Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-3675]</DEPDOC> <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security</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, the Agency, or we) 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 (PRA). </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by June 2, 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 0910-0806. Also include the FDA docket number found in brackets in the heading of this document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, <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">Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security</HD> <HD SOURCE="HD2">OMB Control Number 0910-0806—Revision</HD> This information collection helps support implementation of sections 581 and 582 (21 U.S.C. 360eee and U.S.C. 360eee-1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which govern the pharmaceutical distribution supply chain. Definitions set forth in section 581 of the FD&C Act prescribe specific activities that apply to the individuals identified in section 582, including recordkeeping requirements intended to effectuate the tracing of certain pharmaceutical drugs as they are distributed within the United States. The recordkeeping provisions expressly provided for in sections 582(b) through (e) of the FD&C Act cover tasks associated with product identification, product tracing, transaction data, record verification, and disclosures (exchange) of information. Submissions to FDA, as provided for in section 582 of the FD&C Act, include making specific product notifications, requesting exemption and/or waiver from any of the statutory requirements, and requesting termination of a notification in consultation with FDA. The requirements of section 582 of the FD&C Act included in the information collection are self-executing. We regard most of the information collection activities required by the statute to be usual and customary recordkeeping activities by respondents and have therefore excluded from our estimated burden the time, effort, and financial resources attributable to those activities consistent with 5 CFR 1320.3(b)(2). Additionally, we note that some respondents are also subject to related reporting, recordkeeping, and disclosure requirements applicable under the Controlled Substances Act (Pub. L. 91-513), for which currently active information collection approvals are maintained by the Department of Justice's Drug Enforcement Administration. At the same time, we account for notifications submitted to FDA, and estimate recordkeeping burden attributable to activities corresponding with illegitimate product notifications, including coordination of investigations of suspect products, among trading partners, as required by the statute. To assist respondents with submitting specific product notifications to FDA regarding illegitimate product and product with a high-risk of illegitimacy, we have developed and utilize Form FDA 3911 entitled “Drug Notification” and the corresponding instructional document “INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911—DRUG NOTIFICATION.” Instruction regarding the submission of Form FDA 3911 using the Center for Drug Evaluation and Research “NextGen” portal is available from our website at <E T="03">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products.</E> Form FDA 3911 is intended to provide a uniform format for initial notifications, followup notifications, and requests for the termination of a notification. We believe followup activities regarding suspect and/or illegitimate drug products includes information obtained during the conduct of an official Agency investigation and thus not covered by the PRA. Please see 5 CFR 1320.4(a)(2) and FDA “General Enforcement Regulations” in 21 CFR part 1. We have revised Form FDA 3911, and the instructions for completing the form, to add a new field requesting information about the geographic location of the incident that is the subject of the notification. We have also published guidance documents, as provided for in section 582 of the FD&C Act, developed specifically to facilitate the efficient adoption of secure interoperable product tracing at the package level by respondents. The guidance documents discuss the recordkeeping activities expressly provided for in section 582 of the FD&C Act. To date we have developed and issued the following guidance documents: • “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs” guidance (2023 Standards for Interoperable Exchange Guidance) (September 6, 2023). • “Standardization of Data and Documentation Practices for Product Tracing” draft guidance (Standardization of Data Guidance) (February 28, 2018). • “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act” guidance (Enhanced Drug Distribution Security Guidance) (August 31, 2023). • “Verification Systems Under the Drug Supply Chain Security Act [DSCSA] for Certain Prescription Drugs” guidance (Verification Guidance) (December 7, 2023). • “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act” guidance (Definitions Guidance) (March 16, 2023). • “Product Identifiers Under the Drug Supply Chain Security Act—Questions and Answers” guidance (Product Identifier Guidance) (June 3, 2021). • “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” guidance (Suspect Product Guidance) (June 6, 2021). • “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” guidance (Waivers Guidance) (August 4, 2023). All Agency guidance documents are issued in accordance with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. We maintain a searchable guidance database on our website at <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</E> that utilizes topic specific search terms. We also maintain a web page at <E T="03">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements</E> that communicates FDA's ongoing implementation of the DSCSA requirements. Since DSCSA enactment on November 27, 2013, FDA has established a public docket to receive information and comments on DSCSA standards for the electronic tracking system, including comments regarding paper- and electronic- formats of information. In 2018, we initiated a pilot project, consistent with section 582(j) of the FD&C Act and approved in OMB control number 0910-0859, focusing on system attributes and demonstrating interoperability. Since completion of the pilot project, we continue to focus on the interoperability of the electronic systems described in section 582 of the FD&C Act and have revised this information collection to capture standardized transaction information. Respondents to the information collection are manufacturers, wholesale distributors, dispensers, and repackagers of pharmaceutical drug products, as defined in section 581 of the FD&C Act and identified in section 582(a)(1) of the FD&C Act. Based on Agency data, we assume 70,000 respondents: 1,230 manufacturers and 170 repackagers, (1,400 cumulatively); 1,600 distributors; and 67,000 dispensers (including online and chain pharmacies). In the <E T="04">Federal Register</E> of September 6, 2024 (89 FR 72848), we published a 60-day notice requesting public comment on the proposed collection of information. We received one comment from a trade association suggesting our estimate for burden attendant to requests for waiver, exception, or exemption (WEE) might not include submissions by those respondents who lack readiness to implement final DSCSA requirements and who have more recently submitted such requests to FDA. In anticipation of the end of the enhanced drug security requirements 12-month stabilization period on November 27, 2024, we received an increased number of waiver and exemption requests and have issued two exemptions from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners. The comment thanked FDA for the recent exemptions, acknowledging they allow a phased approach to implementing trading partner data exchange as required under the DSCSA. While the comment proffered no alternative figures, ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 19k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━