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

Forms and Documents

Document Name	Status
1781ss07.docx Supporting Statement A	2014-05-09

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: 201406-2060-002
Status: Historical Active	Previous ICR Reference No: 201106-2060-009
Agency/Subagency: EPA/OAR	Agency Tracking No: 1781.07
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: 05/06/2015
	Date Received in OIRA: 06/13/2014
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. In future collections, costs and time burden estimates should be rounded to the appropriate number of significant digits. If "reading instructions" are provided as potential time or cost burdens, then the location of the instructions or the instructions themselves should be provided. Also, the burden for refreshing on instructions should be included, as appropriate. Any detailed tables should be provided in excel format along with or in lieu of detailed tables provided within the supporting statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	250	0	249
Time Burden (Hours)	44,266	0	44,266
Cost Burden (Dollars)	112,266	0	112,266

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Abstract: The NESHAP for Pharmaceuticals Production were proposed on April 2, 1997, and promulgated on September 21, 1998. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any malfunctions 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, in general, are required of all sources subject to NESHAP. This information is used by the Agency to identify sources subject to the standards to insure that the maximum achievable control technologies are being applied. Semiannual summary reports are also required.

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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:
	78 FR 35023	06/11/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 32280	06/04/2014
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	250	249	0	0	1	0
Annual Time Burden (Hours)	44,266	44,266	0	0	0	0
Annual Cost Burden (Dollars)	112,266	112,266	0	0	0	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:

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Annual Cost to Federal Government: $71,518

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 06/13/2014

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