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Oct 13 -- The Food and Drug Administration (FDA or we) invites comment to OMB by November 20, 2023 regarding the Importation of Prescription Drugs data collection. [Comments due 30 days after submission to OMB on October 20.]

This information collection supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384), and applicable regulations in part 251 (21 CFR part 251), which provide for the importation of certain prescription drugs shipped from Canada. The purpose of section 804 of the FD&C Act is to reduce the cost of covered products to American consumers without imposing additional risk to public health and safety. The regulations in part 251 set forth procedures Section 804 Importation Program sponsors (SIP Sponsors) must follow when submitting plans to implement time-limited programs to begin importation of drugs from Canada. The regulations also establish criteria for FDA review and authorization of a SIP proposal or supplemental proposal. Additionally, the regulations set forth requirements for eligible prescription drugs and requirements for entities that engage in importation of eligible prescription drugs. Finally, the regulations provide that eligible prescription drugs that meet certain requirements are exempt from section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).

The information collection provisions are designed to facilitate programs for importation of products that pose no additional risk to the U.S. public’s health and safety and will result in a significant reduction in the cost of covered products to American consumers.  We will use the information collected to review SIP Proposals, including to assess supply chains.  

A SIP can be co-sponsored by a State, Indian Tribe, pharmacist, or wholesale distributor.  An Importer that is a wholesale distributor or pharmacist licensed in the United States will buy eligible prescription drugs directly from a “foreign seller” in Canada which purchases the drugs directly from the manufacturer.  This information collection will be used by the private sector, State and Tribal Governments (SIP Sponsors), and the Federal Government to maintain the integrity of supply chains, protect the public from interruptions of supply or diversion of these prescription drugs, and ensure that the drugs are authentic, not degraded, and meet established specifications and standards.

We have established a web page at https://www.fda.gov/​about-fda/​reports/​importation-program-under-section-804-fdc-act to communicate news and information about FDA efforts to implement the Section 804 Importation Program. To date, no SIP proposals have been authorized since publication of the final rule on October 1, 2020.

FDA submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202302-0910-012 Click on IC List for questionnaire, View Supporting Statement for technical documentation. Submit comments through this site.
FRN: https://www.federalregister.gov/d/2023-22653
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at https://www.aeaweb.org/content/file?id=5806

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