Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 51326-51328 [2023-16568]
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51326
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Sarita Boyd, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Silver Spring, MD
20993–0002, 301–796–1500.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Fixed-Combinations and Single-Entity
Versions of Previously Approved
Antiretrovirals for the Treatment or
Prevention of HIV–1 Under PEPFAR.’’
This draft guidance provides
recommendations for applications for
single-entity ARV and ARV FC drug
products for the treatment of HIV–1
infection that are intended for
procurement under PEPFAR.
Specifically, this draft guidance
addresses versions of ARV drug
products for which the individual ARV
drug product components are already
FDA-approved and for which
substantial evidence of safety and
efficacy of the specific drug product or
combination drug product already
exists. The draft guidance discusses
regulatory procedures relevant to such
applications and recommendations on
how to identify and address common
issues. The recommendations in this
draft guidance primarily focus on the
tentative approval of marketing
applications intended for procurement
under PEPFAR, where there are patent
or exclusivity barriers to final marketing
approval.
When finalized, this draft guidance
will replace the previous final guidance
for industry entitled ‘‘Fixed Dose
Combinations and Single-Entity
Versions of Previously Approved
Antiretrovirals for the Treatment of
HIV,’’ issued October 18, 2006 (71 FR
61483). Important changes in this draft
guidance compared to the 2006 final
version include the following:
• Addition of information about ARV
drug products for prevention of HIV–1
infection.
• Deletion of references to copackaged products and focus on singleentity ARV and ARV FC drug products
currently most needed under PEPFAR.
• Inclusion of a subsection that
describes the processes for making
changes to applications after tentative
approval.
• Addition of updated descriptions of
regulatory requirements and procedures
in the main text of the document and
deletion of Attachments A, B, and C.
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17:35 Aug 02, 2023
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• Addition of updated information,
for example, in the section on
chemistry, manufacturing, and controls,
to be consistent with other guidances for
industry released after 2006.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Fixed-Combinations and SingleEntity Versions of Previously Approved
Antiretrovirals for the Treatment or
Prevention of HIV–1 Under PEPFAR.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this draft guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 for the
submission of investigational new drug
applications have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 for the submission of new drug
applications, abbreviated new drug
applications and supplemental
applications have been approved under
OMB control number 0910–0001. The
collections of information for the
submission of controlled
correspondence related to generic drug
development have been approved under
OMB control number 0910–0797. The
collections of information pertaining to
Prescription Drug User Fee Program
have been approved under OMB control
number 0910–0297. The collections of
information pertaining to Generic Drug
User Fee Program have been approved
under 0910–0727. The collections of
information related to expedited review
programs for serious conditions have
been approved under OMB control
number 0910–0765. The collections of
information for the submission of
postmarketing adverse drug experience
reporting have been approved under
OMB control number 0910–0230. The
collections of information in 21 CFR
parts 210 and 211 pertaining to current
good manufacturing practice have been
approved under OMB control number
0910–0139. The collections of
information in 21 CFR 201.57 for the
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submission of prescription drug product
labeling have been approved under
OMB control number 0910–0572. The
collections of information pertaining to
good clinical practice have been
approved under OMB control number
0910–0843.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16557 Filed 8–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0465]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 September
5, 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 0910–0520. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.278 to
1.285
OMB Control Number 0910–0520—
Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism Act)
added section 801(m) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381(m)), which requires
that FDA receive prior notice for food,
including food for animals, that is
imported or offered for import into the
United States. Sections 1.278 to 1.282 of
FDA regulations (21 CFR 1.278 to 1.282)
set forth the requirements for submitting
prior notice; §§ 1.283(d) and 1.285(j) (21
CFR 1.283(d) and 1.285(j)) set forth the
procedure for requesting Agency review
after FDA has refused admission of an
article of food under section 801(m)(1)
of the FD&C Act or placed an article of
food under hold under section 801(l) of
the FD&C Act; and § 1.285(i) sets forth
the procedure for post-hold
submissions.
Section 304 of the FDA Food Safety
Modernization Act (Pub. L. 111–353)
amended section 801(m) of the FD&C
Act to require a person submitting prior
notice of imported food, including food
for animals, to report, in addition to
other information already required,
‘‘any country to which the article has
been refused entry.’’ Advance notice of
imported food allows FDA, with the
support of the U.S. Customs and Border
Protection (CBP), to target import
inspections more effectively and help
protect the nation’s food supply against
terrorist acts and other public health
emergencies. By requiring that a prior
notice contain specific information that
indicates prior refusals by any country
and identifies the country or countries,
the Agency may better identify imported
food shipments that may pose safety
and security risks to U.S. consumers.
This information collection enables
FDA to make better informed decisions
in managing the potential risks of
imported food shipments into the
United States. Any person with
knowledge of the required information
may submit prior notice for an article of
food. Thus, the respondents to this
information collection may include
importers, owners, ultimate consignees,
shippers, and carriers.
FDA regulations require that prior
notice of imported food be submitted
electronically using CBP’s Automated
Broker Interface of the Automated
Commercial Environment (ABI/ACE)
(§ 1.280(a)(1)) or the FDA Prior Notice
System Interface (PNSI) (Form FDA
3540) (§ 1.280(a)(2)). PNSI is an
electronic submission system available
on the FDA Industry Systems page at
https://www.access.fda.gov. Information
the Agency collects in the prior notice
submission includes: (1) the submitter
and transmitter (if different from the
submitter); (2) entry type and CBP
identifier; (3) the article of food,
including complete FDA product code;
(4) the manufacturer, for an article of
food no longer in its natural state; (5)
the grower, if known, for an article of
food that is in its natural state; (6) the
FDA Country of Production; (7) the
name of any country that has refused
entry of the article of food; (8) the
shipper, except for food imported by
international mail; (9) the country from
which the article of food is shipped or,
if the food is imported by international
mail, the anticipated date of mailing and
country from which the food is mailed;
(10) the anticipated arrival information
or, if the food is imported by
international mail, the U.S. recipient;
(11) the importer, owner, and ultimate
consignee, except for food imported by
international mail or transshipped
through the United States; (12) the
carrier and mode of transportation,
except for food imported by
51327
international mail; and (13) planned
shipment information, except for food
imported by international mail (§ 1.281).
Much of the information collected for
prior notice is identical to the
information collected for FDA
importer’s entry notice, which has been
approved under OMB control number
0910–0046. The information in an
importer’s entry notice is collected
electronically via CBP’s ABI/ACE at the
same time the respondent files an entry
for import with CBP. To avoid doublecounting the burden hours already
counted in the importer’s entry notice
information collection, the burden hour
analysis in table 1 reflects FDA’s
estimate of the reduced burden for prior
notice submitted through ABI/ACE in
column 6 entitled ‘‘Average Burden per
Response.’’
In addition to submitting a prior
notice, a submitter should cancel a prior
notice and must resubmit the
information to FDA if information
changes after the Agency has confirmed
a prior notice submission for review
(e.g., if the identity of the manufacturer
changes) (§ 1.282). However, changes in
the estimated quantity, anticipated
arrival information, or planned
shipment information do not require
resubmission of prior notice after the
Agency has confirmed a prior notice
submission for review (§ 1.282(a)(1)(i) to
(iii)). In the event that FDA refuses
admission to an article of food under
section 801(m)(1) or the Agency places
it under hold under section 801(l) of the
FD&C Act, §§ 1.283(d) and 1.285(j) set
forth the procedure for requesting FDA’s
review and the information required in
a request for review. In the event that
the Agency places an article of food
under hold under § 801(l) of the FD&C
Act, § 1.285(i) sets forth the procedure
for, and the information to be included
in, a post-hold submission.
In the Federal Register of February
27, 2023 (88 FR 12366), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
FDA form No.
Prior Notice Submissions:
Through ABI/ACE.
1.280 through 1.281 .........................
Number of
respondents
N/A
Number of
responses per
respondent
1,900
7,895
Average
burden per
response
Total annual
responses
15,000,500
0.167 (10 minutes).
Through PNSI.
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E:\FR\FM\03AUN1.SGM
03AUN1
Total hours
2 2,505,084
51328
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
Number of
respondents
FDA form No.
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
1.280 through 1.281 .........................
3 3540
13,000
231
3,003,000
Subtotal .....................................
Cancellations:
Through ABI/ACE.
1.282 .................................................
........................
........................
........................
........................
N/A
25,000
1
25,000
0.25 (15 minutes).
3540
50,000
1
50,000
12,500
Subtotal .....................................
Requests for Review and Post-hold Submissions:
1.283(d) and 1.285(j) ........................
1.285(i) .............................................
Subtotal: ....................................
........................
........................
........................
........................
0.25 (15 minutes).
........................
N/A
N/A
........................
1
500
........................
1
1
........................
1
500
........................
8 .....................
1 .....................
........................
8
500
508
Total ...................................
........................
........................
........................
18,079,001
........................
3,677,494
Through PNSI.
1.282 and 1.283(a)(5) .......................
0.384 (23 minutes).
........................
1,153,152
3,658,236
6,250
18,750
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
are no capital costs or operating and maintenance costs associated with this collection of information.
2 To avoid double counting, an estimated 396,416 burden hours already accounted for in the importer’s entry notice information collection approved under OMB control number 0910–0046 are not included in the total.
3 The term ‘‘Form FDA 3540’’ refers to the electronic submission system known as PNSI, which is available at https://www.access.fda.gov.
Table 1 reflects the annual estimated
reporting burden associated with the
information collection. During the next
3 years, we estimate each respondent
will need approximately 10 minutes per
submission for a total of 15,000,500
annual submissions and 2,505,083.5
rounded up to 2,505,084 annual hours
of burden. Similarly, we estimate 13,000
users submitting an average of 231
notices annually, requiring
approximately 23 minutes per
submission. Cumulatively, this totals
3,003,000 annual responses and
1,153,152 annual hours of burden.
Regarding cancellations of prior
notices, we estimate 25,000 respondents
averaging 1 cancellation annually and
requiring 15 minutes to do so.
Cumulatively, this totals 25,000 annual
submissions and 6,250 annual hours of
burden. Similarly, we estimate 50,000
registered users submitting an average of
1 cancellation annually and requiring 15
minutes to do so. Cumulatively, this
totals 50,000 annual responses and
12,500 annual hours of burden.
We estimate that we will receive one
submission annually under § 1.283(d) or
§ 1.285(j) over the next 3 years. It takes
approximately 8 hours to prepare a
submission, which results in 8 hours of
burden.
Finally, for an average of 500 posthold submissions annually, we estimate
it will take respondents 1 hour to
prepare the written notification
described in § 1.285(i)(2)(i), for a total of
500 annual burden hours.
Based on our experience and the
average number of prior notice
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17:35 Aug 02, 2023
Jkt 259001
submissions, cancellations, and requests
for review received in the past 3 years,
we are adjusting our burden estimate for
this information collection by increasing
the number of responses and total
burden. The number of responses has
increased by 3,146,589 responses (from
14,932,412 to 18,079,001). The total
burden has increased by 769,918 hours
(from 2,907,576 to 3,677,494). We
attribute the adjustment to an increase
in the number of responses.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16568 Filed 8–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2175]
Raidel Figueroa: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act)
permanently debarring Raidel Figueroa
from providing services in any capacity
to a person that has an approved or
pending drug product application. FDA
bases this order on a finding that Mr.
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Figueroa was convicted of a felony
under Federal law for conduct that
relates to the regulation of a drug
product under the FD&C Act. Mr.
Figueroa was given notice of the
proposed permanent debarment and
was given an opportunity to request a
hearing to show why he should not be
debarred within the timeframe
prescribed by regulation. Mr. Figueroa
has not responded to the notice. Mr.
Figueroa’s failure to respond and
request a hearing within the prescribed
timeframe constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is effective August 3,
2023.
ADDRESSES: Any application by Mr.
Figueroa for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) may
be submitted as follows:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application 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
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51326-51328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16568]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0465]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prior Notice of
Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 September 5, 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 0910-0520. Also include the FDA docket
number found in brackets in the heading of this document.
[[Page 51327]]
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to
1.285
OMB Control Number 0910-0520--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)),
which requires that FDA receive prior notice for food, including food
for animals, that is imported or offered for import into the United
States. Sections 1.278 to 1.282 of FDA regulations (21 CFR 1.278 to
1.282) set forth the requirements for submitting prior notice;
Sec. Sec. 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set
forth the procedure for requesting Agency review after FDA has refused
admission of an article of food under section 801(m)(1) of the FD&C Act
or placed an article of food under hold under section 801(l) of the
FD&C Act; and Sec. 1.285(i) sets forth the procedure for post-hold
submissions.
Section 304 of the FDA Food Safety Modernization Act (Pub. L. 111-
353) amended section 801(m) of the FD&C Act to require a person
submitting prior notice of imported food, including food for animals,
to report, in addition to other information already required, ``any
country to which the article has been refused entry.'' Advance notice
of imported food allows FDA, with the support of the U.S. Customs and
Border Protection (CBP), to target import inspections more effectively
and help protect the nation's food supply against terrorist acts and
other public health emergencies. By requiring that a prior notice
contain specific information that indicates prior refusals by any
country and identifies the country or countries, the Agency may better
identify imported food shipments that may pose safety and security
risks to U.S. consumers.
This information collection enables FDA to make better informed
decisions in managing the potential risks of imported food shipments
into the United States. Any person with knowledge of the required
information may submit prior notice for an article of food. Thus, the
respondents to this information collection may include importers,
owners, ultimate consignees, shippers, and carriers.
FDA regulations require that prior notice of imported food be
submitted electronically using CBP's Automated Broker Interface of the
Automated Commercial Environment (ABI/ACE) (Sec. 1.280(a)(1)) or the
FDA Prior Notice System Interface (PNSI) (Form FDA 3540) (Sec.
1.280(a)(2)). PNSI is an electronic submission system available on the
FDA Industry Systems page at https://www.access.fda.gov. Information
the Agency collects in the prior notice submission includes: (1) the
submitter and transmitter (if different from the submitter); (2) entry
type and CBP identifier; (3) the article of food, including complete
FDA product code; (4) the manufacturer, for an article of food no
longer in its natural state; (5) the grower, if known, for an article
of food that is in its natural state; (6) the FDA Country of
Production; (7) the name of any country that has refused entry of the
article of food; (8) the shipper, except for food imported by
international mail; (9) the country from which the article of food is
shipped or, if the food is imported by international mail, the
anticipated date of mailing and country from which the food is mailed;
(10) the anticipated arrival information or, if the food is imported by
international mail, the U.S. recipient; (11) the importer, owner, and
ultimate consignee, except for food imported by international mail or
transshipped through the United States; (12) the carrier and mode of
transportation, except for food imported by international mail; and
(13) planned shipment information, except for food imported by
international mail (Sec. 1.281).
Much of the information collected for prior notice is identical to
the information collected for FDA importer's entry notice, which has
been approved under OMB control number 0910-0046. The information in an
importer's entry notice is collected electronically via CBP's ABI/ACE
at the same time the respondent files an entry for import with CBP. To
avoid double-counting the burden hours already counted in the
importer's entry notice information collection, the burden hour
analysis in table 1 reflects FDA's estimate of the reduced burden for
prior notice submitted through ABI/ACE in column 6 entitled ``Average
Burden per Response.''
In addition to submitting a prior notice, a submitter should cancel
a prior notice and must resubmit the information to FDA if information
changes after the Agency has confirmed a prior notice submission for
review (e.g., if the identity of the manufacturer changes) (Sec.
1.282). However, changes in the estimated quantity, anticipated arrival
information, or planned shipment information do not require
resubmission of prior notice after the Agency has confirmed a prior
notice submission for review (Sec. 1.282(a)(1)(i) to (iii)). In the
event that FDA refuses admission to an article of food under section
801(m)(1) or the Agency places it under hold under section 801(l) of
the FD&C Act, Sec. Sec. 1.283(d) and 1.285(j) set forth the procedure
for requesting FDA's review and the information required in a request
for review. In the event that the Agency places an article of food
under hold under Sec. 801(l) of the FD&C Act, Sec. 1.285(i) sets
forth the procedure for, and the information to be included in, a post-
hold submission.
In the Federal Register of February 27, 2023 (88 FR 12366), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submissions:
Through ABI/ACE.....................
1.280 through 1.281................. N/A 1,900 7,895 15,000,500 0.167 (10 minutes)............ \2\ 2,505,084
Through PNSI........................
[[Page 51328]]
1.280 through 1.281................. \3\ 3540 13,000 231 3,003,000 0.384 (23 minutes)............ 1,153,152
Subtotal........................ .............. .............. .............. .............. .............................. 3,658,236
Cancellations:
Through ABI/ACE.....................
1.282............................... N/A 25,000 1 25,000 0.25 (15 minutes)............. 6,250
Through PNSI........................
1.282 and 1.283(a)(5)............... 3540 50,000 1 50,000 0.25 (15 minutes)............. 12,500
Subtotal........................ .............. .............. .............. .............. .............................. 18,750
Requests for Review and Post-hold
Submissions:
1.283(d) and 1.285(j)............... N/A 1 1 1 8............................. 8
1.285(i)............................ N/A 500 1 500 1............................. 500
Subtotal:....................... .............. .............. .............. .............. .............................. 508
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Total....................... .............. .............. .............. 18,079,001 .............................. 3,677,494
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ To avoid double counting, an estimated 396,416 burden hours already accounted for in the importer's entry notice information collection approved
under OMB control number 0910-0046 are not included in the total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as PNSI, which is available at https://www.access.fda.gov.
Table 1 reflects the annual estimated reporting burden associated
with the information collection. During the next 3 years, we estimate
each respondent will need approximately 10 minutes per submission for a
total of 15,000,500 annual submissions and 2,505,083.5 rounded up to
2,505,084 annual hours of burden. Similarly, we estimate 13,000 users
submitting an average of 231 notices annually, requiring approximately
23 minutes per submission. Cumulatively, this totals 3,003,000 annual
responses and 1,153,152 annual hours of burden.
Regarding cancellations of prior notices, we estimate 25,000
respondents averaging 1 cancellation annually and requiring 15 minutes
to do so. Cumulatively, this totals 25,000 annual submissions and 6,250
annual hours of burden. Similarly, we estimate 50,000 registered users
submitting an average of 1 cancellation annually and requiring 15
minutes to do so. Cumulatively, this totals 50,000 annual responses and
12,500 annual hours of burden.
We estimate that we will receive one submission annually under
Sec. 1.283(d) or Sec. 1.285(j) over the next 3 years. It takes
approximately 8 hours to prepare a submission, which results in 8 hours
of burden.
Finally, for an average of 500 post-hold submissions annually, we
estimate it will take respondents 1 hour to prepare the written
notification described in Sec. 1.285(i)(2)(i), for a total of 500
annual burden hours.
Based on our experience and the average number of prior notice
submissions, cancellations, and requests for review received in the
past 3 years, we are adjusting our burden estimate for this information
collection by increasing the number of responses and total burden. The
number of responses has increased by 3,146,589 responses (from
14,932,412 to 18,079,001). The total burden has increased by 769,918
hours (from 2,907,576 to 3,677,494). We attribute the adjustment to an
increase in the number of responses.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16568 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P
