[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Notices]
[Pages 21195-21197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0895]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Imports and Electronic Import Entries

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 information collection 
associated with our imports program.

DATES: Either electronic or written comments on the collection of 
information must be submitted by June 9, 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 June 9, 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-0895 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Imports and Electronic Import 
Entries.'' 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 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

[[Page 21196]]

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Imports and Electronic Import Entries

OMB Control Number 0910-0046--Revision

    This information collection supports Agency regulations found in 21 
CFR part 1, subparts D (21 CFR 1.70 through 1.81) and E (21 CFR 1.83 
through 1.101), governing FDA import activities and related Agency 
guidance. Specifically, the regulations prescribe the required data 
elements that respondents must submit when importing, or offering for 
import, an FDA-regulated article into the United States. Review of the 
data elements allows FDA to continue to meet its responsibilities 
pertaining to current submission requirements established by the U.S. 
Customs and Border Protection (CBP) related to the submission of entry 
information in using its Automated Commercial Environment (ACE) system, 
or any CBP-authorized electronic data interchange system. The 
regulations were recently revised through rulemaking to include data 
elements associated with import entries for veterinary devices (RIN 
0910-AH66).
    Respondents (ACE filers) submit important and useful information 
about FDA-regulated products being imported or offered for import into 
the United States so that we may effectively and efficiently review 
products and determine their admissibility. In addition, and as set 
forth in the regulations, certain product types are subject to 
additional data elements (for example, 21 CFR 1.77 prescribes 
additional data elements for radiation-emitting products), as well as 
those data elements applicable to all products.
    The information collection also includes our weekly entry filing 
program (WEF). More detailed information on Foreign Trade Zones (FTZ)/
WEF, is available at https://www.fda.gov/industry/import-basics/foreign-trade-zonesweekly-entry-filing. The WEF program allows entry 
filers to file a single entry estimating the amount of merchandise 
anticipated to be removed from an FTZ and offered for U.S. consumption 
during a 7-day period. To participate, we recommend respondents who 
wish to file a weekly entry of FDA-regulated products with CBP to first 
request a preliminary assessment from FDA. As part of the assessment, 
we also recommend submitting specific data elements, as discussed in 
the assessment. The information helps us appropriately route 
submissions within the Agency. Information on whether a product is 
stored or manufactured in the zone is necessary for FDA to determine 
the applicable admissibility requirements. The FTZ and port information 
is necessary to ensure that basic requirements in 19 CFR part 146 are 
met. The importer of record (IOR) and manufacturer FDA establishment 
identification number information is requested by FDA to expedite the 
admissibility review. Requests to participate in the WEF process are 
submitted to the FDA Import Division Office covering the intended port 
of entry.
    The information collection also includes our Import Trade Auxiliary 
Communication System (ITACS). The ITACS is used by the import trade 
community and was implemented to improve communication with FDA. By 
utilizing ITACS, respondents to the information collection have the 
ability to establish an account and electronically check the status of 
FDA-regulated entries and lines, submit entry documentation, submit the 
location of goods availability for those lines targeted for examination 
by FDA, and check the estimated laboratory analysis completion dates 
for lines that have been sampled. For further information regarding 
ITACS, please visit our website at https://www.fda.gov/industry/import-systems/itacs.
    The information collection also includes burden associated with the 
use of Form FDA 766 entitled ``Application for Authorization to Relabel 
or Recondition Non-compliant Articles'' as the collection instrument 
for 21 CFR 1.95. Form FDA 766 facilitates collection of information 
associated with certain general enforcement provisions for importing 
FDA-regulated articles into the United States. The form is available at 
https://www.fda.gov/industry/actions-enforcement/reconditioning.
    Relatedly, we are revising the information collection to include 
burden associated with the use of proposed electronic Form FDA 5054 
entitled ``New Inquiry Form--Import Compliance Branch.'' Currently, 
general drug import inquiries are submitted by email in random format. 
We have developed Form FDA 5054 with accompanying instructions to 
facilitate responding to drug import inquiries, as well as to track 
receipts and responses. We have designed the form to interface with 
current Agency IT systems for optimal utility.
    Finally, the information collection includes burden associated with 
recommendations found in the procedural Agency guidance entitled ``Pre-
Launch Activities Importation

[[Page 21197]]

Requests (PLAIR),'' (March 2022). Historically, when applicants with a 
pending new drug application, abbreviated new drug application, or 
Center for Drug Evaluation and Research-regulated biologics licensing 
application (information collection associated with these submissions 
is currently approved under OMB control number 0910-0001) sought to 
import unapproved finished dosage form drug products into the United 
States in preparation for market launch, we considered such requests, 
informally referred to as ``PLAIRs,'' on a case-by-case basis. Since 
implementing the PLAIR program in 2013, interest continues to increase, 
so we have developed a more formalized process as discussed in the 
guidance document. The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pre-launch-activities-importation-requests-plair and was issued consistent with 
our good guidance practice regulations in 21 CFR 10.115, which provide 
for public comment on Agency guidance documents at any time. The 
guidance document instructs that PLAIR submissions should be made using 
the applicant's letterhead and submitted by email to [email protected] in a file compatible with Portable Document Format 
(PDF).
    Description of Respondents: Respondents to the information 
collection are domestic and foreign importers of FDA-regulated articles 
being imported or offered for import into the United States and entry 
filers who submit import entries on behalf of these importers.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden 1 2
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                                                               Number of
         21 CFR part 1, subpart D              Number of     responses per   Total annual            Average burden per response            Total hours
                                              respondents     respondent       responses
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Importers submission of data elements               95,307           10.14         967,069  0.05576 (3.346 minutes).....................          53,924
 (preparing the required information).
Entry filers (unique lines only)..........           4,133          10,804      44,656,657  0.04466 (2.68 minutes)......................       1,994,336
WEF participants..........................              10               1              10  0.87 (52 minutes)...........................               9
ITACS; creation of new account............             500               1               1  0.5 (30 minutes)............................             250
Form FDA 766 as required under 21 CFR 1.95             324               1             324  0.25 (15 minutes)...........................              81
Form FDA 5054.............................           1,000               1           1,000  .083 (5 minutes)............................              83
Submissions in accordance w/PLAIR.........              80               4             320  16..........................................           5,120
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............      45,625,381  ............................................       2,053,803
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded to reflect electronic submission data.

    Table 1, rows 1 and 2, reflects annual average filing submissions 
through December 31, 2022. An IOR may be the owner or purchaser of the 
article being imported or offered for import, or a customs broker 
licensed by CBP under 19 U.S.C. 1641 who has been designated by the 
owner, purchaser, or consignee to file the import entry. There is only 
one IOR per entry.
    As reflected in table 1, row 3, we estimate 10 respondents will 
submit WEFs. Persons wishing to file weekly entries of FDA-regulated 
products are encouraged to provide the information identified so that 
FDA can conduct a preliminary admissibility assessment of the 
associated products and firms. This submission typically contains the 
information FDA requests for multiple products (i.e., the respondent 
wishes to file weekly entries for multiple products and submits the 
information for each product together). Generally, submissions 
involving multiple products are significantly less burdensome on a per-
product basis. Depending on the product and scale of submission, this 
estimated burden may fluctuate. Filers submitting in ACE typically use 
software that is developed to specifically automate and expedite the 
entry submission process and allows filers to automatically upload 
entry information. While the WEF submission includes an initial one-
time submission burden, we expect reduced burden over a long term 
because filers can subsequently submit one entry covering multiple 
withdrawals from the FTZ in any given 7-day period.
    As reflected in table 1, row 4, we estimate that 500 new ITACS 
accounts will be created annually. Since developing and implementing 
ITACS, we have adjusted this estimate downward to reflect the 
transition from initial program interest to average annual maintenance-
level numbers.
    As reflected in table 1, row 5, we estimate the submission of 324 
Forms FDA 766 in conjunction with FDA-regulated products. This figure 
is based on Agency import data and our experience with the information 
collection. We assume it takes respondents 15 minutes to complete and 
submit Form FDA 766. Although current instructions communicate that 
four copies be submitted (one copy to be returned to respondent), we 
plan to update the form to reduce this number.
    Based on inquiries already received and processed by FDA, we 
anticipate 1,000 respondents will annually submit Form 5054 pertaining 
to general drug import information, as reflected in table 1, row 6.
    As shown in table 1, row 7, we estimate 80 respondents to the PLAIR 
program annually, an increase of 10 since our last evaluation of the 
information collection. At the same time, we estimate one fewer 
submission per respondent to correspond with a decrease in submissions 
received by FDA.
    Cumulatively these changes and adjustments result in an increase of 
3,067,493 responses and 137,719 hours annually.

    Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07442 Filed 4-7-23; 8:45 am]
BILLING CODE 4164-01-P