Table
2:
Estimated
Annual
Burden
of
Reporting
and
Recordkeeping
Requirements
under
NESHAP
GGG
­
Pharmaceutical
Operations
Activitya
(
A)

hours
per
Occurrence
(
B)
Occurrences/

respondent/
yr
(
C)
hours/
respondent/
yr
(
D)
respondents/

year
(
E)
Technical
personhours
yr
(
E
=
CxD)
(
F)
Management
personhours
yr
(
F=
E*
0.05)
G
Clerical
Personhours
per
year
(
G­=
E*
0.1)

$
H
Total
Cost
b
$

1.
Applications
NA
2.
Survey
and
Studies
NA
3.
Reporting
Requirements
A.
Read
Instructions
c
1
1
1
0
0
0
0
0
B.
Required
Activities
Initial
Performance
Test
­
Process
Vents
(
new)
d
1,983
1
1,983
0
0
0
0
0
Process
Vents
(
Reconstructed)
e
661
1
661
1
661
33
66
41,034
Wastewater
­
new
f
271
1
271
0
0
0
0
0
Repeat
Performance
Test
g
60
0
12
0
0
0
0
0
C.
Write
Report
Notification
of
Construction/
Reconstruction
h
2
1
2
1
2
0
0
124
Notification
of
Physical/
Operational
Change
h
8
3
24
103
2,472
124
247
153,458
Notification
of
Anticipated
Startup
h
2
1
2
1
2
0
0
124
Notification
of
Actual
Startup
h
1
1
1
1
1
0
0
62
Notification
of
Initial
Performance
Test
2
1
2
1
2
0
0
124
Notification
of
Applicability
of
Standards
­

Existing
Sources
2
0
0
0
0
0
0
0
Notification
of
Applicability
of
Standards
­

New
Sources
i
2
1
2
1
2
0
0
124
Notification
of
demonstration
of
CMS
j
2
1
2
1
2
0
0
124
Notification
of
Compliance
Status
(
NOCSR)
120
1
120
1
120
6
12
7,449
Implementation
Plan
(
for
Emissions
Averaging)
k
160
0
0
0
0
0
0
0
Startup,
shutdown
and
Malfunction
Report
40
1
40
1
40
2
4
2,483
Quality
Control
Plan
for
CMS
60
1
60
1
60
3
6
3,725
Develop
Record
System
c
40
1
40
1
40
2
4
2,483
Train
Personnel
c
40
1
40
1
40
2
4
2,483
Semiannual
Report
3
2
6
103
618
31
62
38,365
Quarterly
Report
of
excess
emissions
and
CMS
performance
20
4
80
10
800
40
80
49,663
LDAR
Reports
432
1
432
103
44,496
2,225
4,450
2,762,245
4.
Recordkeeping
Requirements
Records
of
Operating
Parameters
for
Control
Devicesm
830.0
1
830
103
85,490
4,275
8,549
5,307,091
Records
of
Operating
Conditions
Exceeding
Last
Perf.
Test
8
1
8
10
80
4
8
4,966
Records
of
Startup,
Shutdown,
Malfunction,

etc.
2
26
52
103
5,356
268
536
332,492
TOTAL
ANNUAL
BURDEN
140,284
7,014
14,028
8,708,620
a
See
attachments
2&
3
for
further
explanation
of
respondent
activities
and
assumptions
used
in
cost
estimates
b
Cost
assumes
a
reate
of
$
54.94/
hour
for
technical
labor,
$
73.93/
hour
for
managerial
labor
and
$
34.42/
hr
for
clerical
labor
(
Source:
United
States
Department
of
Commerce
Bureau
of
Labor
Statistics,
March
1999,
Table
10:
Employment
Costs
for
Private
Industry
by
Occupational
and
Industry
Group.
The
rates
are
from
column
1:
Total
compensation).

c
One
time
only
costs
­
these
costs
were
accounted
for
in
the
initial
ICR
for
the
1st
year
d
Assume
a
performance
test
for
process
vents
costs
$
24,420
per
process.
Assumes
no
new
process
vents
for
this
ICR
renewal.
Person
hour
burden
e
estimates
have
been
back
calculated
from
the
total
cost.

e
Assume
a
performance
test
for
process
vents
costs
$
24,420
per
process.
Assumes
1
reconstructed
process
per
facility,
no
new
facilities.
Person
hour
burden
estimates
have
been
back
calculated
from
the
total
cost.

f
Assumes
a
performance
test
for
wastewater
streams
costs
$
10,000.
Assumes
1
wastewater
stream
per
facility
is
controlled
based
on
information
gathered
in
rulemaking.
Person
hour
burden
estimates
have
been
back
calculated
from
total
costs;
however
no
new
facilities
so
no
costs
for
this
ICR
renewal.

g
Assumes
all
existing
sources
will
require
an
average
of
3
process
changes
per
facility
and
no
new
facilities
(
103*
3=
309)

h
New
source
requirement;
assumes
1
reconstructed
facilities
i
New
source
requirement;
assumes
1
reconstructed
facilities
k.
New
source
requirement;
assumes
1
reconstructed
facilities
l.
New
source
requirement;
assumes
1
reconstructed
facilities
m
Assume
4.55
processes
per
facility
so
hours
are
multiplied
by
4.55
