Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2022-09065 · Docket No. FDA-2001-D-0067

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports.” This guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drugs, biological products, and combination products. This guidance finalizes the revised draft guidance entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports,” issued in June 2014.

Dates

The announcement of the guidance is published in the Federal Register on April 28, 2022.

Supplementary Information

I. Background FDA is announcing the availability of a guidance for industry entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports.” This guidance provides general information pertaining to electronic submission of postmarketing safety reports (ICSRs, ICSR attachments, and other postmarketing safety reports) under the following provisions: • 21 CFR 314.80 and 314.98 (regarding products with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), respectively, including combination products or drug constituent parts with approved NDAs or ANDAs) • 21 CFR 600.80 (regarding products with approved biologics license applications (BLAs), including combination products or biological product constituent parts with approved BLAs) • 21 CFR part 4, subpart B (requiring additional reports for combination products with approved NDAs, ANDAs, or BLAs) • 21 CFR 310.305 (regarding prescription drug products marketed for human use without approved NDAs or ANDAs, including prescription drug products that are compounded by facilities registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b)) • 21 CFR 329.100 and section 760 of the FD&C Act (21 U.S.C. 379aa) (regarding nonprescription drug products marketed for human use without approved NDAs or ANDAs) This guidance does not apply to the following: Vaccines, human cells, tissues, and cellular tissue-based products regulated under section 361 of the Public Health Service Act (42 U.S.C. 264), whole blood or blood components, combination products with a drug or biological product constituent part marketed under a device application, or lot distribution reports. On June 10, 2014, FDA published a final rule (79 FR 33072) to amend its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that the Agency can process, review, and archive. Elsewhere in the June 10, 2014, Federal Register (79 FR 33220), FDA announced the availability of a revised draft guidance entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports,” which revised and replaced the draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports,” issued on June 12, 2008 (73 FR 33436). The guidance announced in this current notice finalizes the June 10, 2014, revised draft guidance of the same title. The Agency considered comments on the draft guidance while finalizing the guidance. Generally, we revised the draft guidance to update and clarify topics, such as: (1) Options for transmitting reports in electronic format; (2) the notification that submitters will receive when FDA has received the electronic postmarketing safety report; (3) requesting temporary waivers from the electronic submission requirement; and (4) information on the receipt date of electronic submissions in the case of submission failure. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Providing Submissions in Electronic Format—Postmarketing Safety Reports.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 pertaining to postmarketing reporting of adverse drug experiences, including periodic and followup reports, have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 207 pertaining to registration of producers of drugs and listing of drugs in commercial distribution have been approved under OMB control number 0910-0045. The collections of information in 21 CFR parts 310, 314, and 600 pertaining to postmarketing reporting of adverse drug experiences for drugs subject to an NDA have been approved under OMB control number 0910-0291 (MedWatch Forms FDA 3500, 3500A, and 3500B). The collections of information in 21 CFR parts 310 and 314 pertaining to: (1) Postmarketing reporting of adverse drug experiences for drugs without approved NDAs and the collections of information and (2) the submissions required by section 760 of the FD&C Act for nonprescription human drug products marketed without an approved application have been approved under OMB control number 0910-0230. The collections of information in 21 CFR part 600 for biological drug products have been approved under OMB control number 0910-0308. The collections of information pertaining to the electronic submission of adverse event reports in 21 CFR parts 310, 314, and 329 have been approved under OMB control number 0910-0645. The collections of information pertaining to submissions required for outsourcing facilities under section 503B of the FD&C Act have been approved under OMB control number 0910-0800. The collections of information in 21 CFR part 4 pertaining to postmarketing safety information sharing by constituent part applicants for combination products have been approved under OMB control number 0910-0834. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Dated: April 21, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022-09065 Filed 4-27-22; 8:45 am]