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, 78971-78973 [2013-30996]
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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices
Dated: December 23, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–30989 Filed 12–26–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0179]
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) 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: Fax written comments on the
collection of information by January 27,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0520. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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)—Revision.
The Public Health Security and
Bioterrorism Preparedness and
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Response Act of 2002 (the 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 we 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
our 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 our review
after we have 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) (21 CFR
1.285(i)) sets forth the procedure for
post-hold submissions.
Section 304 of the FDA Food Safety
Modernization Act (FSMA) (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.’’ In the Federal
Register of May 5, 2011 (76 FR 25542),
we issued an interim final rule (IFR)
entitled ‘‘Information Required in Prior
Notice of Imported Food’’ (2011 IFR)
that implemented section 304 of FSMA
and requested public comments. OMB
approved the collection of information
requirements of the 2011 IFR under
OMB control number 0910–0683. On
May 30, 2013 (78 FR 32359), we
published a final rule that adopts,
without change, the regulatory
requirements established in the 2011
IFR, specifically that a person
submitting prior notice of imported
food, including food for animals, must
report the name of any country that has
refused entry of that product. In this
request for extension of OMB approval
under the PRA, we are combining the
burden hours associated with OMB
control number 0910–0683 (collection
entitled ‘‘Information Required in Prior
Notice of Imported Food’’) with the
burden hours approved under OMB
control number 0910–0520 (collection
entitled ‘‘Prior Notice of Imported Food
Under the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002’’).
Advance notice of imported food
allows us, 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
additional information that indicates
prior refusals by any country and also
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Fmt 4703
Sfmt 4703
78971
identifies the country or countries, we
may better identify imported food
shipments that may pose safety and
security risks to U.S. consumers. This
additional knowledge can further help
us 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.
Our 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
we collect in the prior notice
submission includes: The submitter and
transmitter (if different from the
submitter); entry type and CBP
identifier; the article of food, including
complete FDA product code; the
manufacturer, for an article of food no
longer in its natural state; the grower, if
known, for an article of food that is in
its natural state; the FDA Country of
Production; the name of any country
that has refused entry of the article of
food; the shipper, except for food
imported by international mail; 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; the anticipated arrival
information or, if the food is imported
by international mail, the U.S. recipient;
the importer, owner, and ultimate
consignee, except for food imported by
international mail or transshipped
through the United States; the carrier
and mode of transportation, except for
food imported by international mail;
and 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 our 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
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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices
table 1 of this document reflects our
estimate of the reduced burden for prior
notice submitted through ABI/ACS in
the column labeled ‘‘Hours per
Response.’’
In addition to submitting a prior
notice, a submitter should cancel a prior
notice and must resubmit the
information to us if information changes
after we have 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 we have confirmed
a prior notice submission for review
(§ 1.282(a)(1)(i) to 1.282(a)(1)(iii)). In the
event that we refuse admission to an
article of food under section 801(m)(1)
or we place 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 our review and the
information required in a request for
review. In the event that we place 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 posthold submission.
In the Federal Register of November
1, 2013 (78 FR 65670) 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
21 CFR
Section No.
FDA
Form No.
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Prior Notice Submissions
Prior Notice Submitted Through ABI/ACS
0.167
1,523,040 2
0.384
593,927
New Prior Notice Submissions Subtotal .............................................................................................................................
2,116,967
1.280–1.281
None
15,000
608
9,120,000
Prior Notice Submitted Through PNSI
1.280–1.281
FDA 3540 3
26,667
58
1,546,686
Prior Notice Cancellations
Prior Notice Cancelled Through ABI/ACS
1.282 ............
FDA 3540
4,098
1
4,098
0.25
1,025
33,096
0.25
8,274
Prior Notice Cancellations Subtotal ....................................................................................................................................
9,299
Prior Notice Cancelled Through PNSI
1.282,
1.283(a)(5).
FDA 3540
33,096
1
Prior Notice Requests for Review and Post-Hold Submissions
1.283(d),
1.285(j).
1.285(i) .........
None
1
1
1
8
8
None
1
1
1
1
1
Prior Notice Requests for Review and Post-hold Submissions Subtotal ...........................................................................
9
Total Hours Annually ....................................................................................................................................................
2,126,275
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 No. 0910–0046 are not included in this total.
3 The term ‘‘Form FDA 3540’’ refers to the electronic submission system known as the Prior Notice System Interface (PNSI), which is available
at https://www.access.fda.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
2 To
This estimate is based on our
experience and the average number of
prior notice submissions, cancellations,
and requests for review received in the
past 3 years.
As previously discussed, on May 30,
2013, we published a final rule that
adopts, without change, the regulatory
requirements established in the 2011
IFR, specifically that a person
submitting prior notice of imported
food, including food for animals, must
report the name of any country that has
refused entry of that product. We
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23:48 Dec 26, 2013
Jkt 232001
estimate that it would take on average
about one additional minute (0.016
hours) per entry for each respondent to
submit prior notice with this additional
piece of information. Accordingly, we
have increased our estimate of the hours
per response for prior notices received
through ABI/ACS from 9 minutes, or
0.15 hours, per notice, to 10 minutes, or
0.167 hours, per notice. We have also
increased our estimate of the hours per
response for prior notices received
through PNSI from 22 minutes, or 0.366
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Fmt 4703
Sfmt 4703
hours (rounded to 0.37 hours), per
notice, to 23 minutes, or 0.384 hours,
per notice.
We received 8,570,504 prior notices
through ABI/ACS during 2010;
9,054,187 during 2011; and 9,716,147
during 2012. Based on this experience,
we estimate that approximately 15,000
users of ABI/ACS will submit an
average of 608 prior notices annually,
for a total of 9,120,000 prior notices
received annually through ABI/ACS.
FDA estimates the reporting burden for
a prior notice submitted through ABI/
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices
ACS to be 10 minutes, or 0.167 hours,
per notice, for a total burden of
1,523,040 hours. This estimate takes
into consideration the burden hours
already counted in the information
collection approval for our importer’s
entry notice, as previously discussed in
this document.
We received 1,566,029 prior notices
through PNSI during 2010; 1,498,609
during 2011; and 1,524,901 during 2012.
Based on this experience, we estimate
that approximately 26,667 registered
users of PNSI will submit an average of
58 prior notices annually, for a total of
1,546,686 prior notices received
annually. We estimate the reporting
burden for a prior notice submitted
through PNSI to be 23 minutes, or 0.384
hours, per notice, for a total burden of
593,927 hours.
We received 4,488 cancellations of
prior notices through ABI/ACS during
2010; 3,993 during 2011; and 3,812
during 2012. Based on this experience,
we estimate that approximately 4,098
users of ABI/ACS will submit an
average of 1 cancellation annually, for a
total of 4,098 cancellations received
annually through ABI/ACS. We estimate
the reporting burden for a cancellation
submitted through ABI/ACS to be 15
minutes, or 0.25 hours, per cancellation,
for a total burden of 1,024.5 hours,
rounded to 1,025 hours.
We received 33,353 cancellations of
prior notices through PNSI during 2010;
33,343 during 2011; and 32,592 during
2012. Based on this experience, we
estimate that approximately 33,096
registered users of PNSI will submit an
average of 1 cancellation annually, for a
total of 33,096 cancellations received
annually. We estimate the reporting
burden for a cancellation submitted
through PNSI to be 15 minutes, or 0.25
hours, per cancellation, for a total
burden of 8,274 hours.
We have not received any requests for
review under §§ 1.283(d) or 1.285(j) in
the last 3 years (2010, 2011, and 2012);
therefore, we estimate that one or fewer
requests for review will be submitted
annually. We estimate that it will take
a requestor about 8 hours to prepare the
factual and legal information necessary
to prepare a request for review. Thus,
we have estimated a total reporting
burden of 8 hours.
We have not received any post-hold
submissions under § 1.285(i) in the last
3 years (2010, 2011, and 2012);
therefore, we estimate that one or fewer
post-hold submissions will be submitted
annually. We estimate that it will take
about 1 hour to prepare the written
notification described in § 1.285(i)(2)(i).
Thus, we have estimated a total
reporting burden of 1 hour.
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Dated: December 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30996 Filed 12–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1147]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition
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: Fax written comments on the
collection of information by January 27,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0541. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
FOR FURTHER INFORMATION CONTACT:
Preparing a Claim of Categorical
Exclusion or an Environmental
Assessment for Submission to the
Center for Food Safety and Applied
Nutrition (OMB Control Number 0910–
0541)—Extension
As an integral part of its
decisionmaking process, we are
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Fmt 4703
Sfmt 4703
78973
obligated under the National
Environmental Policy Act of 1969
(NEPA) to consider the environmental
impact of our actions, including
allowing notifications for food contact
substances to become effective and
approving food additive petitions, color
additive petitions, GRAS affirmation
petitions, requests for exemption from
regulation as a food additive, and
actions on certain food labeling citizen
petitions, nutrient content claims
petitions, and health claims petitions. In
1997, we amended our regulations in
part 25 (21 CFR part 25) to provide for
categorical exclusions for additional
classes of actions that do not
individually or cumulatively have a
significant effect on the human
environment (62 FR 40570, July 29,
1997). As a result of that rulemaking, we
no longer routinely require submission
of information about the manufacturing
and production of our regulated articles.
We also have eliminated the previously
required Environmental Assessment
(EA) and abbreviated EA formats from
the amended regulations. Instead, we
have provided guidance that contains
sample formats to help the industry
submit a claim of categorical exclusion
or an EA to the Center for Food Safety
and Applied Nutrition (CFSAN). The
guidance document entitled ‘‘Preparing
a Claim of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition’’
identifies, interprets, and clarifies
existing requirements imposed by
statute and regulation, consistent with
the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists
of recommendations that do not
themselves create requirements; rather,
they are explanatory guidance for our
own procedures in order to ensure full
compliance with the purposes and
provisions of NEPA.
The guidance provides information to
assist in the preparation of claims of
categorical exclusion and EAs for
submission to CFSAN. The following
questions are covered in this guidance:
(1) What types of industry-initiated
actions are subject to a claim of
categorical exclusion, (2) what must a
claim of categorical exclusion include
by regulation, (3) what is an EA, (4)
when is an EA required by regulation
and what format should be used, (5)
what are extraordinary circumstances,
and (6) what suggestions does CFSAN
have for preparing an EA? CFSAN
encourages the industry to use the EA
formats described in the guidance
because standardized documentation
submitted by industry increases the
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]]>Agencies
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78971-78973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30996]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0179]
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) 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: Fax written comments on the collection of information by January
27, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0520.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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)--Revision.
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the 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 we 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 our 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 our review after we have 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) (21 CFR 1.285(i)) sets forth the procedure
for post-hold submissions.
Section 304 of the FDA Food Safety Modernization Act (FSMA) (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.'' In the Federal
Register of May 5, 2011 (76 FR 25542), we issued an interim final rule
(IFR) entitled ``Information Required in Prior Notice of Imported
Food'' (2011 IFR) that implemented section 304 of FSMA and requested
public comments. OMB approved the collection of information
requirements of the 2011 IFR under OMB control number 0910-0683. On May
30, 2013 (78 FR 32359), we published a final rule that adopts, without
change, the regulatory requirements established in the 2011 IFR,
specifically that a person submitting prior notice of imported food,
including food for animals, must report the name of any country that
has refused entry of that product. In this request for extension of OMB
approval under the PRA, we are combining the burden hours associated
with OMB control number 0910-0683 (collection entitled ``Information
Required in Prior Notice of Imported Food'') with the burden hours
approved under OMB control number 0910-0520 (collection entitled
``Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002'').
Advance notice of imported food allows us, 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 additional information that indicates prior
refusals by any country and also identifies the country or countries,
we may better identify imported food shipments that may pose safety and
security risks to U.S. consumers. This additional knowledge can further
help us 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.
Our 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 we
collect in the prior notice submission includes: The submitter and
transmitter (if different from the submitter); entry type and CBP
identifier; the article of food, including complete FDA product code;
the manufacturer, for an article of food no longer in its natural
state; the grower, if known, for an article of food that is in its
natural state; the FDA Country of Production; the name of any country
that has refused entry of the article of food; the shipper, except for
food imported by international mail; 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; the anticipated arrival information or, if the food is imported
by international mail, the U.S. recipient; the importer, owner, and
ultimate consignee, except for food imported by international mail or
transshipped through the United States; the carrier and mode of
transportation, except for food imported by international mail; and
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 our 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
[[Page 78972]]
table 1 of this document reflects our estimate of the reduced burden
for prior notice submitted through ABI/ACS in the column labeled
``Hours per Response.''
In addition to submitting a prior notice, a submitter should cancel
a prior notice and must resubmit the information to us if information
changes after we have 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 we have confirmed a prior notice
submission for review (Sec. 1.282(a)(1)(i) to 1.282(a)(1)(iii)). In
the event that we refuse admission to an article of food under section
801(m)(1) or we place 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 our review and the information required in a request for
review. In the event that we place 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 November 1, 2013 (78 FR 65670) 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 Average
21 CFR Section No. FDA Form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submissions
Prior Notice Submitted Through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280-1.281........................ None 15,000 608 9,120,000 0.167 1,523,040 \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Submitted Through PNSI
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.280-1.281........................ FDA 3540 \3\ 26,667 58 1,546,686 0.384 593,927
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Prior Notice Submissions Subtotal............................................................................................... 2,116,967
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior Notice Cancellations
Prior Notice Cancelled Through ABI/ACS
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1.282.............................. FDA 3540 4,098 1 4,098 0.25 1,025
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Prior Notice Cancelled Through PNSI
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1.282, 1.283(a)(5)................. FDA 3540 33,096 1 33,096 0.25 8,274
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Prior Notice Cancellations Subtotal................................................................................................. 9,299
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Prior Notice Requests for Review and Post-Hold Submissions
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1.283(d), 1.285(j)................. None 1 1 1 8 8
1.285(i)........................... None 1 1 1 1 1
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Prior Notice Requests for Review and Post-hold Submissions Subtotal................................................................. 9
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Total Hours Annually............................................................................................................ 2,126,275
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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 No. 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as the Prior Notice System Interface (PNSI), which is available at https://www.access.fda.gov.
This estimate is based on our experience and the average number of
prior notice submissions, cancellations, and requests for review
received in the past 3 years.
As previously discussed, on May 30, 2013, we published a final rule
that adopts, without change, the regulatory requirements established in
the 2011 IFR, specifically that a person submitting prior notice of
imported food, including food for animals, must report the name of any
country that has refused entry of that product. We estimate that it
would take on average about one additional minute (0.016 hours) per
entry for each respondent to submit prior notice with this additional
piece of information. Accordingly, we have increased our estimate of
the hours per response for prior notices received through ABI/ACS from
9 minutes, or 0.15 hours, per notice, to 10 minutes, or 0.167 hours,
per notice. We have also increased our estimate of the hours per
response for prior notices received through PNSI from 22 minutes, or
0.366 hours (rounded to 0.37 hours), per notice, to 23 minutes, or
0.384 hours, per notice.
We received 8,570,504 prior notices through ABI/ACS during 2010;
9,054,187 during 2011; and 9,716,147 during 2012. Based on this
experience, we estimate that approximately 15,000 users of ABI/ACS will
submit an average of 608 prior notices annually, for a total of
9,120,000 prior notices received annually through ABI/ACS. FDA
estimates the reporting burden for a prior notice submitted through
ABI/
[[Page 78973]]
ACS to be 10 minutes, or 0.167 hours, per notice, for a total burden of
1,523,040 hours. This estimate takes into consideration the burden
hours already counted in the information collection approval for our
importer's entry notice, as previously discussed in this document.
We received 1,566,029 prior notices through PNSI during 2010;
1,498,609 during 2011; and 1,524,901 during 2012. Based on this
experience, we estimate that approximately 26,667 registered users of
PNSI will submit an average of 58 prior notices annually, for a total
of 1,546,686 prior notices received annually. We estimate the reporting
burden for a prior notice submitted through PNSI to be 23 minutes, or
0.384 hours, per notice, for a total burden of 593,927 hours.
We received 4,488 cancellations of prior notices through ABI/ACS
during 2010; 3,993 during 2011; and 3,812 during 2012. Based on this
experience, we estimate that approximately 4,098 users of ABI/ACS will
submit an average of 1 cancellation annually, for a total of 4,098
cancellations received annually through ABI/ACS. We estimate the
reporting burden for a cancellation submitted through ABI/ACS to be 15
minutes, or 0.25 hours, per cancellation, for a total burden of 1,024.5
hours, rounded to 1,025 hours.
We received 33,353 cancellations of prior notices through PNSI
during 2010; 33,343 during 2011; and 32,592 during 2012. Based on this
experience, we estimate that approximately 33,096 registered users of
PNSI will submit an average of 1 cancellation annually, for a total of
33,096 cancellations received annually. We estimate the reporting
burden for a cancellation submitted through PNSI to be 15 minutes, or
0.25 hours, per cancellation, for a total burden of 8,274 hours.
We have not received any requests for review under Sec. Sec.
1.283(d) or 1.285(j) in the last 3 years (2010, 2011, and 2012);
therefore, we estimate that one or fewer requests for review will be
submitted annually. We estimate that it will take a requestor about 8
hours to prepare the factual and legal information necessary to prepare
a request for review. Thus, we have estimated a total reporting burden
of 8 hours.
We have not received any post-hold submissions under Sec. 1.285(i)
in the last 3 years (2010, 2011, and 2012); therefore, we estimate that
one or fewer post-hold submissions will be submitted annually. We
estimate that it will take about 1 hour to prepare the written
notification described in Sec. 1.285(i)(2)(i). Thus, we have estimated
a total reporting burden of 1 hour.
Dated: December 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30996 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P
