7A 29363 Allegro Hood Systems, p144 $ 932.15 ( iv) 21C Air purifying with full face piece and hig h efficiency particulate filters ( H EPAs) $ 180.67 $ 9.76 7A 9838 North Full Face Respirator, p114 $ 210.10 7A 7122 North HEPA Cartridge, p115 $ 11.15 7A 12338 Willson Full Face Silicone Respirator, p116 $ 215.10 7A 7526 Willson HEPA Cartridge, p117 $ 11.75 7A 10516 3M 7800 Full Facepiece Respirator, p118 $ 202.10 7A 11839 3M HEPA Cartridge, p118 $ 7.00 7A 33446 Pro Tech Full Face Respirator, p122 $ 106.45 7A 3070 1 Pro Tech HEPA Cartridge, p123 $ 9.87 7A 3195 Willson 1600/ 1700 Series Full Fave Respirators, p124 $ 215.10 7A 3202 Willson HEPA Cartridge, p125 $ 12.50 7A 23959 AO7Star Full Face Respirator ( Silicone), p126 $ 203.25 7A 9940 AO7Star HEPA Cartridge, p127 $ 9.44 7A 24158 MSA Advantage 1000 Full Face Respirator, p134 $ 112.60 7A 29946 MSA HEPA Cartridge, p134 $ 6.60 ( v) 21C Powered air purifying ( PAPR) with tight fitting facepiece and HEPAs $ 627.45 $ 35.50 7A 13599 3M Face Mounted PAPR System, p142 $ 720.00 7A 13601 3M HEPA Replacement Cartridge, p142 $ 36.50 7A 32505 RACAL Powerflow PAPR, p142 $ 534.90 7A 11936 RACAL Replacement Cartridge, p142 $ 34.50 ( vi) 21C PAPR with loose hood or helmet and HEPAs $ 525.43 $ 26.89 7A 32506 RACAL Air Mate PAPR 12, p143 $ 411.05 7A 24505 RACAL HEPA Replacement Cartridge, p143 $ 24.65 7A 32477 RACAL Breathe Easy HEPA Cartridges and Turbo Unit, p141 $ 548.50 7A 12838 RACAL HEPA Replacement Cartridge $ 29.12 7A 12840 RACAL Breathe Easy 10 Tyvek Hood, p140 $ 91.30 ( vii) 21C Air purifying with H EPA an d disposable resp irators $ 12.53 $ 7.00 7A 15255 3M 6000 Series Low Maintenance Respirator, p135 $ 10.90 7A 12518P 3M Adaptor, p135 $ 1.63 40CFR § 721.63 ( a)( 5) NIOSH type Catalog Item Number Description 1997 Cost 1997 Average Cost Unit Cartridge C 16 7A 11839 3M HEPA Cartridge, p135 $ 7.00 ( viii) 23C air purifying with full facep iece and com bination cartridges a pproved fo r paints, lacquers and enamels ( PLE) $ 192.02 $ 15.71 7A 9838 North Full Face Respirator, p114 $ 210.10 7A 7117 North Organic Vapors Cartridge, p115 $ 10.50 7A 7125 North Paint Spray/ Mists Prefilter, p115 $ 2.38 7A 7125 2 North Filter Covers, p115 $ 4.35 7A 12338 Willson Full Face Silicone Respirator, p116 $ 215.10 7A 7527 Willson Organic Vapors Cartridge, p117 $ 10.25 7A 7531 Willson Dusts/ Mists/ Pesticides/ Paint Spray Prefilter, p117 $ 2.52 7A 7532 Willson Retainer Caps, p117 $ 4.00 7A 10516 3M 7800 Full Facepiece Respirator, p118 $ 202.10 7A 9279 3M Organic Vapors Cartridge, p119 $ 8.91 7A 9284 3M Paint Spray Prefilter, p119 $ 2.37 7A 9292 3M Retainer Caps, p119 $ 3.90 7A 33446 Pro Tech Full Face Respirator, p122 $ 106.45 7A 955 4 Pro Tech Organic Vapors Cartridge, p123 $ 9.27 7A 9605 Pro Tech Paint Spray Prefilter, p123 $ 1.95 7A 3195 Willson 1600/ 1700 Series Full Fave Respirators, p124 $ 215.10 7A 3197 Willson Organic Vapors Cartridge, p125 $ 11.22 7A 3203 Willson Pesticides/ Paint Spray Prefilter, p125 $ 3.36 7A 3858 Willson Retainer Caps, p125 $ 4.27 7A 23959 AO7Star Full Face Respirator ( Silicone), p126 $ 203.25 7A 9935 AO7Star Organic Vapors Cartridge, p127 $ 8.76 7A 10043 AO7Star Dusts/ Mists/ Paint Spray Prefilter, p127 $ 3.07 7A 10044 AO7Star Retainer Clips, p 127 $ 3.20 ( ix) 23C PAPR with tight fitting facepiece and combination cartridges approved PLE $ 627.45 $ 35.50 7A 13599 3M Face Mounted PAPR System, p142 $ 720.00  Paint, Lacquer, Enamel Cartridge* $ 36.50 7A 32505 RACAL Powerflow PAPR, p142 $ 534.90  Paint, Lacquer, Enamel Cartridge* $ 34.50 ( x) 23C PAPR with loose fitting hood or helmet and combination cartridges for PLE $ 525.43 $ 26.88 7A 32506 RACAL Air Mate PAPR 12, p143 $ 411.05  Paint, Lacquer, Enamel Cartridge* $ 24.65 7A 32477 RACAL Breathe Easy HEPA Cartridges and Turbo Unit, p141 $ 548.50 7A 12840 RACAL Breathe Easy 10 Tyvek Hood, p140 $ 91.30  Paint, Lacquer, Enamel Cartridge* $ 29.10 ( xi) 23C Air purifying with co mbination c artridges for PLE , including disposa ble respirators $ 14.30 $ 8.90 7A 12711 Willson Freedom 2000 Series Organic Vapors Respirator, p136 $ 17.85 7A 7531 Willson Dusts/ Mists/ Paint Spray/ Pesticides Prefilter, p136 $ 2.52 40CFR § 721.63 ( a)( 5) NIOSH type Catalog Item Number Description 1997 Cost 1997 Average Cost Unit Cartridge C 17 7A 13509 Willson Retainer Caps, p136 $ 2.03 7A 33826 Moldex 8000 Series Half Mask Respirator, p139 $ 10.75 7A 22751 Moldex Organic Vapors Cartridge, p139 $ 8.03 7A 22753 Moldex Paint Spray/ Pesticides Prefilter, p139 $ 2.56 7A 22754 Moldex Retainer Caps, p139 $ 2.65 ( xii) 23C Air purifying with full facepiece and organic gas/ vapor cartridges $ 192.02 $ 10.47 7A 9838 North Full Face Respirator, p114 $ 210.10 7A 7117 North Organic Vapors Cartridge, p115 $ 10.50 7A 12338 Willson Full Face Silicone Respirator, p116 $ 215.10 7A 7527 Willson Organic Vapors Cartridge, p117 $ 10.25 7A 10516 3M 7800 Full Facepiece Respirator, p118 $ 202.10 7A 9279 3M Organic Vapors Cartridge, p119 $ 8.91 7A 9292 3M Retainer Caps, p119 $ 3.90 7A 33446 Pro Tech Full Face Respirator, p122 $ 106.45 7A 955 4 Pro Tech Organic Vapors Cartridge, p123 $ 9.27 7A 3195 Willson 1600/ 1700 Series Full Fave Respirators, p124 $ 215.10 7A 3197 Willson Organic Vapors Cartridge, p125 $ 11.22 7A 23959 AO7Star Full Face Respirator ( Silicone), p126 $ 203.25 7A 9935 AO7Star Organic Vapors Cartridge, p127 $ 8.76 ( xiii) 23C PAPR with tight fitting facepiece and organic gas/ vapor cartridges $ 826.40 $ 41.15 7A 32473 RACAL Breathe Easy Organic Vapors and Turbo Unit, p141 $ 548.50 7A 12844 RACAL Breathe Easy 7 Full Face, p140 $ 277.90 7A 12830 RACAL Organic Vapors Replacement Cartridges, p141 $ 41.15 ( xiv) 23C PAPR with a loose fitting hood or helmet and organic gas/ vapor cartridges $ 639.80 $ 41.15 7A 32473 RACAL Breathe Easy Organic Vapors and Turbo Unit, p141 $ 548.50 7A 12840 RACAL Breathe Easy 10 Tyvek Hood, p140 $ 91.30 7A 12830 RACAL Organic Vapors Replacement Cartridges, p141 $ 41.15 ( xv) 23C Air purifying with organic gas/ vapor cartridges, including disposable cartridges $ 10.83 $ 8.94 7A 15255 3M 6000 Series Low Maintenance Respirator, p135 $ 10.90 7A 15256 3M Organic Vapors Cartridge, p135 $ 9.85 7A 33826 Moldex 8000 Series Half Mask Respirator, p139 $ 10.75 7A 22751 Moldex Organic Vapors Cartridge, p139 $ 8.03 Source: LSS 1997; EPAB 1999 * Paint, lacq uer and ename l ( PLE) c artridges fo r PAPR s were no t listed in the cata log. The costs for PL E cartridg es are assum ed to be the same a s HEPA cartridges. C 18 C. 2.7 Annual Costs of Protection in the Workplace Requirements Based on the equipment purchase costs shown above in Tables C 7, C 8, C 9 C 10, and the assumptions made regarding replacement intervals for the equipment, Table C 12 below shows the annual costs of providing the various types of personal protective equipment in the workplace, per chemical, at one manufacturing site, with 25 exposed workers.

Table C 12 Annual Costs of Personal Protective Equipment PPE and Requirement Citation at 40 CFR Unit Cost ( 2002 D ollars) Quantity Required Annual Cost ( 2000 D ollars)

Gloves § 721.6 3( a)( 2)( i)

Standard ( disposable) $ 0.48 6250 $ 3,012 Heavy duty butyl $ 38.11 250 $ 9,527 Protective clothing § 721.63( a)( 2)

( ii) Full body ( coverall with hood) $ 68.60 75 $ 5,145 ( iv) Coverall ( no hood) $ 40.63 75 $ 3,047 Eyew ear § 72 1.63( a)( 2)( i)

Standard goggles $ 4.54 75 $ 340 Heavy duty goggles $ 6.78 75 $ 509 Respirators § 721.63( a)( 5) Respirator Cartridge Unit Cost Quan tity Unit Cost Quan tity Total ( i) Type 1 Respirator $ 901.21 25   $ 22,530 ( ii) Type 2 Respirator $ 901.21 25   $ 22,530 ( iii) Type 3 Respirator $ 1,044.82 25   $ 26,121 ( iv) Type 4 Respirator $ 202.51 25 $ 10.94 1250 $ 18,737 ( v) Type 5 Respirator $ 703.29 25 $ 39.79 1250 $ 67,321 ( vi) Type 6 Respirator $ 588.94 25 $ 30.14 1250 $ 52,399 ( vii) Type 7 Respirator $ 14.04 25 $ 7.85 1250 $ 10,159 ( viii) Type 8 Respirator $ 215.23 25 $ 17.61 1250 $ 27,392 ( ix) Type 9 Respirator $ 703.29 25 $ 39.79 1250 $ 67,321 ( x) Type 10 Respirator $ 588.94 25 $ 30.13 1250 $ 52,385 ( xi) Type 11 Respirator $ 16.03 25 $ 9.98 1250 $ 12,870 ( xii) Type 12 Respirator $ 215.23 25 $ 11.74 1250 $ 20,050 ( xiii) Type 13 Respirator $ 926.29 25 $ 46.12 1250 $ 80,812 ( xiv) Type 14 Respirator $ 717.13 25 $ 46.12 1250 $ 75,583 ( xv) Type 15 Respirator $ 12.14 25 $ 10.02 1250 $ 12,829 Note: To tal annua l costs assum e: 1) 25 w orkers ex posed 2 50 day s per year ; 2) standar d glove s replaced daily and heavy duty gloves replaced every 25 days; 3) respirators replaced annually and cartridge sets replaced every five days; 4) goggles and protective clothing re placed th ree times y early Source: Tables C 6, C 7, C 8, C 9, and C 11. C 19 C. 3 Recordkeeping Recordkeeping requirements are specified for all PMN substances listed in the current SNUR. Companies submitting a SNUN must keep records under 40 CFR § 721.40. In addition, whether or not they submit a SNUN, all manufacturers, importers, and processors of the SNUR substance must keep records based on § 721.125( a) through ( k), to document compliance with SNUR conditions for avoiding a Significant New Use. ( Companies manufacturing only for R& D use must add the SNUR chemical to their R& D records system.)

For example, for all chemicals in the current SNUR, manufacturers, importers, and processors must keep records on quantities supplied or purchased under § 721.125( a), ( b), and ( c). For chemicals with water discharge restrictions, companies must keep records concerning water discharge compliance, under § 721.125( k). For those few chemicals with workplace protection or hazard communication restrictions, companies must keep records to document compliance.

The requirements vary between substances ( i. e., there are variations in terms of the types of records that must be kept, reflecting differences in SNUR restrictions) . This analysis estimates recordkeeping costs for a chemical with numerous SNUR restrictions, including workplace protection, hazard communication, water discharge, and disposal. Since few if any chemicals will have all of those restrictions, actual recordkeeping costs may be less than estimated here. However, the differences are judged to have a minimal impact on the type of recordkeeping activities that must be performed and the costs that will be incurred.

All recordkeeping requirements basically involve copying and filing relevant records, including those related to: manufacturing, importing, or processing volumes; shipment amounts and customer information; labels ( documentation of labeling procedures and copies of labels); MSDS; and compliance with any additional restrictions on use, disposal, and discharge. Records must be maintained for five years from the date of their creation.

Costs for compliance with the recordkeeping requirements for substances subject to a SNUR are based on the approach in RIB ( 1989). On an annual basis, recordkeeping associated with each substance is estimated to require: 2.3 hours technical time, 23 hours clerical time, 1,715 photocopies, one half of a 4 drawer file cabinet, and other miscellaneous materials such as folders.

To calculate labor costs associated with these requirements, EPA used the labor rates for chemical technicians and clerical support described earlier in this report and in Appendix B ( BLS 2003d). Also as before, photocopying was inflated from $ 0.5 per page in 1988. A standard, four drawer, full suspension file cabinet was priced from a national office products supplier at $ 195.00 ( BT Office Products 1997; Item # LGM 202401), or $ 218.57, when inflated to 2002 dollars ( BLS 2003b). Miscellaneous materials costs were estimated at $ 23.00 per chemical in 1989 ( RIB 1989), or $ 33.37 when inflated to 2002 dollars ( BLS 2003b). C 20 Other assumptions underlying the recordkeeping cost estimates, based on RIB 1989 and information used in preparing the RIB 1989 report ( Kearney 1988), are listed below.

" The SNUR chemical is present at one of a company  s sites.

" Manufacture and import volume, and sales and transfer data require 480 pages of records per year. This reflects 40 invoices per month ( see Haz Comm Section C. 1 above).

" Disposal compliance records, if required, cover items such as waste production, shipping manifests, permits, and transfer receipts.

" The ratios of labor hours to page count for each labor category, file drawer space to page count, and cost of miscellaneous supplies such as folders and labels to page count, are the same as those estimated for EPA  s Comprehensive Assessment and Reporting Rule ( CAIR).

Total costs for recordkeeping, as shown in Table C 13, are $ 923 per chemical with numerous SNUR restrictions. Recordkeeping costs would be lower for chemicals with relatively few SNUR restrictions and therefore fewer pages needed to document SNUR compliance. C 21 Table C 13 Annual Costs of Recordkeeping Requirements [ 40 CFR § 721.125]

Cost Element Unit Cost ( 2002 D ollars) Hours Total Cost 2.25 hours technical time $ 43.34 per hour 2.25 $ 97.52 23 hours clerical time Pages $ 23.96 per hour 23.0 $ 551.11 1,715 pages of copying resulting from 40 CFR § 721.125 ( a) through ( k):*

( a), ( b), ( c) V olume s & data ** ( d) Protective clothing [ 721.63] ( e) Impermeability [ 721.63( a)( 3)] ( f) Haz com program [ 721.72] ( g) Label copies[ 721.72( b)] ( h) MSDS copies [ 721 .72( c)] ( i) Use limitations compliance [ 721.80] ( j) Disposal compliance [ 721.85] ( k) Water discharge compliance [ 721.90 ] 485 20 250 5 5 250 600 100 1715 $ 0.076 per copy $ 130.34 Half of a four drawer filing cabinet ($ 195 in 1997, inflated using a factor of 1.121) $ 218.57 each $ 109.29 Misc. materials ($ 23 in 1988, inflated using a factor of 1.521) $ 34.98 per chemical $ 34.98 Total 25.3 $ 923 Source: File cabinet 1997 price, LSS 1997; quantities, RIB 1989 and Kearney 1988; labor rates, Appendix B; inflators, BLS 2003b and Appendix B. * 40 CFR 721.125( a) through ( k) lists recordkeeping requirements that are triggered by other SNUR restrictions, indicated in the bracketed CFR references § 721.63, § 721.72, § 721.80, § 721.85, and § 721.90. ** Kearney 1988 had 5 pages for manufacture/ import volume and 480 pages for sales/ transfer data.  Protective clothing  pages assumed same as pages for  protective gloves  in RIB 1989.  Haz com  pages assumed same as pages for  employee information and training  in RIB 1989.  Impermeability  not separately costed in RIB 1989. Assume it is included under  Protective clothing.  Inflated from $ 0.5 per copy in 1988 using Consumer Price Index factor 1.521. See Appendix B. NOTE: Totals were calculated using unrounded values from Appendix B, and may not equal product of the rounded values shown in this table. APPENDIX D COSTS OF TESTING D 1 APPENDIX D COSTS OF TESTING This appendix presents a detailed description of the methodology used to estimate costs for health and environmental effects testing recommended for chemicals subject to the current SNUR.

Table D 2 contains a master list of all guidelines cited in the batch SNUR and the dollar cost and hours estimate for each, based on the assumptions and adjustments discussed below. In cases where cost information was not available for a particular guideline, cost information was obtained from a corresponding test as indicated by parenthesis in the Guideline column.

Testing Guidelines For some or all chemicals in a SNUR, EPA identifies tests that can be used by submitters to characterize risks of the PMN substances. The tests are recommended in the SNUR, not mandatory, and they are identified by guideline numbers which can be used to look up published test protocols. The types of guidelines are described below.

" OPPTS Harmonized. Most SNUR tests are identified by their OPPTS number from the series of OPPTS Harmonized Test Guidelines and OPPTS harmonized public drafts not yet promulgated as OPPTS guidelines. For example, the OPPTS 835 series covers Fate, Transport and Transformation; the 850 series covers Ecological Effects, and the 870 series covers Health Effects. An example is OPPTS Guideline 850.1400, Fish Early Life Stage Toxicity. These guidelines may have equivalent Code of Federal Regulations ( CFR) or Organization for Economic Cooperation and Development ( OECD) guidelines. They are available electronically on EPA  s website.

" CFR. A few SNUR tests are identified as coming from the Code of Federal Regulations. An example is the two year bioassay test at 40 CFR 799.9420. These CFR guidelines may have equivalent OPPTS harmonized guidelines, but are listed in the SNUR by their CFR reference.

" OECD. A few SNUR tests are identified by their OECD number. The OECD guidelines may also have OPPTS equivalents. For example, OECD 407 28 Day Oral Toxicity in Rats is essentially equivalent to OPPTS 870.3050.

" PBT Category. Finally, for some chemicals, the SNUR cites tiered testing according to a testing strategy published in the Federal Register ( FR), Category for Persistant, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999 ( 64 FR 60194), which in turn refers to a number of tests by OPPTS or OECD guideline number. D 2 Testing Costs Testing costs for each PMN substance are calculated by adding up costs of individual tests listed in the SNUR for that substance. EPA regularly develops cost estimates of many test guidelines to support TSCA rule development. These costs are used where possible. If costs of a test have not been estimated, EPA identifies an equivalent guideline for which the cost have been developed, and uses that cost. All test costs have been updated to 2002 dollars using Employment Cost Index inflators from the Bureau of Labor Statistics ( see Appendix B).

In cases where EPA had not estimated costs of the exact test called for in the SNUR, or where the SNUR left open aspects of method, EPA made the adjustments described below.

Default parameters and other adjustments Costs for many of the guidelines have been estimated for different combinations of species, route, length of study and other aspects of methodology, but in some cases the SNUR may not specify all of these variables. Where this occurs, EPA has used certain default parameters, which are listed in Table D 1.

Table D 1 Default Parameters for Species, Route, and Study Type Variab le Defau lt Species Mammals Fish Invertebrates Algae Rats Fathead minnow* Daphnids [ Four spe cies  see text]

Route/ Method Mammalian Fish Invertebrates Gavage Flow through Flow through * For guide line 850.1 400 tests d uplicated in P BT tier te sts, rainbow tro ut is the default. ( See PB T test discus sion below .)

There were other adjustments as well:

" The SNUR recommends algal acute toxicity testing following OPPTS Guideline 850.5400 for several PMNs. This guideline has been previously costed by EPA for four separate algal species ( Navicula pelliculosa, Skeletonema costatum, Anabaena flos aquae, and Selenastrum capricornutum). Since the SNUR does not specify the algal species to be used, the average costs of the four algal species tests were used in this analysis. D 3 " For OPPTS test guideline 870.3700 for prenatal developmental toxicity, the SNUR specified twospecies testing using rats and mice. Test cost information was not available for testing rats and mice as the two species or for mice testing by the gavage route. For a corresponding CFR test ( 40 CFR 798.4900), costs for testing rats are greater than for testing mice. Therefore, cost information was used for rats by the gavage route for 870.3700. Cost information for 870.3700 was used instead of 798.4900 because the cost information was more recent. Using the rat testing by gavage cost information errs on the conservative side ( presents an overestimate of cost).

" In cases where OECD 421 and OECD 422 reproductive and developmental toxicity tests were listed as alternatives, costs for the more expensive test, OECD 422, were used.

Persistent Bioaccumulative Toxic ( PBT) tiered testing For some chemicals, the SNUR cites tiered testing for Persistant Bioaccumulative Toxic chemical substances ( PBTs) according to the testing strategy in Category for Persistant, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at 64 FR 60194. In 64 FR 60194, there are three tiers of testing. The results of tier 1 determine whether tier 2 testing is needed and the results of tier 2 testing determine whether tier 3 testing is needed. To obtain a cost estimate for chemicals citing this tiered testing, two estimates were made: a low estimate which includes Tier 1 test costs plus any additional tests listed in the SNUR for that chemical, and a high estimate that includes Tiers 1, 2, and 3 testing as well as any additional testing listed in the SNUR. Costs were adjusted to avoid doublecounting tests listed in both the PBT tiers and in the SNUR. Further details are provided in Table D 2.

Other assumptions are described below:

" For some chemicals, test guideline 850.1400 is referenced both explicitly in the SNUR and implicitly as part of PBT tier 3. The PBT test referenced at 64 FR 60194 specifies rainbow trout as the species. Test costs for those chemicals assume the test explicitly listed in the SNUR would be conducted with rainbow trout, to be consistent with the species designated in PBT tier 3 for the same test.

" For PBT tier 1 ready biodegradability tests, firms may either choose among six methods in test guideline 835.3110 or follow test guideline 835.3120. The costs estimates assume 835.3110 was used and calculates the average cost of its six methods.

Costs by test and by PMN chemical Table D 3 presents recommended test guidelines, the costs associated with each guideline, and the total testing costestimates for each of the 65 chemicals. An asterisk denotes that the SNUR did not specify which species or route/ method to use and the default assumptions mentioned above were used. No tests were listed in the SNUR for two of the 65 chemicals. D 4 Table D 2 Cost Estimates for Test Guidelines Cited in Batch SNUR Guideline Test Species Route/ Method Cost ($ 2002) Hours 799.9420 Two year bioassay Rats inhalation $ 1,730,120.19 22748 835.1110 Activated sludge sorption/ desorption isotherm $ 9,904.29 82 835.2120 ( 796.3500) Hydrolysis study at 25 degrees centigrade and pH 7 $ 9,541.00 120 835.3110 Ready biodegradability avg of 6 tests $ 10,213.00 112 835.3170 Shake flask die away ( biodegradability) $ 41,645.29 88 835.3220 Porous pot study $ 40,810.68 539 850.1010 ( 797.1300) Daphnid acute toxicity Daphnid flow through $ 8,995.98 54 850.1010 ( 797.1300) Daphnid acute toxicity Daphnid static $ 8,834.23 53 850.1075 ( 797.1400) Fish acute toxicity static $ 10,398.79 84 850.1075 ( 797.1400) Fish acute toxicity Fathead Minnow flow through $ 13,624.62 65 850.1085 Fish acute toxicity mitigated by humic acid Fathead Minnow static $ 10,974.19 74 850.1300 Daphnid chronic toxicity Daphnid flow through $ 31,730.77 173 850.1400 Fish early life stage chronic toxicity Fathead Minnow flow through $ 34,483.17 291 850.1400 Fish early life stage chronic toxicity Rainbow trout flow through $ 52,560.10 432 850.1730 Fish bioaccumulation ( BCF) Fathead Minnow flow through $ 58,716.50 775 850.5400 Algal acute toxicity Average of four species $ 10,983.68 60 870.1100 Acute oral toxicity Rats gavage $ 3,533.69 44 870.3100 90 day subchronic oral study in rats Rats gavage $ 121,128.45 834 870.3465 90 day inhalation toxicity study Rats inhalation $ 340,553.22 2458 870.3700 Prenatal developmental toxicity Rats gavage $ 98,594.95 1157 870.3800 Two generation reproductive and toxicity study Rats gavage $ 529,717.65 5024 870.4200 2 year, two species oral carcinogenicity Rats gavage $ 799,639.42 8275 870.4300 Combined chronic toxicity/ carcinogenicity study Rats gavage $ 972,884.62 9701 870.5100 Ames assay/ salmonella Direct plate $ 7,892.53 48 870.5265 Salmonella typhimurium reverse mutation assay Average of Direct plate and Azo reduction $ 7,347.50 48 Guideline Test Species Route/ Method Cost ($ 2002) Hours D 5 870.5395 In vivo mouse micronucleus assay ( intraperitoneal) Mice gavage ( avg of 1 and 3 day doses) $ 14,687.50 114 OECD 407 28 day oral toxicity study in rats Rats gavage $ 43,750.00 328 OECD 407 ( mod : FOB + histo) 28 day oral toxicity study in rats modified with FOB and histopathology Rats gavage $ 150,629.43 1838 OECD 421 Reproductive/ Development Toxicity Rats gavage $ 51,875.00 445 OECD 422 Combined Repeated Dose with Reproductive/ Developmental Toxicity Rats gavage $ 109,464.00 1146 60 FR 60194 Persistent Bioaccumulative Toxic ( PB T) Tiered Testing TIER 1 $ 60,577.38 275.5 830.7570 ( 796.1570) Log Kow ( liquid chromatography) Liquid chromatography $ 2412.11 28 830.7560 Log Kow ( generator column) Generator column $ 3,316.65 39 Log Kow ( liquid chromatography or generator column) Average of 2 tests $ 2,864.38 33.5 835.2110 Hydrolysis in water $ 47,500.00 130 835.3110 Ready biodegradability ( chose one of six methods) Average of 6 methods $ 10,213.00 112 TIERS 2 and 3 $ 402,989.02 4110 TIER 2 835.3170 Shake flask die away ( biodegradability) $ 41,645.29 88 850.1730 Fish bioaccumulation ( BCF) Fathead minnow Flow through $ 58,716.50 775 TIER 3 OECD 422 Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity screen Rat gavage $ 109,464.00 1146 Guideline Test Species Route/ Method Cost ($ 2002) Hours D 6 835.3180 Sediment/ water microcosm biodegradation Flow through $ 108,872.37 1496 850.1400 Fish chronic toxicity Rainbow trout Flow through $ 52,560.10 432 850.1300 Daphnid chronic toxicity Daphnid Flow through $ 31,730.77 173 TIERS 2 and 3 excluding 850.1400 and 850.1300 $ 318,698.16 3505 TIERS 2 and 3 excluding 850.1400, 850.1300, 835.3170, and 850.1730 $ 218,336.37 2642 Guidelines in parenthesis indicate corresponding test guidelines from which cost information was calculated. D 7 Table D  3 SNU R Testin g Requ irements a nd Co st for 65 C hemicals No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours 1 P 97 1108 850.1400 Fathead Minnow* flow through* $ 34,483.17 291 $ 118,008.30 1,063 850.1300 Daphn id flow through* $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 835.3220   $ 40,810.68 539 2 P 98 848 870.3465 Rats* inhalation $ 340,553.22 2458 $ 2,070,673.41 25206 799.9420 Rats* inhalation $ 1,730,120.19 22748 3 P 98 1033 OECD 407 ( mod : FOB + histo) Rats gavage* $ 150,629.43 1838 $ 297,516.16 3288 870.5395 Mice gavage ( avg of 1 and 3 day doses)* $ 14,687.50 114 870.3700 Rats* gavage* $ 98,594.95 1157 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 4 P 98 1034 OECD 407 ( mod : FOB + histo) Rats gavage* $ 150,629.43 1838 $ 297,516.16 3288 870.5395 Mice gavage ( avg of 1 and 3 day doses)* $ 14,687.50 114 870.3700 Rats* gavage* $ 98,594.95 1157 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 5 P 98 1035 OECD 407 ( mod : FOB + histo) Rats gavage* $ 150,629.43 1838 $ 297,516.16 3288 870.5395 Mice gavage ( avg of 1 and 3 day doses)* $ 14,687.50 114 870.3700 Rats* gavage* $ 98,594.95 1157 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 8 6 P 99 783 850.1010 Daphn id flow through $ 8,995.98 54 $ 19,979.66 114 850.5400 Average of four spec ies*  $ 10,983.68 60 7 P 99 817 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 8 P 99 897 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphnid* flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 9 P 99 920 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 10 P 99 928 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 11 P 99 951 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 12 P 99 952 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 13 P 99 1075 850.1400 Fathead Minnow* flow through* $ 34,483.17 291 $ 77,197.62 524 850.1300 Daphn id flow through* $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 14 P 99 1202 850.1400 Fathead Minnow* flow through $ 34,483.17 291 $ 417,750.84 2982 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 870.3465 Rats* inhalation $ 340,553.22 2458 15 P 99 1288 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 16 P 99 1295 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 9 17 P 99 1304 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 374,157.49 2637 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 870.3465 Rats* inhalation $ 340,553.22 2458 18 P 99 1341 850.1075  static $ 10,398.79 84 $ 30,216.70 197 850.1010 Daphn id static $ 8,834.23 53 850.5400 Average of four spec ies*  $ 10,983.68 60 19 P 99 1342 850.1075  static $ 10,398.79 84 $ 30,216.70 197 850.1010 Daphn id static $ 8,834.23 53 850.5400 Average of four spec ies*  $ 10,983.68 60 20 P 00 7 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 21 P 00 368 870.3465 Rats* inhalation $ 340,553.22 2458 $ 406,767.16 2922 850.1400 Fathead Minnow* flow through* $ 34,483.17 291 850.1300 Daphn id flow through* $ 31,730.77 173 22 P 00 636 870.3800 Rats* gavage* $ 529,717.65 5024 $ 1,329,357.07 13299 870.4200 Rats* gavage* $ 799,639.42 8275 23 P 00 838 850.1400 Fathead Minnow* flow through $ 34,483.17 291 $ 34,483.17 291 24 P 00 912 ( low estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 1,076,619.80 10049 .5 850.1400 Rainbow Trout flow through* $ 52,560.10 432 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 870.4200 Rats* gavage* $ 799,639.42 8275 870.3100 Rats gavage* $ 121,128.45 834 24 P 00 912 ( high estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 1,395,317.95 13554 .5 64 FR 60194  PBT Tiers 2 and 3 ( a) $ 318,698.16 3505 850.1400 Rainbow trout* flow through $ 52,560.10 432 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 870.4200 Rats* gavage* $ 799,639.42 8275 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 10 870.3100 Rats gavage* $ 121,128.45 834 ( a) Excluding 850.1400 and 850 .1300 to avoid doublecounting 25 P 00 966 850.5400 Average of four spec ies*  $ 10,983.68 60 $ 43,817.28 291 850.1010 Daphnid* flow through $ 8,995.98 54 850.1075 Fathead Minnow* flow through $ 13,624.62 65 835.3110 Ready biodegradation avg of 6 tests* $ 10,213.00 112 26 P 00 991 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 27 P 00 1055 870.3700 Rats* gavage $ 98,595.00 1157 $ 1,484,136.38 14797 870.3800 Rats* gavage* $ 529,717.65 5024 870.5100 Salmone lla Direct plate* $ 7,892.53 48 870.5395 Mice gavage ( avg of 1 and 3 day doses)* $ 14,687.50 114 870.4200 Rats gavage* $ 799,639.42 8275 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 28 P 00 1205 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 34,503.10 221 850.1085 Fathead Minnow* static* $ 10,974.19 74 835.1110   $ 9,904.29 82 29 P 00 1220 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies* $ 10,983.68 60 30 P 01 1 835.2130   $ 9,541.00 120 $ 53,358.28 411 835.3110  avg of 6 tests* $ 10,213.00 112 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 31 P 01 7 870.3700 Rats* gavage* $ 98,594.95 1157 $ 898,234.37 9432 870.4200 Rats* gavage* $ 799,639.42 8275 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 11 32 P 01 9 ( low estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 155,851.93 940.5 850.1400 Rainbow Trout flow through $ 52,560.10 432 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 32 P 01 9 ( high estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 474,550.09 4445.5 64 FR 60194  PBT Tiers 2 and 3 ( a) $ 318,698.16 3505 850.1400 Rainbow Trout flow through $ 52,560.10 432 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 ( a) Excluding 850.1400 and 850 .1300 to avoid doublecounting 33 P 01 22 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 34 P 01 69 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 35 P 01 71 850.1400 Rainbow Trout flow through $ 52,560.10 432 $ 84,290.87 605 850.1300 Daphn id flow through $ 31,730.77 173 36 P 01 77 OECD 422 or OECD 421 Rats* gavage $ 109,464.00 1146 $ 143,068.28 1325 850.1075 Fathead Minnow* flow through $ 13,624.62 65 850.1010 Daphn id flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 37 P 01 85 850.1075 Fathead Minnow* flow through $ 13,624.62 65 $ 33,604.28 $ 179.00 850.1010 Daphnid* flow through $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 38 P 01 97 870.3100 Rats gavage* $ 121,128.45 834 $ 920,767.87 9109 870.4200 Rats gavage* $ 799,639.42 8275 39 P 01 144 870.3700 Rats* gavage* $ 98,594.95 1157 $ 274,793.07 3201 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 12 OECD 407 ( mod: FOB + histo) Rats gavage $ 150,629.43 1838 870.1100 Rats* gavage $ 3,533.69 44 870.5395 Mice* gavage ( avg of 1 and 3 day doses)* $ 14,687.50 114 870.5265 Average of Direct p late and Azo reduction* $ 7,347.50 48 40 P 01 149 870.3100 Rats* gavage $ 121,128.45 834 $ 121,128.45 834 41 P 01 152 ( low estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 94,181.66 454.5 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies* $ 10,983.68 60 41 P 01 152 ( high estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 497,170.68 4564.5 64 FR 60194  PBT Tiers 2 and 3 $ 402,989.02 4110 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 42 P 01 170 N/ A [ No tests listed in SNUR] N/ A N/ A $ 0.00 0 43 P 01 298 870.3700 Rats* gavage* $ 98,594.95 1157 $ 98,594.95 1157 44 P 01 320 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 45 P 01 397 850.1400 Fathead Minnow* flow through $ 34,483.17 291 $ 77,197.62 524 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 46 P 01 420 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 47 P 01 423 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 48 P 01 432 870.5395 Mice gavage ( avg of 1 and 3 day doses)* $ 14,687.50 114 $ 1,508,923.02 14575 OECD 407 Rats gavage $ 43,750.00 328 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 13 870.3100 Rats gavage $ 121,128.45 834 870.3800 Rats gavage* $ 529,717.65 5024 870.4200 Rats* gavage* $ 799,639.42 8275 49 P 01 433 870.3465 Rats* inhalation $ 340,553.22 2458 $ 374,157.49 2637 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 50 P 01 441 ( low estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 94,181.66 454.5 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 50 P 01 441 ( high estimate) 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 $ 497,170.68 4564.5 64 FR 60194  PBT Tiers 2 and 3 $ 402,989.02 4110 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 51 P 01 459 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 52 P 01 460 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 53 P 00 992 and P 01 471 850.1400 Fathead Minnow* flow through $ 34,483.17 291 $ 77,197.62 524 850.1300 Daphn id flow through $ 31,730.77 173 850.5400 Average of four spec ies*  $ 10,983.68 60 54 P 01 481 N/ A [ No tests listed in SNUR] N/ A N/ A $ 0.00 0 55 P 01 561 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 56 P 01 573 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 14 57 P 01 578 850.5400 Average of four spec ies*  $ 10,983.68 60 $ 30,216.70 197 850.1010 Daphn id static $ 8,834.23 53 850.1075  static $ 10,398.79 84 58 P 01 646 850.1075  static $ 10,398.79 84 $ 30,216.70 197 850.1010 Daphn id static $ 8,834.23 53 850.5400 Average of four spec ies*  $ 10,983.68 60 59 P 01 716 ( low estimate) 850.5400 Average of four spec ies*  $ 10,983.68 60 $ 256,213.72 1803.5 850.1400 Rainbow Trout flow through* $ 52,560.10 432 850.1300 Daphn id flow through* $ 31,730.77 173 850.1730 Fathead Minnow* flow through* $ 58,716.50 775 835.3170   $ 41,645.29 88 64 FR 60194 PBT T ier 1 $ 60,577.38 275.5 59 P 01 716 ( high estimate) 850.5400 Average of four spec ies*  $ 10,983.68 60 $ 474,550.09 4445.5 850.1400 Rainbow Trout flow through* $ 52,560.10 432 850.1300 Daphn id flow through* $ 31,730.77 173 850.1730 Fathead Minnow* flow through* $ 58,716.50 775 835.3170   $ 41,645.29 88 64 FR 60194  PBT T ier 1 $ 60,577.38 275.5 64 FR 60194  PBT Tiers 2 and 3 ( b) $ 218,336.37 2642 ( b) Excluding OPPT S 850.1400, 850.13 00, 850.1730, and 835 .3170 to avoid doublecounting 60 P 01 781 870.4300 Rats* gavage* $ 972,884.62 9701 $ 1,347,042.11 12338 870.3465 Rats* inhalation $ 340,553.22 2458 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 61 P 01 833 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 62 P 02 17 870.3700 Rats* gavage* $ 98,594.95 1157 $ 98,594.95 1157 63 P 02 90 870.3465 Rats* inhalation $ 340,553.22 2458 $ 340,553.22 2458 64 P 02 207 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 $ 33,604.28 179 No. PMN Guideline Species Route/ Method Cost ($ 2002) Hours Total Cost ($ 2002) Total Hours D 15 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 65 P 02 262 870.3465 Rats inhalation $ 340,553.22 2458 $ 374,157.49 2637 850.1075 Fathead Minnow* flow through* $ 13,624.62 65 850.1010 Daphn id flow through* $ 8,995.98 54 850.5400 Average of four spec ies*  $ 10,983.68 60 * default assumptions used in cases where species and/ or route/ method not specified in SNUR APPENDIX E COSTS OF SUBMITTING A SNUN, REQUEST FOR MODIFICATION OR REVOCATION OF A SNUR, OR EQUIVALENCY DETERMINATION 8In the economic analysis for an earlier SNUR ( EPAB 1999), EPA estimated SNUN submission costs ( before user fee) at $ 6005 to $ 7240 ( 95 to 114 hours), compared with $ 4456 for 105 hours here. This is not meant to suggest that actual costs declined. Rather, the apparent decline is due to a revised method for calculating labor rates. The method was revised to use more current data and to be consistent with recent EPAB economic analyses. See Appendix B for details.

E 1 APPENDIX E COSTS OF SUBMITTING A SNUN, REQUEST FOR MODIFICATION OR REVOCATION OF A SNUR, OR EQUIVALENCY DETERMINATION Estimates of the costs of completing a SNUN form are based on the costs of completing a PMN submission, since the data requirements and the submission form are essentially identical. EPA  s Regulatory Impact Analysis ( RIA) for amendments to the PMN regulations ( RIB 1994) relied on industry estimates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, and submit the form and data to EPA ( RIB 1994). These estimates, based on a survey conducted by the Chemical Manufacturers Association ( CMA 1991), indicate that the average effort required to prepare and submit a PMN is 95 to 114 hours. For this analysis, the costs of a preparing a SNUN were derived using the 2002 loaded wage rates and average of the hours for clerical, technical, and managerial labor. Wage rate derivations are discussed in Appendix B. As shown in Table E 1, the resulting cost of submitting a request to modify or revoke a SNUR is $ 4,456, the cost of submitting a SNUN is $ 6,956, including a $ 2500 user fee, and the cost for an equivalency determination is $ 4,456.8 Table E 1 Industry Costs for SNUN, Request to Modify/ Revoke SNUR, or Equivalency Determination Labor Category Hours Range* Averag e Hours Loaded Wage Rate** ( 2002 dollars) Total Labor Cost ( loaded wage × hours)

Request to Modify SNUR ( Option 2) SNUN ( Option 3) Equivalency Determination ( Option 4)

Clerical 12  14 13.0 $ 23.96 $ 311 $ 311 $ 311 Technical 67 80 73.5 $ 43.34 $ 3,185 $ 3,185 $ 3,185 Manageri al 16  20 18.0 $ 53.29 $ 959 $ 959 $ 959 Subtotal 95  114 104.5 $ 4,456 $ 4,456 $ 4,456 User fees ( SNUN only) $ 0 $ 2,500 TOTAL $ 4,456 $ 6,956 $ 4,456 Figures may not add due to rounding. * Hours range for each labor category are from the PMN Amendments RIA ( RIB 1994) ** Loaded wages include fringe benefits and overhead. See Appendix B for derivation. APPENDIX F AGENCY COSTS F 1 APPENDIX F AGENCY COSTS EPA  s costs to review and process industry submissions ( SNUNs, requests to modify SNUR, and requests for equivalency determination) are assumed to be the same as EPA costs to review PMNs. EPA  s costs associated with SNUR submissions are presented in Table F 1. The EPA staff level ( GS 12), staff year full time equivalents ( FTEs) and extramural costs such as costs for contractor support are derived from the costs estimated for processing PMN submissions ( RIB 1994). The percent of cases are from RIB 1994 and from an 1999 SNUR economic analysis ( EPAB 1999). FTE costs have been calculated using 2002 GS 12 salary data ( OPM 2002) and a loading factor of 1.6 to reflect fringe benefits and overhead ( OPPE 1992).

The original PMN cost estimates were presented as low and high estimates, based on the most junior ( Step 1) and the most senior ( Step 10) GS 12 pay rates, respectively. For simplicity, this analysis uses the average of the two pay rates.

The GS 12 costs in the table below are calculated by multiplying the number of FTEs ( in the first column) by the fully loaded average salary, $ 102,475. This shows EPA staff cost for those chemicals requiring this review step. The Extramural Cost column shows costs for contractor support and other outside purchases for those chemicals requiring this review step, inflated from 1993 prices to 2002 using the Employment Cost Index, Total Compensation for White Collar Occupations ( BLS 2003a). The Weighted Cost column is calculated by multiplying GS 12 staff cost plus extramural costs ( Unweighted Cost) by the percentage of cases requiring this review step. This calculation yields total Agency costs for submission review and processing of $ 4,034 per case. F 2 Table F 1 Agency Costs for SNUN and Other Submission Review and Processing Review Step EPA FTE EPA staff ( GS 12) ( a) Extra mural Cost Unweighted Cost Pct. of Cases Weighted Cost 1993 dollar s 2002 dollars ( b)

( 1) ( 2) ( 3) ( 4) ( 5)=( 2)+( 4) ( 6) ( 7)=( 5)*( 6)

Prenotice consultation 0.0024 $ 245.94 4 $ 5.52 $ 251.46 41% $ 103.10 Administrative prescreen/ notice receipt/ user fee 0.0024 $ 245.94 92 $ 126.96 $ 372.90 100% $ 372.90 CRSS ( Chemical Review and Search Strategy) 0.0025 $ 256.19 268 $ 369.84 $ 626.03 100% $ 626.03 SAT ( Structure Activity Team) 0.0006 $ 61.49 14 $ 19.32 $ 80.81 100% $ 80.81 Engineering/ Exposure 0.0015 $ 153.71 56 $ 77.28 $ 230.99 100% $ 230.99 Exposure/ Fate 0.0008 $ 81.98 0 $ 0.00 $ 81.98 100% $ 81.98 Focus 0.0009 $ 92.23 23 $ 31.74 $ 123.97 100% $ 123.97 Standard Review Functions 0.0219 $ 2,244.21 511 $ 705.18 $ 2,949.39 29% $ 855.32 Division Directors Meeting 0.0129 $ 1,321.93 113 $ 155.94 $ 1,477.87 15% $ 221.68 Order Development/ Negotiation Review 0.0171 $ 1,752.33 22 $ 30.36 $ 1,782.69 3% $ 53.48 Post Order Data Review 0.0886 $ 9,079.30 0 $ 0.00 $ 9,079.30 3% $ 272.38 Order Modification 0.2167 $ 22,206.38 0 $ 0.00 $ 22,206.38 3% $ 666.19 New Chemical SNUR Development 0.0277 $ 2,838.56 85 $ 117.30 $ 2,955.86 7% $ 206.91 Notices of Commencement 0.0012 $ 122.97 40 $ 55.20 $ 178.17 31% $ 55.23 FOIA ( Freedom of Information Act) Requests 0.0333 $ 3,412.42 287 $ 396.06 $ 3,808.48 1% $ 38.08 CBI ( Confidential Business Information) Substantiation 0.0004 $ 40.99 3 $ 4.14 $ 45.13 100% $ 45.13 TOTAL $ 4,034 Sources: FTEs per review step and 1993 extramural costs are from RIB 1994. Percents of cases are from RIB 1994 and EPAB 1999. GS 12 salaries are from OPM 2002.

( a) The average of GS 12 Step 1 and GS 12 Step 10 salaries for 2002 was ($ 55,694 + $ 72,400) / 2 = $ 64,047. This was multiplied by an assumed loading factor of 1.6 to reflect fringe benefits and overhead, resulting in a fully loaded cost per FTE of 1.6 X $ 64,047 = $ 102.475. F 3 ( b) Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process. They were inflated from 1993 prices to 2002 prices using a factor of approximately 1.38 ( see Appendix B). APPENDIX G REFERENCES G 1 APPENDIX G REFERENCES 29 CFR 1910. Occupational Safety and Health Standards. Code of Federal Regualtions, Part 1910, Title 29, November 25, 1983.

Best 1997. Personal communication between Tom DeCoff of Eastern Research Group, Lexington, MA and Best Manufacturing Co. technical support services, Austin, TX, December 1997.

BLS 2003a. Bureau of Labor Statistics. Employment Cost Index, Total Compensation: White Collar Occupations ( Series ID: ECS11102I), extracted May 28, 2003.

BLS 2003b. Bureau of Labor Statistics. Consumer Price Index All Urban Consumers, U. S. City Average ( Series ID: CUUR0000SA0), extracted May 28, 2003.

BLS 2003c. Bureau of Labor Statistics. National Employment, Hours, and Earnings, Average Hourly Earnings of Production Workers ( Series ID: EEU32280006), extracted May 28, 2003.

BLS 2003d. Bureau of Labor Statistics. Employer Costs for Employee Compensation  December 2002: Private industry, goods producing workers by occupational group ( Table 11), March 18, 2003.

BT Office Products 1997. BT Office Products International. Office Products Catalog, 1997.

CMA 1991. Chemical Manufacturers Association. Responses to Questions on Burden Associated with PMN Submissions. Distributed by the Chemical Manufacturers Association, Washington, DC.

EPAB 1998. Economic Analysis of Expedited Significant New Use Rules for 168 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, January 1998.

EPAB 1999. Economic Analysis of Expedited Significant New Use Rules for 41 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, July 20, 1999. EPA Docket OPPTS 50635.

EPAB 2002. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, August 2002.

IHSN 1997. Industrial Hygiene and Safety News. 1997 EHS Salary Survey. August, 1997.

Kearney, 1988. Memorandum to Bill Massouda,  Reporting and recordkeeping costs for a generic SNUR,  February 3, 1988. [ Memo submitted to U. S. EPA/ Office of Toxic Substances ( now OPPT) under contract 68 02 3980 with A. T. Kearney, Inc.].

LSS 1997. Lab Safety Supply. 1997 Product Catalog. G 2 OPM 2002. U. S. Office of Personnel Management. Salary Table 2002 DCB ( Washington Baltimore).

OPPE 1992. Office of Policy, Planning, and Evaluation. Instructions for Preparing Information Collection Requests ( ICRs). Washington, DC: U. S. EPA, June 1, 1992.

OSHA 1983. Final Regulatory Impact and Regulatory Flexibility Analyses of the Hazard Communication Standard. US Dept of Labor, OSHA, Office of Regulatory Analysis, Washington DC, 8/ 9/ 83.

RIB 1989. Regulatory Impacts Branch. Economic Analysis of Final Significant New Rules: General Provisions for New Chemical Follow Up. Washington, DC: U. S. EPA/ OTS/ EETD/ RIB, July 19, 1989.

RIB 1994. Regulatory Impacts Branch. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. Washington, DC: U. S. EPA/ OPPT/ EETD/ RIB, September 9, 1994.

Rice 2002. Cody Rice. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, June 10, 2002.

Silagi 1992. William Silagi. Economic Analysis in Support of the Final Rule Promulgated under TSCA Section 12( b). Washington, DC: U. S. EPA/ OPPT/ RIB, June 1992.


[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11355-11356]
[FR Doc No: 2017-03411]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-79-000.
    Applicants: American Transmission Company LLC, Duke-American
Transmission Company, LLC, ATC Management Inc.
    Description: Application for Authorization for Corporate
Reorganization and Request for Confidential Treatment and Certain
Waivers of American Transmission Company LLC, et. al.
    Filed Date: 2/14/17.
    Accession Number: 20170214-5214.
    Comments Due: 5 p.m. ET 3/7/17.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-60-000.
    Applicants: RE Tranquillity 8 Amarillo LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of RE Tranquillity 8 Amarillo LLC.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5061.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: EG17-61-000.
    Applicants: RE Tranquillity 8 Azul LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of RE Tranquillity 8 Azul LLC.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5063.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: EG17-62-000.
    Applicants: RE Tranquillity 8 Rojo LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of RE Tranquillity 8 Rojo LLC.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5067.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: EG17-63-000.
    Applicants: RE Tranquillity 8 Verde LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of RE Tranquillity 8 Verde LLC.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5069.
    Comments Due: 5 p.m. ET 3/8/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1437-005; ER10-2732-013; ER10-2733-013; ER10-
2734-013; ER10-2736-013; ER10-2737-013; ER10-2741-013; ER10-2749-013;
ER10-2752-013; ER12-2492-009; ER12-2493-009; ER12-2494-009; ER12-2495-
009; ER12-2496-009; ER16-2455-003; ER16-2456-003; ER16-2457-003; ER16-
2458-003; ER16-2459-003.
    Applicants: Tampa Electric Company, Emera Energy Services Inc.,
Emera Energy U.S. Subsidiary No. 1, Inc, Emera Energy U.S. Subsidiary
No. 2, Inc., Emera Energy Services Subsidiary No. 1 LLC, Emera Energy
Services Subsidiary No. 2 LLC, Emera Energy Services Subsidiary No. 3
LLC, Emera Energy Services Subsidiary No. 4 LLC, Emera Energy Services
Subsidiary No. 5 LLC, Emera Energy Services Subsidiary No. 6 LLC, Emera
Energy Services Subsidiary No. 7 LLC, Emera Energy Services Subsidiary
No. 8 LLC, Emera Energy Services Subsidiary No. 9 LLC, Emera Energy
Services Subsidiary No. 10 LLC, Emera Energy Services Subsidiary No. 11
LLC, Emera Energy Services Subsidiary No. 12 LLC, Emera Energy Services
Subsidiary No. 13 LLC, Emera Energy Services Subsidiary No. 14 LLC,
Emera Energy Services Subsidiary No. 15 LLC.
    Description: Notice of Change in Status of the Emera Entities.

    Filed Date: 2/15/17.
    Accession Number: 20170215-5095.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: ER17-259-002.
    Applicants: Darby Power, LLC.
    Description: Compliance filing: Darby Power, LLC Reactive Service
Compliance Filing to be effective 1/30/2017.
    Filed Date: 2/14/17.
    Accession Number: 20170214-5174.
    Comments Due: 5 p.m. ET 3/7/17.

    Docket Numbers: ER17-260-002.
    Applicants: Gavin Power, LLC.
    Description: Compliance filing: Gavin Power, LLC Reactive Service
Compliance Filing to be effective 1/30/2017.
    Filed Date: 2/14/17.
    Accession Number: 20170214-5179.
    Comments Due: 5 p.m. ET 3/7/17.

    Docket Numbers: ER17-261-002.
    Applicants: Lawrenceburg Power, LLC.
    Description: Compliance filing: Lawrenceburg Power, LLC Reactive
Service Compliance Filing to be effective 1/30/2017.
    Filed Date: 2/14/17.
    Accession Number: 20170214-5185.
    Comments Due: 5 p.m. ET 3/7/17.

    Docket Numbers: ER17-262-002.
    Applicants: Waterford Power, LLC.
    Description: Compliance filing: Waterford Power, LLC Reactive
Service Compliance Filing to be effective 1/30/2017.
    Filed Date: 2/14/17.
    Accession Number: 20170214-5190.
    Comments Due: 5 p.m. ET 3/7/17.

    Docket Numbers: ER17-386-001.
    Applicants: New York Independent System Operator, Inc.
    Description: Compliance filing: NYISO compliance: Remove emissions
controls from peaking plant design to be effective 1/17/2017.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5011.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: ER17-549-001.
    Applicants: New York Independent System Operator, Inc.
    Description: Compliance filing: NYISO compliance re: Effective date
for revised fixed block unit pricing logic to be effective 2/28/2017.
    Filed Date: 2/14/17.
    Accession Number: 20170214-5138.
    Comments Due: 5 p.m. ET 3/7/17.

    Docket Numbers: ER17-884-001.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Tariff Amendment: NMPC amendment filing re:
Corrections to TSC formula rate template to be effective 4/1/2017.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5018.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: ER17-971-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4629; Queue No. AB2-097 to be effective 1/23/2017.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5017.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: ER17-972-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4622; Queue No. AB2-045 to be effective 1/26/2017.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5038.
    Comments Due: 5 p.m. ET 3/8/17.

    Docket Numbers: ER17-973-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Attachment O
Reflecting the Current ITPNT Schedule to be effective 4/16/2017.
    Filed Date: 2/15/17.
    Accession Number: 20170215-5084.
    Comments Due: 5 p.m. ET 3/8/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 15, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-03411 Filed 2-21-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Proposed Rules]
[Pages 20663-20665]
[FR Doc No: E9-10243]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2009-N-0100]

Revision of the Requirements for Publication of License
Revocation; Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the biologics regulations to clarify the regulatory procedures for
notifying the public about the revocation of a biologics license to be
consistent with current practices. This proposed rule is a companion
document to the direct final rule published elsewhere in this issue of
the Federal Register.

DATES: Submit written or electronic comments on or before July 20,
2009. If FDA receives any 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-2009-
N-0100, 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, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and docket number 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 ``Request for 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.

FOR FURTHER INFORMATION CONTACT:  Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 25, 1977 (42 FR 4680), FDA
issued a final rule revising, among other things, the procedures under
part 601 (21 CFR part 601) for issuing, revoking, and suspending
biologics licenses; and publishing license revocations. FDA revised
these procedures in order to simplify and codify existing practices,
establish new requirements where appropriate, and ensure that practices
and procedures would be consistently applied throughout the agency.
    A provision under the January 25, 1977, final rule provided that a
``Notice of revocation of a license, with statement of the cause
therefor, shall be issued by the Commissioner and published in the
Federal Register'' (Sec.  601.8). FDA interprets this requirement to
apply only to a license which the Commissioner of Food and Drugs (the
Commissioner) has found grounds to revoke under Sec.  601.5(b). FDA has
not routinely published, in the Federal Register, a notice of
revocation of a biologics license resulting from a manufacturer's
voluntary request for revocation for reasons unrelated to a finding by
the Commissioner that

reasonable grounds to revoke the license exist under Sec.  601.5(b).
Examples of situations in which a manufacturer might voluntarily
request that a license be revoked include economic loss, change in
product marketing strategy, lack of public need, corporate
reorganization, or the emergence of innovative replacement products.
FDA does not consider the revocation of licenses in such circumstances
to require publication in the Federal Register. However, FDA may
publish a notice of revocation for licenses revoked at the voluntary
request of a manufacturer in situations where such notice is in the
interest of public health.

II. Highlights of the Proposed Rule

    FDA is proposing to amend Sec.  601.8 to read: ``The Commissioner,
following revocation of a biologics license under 21 CFR 601.5(b), will
publish a notice in the Federal Register with a statement of the
specific grounds for the revocation.''
    This proposed amendment revises the existing regulation to clarify
that FDA will publish a notice of license revocation in cases where the
Commissioner has made a finding that reasonable grounds for revocation
exist under Sec.  601.5(b). This proposed amendment also clarifies that
the phrase ``with statement of the cause therefor,'' (Sec.  601.8)
refers to the specific grounds for revocation enumerated in Sec.
601.5(b). The proposed rule does not affect other regulations or
procedures for notification of license revocation. The proposed rule
does not alter existing FDA practices for publishing notices of
voluntary withdrawal, including notices of voluntary withdrawal of new
drug applications.

III. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the Public Health Service Act (42 U.S.C. 262 and 264) and
the drugs and general administrative provisions of the Federal Food,
Drug, and Cosmetic Act (sections 201, 301, 501, 502, 503, 505, 510,
701, and 704) (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and
374). Under these provisions of the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act, we have the authority to issue
and enforce regulations designed to ensure that biological products are
safe, pure, and potent; and prevent the introduction, transmission, and
spread of communicable disease.

IV. Companion Document to Direct Final Rulemaking

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described the agency's procedures for when and how we will employ
direct final rulemaking. We have determined that the rule is
appropriate for direct final rulemaking because it includes only
noncontroversial amendments, and we anticipate no significant adverse
comments. Consistent with our procedures on direct final rulemaking,
this proposed rule is a companion to the direct final rule published
elsewhere in this issue of the Federal Register. This companion
proposed rule provides the procedural framework to finalize the rule in
the event that the direct final rule receives any significant adverse
comment and is withdrawn. The comment period for this companion
proposed rule runs concurrently with the comment period for the direct
final rule. Any comments received in response to this companion
proposed rule will also be considered as comments regarding the direct
final rule.
    A significant adverse comment is defined as a comment 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 a change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553). Comments that are frivolous, insubstantial, or outside the scope
of the rule will not be considered significant or adverse under this
procedure.
    A comment recommending a regulation change in addition to that in
this rule will not be considered a significant adverse comment unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to an amendment, paragraph, or section of this rule that can be
severed from the remainder of the rule, we may adopt as final those
provisions of the rule that are not the subject of a significant
adverse comment.
    If any significant adverse comments are received during the comment
period, FDA will publish, before the effective date of the direct final
rule, a document withdrawing the direct final rule. If we withdraw the
direct final rule, any comments received will be applied to the
companion proposed rule and will be considered in developing a final
rule using the usual notice-and-comment procedures under the APA (5
U.S.C. 552a et seq).
    If FDA receives no significant adverse comments during the
specified comment period, FDA intends to publish a document confirming
the effective date within 30 days after the comment period ends.
Additional information about direct rulemaking procedures is set forth
in a guidance published in the Federal Register of November 21, 1997
(62 FR 62466).

V. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Reform Act of 1995

    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 makes current regulations
consistent with existing FDA practices and procedures, the agency
proposed to certify that the final 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.

B. Environmental Impact

    The agency has determined under 21 CFR 25.31(h) that this action is
of a type that does not individually or cumulatively have a significant
adverse effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

C. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed 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 proposed 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.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains no collections of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VII. Request for 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.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.
    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 601 is amended as follows:

PART 601--LICENSING

    1. The authority citation for 21 CFR part 601 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).
    2. Revise Sec.  601.8 to read as follows:

Sec.  601.8  Publication of revocation.

    The Commissioner, following revocation of a biologics license under
21 CFR 601.5(b), will publish a notice in the Federal Register with a
statement of the specific grounds for the revocation.

    Dated: March 25, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10243 Filed 5-4-09; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57452-57454]
[FR Doc No: 2019-23312]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0283]

Postmarketing Studies and Clinical Trials--Implementation of
Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Postmarketing Studies and Clinical Trials--Implementation of Section
505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' This draft
guidance revises the guidance for industry of the same name issued
April 1, 2011. The draft guidance is being revised to describe the
multiple factors that FDA considers, before requiring a postmarketing
study or clinical trial for the purposes described in the Federal Food,
Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of
the reports under the FD&C Act and the active postmarket risk
identification and analysis (ARIA) system available under the FD&C Act
to meet these purposes. The draft guidance is also being revised to
reflect certain provisions enacted under the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for
Patients and Communities Act as they relate to postmarketing studies
and clinical trials.

DATES: Submit either electronic or written comments on the draft
guidance by December 24, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0283 for ``Postmarketing Studies and Clinical Trials--
Implementation of Section 505(o)(3) of the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for Industry; Availability.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ayanna Augustus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20993-0002, 301-
796-3980; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled, ``Postmarketing Studies and Clinical Trials--Implementation
of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.''
    Section 505(o)(3) of the FD&C Act \1\ (21 U.S.C. 355(o)) authorizes
FDA to require certain postmarketing studies or clinical trials for
prescription drugs to obtain more information about a serious risk that
may be associated with a drug. In some cases, FDA may be concerned
about a serious risk that is potentially or known to be associated with
a drug but may not know enough about the risk to determine if or how to
address it, such as by describing the risk in labeling. Section
505(o)(3)(B) of the FD&C Act states that postmarketing studies and
clinical trials may be required for any or all of the following
purposes: (1) To assess a known serious risk related to the use of the
drug; (2) to assess signals of serious risk related to the use of the
drug; or (3) to identify an unexpected serious risk when available data
indicates the potential for a serious risk.
---------------------------------------------------------------------------

    \1\ Section 901 of Title IX of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85) amended the FD&C Act by
adding section 505(o).
---------------------------------------------------------------------------

    Prior to requiring a postmarketing study or clinical trial, FDA
must find that the reports under section 505(k)(1) of the FD&C Act and
the ARIA system \2\ made available under section 505(k)(3) of the FD&C
Act will not be sufficient to meet the purposes described in section
505(o)(3)(B) of the FD&C Act.\3\ Similarly, before requiring a
postmarketing clinical trial, FDA must find that a postmarketing study
will not be sufficient to meet the purposes

described in section 505(o)(3)(B) of the FD&C Act.\4\
---------------------------------------------------------------------------

    \2\ Section 505(k)(3) of the FD&C Act mandates that FDA
establish an active surveillance system for monitoring drugs, using
electronic data from healthcare information holders. The Sentinel
System draws on existing healthcare data from multiple sources to
actively monitor the safety of medical products. The ARIA system is
a subcomponent of the Sentinel System.
    \3\ Section 505(o)(3)(D)(i) of the FD&C Act.
    \4\ Section 505(o)(3)(D)(ii) of the FD&C Act.
---------------------------------------------------------------------------

    In April 2011, FDA issued a guidance describing how it would
implement section 505(o) of the FD&C Act. At that time, the ARIA system
was still in early development. The ARIA system is now officially
launched, and FDA must consider the system's sufficiency to meet the
purposes of section 505(o)(3)(B) of the FD&C Act to determine if a
postmarketing study or clinical trial is necessary. This draft guidance
revises the guidance for industry of the same name issued on April 1,
2011 (76 FR 18226). Significant changes from the 2011 version include
explaining how FDA considers the reporting under section 505(k)(1) of
the FD&C Act and the ARIA system when determining their sufficiency for
the purposes under section 505(o)(3)(B) of the FD&C Act. The guidance
is also being revised to provide examples of postmarketing requirements
under section 505(o)(3) of the FD&C Act to assess a potential reduction
in the expected effectiveness of a drug under certain circumstances.
FDA's authority to require these types of studies or trials was
clarified by a modification to the definition of adverse drug
experience at section 505-1(b)(1)(E) of the FD&C Act (21 U.S.C. 505-
1(b)(1)(E)) enacted under section 3041 of the SUPPORT Act (Pub. L. 115-
271).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking on implementation of
section 505(o)(3)(B) of the FD&C Act. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    The following collections of information for postmarketing reports
and clinical data in 21 CFR 314.50, 314.80, 314.81, 314.98, 314.430,
and 314.610(b), subpart I have been approved under OMB control number
0910-0001: (1) Preparing and submitting reports pertaining to safety,
postmarketing commitments and preparing and submitting spontaneous and
periodic reports, including active postmarket risk identification
(using electronic health care data) and any milestones or submissions
for which projected dates were specified as part of the postmarketing
commitment; (2) submitting a proposed timetable of the postmarketing
commitments; (3) preparing registries and submitting them when
appropriate; (4) designing meta-analyses to evaluate statistical
analyses of data; (5) preparing assay procedures; and (6) prepare a
plan or approach for approval an NDA when human efficacy studies are
not ethical or feasible.
    The following collections of information for postmarketing studies
and clinical trials (including various patient populations) in 21 CFR
312.23 have been approved under OMB control number 0910-0014: (1)
Conducting in vitro laboratory tests and studies to compare pregnancy
incidence an pregnancy outcomes and/or child outcomes for patients
exposed to a drug; (2) submitting an introductory statement and general
investigational plan, including a drug's pharmacological class; and (3)
submitting protocols for drug safety and pharmacology and toxicology
information.
    The collections of information in 21 CFR 310.305, 314.80, and
314.98 for submitting adverse event information to the FDA Adverse
Event Reporting System have been approved under OMB control numbers
0910-0230 and 0910-0291; the collections of information in 21 CFR
312.47 and 312.82 for submitting a meeting request to appeal the
conduct of a postmarketing study or clinical trial have been approved
under OMB control number 0910-0430 (and guidance for industry and
review staff entitled ``Formal Dispute Resolutions: Appeals Above the
Division Level'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm343101.pdf).
    The following collection of information in Sec.  314.510 has been
approved under OMB control number 0910-0765: Requests for serious or
life-threatening diseases or conditions that may be granted accelerated
approval if FDA determines the product has an effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit or on a
clinical endpoint that can be measured earlier than irreversible
morbidity or mortality or other clinical benefit.

III. Electronic Access

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

    Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23312 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


CONTACT US  SHARE        Exposure Assessment Tools by Tiers and Types - Aggregate and Cumulative  Overview  Description  Methods  Input Data  Applications  References Overview

Humans and ecological receptors are exposed to multiple stressors via multiple pathways. Considerable attention has been dedicated to assessing how different stressors interact and how overall exposure is influenced by uptake via different routes and pathways. Assessments that examine exposure to more than one stressor and/or route and pathway are considered "combined" exposure assessments. Cumulative and aggregate assessments represent the two major categories of combined exposure assessments currently in use.

Aggregate exposureAggregate exposureThe combined exposure of an individual (or defined population) to a specific agent or stressor via relevant routes, pathways, and sources. Total exposure can include exposure through multiple routes (e.g., dermal, inhalation, and ingestion). assessment considers combined exposures to a single stressor across multiple routes and multiple pathways (U.S. EPA, 2003).

Cumulative exposureCumulative exposureExposure via mixtures of contaminants both indoors and outdoors. Exposure may also occur through more than one pathway. New directions in risk assessments in U.S. EPA put more emphasis on total exposures via multiple pathways. assessment generally evaluates combined exposure to multiple stressors via multiple exposure pathways (U.S. EPA, 2003) that affect a single biological target. In addition to chemical stressors, cumulative exposure assessments might also take into account non-chemical stressors. Non-chemical stressors may include physical or biological stressors.                                                                     Top of Page


[Federal Register: November 13, 2008 (Volume 73, Number 220)]
[Notices]
[Page 67151-67152]
[DOCID:fr13no08-30]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

November 6, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP09-49-000.
    Applicants: Chandeleur Pipe Line Company.
    Description: Chandeleur Pipe Line Co. submits Seventh Revised Sheet
No. 3 et al. to FERC Gas Tariff, Second Revised Volume No. 1 to be
effective 10/1/08.
    Filed Date: 11/03/2008.
    Accession Number: 20081105-0119.
    Comment Date: 5 p.m. Eastern Time on Monday, November 17, 2008.

    Docket Numbers: RP09-50-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits Eighth Revised Sheet
No. 1 et al. to FERC Gas Tariff, Original Volume No. 1, to be effective
11/1/08 re Jackson Prairie Gas Storage Project Agreement.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0097.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 12, 2008.

    Docket Numbers: RP09-51-000.
    Applicants: Central New York Oil and Gas Co., LLC.
    Description: Central New York Oil and Gas Co. LLC submits Fourth
Revised Sheet No. 0 et al. to FERC Gas Tariff, Original Volume No. 1,
to be effective 12/1/08.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0096.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 12, 2008.

    Docket Numbers: RP09-52-000.
    Applicants: Transcontinental Gas Pipe Line Corporation.
    Description: Transcontinental Gas Pipe Line Corporation submits
First Revised Sheet No. 40R et al. to FERC Gas Tariff, Third Revised
Volume No. 1, to be effective 12/1/08.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0095.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 12, 2008.

    Docket Numbers: RP09-53-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc. submits Second Revised
Sheet No. 1 et al. to FERC Gas Tariff, Third Revised Volume No. 1, to
be effective 12/4/08.
    Filed Date: 11/03/2008.
    Accession Number: 20081104-0094.
    Comment Date: 5 p.m. Eastern Time on Friday, November 14, 2008.

    Docket Numbers: RP09-54-000.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Co. submits Second Revised Sheet
No.3 to FERC Gas Tariff, Second Revised Volume No. 1A to be effective
12/5/08.
    Filed Date: 11/04/2008.
    Accession Number: 20081105-0120.
    Comment Date: 5 p.m. Eastern Time on Monday, November 17, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in

Washington, DC. There is an eSubscription link on the Web site that
enables subscribers to receive e-mail notification when a document is
added to a subscribed dockets(s). For assistance with any FERC Online
service, please e-mail<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-26902 Filed 11-12-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4689-4690]
[FR Doc No: 2014-01666]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2005-0023; FRL 9905-74-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Clean Water Act Section 404 State-Assumed
Programs (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Clean Water Act Section 404
State-Assumed Programs (Renewal)'' to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of
the ICR, which is currently approved through January 31, 2014. Public
comments on the ICR renewal were requested via the Federal Register (78
FR 62629) published on October 22, 2013, during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before February 28,
2014.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2005-0023, to (1) EPA online using www.regulations.gov (our
preferred method), by email<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Kathy Hurld, Office of Wetlands,
Oceans, and Watersheds, Wetlands Division (4502T), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    EPA ICR Number: 0220.12.
    OMB Control Number: 2040-0168.
    Abstract: Section 404(g) of the Clean Water Act (CWA) authorizes
States [and Tribes] to assume the section 404 permit program for
discharges of dredged or fill material into certain Waters of the U.S.
This ICR covers the collection of information EPA needs to perform its
program approval and oversight responsibilities and the State/Tribe
needs to establish and implement its program.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are those States/Tribes requesting assumption of the CWA
section 404 permit program; States/Tribes with approved assumed
programs; and permit applicants in States/Tribes with assumed programs.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (40 CFR 233).
    Estimated number of respondents: EPA anticipates 2 States/Tribes
will

request program assumption; there will be approximately 14,000 permit
applications (3,500 applications per state); and 4 States/Tribes which
have assumed the program (the two current programs and potentially two
who may be approved under this ICR) which will submit an annual report.
    Frequency of response: States/Tribes will respond one time to
request assumption and once the program is approved they will respond
annually for the annual permit and annual report; permit applicants
will respond one time when requesting a permit.
    Total estimated burden: The public reporting and recordkeeping
burden for this collection of information is estimated to be 90,960
hours (per year). Burden is defined at 5 CFR 1320.03(b).
    Total estimated cost: Costs to states for assumed Section 404
permit programs will vary widely by state and permit, however there are
$0 capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 10,400 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is because the estimated number of
permits reviewed by a state per year decreased. This decrease is based
on the experience of the state of New Jersey, due in part to a change
in the economy and to a recalculation in the number of permits
estimated. There was an increase in the number of hours spent reviewing
each permit, due to an increase in the number of times applicants
requested a review of mitigation options. The estimate used here is a
weighted average of Michigan's and New Jersey's estimates.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2014-01666 Filed 1-28-14; 8:45 am]
BILLING CODE 6560-50-P