SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Product Jurisdiction and Combination Products—21 CFR Parts 3 and 4

OMB Control Number 0910-0523—Extension

This information collection helps support implementation of statutory requirements that govern product jurisdiction and combination products. Congress expressly directed FDA to assign combination products to the appropriate Agency component for regulation as set forth in section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)). Congress also expressly directed FDA to determine the classification of a product as a drug, biological product, device, or combination product, or the component of the Agency that will regulate the product, as applicable, in response to a request submitted under section 563 of the FD&C Act (21 U.S.C. 360bbb-2).

Regulations in 21 CFR part 3 provide for product classification determinations and FDA designation on which Agency component will have primary jurisdiction for any drug, device, biological, or combination product, where such jurisdiction is unclear or in dispute. These determinations are made by our Office of Combination Products (OCP) upon receiving Requests for Designation (RFDs). We maintain a web page that includes contact and resource information pertaining to the RFDs process at https://www.fda.gov/​combination-products/​jurisdictional-information. As communicated on our web page, FDA welcomes comments from interested stakeholders on issues pertaining to OCP and encourages medical product developers to contact us if they are uncertain about the classification or assignment of their products and with questions regarding premarket or postmarket considerations for combination products. A dedicated mailbox is established at combination@fda.hhs.gov.

Similar to the RFD process, we have established the Pre-RFD process for sponsors to obtain preliminary, nonbinding feedback regarding medical product classification and assignment. Although Forms FDA 5003, 5004, and 5005 (pre-request and request for designation forms) were previously developed to facilitate information collection for Pre-RFDs and RFDs, we have more recently issued the following Agency guidance documents to provide instruction and recommendations to respondents regarding the submission of RFDs and Pre-RFDs.

• The guidance document entitled, “How to Write a Request for Designation” (April 2011), provides instruction regarding the information that needs to be submitted to OCP in an RFD as described in21 CFR 3.7. The guidance is available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​how-write-request-designation-rfd.
• The guidance document entitled “How to Prepare a Pre-Request for Designation,” (February 2018) was developed to assist sponsors in obtaining a preliminary, non-binding assessment regarding the classification and assignment of products from OCP through the Pre-RFD process. The guidance explains the Pre-RFD process and helps a sponsor understand the type of information to provide in a Pre-RFD submission. The guidance is available athttps://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​how-prepare-pre-request-designation-pre-rfd.
• This information collection also includes burden associated with Combination Product Agreement Meetings (CPAM) requests. The guidance document entitled, “Requesting FDA Feedback on Combination Products,” (December 2020) was developed to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. The guidance is available athttps://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​requesting-fda-feedback-combination-products.

The guidance documents were issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time.

The information collection also includes regulations in 21 CFR part 4 that govern current good manufacturing practice requirements and postmarketing safety requirements for combination products. We expect, however, that burden attendant to the associated recordkeeping, reporting, and/or disclosure activities is already accounted for in approved information collections that apply to drug, device, and/or biologic products specifically and respectively. Therefore, we do not ascribe separate burden in this information collection request for the activities generated by these requirements.

Respondents to the information collection are sponsors of medical products, including combination products. Based on submissions received by OCP during fiscal years 2020, 2021, and 2022, we account for 135 respondents annually.

In the Federal Register of July 31, 2023 (88 FR 49467), we published a 60-day notice soliciting comment on the proposed collection of information. One comment was received expressing interest in combination product ( printed page 83555) submissions, but was not responsive to the four information collection topics solicited in our notice and therefore we do not discuss the comment here.

We estimate the burden of this collection of information as follows:

Our estimated burden reflects a decrease in the number of respondents (four respondents) and a corresponding decrease in total hours (96 hours). Based on a recent evaluation of CPAM requests received from each product center in fiscal years 2020, 2021, and 2022, our estimated annual burden for CPAM requests remains unchanged.

88 FR 83554