Administrative Destruction

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1</CFR> <DEPDOC>[Docket No. FDA-2021-N-1348]</DEPDOC> <RIN>RIN 0910-AI59</RIN> <SUBJECT>Administrative Destruction</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, Agency, or we) is issuing a regulation to implement our authority to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. We are finalizing the change to our internal procedures for administrative destruction of drugs and devices. The notice of proposed rule making (NPRM) published in the <E T="04">Federal Register</E> (October 7, 2022). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective July 1, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Ann M. Metayer, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4375, Silver Spring, MD 20993-0002, 301-796-3324. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <EXTRACT> <HD SOURCE="HD1">Table of Contents</HD> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation/History of This Rulemaking</FP> <FP SOURCE="FP1-2">B. Summary of Comments to the Proposed Rule</FP> <FP SOURCE="FP-2">IV. Legal Authority</FP> <FP SOURCE="FP-2"> V. Comments on the Proposed Rule and FDA Response </FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Summary of General Comments to the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Specific Comments and FDA Response</FP> <FP SOURCE="FP-2">VI. Comments on FDA Procedures for Administrative Destruction and FDA Response</FP> <FP SOURCE="FP-2">VII. Effective Date</FP> <FP SOURCE="FP-2">VIII. Economic Analysis of Impacts</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Overview of Benefits and Costs</FP> <FP SOURCE="FP-2">IX. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">X. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">XI. Federalism</FP> <FP SOURCE="FP-2">XII. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XIII. Reference</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> The final rule provides to an owner or consignee notice and an opportunity to present testimony when the Agency intends to administratively destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States. The Safeguarding Therapeutics Act (STA) (Pub. L. 116-304), signed into law on January 5, 2021, amended section 801(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(a)) to provide FDA with the authority to administratively destroy certain refused devices without providing the owner or consignee with the opportunity for export. FDA is amending § 1.94 (21 CFR 1.94) to provide to the owner or consignee of a refused device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) notice and an opportunity to present testimony to the Agency prior to destruction of the device. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> The final rule provides to an owner or consignee notice and an opportunity to present testimony when the Agency intends to administratively destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under section 801(a) of the FD&C Act. FDA is amending part 1 (21 CFR part 1) by expanding the scope of § 1.94, which provides to the owner or consignee notice and opportunity to present testimony prior to the refusal and destruction of certain refused drugs, to also include notice and opportunity to present testimony prior to the refusal and destruction of certain refused devices. <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing this final rule under sections 701 and 801 of the FD&C Act (21 U.S.C. 371 and 381, respectively). <HD SOURCE="HD2">D. Costs and Benefits</HD> The primary public health benefit of the final rule will be the value of preventing additional illnesses or deaths by destroying, rather than returning, refused devices valued at $2,500 or less, which may pose a public health risk. This benefit will accrue whenever FDA's existing enforcement tools would not have prevented the violative device from entering the U.S. market. The estimated primary costs of the final rule include the additional costs to destroy, rather than return, refused devices valued at $2,500 or less, and the additional costs to store these devices at International Mail Facilities (IMFs) prior to destruction. There will also be one-time costs to FDA to update its electronic Operational and Administrative System for Import Support (OASIS) and System for Entry Review and Import Operations (SERIO); revise its Regulatory Procedures Manual (RPM), Investigations Operations Manual (IOM), and additional FDA and inter-Agency procedures; and train employees on the new procedures. Express couriers will incur one-time costs to read and understand the rule. We estimate that the annualized benefits over 10 years will range from $148,000 to $750,000 at a 7 percent discount rate and a 3 percent discount rate, with a primary estimate of $317,000. The annualized costs will range from $68,000 to $1.59 million at a 7 percent discount rate, with a primary estimate of $475,000, and from $63,000 to $1.58 million at a 3 percent discount rate, with a primary estimate of $470,000. <HD SOURCE="HD1">II. Table of Abbreviations/Commonly Used Acronyms in This Document</HD> <GPOTABLE COLS="02" OPTS="L2,tp0,i1" CDEF="s75,r200"> <CHED H="1">Abbreviation/acronym </CHED> <CHED H="1">What it means</CHED> <ROW> <ENT I="01">Agency </ENT> <ENT>U.S. Food and Drug Administration.</ENT> </ROW> <ROW> <ENT I="01">CBP </ENT> <ENT>U.S. Customs and Border Protection.</ENT> </ROW> <ROW> <ENT I="01">COVID-19</ENT> <ENT>Disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).</ENT> </ROW> <ROW> <ENT I="01">FDA </ENT> <ENT>U.S. Food and Drug Administration.</ENT> </ROW> <ROW> <ENT I="01">FDASIA </ENT> <ENT>Food and Drug Administration Safety and Innovation Act.</ENT> </ROW> <ROW> <ENT I="01">FD&C Act </ENT> <ENT>Federal Food, Drug, and Cosmetic Act.</ENT> </ROW> <ROW> <ENT I="01">IMFs </ENT> <ENT>International Mail Facilities.</ENT> </ROW> <ROW> <ENT I="01">IOM </ENT> <ENT>Investigations Operations Manual.</ENT> </ROW> <ROW> <ENT I="01">NPRM </ENT> <ENT>Notice of Proposed Rule Making.</ENT> </ROW> <ROW> <ENT I="01">OASIS </ENT> <ENT>FDA's Operational and Administrative System for Import Support.</ENT> </ROW> <ROW> <ENT I="01">RPM </ENT> <ENT>Regulatory Procedures Manual.</ENT> </ROW> <ROW> <ENT I="01">SERIO </ENT> <ENT>FDA's System for Entry Review and Import Operations.</ENT> </ROW> <ROW> <ENT I="01">STA </ENT> <ENT>Safeguarding Therapeutics Act.</ENT> </ROW> <ROW> <ENT I="01">TBT Agreement </ENT> <ENT>Technical Barriers to Trade Agreement.</ENT> </ROW> <ROW> <ENT I="01">USPS </ENT> <ENT>U.S. Postal Service.</ENT> </ROW> <ROW> <ENT I="01">We, Our, Us </ENT> <ENT>U.S. Food and Drug Administration.</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">III. Background</HD> <HD SOURCE="HD2">A. Need for the Regulation/History of This Rulemaking</HD> Section 708 in the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), enacted in 2012, gave FDA the authority in section 801(a) of the FD&C Act to destroy, without providing an opportunity for export, any refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). Section 801(a) of the FD&C Act, as amended by FDASIA, allows the Agency to combine the notice and opportunity to introduce testimony on the admissibility of the drug under section 801(a) of the FD&C Act with the notice and opportunity to introduce testimony on the destruction of the drug, as long as appropriate notice is provided to the owner or consignee. To implement that authority, FDA published a final rule in the <E T="04">Federal Register</E> on September 15, 2015 (80 FR 55237) that revised § 1.94 to provide notice and an opportunity for the owner or consignee to appear before the Agency and introduce testimony prior to the destruction of a drug. The STA expanded FDA's administrative destruction authority to include any refused device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). To ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 43k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━