83-C to add AER for Combo Products as Drugs

UNITED STATES FOOD & DRUG ADMINISTRATION

OMB Control No. 0910-0230

Adverse Drug Experience Reporting; Combination Products –

21 CFR part 314 and 21 CFR part 4

Request for Non-Substantive/Non-Material Change:

For operational efficiency, we are requesting to add burden attributable to provisions set forth in 21 CFR part 4 subpart B, currently approved in OMB control no. 0910-0834, into the information collection. Established through agency rulemaking that became effective in 2021 (RIN 0910-AF82; 81 FR 92603), specific provisions include 21 CFR 4.103, which provides that when information regarding an event that involves a death or serious injury, or an adverse event, associated with the use of a combination product is received by the product sponsor, the information must be provided to the other constituent part applicant(s) no later than 5 calendar days after receipt. Relatedly, 21 CFR 4.104 explains how and where to submit reports. Finally, 21 CFR 4.105 provides for associated recordkeeping. We have added the IC “Postmarketing Safety Reporting for Combination Products,” to reflect 198 responses and 89 hours annually to account for the estimated burden. These requirements are described in 21 CFR § 314.80(a), as well as regulations in 21 CFR § 600.80(a) and 21 CFR § 803.3, where we are submitting corresponding requests to modify control nos. 0910-0308 and 0910-0437 with regard to these notifications as they pertain to biologic-led or device-led combination products. Burden we attribute to the provisions of 21 CFR part 4 subpart A setting forth current good manufacturing practice requirements is discussed and accounted for in control no. 0910-0523. Upon OMB approval of our request to account for the postmarket safety reporting for combination products in the respective collections, we intend to discontinue control no. 0910-0834, established for the rulemaking noted above.

Submitted: March 2023