[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37549-37551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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, Agency, or we) 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 August 7, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 7, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2023-N-1189 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 https://www.regulations.gov or at the

[[Page 37550]]

Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: 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: 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.
    We estimate the burden of the collection of information as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of
 21 CFR section 251; information     Number of      records per    Total annual   Average burden    Total hours
       collection activity          respondents    recordkeeper       records       per record
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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 https://www.fda.gov/about-fda/reports/importation-drugs-originally-intended-foreign-markets to 
communicate news and information about FDA efforts to implement the 
Section 804 Importation Program. To date, however, no SIP proposals 
have been authorized since publication of the final rule on October 1, 
2020 (85 FR 62094). We have therefore retained figures based on our 
original impact analysis estimating that 40 SIP sponsors will each 
submit a SIP proposal or pre-import request. We assume burden 
attributable to the

[[Page 37551]]

required retention 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.

    Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12258 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P