010; or Bombardier Service Bulletin 601R-32-
107, Revision B, dated December 8, 2010; as applicable.

                                           Table 5--Bombardier Service Information for Accumulator Replacement
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Accumulator                                Document                             Revision                              Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydraulic System No. 1................  Bombardier Service Bulletin 601R-29-035..  ..............................  May 11, 2010.
Hydraulic System No. 1................  Bombardier Service Bulletin 601R-29-035..  A.............................  December 8, 2010.
Inboard and Outboard Brake............  Bombardier Service Bulletin 601R-32-107..  A.............................  June 17, 2010.
Inboard and Outboard Brake............  Bombardier Service Bulletin 601R-32-107..  B.............................  December 8, 2010.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(n) Retained Action for Airplanes on Which Bombardier Service Bulletin
601R-29-035, Dated May 11, 2010, Is Done and Reducer Having P/N
MS21916D8-6 is Installed, With No New Service Information

    This paragraph restates the action required by paragraph (q) of
AD 2011-23-08, Amendment 39-16859 (76 FR 71241, November 17, 2011),
with reduced compliance time for paragraph (n) of this AD, and no
new service information. For airplanes on which Bombardier Service
Bulletin 601R-29-035, dated May 11, 2010, is done, and reducer
having P/N MS21916D8-6 is installed: At the later of the times
specified in paragraph (n)(1) or (n)(2) of this AD: Replace the
reducer of the hydraulic system No. 1 with a new reducer, in
accordance with Part B of Bombardier Service Bulletin 601R-29-035,
Revision A, dated December 8, 2010.
    (1) Within 1,200 flight cycles or 8 months after December 22,
2011 (the effective date of AD 2011-23-08, Amendment 39-16859 (76 FR
71241, November 17, 2011)), whichever occurs first.
    (2) Within 60 days after the effective date of this AD.

(o) Credit for Previous Actions

    (1) This paragraph provides credit for deactivating the
hydraulic system No. 3 accumulator, as required by paragraph (h) of
this AD, if the deactivation was performed before November 4, 2010
(the effective date of AD 2010-22-02, Amendment 39-16481 (75 FR
64636, October 20, 2010)) using Bombardier Alert Service Bulletin
A601R-29-031, dated December 23, 2008.
    (2) This paragraph provides credit for removing the hydraulic
system No. 2 accumulator as required by paragraph (i) of this AD, if
the removal was performed before November 4, 2010 (the effective
date of AD 2010-22-02, Amendment 39-16481 (75 FR 64636, October 20,
2010)) using Bombardier Service Bulletin 601R-29-032, dated November
12, 2009.
    (3) This paragraph provides credit for an ultrasonic inspection
for cracks as required by paragraph (j) of this AD, if the
ultrasonic inspection was performed before November 4, 2010 (the
effective date of AD 2010-22-02, Amendment 39-16481 (75 FR 64636,
October 20, 2010)), using the applicable service bulletin identified
in table 3 of this AD, or the applicable service bulletin identified
in table 4 of this AD.
    (4) This paragraph provides credit for removing the hydraulic
system No. 3 accumulator as required by paragraph (l) of this AD, if
the removal was performed before December 22, 2011 (the effective
date of AD 2011-23-08, Amendment 39-16859 (76 FR 71241, November 17,
2011)), using Bombardier Alert Service Bulletin A601R-29-031, dated
December 23, 2008.
    (5) This paragraph provides credit for replacing any inboard
brake or outboard brake accumulator as required by paragraph (m) of
this AD, if the replacement was performed before December 22, 2011
(the effective date of AD 2011-23-08, Amendment 39-16859 (76 FR
71241, November 17, 2011)), using Bombardier Service Bulletin 601R-
32-107, dated May 11, 2010.

(p) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, (ACO), ANE-170, 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 NYACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531. 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. AMOCs approved previously in accordance with AD
2010-22-02, Amendment 39-16481 (75 FR 64636, October 20, 2010), are
approved as AMOCs for the corresponding provisions of this AD. AMOCs
approved previously in accordance with AD 2011-23-08, Amendment 39-
16859 (76 FR 71241, November 17, 2011), are approved as AMOCs for
the corresponding provisions of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State

of Design Authority (or their delegated agent). You are required to
assure the product is airworthy before it is returned to service.

(q) Related Information

    Refer to MCAI Canadian Airworthiness Directive CF-2010-24, dated
August 3, 2010; and the service bulletins specified in paragraphs
(q)(1), (q)(2), (q)(3), (q)(4), (q)(5), (q)(6), (q)(7), (q)(8), and
(q)(9) of this AD; for related information.
    (1) Canadair Regional Jet Temporary Revision RJ/186-1, dated
August 24, 2010, to the Canadair Regional Jet Airplane Flight
Manual, CSP A-012.
    (2) Bombardier Alert Service Bulletin A601R-29-029, Revision B,
dated May 11, 2010, including Appendix A, dated October 18, 2007.
    (3) Bombardier Alert Service Bulletin A601R-29-031, Revision A,
dated March 26, 2009.
    (4) Bombardier Alert Service Bulletin A601R-32-103, Revision D,
dated May 11, 2010, including Appendix A, Revision A, dated October
18, 2007.
    (5) Bombardier Service Bulletin 601R-29-032, Revision A, dated
January 26, 2010.
    (6) Bombardier Service Bulletin 601R-29-033, Revision A, dated
May 11, 2010, including Appendix A, dated May 5, 2009.
    (7) Bombardier Service Bulletin 601R-29-035, Revision A, dated
December 8, 2010.
    (8) Bombardier Service Bulletin 601R-32-106, Revision A,
including Appendix A, dated May 11, 2010.
    (9) Bombardier Service Bulletin 601R-32-107, Revision B, dated
December 8, 2010.

    Issued in Renton, Washington, on April 11, 2012.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2012-9477 Filed 4-18-12; 8:45 am]
BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA, Office of Prevention, Pesticides & Toxic Substances 2. OMB control number b. G None a. 2 0 7 0  0 0 7 2 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. O Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. O Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes O No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. G Three years from approval date b. O Other Specify: 09 / 30/ 2001 7. Title Rule Related Replacement ICR to the Existing ICR entitled Reporting and Recordkeeping for Asbestos Abatement Worker Protection 8. Agency form number( s) ( If applicable) EPA ICR # 1246.08 9. Keywords Environmental Protection; Hazardous Substances; Reporting and Recordkeeping Requirements; Asbestos 10. Abstract This ICR describes the information collection activities, and related burden and costs, contained in the proposed amendment. This amendment would require employers to collect, disseminate, and maintain information relating to employee asbestos exposures, respiratory protection, medical surveillance, and training. The records maintained as a result of this information collection will provide EPA with the data necessary for effective enforcement of the WPR, as authorized under TSCA sections 6 and 8.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. Business or other for profit e. Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 25,312 b. Total annual responses 1,272,138 1. Percentage of these responses collected electronically n/ a % c. Total hours requested 436,289 d. Current OMB inventory 47,133 e. Difference + 389,156 f. Explanation of difference 1. Program Change + 389,156 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. O Recordkeeping b. O Third party disclosure c. O Reporting 1. O On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi annually 6. G Annually 7. G Biannually 8. G Other ( describe)

17. Statistical methods Does this information collection employ statistical methods? G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director, Regulatory Coordination Staff Phone: 202 260 2922 OMB 83 I 10/ 95 RECEIVED OPPT NCIC 2003 July 25 9: 56AM OPPT 2003 0041 0001 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff ( OPPTS) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division ( 2822) Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95


[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Rules and Regulations]
[Pages 22-25]
[FR Doc No: 2012-31234]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Meloxicam; Nicarbazin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect

approval actions for new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs) during October 2012.
FDA is also informing the public of the availability of summaries of
the basis of approval and of environmental review documents, where
applicable.

DATES: This rule is effective January 2, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect original and supplemental approval actions during October
2012, as listed in table 1 of this document. In addition, FDA is
informing the public of the availability, where applicable, of
documentation of environmental review required under the National
Environmental Policy Act (NEPA) and, for actions requiring review of
safety or effectiveness data, summaries of the basis of approval (FOI
Summaries) under the Freedom of Information Act (FOIA). These public
documents may be seen in the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons
with access to the Internet may obtain these documents at the Center
for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During October 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            New animal drug                            21 CFR
            NADA/ANADA                    Sponsor            product name             Action          section       FOIA summary         NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
009-476..........................  Phibro Animal Health  NICARB 25%            Supplement revising     558.366  No.................  CE \1\
                                    Corp., GlenPointe     (nicarbazin) Type A   nicarbazin dosage
                                    Centre East, Third    medicated article.    to a range
                                    floor, 300 Frank W.                         consistent with
                                    Burr Blvd., suite                           dosage approved for
                                    21, Teaneck, NJ                             use in combination
                                    07666.                                      feeds.
098-378..........................  Phibro Animal Health  NICARB 25%            Supplement revising     558.366  No.................  CE \1\
                                    Corp., GlenPointe     (nicarbazin) and      nicarbazin dosage
                                    Centre East, Third    bacitracin            to a range
                                    floor, 300 Frank W.   methylene             consistent with
                                    Burr Blvd., suite     disalicylate Type A   dosage approved for
                                    21, Teaneck, NJ       medicated articles.   use in combination
                                    07666.                                      feeds.
200-496..........................  Cross Vetpharm Group  AMPROMED P for        Original approval as    520.100  Yes................  CE \1\
                                    Ltd., Broomhill       Poultry (amprolium)   a generic copy of
                                    Rd., Tallaght,        9.6% Oral Solution.   NADA 13-149.
                                    Dublin 24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.

    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
2. In Sec.  520.100, revise paragraph (b)(4) and the introductory text
in paragraph (d)(1) to read as follows:

Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (4) No. 061623 for use of products described in paragraphs (a)(1)
and (a)(2) of this section as in paragraph (d) of this section.
* * * * *
    (d) * * * (1) Growing chickens, turkeys, and laying hens. It is
used in drinking water as follows:
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
4. In Sec.  558.366, in paragraph (d), amend the table as follows:
0
a. Revise the entries for ``90.8 to 181.6 (0.01 to 0.02 pct)''.
0
b. In the entry for ``113.5 (0.0125 pct)'', in the entry for
``Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and
intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti)

coccidiosis'', remove ``066104'' from the ``Sponsor'' column.
0
c. In the entry for ``113.5 (0.0125 pct)'', in the entry for
``Bacitracin methylene disalicylate 30'', remove ``066104'' from the
``Sponsor'' column.
    The revisions read as follows:

Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

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                                      Combination in  grams
    Nicarbazin in  grams per ton             per ton                   Indications for use                          Limitations                 Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
90.8 to 181.6 (0.01 to 0.02 pct)...  ......................  Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                                              preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard. Do not use as a
                                                              and E. brunetti) coccidiosis.            treatment for coccidiosis. Do not feed
                                                                                to laying hens. Withdraw 4 days before
                                                                                slaughter for use levels at or below
                                                                                113.5 g/ton. Withdraw 5 days before
                                                                                slaughter for use levels above 113.5 g/
                                                                                ton.
                                     Bacitracin methylene    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      disalicylate 4 to 50    preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                      and roxarsone 22.7 to   tenella) and intestinal (E.              past the time when coccidiosis is
                                      45.4.                   acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis; and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Discontinue medication 5
                                                              improved feed efficiency.                days before marketing the birds for
                                                                                human consumption to allow for
                                                                                elimination of the drug from edible
                                                                                tissue. Do not feed to laying hens in
                                                                                production. Nicarbazin as provided by
                                                                                No. 066104; bacitracin methylene
                                                                                disalicylate and roxarsone by No.
                                                                                046573 in Sec.   510.600(c) of this
                                                                                chapter.
                                     Bacitracin methylene    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      disalicylate 30.        preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard. Do not use as a
                                                              and E. brunetti) coccidiosis; and for    treatment for coccidiosis. Do not feed
                                                              increased rate of weight gain and        to laying hens. Withdraw 4 days before
                                                              improved feed efficiency.                slaughter for use levels at or below
                                                                                113.5 g/ton. Withdraw 5 days before
                                                                                slaughter for use levels above 113.5 g/
                                                                                ton.
                                     Penicillin 2.4 to 50..  Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                                              preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis, and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Do not use in flushing
                                                              improved feed efficiency.                mashes. Do not feed to chickens
                                                                                producing eggs for human consumption.
                                                                                Discontinue medication 5 days before
                                                                                marketing the birds for human
                                                                                consumption to allow for elimination
                                                                                of the drug from edible tissue.
                                                                                Penicillin as procaine penicillin G.
                                                                                Nicarbazin and penicillin as provided
                                                                                by No. 066104 in Sec.   510.600(c) of
                                                                                this chapter.

                                     Penicillin 2.4 to 50    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      and roxarsone 22.7 to   preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                      45.4.                   tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis, and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Feed as the sole source
                                                              improved feed efficiency, and improved   of organic arsenic; drug overdose or
                                                              pigmentation.                            lack of water may result in leg
                                                                                weakness; do not use in flushing
                                                                                mashes. Discontinue medication 5 days
                                                                                before marketing the birds for human
                                                                                consumption to allow for elimination
                                                                                of the drug from edible tissue. Do not
                                                                                feed to laying hens in production.
                                                                                Penicillin as procaine penicillin G.
                                                                                Nicarbazin and penicillin as provided
                                                                                by No. 066104; roxarsone by No. 046573
                                                                                in Sec.   510.600(c) of this chapter.

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

    Dated: December 21, 2012
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31234 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P