View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
201104-2060-011
Status:
Historical Inactive
Previous ICR Reference No:
201005-2060-011
Agency/Subagency:
EPA/OAR
Agency Tracking No:
1781.06
Title:
NESHAP for Pharmaceutical Production (40 CFR part 63, subpart GGG) (Final Rule)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Preapproved
Conclusion Date:
06/29/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/19/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2014
10/31/2013
10/31/2013
Responses
249
0
249
Time Burden (Hours)
44,266
0
44,246
Cost Burden (Dollars)
112,266
0
112,266
Abstract:
This ICR is prepared for a U.S. Environmental Protection Agency (EPA) rulemaking developed under authority of section 112 of the Clean Air Act (CAA). The rulemaking amends title 40, chapter I, part 63, subpart GGG, National Emission Standards for Hazardous Air Pollutants from Pharmaceuticals Production, of the Code of Federal Regulations (CFR). The current Pharmaceuticals Production NESHAP were proposed on April 2, 1997, and promulgated on September 21, 1998. These standards apply to facilities in the 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 commencing construction or reconstruction after the date of that proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart GGG. HAP emissions are the pollutants regulated under this subpart. The amendments to the rule eliminate the startup, shutdown, and malfunction exemption, remove the SSM plan requirement, add provisions to provide an affirmative defense against civil penalties for exceedances of emission standards caused by malfunctions, and a requirement for electronic submittal of performance test data, and correct an editorial error. The remaining portions of the NESHAP remain unchanged.
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:
2060-AO91
Final or interim final rulemaking
Federal Register Notices & Comments
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 Request
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
249
0
0
0
0
Annual Time Burden (Hours)
44,266
44,246
0
20
0
0
Annual Cost Burden (Dollars)
112,266
112,266
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This ICR is prepared for a U.S. Environmental Protection Agency (EPA) rulemaking developed under authority of section 112 of the Clean Air Act (CAA). The rulemaking amends title 40, chapter I, part 63, subpart GGG, National Emission Standards for Hazardous Air Pollutants from Pharmaceuticals Production, of the Code of Federal Regulations (CFR). The current Pharmaceuticals Production NESHAP were proposed on April 2, 1997, and promulgated on September 21, 1998. These standards apply to facilities in the 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 commencing construction or reconstruction after the date of that proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart GGG. HAP emissions are the pollutants regulated under this subpart. The amendments to the rule eliminate the startup, shutdown, and malfunction exemption, remove the SSM plan requirement, add provisions to provide an affirmative defense against civil penalties for exceedances of emission standards caused by malfunctions, and a requirement for electronic submittal of performance test data, and correct an editorial error. The remaining portions of the NESHAP remain unchanged.
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:
Mary Kissell 919 541-4516 kissell.mary@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:
04/19/2011
An official website of the United States government
The .gov means it's official.
The site is secure.
