Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of Prescription Drugs

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs

DATES:

Submit written comments (including recommendations) on the collection of information by September 28, 2026.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Importation of Prescription Drugs-21 CFR Part 251

OMB Control Number 0910-0888-Extension

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). 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 for exempt eligible prescription drugs that meet certain requirements from section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).

Description of Respondents: Respondents to the collection of information are SIP Sponsors (States or Indian Tribes, or in certain future circumstances, pharmacists or wholesale distributors, and any cosponsor(s)), importers (pharmacists or wholesaler distributors), and manufacturers of eligible prescription drugs.

In the Federal Register of April 16, 2026 (91 FR 20462) FDA published a 60-day notice soliciting comment on the proposed collection of information. We received one comment containing several topics. These issues included cost savings, patient risks, continuity of care, and product labeling. Because these topics are outside the scope of the 60-day notice, we decline to address them here. The submitter also raised an issue regarding whether FDA had overestimated the burden associated with individual provisions established by part 251 (21 CFR part 251) (Section 804 Importation Program) although no alternative figures were given by the commenter. The commenter questions the number of recordkeepers and how FDA derived its count. In this regard, we note that the scope of the information collection is set forth in §  251.1 (21 CFR 251.1) and that our estimate of the number of recordkeepers is forward-looking and its baseline is based on historical experience. Consistent with Executive Order 14273, FDA is taking steps to streamline and improve the section 804 importation program to make it easier for States to obtain authorization without sacrificing safety or quality in accordance with section 804 of the FD&C Act and FDA's implementing regulations. Additionally, in June 2026, FDA authorized another state's drug importation program proposal under section 804 of the FD&C Act. Consequently, we recognize that the number of respondents may fluctuate, especially during the initial phases of the program's implementation. Because of this, the number of recordkeepers is based on our current best estimate of state involvement and interest.

We appreciate all comments on this information collection but refrain from making further modifications to our estimate until we gain more experience with its implementation. Upon receipt of such information FDA will revise our burden estimate accordingly in our next submission to OMB.

FDA estimates the burden of this collection of information as follows:

We have established a web page at https://www.fda.gov/drugs/importation-program-under-section-804-fdc-act/section-804-importation-program-policies-and-authorizations to communicate news and information about FDA efforts to implement the SIP. We assume the burden attributable to the required retention, reporting, and disclosure of records pertaining to these information collection activities will be distributed among respondents at an average of 100 responses and 6,040 hours annually. Based on a review of the information collection since our last request for OMB approval we have made no adjustments to our burden estimate.