Laboratory Quality Assurance Evalution Program for Analysis of Cryptosporidum Under the Safe Drinking Water Act (Renewal)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form TBD Application Package for Assessment of Crypto Lab QA	Form and Instruction	Modified	Available
Form TBD Cryptosporidium Laboratory Audit Application Form	Form	Modified	Available
Form TBD Checklist C - Method 1623_1623.1 Technical Review_Sample Processing and Microscopy	Form and Instruction	Modified	Available
Form TBD Checklist B - Laboratory SOP Review	Form and Instruction	Modified	Available
Form TBD Checklist A - Method 1623_1623.1 Audit Package and Data Review	Form and Instruction	Modified	Available
Form TBD Application Package for Assessment of Crypto Lab QA.	Form and Instruction	Modified	Available
Form TBD Cryptosporidium Laboratory Audit Application Form	Form	Modified	Available
Form TBD Checklist C - Method 1623_1623.1 Technical Review_Sample Processing and Microscopy	Form and Instruction	Modified	Available
Form TBD Checklist B - Laboratory SOP Review	Form and Instruction	Modified	Available
Form TBD Checklist A - Method 1623_1623.1 Audit Package and Data Review	Form and Instruction	Modified	Available
2067ss06 - revised.docx	Supporting Statement A	Uploaded 2018-06-22	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
23747	Laboratory Certification (Private)	Form and Instruction	Modified	Application Package for Assessment of Crypto Lab QA
23747	Laboratory Certification (Private)	Form	Modified	Cryptosporidium Laboratory Audit Application Form
23747	Laboratory Certification (Private)	Form and Instruction	Modified	Checklist C - Method 1623_1623.1 Technical Review_Sample Processing and Microscopy
23747	Laboratory Certification (Private)	Form and Instruction	Modified	Checklist B - Laboratory SOP Review
23747	Laboratory Certification (Private)	Form and Instruction	Modified	Checklist A - Method 1623_1623.1 Audit Package and Data Review
210017	Certification Program Administration (State)		Modified
189179	Laboratory Certification (State & Local)	Form and Instruction	Modified	Application Package for Assessment of Crypto Lab QA.
189179	Laboratory Certification (State & Local)	Form	Modified	Cryptosporidium Laboratory Audit Application Form
189179	Laboratory Certification (State & Local)	Form and Instruction	Modified	Checklist C - Method 1623_1623.1 Technical Review_Sample Processing and Microscopy
189179	Laboratory Certification (State & Local)	Form and Instruction	Modified	Checklist B - Laboratory SOP Review
189179	Laboratory Certification (State & Local)	Form and Instruction	Modified	Checklist A - Method 1623_1623.1 Audit Package and Data Review

ICR Details

OMB Control No: 2040-0246	ICR Reference No: 201801-2040-002
Status: Historical Active	Previous ICR Reference No: 201401-2040-001
Agency/Subagency: EPA/OW	Agency Tracking No: 2067.06
Title: Laboratory Quality Assurance Evalution Program for Analysis of Cryptosporidum Under the Safe Drinking Water Act (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 with change	Conclusion Date: 06/22/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/31/2018
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
Responses	258	0	65
Time Burden (Hours)	3,741	0	5,472
Cost Burden (Dollars)	332,891	0	295,056

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Abstract: The US Environmental Protection Agency (EPA) is renewing a Laboratory Quality Evaluation Program ICR for Analysis of Cryptosporidium Under the Safe Drinking Water Act. Under the Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium ("Lab QA Program"), EPA has approved voluntary laboratories that have demonstrated, and continue to demonstrate, proficient detection and enumeration of Cryptosporidium in surface water sources for public water systems. Approved laboratories that do not continue to meet the criteria for the Lab QA Program, including successful participation in tri-annual proficiency tests, may have their status downgraded to "provisional" or have their approval suspended.

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Authorizing Statute(s): PL: Pub.L. 93 - 523 1442 Name of Law: Safe Drinking Water 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 48077	06/16/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 4478	01/31/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Certification Program Administration (State)
Laboratory Certification (Private)	TBD, TBD, TBD, TBD, TBD	Checklist A - Method 1623_1623.1 Audit Package and Data Review ,   Checklist B - Laboratory SOP Review ,   Checklist C - Method 1623_1623.1 Technical Review_Sample Processing and Microscopy ,   Cryptosporidium Laboratory Audit Application Form ,   Application Package for Assessment of Crypto Lab QA
Laboratory Certification (State & Local)	TBD, TBD, TBD, TBD, TBD	Checklist A - Method 1623_1623.1 Audit Package and Data Review ,   Checklist B - Laboratory SOP Review ,   Checklist C - Method 1623_1623.1 Technical Review_Sample Processing and Microscopy ,   Cryptosporidium Laboratory Audit Application Form ,   Application Package for Assessment of Crypto Lab QA.

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ICR Summary of Burden

table that charts list 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	258	65	0	0	193	0
Annual Time Burden (Hours)	3,741	5,472	0	0	-1,731	0
Annual Cost Burden (Dollars)	332,891	295,056	0	0	37,835	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: This decrease in burden due to a reduced number of laboratories (45 to 43), re-evaluation of hours for tasks, and an improved demonstration of capability by the laboratories. The O&M cost increase is due to higher prices for lab reagents and supplies, increased state fees for laboratory audits and costs associated with proficiency tests (PTs).

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Annual Cost to Federal Government: $564,132

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: 01/31/2018

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