View Information Collection Request (ICR) Package

OMB Control No: 3150-0035	ICR Reference No: 201312-3150-003
Status: Historical Active	Previous ICR Reference No: 201009-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR Part 21, Reporting of Defects and Noncompliance
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: 02/27/2014
	Date Received in OIRA: 12/26/2013
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2017	36 Months From Approved	02/28/2014
Responses	447	0	122
Time Burden (Hours)	34,705	0	8,926
Cost Burden (Dollars)	2,741	0	0

Abstract: The 10 CFR 21 regulation requires each individual, corporation, partnership, commercial grade dedicating entity, or other entity subject to the regulations in this Part to adopt appropriate procedures to evaluate deviations and failures to comply to determine whether a defect exists that could result in a substantial safety hazard. Depending upon the outcome of the evaluation, a report of the defect must be submitted to NRC. Reports submitted under 10 CFR 21 are reviewed by the NRC staff to determine whether the reported defects or failures to comply in basic components at NRC licensed facilities or activities are potentially generic safety problems. These reports have been the basis for the issuance of numerous NRC Generic Communications that have contributed to the improved safety of the nuclear industry. The records required to be maintained in accordance with 10 CFR 21 are subject to inspection by the NRC to determine compliance with the subject regulation.

Authorizing Statute(s): PL: Pub.L. 83 - 703 68 Stat. 919 Name of Law: Atomic Energy 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 49551	08/14/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 71673	11/29/2013
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
10 CFR Part 21, Reporting of Defects and Noncompliance

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	447	122	325
Annual Time Burden (Hours)	34,705	8,926	25,779
Annual Cost Burden (Dollars)	2,741	0	2,741

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: The estimated burden increased by 25,779 hours from 8,926 hours (5,350 hours for reporting and 3,576 hours for recordkeeping) to 34,705 hours (9,420 hours reporting + 25,190 hours recordkeeping + 95 hours third-party disclosure). This increase in the estimate is based on an increase actual number of reports received during the past three years (2010-2012) and a correction in the calculation of recordkeeping hours. Reporting. The estimated reporting burden increased from 5,350 hours to 9,420 hours, an increase of 4,070 hours. Reporting estimates are based on actual data from 2010-2012. The increase in burden is due to an increase in the number of interim reports (from 2 to 28) and 30-day reports (from 35 to 48). These estimates are based on actual data from the past three years. Recordkeeping. For this submission, the NRC staff reviewed the recordkeeping requirements in Part 21 and corrected and updated the number of recordkeepers and burden estimates as follows: --On the recordkeeping table, the requirement in 21.51(a)(1) for licensees, vendors, and fuel facilities to retain evaluations for 5 years was combined with the requirement in 21.51(a)(2) to retain notifications for 5 years, because the staff determined that these requirements related to the documentation for a single issue and constituted a single record. --The number of respondents for 21.51(a)(3) was corrected. Section 21.51(a)(3) of 10 CFR requires that suppliers of basic components retain a record of the purchasers of basic components for 10 years after delivery. The NRC staff estimates that there are 350 suppliers of basic components who must retain records of purchasers. In the previous submission, the estimated number of recordkeepers reflected the number of suppliers who had a reportable condition, rather than all suppliers of basic components who were keeping records of purchasers. The NRC staff has corrected the number of recordkeepers from 48 to 350 recordkeepers, resulting in an increase of 21,753.5 hours for this requirement. --On the recordkeeping table, requirements for applicants and holders of design certifications to retain notifications for 5 years and purchase records for 15 years were combined. The requirements in 21.51(a)(4) for applicants for standard design certification under subpart B of part 52 to retain notifications for 5 years and purchase records for 15 years was combined with the requirement in 21.51(a)(5) for applicants for or holders of a standard design approval to retain notifications for 5 years and purchase records for 15 years. The number of recordkeepers for these requirements decreased from 11 to 10 based on the actual number of known applicants and holders of design certifications. --The number of responses for the collection increased from 122 responses (74 reporting responses + 48 recordkeepers) to 447 responses (96 reporting responses + 350 recordkeepers + 1 third party disclosure response). The increase is primarily due to the correction in the number of recordkeepers for the collection, from 48 to 350 to include all entities subject to Part 21 who are selling basic components and keeping records of their purchasers. In this submission, third-party disclosure requirements have been broken out separately from reporting requirements. In the last submission, the requirement under 10 CFR 21.21(b) was included as a reporting requirement. This requirement specifies that a supplier of basic components must inform the purchasers or affected licensees of their inability to perform the evaluation to determine if a defect exists. The requirement is now correctly categorized as a third-party disclosure requirement (total of 95 hours).

Annual Cost to Federal Government: $639,744

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: Leslie Hill 3014152158 lah1@nrc.gov

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