Document ID: FDA-2023-N-1189-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs
Posted Date: 2023-10-13T04:00Z

[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 70993-70995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22653]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1189]

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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[[Page 70994]]

SUMMARY: The Food and Drug Administration (FDA or we) 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 November 13, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

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

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), 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)).
    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 June 8, 2023 (88 FR 37549), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment communicating that 
we had revised our burden estimates from those found in the final rule 
that issued October 1, 2020 (85 FR 62094). The comment also suggested 
that our figures underestimated burden associated with individual 
provisions established by part 251 although no alternative figures were 
proffered. We note also, that both FDA and respondents continue to 
carry out certain provisions in part 251, including activities related 
to the information collection elements. The comment also appeared to 
question how FDA derived its count of respondents included in the 
information collection. In this regard, we note that the scope of the 
information collection is set forth in Sec.  251.1. We appreciate all 
comments but refrain from making further modifications to our estimate 
until we have more experience with the implementation of the 
information collection.
    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 record      Total hours
       collection activity          respondents    recordkeeper       records         (hours)
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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 assume burden attributable to the information collection tasks 
will be averaged and distributed among respondents. As noted in the 
previous submission, FDA estimates that there will be 10 SIP Sponsors 
requiring 360 hours each to research, prepare, and administer 
requirements annually; 10 Pre-Import Requests requiring 24 hours each 
annually; and 20 manufacturers also requiring 24 hours each annually to 
participate in the program. In addition, FDA estimates that a 
recordkeeping burden of 52 hours will be imposed annually on the 10 SIP 
Sponsors, and a recordkeeping burden of 24 hours will be imposed 
annually on each of the 10 Importers and the 20 manufacturers. The 20 
manufacturers anticipated to participate in the program will also incur 
an estimated burden of 24 hours each for copying and providing records 
to SIP Sponsors and Importers of foreign transactions.
    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. We have 
therefore retained figures from the previous information collection 
approval. We assume burden attributable to the required retention, 
reporting and disclosure of records pertaining to these information 
collection activities will be distributed among respondents for an 
average of 100 responses and 6,040 hours annually.

[[Page 70995]]

    Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22653 Filed 10-12-23; 8:45 am]
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