In accordance
with 5 CFR 1320, the information collection is approved for three
years.
Inventory as of this Action
Requested
Previously Approved
07/31/2021
36 Months From Approved
06/30/2018
249
0
250
44,300
0
44,266
111,817
0
112,266
The National Emission Standards for
Hazardous Air Pollutants (NESHAP) for Pharmaceuticals Production
(40 CFR Part 63, Subpart GGG) were proposed on April 2, 1997;
promulgated on September 21, 1998; and amended on both April 21,
2011 and February 27, 2014. The 2014 amendment promulgated
technical correction was made to allow for EPA Method 320 as an
alternative to EPA Method 18 for demonstrating that a vent is not a
process vent. These regulations apply to existing and new
pharmaceuticals manufacturing operations that are major sources of
hazardous air pollutants (HAP). The affected facilities encompass
all pharmaceuticals manufacturing operations that include process
vents, storage tanks, equipment components, and wastewater systems.
New facilities include those that commenced construction or
reconstruction after the date of proposal. This information is
being collected to assure compliance with 40 CFR Part 63, Subpart
GGG. In general, all NESHAP standards require initial
notifications, performance tests, and periodic reports by the
owners/operators of the affected facilities. They are also required
to maintain records of the occurrence and duration of any startup,
shutdown, or malfunction in the operation of an affected facility,
or any period during which the monitoring system is inoperative.
These notifications, reports, and records are essential in
determining compliance, and are required of all affected facilities
subject to NESHAP.
There is a reduction in the
estimated number of responses, by one. The previous ICR included
one response for affirmative defense. However, that item has
subsequently been removed from this ICR as those provisions are
outdated. There is an adjustment increase in the respondent labor
hours as currently identified in the OMB Inventory of Approved
Burdens. This increase is not due to any program changes. The
change in the burden and cost estimates occurred due to a change in
assumption. In accordance with the Terms of Clearance, this ICR
assumes all existing respondents will have to familiarize with the
regulatory requirements each year. There is also a small adjustment
decrease in the total capital and O&M costs as compared the
previously-approved ICR. This decrease is not due to any program
changes, but occurred because, in accordance with the terms of
clearance, this ICR rounds totals to three significant
figures.
$74,400
No
No
No
No
No
No
Uncollected
Patrick Yellin 202 564-2970
yellin.patrick@epa.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(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;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.