Notice2023-07442
Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
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Published
April 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 68 (Monday, April 10, 2023)</title>
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[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Notices]
[Pages 21195-21197]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#bdedeffceec9dcdbdbfddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="18484a594b6c797e7e587e7c793670706b367f776e">[email protected]</span></a>.
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 <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). 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 <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
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 <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 document instructs that PLAIR submissions should be made using
the applicant's letterhead and submitted by email to <a href="/cdn-cgi/l/email-protection#3e7d7a7b6c13717d136e727f776c7e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="0e4d4a4b5c23414d235e424f475c4e686a6f2066667d20696178">[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.
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
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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
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