Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food, 30713-30715 [2020-10825]
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Federal Register / Vol. 85, No. 98 / Wednesday, May 20, 2020 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section; activity
101.3, 101.22, parts 102 and 104; statement of identity labeling requirements .........
101.4, 101.22, 101.100, parts 102, 104 and 105; ingredient labeling requirements ...
101.5; requirement to specify the name and place of business of the manufacturer,
packer, or distributor and, if the food producer is not the manufacturer of the food
product, its connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and part 104; labeling requirements for disclosure of nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative means of compliance permitted ..................
101.10; requirements for nutrition labeling of restaurant foods ...................................
101.12(b); RACC for baking powder, baking soda, and pectin ...................................
101.12(e); adjustment to the RACC of an aerated food permitted ..............................
101.12(g); requirement to disclose the serving size that is the basis for a claim
made for the product if the serving size on which the claim is based differs from
the RACC.
101.13(d)(1) and 101.67; requirements to disclose nutrition information for any food
product for which a nutrient content claim is made.
101.13(j)(2) and (k), 101.54, 101.56, 101.60, 101.61, and 101.62; additional disclosure required if the nutrient content claim compares the level of a nutrient in one
food with the level of the same nutrient in another food.
101.13(q)(5); requirement that restaurants disclose the basis for nutrient content
claims made for their food.
101.14(d)(2); general requirements for disclosure of nutrition information related to
health claims for food products.
101.15; requirements pertaining to prominence of required statements and use of
foreign language.
101.22(i)(4); supplier certifications for flavors designated as containing no artificial
flavors.
101.30 and 102.33; labeling requirements for fruit or vegetable juice beverages ......
101.36; nutrition labeling of dietary supplements .........................................................
101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and fish ....................
101.45(c); databases of nutrient values for raw fruits, vegetables, and fish ...............
101.79(c)(2)(i)(D); disclosure requirements for food labels that contain a folate/neural tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of folate for food labels that contain a folate/
neural tube defect health claim.
101.100(d); disclosure of agreements that form the basis for exemption from the labeling requirements of section 403(c), (e), (g)–(i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements for food not accurately labeled for
quantity of contents and for claiming certain labeling exemptions.
Nutritional labeling for new products ............................................................................
Total .......................................................................................................................
1 There
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
25,000
25,000
25,000
1.03
1.03
1.03
25,750
25,750
25,750
0.5 (30 minutes) .....
1 .............................
0.25 (15 minutes) ...
12,875
25,750
6,438
25,000
1.03
25,750
4 .............................
103,000
12
300,000
29
25
5,000
1
1.5
2.3
1
1
12
450,000
67
25
5,000
4 .............................
0.25 (15 minutes) ...
1 .............................
1 .............................
1 .............................
48
112,500
67
25
5,000
200
1
200
1 .............................
200
5,000
1
5,000
1 .............................
5,000
300,000
1.5
450,000
0.75 (45 minutes) ...
337,500
300,000
1.5
450,000
0.75 (45 minutes) ...
337,500
160
10
1,600
8 .............................
12,800
25
1
25
1 .............................
25
1,500
300
1,000
5
1,000
5
40
1
4
1
7,500
12,000
1,000
20
1,000
1 .............................
4.025 ......................
0.5 (30 minutes) .....
4 .............................
0.25 (15 minutes) ...
7,500
48,300
500
80
250
100
1
100
0.25 (15 minutes) ...
25
1,000
1
1,000
1 .............................
1,000
25,000
1.03
25,750
0.5 (30 minutes) .....
12,875
500
1
500
2 .............................
1,000
....................
....................
1,513,799
................................
1,030,258
are no capital costs or operating and maintenance costs associated with this collection of information.
Because of the consolidation of OMB
control number 0910–0813, our estimate
reflects an annual increase of 188,442
responses and 188,282 hours. These
estimates are based on our experience
with food labeling, related submissions
of petitions, and informal
communications with industry.
Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10824 Filed 5–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0118]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prior Notice of
Imported Food
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
SUMMARY:
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collection of information by June 19,
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 0910–0520. 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
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Federal Register / Vol. 85, No. 98 / Wednesday, May 20, 2020 / Notices
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 System (ABI/ACS)
(§ 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
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
has submitted the following proposed
collection of information to OMB for
review and clearance.
Prior Notice of Imported Food—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 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 through 1.282 of
FDA regulations (21 CFR 1.278 through
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
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/ACS 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/ACS 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 section 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 6,
2020 (85 FR 6955), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
but was not responsive to the four
information collection topics solicited
and therefore is not addressed.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA
Form No.
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total
hours
Prior Notice Submissions:
Through ABI/ACS
1.280 through 1.281 ....................
N/A
1,700
7,647
12,999,900
0.167 (10 minutes) .....
2 2,170,983
1,890,000
0.384 (23 minutes) .....
725,760
Through PNSI
1.280 through 1.281 ....................
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Federal Register / Vol. 85, No. 98 / Wednesday, May 20, 2020 / Notices
30715
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
Subtotal ................................
FDA
Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
........................
........................
........................
.....................................
2,896,743
1
7,040
0.25 (15 minutes) .......
1,760
Total
hours
Cancellations:
Through ABI/ACS
1.282 ...........................................
3540
7,040
Through PNSI
1.282 and 1.283(a)(5) .................
3540
35,208
1
35,208
0.25 (15 minutes) .......
8,802
Subtotal ................................
........................
........................
........................
........................
.....................................
10,562
Requests for Review and Post-hold Submissions
1.283(d) and 1.285(j), .................
1.285(i) ........................................
N/A
N/A
1
263
1
1
1
263
8 .................................
1 .................................
8
263
Subtotal ................................
........................
........................
........................
........................
.....................................
271
Total ..............................
........................
........................
........................
14,932,412
.....................................
2,907,576
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 this 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.
2 To
Based on our experience and the
average number of prior notice
submissions, cancellations, and requests
for review received in the past 3 years,
we have made no adjustments in our
burden estimate for the information
collection. We estimate that 1,700 users
of ABI/ACS will submit an average of
7,647 prior notices annually, for a total
of 12,999,900 prior notices received
through ABI/ACS. We assume the
reporting burden for a prior notice
submitted through ABI/ACS to be 10
minutes, or 0.167 hour, per notice, for
a total annual burden of 2,170,983
hours. This estimate takes into
consideration the burden hours already
counted in the information collection
approval for FDA importer’s entry
notice (OMB control number 0910–
0046), as previously discussed.
We estimate that 27,000 registered
users of PNSI will submit an average of
70 prior notices annually, for a total of
1,890,000 prior notices received
annually. We assume the reporting
burden for a prior notice submitted
through PNSI to be 23 minutes, or 0.384
hour, per notice, for a total burden of
725,760 hours.
We estimate that 7,040 users of ABI/
ACS will submit an average of 1
cancellation annually, for a total of
7,040 cancellations received annually
through ABI/ACS. We assume the
reporting burden for a cancellation
submitted through ABI/ACS to be 15
minutes, or 0.25 hour, per cancellation,
for a total burden of 1,760 hours.
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We estimate that 35,208 registered
users of PNSI will submit an average of
1 cancellation annually, for a total of
35,208 cancellations received annually.
We assume the reporting burden for a
cancellation submitted through PNSI to
be 15 minutes, or 0.25 hour, per
cancellation, for a total burden of 8,802
hours.
We estimate that one or fewer
requests for review under § 1.283(d) or
§ 1.285(j) will be submitted annually.
We assume that it will take respondents
8 hours to prepare the factual and legal
information necessary to prepare a
request for review. Thus, we estimate a
total reporting burden of 8 hours.
We estimate that 263 post-hold
submissions under § 1.285(i) will be
submitted annually. We assume that it
will take about 1 hour to prepare the
written notification described in
§ 1.285(i)(2), for a total reporting burden
of 263 hours.
Dated: May 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10825 Filed 5–19–20; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Research
Education on Alzheimer’s Disease and
Related Dementias.
Date: June 4, 2020.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Kimberly Firth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, Gateway Building, 7201
Wisconsin Avenue, Suite 2W200, Bethesda,
E:\FR\FM\20MYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Notices]
[Pages 30713-30715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0118]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prior Notice of
Imported Food
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 June 19, 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 0910-0520. 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
[[Page 30714]]
has submitted the following proposed collection of information to OMB
for review and clearance.
Prior Notice of Imported Food--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 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
through 1.282 of FDA regulations (21 CFR 1.278 through 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 System (ABI/ACS) (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/ACS
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/ACS 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 section 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 6, 2020 (85 FR 6955), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but was not
responsive to the four information collection topics solicited and
therefore is not addressed.
We estimate the burden of the information collection 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/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280 through 1.281................. N/A 1,700 7,647 12,999,900 0.167 (10 minutes)................ \2\ 2,170,983
--------------------------------------------------------------------------------------------------------------------------------------------------------
Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280 through 1.281................. \3\ 3540 27,000 70 1,890,000 0.384 (23 minutes)................ 725,760
-------------------------------------------------------------------------------------------------------------------
[[Page 30715]]
Subtotal........................ .............. .............. .............. .............. .................................. 2,896,743
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancellations:
Through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282............................... 3540 7,040 1 7,040 0.25 (15 minutes)................. 1,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282 and 1.283(a)(5)............... 3540 35,208 1 35,208 0.25 (15 minutes)................. 8,802
-------------------------------------------------------------------------------------------------------------------
Subtotal........................ .............. .............. .............. .............. .................................. 10,562
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 263 1 263 1................................. 263
-------------------------------------------------------------------------------------------------------------------
Subtotal........................ .............. .............. .............. .............. .................................. 271
-------------------------------------------------------------------------------------------------------------------
Total....................... .............. .............. .............. 14,932,412 .................................. 2,907,576
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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 this 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.
Based on our experience and the average number of prior notice
submissions, cancellations, and requests for review received in the
past 3 years, we have made no adjustments in our burden estimate for
the information collection. We estimate that 1,700 users of ABI/ACS
will submit an average of 7,647 prior notices annually, for a total of
12,999,900 prior notices received through ABI/ACS. We assume the
reporting burden for a prior notice submitted through ABI/ACS to be 10
minutes, or 0.167 hour, per notice, for a total annual burden of
2,170,983 hours. This estimate takes into consideration the burden
hours already counted in the information collection approval for FDA
importer's entry notice (OMB control number 0910-0046), as previously
discussed.
We estimate that 27,000 registered users of PNSI will submit an
average of 70 prior notices annually, for a total of 1,890,000 prior
notices received annually. We assume the reporting burden for a prior
notice submitted through PNSI to be 23 minutes, or 0.384 hour, per
notice, for a total burden of 725,760 hours.
We estimate that 7,040 users of ABI/ACS will submit an average of 1
cancellation annually, for a total of 7,040 cancellations received
annually through ABI/ACS. We assume the reporting burden for a
cancellation submitted through ABI/ACS to be 15 minutes, or 0.25 hour,
per cancellation, for a total burden of 1,760 hours.
We estimate that 35,208 registered users of PNSI will submit an
average of 1 cancellation annually, for a total of 35,208 cancellations
received annually. We assume the reporting burden for a cancellation
submitted through PNSI to be 15 minutes, or 0.25 hour, per
cancellation, for a total burden of 8,802 hours.
We estimate that one or fewer requests for review under Sec.
1.283(d) or Sec. 1.285(j) will be submitted annually. We assume that
it will take respondents 8 hours to prepare the factual and legal
information necessary to prepare a request for review. Thus, we
estimate a total reporting burden of 8 hours.
We estimate that 263 post-hold submissions under Sec. 1.285(i)
will be submitted annually. We assume that it will take about 1 hour to
prepare the written notification described in Sec. 1.285(i)(2), for a
total reporting burden of 263 hours.
Dated: May 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10825 Filed 5-19-20; 8:45 am]
BILLING CODE 4164-01-P
