                             SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

A.	JUSTIFICATION

1.	IDENTIFICATION OF INFORMATION COLLECTION

a)	Title: NESHAP for Radionuclides (40 CFR part 61, subparts B, K, R and W) (Renewal)

      EPA Number 1100.14, OMB Number 2060-0191

b)	Short Characterization

      On July 31, 2012, OMB approval to collect information associated with National Emission Standards for Hazardous Air Pollutants (NESHAPs) relative to radionuclides will expire.  This renewal request is for continued collection of information from various source categories.  The information to be collected is non-statistical in nature and, therefore, only Part A of the supporting statement requesting for OMB approval under the Paperwork Reduction Act and 5 CFR 1320 is addressed below.
      On January 24, 2012 (77 FR 3472), EPA requested comments on specific aspects of this ICR, with the comment period closing on March 26, 2012.  By this deadline, there were no comments.
      On December 15, 1989, pursuant to Section 112 of the Clean Air Act as amended in 1977 (42 USC 1857), the Environmental Protection Agency (EPA) promulgated NESHAPs to control radionuclide emissions from several source categories.  The regulations were published in 54 FR 51653, and are codified at 40 CFR Part 61 subparts B, K, R, and W, and impose the following radionuclide dose and emission standards:

      Subpart B--Underground Uranium Mines		- 10 mrem/yr

      Subpart K--Elemental Phosphorous Plants 		- 2 curies/yr

      Subpart R--Phosphogypsum Stacks			- 20 pCi/m[2]-s

      Subpart W--Uranium Mill Tailings			- 20 pCi/m[2]-s

      Originally there were seven subparts:B, H, I, K, R, T and W--that were published in the December 15, 1989 Federal Register (54 FR 51653).  Since the 1989 notice, subparts I and T are no longer regulated by EPA.  Due to petitions for reconsideration, EPA rescinded subpart T as it applies to owners and operators of uranium mill tailings disposal sites licensed by NRC or an affected Agreement State on July 15, 1994, 59 FR 36280.  Subpart I as it applies to NRC-licensed facilities was rescinded on December 30, 1996 (61 FR 68971) because in the 1990 Clean Air Act amendments, Congress directed EPA to stop regulating radionuclide emissions from NRC licensed facilities if EPA determines that the NRC regulatory program protects the public health with an ample margin of safety.  After careful review, EPA determined that public health would be protected with an ample margin of safety by NRC's program.  Subpart H does not require an ICR because it covers Federal facilities, which are not subject to the Paperwork Reduction Act.  The existing subpart I of the radionuclide NESHAP now only applies to non-DOE federal facilities not licensed by NRC.   The non-DOE federal facilities not licensed by NRC, namely, DoD facilities, are expected to have emissions below 1% of the standards and are therefore not subject to the reporting requirements.
      Information collected is used by EPA to ensure that public health continues to be protected from the hazards of airborne radionuclides by compliance with these standards.  If the information were not collected, it is unlikely that a violation of these standards would be identified and, thus, there would be no corrective action initiated to bring the facilities back into compliance.  Compliance is demonstrated through emission testing and/or dose calculation.  All facilities are required to monitor and calculate emissions, and maintain their records for 5 years.  The rationale for the 5 year record keeping requirement is from the Code of Federal Regulations (CFR), 40 CFR part 61, Section 61.95.  In some cases, facility operators also report their results to EPA.
2. NEED FOR AND USE OF THE COLLECTION
      (a) Need/Authority for the Collection
      In the context of the Clean Air Act (42 USC 1857), Section 114 authorizes the Administrator of EPA to require any person who owns or operates any emission source or who is subject to any requirements of the Act to:
      - Establish and maintain records
      - Make reports, install, use, and maintain monitoring equipment or method
      - Sample emissions in accordance with EPA-prescribed locations, intervals and methods
      - Provide information as may be requested
      (b) Practical Utility/Users
      EPA's regional offices use the information collected to ensure that public health continues to be protected from the hazards of radionuclides by compliance with health based standards.
      EPA's compliance monitoring activities vary widely.  EPA could issue a letter requesting information about compliance or could conduct a full -  scale investigation, including on-site inspections.
      When EPA first learns of a compliance problem, EPA attempts to remedy the problem by holding informal discussions with the owner/operator of the source.  If it is not possible to remedy the problem informally, formal action is taken.  EPA's Clean Air Act Compliance Enforcement Guidance Manual identifies the Agency's informal and formal enforcement operating procedures.
3.  NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA
    (a)  Non-duplication
    In accordance with 40 CFR Part 61, the specific information requested by this notice is not currently collected by any other office within EPA or any other governmental agency.
    (b) Public Notice Required Prior to ICR Submission to OMB
    On January 24, 2012 (77 FR 3472), EPA requested comments on specific aspects of this ICR, with a 60 day comment period which closed on March 26, 2012.  Specifically, there were no comments received from affected entities or the general public by this deadline.
    (c) Consultations
    In developing the regulations, EPA gathered extensive background information on the affected facilities.  In addition to background information collected from the regulated sources, public comments were received during the rulemaking process and they are contained in the public docket.  Since the rules were promulgated, there have been opportunities for dialogue between EPA and affected facilities which have resulted in changes to the rules, memorandums of understanding, and rescissions.  In preparing this request, EPA also contacted contractors, EPA and State staff, and facility emission monitoring and compliance professionals.  As a result of these consultations and the provision in the Clean Air Act Amendments, EPA was able to eliminate duplication of effort between EPA and NRC in instances where EPA determined that the NRC program could provide protection of the public health with an ample margin of safety.
    (d)  Effects of Less Frequent Collection
    All reporting is annually or less frequent than annually.
    (e)  General Guidelines
      This ICR meets OMB's collection guidelines, had no public comments during the comment period which ended March 26, 2012, and does not duplicate another collection.
    (f)	Confidentiality
      This section does not apply because this ICR does not request information of confidential nature.
	(g) Sensitive Questions
      This section is not applicable because this ICR does not request sensitive information.

4.  THE RESPONDENTS AND THE INFORMATION REQUESTED
      (a) Respondents NAICS Codes
      The NAICS Codes associated with the activity of the respondents are:
      Elemental Phosphorous		-   325188
      Phosphogypsum Stacks		-   212392
      Underground Uranium Mines		-   212291
      Uranium Mill Tailings		-   212291
      (b) Information Requested
      Descriptions of the reporting requirements are listed separately for each subpart.
Reporting
Subpart B - Underground Uranium Mines
      The mine owner or operator shall annually calculate and report the results of the compliance calculations and the input parameters used in making the calculation.  The compliance calculations include using 40 CFR part 61, Appendix B, Method 115 to calculate the source terms used in the program COMPLY-R which calculates the dose.  The report shall cover the emissions of a calendar year and shall be sent to EPA by March 31 of the following year.  Each report shall also include the following information:
      (1) The name and location of the mine (including latitude and longitude),
      (2) The name of the person responsible for the operation of the facility and the name of the person preparing the report (if different),
      (3) The results of the emissions testing conducted and the dose calculated using the procedures in Section 61.23,
      (4) A list of the stacks or vents or other points where radioactive materials are released to the atmosphere, including their location, diameter, flow rate, effluent temperature and release height,
      (5) A description of the effluent controls that are used on each stack, vent, or other release point and the effluent controls used inside the mine, and an estimate of the efficiency of each control method or device,
      (6) Distances from the points of release to the nearest residence, school, business or office and the nearest farms producing vegetables, milk and meat,
      (7) The values used for all other user-supplied input parameters for the computer model and the source of these data,
      (8) Each report shall be signed and dated by a corporate officer in charge of the facility and contain the following declaration immediately above the signature line:  "I certify under penalty of law that I have personally examined and am familiar with the information submitted herein and based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate and complete.  I am aware that there are significant penalties for submitting false information including the possibility of fine and imprisonment.  See 18 U.S.C. 1001."
       In order to complete the Subpart B reporting requirements respondents will:
      a.  read and understand the regulatory provision,
      b.  perform radon-222 emission measurements as required in Appendix B, Method 115,
      c.  perform data analysis including Method 115 source term calculations and COMPLY-R dose calculation,
      d.  prepare and submit report.
      For recordkeeping requirements, all facilities are required to calculate, monitor, and maintain their records for five years and upon request be made available for inspection by the Administrator, or his/her authorized representative.  (See Table B)
Subpart K - Elemental Phosphorus Plants
      Each owner or operator of an elemental phosphorus plant shall test emissions from the plant annually according to the procedures in Section 61.123 and using the test methods in Section 61.125.
      Each owner or operator of an elemental phosphorus plant shall furnish the Administrator with a written report on the results of the emission test within 60 days of conducting the test.  The report must provide the following information:
      (1) The name and location of the facility (including latitude and longitude),
      (2) The name of the person responsible for the operation of the facility and the name of the person preparing the report (if different),
      (3) A description of the effluent controls that are used on each stack, vent or other release point and an estimate of the efficiency of each device,
      (4) The results of the testing, including the results of each sampling run completed,
      (5) The values used in calculating the emissions and the source of these data,
      (6)  Each report shall be signed and dated by a corporate officer in charge of the facility and contain the following declaration immediately above the signature line:  "I certify under penalty of law that I have personally examined and am familiar with the information submitted herein and based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate and complete.  I am aware that there are significant penalties for submitting false information including the possibility of fine and imprisonment.  See, 18 U.S.C. 1001."
      In order to complete these reporting requirements respondents will:
      a.  read and understand the regulatory provision,
      b.  perform the emission monitoring and test procedures in Section 61.125,
      c.  perform data analysis including calculation of annual emission rate,
      d.  prepare and submit the report to EPA.
      For recordkeeping requirements, all facilities are required to calculate, monitor, and maintain their records for five years and upon request be made available for inspection by the Administrator, or his/her authorized representative.  (See Table K)
Subpart R- Phosphogypsum Stacks
      Sixty days following the date at which a stack becomes an inactive stack the owners or operators of the inactive phosphogypsum stack shall test the stack in accordance with the procedures described in 40 CFR part 61, Appendix B, Method 115.  This is a one-time report.  However, if an owner or operator removes phosphogypsum from an inactive stack, the owner shall test the stack once a year for every year in which phosphogypsum is removed from the stack.
      EPA shall be notified at least 30 days prior to an emission test so that EPA may, at its option, observe the test.  Ninety days after the testing is required, the owner or operator shall provide EPA with a report detailing the actions taken and the results of the radon-222 flux testing.  Each report shall also include the following information:
      (1) The name and location of the facility,
      (2) A list of the stacks at the facility including the size and dimensions of the stack,
      (3) The name of the person responsible for the operation of the facility and the name of the person preparing the report (if different),
      (4) A description of the control measures taken to decrease the radon flux from the source and any actions taken to insure the long term effectiveness of the control measures, and
      (5) The results of the testing conducted, including the results of each measurement,
      (6) Each report shall be signed and dated by a corporate officer in charge of the facility and contain the following declaration immediately above the signature line:  "I certify under penalty of law that I have personally examined and am familiar with the information submitted herein and based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate and complete. I am aware that there are significant penalties for submitting false information including the possibility of fine and imprisonment. See 18 U.S.C. 1001."
      Also, the owner or operator of the stack from which the phosphogypsum is removed shall determine annually the average radium-226 concentration at the location in the stack from which the phosphogypsum will be removed as provided by Section 61.207.  Each distributor, retailer, or reseller who distributes phosphogypsum for use in agriculture shall prepare certification documents which conform to the requirements of Section 61.208.
      The owner or operator of a stack from which phosphogypsum will be removed and distributed in commerce pursuant to Section 61.204, Section 61.205, or Section 61.206 shall prepare a certification document for each quantity of phosphogypsum which is distributed in commerce which includes:
      (1) The name and address of the owner or operator,
      (2) The name and address of the purchaser or recipient of the phosphogypsum,
      (3) The quantity (in pounds) of phosphogypsum sold or transferred,
      (4) The date of sale or transfer,
      (5) The average radium-226 concentration, in pCi/g, of the phosphogypsum to Section 61.207, and
      (6) The signature of the person who prepared the certification.
      Each distributor, retailer, or reseller who purchases or receives phosphogypsum for subsequent resale or transfer shall prepare a certification document for each quantity of phosphogypsum which is resold or transferred which includes:
      (1) The name and address of the owner or operator,
      (2) The name and address of the purchaser or recipient of the phosphogypsum,
      (3) The quantity (in pounds) of phosphogypsum sold or transferred,
      (4) The date of resale or transfer,
      (5) A description of the intended end use for the phosphogypsum,
      (6) A copy of each certification document which accompanied the phosphogypsum at the time it was purchased or received by the distributor, retailer, or reseller, and
      (7) The signature of the person who prepared the certification.  Submission of certification documents to EPA is not a requirement.
In order to complete these reporting requirements respondents will:
      a.  read and understand the regulatory provision,
      b.  perform the radon flux testing in Section 61.203,
      c.  perform radium-226 sampling and measurement procedures in Section 61.207 (if required),
      d.  perform data analysis including Method 115 radon flux or radium-226 concentration calculations,
      e.  prepare and submit the report and prepare a certification document if required.
      For record keeping requirements, all facilities are required to calculate, monitor, and maintain their records for five years and upon request be made available for inspection by the Administrator, or his/her authorized representative.  (See Table R)
Subpart W - Uranium Mill Tailings
      The owners or operators of operating existing mill impoundments shall report the results of the compliance calculations required in Section 61.253 and the input parameters used in making the calculation for each calendar year shall be sent to EPA by March 31 of the following year.  Each report shall also include the following information:
      (1) The name and location of the mill,
      (2) The name of the person responsible for the operation of the facility and the name of the person preparing the report (if different),
      (3) The results of the testing conducted, including the results of each measurement,
      (4) Each report shall be signed and dated by a corporate officer in charge of the facility and contain the following declaration immediately above the signature line:  "I certify under penalty of law that I have personally examined and am familiar with the information submitted herein and based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate and complete. I am aware that there are significant penalties for submitting false information including the possibility of fine and imprisonment. See 18 U.S.C. 1001."
In order to complete these reporting requirements respondents will:
      a.  read and understand the regulatory provision,
      b.  perform testing required in 40 CFR part 61, Appendix B, Method 115,
      c.  perform data analysis including Method 115 radon flux calculations,
      d.  prepare and submit the report to EPA.
      For record keeping requirements, all facilities are required to calculate, monitor, and maintain their records for five years and upon request be made available for inspection by the Administrator, or his/her authorized representative.  (See Table W)

Record Keeping
      The record keeping requirements of each subpart are similar and have been summarized in the paragraph below.
      The owner or operator of the facility must maintain records documenting the source of input parameters including the results of all measurements upon which they are based, the calculations and/or analytical methods used to derive values for input parameters, and the procedure used to determine compliance.  This documentation should be sufficient to allow an independent auditor to verify the accuracy of the determination made concerning the facility's compliance with the standard.  These records must be kept at the mill or facility for at least five years and, upon request, be made available for inspection by the Administrator, or his/her authorized representative.
5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
      (a) Agency Activities
      Information being collected is pursuant to Federal regulation. Agency activities consist of reviewing owner or operator test reports and maintaining files.
      (b) Collection Methodology and Management
      The Office of Radiation and Indoor Air and the EPA regional offices have planned and allocated resources for the efficient and effective management and use of this information.
      Records must be maintained documenting the source of input parameters including the results of all measurements upon which they are based, the calculations and/or analytical methods used to derive values for input parameters, and the procedure used to determine effective dose equivalent.  This documentation should be sufficient to allow an independent auditor to verify the accuracy of the determination made concerning the facility's compliance with the standard.  These records must be kept at the site of the facility for at least five years and, upon request, be made available for inspection by the Administrator, or the Administrator=s authorized representative.
      The Agency has determined that the annual report review and periodic on site inspection is the most effective method to insure compliance.  EPA regional office staff review facility annual reports to determine if compliance with the regulatory standards are being maintained.  Verification of data is accomplished by recalculation of dose using computer models and conducting site inspections or witnessing an emission test.
      (c) Small Entity Flexibility
      None of the regulations covered by this ICR are applicable to small entities.
      (d) Collection Schedule
      For some subparts, annual reports are required to provide yearly certification of compliance with a health based standard; therefore, less frequent reporting was not considered an option to reduce burden because of the yearly stipulation in the rule.  However, for other subparts (such as subpart R), it was determined during rulemaking that less frequent reports were adequate to protect public health.
	6.  ESTIMATING THE BURDEN AND COST OF THE COLLECTION
      Burden and costs estimates have been calculated separately for each subpart.  Respondent
labor rates are based on `mean' values from the May 2011 data of the US Department of Labor, Bureau of Labor Statistics (BLS) for the mining industrial sector.  These national industry-specific occupational employment and wage estimates are calculated with data collected from employers of all sizes, in metropolitan and non-metropolitan areas in every State and the District of Columbia, in NAICS 212200 - Mining (except Oil and Gas).  These rates are increased by 120% in the cost estimate to include inflation and overhead.  The labor key is as follows: Management (Mgmt) ($127.93/hr) was based on the Total Compensation for the Management Occupational Group in the mining sector in the BLS data.  Technical (Tech) was based on the mean salary for "all production operations" ($71.32/hr) in the mining sector which includes mining machine operators, water and liquid waste treatment plant and system operators, and chemical plant and system operators.  Clerical (Cler) ($48.04/hr) was based on the Total Compensation for the Office and Administrative Support Occupations in the mining sector in the BLS data.
        The tables representing each subpart are listed below with their reporting requirement information.  (Note: Subpart R has 2 tables; Table 1 represents the 18 stacks required to complete a one-time report. Table 2 represents 1 stack that has to conduct radon flux testing and sampling for radium-226 every year when phosphogypsum is removed from the stacks.)  Table 2 is actually a placeholder because phosphogypsum is currently not being removed from any stacks for distribution in commerce; however, since it is possible in the next three-year period, we include one stack.
Information Collection                                 Hours and Costs for Underground Uranium Mines                          Total Hours and Costs/Activity

                                   Table B.

Subpart B-- Underground Uranium Mines

Manager

$128/h

Technical

$71.00/h

Clerical

$48.00/h

Respond.
hours/
year

Labor cost/year/Respond.

Total Capital/
startup cost

Total
O & M
Cost

Number of Respon.

Total hours/
year

Total cost/
year

Reporting

Read and understand the regulatory provision (Mgmt)

                                      10

                                      10

                                    $1,280

                                       4

                                      40

                                    $5,120

Perform emission monitoring (Tech.)

                                      160

                                      160

                                    $11,360

                                    $30,000

                                    $20,000
                                       4

                                      640

                                    $95,440

Perform data analysis (Technical)

                                      40

                                      40

                                    $2,840

                                       4

                                      160

                                    $11,360

Prepare report (Mgmt)

                                      10

                                      10

                                    $1,280

                                       4

                                      40

                                    $5,120

Record Keeping

File and maintain data (Clerical)

                                      10

                                      10

                                    $   480

                                       4

                                      40

                                    $1,920

TOTAL

                                      20

                                      200

                                      10

                                      230

                                    $17,240

                                    $30,000

                                    $20,000
                                       4

                                      920

                                   $118,960

Assumptions:
1.  Capital/start up cost: = $30K
2.  Annual cost (O & M): 4 facilities x $5,000 = $20,000
B -- Underground Uranium Mines
      In order to complete Subpart B reporting requirements respondents will:
         a. read and understand the regulatory provision,
         b. perform radon-222 emission measurements as required in 40 CFR part 61, Appendix B, Method 115,
         c. perform data analysis including Method 115 source term calculations and dose calculation using an approved model
         d. prepare and submit report.
      -  The estimated capital/start-up cost includes the monitoring equipment needed to perform Method 115 testing for one mine.
      -  Capital/start-up burden includes understanding regulatory provisions and installation of equipment (there was limited capital cost in this cycle since only one new mine needed to purchase capital equipment, (and subsequently closed).  Other mines that reopened had equipment at the site.
      -  Estimated annual costs related to testing include calibration, and repairs costs.
      -  Estimated annual burden hours collecting emission data from monitoring equipment and performing data analysis and calculations, report preparation and data management.
      -  Based on reports received during the reporting period, only 4 mines at this time are venting and required to submit a report due to downturns in the price of uranium.

Information Collection                                 Hours and Costs for Elemental Phosphorus                        Total Hours and Costs/Activity

                                                            Table  K

Subpart K-- Elemental Phosphorus Plants

Manager

$128/hour

Technical

$71/hour

Clerical

$48/hour

Respon.
hours/
year

Labor cost/year

Total Capital/
startup cost

Total
O & M
Cost

Number of Respon.

Total hours/
year

Total cost/
year

Reporting

Read and understand the regulatory provision (Mgmt)

                                      10

                                      10

                                    $1,280

                                       1

                                      10

                                    $1,280

Perform emission monitoring (Tech.)

                                      240

                                      240

                                    $17,040

                                    $5,559

                                       1

                                      240

                                    $22,599

Perform data analysis (Technical)

                                       8

                                       8

                                   $     568

                                       1

                                       8

                                     $568

Prepare report (Mgmt)

                                      10

                                      10

                                  $     1,280

                                       1

                                      10

                                    $1,280

Record Keeping

File and maintain data (Clerical)

                                      10

                                      10

                                   $     340

                                       1

                                      10

                                     $340

TOTAL

                                      20

                                      248

                                      10

                                      278

                                    $20,498

                                    $5,559

                                       1

                                      278

                                    $26,207

Assumptions:
1. Capital/start up cost: 0 facilities x $0 = $0
2. Annual cost (O & M): 1 facilities x $5,559 = $5,559

K--Elemental Phosphorus Plants
      In order to complete these reporting requirements respondents will:
      a.	read and understand the regulatory provision,
      b.	perform the emission monitoring and test procedures in Section 61.125,
      c.	perform data analysis including calculation of annual emission rate,
      d.	prepare and submit the report to EPA.
      - It is estimated that 1 facility will complete these reporting requirements.
      - The estimated cost for a contractor to complete testing is $5,559.

	Information Collection Activity	   Hours and Costs for Phosphogypsum Stack    		Total Hours and Costs/Activity

                                   Table R1

Subpart R-- Phosphogypsum Stacks

Manager

$128/hour

Technical

$71/hour

Clerical

$48/hour

Respond.
Hours/
year

Labor cost/year/Respond.

Total Capital/
startup cost

Total
O & M
Cost

Number of Respon.

Total hours/
year

Total cost/
year

Reporting

Read and understand the regulatory provision (Mgmt)

                                      10

                                      10

                                    $1,280

                                      10

                                      100

                                    $12,800

Perform emission monitoring (Tech.)

                                      64

                                      64

                                    $4,544

                                   $105,000
                                      10
                                      640

                                   $150,440

Perform data analysis (Technical)

                                      12

                                      12

                                    $   852

                                      10
                                      120

                                    $8,250

Prepare report (Mgmt)

                                      10

                                      10

                                   $   1,280

                                      10
                                      100

                                    $12,800

Record Keeping

File and maintain data (Clerical)

                                      10

                                      10

                                    $   480

                                      10

                                      100

                                    $4,800

TOTAL

                                      20

                                      76

                                      10

                                      106

                                    $8,436

                                   $105,000
                                      10

                                     1,060

                                   $189,360
	Assumptions: Tables R1 & R2
	1. Capital/start up cost: 10 facilities x $0 = $0; (Table 2) 10 facilities x $0 = $0
      	2. Annual cost (O & M): 10 facilities x $10,500 = $105,000   (Table 2)  1 facilities x $10,000 = $10,000.
		Total O & M for Tables R1 & R2 = $105,000 + $115,000 = $220,000

      Information Collection Activity        Hours and Costs Per Respondent                                 Total Hours and Costs/Activity

                                   Table R2

Subpart R--  Phosphogypsum Stacks

Manager

$128/hour

Technical

$71/hour

Clerical

$48/hour

Respond.
Hours/
year

Labor cost/year/Respond.

Total Capital/
startup cost

Total
O & M
Cost

Number of Respond.

Total hours/
year

Total cost/
year

Reporting

Read and understand the regulatory provision (Mgmt)

                                      10

                                      10

                                    $1,280

                                       1

                                      10

                                    $1,280

Perform radon flux testing (Tech.)

                                      64

                                      64

                                    $4,544

                                    $10,500
                                       1
                                      64
                                    $15,044

Perform radium-226 sampling and measurement proce-    dures (Tech.)

                                      48

                                      48

                                    $3,408

                                   $105,000
                                       1
                                      48
$108,408

Prepare data analysis (Tech.)

                                      12

                                      12

                                     $ 852

                                       1
                                      12
                                     $852

Prepare report and certification papers (Mgmt)

                                      10

                                      10

                                    $1,280

                                       1

                                      10

                                    $1,280

Record Keeping

File and maintain data (Clerical)

                                      20

                                      20

                                     $960

                                       1
                                      100
                                     $960

TOTAL

                                      20

                                      124

                                      20

                                      164

                                    $12,324

                                   $115,500
                                       1
                                      244
                                   $127,824

R-Phosphogypsum
      In order to complete these reporting requirements respondents will:
      a.	read and understand the regulatory provision,
      b.	perform the radon flux testing in Section 61.203,
      c.	perform radium-226 sampling and measurement procedures in Section 61.207 (if required),
      d.	perform data analysis including Method 115 radon flux or radium-226 concentration calculations,
      e.	prepare and submit the report and certification document if required.
      - It is estimated that the testing materials for 300 flux measurements and the analysis is obtained from a contract source at a cost of $35/measurement.
      - It is estimated that it will take four days for two people to place, collect and ship 300 samples to a testing lab.
      - It is estimated that 10 stacks will be required to complete this one-time report since they have active air permits.
	- It is estimated that 1 phosphogypsum stack will have to conduct radon flux testing every year.  Phosphogypsum is not removed from any stacks at this point in time, however we use one facility in this calculation in anticipation that some removal may occur during the next three years.  For these stacks, the radium-226 concentration must also be determined and included in certification papers. Radon flux measurements for these sites will be as discussed above.  Section 61.207 requires a minimum of 30 samples from each area where phosphogypsum is being removed from the stack.  Additional sampling is required where the concentrations approach 10 pCi/g Ra-226.  Therefore, we  conservatively estimate that 100 samples per stack will be necessary to document radium-226 concentrations and that radium analysis will be at $100 per sample from a contract source.  It is estimated that it will take two people three days to collect prepare and ship the samples.
Information Collection                                 Hours and Costs Per Respondent                                        Total Hours and Costs/Activity

                                    Table W

Subpart W-- Uranium Mill Tailings Piles

Manager

$128/hour

Technical

$71/hour

Clerical

$48/hour

Respond.
Hours/
year

Labor cost/year/Respond.

Total Capital/
startup cost

Total
O & M
Cost

Number of Respond.

Total hours/
year

Total cost/
year

Reporting

Read and understand the regulatory provision (Mgmt)

                                      10

                                      10

                                    $1,280

                                       5

                                      50

                                    $7,140

Perform radon flux testing (Tech.)

                                      32

                                      32

                                    $2,272

                                    $35,000

                                       5
                                      160
                                    $46,360

Perform data analysis (Technical)

                                      12

                                      12

                                     $ 852

                                       5

                                      60

                                    $4,260

Prepare report (Mgmt)

                                      10

                                      10

                                    $1,280

                                       5
                                      50
                                    $6,400

Record Keeping

File and maintain data (Clerical)

                                      10

                                      10

                                     $ 480

                                       5

                                      50

                                    $2,400

TOTAL

                                      20

                                      44

                                      10

                                      74

                                    $6,164

                                    $35,000

                                       5

                                      370

                                    $65,820
Assumptions:
1. Capital/start up cost: 0 facilities x $0 = $0
2.  Annual cost (O & M): 5 facilities x $7,000 = $35,000
W--Uranium Mill Tailings
      In order to complete these reporting requirements respondents will:
      a.	read and understand the regulatory provision,
      b.	perform radon flux testing required in 40 CFR part 61, Appendix B, Method 115,
      c.	perform data analysis including Method 115 radon flux calculations,
      d.	prepare and submit the report to EPA.
      - It is estimated that the testing materials for 200 measurements and the analysis is obtained from a contract source at a cost of $35/measurement.
      - It is estimated that it will take one day for two people to place 100 canisters and one for two people to collect the canisters and ship them to a testing lab.
      - It is estimated that 5 facilities will file a report annually.
      - The estimated cost for a contractor to complete the testing is $2,834
SUMMARY OF BURDEN ESTIMATE FOR RESPONDENTS
Subpart
No of Respondents
Capital/Start-up Cost
(O & M) Cost
Annual Burden Hours
Annual Costs

                                       B
                                       4
                                                                        $30,000
                                                                       $20,000
                                                                            920
                                                                      $118,960

                                       K
                                       1
                                                                             $0
                                                                        $5,559
                                                                            278
                                                                       $26,207

                                       R
                                      10
                                                                             $0
                                                                      $220,500
                                                                          1,304
                                                                      $317,184

                                       W
                                       5
                                                                             $0
                                                                       $35,000
                                                                            370
                                                                       $65,820

                                    Totals

                                      20

                                                                        $30,000

                                                                       $281,059

2,872

                                                                       $528,171

Average annual burden per response:  2,872 hours/20 respondents = 144hours.  For capital with a 20 year life, and assuming 5% discount rate, the annualized cost is 8.02% of the capital cost.
      Total Annualized capital/start up cost: $30,000 x 0.082 = $2,460
      Total Annualized Capital and O&M Costs: $2,460+ $281,000 = $283,460.
      Total Costs: $283,460 (annualized capital and O&M) + $217,112 (labor) = $500,572
ESTIMATED AGENCY BURDEN AND COST
The burden to the EPA is only for reviewing the reports submitted by the regulated community to ensure that emissions and dose are within the limits set by the regulations. The main burden is on the regulated community as they have to monitor emissions, compile the data, and submit the necessary reports for compliance purposes. The estimated agency burden and costs are as shown in the table below.   Agency salaries were found in 2012 General Schedule Salary Table.  The data for review of reports for compliance was based on the salary scale for GS-13, step 5 (Tech), with a multiplier of 1.6 to include overhead; this resulted in $62.27/hr.  For the Clerical category, the salary scale for a GS-9, step 5 (Cler) was used with a multiplier of 1.6 to account for overhead; this resulted in $36.11/hr.
SUMMARY OF BURDEN ESTIMATE FOR THE AGENCY

AGENCY

Capital/Start-Up Burden Hours

Capital/Start-up Cost

Annual Burden Hrs per Report

Annual Costs per Report

Review  reports for compliance verification (Tech)

                                                                             10

                                                                        $30,000

                                                                       4@$62/hr

                                                                           $248

File reports (Cler)

                                                                      4@ $36/hr

                                                                           $144

SUB-TOTAL

                                                                             10

                                                                        $30,000

                                                                             40

                                                                           $392

Total for 20 Respondents

                                                                         $7,840

EXPLANATION OF BURDEN ESTIMATE CHANGE
      Some burden estimates decreased because the number of affected facilities has decreased due to a reduced interest in underground uranium mining.  The number of sites under Subpart W has also decreased, as has the number of facilities under Subpart R.  Some costs relative to monitoring phosphgypsum concentrations have risen due to increased costs of Radium-226 sampling, yet only one facility may be subject to sampling since removal of phosphogypsum for alternate uses has decreased substantially.
      Burden Statement:  The annual public reporting and record keeping burden for this collection of information is estimated to average 144 hours per response.  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.
      To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID HQ-EPA-OAR-2003-0085, which is available for public viewing at the Office of Indoor Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Office of Indoor Air and Radiation Docket is<PHONE_NUMBER>.
      An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments 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.  Please include the EPA Docket ID OAR-2003-0085 and OMB Control Number 2060-0191 in any correspondence.


[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Page 2976]
[FR Doc No: 2022-01000]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT:  To be published.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:  Thursday, January
20, 2022 at 2 p.m.

CHANGES IN THE MEETING:  The Closed Meeting scheduled for Thursday,
January 20, 2022 at 2 p.m. has been changed to Thursday, January 20,
2022 at 2:15 p.m.

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.
    Authority: 5 U.S.C. 552b.

    Dated: January 13, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-01000 Filed 1-14-22; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: November 12, 2008 (Volume 73, Number 219)]
[Proposed Rules]
[Page 66811-66815]
[DOCID:fr12no08-26]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2008-N-0561]

Maximum Civil Money Penalty Amounts and Compliance With the
Federal Civil Penalties Inflation Adjustment Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing this
companion proposed rule to the direct final rule, published elsewhere
in this issue of the Federal Register, which is intended to amend our
regulations to adjust for inflation the maximum civil money penalty
amounts for the various civil money penalty authorities within our
jurisdiction. We are taking this action to comply with the Federal
Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended.
The last adjustment was published in the Federal Register of July 20,
2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust
their civil money penalties at least once every 4 years. This proposed
rule does not adjust the civil money provisions

enacted by the Food and Drug Administration Amendments Act of 2007
(FDAAA).

DATES: Submit written or electronic comments on the proposed rule by
December 26, 2008. If FDA receives any timely significant adverse
comments, the agency will publish a document withdrawing the direct
final rule within 30 days after the comment period ends. FDA will then
proceed to respond to comments under this proposed rule using the usual
notice-and-comment procedures.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0561, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. FDA-2008-N-0561 for this rulemaking. All comments
received may be posted without change to  http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to  http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In general, the FCPIAA (28 U.S.C. 2461 note, as amended by the Debt
Collection Improvement Act of 1996 (31 U.S.C. 3701)) requires Federal
agencies to issue regulations to adjust for inflation each civil
monetary penalty provided by law within their jurisdiction. The FCPIAA
directs agencies to adjust the civil monetary penalties by October 23,
1996, and to make additional adjustments at least once every 4 years
thereafter. The adjustments are based on changes in the cost of living,
and the FCPIAA defines the cost of living adjustment as: `` * * * the
percentage (if any) for each civil monetary penalty by which--(1) the
Consumer Price Index for the month of June of the calendar year
preceding the adjustment, exceeds (2) the Consumer Price Index for the
month of June of the calendar year in which the amount of such civil
monetary penalty was last set or adjusted pursuant to law'' (28 U.S.C.
2461 note, section 5(b)).
    The FCPIAA also prescribes a rounding method based on the size of
the penalty after the calculated increase, but states that the first
adjustment of a civil monetary penalty may not exceed 10 percent of the
penalty.
    The FCPIAA defines a civil monetary penalty as: ``any penalty,
fine, or other sanction that--(A)(i) is for a specific monetary amount
as provided by Federal law; or (ii) has a maximum amount provided for
by Federal law; and (B) is assessed or enforced by an agency pursuant
to Federal law; and (C) is assessed or enforced pursuant to an
administrative proceeding or a civil action in the Federal Courts'' (28
U.S.C. 2461 note, section 3(2)).
    Congress enacted the FCPIAA, in part, because it found that the
impact of civil monetary penalties had been reduced by inflation and
that reducing the impact of civil monetary penalties had weakened their
deterrent effect.
    In the Federal Register of July 20, 2004 (69 FR 43299), we
published a final rule that identified 14 civil monetary penalties that
fall within our jurisdiction and are subject to adjustments under the
FCPIAA. The final rule amended our regulations governing civil money
penalties hearings found at part 17 (21 CFR part 17) to establish a new
Sec.  17.2 entitled ``Maximum penalty amounts'' to show the maximum
civil monetary penalty amounts that were adjusted under the FCPIAA. The
final rule also revised Sec.  17.1, which lists statutory provisions
authorizing civil money penalties governed by the civil money penalty
regulations as of August 28, 1995, updating the statutory citations.

II. What Changes Did We Make?

    We revised the list of statutory monetary penalties in Sec.  17.1
to include the new penalties prescribed by the Federal Food, Drug, and
Cosmetic Act, as amended by FDAAA in 2007. These new penalties have
been added as proposed new paragraphs (c) and (d). The table in Sec.
17.2 has also been amended to include the new penalties, and the
adjusted maximum penalty amounts for the pre-FDAAA penalties have been
updated to account for the inflation between June 2004 (the year of the
last adjustment) and June 2007 as prescribed by FCPIAA. The per
violation amount for 21 U.S.C. 333(f)(1)(A), the per violation per
person amount for 21 U.S.C. 360pp(b)(1), and the per violation amount
for 42 U.S.C. 263b(h)(3) have not been adjusted because the rounding
rules of FCPIAA prevent an inflation adjustment in these cases. The new
FDAAA penalties have also not been adjusted because Congress only
recently passed FDAAA on September 27, 2007. Finally, the ``Description
of the Violation'' column in the table in Sec.  17.2 is proposed to be
removed, as it is unnecessary for purposes of merely showing the
adjustment in penalty amounts.

III. What is Proposed?

    In brief, the proposed rule would:
     Revise Sec.  17.1 to update the statutory citations
regarding the new civil monetary penalties prescribed by FDAAA, and
     Revise the table in Sec.  17.2 to include the new FDAAA
penalties, and adjusts the pre-FDAAA maximum civil penalty amounts for
inflation as prescribed by FCPIAA.

IV. Additional Information

    This proposed rule incorporates requirements specifically set forth
in the FCPIAA requiring FDA to issue a

regulation implementing inflation adjustments for all its civil penalty
provisions. These technical changes, required by law, do not
substantively alter the existing regulatory framework, nor do they in
any way affect the terms under which civil penalties are assessed by
FDA. The formula for the amount of the penalty adjustment is prescribed
by Congress in the FCPIAA, and these changes are not subject to the
exercise of discretion by FDA. In addition, FDA has made conforming
changes to the regulations, which have no substantive effect, to
reflect the new penalties prescribed by Congress in FDAAA.
    This proposed rule is a companion to the direct final rule
published elsewhere in this issue of the Federal Register. This
companion proposed rule and the direct final rule are identical in
substance. This companion proposed rule will provide the procedural
framework to proceed with standard notice-and-comment rulemaking in the
event the direct final rule receives significant adverse comment and is
withdrawn. The comment period for the companion proposed rule runs
concurrently with the comment period of the direct final rule. Any
comments received under the companion proposed rule will be treated as
comments regarding the direct final rule and vice versa.
    A significant adverse comment is one that explains why the rule
would be inappropriate, including challenges to the rule's underlying
premise or approach, or would be ineffective or unacceptable without
change. A comment recommending a rule change in addition to this rule
will not be considered a significant adverse comment unless the comment
states why this rule would be ineffective without the additional
change.
    If no significant adverse comment is received in response to the
direct final rule, no further action will be taken related to the
companion proposed rule. Instead, we will publish a confirmation
document within 30 days after the comment period ends. We intend the
direct final rule to become effective 30 days after publication of the
confirmation document.
    If we receive significant adverse comments, we will withdraw the
direct final rule. We will proceed to respond to all the comments
received regarding the direct final rule, treating those comments as
comments to this proposed rule. The agency will address the comments in
the subsequent final rule. We will not provide additional opportunity
for comment. If we receive a significant adverse comment which applies
to part of the rule and that part may be severed from the remainder of
the rule, we may adopt as final those parts of the rule that are not
the subject of significant adverse comment.
    For additional background information, see the corresponding direct
final rule published elsewhere in this issue of the Federal Register.

V. Environmental Impact

    We have determined under 21 CFR 25.30(a) and (h) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. Paperwork Reduction Act 1995

    We conclude that the civil monetary penalties adjustments in this
proposed rule are not subject to review by the Office of Management and
Budget because they do not constitute a ``collection of information''
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
adjustments do not require disclosure of any information to FDA, third
parties, or the public.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VIII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule simply proposes to adjust
the maximum amount of civil monetary penalties administered by FDA, and
because the adjustment is required by the FCPIAA, the agency certifies
that the proposed rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

IX. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
This comment period runs concurrently with the comment period for the
direct final rule; any comments received will be considered as comments
regarding the direct final rule. 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.

List of Subjects in 21 CFR Part 17

    Administrative practice and procedure, Penalties.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 17 is amended as follows:

PART 17--CIVIL MONEY PENALTIES HEARINGS

    1. The authority citation for 21 CFR part 17 continues to read as
follows:

    Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.
    2. Section 17.1 is amended by redesignating paragraphs (c) through
(g) as paragraphs (e) through (i) and by adding new paragraphs (c) and
(d) to read as follows:

Sec.  17.1  Scope.

* * * * *
    (c) Section 303(f)(3) of the act authorizing civil money penalties
for certain violations relating to the submission of certifications
and/or clinical trial information to the clinical trial data bank and
section 303(f)(4) of the act authorizing civil money penalties for
certain violations of the act relating to postmarket studies, clinical
trial requirements, and risk evaluation and mitigation strategies for
drugs.
    (d) Section 303(g)(1) of the act authorizing civil money penalties
for certain violations of the act that relate to dissemination of
direct-to-consumer advertisements for approved drugs or biological
products.
* * * * *
    3. Section 17.2 is revised to read as follows:

Sec.  17.2  Maximum penalty amounts.

    The following table shows maximum civil monetary penalties
associated with the statutory provisions authorizing civil monetary
penalties under the act or the Public Health Service Act.

  Civil Monetary Penalties Authorities Administered by FDA and Adjusted
                         Maximum Penalty Amounts
------------------------------------------------------------------------
               Former                                          Adjusted
              Maximum                        Date of Last      Maximum
  U.S.C.      Penalty       Assessment      Penalty Figure     Penalty
  Section    Amount (in       Method         or Adjustment    Amount (in
              dollars)                                         dollars)
------------------------------------------------------------------------
21 U.S.C.
------------------------------------------------------------------------
  333(b)(2  55,000       For each of the               2008       60,000
   )(A)                   first two
                          violations in
                          any 10-year
                          period
------------------------------------------------------------------------
  333(b)(2  1,100,000    For each                      2008    1,200,000
   )(B)                   violation after
                          the second
                          conviction in
                          any 10-year
                          period
------------------------------------------------------------------------
  333(b)(3  110,000      Per violation                 2008      120,000
   )
------------------------------------------------------------------------
  333(f)(1  16,500       Per violation                 2008  16,500 (not
   )(A)                                                        adjusted)
------------------------------------------------------------------------
  333(f)(1  1,100,000    For the                       2008    1,200,000
   )(A)                   aggregate of
                          violations
------------------------------------------------------------------------
  333(f)(2  55,000       Per individual                2008       60,000
   )(A)
------------------------------------------------------------------------
  333(f)(2  275,000      Per ``any other               2008      300,000
   )(A)                   person''
------------------------------------------------------------------------
  333(f)(2  550,000      For all                       2008      600,000
   )(A)                   violations
                          adjudicated in
                          a single
                          proceeding
------------------------------------------------------------------------
  333(f)(3  10,000       For all                       2007  10,000 (not
   )(A)                   violations                           adjusted)
                          adjudicated in
                          a single
                          proceeding
------------------------------------------------------------------------
  333(f)(3  10,000       For each day the              2007  10,000 (not
   )(B)                   violation is                         adjusted)
                          not corrected
                          after a 30-day
                          period
                          following
                          notification
                          until the
                          violation is
                          corrected
------------------------------------------------------------------------
  333(f)(4  250,000      Per violation                 2007      250,000
   )(A)(i)                                                          (not
                                                               adjusted)
------------------------------------------------------------------------
  333(f)(4  1,000,000    For all                       2007    1,000,000
   )(A)(i)                violations                                (not
                          adjudicated in                       adjusted)
                          a single
                          proceeding
------------------------------------------------------------------------
  333(f)(4  250,000      For the first 30-             2007      250,000
   )(A)(ii                day period (or                            (not
   )                      any portion                          adjusted)
                          thereof) of
                          continued
                          violation
                          following
                          notification
------------------------------------------------------------------------
  333(f)(4  1,000,000    For any 30-day                2007    1,000,000
   )(A)(ii                period, where                             (not
   )                      the amount                           adjusted)
                          doubles for
                          every 30-day
                          period of
                          continued
                          violation after
                          the first 30-
                          day period
------------------------------------------------------------------------
  333(f)(4  10,000,000   For all                       2007   10,000,000
   )(A)(ii                violations                                (not
   )                      adjudicated in                       adjusted)
                          a single
                          proceeding
------------------------------------------------------------------------

  333(g)(1  250,000      For the first                 2007      250,000
   )                      violation in                              (not
                          any 3-year                           adjusted)
                          period
------------------------------------------------------------------------
  333(g)(1  500,000      For each                      2007      500,000
   )                      subsequent                                (not
                          violation in                         adjusted)
                          any 3-year
                          period
------------------------------------------------------------------------
  335b(a)   275,000      Per violation                 2008      300,000
                          for an
                          individual
------------------------------------------------------------------------
  335b(a)   1,100,000    Per violation                 2008    1,200,000
                          for ``any other
                          person''
------------------------------------------------------------------------
  360pp(b)  1,100        Per violation                 2008   1,100 (not
   (1)                    per person                           adjusted)
------------------------------------------------------------------------
  360pp(b)  330,000      For any related               2008      355,000
   (1)                    series of
                          violations
------------------------------------------------------------------------
42 U.S.C.
------------------------------------------------------------------------
  263b(h)(  11,000       Per violation                 2008  11,000 (not
   3)                                                          adjusted)
------------------------------------------------------------------------
  300aa-28  110,000      Per occurrence                2008      120,000
   (b)(1)
------------------------------------------------------------------------

    Dated: October 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26864 Filed 11-10-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73736-73737]
[FR Doc No: 2012-29844]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket No. NHTSA-2012-0169]

Reports, Forms, and Recordkeeping Requirements: Agency
Information Collection Activity Under OMB Review

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

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatements of previously approved collections. This
document describes one collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before February 11, 2013.

ADDRESSES:  Refer to the docket notice number cited at the beginning of
this notice and send your 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 Ave. 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 Ave. SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jonathan Walker, contract task order
manager, Office of Regulatory Analysis and Evaluation, National Highway
Traffic Safety Administration, 1200 New Jersey Ave. SE., NVS-432,
Washington, DC 20590. Mr. Walker's phone number is<PHONE_NUMBER> and his
email address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulations (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following: (i)
Whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information will have practical utility; (ii) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) How to enhance the quality, utility, and clarity of the
information to be collected; and (iv) How to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology, e.g., permitting electronic submissions of responses. In
compliance with these requirements, NHTSA asks public comment on the
following proposed collection of information:
    Title: Tire Pressure Monitoring Systems Special Studies.
    Type of Request: Renewal.
    OMB Clearance Number: 2127-0626.
    Form Number: This collection of information uses no standard forms.
    Required Expiration Date of Approval: June 30, 2016.

Abstract

    The National Highway Traffic Safety Administration (NHTSA) is an
agency within the U.S. Department of Transportation. NHTSA has issued
Corporate Average Fuel Economy (CAFE) standards for light vehicles
since 1978 under the statutory authority of the Energy Policy and
Conservation Act (EPCA). The Energy Independence and Security Act
(EISA), enacted on December 19, 2007, amended EPCA and mandated that
NHTSA, in consultation with EPA, set fuel economy standards for medium
and heavy-duty (MD/HD) on-highway vehicles and work trucks to the
maximum feasible level in each model year, providing four full model
years of regulatory lead-time. 49 U.S.C. 32902 requires the agency to
implement test methods, measurement metrics, fuel economy standards,
and compliance and enforcement protocols that are

appropriate, cost-effective, and technologically feasible for the
various vehicle classes.
    The first MD/HD fuel consumption standards, covering model year
2014-2018 vehicles, built on many years of engine and vehicle
technology development to achieve what the agency believes is the
greatest degree of fuel consumption reduction consistent with
principles of technological and economic feasibility. In addition to
taking aggressive steps that are reasonably possible now, the agency is
committed to continue learning about this complex sector to further
reduce fuel consumption through future regulatory steps. This special
study is aligned with this commitment, by improving NHTSA's
understanding of three operational characteristics related to MD/HD
trucks that impact the estimation of regulatory costs and benefits for
the next phase of MD/HD fuel economy rulemaking covering model years
2019 and beyond.
    The first topic for which this special study seeks to gather data
is known as the ``fuel economy rebound effect.'' As the operating cost
per mile driven decreases due to improved vehicle fuel economy, a
``rebound effect'' may occur (i.e., demand for trucking operations may
increase, resulting in increased vehicle miles traveled (VMT) across
MD/HD fleets). The magnitude of this effect is a subject of
uncertainty; therefore, a survey to gather data on the relationship
between VMT and operating cost per mile will help to refine estimates
of the rebound effect.
    This special study also seeks to gather data to profile the
characteristics of MD/HD vehicle refueling trips, in effort to estimate
the value of time saved at the pump due to improvements in fuel
economy. With the 2017-2025 MY light-duty vehicle CAFE rule, NHTSA
utilized survey data gathered at refueling stations to quantify this
regulatory impact; however, no analogous data exist for MD/HD vehicles.
    NHTSA also seeks to estimate the value of time savings that may
result from the implementation of active tire pressure monitoring
systems in MD/HD vehicles, as these systems are among the fuel-economy-
improving technologies under evaluation for future standards. To
properly estimate this value, data are needed on the frequency with
which maintenance staff or vehicle operators check tire pressures and
how many minutes a tire pressure check and adjustment takes.
    Description of the Likely Respondents (Including Estimated Number,
and Proposed Frequency of Response to the Collection of Information): A
list of MD/HD truck fleet operators will be developed and a sub-set of
these operators will be contacted for initial pre-screening to
determine survey eligibility. To be deemed eligible for inclusion,
fleet operators must operate MD/HD fleets consisting of one or more
vehicle classes ranging from class 2b through class 8. The sample will
include sufficient diversity to gather data on all class 2b through
class 8 MD/HD vehicles. Respondents will include management or other
administrative staff with knowledge of macro-level fleet data and
operational policies.
    100 or more responding sample units are sought. To achieve this
target, it is estimated that the initial sample be comprised of 200 MD/
HD truck fleet operators, allowing for a response rate minimum of 50
percent. The universe under study includes the entirety of MD/HD truck
fleet operators.
    Separately, a list of between 20 and 30 refueling locations will be
developed, identifying those areas at which to survey MD/HD truck
drivers to gather additional data regarding refueling and tire pressure
maintenance activities. Collection of up to 4,000 successful responses
is desired, from a universe comprised of all Class 2b through Class 8
truck drivers, and sufficient overall sample diversity must be present
to gather data on all MD/HD classes. Allowing for a 50 percent response
rate, up to 8,000 interview attempts may be required.
    There will be separate survey instruments for fleet operators and
for vehicle drivers. These survey instruments will target fleet
operators or vehicle drivers as appropriate with questions intended to
gather data on the following topics:
    (1) Data to facilitate analysis of MD/HD truck fuel economy rebound
effect.
    (2) Data to facilitate analysis of MD/HD truck refueling practices.
    (3) Data regarding the maintenance of cab and trailer tire
pressures.
    The survey of vehicle drivers will utilize in-person interviews as
the sole method of data collection. The survey of fleet operators will
involve telephone interviews, web-based forms, and--if necessary to
meet response rate objectives--hard copy forms.
    Estimate of the Total Annual Reporting and Recordkeeping Burden
Resulting From the Collection of Information: NHTSA estimates that the
average length of time to complete the fleet operator survey will be 30
minutes per respondent for a successful response (equivalent to a total
of 100 hours in the event that the full sample responds), plus an
additional 10 minutes each (or a total of approximately 33 hours) for
the initial pre-screening to determine respondent eligibility.
Consequently, the total fleet operator respondent burden is estimated
to be 133 hours.
    The on-site interview-based portion of this survey, to be conducted
of MD/HD truck drivers at refueling locations, is expected to require
10 minutes of respondent time per successful response, plus 2 minutes
per refusal. Assuming 4,000 successful collections and 4,000 refusals,
this equates to 800 hours of respondent burden borne by MD/HD truck
drivers.

    Authority: 44 U.S.C. Section 3506(c)(2)(A).

James F. Simons,
Director, Office of Regulatory Analysis and Evaluation.
[FR Doc. 2012-29844 Filed 12-10-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Rules and Regulations]
[Page 85138]
[FR Doc No: 2016-28399]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 133

[Docket No. 1529; Amdt. No. 133-9A]

Rotorcraft External-Load Operations; Technical Amendment

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; technical amendment.

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

SUMMARY: The FAA is correcting two regulatory cross-references. The
pertinent section was not amended to reflect changes that were
implemented in the final rule dated November 7, 1986 (Doc. No. 24550,
51 FR 40692, 40708).

DATES: This action becomes effective on November 25, 2016.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Raymond T. Plessinger, General Aviation and
Commercial Divisions, AFS-820, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
1100; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Good Cause for Immediate Adoption Without Prior Notice

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency for ``good cause'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without seeking comment prior to the
rulemaking.
    Section 553(d)(3) of the Administrative Procedure Act requires that
agencies publish a rule not less than 30 days before its effective
date, except as otherwise provided by the agency for good cause found
and published with the rule.
    This document is correcting an error that is in 14 CFR part 133.
This correction will not impose any additional restrictions on the
persons affected by these regulations. Furthermore, any additional
delay in making the regulations correct would be contrary to the public
interest. Accordingly, the FAA finds that (i) public comment on these
standards prior to promulgation is unnecessary, and (ii) good cause
exists to make this rule effective in less than 30 days.

Background

    On November 7, 1986, the FAA published a final rule (Doc. No.
24550, 51 FR 40692, 40708) that amended and updated the operations and
maintenance requirements pertaining to rotorcraft and established a new
Class D rotorcraft-load combination. The final rule created a new Sec.
133.35, Carriage of persons. With the creation of Sec.  133.35, the
occupancy limitations cross-referenced in Sec.  133.49(a) were moved
from Sec.  133.45(a) to Sec.  133.35(a). The cross-reference in Sec.
133.49(a) was not amended to reflect this change.
    The final rule also amended Sec.  133.45, Operating limitations, by
removing paragraph (a). This resulted in paragraphs (b), (c), (d), and
(e) to be redesignated as paragraphs (a), (b), (c), and (d),
respectively. The cross-reference in Sec.  133.49(b) was not amended to
reflect these changes. In this final rule, the FAA failed to update the
regulatory cross-references in Sec.  133.49(a) and (b), based on the
changes previously described. This technical amendment updates the
cross-references in Sec.  133.49(a) and (b), based on the 1986 final
rule.

Technical Amendment

    This technical amendment will correct the noted cross-references
currently in Sec.  133.49(a) and (b). Because this action results in no
substantive change to part 133, we find good cause exists under 5
U.S.C. 553(d)(3) to make this technical amendment effective in less
than 30 days and upon its publication in the Federal Register.

List of Subjects in 14 CFR Part 133

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends chapter I of title 14, Code of Federal
Regulations as follows:

PART 133--ROTORCRAFT EXTERNAL-LOAD OPERATIONS

0
1. The authority citation for part 133 continues to read as follows:

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

0
2. Revise Sec.  133.49 to read as follows:

Sec.  133.49   Markings and placards.

    The following markings and placards must be displayed conspicuously
and must be such that they cannot be easily erased, disfigured, or
obscured:
    (a) A placard (displayed in the cockpit or cabin) stating the class
of rotorcraft-load combination for which the rotorcraft has been
approved and the occupancy limitation prescribed in Sec.  133.35(a).
    (b) A placard, marking, or instruction (displayed next to the
external-load attaching means) stating the maximum external load
prescribed as an operating limitation in Sec.  133.45(b).

    Issued under authority of 49 U.S.C. 106(g), 40113, 44701-44702
in Washington, DC, on November 16, 2016.
Dale Bouffiou,
Acting Director, Office of Rulemaking.
[FR Doc. 2016-28399 Filed 11-23-16; 8:45 am]
 BILLING CODE 4910-13-P