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

Forms and Documents

Document Name	Status
1781ss08.docx Supporting Statement A	2018-05-31

IC Document Collections

IC ID	Document Title	Status
24504	NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG)	Modified

ICR Details

OMB Control No: 2060-0358	ICR Reference No: 201805-2060-004
Status: Active	Previous ICR Reference No: 201406-2060-002
Agency/Subagency: EPA/OAR	Agency Tracking No: 1781.08
Title: NESHAP for Pharmaceutical Production (40 CFR part 63, subpart GGG) (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/02/2018
	Date Received in OIRA: 05/31/2018
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2021	36 Months From Approved	06/30/2018
Responses	249	0	250
Time Burden (Hours)	44,300	0	44,266
Cost Burden (Dollars)	111,817	0	112,266

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 7401 et seq Name of Law: Clean Air Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 29552	06/29/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 24472	05/29/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $74,400

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(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 language 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) about:

(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.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 05/31/2018

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