1781t10

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Overview

Summary
Table 1
Table 2
Capital O&M
Responses
Respondents

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Sheet 1: Summary

ICR Summary Information
Hours per Response	178
Number of Respondents	27
Total Estimated Burden Hours	44,300
Total Estimated Costs	$5,750,000
Annualized Capital O&M	$174,000
Form Number	Not Applicable

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Sheet 2: Table 1

Table 1: Annual Respondent Burden and Cost – NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Renewal)
Burden Item	(A) Person hours per occurrence	(B) No. of occurrences per respondent per year	(C) Person hours per respondent per year (C=AxB)	(D) Respondents per year a	(E) Technical person- hours per year (E=CxD)	(F) Management person hours per year (Ex0.05)	(G) Clerical person hours per year (Ex0.1)	(H) Cost, $ b
1. Applications	N/A									Labor Rates
2. Surveys and studies	N/A									Management	$163.17
3. Reporting Requirements										Technical	$130.28
A. Familiarization with Regulatory Requirements	1	1	1	27	27	1.35	2.7	$3,915.26		Clerical	$65.71
B. Required Activities
i. Initial Performance Tests c
New	480	1	480	0	0	0	0	$0
Reconstructed	160	1	160	0	0	0	0	$0
Wastewater	160	1	160	0	0	0	0	$0
ii. Quality control plan for CMS c	60	1	60	0	0	0	0	$0
iii. Repeat performance test d	60	1	60	0	0	0	0	$0
C. Write reports
i. Notification of construction/reconstruction c	2	1	2	0	0	0	0.0	$0
ii. Notification of physical or operational changes c, e	8	3	24	27	648	32.4	64.8	$93,966.16
iii. Notification of actual startup c	2	1	2	0	0	0	0	$0
iv. Notification of initial performance test c	2	1	2	0	0	0	0	$0
v. Notification of applicability c	2	1	2	0	0	0	0	$0
vi. Notification of demonstration of CMS c	2	1	2	0	0	0	0	$0
vii. Notification of compliance status c	120	1	120	0	0	0	0	$0
viii. Pre-compliance report (with and without emission averaging implementation plan) c	180	1	180	0	0	0	0	$0
ix. Malfunction report f	40	2	80	27	2,160	108	216	$313,220.52
x. Semiannual summary report
a. No deviations g	8	2	16	24	384	19.2	38.4	$55,683.65
b. Deviations h	24	2	48	3	144	7.2	14.4	$20,881.37
xi. Leak detection and repair (LDAR) report i	432	2	864	27	23328	1166.4	2332.8	$3,382,781.62
xii. Emissions averaging report j	20	2	40	3	120	6	12	$17,401.14
Subtotal for Reporting Requirements					30,833			$3,887,850
4. Recordkeeping requirements
A. Develop record system	40	1	40	0	0	0	0	$0
B. Train personnel	40	1	40	0	0	0	0	$0
C. Records for operating parameters for control devices k	1	365	365	27	9,855	492.75	985.5	$1,429,069
D. Records of malfunctions l	2	26	52	27	1,404	70.2	140.4	$203,593
E. Calibration of CMS m	16	1	16	27	432	21.6	43.2	$62,644
F. LDAR	See 3C
Subtotal for Recordkeeping Requirements					13,445			$1,695,306		178	hr/response
Total Labor Burden and Costs (rounded) n					44,300			$5,580,000
Total Capital and O&M Cost (rounded) n								$174,000
GRAND TOTAL (rounded) n								$5,750,000
Assumptions:
a We have assumed that the annual average number of respondents that will be subject to this rule will be 27. There will be no new additional sources during the next three years of this ICR.
b This ICR uses the following labor rates: Managerial $163.17 ($77.70 + 110%); Technical $130.28 ($62.04 + 110%); and Clerical $65.71 ($31.29 + 110%). These rates are from the United States Department of Labor, Bureau of Labor Statistics, September 2022, “Table 2. Civilian Workers, by occupational and industry group.” The rates are from column 1, “Total compensation.” The rates have been increased by 110 percent to account for varying industry wage rates and the additional overhead business costs of employing workers beyond their wages and benefits, including business expenses associated with hiring, training, and equipping their employees.
c We have assumed that there will be no new or reconstructed facilities during the next three years of this ICR, and these one-time initial requirements do not apply; however, the ICR estimates that all existing sources will have changes in their operations.
d We have assumed that 20 percent of new respondents would have to repeat initial performance tests due to failure. Since there are no new respondents estimated, no one is assumed to conduct a repeat test.
e We have assumed that each source will require an average of three processing changes each year over the next three years of this ICR.
f We have assumed that each respondent will take 40 hours two times per year to complete the startup, shutdown, malfunction reports.
g We have assumed that 90 percent of respondents will each take eight hours two times per year to complete the no deviation report.
h We have assumed that 10 percent of respondents will each take 24 hours two times per year to complete the deviation report.
i We have assumed that it will take each respondent 432 hours two times per year to complete the LDAR report.
j We have assumed that ten percent of respondents will each take 20 hours two times per year to complete the emissions averaging report.
k We have assumed that it will take each respondent 1 hour 365 times per year to record the operating parameters for control devices.
l We have assumed that it will take each respondent 2 hours 26 times per year to record the occurrence and duration of each malfunction.
m We have assumed that it will take each respondent 16 hours one time per year to record the calibration of CMS.
n Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

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Sheet 3: Table 2

Table 2: Average Annual EPA Burden and Cost – NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Renewal)
Burden item	(A) Person hours per occurrence	(B) No. of occurrences per respondent per year	(C) Person hours per respondent per year (C=AxB)	(D) Respondents per year a	(E) Technical person- hours per year (E=CxD)	(F) Management person hours per year (Ex0.05)	(G) Clerical person hours per year (Ex0.1)	(H) Cost, $ b
1. Required activities										Labor Rates
i. Initial performance tests c	2	1	2	0	0	0	0	$0		Management	$73.46
ii. Repeat performance test d	24	1	24	0	0	0	0	$0		Technical	$54.51
2. Report review - one time c										Clerical	$29.50
i. Notification of construction/reconstruction	2	1	2	0	0	0	0	$0
ii. Notification of actual startup	2	1	2	0	0	0	0	$0
iii. Notification of demonstration of CMS	2	1	2	0	0	0	0	$0
iv. Initial notification of applicability	2	1	2	0	0	0	0	$0
v. Notification of compliance status report	40	1	40	0	0	0	0	$0
vi. Pre-compliance report e
a. With emissions averaging f	20	1	20	0	0	0	0	$0
b. Without emissions averaging	4	1	4	0	0	0	0	$0
3. Report review - on-going
i. Semiannual summary report
a. No deviations g	2	2	4	24	96	4.8	9.6	$5,868.77
b. Deviations h	8	2	16	3	48	2.4	4.8	$2,934.38
ii. Notification of physical or operational changes i	8	3	24	27	648	32.4	64.8	$39,614.18
iii. Malfunction j	2	2	4	27	108	5.4	10.8	$6,602.36
iv. Leak detection and repair (LDAR) report k	8	2	16	27	432	21.6	43.2	$26,409.46
v. Emissions averaging report l	8	2	16	3	48	2.4	4.8	$2,934.38
TOTAL (rounded) m					1,590			$84,400
Assumptions:
a We have assumed that the average number of respondents that will be subject to this rule will be 27. There will be no new additional sources during the next three years of this ICR.
b This cost is based on the average hourly labor rate as follows: Managerial $73.46 (GS-13, Step 5, $45.91 + 60%); Technical $54.51 (GS-12, Step 1, $34.07 + 60%); and Clerical $29.50 (GS-6, Step 3, $18.44 + 60%). This ICR assumes that Managerial hours are 5 percent of Technical hours, and Clerical hours are 10 percent of Technical hours. These rates are from the Office of Personnel Management (OPM), 2023 General Schedule, which excludes locality, rates of pay. The rates have been increased by 60 percent to account for the benefit packages available to government employees.
c We have assumed that there will be no new or reconstructed facilities during the next three years of this ICR, and these one-time initial requirements do not apply.
d We have assumed that 20 percent of respondents would have to repeat performance tests due to failure. Since there are no new respondents estimated, no one is assumed to conduct a repeat test.
e We have assumed that 50 percent of new facilities will submit a pre-compliance report.
f We have assumed that 10 percent of existing facilities will have to comply with emission averaging requirements; however, this is a one-time requirement; new facilities are not allowed to use emissions averaging.
g We have assumed that 90 percent of respondents will report no deviations.
h We have assumed that 10 percent of respondents will have to report deviations.
i We have assumed that each respondent will be required to submit the physical/operational changes three times per year over the next three-year period of this ICR.
j We have assumed that each respondent will report actions on malfunction that are consistent.
k We have assumed that each respondent will have to comply with the LDAR report two times per year.
l We have assumed that 10 percent of respondents will submit the emission averaging report.
m Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

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Sheet 4: Capital O&M

Capital/Startup vs. Operation and Maintenance (O&M) Costs
(A)	(B)	(C)	(D)	(E)	(F)	(G)
Continuous Monitoring Device	Capital/Startup Cost for One Respondent b	Number of New Respondents	Total Capital/Startup Cost, (B X C)	Annual O&M Costs for One Respondent c	Number of Respondents with O&M	Total O&M, (E X F)
Data-logger and Thermocouple	$6,834	0	$0	$6,458	27	$174,361
Totals (rounded) a			$0			$174,000		$174,000
a Totals have been rounded to 3 significant digits. Figures may not add exactly due to rounding.
b Assume that capital/startup costs for a new data-logger and Thermocouple is $6,240. Capital costs have been increased from 2007 to 2022 $ using the CEPCI Equipment Cost Index.
c Assume that the annual O&M costs of the sulfur CEMS and control outlet is $5,897. Costs have been increased from 2007 to 2022 $ using the CEPCI Equipment Cost Index.

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Sheet 5: Responses

Total Annual Responses
(A)	(B)	(C)	(D)	(E)
Information Collection Activity	Number of Respondents a	Number of Responses	Number of Existing Respondents That Keep Records But Do Not Submit Reports	Total Annual Responses E=(BxC)+D
Notification of construction/reconstruction	0	1	0	0
Notification of physical or operational changes	27	3	0	81
Notification of actual startup	0	1	0	0
Notification of initial performance test	0	1	0	0
Notification of applicability	0	1	0	0
Notification of demonstration of CMS	0	1	0	0
Notification of compliance status	0	1	0	0
Pre-compliance report (emission averaging)	0	1	0	0
Malfunction report	27	2	0	54
Semiannual report - No deviations	24	2	0	48
Semiannual report - Deviations	3	2	0	6
LDAR report	27	2	0	54
Emissions averaging report	3	2	0	6
			Total	249

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Sheet 6: Respondents

Number of Respondents
	Respondents That Submit Reports		Respondents That Do Not Submit Any Reports
	(A)	(B)	(C)	(D)	(E)
Year	Number of New Respondents a	Number of Existing Respondents	Number of Existing Respondents that keep records but do not submit reports	Number of Existing Respondents That Are Also New Respondents	Number of Respondents (E=A+B+C-D)
1	0	27	0	0	27
2	0	27	0	0	27
3	0	27	0	0	27
Average	0	27	0	0	27
a New respondents include sources with constructed, reconstructed, and modified affected facilities.