Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries, 23048-23050 [2020-08763]
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23048
Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices
plant, Pataya Food Industries Ltd.,
located at 90/6 Moo 7, Settakit Road,
Tambol Tarsai, Amphur Maung,
Samutsakorn 74000 Thailand. All other
conditions and terms of this permit
remain the same.
Dated: April 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08762 Filed 4–23–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1423]
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
(PRA).
DATES: Submit written comments
(including recommendations) on the
collection of information by May 26,
2020.
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, PRAStaff@
fda.hhs.gov.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:03 Apr 23, 2020
Jkt 250001
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 (§§ 1.70 through 1.81
(21 CFR 1.70 through 1.81)) and E
(§§ 1.83 through 1.101 (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 (EDI) system. 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.
We are revising the information
collection to provide for a 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, which is available
for some FDA-regulated products,
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 this assessment, we recommend
submission of the following
information:
• FDA Import Division(s) 1 with
geographic oversight over the FTZ
location;
• Identification of whether products
are manufactured or stored in the FTZ;
1 Some FTZs are covered by multiple Import
Divisions.
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Frm 00056
Fmt 4703
Sfmt 4703
• FTZ site/subzone number and
address;
• Importer of Record (IOR) Facility
Establishment Identifier (FEI), if known;
• Manufacturer FEI, if known; and
• Port of entry.
The division information is necessary
so that we can appropriately route the
submission within the Agency.
Information on whether the 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 IOR and manufacturer FEI
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.
We are also revising the information
collection to include our Import Trade
Auxiliary Communication System
(ITACS), currently approved under
OMB control number 0910–0842. 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 FDAregulated 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.
In the Federal Register of January 3,
2020 (85 FR 318), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received. Upon review of our active
information collection inventory,
however, and on our own initiative, we
have decided to make additional
revisions to the information collection
to improve the efficiency of Agency
operations. Specifically, we are
including Form FDA 766 ‘‘Application
for Authorization to Relabel or to
Perform Other Action of the Federal
Food, Drug, and Cosmetic Act and Other
Related Acts’’ (currently approved
under OMB control number 0910–0025)
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
E:\FR\FM\24APN1.SGM
24APN1
Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices
is available on the internet at https://
www.fda.gov/industry/actionsenforcement/reconditioning.
Relatedly, we also are revising the
information collection to include
reference to Agency guidance entitled
‘‘Pre-Launch Activities Importation
Requests (PLAIR).’’ Historically, when
applicants with a pending new drug
application, abbreviated new drug
application, or Center of 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 continue to develop a more
formalized process.
Accordingly, to facilitate submissions
and improve our own efficiencies, we
published a notice of availability in the
Federal Register of July 24, 2013 (78 FR
44572), announcing a draft guidance
document discussing our PLAIR
program, including an analysis under
the PRA of the burden we estimate is
attributable to the applicable
information collection activities. We
ultimately intend to finalize the
guidance document to further clarify
our recommendations on what products
are eligible for a PLAIR, what
information should be included in a
PLAIR submission, when and how a
PLAIR can be submitted to FDA, and the
circumstances under which the Agency
intends to grant a PLAIR. We therefore
are including this estimate to account
23049
for burden that may be associated with
this information collection. The draft
guidance is available from our website
at: https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
human-drug-imports and is being 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.
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.
As a result of these revisions, we have
adjusted our burden estimate for the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part 1, subpart D
Total annual
responses
Average burden per response
Total hours
0.05576 hours (3.346 minutes)
47,902
Importers submission of data elements (preparing
the required information).
Entry filers (unique lines only) ...................................
WEF participants .......................................................
ITACS; creation of new account ...............................
Form FDA 766 ...........................................................
Submissions in accordance w/PLAIR .......................
85,480
10.05
859,074
3,419
15
500
324
70
12,196
1
1
1
5
41,698,124
15
1
324
350
0.04466 hours (2.68 minutes)
0.87 hours (52 minutes) ..........
0.5 (30 minutes) .......................
0.25 (15 minutes) .....................
16 .............................................
1,862,238
13.05
250
81
5,600
Total ...................................................................
....................
....................
42,557,888
..................................................
1,916,084
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses
per
respondent
are no capital or operational and maintenance costs associated with the information collection.
As reflected in table 1, rows 1 and 2,
we estimate 85,480 importers and 3,419
entry filers will make submissions. An
importer of record 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
importer of record per entry. We have
updated the number of responses and
respondents since last OMB review of
the information collection to reflect the
best data available to the Agency from
January 1, 2018, to December 31, 2018.
We retain our currently approved
estimate of the number of responses per
respondent and time per response as
representative of the industry average.
As reflected in table 1, row 3, we
estimate 15 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
VerDate Sep<11>2014
17:03 Apr 23, 2020
Jkt 250001
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. We
estimate that the burden for each
product in a WEF submission is
approximately 52.5 minutes, for a total
of 13.125 hours annually. Depending on
the product and scale of submission,
this estimated burden can fall to as low
as 15 minutes per product. The reason
why this burden can be significantly
higher than an ACE submission is that
the WEF submission is done manually,
typically through a spreadsheet. 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
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Fmt 4703
Sfmt 4703
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 believe that most users have already
created an account and, therefore, we
have adjusted this estimate downward
since last OMB review and approval.
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
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.
E:\FR\FM\24APN1.SGM
24APN1
23050
Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices
As reflected in table 1, row 6, we
estimate 70 submissions under the
PLAIR program. Since implementation
of PLAIR there has been significant
interest. We have therefore doubled our
original estimate of 35 to 70 respondents
annually but retain the average burden
per response of 16 hours to provide the
information recommended in the draft
guidance.
Cumulatively these changes and
adjustments result in a reduction in
annual responses by 40,111,035 and an
increase in burden hours by 130,572.
These changes and adjustments reflect
the realization of one-time burden
associated with conforming to new CBP
electronic reporting requirements since
last OMB approval of the information
collection that we believe no longer
applies. Finally, we consolidated related
information collection activities
associated with CFR part 1, subparts D
(§§ 1.70 through 1.81) and E (§§ 1.83
through 1.101) governing FDA import
activities.
Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08763 Filed 4–23–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Drug Supply Chain
Security Act Implementation
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
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 May 26,
2020.
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:03 Apr 23, 2020
Jkt 250001
by using the search function. The OMB
control number for this information
collection is 0910–0806. 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.
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.
Drug Supply Chain Security Act
Implementation OMB Control Number
0910–0806—Revision
This information collection supports
Agency implementation of section 582
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360eee–1) (FD&C Act) as
revised by the Drug Supply Chain
Security Act (DSCSA) (Pub. L. 113–54).
For efficiency of Agency operations, we
are revising information collection
currently approved under OMB control
number 0910–0806 pertaining to certain
provisions of the DSCSA to also include
information collection activity
associated with waivers, exceptions,
and exemptions from requirements.
Finally, we are revising the title of the
information collection from
‘‘Identification of Suspect Product and
Notification’’ to ‘‘Drug Supply Chain
Security Act Implementation’’ to reflect
the broadening scope of this information
collection request. As information
collection activity is planned and
undertaken by FDA, we find
consolidating related collection
elements better utilizes our resources.
We have developed guidance to assist
respondents to the information
collection with this topic and are
including it in the information
collection accordingly.
In the Federal Register of May 9, 2018
(83 FR 21297), we published a notice
announcing the availability of a draft
guidance for industry entitled ‘‘Waivers,
Exceptions, and Exemptions From the
Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act,’’
including an analysis and inviting
public comment under the PRA
regarding the proposed information
collection.
The draft guidance was issued
consistent with FDA’s good guidance
practice regulation (21 CFR 10.115)
which provides for public comment at
any time. We intend to finalize the
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
guidance document and are seeking
OMB approval of the attendant
information collection discussed in the
document.
The most recent version of the draft
guidance is available at: https://
www.fda.gov/media/113342/download.
In the 2018 NOA, we estimated that
annually 20 trading partners or
stakeholders would submit
approximately 20 requests for a waiver,
exception, or exemption. This estimate
was based on communications we had
with trading partners and stakeholders
since the 2013 enactment of the DSCSA.
We also estimated that it would require
an average of 40 hours for respondents
to prepare and submit each request and
to submit any additional followup
information that we may request, for a
total burden of approximately 800
hours.
As described in the draft guidance, a
recipient of a waiver, exception, or
exemption should notify us whenever
there is a material change in the
circumstances that is the basis for the
relief. In addition, we intend to
biennially review waivers, exceptions,
and exemptions that extend longer than
2 years in duration and may ask the
recipient to submit information to
determine whether a material change in
the circumstances has occurred. We
estimated that annually we would
receive approximately 1 notification or
other information from approximately 1
respondent that there has or has not
been a material change in the
circumstances that warranted the
waiver, exception, or exemption and
that each notification will require
approximately 16 hours to prepare and
submit to us, for a total of
approximately 16 hours.
A trading partner may request that we
renew a waiver, exception, or
exemption that is of limited duration.
This request should include a detailed
statement justifying the continuance of
the relief and the desired length of the
extension. We estimated that annually
we would receive approximately 1
renewal request from approximately 1
respondent and that each request would
require approximately 16 hours to
prepare and submit to us, for a total of
approximately 16 hours.
To address the comment that that it
will require more than 40 hours to
prepare and submit requests for a
waiver, exception, or exemption from
the requirements of section 582 of the
FD&C Act and to submit any additional
follow up information that we may
request, we increased the estimate to 80
hours. Therefore, we now estimate that
the total annual burden hours for
submitting these requests is
E:\FR\FM\24APN1.SGM
24APN1
]]>Agencies
[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23048-23050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08763]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1423]
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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by May 26, 2020.
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 (Sec. Sec. 1.70 through 1.81 (21 CFR 1.70
through 1.81)) and E (Sec. Sec. 1.83 through 1.101 (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 (EDI) system.
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.
We are revising the information collection to provide for a 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, which
is available for some FDA-regulated products, 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 this assessment, we
recommend submission of the following information:
FDA Import Division(s) \1\ with geographic oversight over
the FTZ location;
---------------------------------------------------------------------------
\1\ Some FTZs are covered by multiple Import Divisions.
---------------------------------------------------------------------------
Identification of whether products are manufactured or
stored in the FTZ;
FTZ site/subzone number and address;
Importer of Record (IOR) Facility Establishment Identifier
(FEI), if known;
Manufacturer FEI, if known; and
Port of entry.
The division information is necessary so that we can appropriately
route the submission within the Agency. Information on whether the
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 IOR and manufacturer FEI 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.
We are also revising the information collection to include our
Import Trade Auxiliary Communication System (ITACS), currently approved
under OMB control number 0910-0842. 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.
In the Federal Register of January 3, 2020 (85 FR 318), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. Upon review of
our active information collection inventory, however, and on our own
initiative, we have decided to make additional revisions to the
information collection to improve the efficiency of Agency operations.
Specifically, we are including Form FDA 766 ``Application for
Authorization to Relabel or to Perform Other Action of the Federal
Food, Drug, and Cosmetic Act and Other Related Acts'' (currently
approved under OMB control number 0910-0025) 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
[[Page 23049]]
is available on the internet at https://www.fda.gov/industry/actions-enforcement/reconditioning.
Relatedly, we also are revising the information collection to
include reference to Agency guidance entitled ``Pre-Launch Activities
Importation Requests (PLAIR).'' Historically, when applicants with a
pending new drug application, abbreviated new drug application, or
Center of 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 continue to develop a more formalized process.
Accordingly, to facilitate submissions and improve our own
efficiencies, we published a notice of availability in the Federal
Register of July 24, 2013 (78 FR 44572), announcing a draft guidance
document discussing our PLAIR program, including an analysis under the
PRA of the burden we estimate is attributable to the applicable
information collection activities. We ultimately intend to finalize the
guidance document to further clarify our recommendations on what
products are eligible for a PLAIR, what information should be included
in a PLAIR submission, when and how a PLAIR can be submitted to FDA,
and the circumstances under which the Agency intends to grant a PLAIR.
We therefore are including this estimate to account for burden that may
be associated with this information collection. The draft guidance is
available from our website at: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports and is being
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.
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.
As a result of these revisions, we have adjusted our burden
estimate for the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average burden per
21 CFR part 1, subpart D respondents per annual response Total hours
respondent responses
----------------------------------------------------------------------------------------------------------------
Importers submission of data 85,480 10.05 859,074 0.05576 hours (3.346 47,902
elements (preparing the required minutes).
information).
Entry filers (unique lines only).... 3,419 12,196 41,698,124 0.04466 hours (2.68 1,862,238
minutes).
WEF participants.................... 15 1 15 0.87 hours (52 13.05
minutes).
ITACS; creation of new account...... 500 1 1 0.5 (30 minutes)...... 250
Form FDA 766........................ 324 1 324 0.25 (15 minutes)..... 81
Submissions in accordance w/PLAIR... 70 5 350 16.................... 5,600
---------------------------------------------------------------------------
Total........................... ........... ........... 42,557,888 ...................... 1,916,084
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operational and maintenance costs associated with the information collection.
As reflected in table 1, rows 1 and 2, we estimate 85,480 importers
and 3,419 entry filers will make submissions. An importer of record 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 importer of record per entry. We have
updated the number of responses and respondents since last OMB review
of the information collection to reflect the best data available to the
Agency from January 1, 2018, to December 31, 2018. We retain our
currently approved estimate of the number of responses per respondent
and time per response as representative of the industry average.
As reflected in table 1, row 3, we estimate 15 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. We estimate that the burden for each product in a WEF
submission is approximately 52.5 minutes, for a total of 13.125 hours
annually. Depending on the product and scale of submission, this
estimated burden can fall to as low as 15 minutes per product. The
reason why this burden can be significantly higher than an ACE
submission is that the WEF submission is done manually, typically
through a spreadsheet. 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 believe that most users have already created an account and,
therefore, we have adjusted this estimate downward since last OMB
review and approval.
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.
[[Page 23050]]
As reflected in table 1, row 6, we estimate 70 submissions under
the PLAIR program. Since implementation of PLAIR there has been
significant interest. We have therefore doubled our original estimate
of 35 to 70 respondents annually but retain the average burden per
response of 16 hours to provide the information recommended in the
draft guidance.
Cumulatively these changes and adjustments result in a reduction in
annual responses by 40,111,035 and an increase in burden hours by
130,572. These changes and adjustments reflect the realization of one-
time burden associated with conforming to new CBP electronic reporting
requirements since last OMB approval of the information collection that
we believe no longer applies. Finally, we consolidated related
information collection activities associated with CFR part 1, subparts
D (Sec. Sec. 1.70 through 1.81) and E (Sec. Sec. 1.83 through 1.101)
governing FDA import activities.
Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08763 Filed 4-23-20; 8:45 am]
BILLING CODE 4164-01-P
