View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
Authorizing Statute(s):
US Code:
42 USC 7401 et seq
Name of Law: Clean Air Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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)
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:
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
Agency Contact:
Patrick Yellin 202 564-2970 yellin.patrick@epa.gov
Common Form ICR:
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:
(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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