In accordance with 5 CFR 1320, the information collection is approved for three years.
Inventory as of this Action
Requested
Previously Approved
02/28/2017
36 Months From Approved
02/28/2014
447
0
122
34,705
0
8,926
2,741
0
0
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.
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).
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:
(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;
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.
Part 21 Final SS.docx
10 CFR Part 21, Reporting of Defects and Noncompliance