PAPERWORK
REDUCTION
ACT
SUBMISSION
Please
read
the
instructions
before
completing
this
form.
For
additional
forms
or
assistance
in
completing
this
form,
contact
your
agency's
Paperwork
Clearance
Officer.
Send
two
copies
of
this
form,
the
collection
instrument
to
be
reviewed,
the
Supporting
Statement
and
any
additional
documentation
to:
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
Docket
Library,
Room
10102,
725
17th
Street
NW
Washington,
DC
20503.

1.
Agency/
Subagency
originating
request
U.
S.
EPA,
OECA
2.
OMB
control
number
b.
G
None
a
2060­
0358
__
__
__
__

3.
Type
of
information
collection
(
check
one)
a.
G
New
collection
b.
G
Revision
of
a
currently
approved
collection
c.
X
Extension
of
a
currently
approved
collection
d.
G
Reinstatement,
without
change,
of
a
previously
approved
collection
for
which
approval
has
expired
e.
G
Reinstatement,
with
change,
of
a
previously
approved
collection
for
which
approval
has
expired
f.
G
Existing
collection
in
use
without
an
OMB
control
number
4.
Type
of
review
requested
(
check
one)
a.
X
Regular
b.
G
Emergency
­
Approval
requested
by:
/
/
c.
G
Delegated
5.
Small
entities
Will
this
information
collection
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities?
G
Yes
X
No
For
b­
f,
note
item
A2
of
Supporting
Statement
Instructions
6.
Requested
expiration
date
a.
X
Three
years
from
approval
date
b.
G
Other
Specify:
/
/___

7.
Title
National
Emission
Standard
for
hazardous
Air
Pollutants
for
Source
Categories;
Pharmaceutical
Production,
40
CFR
Part
63,
Subpart
GGG
8.
Agency
form
number(
s)
(
If
applicable)
EPA
ICR
1781.02
9.
Keywords
Air
Pollution
Control,
Clean
Air
Act,
Environmental
Protection
10.
Abstract
Respondents
are
owners
and
operators
of
pharmaceuticals
production
operations.
Respondents
must
submit
one­
time
reports
of
initial
performance
tests
and
semiannual
reports
of
noncompliance.
Recordkeeping
of
parameters
related
to
air
pollution
control
technologies
is
required.
The
reports
and
records
will
be
used
to
demonstrate
compliance
with
the
standards.

11.
Affected
public
(
Mark
primary
with
"
P"
and
all
others
that
apply
with
"
X")
a.
Individuals
or
households
d.
Farms
b.
P
Business
or
other
for­
profit
e.
Federal
Government
c.
Not­
for­
profit
institutions
f.
State,
Local
or
Tribal
Government
12.
Obligation
to
respond
(
Mark
primary
with
"
P"
and
all
others
that
apply
with
"
X")
a.
G
Voluntary
b.
G
Required
to
obtain
or
retain
benefits
c.
P
Mandatory
13.
Annual
reporting
and
recordkeeping
hour
burden
a.
Number
of
respondents
103
b.
Total
annual
responses
209
1.
Percentage
of
these
responses
collected
electronically
20
%
c.
Total
annual
hours
requested
161,326
d.
Current
OMB
inventory
350,501
e.
Difference
(
189,175)
f.
Explanation
of
difference
1.
Program
Change
2.
Adjustment
(
189,175)
14.
Annual
reporting
and
recordkeeping
cost
burden
(
in
thousands
of
dollars)

a.
Total
annualized
capital/
startup
costs
3.39
b.
Total
annual
costs
(
O&
M)
4.16
c.
Total
annualized
cost
requested
7.55
d.
Current
OMB
inventory
48
e.
Difference
(
40.45)
f.
Explanation
of
difference
1.
Program
change
2.
Adjustment
(
40.45)

15.
Purpose
of
information
collection
(
Mark
Primary
With
"
P"
and
all
others
that
apply
with
"
X")
a.
__
Application
for
benefits
e.
__
Program
planning
or
management
b.
__
Program
evaluation
f.
__
Research
c.
__
General
purpose
statistics
g.
_
P_
Regulatory
or
compliance
d.
__
Audit
16.
Frequency
of
recordkeeping
or
reporting
(
check
all
that
apply)
a.
X
Recordkeeping
b.
Q
Third
party
disclosure
c.
X
Reporting
1.
X
On
occasion
2.
Q
Weekly
3.
Q
Monthly
4.
X
Quarterly
5.
X
Semi­
annually
6.
Q
Annually
7.
Q
Biannually
8.
Q
Other
(
describe)

17.
Statistical
methods
Does
this
information
collection
employ
statistical
methods?

Q
Yes
X
No
18.
Agency
contact
(
person
who
can
best
answer
questions
regarding
the
content
of
this
submission)
Name:
Marcia
B.
Mia
Phone:
202­
564­
7042
OMB
83­
I
10/
95
