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:
USEPA/
Office
of
Enforcement
and
Compliance
Assurance/
Office
of
Compliance
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
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG)

8.
Agency
form
number(
s)
(
If
applicable)
EPA
ICR
Number
1781.03
9.
Keywords
Pharmaceutical
products,
storage
tanks,
wastewater
systems,
process
vents.

10.
Abstract
Respondents
are
owners
and
operators
of
pharmaceuticals
production
operations
which
include
process
vents,
storage
tanks,
equipment
components
and
wastewater
systems.
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
101
b.
Total
annual
responses
632
1.
Percentage
of
these
responses
collected
electronically
20
_____
%
c.
Total
hours
requested
158,179
d.
Current
OMB
inventory
161,326
e.
Difference
(
3,147)

f.
Explanation
of
difference
1.
Program
Change
2.
Adjustment
(
3,147)
14.
Annual
reporting
and
recordkeeping
cost
burden
(
in
thousands
of
dollars)
a.
Total
annualized
capital/
startup
costs
5
b.
Total
annual
costs
(
O&
M)
4
c.
Total
annualized
cost
requested______
9______
d.
Current
OMB
inventory
8
e.
Difference
1
f.
Explanation
of
difference
1.
Program
change
2.
Adjustment
1
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:
Learia
A.
Williams
Phone:
(
202)
564­
4113
OMB
83­
I
10/
95
19.
Certification
for
Paperwork
Reduction
Act
Submissions
On
behalf
of
this
Federal
agency,
I
certify
that
the
collection
of
information
encompassed
by
this
request
complies
with'
5
CFR
1320.9.

NOTE:
The
text
of
5
CFR
1320.9,
and
the
related
provisions
of
5
CFR
1320.8(
b)(
3),
appear
at
the
end
of
the
instructions.
The
certification
is
to
be
made
with
reference
to
those
regulatory
provisions
as
set
forth
in
the
instructions.

The
following
is
a
summary
of
the
topics,
regarding
the
proposed
collection
of
information,
that
the
certification
covers:

(
a)
It
is
necessary
for
the
proper
performance
of
agency
functions;

(
b)
It
avoids
unnecessary
duplication;

(
c)
It
reduces
burden
on
small
entities;

(
d)
It
uses
plain,
coherent,
and
unambiguous
terminology
that
is
understandable
to
respondents;

(
e)
Its
implementation
will
be
consistent
and
compatible
with
current
reporting
and
recordkeeping
practices;

(
f)
It
indicates
the
retention
periods
for
recordkeeping
requirements;

(
g)
It
informs
respondents
of
the
information
called
for
under
5
CFR
1320.8(
b)(
3):

(
i)
Why
the
information
is
being
collected;
(
ii)
Use
of
information;
(
iii)
Burden
estimate;
(
iv)
Nature
of
response
(
voluntary,
required
for
a
benefit,
or
mandatory);
(
v)
Nature
and
extent
of
confidentiality;
and
(
vi)
Need
to
display
currently
valid
OMB
control
number;

(
h)
It
was
developed
by
an
office
that
has
planned
and
allocated
resources
for
the
efficient
and
effective
management
and
use
of
the
information
to
be
collected
(
see
note
in
Item
19
of
the
instructions);

(
i)
It
uses
effective
and
efficient
statistical
survey
methodology;
and
(
j)
It
makes
appropriate
use
of
information
technology.

If
you
are
unable
to
certify
compliance
with
any
of
these
provisions,
identify
the
item
below
and
explain
the
reason
in
Item
18
of
the
Supporting
Statement.
Signature
of
Program
Official
Michael
S.
Alushin,
Director
Compliance
Assessment
and
Media
Programs
Division
Office
of
Compliance
Office
of
Enforcement
and
Compliance
Assurance
Date
Signature
of
Senior
Official
or
designee
Oscar
Morales,
Director
Collection
Strategies
Division
Office
of
Environmental
Information
Date
OMB
83­
I
10/
95
Certification
Requirement
for
Paperwork
Reduction
Act
Submissions
5
CFR
1320.9
reads
"
As
part
of
the
agency
submission
to
OMB
of
a
proposed
collection
of
information,
the
agency
(
through
the
head
of
the
agency,
the
Senior
Official
or
their
designee)
shall
certify
(
and
provide
a
record
supporting
such
certification)
that
the
proposed
collection
of
information
­­

"(
a)
is
necessary
for
the
proper
performance
of
the
functions
of
the
agency,
including
that
the
information
to
be
collected
will
have
practical
utility;

"(
b)
is
not
unnecessarily
duplicative
of
information
otherwise
reasonably
accessible
to
the
agency;

"(
c)
reduces
to
the
extent
practicable
and
appropriate
the
burden
on
persons
who
shall
provide
information
to
or
for
the
agency,
including
with
respect
to
small
entities,
as
defined
in
the
Regulatory
Flexibility
Act
5
U.
S.
C.
§
601(
6)),
the
use
of
such
techniques
as:

"(
1)
establishing
differing
compliance
or
reporting
requirements
or
timetables
that
take
into
account
the
resources
available
to
those
who
are
to
respond;
"(
2)
the
clarification,
consolidation,
or
simplification
of
compliance
and
reporting
requirements;
or
collection
of
information
,
or
any
part
thereof;
"(
3)
an
exemption
from
coverage
of
the
collection
of
information,
or
any
part
thereof;

"(
d)
is
written
using
plain,
coherent,
and
unambiguous
terminology
and
is
understandable
to
those
who
are
to
respond;

"(
e)
is
to
be
implemented
in
ways
consistent
and
compatible,
to
the
maximum
extent
practicable,
with
the
existing
reporting
and
recordkeeping
practices
of
those
who
are
to
respond;

"(
f)
indicates
for
each
recordkeeping
requirement
the
length
of
time
persons
are
required
to
maintain
the
records
specified;

"(
g)
informs
potential
respondents
of
the
information
called
for
under
§
1320.8(
b)(
3);
[
see
below]

"(
h)
has
been
developed
by
an
office
that
has
planned
and
allocated
resources
for
the
efficient
and
effective
management
and
use
of
the
information
to
be
collected,
including
the
processing
of
the
information
in
a
manner
which
shall
enhance,
where
appropriate,
the
utility
of
the
information
to
agencies
and
the
public;

"(
i)
uses
effective
and
efficient
statistical
survey
methodology
appropriate
to
the
purpose
for
which
the
information
is
to
be
collected;
and
"(
j)
to
the
maximum
extent
practicable,
uses
appropriate
information
technology
to
reduce
burden
and
improve
data
quality,
agency
efficiency
and
responsiveness
to
the
public."

NOTE:
5
CFR
1320.8(
b)(
3)
requires
that
each
collection
of
information:

"(
3)
informs
and
provides
reasonable
notice
to
the
potential
persons
to
whom
the
collection
of
information
is
addressed
of:

"(
i)
the
reasons
the
information
is
planned
to
be
and/
or
has
been
used
to
further
the
proper
performance
of
the
functions
of
the
agency;
"(
ii)
the
way
such
information
is
planned
to
be
and/
or
has
been
used
to
further
the
proper
performance
of
the
functions
of
the
agency;
"(
iii)
an
estimate,
to
the
extent
practicable,
of
the
average
burden
of
the
collection
(
together
with
a
request
that
the
public
direct
to
the
agency
any
comments
concerning
the
accuracy
of
this
burden
estimate
and
any
suggestions
for
reducing
this
burden);
"(
iv)
whether
responses
to
the
collection
of
information
are
voluntary,
required
to
obtain
or
retain
a
benefit
(
citing
authority),
or
mandatory
(
citing
authority);
"(
v)
the
nature
and
extent
of
confidentiality
to
be
provided,
if
any
(
citing
authority);
and
"(
vi)
the
fact
that
any
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."
OMB
83­
I
(
Instructions)
10/
95
