Daimler. 2006. Annual Report 2006. Available at: http://www.daimler.com/investor-relations/reports-and-key-figures/annual-documents/daimler-ag. Accessed February 7, 2010.
Daimler. 2008. Annual Report 2008. Available at: http://www.daimler.com/investor-relations/reports-and-key-figures/annual-documents/daimler-ag. Accessed February 7, 2010.
Detroit Diesel Corporation. 2010. Detroit Diesel: DD 15. Detroit, MI: Detroit Diesel Corporation. Available at: http://www.detroitdiesel.com /pdf/engines/2009-dd15-brochure.pdf. Accessed on March 30, 2010.
Forbes Inc. 2010. Investopedia. Cost of Goods Sold -- COGS. Available at: http://www.investopedia.com/terms/c/cogs.asp>. Accessed on March 22, 2010.
Helfand, G., and T. Sherwood. 2009. "Memorandum: Documentation of the Development of Indirect Cost Multipliers for Three Automotive Technologies." Washington, DC: Office of Transportation and Air Quality, U.S. Environmental Protection Agency.
 Henderson, R.M., and K.B. Clark. 1990. "Architectural Innovation: The Reconfiguration of Existing Product Technologies and the Failure of Established Firms." Administrative Science Quarterly 35(1):9-30.
Hino Motors, Ltd. and Consolidated Subsidiaries. 2009a. Hino: Financial Results of the Fiscal Year Ended March 31, 2009.
Hino Motors, Ltd. and Consolidated Subsidiaries. 2009b. Hino: Five-year Summary Ended March 31, 2009.
IBIS.  January 2010, IBISWorld Industry Report 33612: Truck & Bus Manufacturing in the US. CA: IBIS.
IHS Global Insight. September 14, 2009. HIS Global Insight Report: Daimler Trucks (Automotive). Waltham, MA: IHS Global Insight.
IHS Global Insight. September 18, 2009. HIS Global Insight Report: Navistar (Automotive). Waltham, MA: IHS Global Insight.
IHS Global Insight. September 18, 2009. HIS Global Insight Report: Volvo Trucks (Automotive). Waltham, MA: IHS Global Insight.
IHS Global Insight. September 30, 2009. HIS Global Insight Report: Volvo Trucks (Automotive). Waltham, MA: IHS Global Insight.
IHS Global Insight. October 01, 2009. HIS Global Insight Report: PACCAR (Automotive). Waltham, MA: IHS Global Insight.
Jack Faucett Associates. September 4, 1985. Update of EPA's Motor Vehicle Emission Control Equipment Retail Price Equivalent (RPE) Calculation Formula. Chevy Chase, MD: Jack Faucett Associates.
McKinsey & Company. October 2003. "Preface to the Auto Sector Cases." In New Horizons: Multinational Company Investment in Developing Economies. San Francisco, CA: McKinsey & Company.
McManus, Walter. Personal communication on February 16, 2010.
National Research Council (NRC). 2002. Technologies for Improving the Fuel Economy of Passenger Cars and Light-Duty Trucks. Washington, DC: National Research Council. Available at: http://books.nap.edu/openbook.php?isbn =0309076013. Accessed on December 8, 2008.
Navistar. 2005. Annual Report 2005. Available at: http://ir.navistar.com/sec.cfm. Accessed February 7, 2010.
Navistar. 2008. Annual Report 2008. Available at: http://ir.navistar.com/sec.cfm. Accessed February 7, 2010.
Niazi, A., J. Dai, S. Balabani, and L. Seneviratne. 2007. "A New Overhead Estimation Methodology: A Case Study in an Electrical Engineering Company." Proceedings of the Institution of Mechanical Engineers, Part B: Journal of Engineering Manufacture 221(4):699-710.
PACCAR. 2006. PACCAR: Annual Report 2005. Available at: http://www.paccar.com/ investors/investor_resources_history.asp. Accessed on February 7, 2010.
PACCAR. 2009. PACCAR: Annual Report 2008. Available at: http://www.paccar.com/investors/investor_resources_history.asp. Accessed on February 7, 2010.
Ricardo, Inc. June 2008. A Study of Potential Effectiveness of Carbon Dioxide Reducing Vehicle Technologies, Revised Final Report. EPA420-R-08-004a. Washington, DC: Environmental Protection Agency. Available at: http://www.epa.gov/oms/technology/420r08004a.pdf. Accessed on February 17, 2009.
Rogozhin, A., M. Gallaher, and W. McManus. February 2009. Automobile Industry Retail Price Equivalent and Indirect Cost Multipliers. EPA-420-R-09-003. Washington, DC: Environmental Protection Agency. Available at: http://www. epa.gov/otaq/ld-hwy/420r09003.pdf.
Rogozhin, A., M. Gallaher, G. Helfand, and W. McManus. 2010. "Using Indirect Cost Multipliers to Estimate the Total Cost of Adding New Technology in the Automobile Industry." International Journal of Production Economics 124(2):360-368.
Scania Group. 2010. "Scania Turbocompound: Turbocompounding Converts Excess Energy Into Power." Available at: http://www.scania.com/products-services/trucks/main-components/engines/engine-technology/turbocompound/index.aspx. Accessed on March 30, 2010.
Sierra Research, Inc. November 21, 2007. Study of Industry -- Average Mark-Up Factors Used to Estimate Changes in Retail Price Equivalent (RPE) for Automotive Fuel Economy and Emissions Control Systems. Sacramento, CA: Sierra Research, Inc.
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Supplier Relations US LLC. December 5, 2009. "Heavy Duty Truck Manufacturing Industry in the U.S. and its International Trade. NAICS 336120." Irvine, CA: Supplier Relations US LLC.
U.S. Department of Commerce, Bureau of Census (Census). 2009. American Factfinder: Sector 31: EC0731I1: Manufacturing: Industry Series: Detailed Statistics by Industry for the United States: 2007. Washington, DC: Department of Commerce.
U.S. Census. 2010. American Factfinder: Sector 31: EC0731I1: Manufacturing: Industry Series: Detailed Statistics by Industry for the United States: 2007. Washington, DC: Department of Commerce.
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Appendix A
Calculation of RPE Multipliers for Individual Manufacturers
This appendix describes calculations of RPE multipliers for the heavy duty truck manufacturing industry as a whole and for individual heavy duty truck and engine manufacturers. The appendix is structured in the following manner:
Appendix A.1: Heavy Duty Truck Industry (Supplier Relations LLC, Census)
Appendix A.2: Cummins
Appendix A.3: Hino
Appendix A.4: PACCAR
Appendix A.5: Navistar
Appendix A.6: Daimler
Appendix A.7: Volvo
A.1	Heavy Duty Truck Industry (Supplier Relations LLC, Census)
An industry report by Supplier Relations LLC (referred to as "SR LLC report") presents heavy duty truck industry income statements and balance sheets (2009). The industry report was based on data from the U.S. Census, McKinsey & Company, and industry associations. These costs are presented in Table A-1. In instances where cost contributors were unavailable from SR LLC report, we used Census data or pivoted off cost contributors from the LD RPE/IC study. We describe these calculations below.
The manufacturing cost was calculated by adding cost of materials and wages. One can notice that the total for manufacturing costs ($14,652 million) is less than the sum of manufacturing costs for four manufacturers (PACCAR, Navistar, Daimler, and Volvo). Manufacturing costs for these four companies include their global operations, while manufacturing costs from the SR LLC report are mainly based on U.S. operations. We can, nevertheless, compare cost contributors derived using the SR LLC report data with individual company contributors, because they represent ratios and not absolute quantities.
The SR LLC report did not report warranty and R&D costs. We used the LD RPE/IC study's cost contributors as a proxy. The SR LLC report also did not report maintenance, repair, and operations (MRO) costs. We used the data from the U.S. Census Other Engine Equipment
Table A-1.	Supplier Relations LLC, Census RPE Multiplier Calculations: 2008
RPE Multiplier Contributor
                              Expense ($ Million)
                        Relative to Manufacturing Cost
                            Calculation and Source
Vehicle Manufacturing

 Manufacturing cost
14,652.0
1.00
Cost of materials (13,896) [p. 161, Supplier Relations LLC, 2009] + Wages (756) [p. 161, Supplier Relations LLC, 2009]
Production Overhead

 Warranty

0.03
LD RPE/IC Study (only used to break out G&A)
 R&D (product development)

0.05
LD RPE/IC Study (only used to break out G&A)
 Depreciation and amortization
692.0
0.05
Depreciation, depletion, and amortization of property, plant and equipment [p. 161, Supplier Relations LLC, 2009]
 Maintenance, repair, operations cost for engine manufacturers (truck manufactures in brackets)
232.8
0.02
U.S. Census
 Total production overhead

0.14

Corporate Overhead

 General and administrative
3,118.1
0.12
Administrative, sales, and marketing costs (2,992) [p. 161, Supplier Relations LLC, 2009] − Marketing − Transportation -Salaries (330) [p. 161, Supplier Relations LLC, 2009]
 Retirement for engine manufacturers (truck manufacturers in brackets)

0.01
Fringe benefits (433) [p. 161, Supplier Relations LLC, 2009]
 Health for engine manufacturers (truck manufacturers in brackets)

0.01
Fringe benefits (433) [p. 161, Supplier Relations LLC, 2009]
 Total corporate overhead

0.15

Selling

 Transportation
58.0
0.004
Energy and fuel costs [p. 161, Supplier Relations LLC, 2009]
 Marketing
145.9
0.01
LD RPE/IC Study Marketing * 20%, personal communication with Walter McManus
Dealers

 Dealer new vehicle net income
58.6
0.004
LD RPE/IC Study, personal communication with Walter McManus
 Dealer new vehicle selling cost
879.1
0.06
LD RPE/IC Study, personal communication with Walter McManus
 Total selling and dealer contributors

0.08

Sum of Indirect Costs

0.37

 Net income

0.05
5-year average net income [p. 161, Supplier Relations LLC, 2009]
 Other costs (not included as contributors)

0.00

 RPE multiplier

1.42

Sources:	Supplier Relations US LLC. December 5, 2009. "Heavy Duty Truck Manufacturing Industry in the U.S. and its International Trade. NAICS 336120." Irvine, CA: Supplier Relations US LLC.
	Personal communication with Walter McManus
Manufacturing (NAICS 333618) and Heavy Duty Truck Manufacturing (NAICS 336120) industries to calculate cost contributors for heavy duty engine truck manufacturers, respectively. The resulting cost contributors equaled 0.01 for engine manufacturers and 0.02 for truck manufacturers. These calculations are presented in Table A-2.
Table A-2.	Calculation of Maintenance, Repair, and Operations Cost Contributors

                Heavy Duty Engine Manufacturers (NAICS 333618)
                 Heavy Duty Truck Manufacturers (NAICS 336120)
                                  Calculation
Payroll
                                                                     $2,391,425
                                                                     $1,335,228
                                       A
Cost of materials
                                                                    $18,348,214
                                                                    $15,025,846
                                       B
Manufacturing cost
                                                                    $20,739,639
                                                                    $16,361,074
                                   C = A + B
Repair and maintenance
                                                                       $160,217
                                                                        $53,442
                                       D
Contract work
                                                                       $117,910
                                                                       $206,492
                                       E
Maintenance, repair, operations cost
                                                                       $278,127
                                                                       $259,934
                                   F = D + E
Share of manufacturing cost
                                                                           0.01
                                                                           0.02
                                      F/C
Source: U.S. Census. 2010. American Factfinder: Sector 31: EC0731I1: Manufacturing: Industry Series: Detailed Statistics by Industry for the United States: 2007. Washington DC: Department of Commerce.
General and administrative (G&A) costs were calculated by subtracting salaries' cost (costs of corporate labor) and marketing and transportation cost contributors from the administrative, sales, and marketing costs provided in the SR LLC report. The SR LLC report provided fringe benefits' cost ($433 million, or 0.0296 as a share of manufacturing costs [$14,652 million]) or a sum of health care and retirement costs for manufacturing labor. The report did not provide a clear breakout for health care and retirement costs. We used a ratio of health care to retirement costs from Cummins to calculate proxies of these costs for engine manufacturers and similar ratio from Navistar to calculate proxies of these costs for truck manufacturers. These calculations are presented in Table A-3.
Neither the SR LLC report nor the U.S. Census provided marketing costs; thus, we used a proxy from the LD RPE/IC report. However, we believe that heavy duty vehicle manufacturers spend a lot less on marketing than light duty vehicle manufacturers. The heavy duty trucks industry engages in business-to-business marketing rather than business-to-consumer marketing. Our judgment is that business-to-business marketing costs are significantly lower than business-to-consumer marketing costs, possibly as low as 3 to 5% of business-to-consumer marketing costs per unit. We defined business-to-business marketing costs as 20% of the
Table A-3.	Calculation of Health Care and Retirement Cost Contributors
                               Cost Contributor
            Fringe Benefits Share of Manufacturing Cost (SP LLC)[a]
                      Cost Contributors (from Cummins)[b]
                        Heavy Duty Engine Manufacturers
                      Cost Contributors (from PACCAR)[c]
                        Heavy Duty Truck Manufacturers
Retirement
                                    0.0296
                                     0.01
                                     0.01
                                     0.03
                                     0.02
Health care

                                     0.01
                                     0.02
                                     0.02
                                     0.01
Sources:	[a] Supplier Relations US LLC. December 5, 2009. "Heavy Duty Truck Manufacturing Industry in the U.S. and its International Trade. NAICS 336120." Irvine, CA: Supplier Relations US LLC.
	b Table A-4; c Table A-10.
business-to-consumer marketing costs per unit from Rogozhin et al. (2009) as an upper bound. Finally, because no data were available to calculate dealer new vehicle net income nor dealer new vehicle selling cost contributors, we used the LD RPE/IC study contributors as a proxy. The LD RPE/IC study dealer new vehicle net income and dealer new vehicle selling cost contributors were based on National Association of Automobile Dealers (NADA) data. For an exact calculation of these cost contributors, refer to Section A.2 of the LD RPE/IC study.
A.2	Cummins Inc. (Engine Manufacturer)
The general approach to estimate cost contributors to RPE multipliers is presented in Section 3. This appendix outlines calculations specific to each manufacturer. We performed several adjustments to numbers presented in the Cummins annual report so they could be applied to our methodology. Calculations and citations for cost values (referencing pages where specific cost item is located) that we used in our analysis are outlined in Table A-4.
The Cummins annual report stated that manufacturing cost includes maintenance and repair costs (valued at $49 million). Therefore, we subtracted that cost from manufacturing cost. We also added 70% of health care and retirement costs, because these costs are attributable to manufacturing labor (see Section 3.3 for justification of this assumption).
The Cummins annual report did not clearly provide warranty costs for 2008. Warranty costs were estimated by subtracting the balance of warranty provisions at the beginning of 2008 from the balance of warranty provisions at the end of 2008. Cummins also did not clearly state operations costs, which is a large share of the MRO contributor. Therefore, we used the industry average (calculated using Census data) as a proxy. Calculations of industry averages, which are based on the data from the industry report by SR LLC and Census, are presented in Section A.1 of this appendix. Cummins' annual report also stated that transportation cost is a part of G&A costs; thus, the transportation cost contributor was subtracted from the G&A cost contributor.
Table A-4.	Cummins' RPE Multiplier Calculations: 2008
                          RPE Multiplier Contributor
                             Expense
 ($ Million)
                 Relative to Cost of Sales Manufacturing Cost
                            Calculation and Source
Vehicle Manufacturing

 Manufacturing Cost
11,726.5
1.00
[p. 36, Cummins, 2009] − Maintenance and repair (49)+70% *( Health care + retirement)
Production Overhead

 Warranty
221.0
0.02
End of 2008 balance warranty provisions (962) − Beginning of 2008 Balance Warranty Provisions (749) [p. 104, Cummins, 2009]
 R&D (product development)
422.0
0.04
[p. 24, Cummins, 2009]
 Depreciation and amortization
314.0
0.03
[p. 71, Cummins, 2009]
 Maintenance, repair, operations cost
152.9
0.01
Census
 Total production overhead
1,109.9
0.08

Corporate Overhead

 General and administrative
1,404.9
0.12
[p. 27, Cummins, 2009] − Transportation
 Retirement
62.4
0.01
0.3 * Retirement ((71) [p. 56, Cummins, 2009] + (102) [p. 58, Cummins, 2009] + 35 [p. 71, Cummins 2009])
 Health
142.2
0.01
0.3*Health care [p. 87, Cummins, 2009]
 Total corporate overhead
1,609.5
0.14

Selling

 Transportation
45.1
0.004
Supplier Relations, LLC
 Marketing
120.0
0.01
Warranty and Marketing (341) [p. 87, Cummins, 2009] − Warranty Cost
Dealers

 Dealer new vehicle net income

 Dealer new vehicle selling cost

 Total selling and dealer contributors
165.1
0.01

Sum of Indirect Costs

0.23

 Net income
755.0
0.06
[p. 27, Cummins, 2009] − Dealer Gross
 Other costs (not included as contributors)
70.0
0.01
[p. 27, Cummins, 2009]
 RPE multiplier

1.29

Sources:	Supplier Relations LLC (2009); Census (2010) (see references in Section A.1)
        Cummins Inc. 2009. 2008 Annual Report on 10-K Form. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=112916&p=irol-reportsannual. Accessed on February 15, 2010.
We made an assumption that corporate labor represents 30% of total labor (total labor comprised of corporate and manufacturing labor). Thus, 30% of retirement and health care cost were attributed to retirement and health care cost contributors. Please refer to Section 3.3 for a detailed explanation of this assumption. The Cummins annual report presented retirement costs by division; thus, retirement costs for the three divisions were added to calculate total retirement cost (see Table A-4).
Cummins did not provide transportation cost; thus, the industry average (based on the industry report and Census data) was used as a proxy. Finally, the Cummins annual report did not separate warranty and marketing costs but reported them as one figure. Therefore, we subtracted the warranty cost from the warranty and marketing cost to arrive at the marketing cost contributor. The remaining contributors to the RPE multiplier are shown in Table A-4. Based on these numbers, the RPE multiplier for Cummins was calculated to be 1.29 in 2008.
Table A-5 provides a sum of the largest indirect cost contributors to RPE for Cummins from 2002 to 2007. Largest indirect cost contributors were readily available in manufacturers' annual reports. Funds and timing of the project did not allow performing an extended analysis (similar to one done for year 2008) for historical data. The values of cost contributors are not adjusted as in Table A-4but cited as they were reported in annual reports. Table A-5 illustrates that the sum of the main indirect cost contributors had little variation between 2004 and 2007.
Table A-5.	Cummins' Main Indirect Cost Contributors
Indirect Cost Contributor
                                     2007
                                     2006
                                     2005
                                     2004
Cost of sales
1.00
1.00
1.00
1.00
Selling, administrative, and other expenses
0.13
0.12
0.13
0.15
Operating and other expenses
0.04
0.03
0.04
0.04
Depreciation
< 0.01
 < 0.01
< 0.01
< 0.01
Net income
0.03
0.03
0.03
0.04
Sum of main indirect cost contributors (including net income)
1.26
1.26
1.28
1.29
Sources:	Cummins Inc. 2006. 2005 Annual Report on 10-K Form. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=112916&p=irol-reportsannual. Accessed on February 15, 2010.
        Cummins Inc. 2009. 2008 Annual Report on 10-K Form. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=112916&p=irol-reportsannual. Accessed on February 15, 2010.
A.2	Hino Motor Company (Engine Manufacturer)
Relevant RPE contributing factors gathered from Hino's annual report are presented in Table A-6. The RPE multiplier calculations are based on 2008 data.
As Table A-6 shows, Hino's manufacturing cost includes 70% of health care and retirement costs, an assumption covered in Section 3.3 of this report. With the exception of the
Table A-6.	Hino's RPE Multiplier Calculations: 2008
RPE Multiplier Contributor
                                                        Expense
(Yen Millions)
                                                      Relative to Cost of Sales
Calculation and Source
Vehicle Manufacturing

 Manufacturing cost
1,137,120
1.00
[p. 1, Hino, 2009b] + 70% (Retirement)
Production Overhead

 Warranty
10,935
0.01
[p. 7, Hino, 2009a]
 R&D (product development)
39,547
0.03
[p. 1, Hino, 2009b]
 Depreciation and amortization
44,206
0.04
[p. 1, Hino, 2009b]
 Maintenance, repair, operations cost
15,730
0.01
Census
 Total production overhead
110,418
0.10

Corporate Overhead

 General and administrative
99,066
0.09
General and Administrative (149,769) [p. 7, Hino, 2009a] − Retirement [p. 7, Hino, 2009a] − Transportation [p. 7, Hino, 2009a] − Advertising [p. 7, Hino, 2009a] − Health care
 Retirement
11,555
0.01
Supplier Relations, LLC
 Health
23,109
0.02
Supplier Relations, LLC
 Total corporate overhead
133,730
0.12

Selling

 Transportation
12,158
0.01
[p. 7, Hino, 2009a]
 Marketing
3,879
0.003
Advertising [p. 7, Hino, 2009a]
Dealers

 Dealer new vehicle net income

 Dealer new vehicle selling cost

 Total selling and dealer contributors
16,037
0.01

Sum of Indirect Costs
260,185
0.23

  Net income
22,178
0.02
[p. 7, Hino, 2009a]

  Other costs (not included as contributors)
10,602
0.01
Total nonoperating expenses [p. 7, Hino, 2009a]
 RPE multiplier
1,419,483
1.25

Sources:	Supplier Relations LLC (2009); Census (2010) (see references in Section A.1)
        Hino Motors, Ltd. and Consolidated Subsidiaries, 2009a. Hino: Financial Results of the Fiscal Year Ended March 31, 2009.
        Hino Motors, Ltd. and Consolidated Subsidiaries, 2009b. Hino: Five-year Summary Ended March 31, 2009.
MRO costs, values for production overhead were reported from Hino's financial statements. Because Hino did not report MRO costs, an industry average (based on Census data) was used as a proxy. Hino's G&A expense included retirement, health care, transportation, and advertising. These costs have been subtracted from the G&A cost reported by Hino. Hino did not report health care and retirement costs, so we used an industry average as a proxy (based on data from SR LLC report; see Section A.1 for a detailed calculation). Hino's remaining contributors to the RPE multiplier are shown in Table A-6. Based on these figures, Hino's RPE for 2008 was 1.25.
Hino's sum of the main indirect cost contributors remained relatively flat from 2004 to 2007. The sum of the main indirect cost contributors varied between 1.21 and 1.25 in the 2004 to 2007 time period (Table A-7).
Table A-7.	Hino's Main Indirect Cost Contributors
                           Indirect Cost Contributor
                                     2007
                                     2006
                                     2005
                                     2004
Cost of sales
                                     1.00
                                     1.00
                                     1.00
                                     1.00
Selling, administrative, and other expenses
                                     0.13
                                     0.13
                                     0.13
                                     0.14
Operating and other expenses
                                      NA
                                      NA
                                      NA
                                      NA
Depreciation
                                     0.03
                                     0.03
                                     0.03
                                     0.03
Net income
                                     0.02
                                     0.03
                                     0.02
                                     0.04
Sum of main indirect cost contributors (including net income)
                                     1.22
                                     1.23
                                     1.21
                                     1.25
Sources: Hino Motors, Ltd. and Consolidated Subsidiaries, 2009b. Hino: Five-year Summary Ended March 31, 2009.
A.3	PACCAR (Heavy Duty Truck Manufacturer)
Relevant RPE contributing factors gathered from PACCAR's annual report are presented in Table A-8. PACCAR included "transportation expense" in its cost of sales, representing approximately 0.4% of the cost of sales. We subtracted this line item, $46.5 million (see Table A-8), from the cost of sales to arrive at an adjusted value for the manufacturing cost of $11.5 billion. PACCAR's reported G&A cost included transportation ($46.5) and marketing costs ($115 million), which were subtracted from G&A to arrive at an adjusted cost contributor of $308.7 million. Marketing costs were not reported by PACCAR, so an industry average of 0.01 was used as a proxy. Also, PACCAR did not directly report transportation costs, which were assumed to be an industry average based on SR LLC data (see Section A.1 for these calculations).
PACCAR did not report MRO costs; therefore, we used an industry average of 0.02 (based on the Census data) as a proxy. Results of these calculations are presented in Table A-8.
Table A-8.	PACCAR RPE Multiplier Calculations: 2008
RPE Multiplier Contributor
                             Expense
($ Million)
                           Relative to Cost of Sales
                            Calculation and Source
Vehicle Manufacturing

 Manufacturing cost
                                                                         11,550
1.00
Cost of sales − transportation expense (0.4%) [Walter McManus, personal communication]
Production Overhead

 Warranty
                                                                          304.6
0.03
[p. 40, PACCAR, 2008]

 R&D (product development)
                                                                          341.8
0.03
[p. 31, PACCAR, 2008]

 Depreciation and amortization
                                                                          649.4
0.06
[p. 49, PACCAR, 2008]

 Maintenance, repair, operations cost
                                                                          186.5
0.02
Census
 Total production overhead
                                                                        1,482.3
0.13

Corporate Overhead

 General and administrative
                                                                          308.7
0.03
General & administrative (470.2) [p. 24, PACCAR, 2008] − Transportation (46.5) − Marketing (115.0)
 Retirement
                                                                          118.7
0.01
Benefits paid (48.8) [p. 42 of PACCAR Annual Report 2008] + Employer contributions (69.9) [p. 42 of PACCAR Annual Report 2008]
 Health
                                                                           12.0
0.001
Benefits paid (4.1) [p. 43, PACCAR, 2009] + Service cost (3.2) [p. 43, PACCAR, 2009] + Interest cost (4.7) [p. 43, PACCAR, 2009]
 Total corporate overhead
                                                                          439.4
0.04

Selling

 Transportation
                                                                           46.5
0.004
Supplier Relations, LLC
 Marketing
                                                                          115.0
0.01
20% * [Marketing cost from LD Study] (Walter McManus, personal communication)
Dealers

 Dealer new vehicle net income
                                                                           46.2
0.004
Walter McManus, personal communication
 Dealer new vehicle selling cost
                                                                          693.0
0.06
Walter McManus, personal communication
 Total selling and dealer contributors
                                                                          900.7
0.08

Sum of Indirect Costs
                                                                        1,921.7
0.24

 Net income
                                                                        1,017.9
0.09
[p. 1, PACCAR, 2008]
 Other costs (not included as contributors)
                                                                            1.1
<0.001
[p. 34, PACCAR, 2008]
 RPE multiplier

1.33

Sources:	 Supplier Relations LLC (2009); Census (2010) (see references in Section A.1)
      PACCAR, 2008. PACCAR: Annual Report 2008. Available at: http://www.paccar.com/investors/ investor_resources_history.asp. Accessed on February 7, 2010.
	Walter McManus, personal communication on February 16, 2010.

As mentioned in Section 3.3 of this report, health care and retirement costs include expenditures for manufacturing and corporate workers. PACCAR's annual report provided figures for retirement costs in two categories: "benefits paid" of $48.8 million and "employer contributions" of $69.9 million in 2008. These two costs were summed, totaling $118.7 million for our retirement cost contributor. As with retirement, PACCAR disaggregated 2008 health care costs into several categories: "benefits paid" of $4.1 million, "service cost" of $3.2 million, and "interest cost" of $4.7. These costs were summed together, bringing the health care cost contributor to a total of $12.0 million. The industry average values of 0.004 and 0.06 were used for dealer new vehicle net income and dealer new vehicle selling cost contributors. As a result, the value of the RPE multiplier for PACCAR was 1.33 in 2008.
Table A-9 presents PACCAR's sum of the main indirect cost contributors for years prior to 2008. The sum of the main indirect cost contributors for earlier years was lower than the RPE multiplier value derived for 2008; however, the main cost contributors reported in Table A-9 range within 0.02 from cost contributors reported in Table A-8.
Table A-9.	PACCAR Main Indirect Cost Contributors
                           Indirect Cost Contributor
                                     2007
                                     2006
                                     2005
                                     2004
Cost of sales
                                     1.00
                                     1.00
                                     1.00
                                     1.00
Selling, administrative, and other expenses
                                     0.04
                                     0.04
                                     0.04
                                     0.04
Operating and other expenses
                                      NA
                                      NA
                                      NA
                                      NA
Depreciation
                                     0.04
                                     0.03
                                     0.03
                                     0.03
Net income
                                     0.10
                                     0.11
                                     0.10
                                     0.10
Sum of main indirect cost contributors (including net income)
                                     1.21
                                     1.20
                                     1.18
                                     1.19
Sources:	PACCAR, 2006. PACCAR: Annual Report 2005. Available at: http://www.paccar.com/ investors/investor_resources_history.asp. Accessed on February 7, 2010.
      PACCAR, 2009. PACCAR: Annual Report 2008. Available at: http://www.paccar.com/ investors/investor_resources_history.asp. Accessed on February 7, 2010.
A.4	Navistar (Heavy Duty Truck Manufacturer)
Table A-10 presents relevant RPE cost contributors and the RPE multiplier for Navistar in 2008. Navistar allocates a portion of "postretirement benefit expense" in its cost of sales reporting. Thus, we subtracted this cost ($33 million) from the cost of sales to arrive at an adjusted manufacturing cost of $11,849 million. Navistar also allocates a portion of
Table A-10.	Navistar RPE Multiplier Calculations: 2008
RPE Multiplier Contributor
                             Expense
($ Millions)
                           Relative to Cost of Sales
                            Calculation and Source
Vehicle Manufacturing

 Manufacturing cost
11,849.4
1.00
Cost of sales [p. 23, Navistar, 2008] − Truck postretirement benefit expense allocated to costs of products sold (22) [p. 42, Navistar, 2008] − Engine postretirement benefit expense allocated to costs of products sold (11) [p. 45, Navistar, 2008]
Production Overhead

 Warranty
257.0
0.02
[p. 24, Navistar, 2008]
 R&D (product development)
384.0
0.03
[p. E-28, Navistar, 2008]
 Depreciation and amortization
393.0
0.03
[p. 72, Navistar, 2008]
 Maintenance, repair, operations cost
358.0
0.03
[p. E-28, Navistar, 2008]
 Total production overhead
1,392.0
0.12

Corporate Overhead

 General and administrative
1,389.8
0.12
[p. E-28, Navistar, 2008] − Postretirement benefits expense allocated to selling, general and administrative expenses (6) [p. 43, Navistar, 2008] − Transportation (47.2) [Supplier Relations, LLC]
 Retirement
355.0
0.03
[p. 116, Navistar, 2008]
 Health
209.0
0.02
[p. 116, Navistar, 2009]
 Total corporate overhead
1,953.8
0.16

Selling

 Transportation
47.2
0.004
Supplier Relations, LLC
 Marketing
24.0
0.00
[p. 83, Navistar, 2008]
Dealers

 Dealer new vehicle net income
47.4
0.004
Walter McManus, personal communication
 Dealer new vehicle selling cost
711.0
0.06
Walter McManus, personal communication
 Total selling and dealer contributors
829.6
0.07
[p. 25, Navistar, 2008]
Sum of Indirect Costs
4,175.4
0.35

 Net income
134.0
0.01
[p. 23, Navistar, 2008]
 Other costs (not included as contributors)
14.0
0.001
[p. 26, Navistar, 2008]
 RPE multiplier

1.36

Sources:	Supplier Relations LLC (2009) (see references in Section A.1)
	Navistar, 2008. Annual Report 2008. Available at: http://ir.navistar.com/sec.cfm. Accessed February 7, 2010.
      Walter McManus, personal communication on February 16, 2010.
"postretirement benefit expense" ($6 million) to G&A cost. Thus, we subtracted this expense from G&A. As with all the heavy duty truck manufacturers, we assumed the transportation cost ($47.2 million) was 0.4% of manufacturing costs (SR LLC). Based on the light duty vehicle study and personal communications with Walter McManus (February 16, 2010), we imputed a dealer cost of $758 million. Navistar's RPE multiplier value was calculated to be 1.36 for 2008.
Navistar's annual reports were available dating back to 2004. Similar to PACCAR, Navistar's sum of the main indirect cost contributors from 2004 to 2007 is lower than the RPE derived for 2008 (see Table A-11). However, the main cost contributors reported in Table A-9 range within 0.03 of cost contributors reported in Table A-8.
Table A-11.	Navistar Main Indirect Cost Contributors (as a Share of Cost of Sales)
                           Indirect Cost Contributor
                                     2007
                                     2006
                                     2005
                                     2004
Cost of sales
1.00
1.00
1.00
1.00
Selling, administrative, and other expenses
0.14
0.11
0.10
0.11
Operating and other expenses
< 0.01
< 0.01
< 0.01
< 0.01
Depreciation
0.04
0.03
0.03
0.03
Net income
−0.01
0.03
0.01
−0.01
Sum of main indirect cost contributors (including net income)
1.21
1.21
1.19
1.18
Sources:	Navistar, 2005. Annual Report 2005. Available at: http://ir.navistar.com/sec.cfm. Accessed February 7, 2010.
      Navistar, 2008. Annual Report 2008. Available at: http://ir.navistar.com/sec.cfm. Accessed February 7, 2010.
A.6	Daimler (Heavy Duty Truck Manufacturer)
Relevant RPE contributing factors gathered from Daimler's annual report are presented in Table A-12. As with Volvo, Daimler has several operating divisions, one of which is exclusive to the manufacturing of heavy duty diesel trucks. The following reporting of cost contributors is based on Daimler's truck division. Daimler's annual report did not provide an estimate of MRO cost; therefore, the industry average (based on Census data) was used as a proxy (see Table A-12). In congruence with the other manufacturers that did not directly report health care cost, we assumed manufacturing cost would reflect the industry average of 70% of health care cost (see Table A-12). Warranty costs were reported as containing a portion of pension (Euro15 million) and health care costs (Euro3.2 million), and these two costs were subtracted to arrive at an adjusted warranty cost contributor of Euro953.7 million.
Table A-12.	Daimler (Truck) RPE Multiplier Calculations: 2008
RPE Multiplier Contributor
                            Expense
(Euro Millions)
                           Relative to Cost of Sales
                            Calculation and Source
Vehicle Manufacturing

 Manufacturing cost
22,345.9
1.00
Cost of sales [p. 207, Daimler, 2008] + (70% * Health care)
Production Overhead

 Warranty
953.7
0.04
[p. 73, Daimler, 2008] (Warranty, pensions, and Health care lumped together (18.2) − Pensions provisions (15.0))*Adjustment factor from Daimler Group to Daimler Trucks
 R&D (product development)
1,056.0
0.05
[p. 62, Daimler, 2008]
 Depreciation and amortization
646.0
0.03
[p. 207, Daimler, 2008]
 Maintenance, repair, operations cost
355.0
0.02
Census
 Total production overhead
3,010.7
0.13

Corporate Overhead

 General and administrative
655.4
0.03
[p. 144, Daimler, 2008] ( General & administrative for Daimler Group was reported as 4,124) − Health care − Transportation − Marketing
 Retirement
236.0
0.01
30% * [p. 53, Daimler, 2008]
 Health
261.8
0.01
Supplier Relations, LLC
 Total corporate overhead
1,153.2
0.05

Selling

 Transportation
87.7
0.004
Supplier Relations, LLC
 Marketing
222.6
0.01
20% * [Marketing cost from LD Study] (Walter McManus, personal communication)
Dealers

 Dealer new vehicle net income
89.4
0.004
Walter McManus, personal communication
 Dealer new vehicle selling cost
1,340.8
0.06
Walter McManus, personal communication
 Total selling and dealer contributors
1,740.4
0.08

Sum of Indirect Costs
5,904.2
0.26

 Net income
1,607.0
0.07
[p. 207, Daimler, 2008]
 Other costs (not included as contributors)

0

 RPE multiplier

1.34

Sources:	Supplier Relations LLC (2009); Census (2010) (see references in Section A.1)
	Daimler, 2008. Annual Report 2008. Available at: http://www.daimler.com/investor-relations/reports-and-key-figures/annual-documents/daimler-ag. Accessed February 7, 2010.
      Walter McManus, personal communication on February 16, 2010.

Daimler (truck) did not directly report G&A expenses. Our methodology for determining G&A for Daimler (truck) was based on an imputed ratio of Daimler Group's G&A expense to Daimler Group's cost of sales (see Table A-12). G&A costs were reported to contain health care costs and transportation costs, both of which were subtracted from the imputed G&A cost to arrive at an adjusted G&A cost contributor for Daimler's truck division. Selling expenses (transportation, marketing, dealer support, and dealer discount) were reported as an industry average based on information from SR LLC and personal communication with Walter McManus. Daimler also did not provide an estimate of health care cost, so we calculated the health care cost contributor based on an industry average (SR LLC). Daimler's (truck) RPE multiplier value was calculated to be 1.34 in 2008.
Daimler experienced mild variation in its sum of main indirect cost contributors (see Table A-13). Between 2005 and 2007, the sum of main indirect cost contributors varied between 1.33 and 1.42.
Table A-13.	Daimler Main Indirect Cost Contributors
                           Indirect Cost Contributor
                                     2007
                                     2006
                                     2005
Cost of sales
1.00
                                     1.00
                                     1.00
Selling, administrative, and other expenses
0.17
                                     0.17
                                     0.17
Operating and other expenses
< 0.01
                                     0.01
                                     0.00
Depreciation
0.11
                                     0.16
                                     0.16
Net income
0.05
                                     0.05
                                       --
Sum of main indirect cost contributors (including net income)
1.37
                                     1.42
                                     1.33
Sources:	Daimler, 2006. Annual Report 2006. Available at: http://www.daimler.com/investor-relations/reports-and-key-figures/annual-documents/daimler-ag. Accessed February 7, 2010.
      Daimler, 2008. Annual Report 2008. Available at: http://www.daimler.com/investor-relations/reports-and-key-figures/annual-documents/daimler-ag. Accessed February 7, 2010.
A.7	Volvo (Heavy Duty Truck Manufacturer)
RPE calculations for Volvo's truck division are presented in Table A-14. Volvo's annual report segregated its financials among six operating divisions, one of which was the heavy duty diesel truck division. In 2008, Volvo's (truck) manufacturing cost equaled SEK 231,435. Volvo (truck) did not report transportation, marketing, or dealer costs; therefore, imputed values from SR LLC and personal communications with Walter McManus were used as proxies. G&A costs were reported for Volvo (truck) and included transportation and marketing costs; these costs

Table A-14.	Volvo (Truck) RPE Multiplier Calculations: 2008
RPE Multiplier Contributor
                            Expense (SEK Millions)
                           Relative to Cost of Sales
                            Calculation and Source
Vehicle Manufacturing

 Manufacturing cost
                                   231,435.5
                                      1.00
                             [p. 75, Volvo, 2008]
Production Overhead

 Warranty
                                   10,354.0
                                     0.04
                             [p. 86, Volvo, 2008]
 R&D (product development)
                                   14,348.0
                                     0.06
                             [p. 75, Volvo, 2008]
 Depreciation and amortization
                                   13,524.0
                                     0.06
                             [p. 78, Volvo, 2008]
 Maintenance, repair, operations cost
                                    1,915.0
                                     0.01
                             [p. 78, Volvo, 2009]
 Total production overhead
                                   40,141.0
                                     0.17

Corporate Overhead

 General and administrative
                                   28,518.4
                                     0.12
Administrative expenses and selling expenses (31,763.9) [p. 75, Volvo, 2008] − Transportation (940.5) − Marketing (2,301.1)
 Retirement
                                    1,365.0
                                     0.01

 Health
                                     847.2
                                     0.004
                          30% * [p. 106, Volvo, 2008]
 Total corporate overhead
                                   30,730.6
                                     0.13

Selling

 Transportation
                                     940.5
                                     0.004
                          30% * [p. 106, Volvo, 2008]

 Marketing
                                    2,305.1
                                     0.01
 20% * [Marketing cost from LD Study] (Walter McManus, personal communication)
Dealers

 Dealer new vehicle net income
                                     925.7
                                     0.004
                    Walter McManus, personal communication
 Dealer new vehicle selling cost
                                   13,886.1
                                     0.06
                    Walter McManus, personal communication
 Total selling and dealer contributors
                                   18,057.4
                                     0.08

Sum of Indirect Costs

                                     0.38

 Net income
                                   10,016.0
                                     0.04
                             [p. 93, Volvo, 2008]
 Other costs (not included as contributors)
                                    1,802.0
                                     0.01
                       Dealer bonus [p.109, Volvo, 2008]
 RPE multiplier

                                     1.43

Sources:	Supplier Relations LLC (2009); Census (2010) (see references in Section A.1)
	Volvo Group, 2008. Annual Report 2008. Available at: http://www.volvogroup.com/GROUP/GLOBAL/EN-GB/INVESTORS/Pages/investor_relations.aspx. Accessed February 7, 2010.
      Walter McManus, personal communication on February 16, 2010.

were subtracted to determine G&A (see Table A-12). The RPE multiplier for Volvo (truck) equaled 1.43 in 2008.
Table A-15 presents Volvo's sum of the main indirect cost contributors, which are again lower than the RPE value derived above for 2008.
Table A-15.	Volvo Main Indirect Cost Contributors
                           Indirect Cost Contributor
                                     2007
                                     2006
                                     2005
                                     2004
Cost of sales
 1.00
 1.00
 1.00
 1.00
Selling, administrative, and other expenses
 0.15
 0.14
 0.14
 0.15
Operating and other expenses
 < 0.01
 < 0.01
 < 0.01
 < 0.01
Depreciation
 0.06
 0.06
 0.05
 0.06
Net income
 0.07
 0.08
 0.07
 0.06
Sum of main indirect cost contributors (including net income)
 1.33
 1.33
 1.31
 1.32
Sources:	Volvo Group, 2006. Annual Report 2006. Available at: http://www.volvogroup.com/GROUP/ GLOBAL/EN-GB/INVESTORS/Pages/investor_relations.aspx. Accessed on February 7, 2010.
      Volvo Group, 2008. Annual Report 2008. Available at: http://www.volvogroup.com/GROUP/ GLOBAL/EN-GB/INVESTORS/Pages/investor_relations.aspx. Accessed on February 7, 2010.


[Federal Register: August 7, 2009 (Volume 74, Number 151)]
[Notices]
[Page 39704-39705]
[DOCID:fr07au09-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0354]

Guidance for Industry on Pharmaceutical Components at Risk for
Melamine Contamination; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Pharmaceutical
Components at Risk for Melamine Contamination.'' This guidance provides
recommendations that will help pharmaceutical manufacturers of finished
products, repackers, other suppliers, and pharmacists who engage in
drug compounding avoid the use of components that are at risk for
melamine contamination. As of the date of this announcement, FDA is not
aware of any pharmaceutical components that are contaminated with
melamine.

DATES:  Submit written or electronic comments on the guidance by
October 6, 2009. General comments on agency guidance documents are
welcome at any time.

ADDRESSES:  Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Communications Staff
(HFV-12), Center for Veterinary Medicine, Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the 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 guidance document.

FOR FURTHER INFORMATION CONTACT:
     Frank W. Perrella, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,
rm. 4337, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
    Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,
rm. 4364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
    Diane Heinz, Center for Veterinary Medicine (HFV-6), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Pharmaceutical Components at Risk for Melamine
Contamination.'' This guidance provides recommendations that will help
pharmaceutical manufacturers of finished products, repackers, other
suppliers, and pharmacists who engage in drug compounding to better
control their use of at-risk components that might be contaminated with
melamine. The guidance explains that the agency is recommending that
at-risk components be properly tested for melamine contamination before
they are used in the manufacture or preparation of drugs or drug
products. This recommendation applies to nitrogen-based components.
    As discussed in the guidance, FDA has posted on its Web site
methods for measuring melamine contamination in foods using liquid
chromatography triple quadrupole tandem mass spectrometry (LC-
MS[sol]MS) and gas chromatography/mass spectrometry (GC-MS). Although
these methods have been evaluated using dry protein materials, they can
also be applicable to other material, including at-risk components.
Manufacturers are encouraged to validate test methods that

are suitable for detecting melamine contamination in at-risk components
down to 2.5 parts per million (ppm) to give a high degree of assurance
that they are not contaminated. At this time, FDA has not established
an appropriate level of melamine in drug products.
    As explained in detail in the guidance, there have been repeated
instances of melamine contamination in food articles, including in the
U.S. market. In 2007, FDA learned that certain pet foods were sickening
and killing cats and dogs. In September 2008, FDA received reports of
melamine-contaminated infant formula in China. These two incidents
share the following similarities:
     Melamine, a nitrogen-based compound, was apparently added
to bolster the apparent protein content in foods or in ingredients used
in processed food products intended to contain protein.
     The recipients of the ingredients using a test for
nitrogen content would not have been able to distinguish between
melamine and the desired protein.
     Melamine contamination became public only after numerous
adverse health events, including deaths, were reported and associated
with the use of contaminated products.
    These incidents illustrate the potential for drug components to be
contaminated with melamine; therefore, it is important for drug
manufacturers to be diligent in assuring that no component used in the
manufacture of any drug is contaminated with melamine. As of the date
of this guidance, FDA is not aware of any pharmaceuticals that are
contaminated with melamine. However, because of the potential risk of
drug contamination, it is important that manufacturers take steps to
ensure that susceptible components are not contaminated with melamine.
    We are issuing this level 1 guidance for immediate implementation,
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The agency is not seeking comment before implementing this
guidance because of the potential for a serious public health impact if
melamine-contaminated pharmaceuticals were to enter the domestic
market. The guidance represents the agency's current thinking on this
issue. 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 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
http://www.regulations.gov.

    Dated: July 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18952 Filed 8-6-09; 8:45 am]

BILLING CODE 4160-01-S


Comment Info: =================

General Comment:i have read all the comments on this matter. thus far it is clear that the proposed regulations of electronic cigarettes and e-liquid will not only have a devastating impact on the industry, but over 95% of the comment are against these proposed regulations. as i have 7,500 possible combinations of flavors, nicotine levels and PG/VG variations, and i am a very small company. i do not have the multi-millions of dollars, nor does the rest of the industry other than big tobacco, big pharma and big e-cigarette companies like NJOY, PURE SMOKE, and BLU.

i was a smoker from age 13, now 53 i started using an e-cigarette on my 50th birthday. i tried every way of quitting available, but nothing worked, until the e-cigarette. i have not smoked since that day. i can breath deeply again and have not been sick, not even a sniffle since.

if your decision is based in fact, then take this fact into consideration: if a child sees a pack of nicorette gum, he is most likely to eat it, rather than a child reading a label on a bottle of flavored e-liquid and drinking it. adults like flavor in their e-liquid. 95% of my sales to adults are flavored other that a tobacco flavor. having flavor other than tobacco allows the person to make the choice to stay away from tobacco, and the reminder of tobacco. if their e-liquid runs out, adults using a tobacco flavor are more likely going to buy a pack of cigarettes to get them buy, rather than buy an orange, apple or even a bag of gummi bears to get them by because that is their flavor of choice.

e-cigarettes do not contain tobacco, some, not all, may contain nicotine. as any 2nd grade student can surmise, you can should also be able to find that there are many products both natural and man-made that contain nicotine to which you are not addressing, nor have any plans to address. e-liquid does not contain tobacco, therefore based on that fact alone, the FDA should not be making regulations and has no jurisdiction.

the industry has been self regulated for many years now, without your deeming regulations. if any regulations on e-cigarettes and e-liquid come from this, 1. it would be that they must not be sold to minors. 2. e-liquid bottles should have a child-resistant cap. those should be the only regulations. any additional regulations would been perceived as influenced by big tobacco, big pharmaceuticals and hysteria. law suits and long drawn out court battles would ensue.

not one person has even died using an e-cigarette. many hundreds of thousands of people, now e-cigarette users have given up tobacco without regulation. CHANTIX, one of your "approved" products have brought many deaths, along with hundreds of other side-effects. nicorette gum and patches, another of your "approved products" do not work and have made many very sick due to the many chemicals in them, and a person using them will still smoke cigarettes, causing sickness. peanuts killed over 1,000 people last year, including hundreds of children. FDA is not acting on peanuts, why e-cigarettes, just because you can?

please use science, fact and testimony of actual former smokers and those without a substantial interest in this matter. big tobacco, big pharma, even big e-cigarette companies have financial incentive to distort the truth, as they have proven by their past performances on matters that pertain to their bottom line. lies and hysteria should have no place in the FDA decision making process.

i feel that A 75 day period time to review the proposed regulations is insufficient. We are requesting that the review period be extended to 180 days. you will see that there are many thousands more people that will comment against any regulations, other than the 2 i mentioned. thank you for reading.


[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Page 71389]
[FR Doc No: 2022-25359]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96335; File No. SR-CboeBZX-2022-043]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Amend Exchange Rule 14.11(d) To
Accommodate Exchange Listing and Trading of Options-Linked Securities

November 16, 2022.
    On August 18, 2022, Cboe BZX Exchange, Inc. (``BZX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend BZX Rule 14.11(d) to accommodate the
listing and trading of Options-Linked Securities.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The proposed rule change was published for comment in the Federal
Register on September 8, 2022.\3\ On October 14, 2022, pursuant to
Section 19(b)(2) of the Act,\4\ the Commission designated a longer
period within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ The Commission received no
comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 95655 (Sept. 1,
2022), 87 FR 55068.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 96077, 87 FR 63830
(Oct. 20, 2022).
---------------------------------------------------------------------------

    On November 10, 2022, the Exchange withdrew the proposed rule
change (SR-CboeBZX-2022-043).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-25359 Filed 11-21-22; 8:45 am]
BILLING CODE 8011-01-P