Notice2023-13729
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries
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Published
June 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 123 (Wednesday, June 28, 2023)</title>
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[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41964-41966]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 0910-0046. 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,
<a href="/cdn-cgi/l/email-protection#96c6c4d7c5e2f7f0f0d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="2f7f7d6e7c5b4e49496f494b4e0147475c01484059">[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.
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 <a href="https://www.fda.gov/industry/import-basics/foreign-trade-zonesweekly-entry-filing">https://www.fda.gov/industry/import-basics/foreign-trade-zonesweekly-entry-filing</a>. 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 <a href="https://www.fda.gov/industry/import-systems/itacs">https://www.fda.gov/industry/import-systems/itacs</a>.
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
<a href="https://www.fda.gov/industry/actions-enforcement/reconditioning">https://www.fda.gov/industry/actions-enforcement/reconditioning</a>.
Relatedly, we are revising the information collection to include
burden associated with the use of proposed electronic Form FDA 5054
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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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pre-launch-activities-importation-requests-plair">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pre-launch-activities-importation-requests-plair</a> 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 <a href="/cdn-cgi/l/email-protection#adeee9e8ff80e2ee80fde1ece4ffedcbc9cc83c5c5de83cac2db"><span class="__cf_email__" data-cfemail="3e7d7a7b6c13717d136e727f776c7e585a5f1056564d10595148">[email protected]</span></a> 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
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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
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