Notice2026-07421
Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 16, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions related to FDA's regulation on importation of prescription drugs.
Full Text
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<title>Federal Register, Volume 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Pages 20462-20464]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07421]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3240]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions
related to FDA's regulation on importation of prescription drugs.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 15, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 15, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
[[Page 20463]]
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-3240 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Importation of Prescription
Drugs.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, 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.
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#96c6c4d7c5e2f7f0f0d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="46161407153227202006202227682e2e3568212930">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
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We estimate the burden of the 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. 2026-07421 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P
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