[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41964-41966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13729]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 July 28, 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 0910-0046. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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). 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

[[Page 41965]]

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 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. 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 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.
    In the Federal Register of April 10, 2023 (88 FR 21195) we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received suggesting FDA 
underestimated burden that might be attributable to transactional data 
entry and necessary preparation. We note that included in our estimate 
is the time we believe necessary for associated recordkeeping, and that 
we assume certain recordkeeping attendant to import activities is usual 
and customary. At the same time, we have increased our estimate 
associated with the preparation of line-item data to reflect this 
comment. Another comment suggested FDA invest in utility enhancements 
that might improve that Agency's electronic interface with importers' 
systems. We appreciate this comment and continue to make process 
improvements including upgrades in automated technology as our limited 
resources permit.
    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  0.08 (5 minutes)............................          77,366
 (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  ............................................       2,077,245
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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

[[Page 41966]]

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 161,161 hours annually.

    Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13729 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P