Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production-Recordkeeping and Registration Provisions, 18605-18609 [2013-07032]
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR Section and/or section of
FD&C act
FDA form No.
No. of
respondents
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
New Facility Registration Subtotal ..........
.................................
........................
........................
........................
........................
207,026
Total
hours
Previously Registered Facilities
Updates under § 1.234 and section 415
of the FD&C Act.
Cancellations under § 1.235 ....................
Biennial renewal of registration required
by section 415 of the FD&C Act.
FDA 3537
118,530
1
118,530
1.2
142,236
FDA 3537a
FDA 3537
6,390
224,930
1
1
6,390
224,930
1
0.5
(30 minutes)
6,390
112,465
Updates, Cancellations or Biennial Renewals Subtotal.
Total Hours Annually ...............................
.................................
........................
........................
........................
........................
261,091
.................................
........................
........................
........................
........................
468,117
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
term ‘‘Form FDA 3537’’ refers to both the paper version of the form and the electronic system known as the Food Facility Registration
Module, which is available at https://www.access.fda.gov.
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2 The
This estimate is based on FDA’s
experience and the average number of
new facility registrations, updates and
cancellations received in the past 3
years. FDA received 12,011 new
domestic facility registrations during
2010; 10,646 during 2011; and 10,584
during 2012. Based on this experience,
FDA estimates the annual number of
new domestic facility registrations will
be 11,080. FDA estimates that listing the
information required by the
Bioterrorism Act and presenting it in a
format that will meet the Agency’s
registration regulations will require a
burden of approximately 2.5 hours per
average domestic facility registration.
We estimate that the FSMA-required
additional information for new facility
registrations will require an additional
12 minutes (0.2 hour) per response for
domestic facilities. The average
domestic facility burden hour estimate
of 2.7 hours takes into account that
some respondents completing the
registration may not have readily
available Internet access. Thus, the total
annual burden for new domestic facility
registrations is estimated to be 29,916
hours (11,080 x 2.7 hours).
FDA received 20,598 new foreign
facility registrations during 2010; 20,009
during 2011; and 19,092 during 2012.
Based on this experience, FDA estimates
the annual number of new foreign
facility registrations will be 19,900. FDA
estimates that listing the information
required by the Bioterrorism Act and
presenting it in a format that will meet
the Agency’s registration regulations
will require a burden of approximately
8.5 hours per average foreign facility
registration. We estimate that the
FSMA-required additional information
for new facility registrations will require
an additional 24 minutes (0.4 hour) per
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response for foreign facilities. The
average foreign facility burden hour
estimate of 8.9 hours includes an
estimate of the additional burden on a
foreign facility to obtain a U.S. agent,
and takes into account that for some
foreign facilities the respondent
completing the registration may not be
fluent in English and/or not have
readily available Internet access. Thus,
the total annual burden for new foreign
facility registrations is estimated to be
177,110 hours (19,900 × 8.9 hours).
Based on its experience, FDA
estimates that the average annual
number of updates to facility
registrations will remain unchanged at
118,530 updates annually over the next
3 years. FDA also estimates that
updating a registration will, on average,
require a burden of approximately 1
hour, taking into account fluency in
English and Internet access. We estimate
that the FSMA-required additional
information for updates will require an
additional 12 minutes (0.2 hour) per
response. Thus, the total annual burden
of submitting updates to facility
registrations is estimated to be 142,236
hours (118,530 x 1.2 hours).
Based on its experience, FDA
estimates that the average annual
number of cancellations of facility
registrations will remain unchanged at
6,390 cancellations annually over the
next 3 years. FDA also estimates that
cancelling a registration will, on
average, require a burden of
approximately 1 hour, taking into
account fluency in English and Internet
access. FSMA did not change the
required information for cancellations.
Thus, the total annual burden for
cancelling registrations is estimated to
be 6,390 hours.
We estimate that the new biennial
registration required by FSMA, which
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will require the submission of certain
new data elements and the verification
and possible updating of other
information rather than re-entering all
information, will require 30 minutes
(0.5 hour) per response, including time
for the new FSMA-required information.
FDA estimates that, on an annualized
basis, the number of biennial
registrations submitted over the next 3
years will be 224,930. This estimate is
based on the number of currently
registered firms (449,860) divided by 2.
Thus, the total annual burden for
biennial registration is estimated to be
112,465 hours (224,930 × 0.5 hours).
Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–07029 Filed 3–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0297]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prevention of
Salmonella Enteritidis in Shell Eggs
During Production—Recordkeeping
and Registration Provisions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
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Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
FDA’s recordkeeping and registration
requirements for shell egg producers.
DATES: Submit either electronic or
written comments on the collection of
information by May 28, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
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the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prevention of Salmonella Enteritidis
in Shell Eggs During Production—
Recordkeeping and Registration
Provisions—21 CFR 118.10 and 118.11
(OMB Control Number 0910–0660)—
Extension
Shell eggs contaminated with
Salmonella Enteritidis (SE) are
responsible for more than 140,000
illnesses per year. The Public Health
Service Act (PHS Act) authorizes the
Secretary of Health and Human Services
to make and enforce such regulations as
‘‘are necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the States * * * or from
one State * * * into any other State’’
(section 361(a) of the PHS Act). This
authority has been delegated to the
Commissioner of Food and Drugs.
Under section 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 342(a)(4)), a food
is adulterated if it is prepared, packed,
or held under insanitary conditions
whereby it may have been contaminated
with filth or rendered injurious to
health. Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the
efficient enforcement of the FD&C Act.
On July 9, 2009, FDA published in the
Federal Register a final rule that
established a regulation at part 118 (21
CFR part 118) entitled ‘‘Prevention of
Salmonella Enteritidis in Shell Eggs
During Production, Storage, and
Transportation’’ (74 FR 33030) (the
Shell Eggs final rule). Part 118 requires
shell egg producers to implement
measures to prevent SE from
contaminating eggs on the farm and
from further growth during storage and
transportation, and requires these
producers to maintain records
concerning their compliance with the
rule and to register with FDA. As
described in more detail with regard to
each information collection provision of
part 118, each farm site with 3,000 or
more egg-laying hens that sells raw shell
eggs to the table egg market, other than
directly to the consumer, must
refrigerate, register, and keep certain
records. Farms that do not send all of
their eggs to treatment are also required
to have an SE prevention plan and to
test for SE.
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Sfmt 4703
Section 118.10 of FDA’s regulations
requires recordkeeping for all measures
the farm takes to prevent SE in its
flocks. Since many existing farms
participate in voluntary egg quality
assurance programs, those respondents
may not have to collect any additional
information. Records are maintained on
file at each farm site and examined there
periodically by FDA inspectors.
Section 118.10 also requires each farm
site with 3,000 or more egg-laying hens
that sells raw shell eggs to the table egg
market, other than directly to the
consumer, and does not have all of the
shell eggs treated, to design and
implement an SE prevention plan.
Section 118.10 requires recordkeeping
for each of the provisions included in
the plan and for plan review and
modifications if corrective actions are
taken.
Finally, § 118.11 of FDA’s regulations
requires that each farm covered by
§ 118.1(a) register with FDA using Form
FDA 3733. The term ‘‘Form FDA 3733’’
refers to both the paper version of the
form and the electronic system known
as the Shell Egg Producer Registration
Module, which is available at https://
www.access.fda.gov. The Agency
strongly encourages electronic
registration because it is faster and more
convenient. The system the Agency has
developed can accept electronic
registrations 24 hours a day, 7 days a
week. A registering shell egg producer
will receive confirmation of electronic
registration instantaneously once all the
required fields on the registration screen
are completed. However, paper
registrations will also be accepted. Form
FDA 3733 is available for download for
registration for submission by mail or
CD–ROM (see https://www.fda.gov/Food/
GuidanceRegulation/FoodFacility
Registration/ShellEggProducer
Registration/ucm217952.htm#cdrom).
Recordkeeping and registration are
necessary for the success of the SE
prevention measures. Written SE
prevention plans and records of actions
taken due to each provision are essential
for farms to implement SE prevention
plans effectively. Further, they are
essential for us to be able to determine
compliance. Information provided
under these regulations helps us to
notify quickly the facilities that might
be affected by a deliberate or accidental
contamination of the food supply. In
addition, data collected through
registration is used to support our
enforcement activities.
Description of Respondents:
Respondents to this information
collection include farm sites with 3,000
or more egg-laying hens that sell raw
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eggs to the table egg market, other than
directly to the consumer.
We estimate the burden of this
collection of information as follows:
Recordkeeping Burden
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of recordkeepers 2
Description and 21 CFR section
No. of records
per recordkeeper
2,600
52
135,200
0.5
67,600
343
331
6,308
52
7
23
17,836
2,317
145,084
0.5
8.3
0.25
8,918
19,231
36,271
5,965
331
4,731
1
1
1
5,965
331
4,731
0.5
10
0.5
2,983
3,310
2,366
9,462
150
331
52
1
1
492,024
150
331
0.5
20
0.5
246,012
3,000
166
........................
........................
........................
........................
389,857
Refrigeration Records, § 118.10(a)(3)(iv) ............................
Testing,
Diversion,
and
Treatment
Records,
§ 118.10(a)(3)(v) to (a)(3)(viii) (positive) 3 ........................
Egg Testing, § 118.10(a)(3)(vii) ...........................................
Environmental Testing, § 118.10(a)(3)(v) 3 ..........................
Testing,
Diversion,
and
Treatment
Records,
§ 118.10(a)(3)(v) to (a)(3)(viii) (negative) 3 .......................
Prevention Plan Review and Modifications, § 118.10(a)(4)
Chick and Pullet Procurement Records, § 118.10(a)(2) ......
Rodent and Other Pest Control, § 118.10(a)(3)(ii), and Biosecurity Records, § 118.10(a)(3)(i) ...................................
Prevention Plan Design, § 118.10(a)(1) ...............................
Cleaning and Disinfection Records, § 118.10(a)(3)(iii) ........
Total hours ....................................................................
Average
burden per
recordkeeping
Total annual
records
Total hours
1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
2 Some records are kept on a by-farm basis and others are kept on a by-house basis.
3 Calculations include requirements for pullet and layer houses.
FDA is retaining most of the estimates
published in the Shell Eggs final rule
with regard to the estimated number of
respondents and the average burden per
recordkeeping (74 FR 33030 at 33089 to
33091). FDA bases the remaining
recordkeeping burden estimates and the
reporting burden estimates on its
experience implementing the final rule
and the number of registrations and
cancellations received in the past 3
years.
The number of recordkeepers
estimated in column 2 of table 1 and all
other estimates discussed in this section
are drawn from estimates of the total
number of layer and pullet houses
affected by the Shell Eggs final rule (74
FR 33030 at 33078 to 33080). In the final
rule, we assumed that those farms that
were operating according to recognized
industry or State quality assurance
plans were already largely in
compliance with the plan design and
recordkeeping provisions discussed in
this section, and therefore would not
experience additional costs to comply
with recordkeeping provisions. We
found that 59 percent of farms with
more than 50,000 layers were members
of State or industry quality assurance
plans. Fewer than 8 percent of farms
with fewer than 50,000 layers were
members of quality assurance plans.
Thus, we estimated the number of layer
farms incurring a new recordkeeping
burden because of the Shell Eggs final
rule to be 2,600, and the number of
houses affected to be 4,731. A detailed
breakdown of this estimation is shown
in table 29 of the Shell Eggs final rule
(74 FR 33030 at 33078).
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Prevention plan design
(§ 118.10(a)(1)) records will be kept on
a per farm basis but because the Shell
Eggs final rule has been fully
implemented, FDA assumes that new
prevention plan design will only be
undertaken by new entrants to the
industry. Refrigeration records
(§ 118.10(a)(3)(iv)) will also be kept on
a per farm basis so the estimated
number of recordkeepers for this
provision is 2,600.
Records of chick and pullet
procurement (§ 118.10(a)(2)), rodent and
other pest control (§ 118.10(a)(3)(ii)),
and biosecurity (§ 118.10(a)(3)(i)) will be
kept on a per house basis, so the
estimated number of recordkeepers for
these provisions is 4,731.
Records of cleaning and disinfection
(§ 118.10(a)(3)(iii)) will also be kept on
a per house basis, but will only need to
be kept in the event that a layer house
tests environmentally positive for SE.
Prevention plan review and
modifications (§ 118.10(a)(4)) will also
need to be performed every time a house
tests positive. As discussed in section
V.F of the Shell Eggs final rule (74 FR
33030 at 33078 to 33080), FDA
estimated that 7.0 percent will test
positive after the provisions of the rule
took effect. Therefore, the number of
recordkeepers for these provisions is
estimated to be 331 (4,731 houses ×
0.070) annually.
Records of testing, diversion, and
treatment (118.10(a)(3)(v) to (a)(3)(viii))
will be kept on a per house basis and
will include records on flocks from
pullet houses. In the Shell Eggs final
rule, FDA estimated that there are one
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third as many pullet houses as there are
layer houses. Therefore the total number
of recordkeepers for these provisions is
6,308 (4,731 + (4,731/3)). The number of
annual records kept depends on
whether or not houses test positive for
SE. Annually, 343 layer and pullet
houses ((4,731 layer houses × 0.070) +
((4731/3 pullet houses) × 0.0075)) are
expected to test positive and 5,965 are
expected to test negative ((4,731 layer
houses × 0.930) + ((4731/3 pullet
houses) × 0.9925)).
We assume that refrigeration records
will be kept on a weekly basis on a per
farm basis under § 118.10(a)(3)(iv)). We
estimate that 2,600 recordkeepers will
maintain 52 records each for a total of
135,200 records and that it will take
approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for refrigeration records is
estimated to be 67,600 hours (135,200 ×
0.5 hour).
We assume that records of testing,
diversion, and treatment under
§ 118.10(a)(3)(v) to (a)(3)(viii)) will be
kept weekly in the event a layer house
tests environmentally positive for SE.
We estimate that 343 layer and pullet
houses will test positive and thus 343
recordkeepers will maintain 52 records
each for a total of 17,836 records and
that it will take approximately 0.5 hour
per recordkeeping. Thus, the total
annual burden for testing, diversion,
and treatment records in the event of a
positive test result is estimated to be
8,918 hours (17,836 × 0.5 hour).
Given a positive environmental test
for SE., we estimate the weighted
average number of egg tests per house
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under § 118.10(a)(3)(vii)) to be 7. We
estimate that 331 recordkeepers will
maintain 7 records each for a total of
2,317 records and that it will take
approximately 8.3 hours per
recordkeeping. Thus, the total annual
burden for egg testing is estimated to be
19,231 hours (2,317 × 8.3 hours).
FDA estimates that all 1,577 pullet
and 4,731 layer houses not currently
testing (6,308 recordkeepers) will incur
the burden of a single environmental
test annually under § 118.10(a)(3)(v)).
The number of samples taken during the
test depends on whether a farm employs
the row based method (an average of 12
samples per house) or the random
sampling method (32 samples per
house). For the purposes of this analysis
we estimate that roughly 50 percent of
the houses affected will employ a row
based method and 50 percent will
employ a random sampling method,
implying an average of 23 samples per
house. Thus, we estimate that 6,308
recordkeepers will take 23 samples each
for a total of 145,084 samples. The time
burden of sampling is estimated on a
per swab sample basis. We estimate that
it will take approximately 15 minutes to
collect and pack each sample. Thus, the
total annual burden for environmental
testing is estimated to be 36,271hours
(145,084 × 0.25 hour).
We estimate that records of testing,
diversion, and treatment under
§ 118.10(a)(3)(v) to (a)(3)(viii) will be
kept annually in the event a layer house
tests environmentally negative for SE.
We estimate that 5,965 layer and pullet
houses will test negative and thus 5,965
recordkeepers will maintain one record
of that testing that will take
approximately 0.5 hour per record.
Thus, the total annual burden for
testing, diversion, and treatment records
in the event of a negative test result is
estimated to be 2,983 hours (5,965 × 0.5
hour).
Prevention plan review and
modifications under § 118.10(a)(4) will
need to be performed every time a house
tests positive. As discussed, we estimate
that 331 layer houses will test positive
requiring plan review and modifications
and that it will take 10 hours to
complete this work. Thus, the total
annual burden for prevention plan
review and modifications in the event of
a positive test result is estimated to be
3,310 hours (331 × 10 hours).
We estimate that chick and pullet
procurement records under
§ 118.10(a)(2) will be kept roughly once
annually per layer house basis. We
estimate that 4,731 layer houses will
maintain 1 record each and that it will
take approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for chick and pullet
procurement recordkeeping is estimated
to be 2,366 hours (4,731 × 0.5 hour).
We estimate that rodent and other
pest control records under
§ 118.10(a)(3)(ii)) and biosecurity
records under § 118.10(a)(3)(i) will be
kept weekly on a per layer house basis.
We assume that 4,731 layer houses will
maintain a weekly record under each
provision. Thus, we estimate 9,462
recordkeepers will maintain 52 records
each for a total of 492,024 records. We
estimate a recordkeeping burden of 0.5
hours per record for a total of 246,012
burden hours (492,024 × 0.5 hour).
New prevention plan design required
by § 118.10(a)(1) will only be
undertaken by new farms and records
will be kept on a per farm basis. We
estimate that there are 150 new farm
registrations annually and we assume
that this reflects 150 new farms
requiring prevention plan design. We
estimate that it will take 20 hours to
complete this work. Thus, the total
annual burden for prevention plan
design is estimated to be 3,000 hours
(150 × 20 hours).
Cleaning and disinfection
recordkeeping under § 118.10(a)(3)(iii)
will need to be performed every time a
house tests positive. As discussed, we
estimate that 331 layer houses will test
positive requiring 1 record each and that
it will take approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for cleaning and disinfection
recordkeeping in the event of a positive
test result is estimated to be 166 hours
(331 × 0.5 hour).
Reporting Burden
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
No. of
responses per
respondent
Average
burden per
response
Total annual
responses
Description and 21 CFR section
FDA form No.
Total hours
Registrations or Updates, § 118.11 ...
Cancellations, § 118.11 ......................
Form FDA 3733 2
Form FDA 3733 ...
150
15
1
1
150
15
2.3
1
345
15
Total ............................................
..............................
........................
........................
........................
........................
360
1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 3733’’ refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at https://www.access.fda.gov per § 118.11(b)(1).
This estimate is based on FDA’s
experience implementing the Shell Eggs
final rule and the average number of
new Shell Egg Producer registrations
and cancellations received in the past 3
years under § 118.11. Based on FDA
experience with implementing the
registration provisions of the Shell Eggs
final rule, which had staggered
compliance dates and gave producers
with fewer than 50,000 but at least 3,000
laying hens until July 9, 2012, to register
(74 FR 33030 at 33034), FDA expects
that it will receive fewer registrations or
updates each year over the next 3 years,
reflecting compliance with the final
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rule’s registration deadlines. FDA
estimates that it will receive 200
registrations or updates in 2013, 150
registrations or updates in 2014, and
100 registrations or updates in 2015, for
an average of 150 registrations or
updates per year over the next 3 years.
FDA received 12 cancellations in 2011
and 19 cancellations in 2012. Based on
this experience, FDA estimates that it
will receive approximately 15
cancellations per year over the next 3
years.
FDA estimated in the Shell Eggs final
rule that listing the information required
by the final rule and presenting it in a
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format that will meet the Agency’s
registration regulations will require a
burden of approximately 2.3 hours per
average registration. As detailed in
section V.F of the final rule (see 74 FR
33030 at 33080), FDA estimates that it
will take the average farm 2.3 hours to
register taking into account that some
respondents completing the registration
may not have readily available Internet
access. Thus, the total annual burden for
new Shell Egg Producer registrations or
updates is estimated to be 345 hours
(150 × 2.3 hours).
FDA estimates cancelling a
registration will, on average, require a
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Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices
burden of approximately 1 hour, taking
into account that some respondents may
not have readily available Internet
access. Thus, the total annual burden for
cancelling Shell Egg Producer
registrations is estimated to be 15 hours
(15 cancellations × 1 hour).
Dated: March 20, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07032 Filed 3–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0350]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Tobacco Retailer Training
Programs
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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 April 26,
2013.
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–NEW and
title ‘‘Guidance for Industry on Tobacco
Retailer Training Programs.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@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.
VerDate Mar<15>2010
18:10 Mar 26, 2013
Jkt 229001
Guidance for Industry on Tobacco
Retailer Training Programs—(OMB
Control Number 0910–NEW)
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act grants FDA
important authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
The Tobacco Control Act provides for
lower civil money penalties for
violations of sale and distribution,
including youth access, and advertising
and promotion restrictions issued under
section 906(d) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 387f(d)), as amended by the
Tobacco Control Act, for retailers who
have implemented a training program
that complies with standards developed
by FDA for such programs (section
103(q)(2) of the Tobacco Control Act).
FDA intends to issue regulations
establishing standards for approved
retailer training programs. In the
interim, the guidance is intended to
assist tobacco retailers in implementing
training programs for employees.
The guidance discusses the elements
that should be covered in a training
program, such as: (1) Federal laws
restricting the sale and distribution,
including youth access to, and the
advertising and promotion of, cigarettes
and smokeless tobacco products; (2) the
health and economic effects of tobacco
use, especially when the tobacco use
begins at a young age; (3) written
company policies against the sale of
cigarettes and smokeless tobacco to
minors; (4) identification of the
cigarettes and smokeless tobacco sold in
the retail establishment that are subject
to the Federal laws prohibiting their sale
to persons under the age of 18; and (5)
age verification methods.
The guidance recommends that
retailers train current employees as soon
as practicable and that new employees
be trained prior to selling cigarettes and
smokeless tobacco. Refresher training
should be provided at least annually
and more frequently, as needed. In
addition, the guidance recommends that
retailers review and update their
training program, as needed, and take
appropriate corrective action after any
violation of the regulations restricting
sale and distribution, including youth
access, and advertising and promotion
of cigarettes and smokeless tobacco. The
guidance recommends that retailers
document any modifications to the
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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training program following such a
review.
The guidance recommends that
retailers maintain certain records
documenting that all individual
employees have been trained and that
retailers retain these records for 4 years
in order to be able to provide evidence
of a training program during the 48month time period covered by the civil
money penalty schedules in section
103(q)(2)(A) of the Tobacco Control Act.
The guidance also recommends that
retailers implement certain hiring and
management practices as part of a
retailer training program.
In the Federal Register of July 16,
2010 (75 FR 41498), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received seven
comments in response to the notice,
with four comments on the information
collection. In the Federal Register of
November 25, 2011 (76 FR 72710), FDA
republished notice of the proposed
collection of information in order to
comply with section 3506(c)(2)(A) of the
Paperwork Reduction Act. FDA received
two comments that were beyond the
scope of the information request (e.g.,
raising fines will be more successful
than retailer training, support for
educating retail employees about the
negative effects of using tobacco
products). Comments relevant to the
information request are addressed in
this document.
(Comment 1) Several comments stated
that it would be burdensome and costly
to keep training records for 4 years due
to the high turnover in the retail
industry.
(Response) The Tobacco Control Act
does not require retailers to implement
retailer training programs. However, it
provides for two schedules of civil
money penalties for violations of
restrictions issued under section 906(d)
of the FD&C Act pertaining to the sale
and distribution of tobacco products,
including access, advertising, and
promotion restrictions—a schedule of
lower penalties for retailers who have
implemented a training program that
complies with the standards set by FDA
and a schedule of higher penalties for
those who have not. Until FDA issues
regulations establishing standards for
approved retailer training programs, the
Agency intends to seek penalties within
the range provided by section
103(q)(2)(A)(i) of the Tobacco Control
Act (for retailers with an approved
retailer training program) whether or not
the retailer has implemented a training
program. FDA may consider further
reducing the civil money penalty for
retailers who have implemented a
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]]>Agencies
[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18605-18609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07032]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0297]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs
During Production--Recordkeeping and Registration Provisions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the
[[Page 18606]]
PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's recordkeeping and registration requirements for shell egg
producers.
DATES: Submit either electronic or written comments on the collection
of information by May 28, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Prevention of Salmonella Enteritidis in Shell Eggs During Production--
Recordkeeping and Registration Provisions--21 CFR 118.10 and 118.11
(OMB Control Number 0910-0660)--Extension
Shell eggs contaminated with Salmonella Enteritidis (SE) are
responsible for more than 140,000 illnesses per year. The Public Health
Service Act (PHS Act) authorizes the Secretary of Health and Human
Services to make and enforce such regulations as ``are necessary to
prevent the introduction, transmission, or spread of communicable
diseases from foreign countries into the States * * * or from one State
* * * into any other State'' (section 361(a) of the PHS Act). This
authority has been delegated to the Commissioner of Food and Drugs.
Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 342(a)(4)), a food is adulterated if it is
prepared, packed, or held under insanitary conditions whereby it may
have been contaminated with filth or rendered injurious to health.
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the efficient enforcement of the
FD&C Act.
On July 9, 2009, FDA published in the Federal Register a final rule
that established a regulation at part 118 (21 CFR part 118) entitled
``Prevention of Salmonella Enteritidis in Shell Eggs During Production,
Storage, and Transportation'' (74 FR 33030) (the Shell Eggs final
rule). Part 118 requires shell egg producers to implement measures to
prevent SE from contaminating eggs on the farm and from further growth
during storage and transportation, and requires these producers to
maintain records concerning their compliance with the rule and to
register with FDA. As described in more detail with regard to each
information collection provision of part 118, each farm site with 3,000
or more egg-laying hens that sells raw shell eggs to the table egg
market, other than directly to the consumer, must refrigerate,
register, and keep certain records. Farms that do not send all of their
eggs to treatment are also required to have an SE prevention plan and
to test for SE.
Section 118.10 of FDA's regulations requires recordkeeping for all
measures the farm takes to prevent SE in its flocks. Since many
existing farms participate in voluntary egg quality assurance programs,
those respondents may not have to collect any additional information.
Records are maintained on file at each farm site and examined there
periodically by FDA inspectors.
Section 118.10 also requires each farm site with 3,000 or more egg-
laying hens that sells raw shell eggs to the table egg market, other
than directly to the consumer, and does not have all of the shell eggs
treated, to design and implement an SE prevention plan. Section 118.10
requires recordkeeping for each of the provisions included in the plan
and for plan review and modifications if corrective actions are taken.
Finally, Sec. 118.11 of FDA's regulations requires that each farm
covered by Sec. 118.1(a) register with FDA using Form FDA 3733. The
term ``Form FDA 3733'' refers to both the paper version of the form and
the electronic system known as the Shell Egg Producer Registration
Module, which is available at https://www.access.fda.gov. The Agency
strongly encourages electronic registration because it is faster and
more convenient. The system the Agency has developed can accept
electronic registrations 24 hours a day, 7 days a week. A registering
shell egg producer will receive confirmation of electronic registration
instantaneously once all the required fields on the registration screen
are completed. However, paper registrations will also be accepted. Form
FDA 3733 is available for download for registration for submission by
mail or CD-ROM (see https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm#cdrom).
Recordkeeping and registration are necessary for the success of the
SE prevention measures. Written SE prevention plans and records of
actions taken due to each provision are essential for farms to
implement SE prevention plans effectively. Further, they are essential
for us to be able to determine compliance. Information provided under
these regulations helps us to notify quickly the facilities that might
be affected by a deliberate or accidental contamination of the food
supply. In addition, data collected through registration is used to
support our enforcement activities.
Description of Respondents: Respondents to this information
collection include farm sites with 3,000 or more egg-laying hens that
sell raw
[[Page 18607]]
eggs to the table egg market, other than directly to the consumer.
We estimate the burden of this collection of information as
follows:
Recordkeeping Burden
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of No. of records Average
Description and 21 CFR section recordkeepers per Total annual burden per Total hours
\2\ recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Refrigeration Records, Sec. 2,600 52 135,200 0.5 67,600
118.10(a)(3)(iv)...............
Testing, Diversion, and 343 52 17,836 0.5 8,918
Treatment Records, Sec.
118.10(a)(3)(v) to (a)(3)(viii)
(positive) \3\.................
Egg Testing, Sec. 331 7 2,317 8.3 19,231
118.10(a)(3)(vii)..............
Environmental Testing, Sec. 6,308 23 145,084 0.25 36,271
118.10(a)(3)(v) \3\............
Testing, Diversion, and 5,965 1 5,965 0.5 2,983
Treatment Records, Sec.
118.10(a)(3)(v) to (a)(3)(viii)
(negative) \3\.................
Prevention Plan Review and 331 1 331 10 3,310
Modifications, Sec.
118.10(a)(4)...................
Chick and Pullet Procurement 4,731 1 4,731 0.5 2,366
Records, Sec. 118.10(a)(2)...
Rodent and Other Pest Control, 9,462 52 492,024 0.5 246,012
Sec. 118.10(a)(3)(ii), and
Biosecurity Records, Sec.
118.10(a)(3)(i)................
Prevention Plan Design, Sec. 150 1 150 20 3,000
118.10(a)(1)...................
Cleaning and Disinfection 331 1 331 0.5 166
Records, Sec.
118.10(a)(3)(iii)..............
-------------------------------------------------------------------------------
Total hours................. .............. .............. .............. .............. 389,857
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Some records are kept on a by-farm basis and others are kept on a by-house basis.
\3\ Calculations include requirements for pullet and layer houses.
FDA is retaining most of the estimates published in the Shell Eggs
final rule with regard to the estimated number of respondents and the
average burden per recordkeeping (74 FR 33030 at 33089 to 33091). FDA
bases the remaining recordkeeping burden estimates and the reporting
burden estimates on its experience implementing the final rule and the
number of registrations and cancellations received in the past 3 years.
The number of recordkeepers estimated in column 2 of table 1 and
all other estimates discussed in this section are drawn from estimates
of the total number of layer and pullet houses affected by the Shell
Eggs final rule (74 FR 33030 at 33078 to 33080). In the final rule, we
assumed that those farms that were operating according to recognized
industry or State quality assurance plans were already largely in
compliance with the plan design and recordkeeping provisions discussed
in this section, and therefore would not experience additional costs to
comply with recordkeeping provisions. We found that 59 percent of farms
with more than 50,000 layers were members of State or industry quality
assurance plans. Fewer than 8 percent of farms with fewer than 50,000
layers were members of quality assurance plans. Thus, we estimated the
number of layer farms incurring a new recordkeeping burden because of
the Shell Eggs final rule to be 2,600, and the number of houses
affected to be 4,731. A detailed breakdown of this estimation is shown
in table 29 of the Shell Eggs final rule (74 FR 33030 at 33078).
Prevention plan design (Sec. 118.10(a)(1)) records will be kept on
a per farm basis but because the Shell Eggs final rule has been fully
implemented, FDA assumes that new prevention plan design will only be
undertaken by new entrants to the industry. Refrigeration records
(Sec. 118.10(a)(3)(iv)) will also be kept on a per farm basis so the
estimated number of recordkeepers for this provision is 2,600.
Records of chick and pullet procurement (Sec. 118.10(a)(2)),
rodent and other pest control (Sec. 118.10(a)(3)(ii)), and biosecurity
(Sec. 118.10(a)(3)(i)) will be kept on a per house basis, so the
estimated number of recordkeepers for these provisions is 4,731.
Records of cleaning and disinfection (Sec. 118.10(a)(3)(iii)) will
also be kept on a per house basis, but will only need to be kept in the
event that a layer house tests environmentally positive for SE.
Prevention plan review and modifications (Sec. 118.10(a)(4)) will also
need to be performed every time a house tests positive. As discussed in
section V.F of the Shell Eggs final rule (74 FR 33030 at 33078 to
33080), FDA estimated that 7.0 percent will test positive after the
provisions of the rule took effect. Therefore, the number of
recordkeepers for these provisions is estimated to be 331 (4,731 houses
x 0.070) annually.
Records of testing, diversion, and treatment (118.10(a)(3)(v) to
(a)(3)(viii)) will be kept on a per house basis and will include
records on flocks from pullet houses. In the Shell Eggs final rule, FDA
estimated that there are one third as many pullet houses as there are
layer houses. Therefore the total number of recordkeepers for these
provisions is 6,308 (4,731 + (4,731/3)). The number of annual records
kept depends on whether or not houses test positive for SE. Annually,
343 layer and pullet houses ((4,731 layer houses x 0.070) + ((4731/3
pullet houses) x 0.0075)) are expected to test positive and 5,965 are
expected to test negative ((4,731 layer houses x 0.930) + ((4731/3
pullet houses) x 0.9925)).
We assume that refrigeration records will be kept on a weekly basis
on a per farm basis under Sec. 118.10(a)(3)(iv)). We estimate that
2,600 recordkeepers will maintain 52 records each for a total of
135,200 records and that it will take approximately 0.5 hour per
recordkeeping. Thus, the total annual burden for refrigeration records
is estimated to be 67,600 hours (135,200 x 0.5 hour).
We assume that records of testing, diversion, and treatment under
Sec. 118.10(a)(3)(v) to (a)(3)(viii)) will be kept weekly in the event
a layer house tests environmentally positive for SE. We estimate that
343 layer and pullet houses will test positive and thus 343
recordkeepers will maintain 52 records each for a total of 17,836
records and that it will take approximately 0.5 hour per recordkeeping.
Thus, the total annual burden for testing, diversion, and treatment
records in the event of a positive test result is estimated to be 8,918
hours (17,836 x 0.5 hour).
Given a positive environmental test for SE., we estimate the
weighted average number of egg tests per house
[[Page 18608]]
under Sec. 118.10(a)(3)(vii)) to be 7. We estimate that 331
recordkeepers will maintain 7 records each for a total of 2,317 records
and that it will take approximately 8.3 hours per recordkeeping. Thus,
the total annual burden for egg testing is estimated to be 19,231 hours
(2,317 x 8.3 hours).
FDA estimates that all 1,577 pullet and 4,731 layer houses not
currently testing (6,308 recordkeepers) will incur the burden of a
single environmental test annually under Sec. 118.10(a)(3)(v)). The
number of samples taken during the test depends on whether a farm
employs the row based method (an average of 12 samples per house) or
the random sampling method (32 samples per house). For the purposes of
this analysis we estimate that roughly 50 percent of the houses
affected will employ a row based method and 50 percent will employ a
random sampling method, implying an average of 23 samples per house.
Thus, we estimate that 6,308 recordkeepers will take 23 samples each
for a total of 145,084 samples. The time burden of sampling is
estimated on a per swab sample basis. We estimate that it will take
approximately 15 minutes to collect and pack each sample. Thus, the
total annual burden for environmental testing is estimated to be
36,271hours (145,084 x 0.25 hour).
We estimate that records of testing, diversion, and treatment under
Sec. 118.10(a)(3)(v) to (a)(3)(viii) will be kept annually in the
event a layer house tests environmentally negative for SE. We estimate
that 5,965 layer and pullet houses will test negative and thus 5,965
recordkeepers will maintain one record of that testing that will take
approximately 0.5 hour per record. Thus, the total annual burden for
testing, diversion, and treatment records in the event of a negative
test result is estimated to be 2,983 hours (5,965 x 0.5 hour).
Prevention plan review and modifications under Sec. 118.10(a)(4)
will need to be performed every time a house tests positive. As
discussed, we estimate that 331 layer houses will test positive
requiring plan review and modifications and that it will take 10 hours
to complete this work. Thus, the total annual burden for prevention
plan review and modifications in the event of a positive test result is
estimated to be 3,310 hours (331 x 10 hours).
We estimate that chick and pullet procurement records under Sec.
118.10(a)(2) will be kept roughly once annually per layer house basis.
We estimate that 4,731 layer houses will maintain 1 record each and
that it will take approximately 0.5 hour per recordkeeping. Thus, the
total annual burden for chick and pullet procurement recordkeeping is
estimated to be 2,366 hours (4,731 x 0.5 hour).
We estimate that rodent and other pest control records under Sec.
118.10(a)(3)(ii)) and biosecurity records under Sec. 118.10(a)(3)(i)
will be kept weekly on a per layer house basis. We assume that 4,731
layer houses will maintain a weekly record under each provision. Thus,
we estimate 9,462 recordkeepers will maintain 52 records each for a
total of 492,024 records. We estimate a recordkeeping burden of 0.5
hours per record for a total of 246,012 burden hours (492,024 x 0.5
hour).
New prevention plan design required by Sec. 118.10(a)(1) will only
be undertaken by new farms and records will be kept on a per farm
basis. We estimate that there are 150 new farm registrations annually
and we assume that this reflects 150 new farms requiring prevention
plan design. We estimate that it will take 20 hours to complete this
work. Thus, the total annual burden for prevention plan design is
estimated to be 3,000 hours (150 x 20 hours).
Cleaning and disinfection recordkeeping under Sec.
118.10(a)(3)(iii) will need to be performed every time a house tests
positive. As discussed, we estimate that 331 layer houses will test
positive requiring 1 record each and that it will take approximately
0.5 hour per recordkeeping. Thus, the total annual burden for cleaning
and disinfection recordkeeping in the event of a positive test result
is estimated to be 166 hours (331 x 0.5 hour).
Reporting Burden
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
Description and 21 CFR section FDA form No. No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates, Sec. 118.11... Form FDA 3733 \2\........... 150 1 150 2.3 345
Cancellations, Sec. 118.11.............. Form FDA 3733............... 15 1 15 1 15
-------------------------------------------------------------------------------------------------------------
Total................................. ............................ .............. .............. .............. .............. 360
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration
Module, which is available at https://www.access.fda.gov per Sec. 118.11(b)(1).
This estimate is based on FDA's experience implementing the Shell
Eggs final rule and the average number of new Shell Egg Producer
registrations and cancellations received in the past 3 years under
Sec. 118.11. Based on FDA experience with implementing the
registration provisions of the Shell Eggs final rule, which had
staggered compliance dates and gave producers with fewer than 50,000
but at least 3,000 laying hens until July 9, 2012, to register (74 FR
33030 at 33034), FDA expects that it will receive fewer registrations
or updates each year over the next 3 years, reflecting compliance with
the final rule's registration deadlines. FDA estimates that it will
receive 200 registrations or updates in 2013, 150 registrations or
updates in 2014, and 100 registrations or updates in 2015, for an
average of 150 registrations or updates per year over the next 3 years.
FDA received 12 cancellations in 2011 and 19 cancellations in 2012.
Based on this experience, FDA estimates that it will receive
approximately 15 cancellations per year over the next 3 years.
FDA estimated in the Shell Eggs final rule that listing the
information required by the final rule and presenting it in a format
that will meet the Agency's registration regulations will require a
burden of approximately 2.3 hours per average registration. As detailed
in section V.F of the final rule (see 74 FR 33030 at 33080), FDA
estimates that it will take the average farm 2.3 hours to register
taking into account that some respondents completing the registration
may not have readily available Internet access. Thus, the total annual
burden for new Shell Egg Producer registrations or updates is estimated
to be 345 hours (150 x 2.3 hours).
FDA estimates cancelling a registration will, on average, require a
[[Page 18609]]
burden of approximately 1 hour, taking into account that some
respondents may not have readily available Internet access. Thus, the
total annual burden for cancelling Shell Egg Producer registrations is
estimated to be 15 hours (15 cancellations x 1 hour).
Dated: March 20, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07032 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P
