Rules and Regulations. Notification of availability

Agency: Food and Drug Administration, HHS
Action: Notification of availability
Citation: FR Doc. 2019-08284 · Docket No. FDA-2008-N-0424 · 21 CFR 4

Summary

The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.

Dates

The announcement of the updated guidance is published in the Federal Register on April 24, 2019.

Supplementary Information

I. Background FDA is announcing an update to the immediately in effect guidance for industry entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” This guidance was originally issued on March 21, 2018 (83 FR 12259). This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under 21 CFR part 4, subpart B, which was published in the Federal Register of December 20, 2016 (81 FR 92603) and addresses postmarketing safety reporting for combination products. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements. We are updating this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this updated guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115(g)(2)). We made this determination because FDA needs to communicate its compliance policy in a timely manner given the compliance deadlines for certain provisions in 21 CFR part 4, subpart B, and the amount of time needed for firms to prepare for them. Although this guidance is immediately effective, it remains subject to comment in accordance with FDA's GGP regulation. This guidance represents the current thinking of FDA on this topic. 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.80(c) and (e), as well as for 21 CFR 314.81(b) are approved under OMB control numbers 0910-0001, 0910-0230, and 0910-0291. The information collection provisions for 21 CFR 600.80 and 600.81 are approved under OMB control number 0910-0308. Those for 21 CFR 606.170 are approved under OMB control number 0910-0116. Those for 21 CFR 606.171 are approved under OMB control number 0910-0458. The information collection provisions for 21 CFR 803.50, 803.53, and 803.56 are approved under OMB control numbers 0910-0291 and 0910-0437. The information collection provisions for 21 CFR 806.10 and 806.20 are approved under OMB control number 0910-0359. The information collection provisions for 21 CFR 4.102, 4.103, and 4.105 are 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: April 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-08284 Filed 4-23-19; 8:45 am]