Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-3112]</DEPDOC> <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by February 18, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0230. Also include the FDA docket number found in brackets in the heading of this document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. <HD SOURCE="HD1">Postmarketing Adverse Experience Reporting</HD> <HD SOURCE="HD2">OMB Control Number 0910-0230—Revision</HD> This information collection helps support provisions found in sections 201, 502, 505, 701, and 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 352, 355, 371, and 379aa) governing adverse experience reporting (AER) and associated recordkeeping for FDA-regulated drug products. FDA has issued applicable regulations in part 4 and §§ 310.305, 314.80, 314.81, 314.98, and 329.100 (21 CFR part 4 and 21 CFR 310.305, 314.80, 314.81, 314.98, and 329.100) that implement the statutory requirements, identify specific content and format elements, and establish reporting and retention schedules for the required information. Postmarketing safety data collection and adverse event reporting are critical elements of FDA's monitoring of drugs. For more information, please visit <E T="03">https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-program.</E> Respondents to the information collection are manufacturers, packers, distributors, and applicants of FDA-regulated drug and biologic products marketed with or without an FDA-approved application, including over-the-counter (OTC) drug products marketed without an approved application; OTC drug products marketed under the OTC Drug Monograph Review process (whether subject to a final monograph or not); and drug products marketed outside the monograph system. All reports and followup reports must be submitted to FDA in electronic format, although waivers of the electronic requirements are available for good cause. Adverse experience reporting for products associated with drug marketing applications are governed by regulations in §§ 314.80, 314.81, and 314.98. The regulations identify required reporting content and format elements, as well as establish followup reporting requirements and mandatory reporting schedules. The regulations also establish associated recordkeeping and require that written procedures be developed for the surveillance, receipt, evaluation, and reporting of postmarketing adverse experiences to FDA. The regulations require reporting in an electronic format that FDA can process, although temporary waivers may be granted on a limited basis for good cause. A final guidance for industry entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports” (April 2022) is available for general information pertaining to electronic submission of postmarketing safety reports for certain human drugs, biological products, and combination products. The guidance is available at <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports.</E> We have established and maintain the FDA Adverse Event Reporting System (FAERS) at <E T="03">https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.</E> Information may be submitted via FDA's Electronic Submissions Gateway or utilizing the “Safety Reporting Portal,” developed by FDA and the National Institutes of Health to streamline reporting and review of adverse events. The primary purpose of FDA's adverse drug experience reporting system is to enable identification of signals for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed product provide the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, clinical investigators, and literature. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product's labeling (such as adding a new warning), to make decisions about risk evaluation and mitigation strategies; the need for postmarketing studies or clinical trials; and, when necessary, to initiate removal of a product from the market. In the <E T="04">Federal Register</E> of September 23, 2024 (89 FR 77515), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s150,12,12,12,12,12"> <TTITLE> Table 1—Estimated Annual Reporting Burden  <E T="0731">1 2 3</E> </TTITLE> <CHED H="1">21 CFR section or guidance; activity</CHED> <ENT I="01">310.305(c)(5); AERs for prescription products not the subject of a marketing application</ENT> <ENT>36 </ENT> <ENT>88.8</ENT> <ENT>3,197</ENT> <ENT>1</ENT> <ENT>3,197</ENT> </ROW> <ROW> <ENT I="01">314.80(c)(1); 15-day alerts for approved products</ENT> <ENT>682 </ENT> <ENT>1,832.84</ENT> <ENT>1,250,000</ENT> <ENT>1</ENT> <ENT>1,250,000 </ENT> </ROW> <ROW> <ENT I="01">314.80(c)(2); periodic reports for approved products</ENT> <ENT>682</ENT> <ENT>1,228.73</ENT> <ENT>838,000</ENT> <ENT>60</ENT> <ENT>50,280,000</ENT> </ROW> <ROW> <ENT I="01">329.100; AERs for non-prescription drug products</ENT> <ENT>312</ENT> <ENT>62.522</ENT> <ENT>19,507</ENT> <ENT>6</ENT> <ENT>117,042</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">ICH E2C(R2) Guidance;</E> Periodic safety updates; Applicants w/waiver for an approved application (section III.A.) </ENT> <ENT>471</ENT> <ENT>8.885</ENT> <ENT>4,185</ENT> <ENT>1</ENT> <ENT>4,185 </ENT> </ROW> <ROW> <ENT I="01"> <E T="03">ICH E2C(R2) Guidance;</E> Periodic safety updates; Applicants w/no waiver for an approved application (section III.B.) </ENT> <ENT>1,115</ENT> <ENT>16.254</ENT> <ENT>18,123</ENT> <ENT>2</ENT> <ENT>36,246</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">AER During Pandemic Guidance;</E> notifying FDA when normal reporting is not feasible (section III.C.) <ENT I="01">4.103, 4.104, 4.105, 310.305, 314.80, 314.98, 329.100(c); Waiver requests from electronic reporting requirements</ENT>  There are no capital costs associated with this collection. The operating and maintenance costs associated with this collection of information are approximately $25,000 annually. </TNOTE> <TNOTE> <SU>2</SU>  The reporting burdens for § 310.305(c)(1), (2), and (3), and voluntary reports by healthcare providers received under § 314.80(c)(1)(i) and (ii) are covered under OMB control number 0910-0291. </TNOTE> <TNOTE> <SU>3</SU>  Totals may not sum due to rounding. </TNOTE> <TNOTE> <SU>4</SU>  Total of unique respondents. </TNOTE> </GPOTABLE> <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s150,12,12,12,13,12"> <TTITLE> Table 2—Estimated Annual Recordkeeping Burden  <E T="0731">1 2</E> </TTITLE> <CHED H="1">21 CFR section or guidance section; activity</CHED> <CHED H="1">Number of recordkeepers</CHED> <CHED H="1">Number of records per recordkeeper</CHED> <CHED H="1">Total annual records</CHED> <ENT I="01"> 310.305; AER records—prescription product not the subject of a marketing application</ENT> <ENT>36</ENT> <ENT>88.8</ENT> <ENT>3,197</ENT> <ENT>16</ENT> <ENT>51,152</ENT> </ROW> <ROW> <ENT I="01">314.80(j); AER records—product associated w/marketing application</ENT> <ENT>841</ENT> <ENT>1,814.0606</ENT> <ENT>1,525,625</ENT> <ENT>16</ENT> <ENT>24,410,000</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Postmarket AER for Nonprescription Drug Products Guidance;</E> (§ 329.100) </ENT> <ENT>312</ENT> <ENT>62.5224</ENT> <ENT>19,507</ENT> <ENT>8</ENT> <ENT>156,056</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">AERs During Pandemic Guidance;</E> Continuity of operations planning (section III.B.) <E T="03">AERs During Pandemic Guidance;</E> documenting conditions and resultant h ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 21k characters. 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