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

Issuing agencies

Abstract

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.

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<title>Federal Register, Volume 91 Issue 166 (Friday, August 28, 2026)</title>
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[Federal Register Volume 91, Number 166 (Friday, August 28, 2026)]
[Notices]
[Pages 55608-55609]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-3240]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

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

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0888. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-1244, 
<a href="/cdn-cgi/l/email-protection#702022312304111616301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="26767467755247404066404247084e4e5508414950">[email&#160;protected]</span></a>.

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

[[Page 55609]]

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 Sec.  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:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                      Number of                     Average burden
 21 CFR section 251; information     Number of       records per    Total annual         per         Total hours
       collection activity         recordkeepers    recordkeeper       records      recordkeeping
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Subpart B; SIP proposals and pre-              40             1.5              60               72         4,320
 import requests................
Subpart C; Certain requirements                40               1              40               43         1,720
 for importation programs.......
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    Total.......................  ...............  ..............             100  ...............         6,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have established a web page at <a href="https://www.fda.gov/drugs/importation-program-under-section-804-fdc-act/section-804-importation-program-policies-and-authorizations">https://www.fda.gov/drugs/importation-program-under-section-804-fdc-act/section-804-importation-program-policies-and-authorizations</a> 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.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17603 Filed 8-27-26; 8:45 am]
BILLING CODE 4164-01-P


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