FDA Asks OMB to Okay Prescription Drug Import Paperwork
Published Date: 8/28/2026
Notice
Summary
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.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Recordkeeping Burden for Importation Program
If you are a Section 804 Importation Program respondent (SIP Sponsor, importer, or manufacturer), the FDA estimates the information-collection recordkeeping will total 100 records and 6,040 hours annually under OMB control number 0910-0888. The agency breaks this down as 40 recordkeepers for Subpart B producing 60 records (72 hours per record) and 40 recordkeepers for Subpart C producing 40 records (43 hours per record); FDA says there are no capital or operating costs associated with this collection.
Program Intended to Lower Drug Prices
The FDA says the Section 804 Importation Program (21 U.S.C. 384; 21 CFR part 251) exists to reduce the cost of covered prescription products to American consumers without imposing additional public health or safety risk, by authorizing time-limited importation programs to begin importation of drugs from Canada. FDA notes it has established procedures and review criteria for SIP proposals and in June 2026 authorized another State's program.
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Previous: 2026-17602, Agency Information Collection Activities: Requests for Comments; Clearance for Renewal of Information Collection: Privacy International Civil Aviation Organization (ICAO) Address
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for an information collection renewal. The collection involves an aircraft operator's request for a privacy ICAO address through a web-based application process. The information to be collected is necessary to qualify for the authorized use of the privacy ICAO address services and for monitoring to support continued airworthiness and enforcement activities.
Next: 2026-17604, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension: Rule 2a-5