Notice2023-22653
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
October 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 197 (Friday, October 13, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 70993-70995]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22653]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
[[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 <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: 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,
<a href="/cdn-cgi/l/email-protection#f6a6a4b7a582979090b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="8ddddfccdef9ecebebcdebe9eca3e5e5fea3eae2fb">[email 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
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\
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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.......
-------------------------------------------------------------------------------
Total....................... .............. .............. 100 .............. 6,040
----------------------------------------------------------------------------------------------------------------
\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 <a href="https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act">https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act</a> 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]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 13, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.