Supporting Statement for Information Collection Request Spark Ignition Marine Engine Application for Emission Certification and, Participation in the Averaging, Banking, and Trading Program 42 USC 7521 § 206 42 USC 7521 § 208 42 USC 7521 § 213( d) 40 CFR Subparts B and C November 2000 Certification and Compliance Division Office of Transportation and Air Quality Office of Air and Radiation U. S. Environmental Protection EPA  2 Part A SUBMISSION 1. Identification of the Information Collection 1 ( a) Title and Number of the Information Collection Spark Ignition Marine Engine Application for Emission Certification, and Participation in the Averaging, Banking, and Trading Program.

1( b) Short Characterization Under Title II of the Clean Air Act ( 42 U. S. C. 7521 et seq.; CAA), EPA is charged with issuing certificates of conformity for certain spark ignition engines used to propel marine vessels that comply with applicable emission standards. Such a certificate must be issued before engines may be legally introduced into commerce. To apply for a certificate of conformity, manufacturers are required to submit descriptions of their planned production line, including descriptions of the emission control system, and engine emission test data. This information is organized by " engine family", which are groups of engines expected to have similar emission characteristics. There are also record keeping requirements.

Under the regulations governing spark ignition marine engines, manufacturers must use the Averaging, Banking and Trading Program ( ABT) and must submit information regarding the calculation, actual generation and usage of emission credits in a certification application, an end of the year report, and final report. These reports are used for certification and enforcement purposes. Manufacturers will also maintain records for eight years on the engine families included in the program.

This information is collected by the Engine Programs Group ( EPG), Certification and Compliance Division ( CCD), Office of Transportation and Air Quality, Office of Air and Radiation, U. S. Environmental Protection EPA. Besides CCD, this information could be used by EPA's Office of Enforcement and Compliance Assurance ( OECA) and the Department of Justice for enforcement purposes. Information that is not confidential business  3 information ( CBI) is also disclosed in a public database and through EPA's Internet web site. It is used by trade associations, environmental groups, and the public. The information is usually submitted in an electronic format, and it is stored in EPG's certification database.

It has been estimated that a total of ten ( 10) manufacturers will respond to this collection with an approximate cost of $ 1,732,835.

2. Need for and Use of the Collection 2( a) Need/ Authority for the collection Under the Title II of the Clean Air Act, ( 42 USC 7521 et seq.), EPA is charged with issuing certificates of conformity for engines that comply with applicable emission standards. Such certificates must be issued before engines are legally introduced into commerce. To ensure compliance with these statutes, EPA reviews product information and manufacturers' emissions test results; EPA also may test some engines to confirm manufacturers' results.

EPA's emission certification programs are statutorily mandated; the EPA does not have discretion to cease these functions. Under Section 206( a) of the CAA ( 42 USC 7521):

" The Administrator shall test, or require to be tested in such manner as he deems appropriate, any new motor vehicle or new motor vehicle engine submitted by a manufacturer to determine whether such vehicle or engine conforms with the regulations prescribed under § 202 of this Act. If such vehicle or engine conforms to such regulations, the Administrator shall issue a certificate of conformity upon such terms, and for such period ( not in excess of one year) as he may prescribe."

This provision applies to spark ignition marine engines, pursuant to § 213( d) of the CAA. No fees currently apply to a manufacturer of spark ignition marine engines when applying for a certificate of conformity.  4 EPA also conducts, under 40 CFR Part 91, Subpart C, an Averaging, Banking, and Trading ( ABT) program. This program is one of many regulatory features designed to enhance compliance flexibility for, and reduce the burden on, the affected engine manufacturers, without compromising the expected emissions benefit derived from these emissions standards.

Relevant portions of the applicable statutes can be found in Appendix 1.

2( b) Practical Utility/ Users of the Data EPA uses certification information to verify that the proper test engines have been selected and that the necessary testing has been performed to assure that each engine complies with emission standards. Once the engines have been produced, EPA uses the information to support various enforcement actions including assembly line audits and in use compliance testing.

Participation in the Averaging, Banking, and Trading ( ABT) program is required. The ABT program allows manufacturers to generate emission credits. Under averaging, a manufacturer could certify one or more engine families within its product line at emission levels greater than the standard, provided the increased emissions are offset by emission reductions from one or more families certified below the standard. The average emissions ( weighted by horsepower and production) from all the manufacturer's families in a given model year must be at or below the corporate average emission standard. Additionally, the banking program would allow a manufacturer to bank emission credits generated in one model year for use in averaging or trading in subsequent model years. The trading program would allow credit transactions between manufacturers. The ABT program minimizes the economic burden on the manufacturers by allowing them to apply a fleet average technology mix to minimize their cost and maintain a variety of products. It reduces the impact of the program by allowing higher emitting engines to be off set by engines with lower emissions.

The information will be received, reviewed, and used by the Engine Programs Group ( EPG), Certification and Compliance Division, Office of Transportation and Air Quality, Office of Air and Radiation. Non confidential portions of the information  5 submitted to EPG is also used by importers, engine users, and environmental groups.

3. Nonduplication, Consultations and Other Collection Criteria 3( a) Nonduplication The information requested under this ICR is required by statue. Because of its specialized ( and sometimes confidential) nature, and the fact that it must be submitted to EPA prior to the start of production, the information collected is not available from any other source. Information requested under the ABT program is submitted voluntarily by manufacturers.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of the public comment period for this ICR renewal was published in the Federal Register ( 65 FR 53005) on August 31, 2000. No comments were received. A copy of this FR notice is provided in Appendix 2.

3( c) Consultations EPA consulted the representatives of the following respondents regarding this information collection burden.

Contact: Thomas Pugh Company: Yamaha Motor Corporation, U. S. A Phone: ( 714) 761 7807 Contact: Susan Bucheger Company: Mercury Marine Phone: ( 920) 929 4978 Contact: Christine Platt Company: Bombardier Recreational Products Phone: ( 321) 722 4021 3( d) Effects of Less Frequent Collection The CAA states that emission certification must be done on a basis not to exceed one year ( CAA 206( a)( 1)). This period coincides with the industry's " model year." Major product  6 changes typically occur at the start of a model year. For these reasons, a collection frequency of less than a model year is not appropriate. However, when an engine design is " carried over" to a subsequent model year, the amount of new information required is substantially reduced.

3( e) General Guidelines According to 40 CFR 91.121 (" Certification procedure  recordkeeping" and 91.209 (" Maintenance of records" for AB& T), certain records must be maintained for eight years. However, " records may be retained as hard copy or reduced to microfilm, ADP film, etc., depending on the manufacturer's record retention procedure, provided that in every case all the information contained in the hard copy is retained." These record keeping requirements originate, in large part, from the statutory requirement to warrant some emission related components for long periods of time. In addition, the manufacturers must comply with requirements to recall vehicles and engines failing to meet emission standards during their useful life.

Manufacturers are required to submit confidential business information such as sales volume projections and certain sensitive technical descriptions ( see section 4( b)( i) below for reference). This information is kept confidential in accordance with the Freedom of Information Act, EPA regulations at 40 CFR Part 2, and class determinations issued by EPA's Office of General Counsel. Also, non proprietary information submitted by manufacturers is held confidential until the specific engine to which it pertains is available for purchase.

No other general guideline is exceeded by this information collection.

3( f) Confidentiality Manufacturers are allowed to assert a claim of confidentiality over information provided to EPA. Confidentiality is provided in accordance with the Freedom of Information Act and EPA regulations at 40 CFR Part 2. For further detail, refer to section 3( e).

3( g) Sensitive Questions  7 No sensitive questions are asked in this information collection.

4. Respondents and Information Requested 4( a) Respondents/ SIC Codes The respondents are manufacturers of spark ignition marine engines. The following Standard Industrial Classification code is associated with this information collection:

3519 Marine engines: diesel, semi diesel, and other internal combustion 4( b) Information Requested All manufacturers must describe their product( s) and supply test data to verify compliance. This information is organized by " engine family" groups expected to have similar emission characteristics. Manufacturers must also retain records.

Generally speaking, with regard to typical certification of engines and vehicles, a manufacturer's burden for a given engine family is reduced after the model's first production year, because data and information on an engine family from previous years can be " carried over" when no significant changes have occurred. For instance, an engine family certified in model year 1998 can be certified in the 1999 model year by " carry over" of data and paperwork from the 1998 model year if no significant changes have occurred to the engine family between model years. Allowing manufacturers to " carry over" data and paperwork saves manufacturers the burden of duplication of data and paperwork which would occur in the absence of such provisions. This " carry over" provision is included in the regulations for sparkignition marine engines.

For " existing technology" engine families ( that is, those engines in production for the 1997 or previous model years that do not utilize newer technologies), the program allows a simplified certification process involving the acceptance of alternative test data. The regulations allow use of surrogate data ( that is, previous test results that may not fully comply with " certification" quality testing standards) to estimate the  8 emissions levels of existing technology engine families. However, beginning in model year 2001, all engine families must have certification quality test results. This flexibility provision of the program will allow manufacturers to focus their resources on developing the technology necessary to comply with tightening corporate average emission standards.

As noted previously, manufacturers of spark ignition marine engines are not currently required to pay a fee for engine certification.

( i) Data Items The data items in the Tables A to F are requested under these information collections. Different items are requested depending on the type and specific characteristics of the engine family to be certified. Although most of the items must be included in the certification application, some of them are only required to be kept in records and submitted upon EPA's request, as provided by 91.107( f)( 1).

EPA encourages manufacturers to apply for certification electronically, and has developed a simple electronic application format, a copy of which can be found in Appendix 3. The Spark Ignition Marine Engine Application Form is designed to be used by engine manufacturers. A complete application consists of ( 1) a Statement of Compliance, ( 2) a Family Information Form ( FIF), ( 3) a Test Information Form ( TIF), ( 4) a Part Number Information Form ( PNIF), ( 4) a Model Summary ( MS), and ( 6) an A, B & T Information form ( ABTIF).

A. Certification:

Table A Information Items Requested Under The Certification Program Item in application Information Description Basis for Requirement Signed Letter Statement of compliance 91.107( b),( d)( 1 0)& ( 11)

FAMILY INFORMATION FORM Item in application Information Description Basis for Requirement  9 1 8,14,16 Identification and description of the basic engine design including, but not limited to, the engine family specifications ( fuel, cooling medium, etc.) 91.107( d)

9 Explanation of how the emission control system operates 91.107( d)( 2)

10 Vessel type( Useful life Period) 91.105( a)

11  13 Production period, estimated volume, plant & contact 91.107( e), 91.604( 6)

15 Family Emission Limit 91.107( d)( 7) 91.208( a)( 2)

17 Adjustable Parameters description 91.107( d)( 6)

TEST INFORMATION FORM 18 20, 22 23 Test fleet description 91.107( d)( 3)

21 Service accumulation duration 91.107( d)( 5)

24  32 Cert test description & data 91.107( d)( 4)

PART NUMBER INFORMATION FORM 33, 39  50 Emission related part numbers 91.107( d)( 2)

MODEL INFORMATION FORM 34  38 Engine model description 91.107( d)( 1)

AB& T INFORMATION FORM ( 51) ( item 51 does not exist)

52 & 53 Number and type of credits 91.208( a)( 3)

54 & 55 Power & Average actual life 91.208( a)( 4)

56 Use or Source of Credit( s) 91.208( a)( 5)

The part number information form allows EPA to make sure that a production engine is actually built in its certified configuration. This information is used when conducting Selective  10 Enforcement Audits. The Selective Enforcement Program is covered by a separate ICR.

The engine Model Information Form is requested to evaluate whether engine families were developed correctly. The information contained in this form allows EPA engineers to determine whether the engine models were grouped correctly, and whether the certification test engine corresponds to the worst case within the engine family. The calculation of the engine's rated power, torque, etc., is customary business practice.

Manufacturers must use the averaging provisions to demonstrate compliance with the corporate average emission standard, and may use any " banked" emission credits for averaging or trading in the following three model years.

Table B Record keeping requirements  Certification and ABT Records are to be kept for eight years, except routine emission records that are to be kept for one year.

Copies of applications & other summary information filed with EPA 91.121( a)( 1)

Copy of all data obtained thru the production line and in use testing program 91.121( a)( 2)

A history of each test engine used for certification, including:

A description of test engine's construction 91.121( a)( 3)( i)

A description of engine's service accumulation method 91.121( a)( 3)( ii)

A description of all maintenance and other servicing performed 91.121( a)( 3)( iii)

A description of all emission tests performed 91.121( a)( 3)( iv)

A description of all tests performed to diagnose engine or emission control performance 91.121( a)( 3)( v)

A description of any significant event( s) affecting the test engine 91.121( a)( 3)( vi)

Routine data from emission testing 91.121( b)  11 When a manufacturer needs to make changes to a certified engine, or to add an engine model to an already certified engine family, the following information must be submitted. Running changes are submitted using the same electronic application template used to apply for the certificate of conformity. However, EPA asks that only the new or changed information be provided on the running change template.

Table C For Running Changes ( Amendments to the Application)

Notification of changes made to the application and request to amend the application 91.122( a)

A full description of the engine to be added, or change to be made 91.122( b)( 1)

Manufacturer's proposed test engine 91.122( b)( 2)

Engineering evaluations or reasons why the original test engine is/ is not still appropriate 91.122( b)( 3)

Upon EPA request, test data on the engine changed or added 91.122( c)

Supporting documentation, test data and engineering evaluations as appropriate to demonstrate that all affected engines will still meet applicable emission standards 91.122( e)( 1)

Further, each manufacturer is required to submit the following information:

B. Average, Banking and Trading:

Table D Record keeping Requirements under the Average, Banking and Trading Provisions Records are to be kept for eight years per 91.209( d).

EPA engine family 91.209( a)( 1)

Engine identification number 91.209( a)( 2)

Engine build date and model year 91.209( a)( 3)

Power rating 91.209( a)( 4)

Purchaser and destination 91.209( a)( 5)  12 Assembly plant 91.209( a)( 6)

Family identification code 91.209( b)( 1)

Family emission Limit 91.209( b)( 2)

Power rating 91.209( b)( 3)

Projected sales volume for the model year 91.209( b)( 4)

Actual sales volume where FEL changes during year 91.209( b)( 5)

For families participating in trading, the following records must be kept quarterly:

Actual quarterly and cumulative applicable production/ sales volume 91.209( c)( 2)

Value required to calculate credits 91.209( c)( 3)

Resulting type and number of credits generated/ required 91.209( c)( 4)

How and where credit surpluses are dispersed 91.209( c)( 5)

How and through what means credit deficits are met 91.209( c)( 6)

Table E End of Year and Final reports For each family: actual sales volume, values required to calculate credits, and number of credits generated/ required. Also: where credit surpluses were dispersed and how credit deficits were met. Copies related to credit trading. Calculation of credit balances. 91.210( a)  13 Table F Hearings If the manufacturer requests a hearing on the Administrator's denial or revocation of a certificate of conformity, then the request shall be filed within 30 days of the Administrator's decision, shall be in writing, and shall set forth the manufacturer's objections to the Administrator's decision and data to support the objections. 91.124 ( b), 91.211 ( ii) Respondent Activities The following are a manufacturer's activities associated with certifying an engine family. ( Averaging, Banking, and Trading is a required part of the certification process for spark ignition marine engines.)

$ review the regulations and guidance $ develop engine family groups $ test engines for compliance $ develop deterioration factors $ gather production volume projections for all engine families $ analyze data to determine compliance $ compile all information, prepare and submit the application $ prepare, support & submit running changes $ collect actual production volumes and engine sale $ develop and submit end of year reports $ develop and submit final reports $ maintain records, and submit them upon request 5. The Information Collected EPA Activities, Collection Methodology, and Information Management 5( a) EPA Activities A portion of EPA's emission certification activity is spent reviewing applications, verifying that the correct engines have been selected and tested, answering manufacturers' questions, issuing appropriate certificates of conformity, and storing the  14 data. A part of the certification process involves determining if " carry over" of data from a previous model year is appropriate or if new testing will be required. The EPA also analyzes requests for confidentiality and provides appropriate protection.

Historically, ( that is, for most other engine categories) certification and ABT are separate programs, because participation in the ABT program is voluntary in other programs. However, in the spark ignition marine engine program, participation in the ABT program is necessary to demonstrate compliance with the corporate average standard. The ABT program allows manufacturers to certify to a corporate average emission standard and to earn emission credits on cleaner engine families and use them to certify engine families with emission levels above the standards. As has been described above, this feature provides special flexibility to marine engine manufacturers. The average emissions of all the manufacturer's spark ignition marine engine families participating in the program must not exceed the corporate average standards.

The following are EPA's activities associated with certifying an engine family:

$ Answer respondent questions $ review the regulations and guidance $ Enter applications into database $ Review applications $ Review running changes & Corrections $ Issue appropriate certificates $ Store data $ Answer questions from the public $ Review end of year report $ Review final report $ Enter data from reports into database 5( b) Collection Methodology and Management EPA currently makes extensive use of computers in evaluating information from vehicle and engine manufacturers. All manufacturers use the electronic format provided by EPA to submit certification applications. Once the email or diskette containing the application is received, the application is entered into the certification database and reviewed for completeness. ( Manufacturers no longer submit applications in hard copy.) The certification reviewer analyzes the application to ensure compliance with the CAA and applicable regulations. Nonconfidential parts of the application can be accessed by the public by contacting the Engine Programs Group or through OTAQ's  15 " Engine Certification Information Center" web site located on the Internet at www. epa. gov/ omswww/ certdata. htm.

EPA receives the complete application by electronic transmission directly from the manufacturer, further reducing costs and burden for both the industry and the EPA. Currently, the Statement of Compliance is required to be submitted in hard copy.

As necessary, the manufacturer submits applications for running changes, or corrections to previous submittals. Running changes would be necessary whenever a manufacturer makes an emission related change during its production period. A correction is necessary when previously submitted information is erroneous. These applications, also submitted electronically, contain only information that is different from that previous submitted ( that is, a complete application is not required). These applications are reviewed by EPA.

EPA makes use of computerized screening and use of senior technical aids provided through the Senior Environmental Employees Program ( SEEP). Essentially all of the review of new applications, running changes, and corrections are conducted by senior aids. EPA staff review the end of year and final reports to ensure that compliance is achieved by manufacturer's on the basis of the actual production volumes and corporate average standards.

5( c) Small Entity Flexibility EPA has determined that the final regulations do not have a significant impact on a substantial number of small entities. It appears that there may be at most two small entities affected by this rule. Therefore, there are no specific procedures for small spark ignition marine engine manufacturers to use for demonstrating compliance with the general standards and specific emission requirements.

However, EPA finalized many flexibilities for smaller volume OB/ PWC engine manufacturers, and smaller volume families, such as: corporate average standard, nine year phase in, multi year averaging, reduced certification submission for " existing technology" engines, use of surrogate data for certification, and exemption from production line testing, SEA & in use testing, emission defect reporting, reporting of voluntary emission recalls, and warranty provisions.  16 The information being requested from spark ignition marine engine manufacturers is considered to be the minimum needed to effectively conduct and maintain integrity of the required certification and enforcement programs. Further measures to simplify reporting for small businesses do not appear prudent or necessary.

EPA has no certification application fee for spark ignition marine engines.

5( d) Collection Schedule Collection frequency is largely determined by the manufacturer's marketing and product plans. Information must be submitted for each " model year" that a manufacturer intends to build ( or import) an engine model, and a certificate of conformity must be obtained each year before the start of production ( or importation) of each engine family. Taking these two considerations into account, manufacturers are encouraged to submit their applications at their earliest convenience.

Running change and correction applications are submitted by manufacturers as the need occurs.

6. Estimating the Burden and Cost of the Collection Refer below to Tables 1 to 4 for details.

6( a) Estimating Respondent Burden Estimates of respondent burden hours were taken from comments from fewer than 10 respondents consulted by EPA, for each of the activities listed in Table 1.

Average labor rates, for different categories of labor, are discussed below in Table 2 of section 6( b)( i).  17

Table 1: Respondent Burden Average Hours Per Respondent Per Engine Family ACTIVITY Technical ( engineer) Exec/ Mgr Admin Supp &

Cler Machine/ Te st Cell Operator Inspectors Transportati on &

Material Moving Labor Hours for Activity review regulations/ guidance 4.0 5.7 1.0 0.0 0.0 0.0 10.7 develop engine family groups 2.3 0.2 1.3 0.0 0.0 0.0 3.8 test engines for compliance 19.7 13.3 0.7 21.3 0.0 1.3 56.3 develop deterioration factors 11.3 4.3 3.3 38.0 0.0 3.3 60.3 gather prod'n volume projection and emission data 1.0 8.7 14.0 0.0 0.0 0.0 23.7 analyze data to determine compliance 11.0 6.0 0.7 0.0 0.0 0.0 17.7 compile information, prepare, submit application 1.3 14.0 3.7 0.0 0.0 0.0 19.0 prepare, support & submit running changes 6.3 5.3 2.0 3.3 0.0 0.7 17.7 collect actual prod'n volumes and engine sales 1.0 3.3 5.3 0.0 0.0 0.0 9.7 develop and submit end of year reports 1.3 6.0 5.3 0.0 0.0 0.0 12.7 develop and submit final reports 0.7 5.7 1.0 0.0 0.0 0.0 7.3 maintain records, and submit them upon request 0.2 3.0 7.3 0.0 0.0 0.0 10.5 Sum of Column ( Hours) 60.2 75.5 45.7 62.7 0.0 5.3 249.333 Average Labor Rate $/ hr ( from Table 2) $ 44.50 $ 65.00 $ 30.00 $ 33.50 $ 35.00 $ 23.50 Labor Cost for Column $ 2,677.42 $ 4,907.50 $ 1,370.00 $ 2,099.33 $ 0.00 $ 125.33 Cost Per Eng Fam ( Sum of all Labor Cost Columns) $ 11,179.58 Total Labor Burden Hours for Industry ( 155 Eng Fam) 38,647 Total Labor Cost for Industry ( 155 Eng Fam) $ 1,732,835  18 6( b) Estimating Respondent Costs ( i) Estimating Labor Costs The hourly rates, for the labor categories related to certification, were provided from the respondents listed above in Section 3( c). Table 2 below lists the average hourly rates for these labor categories, and include the cost of salaries, fringe benefits, such as paid leave, health insurance, retirement savings, and legally required benefits and other overhead costs such as office space, furniture, equipment and computers, supplies and other business expenses. ( Note: Table 2 lists several labor categories for which labor rates were not necessary to determinate the respondent burden estimated above in Table 1.)

Table 2: Average Labor Rates LABOR CATEGORY AVERAGE HOURLY RATE Professional Specialty ( e. g., legal) $ 65.00 Technical ( e. g., engineer) $ 44.50 Executive/ Managerial $ 65.00 Admin Support & Clerical $ 30.00 Precision Production, craft & repair

Machine/ Test Cell Operator $ 33.50 Assemblers

Inspectors $ 35.00 Transportation & Material Moving $ 23.50 Equipment Cleaners, Helper & Laborers

Service

Other

For an average engine family, the labor cost per labor category is determined by multiplying the average labor rate for the labor category ( from Table 2) by the burden time for the labor category for all of the activities. The total labor cost for an average engine family is the sum of these labor category costs for all labor categories. As displayed above in Table 1, the total labor cost for an engine family is calculated to be $ 11,179.58.

The estimate of total labor cost for all respondents is determined by multiplying the cost of an average engine family by the  19 estimated number of engine families ( which is currently 155). The total labor cost for all respondents, as displayed above in Table 1, is calculated to be $ 1,732,835.

The certification and ABT program are no longer new for this industry, and EPA believes that the manufacturers will not have to spend as much time reviewing regulations. However, EPA listed " review of regulations" as a separate activity in the burden table because the program began with 1998 model year engines and manufacturers may require some time each year to re familiarize themselves with the regulations and/ or guidance. Therefore, the burden associated with the occasional review of the regulations is included as an activity above in Table 1.

( ii) Estimating Capital and Operations and Maintenance Costs Capital costs were covered by the original ICR and incurred by engine manufacturers at the beginning ( that is, during " start up") of the certification programs. Therefore, these costs are excluded from this ICR.

Operation and Maintenance costs associated with this information collection include computer diskettes, photocopying, and postage expenses. From information in our certification database, diskettes are used for roughly 40 percent of the engine families that are submitted as original (" new submission") electronic applications. In model year 2000, there were 155 " new submission" applications ( one per engine family). ( The other 60 percent of the engine families applications are submitted using electronic mail over the internet.) Twenty four ( 24) percent of running changes ( RC) are sent on diskettes, usually with a 2 page cover letter. ( Seventy six ( 76) percent of running changes are sent by email). There were 91 running changes in model year 2000. All manufacturers must submit a signed hard copy of their statement of compliance, and this is mailed to EPA with a cover page ( for a total of 2 pages). Postage applies to both the diskette and statement of compliance ( SOC), at an estimated $ 10.00 per package. Diskettes are estimated to cost $ 0.50 each. As noted above, there is currently no certification fee. Photocopying is estimated at $ 0.20 per page. An estimate of annual operation and maintenance costs related to submission of the required information is determined as follows:

Postage costs: ($ 10.00/ package)[( 155) + ( 0.24)( 91)] = $ 1,768.40  20 Diskettes costs: ($ 0.50/ disk)[( 0.40)( 155) + ( 0.24)( 91)] = $ 42.00 Copying costs: ($ 0.20/ page)[( 2 pages/ SOC)( 155) + ( 2 pages/ RC)( 0.24)( 91)] = $ 71.40 TOTAL RESPONDENT OPERATION AND MAINTENANCE COST: $ 1,768.40 + $ 42.00 + $ 71.40 = $ 1,881.80 On a per engine family basis: ($ 1,881.80)/( 155) = $ 12.14 per engine family The average operation and maintenance cost ($ 12.14 per engine family), is very small ( about 0.1 percent) compared with the labor cost per engine family determined for respondents above in Table 1.

EPA does not expect any new spark ignition marine engine manufacturers in the near future.

( iii) Capital/ Start There are no capital or start up costs associated with the renewal of this ICR. ( See 6( b)( ii) for details.)

( iv) Annualizing capital costs There are no capital costs associated with the renewal of this ICR. ( See 6( b)( ii) above for details.)

6( c) Estimating EPA Burden Table 3 below estimates both EPA's burden hours and costs. The burden hours is based on interviews with EPA technical staff and senior aids that are responsible for the listed activities associated with certification and ABT. Currently, the activities listed above under section 5( a) for the certification application are conducted by senior aids hired under the senior environmental employment program ( SEEP). EPA staff reviews only the activities listed above under section 5( a) related to averaging, banking and trading. The costs of Table 3 is calculated by multiplying the indicated labor hours by the labor cost discussed as follows.

Government cost is based on GS 13 salary for professional engineers and on support of a senior aid. The government hourly salary rate ($ 29.18/ hr), when multiplied by 1.6 ( the multiplier required by ICR guidelines) produces $ 46.69/ hour, an hourly pay rate that purports to reflect the true cost to the federal government to  21 employ such staff. The government hourly rate was obtained from the web site of the Office of Personnel Management entitled " 2000 General Schedule, Locality Rates of Pay for Washington DC, Effective January 2000" ( http:// www. opm. gov/ oca/ 2000tbls/ GShrly/ html/ GSHRDCB. HTM).

The hourly cost for the senior aid is determined by adding the employees salary ($ 5,767.38), fringe benefits ($ 1,730.22), and administrative costs ($ 1,316.70), all paid by EPA, for 7 pay periods ( that is, for 14 weeks at 32 hours per week). These costs include fringe benefits and administrative costs. The calculation produces a labor cost for a senior aid of $ 19.67/ hour. These costs are available from Certification and Compliance Division's administrative data.  22

Table 3 : Estimated Annual EPA Burden Hours and Cost Activity per Engine Family: EPA Engr Hours EPA Engr Cost @

$ 46.69/ hr Senior Aid Hours Senior Cost @

$ 19.67/ hr Applications per Year1 Labor Cost/ Year per Eng Family Answer respondent questions 0.0 $ 0.00 0.5 $ 9.84 155 $ 9.84 Review the regulations and guidance 0.0 $ 0.00 0.3 $ 4.92 155 $ 4.92 Enter applications into database 0.0 $ 0.00 0.8 $ 14.75 155 $ 14.75 Review application 0.0 $ 0.00 1.5 $ 29.51 155 $ 29.51 Review running changes & Corrections 0.0 $ 0.00 0.8 $ 14.75 155 $ 14.75 Issue appropriate certificate 0.0 $ 0.00 0.5 $ 9.84 155 $ 9.84 Store data 0.0 $ 0.00 0.3 $ 4.92 155 $ 4.92 Answer questions from the public 0.0 $ 0.00 0.1 $ 1.97 155 $ 1.97 Review end of year report 0.1 $ 4.67 0.0 $ 0.00 155 $ 4.67 Review final report 0.2 $ 9.34 0.0 $ 0.00 155 $ 9.34 Enter data from reports into database 0.1 $ 4.67 0.0 $ 0.00 155 $ 4.67 Column Sub totals 0.4 $ 18.68 4.6 $ 90.48 Cost per Engine Family $ 109.16 Total Cost per Year for 155 Eng Fam2 $ 16,919.49 1 Based on model year 2000 data.

2 Ten ( 10) manufacturers.  23 An estimate of the labor cost for an average engine family is determined by multiplying the appropriate average labor rate by the estimated average burden time per activity. The total labor cost to EPA for an average engine family, as displayed above in Table 3, is estimated to be $ 109.16.

The estimate of total annual cost to EPA for all certification activity is determined by multiplying the cost of an average engine family by the estimated number of engine families each year ( which is currently 155). EPA's total labor cost, as displayed above in Table 3, is calculated to be $ 16,919.49.

6( d) Estimating the Respondent Universe and Total Burden and Costs There were 11 respondents in model year 1999, and 10 in model year 2000. EPA expects no new manufacturers to enter the program.

In model years 1999 and 2000, EPA respectively received 156 and 155 certification applications from spark ignition marine engine manufacturers. An annual average of one hundred seventeen ( 117) of these applications come from 4 of the manufacturers. In 1999, seventy two ( 72) certification applications relied upon carry over emissions test data and, in 2000, ninety one ( 91) relied on carryover data.

Over the two model years, an annual average of Ninety eight ( 98) running changes were submitted by manufacturers, an average of 9.8 running changes per manufacturer or, 0.6 running changes per certification application. All of the manufacturers participate in the ABT Program.

6( e) Bottom Line Burden Hours and Cost Tables ( i) Respondent Tally Table 4 Total Estimated Respondent Burden And Cost Summary Program Number of Respond Number of Activities Total Hours Per Year Total Labor Cost Per Year Total Annual Capital Costs Total Annual O& M Costs Certification ( w/ ABT) 10 12 38,647 $ 1,732,835.42 $ 0.00 $ 0.00  24 ( ii) The EPA Tally Table 5 Total Estimated EPA Burden And Cost Summary Program Number of Respond Number of Activities Total Hours Per Year Total Labor Cost Per Year Total Annual Capital Costs Total Annual O& M Costs Certification (+ ABT) 10 11 775.0 $ 16,919.49 $ 0.00 $ 0.00 6( f) Reasons for change in burden Table 6 Change in Respondent Burden Program Previous ICR ( hours) Current ICR ( hours) Change Category Certification (+ ABT) 51,099 38,647 ( 12,452) program adjustment Based on comparison of the total annual hours of the previouslyapproved ICR and that determined by the current ( that is, today's) ICR supporting statement, respondents' total burden hours has decreased. As noted above in Table 6, the total burden hours of the respondents has decreased from the previous ICR by ( 12,452) hours per year.

Today's ICR presents a decrease in burden on respondents for several reasons, all of which are considered " program adjustments". First, the previous ICR estimated that additional time would be necessary during the first program year for respondents to become familiar with program requirements and provisions. Second, while the previous ICR contemplated the current use of electronically submitted submissions of software based certification applications based on limited use of similar applications in other regulated industry, today's ICR is based on the actual use of such submissions, both by the actual respondents and EPA. This application format and submittal means reduces respondents' burden in terms of the time and cost related to the traditional use of paper products, such as assembly, copying, mailing, and storage. Finally, today's ICR is based solely on information provided from actual consultations with  25 individuals of the specific regulated industry ( as is discussed in above sections), whereas the previous ICR was based on adjustments made by EPA to information provided by manufacturers of another industry ( on highway, heavy duty engines).

6( g) Burden Statement Spark ignition marine engine manufacturers spend, on average, 3,865 hours per respondent annually to get their entire production certified. This is determined by dividing the total industry burden hours of Table 1 by the number of respondents ( 10).

These estimates include time to review applicable regulations and guidance documents, generate and gather the necessary information, submit applications and reports, and maintain records.

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 EPA. 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 EPA 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 EPA'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 Sandy Farmer, U. S. Environmental Protection Agency, Collection Strategies Division ( Mail Code 2822), 1200 Pennsylvania Avenue, NW, Washington DC 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 and OMB control number in any correspondence. Attachment 1 Legal Authority:

Clean Air Act, as amended;

Title II Emission Standards for Moving Sources Motor Vehicle and Motor Vehicle Engine Compliance Testing and Certification. § 206( a)( 1) The Administrator shall test, or require to be tested in such manner as he deems appropriate, any new motor vehicle or new motor vehicle engine submitted by a manufacturer to determine whether such vehicle or engine conforms with the regulations prescribed under section 202 of this Act. If such vehicle or engine conforms to such regulations, the Administrator shall issue a certificate of conformity upon such terms, and for such period ( not in excess of one year) as he may prescribe..." [ 42 USC 7525]

§ 208. Information Collection. ( a) Manufacturer's Responsibility. Every manufacturer ... shall establish and maintain records, ... make reports and provide information the Administrator may reasonably require to determine whether the manufacturer ... is acting in compliance with this part and part C and regulations thereunder, or to otherwise carry out the provision of this part and part C, and shall, upon request of an officer or employee duly designated by the Administrator, permit such officer or employee at reasonable times to have access to and copy such records. [ 42 USC 7542]

§ 213 Nonroad Engines and Vehicles.( d) Enforcement. The standards under this section shall be subject to sections 206, 207, 208, and 209, with such modifications of the applicable regulations implementing such sections as the Administrator deems appropriate, and shall be enforced in the same manner as standards prescribed under section 202. The Administrator shall revise or promulgate regulations as may be necessary to determine compliance with, and enforce, standards in effect under this section. [ 42 USC 7547]

Attachment 2  27 Attached is the Federal Register announcement ( 65 FR 53005; August 31, 2000) of the public comment period for this ICR renewal.  28 Attachment 3 The attached 8 pages are a print out of the software Certification Application Template.

Upon approval by OMB of the requested extension, the following information will be added:

OMB Control Number Expiration Date 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 EPA. 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 EPA 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.


[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Notices]
[Page 35090]
[FR Doc No: 2016-12948]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, June 2,
2016 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: May 26, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-12948 Filed 5-27-16; 11:15 am]
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[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45466-45467]
[DOCID:fr05au08-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2008-D-0399]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex on
Disintegration Test General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 5: Disintegration Test General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Disintegration Test General
Chapter harmonized text from each of the three pharmacopoeias (United
States, European, and Japanese) represented by the Pharmacopoeial
Discussion Group (PDG). The draft guidance conveys recognition of the
three pharmacopoeial methods by the three ICH regulatory regions and
provides specific information regarding the recognition. The draft
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. This draft
guidance is the fifth annex to the core Q4B guidance, which was made
available in the Federal Register of February 21, 2008 (73 FR 9575).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 6, 2008.

ADDRESSES: 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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 400N, Rockville, MD
20852-1448. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. Send two self-addressed
adhesive labels to assist the office in processing your requests.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the draft guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
    Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-1), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with

harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In June 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 5: Disintegration Test General
Chapter'' should be made available for public comment. The draft
guidance is the product of the Q4B Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q4B Expert
Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Disintegration Test General Chapter
harmonization proposal originating from the three-party PDG. This draft
guidance is in the form of an annex to the core ICH Q4B guidance. Once
finalized, the annex will provide guidance to assist industry and
regulators in the implementation of the specific topic evaluated by the
ICH Q4B process.
    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 agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http://www.fda.gov/cber/guidelines.htm.

    Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17864 Filed 8-4-08; 8:45 am]

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