NESHAP for Hospital Ethylene Oxide Sterilization (40 CFR part 63, subpart WWWWW) (Proposed Rule)

Forms and Documents

Document Name	Status
2245ss01.doc Supporting Statement A	2006-10-27

IC Document Collections

IC ID	Document Title	Status
45831	NESHAP for Hospital Ethylene Oxide Sterilization (40 CFR part 63, subpart WWWWW) (Proposed Rule)	New

ICR Details

OMB Control No: 2060-0713	ICR Reference No: 200610-2060-014
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: EPA/OAR	Agency Tracking No: 2245.01
Title: NESHAP for Hospital Ethylene Oxide Sterilization (40 CFR part 63, subpart WWWWW) (Proposed Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 12/28/2006
	Date Received in OIRA: 11/06/2006
Terms of Clearance: In accordance with 5 CFR 1320, OMB is withholding approval of this information collection. Prior to the publication of the final rule, the agency must provide to OMB a summary of all comments pertaining to the information collection burden imposed by this rule and any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The U.S. Environmental Protection Agency (EPA) is charged under Section 112 of the Clean Air Act (CAA) to establish National Emission Standards for Hazardous Air Pollutants (NESHAP) for new and existing area sources of hazardous air pollutants (HAP). Certain records and reports are necessary for the Administrator to confirm the compliance status of affected sources and identify new or reconstructed sources subject to the standards. Specific information needed by EPA for the proposed Hospital EO Sterilization NESHAP includes verification that the management practice is followed and that exempted facilities are venting emissions to control devices and following manufacturer recommended procedures. These recordkeeping and reporting requirements are specifically authorized by section 114 of the CAA (42 U.S.C. 7414) and set out in the General Provisions to 40 CFR part 63. Respondents to this request are owners and operators of hospitals that are area sources of HAP that operate ethylene oxide sterilization facilities. There are an estimated 1,900 affected facilities currently in operation. No new facilities are expected during the first 3 years of the proposed rule. Respondents would be required to submit an initial Notification of Compliance Status. Uncontrolled respondents also would be required to keep records of sterilization cycles and their required notifications.

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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:
2060-AM14	Proposed rulemaking	71 FR 64907	11/06/2006

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Federal Register Notices & Comments

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 Hospital Ethylene Oxide Sterilization (40 CFR part 63, subpart WWWWW) (Proposed Rule)

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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: $69,287

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 11/06/2006

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