NESHAP for Pharmaceutical Production (40 CFR part 63, subpart GGG) (Renewal)

ICR 201805-2060-004

OMB: 2060-0358

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-05-31
IC Document Collections
ICR Details
2060-0358 201805-2060-004
Active 201406-2060-002
EPA/OAR 1781.08
NESHAP for Pharmaceutical Production (40 CFR part 63, subpart GGG) (Renewal)
Extension without change of a currently approved collection   No
Regular
Approved without change 07/02/2018
Retrieve Notice of Action (NOA) 05/31/2018
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.

US Code: 42 USC 7401 et seq Name of Law: Clean Air Act
  
None

Not associated with rulemaking

  82 FR 29552 06/29/2017
83 FR 24472 05/29/2018
No

1
IC Title Form No. Form Name
NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG)

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 249 250 0 0 -1 0
Annual Time Burden (Hours) 44,300 44,266 0 0 34 0
Annual Cost Burden (Dollars) 111,817 112,266 0 0 -449 0
No
No
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.
05/31/2018


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