Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries, 41964-41966 [2023-13729]
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41964
Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices
Estimated Total Annual Burden
Hours: 1,050.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 5106, Public Law
111–320, the Child Abuse Prevention
and Treatment Act Reauthorization Act
of 2010, and titles IV–B and IV–E of the
Social Security Act.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–13677 Filed 6–27–23; 8:45 am]
BILLING CODE 4184–29–P
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.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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Jkt 259001
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 CBPauthorized 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 radiationemitting 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.
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
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
E:\FR\FM\28JNN1.SGM
28JNN1
Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices
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-bycase 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-fdaguidance-documents/pre-launchactivities-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
CDER-OC-PLAIR@fda.hhs.gov 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.
41965
In the Federal Register of April 10,
2023 (88 FR 21195) we published a 60day 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
Number of
respondents
21 CFR part 1, Subpart D
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Importers submission of data elements (preparing the required information).
Entry filers (unique lines only) .............................
WEF participants .................................................
ITACS; creation of new account .........................
Form FDA 766 as required under 21 CFR 1.95
Form FDA 5054 ...................................................
Submissions in accordance w/PLAIR .................
95,307
10.14
967,069
0.08 (5 minutes) .............
77,366
4,133
10
500
324
1,000
80
10,804
1
1
1
1
4
44,656,657
10
1
324
1,000
320
0.04466 (2.68 minutes) ..
0.87 (52 minutes) ...........
0.5 (30 minutes) .............
0.25 (15 minutes) ...........
.083 (5 minutes) .............
16 ...................................
1,994,336
9
250
81
83
5,120
Total .............................................................
........................
........................
45,625,381
........................................
2,077,245
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
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
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18:48 Jun 27, 2023
Jkt 259001
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
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
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 FDAregulated 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
E:\FR\FM\28JNN1.SGM
28JNN1
41966
Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2613]
Presenting Quantitative Efficacy and
Risk Information in Direct-toConsumer Promotional Labeling and
Advertisements; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Presenting Quantitative Efficacy and
Risk Information in Direct-to-Consumer
(DTC) Promotional Labeling and
Advertisements.’’ This guidance
provides recommendations for
presenting quantitative efficacy and risk
information in DTC promotional
labeling and advertisements for
prescription human drug and biological
products and prescription animal drugs
and in DTC promotional labeling for
over-the-counter (OTC) animal drugs
(collectively, ‘‘promotional
communications’’). FDA is issuing this
guidance to describe the Agency’s
recommendations for how
manufacturers, distributors, and packers
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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18:48 Jun 27, 2023
Jkt 259001
(collectively, ‘‘firms’’) that include
quantitative efficacy or risk information
about their drugs in DTC promotional
communications can make the language
and presentation more consumerfriendly. This guidance finalizes the
draft guidance of the same title issued
in October 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on June 28, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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–
2018–D–2613 for ‘‘Presenting
Quantitative Efficacy and Risk
Information in Direct-to-Consumer
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
(DTC) Promotional Labeling and
Advertisements.’’ Received comments
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
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 1, Subpart D Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
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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
