Part 21 of title 10 of the Code of Federal Regulations (10 CFR), 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 the NRC. Reports submitted under 10 CFR part 21 are reviewed by the NRC staff to determine whether the reported defects or failures to comply in basic components at the 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 part 21 are subject to inspection by the NRC to determine compliance with the subject regulation.
The burden decreased by 3,108 hours, from 32,083 hours to 28,975 hours. In addition, the estimated responses for the collection decreased from 800 responses (88 reporting responses + 355 recordkeepers + 357 third party disclosure responses) to 755 responses (43 reporting responses + 355 recordkeepers + 357 third party disclosure response). The decrease in reporting responses is due to the near completion of new reactor construction activities, and the decommissioning (no longer operating) of several nuclear power plant facilities.
Reporting. The estimated reporting burden decreased from 6,500 hours to 3,407 hours, a decrease of 3,093 hours. Reporting estimates are based on actual data from 2019-2021 and staff knowledge of industry trends. The decrease in burden is due to an decrease in the number of interim reports (from 22 to 9), initial telephone or fax notifications (from 35 to 16) and 30-day reports (from 31 to 18). This decrease is due to the near completion of new reactor construction activities, and the decommissioning (no longer operating) of several nuclear power plant facilities.
The NRC staff anticipates that the agency will continue to receive similar numbers of reports in the next three years.
Recordkeeping. For this submission, the NRC staff reviewed the recordkeeping requirements in Part 21 and updated the number of recordkeepers maintaining evaluations and notifications under 10 CFR 21.51(a)(1) and (2) which decreased from 65 to 59, decreasing the burden by 15 hours. The change in the number of entities maintaining these records is attributed to a decrease in notifications received during the licensing phase of an application.
Finally, note the addition of the requirements under 10 CFR 21.21(c), the evaluation, reporting and record maintaining requirements for dedicated items. This requirement was inadvertently omitted in prior submissions; however, there is no additional burden imposed, the burden is being captured in existing requirements under 10 CFR Part 21 since all the component(s) are being evaluated under the same requirements.
Third-Party Disclosure
There is an existing third-party disclosure requirement in 10 CFR Part 21, 10 CFR Part 21.6 requires the posting of procedures and the name of the individual to whom reports can be made. The burden and responses for this requirement remains constant for this renewal cycle.
The hourly rate changed from $275 to $290 per hour. The estimated cost per burden hour is based upon NRCâs annual fee recovery rate, as published in NRCâs annual fee recovery rule.
It is important to note that these estimates are based on historical data and staff knowledge of industry trends. However, the number of 10 CFR Part 21 reports generated or received in any given year is dependent upon the number or issues that arise, that is, this is an event-based burden, not a burden as a consequence of a regular reporting requirement.
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 burden tables for 2023 renewal.xlsx
Part 21 Final supporting statement 2023.docx
10 CFR Part 21, Reporting of Defects and Noncompliance