Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions, 34191-34194 [2019-15162]
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Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation refers to the document
entitled ‘‘Class II Special Controls
Guidance Document: Reagents for
Detection of Specific Novel Influenza A
Viruses,’’ which provides
recommendations for measures to help
provide a reasonable assurance of safety
and effectiveness for these reagents. The
guidance recommends that sponsors
obtain and analyze postmarket data to
ensure the continued reliability of their
device in detecting the specific novel
influenza A virus that it is intended to
detect, particularly given the propensity
for influenza viruses to mutate and the
potential for changes in disease
prevalence over time. As updated
sequences for novel influenza A viruses
become available from the World Health
Organization, National Institutes of
Health, and other public health entities,
sponsors of reagents for detection of
specific novel influenza A viruses will
collect this information, compare them
with the primer/probe sequences in
their devices, and incorporate the result
of these analyses into their quality
management system, as required by 21
CFR 820.100(a)(1). These analyses will
be evaluated against the device design
validation and risk analysis required by
21 CFR 820.30(g) to determine if any
design changes may be necessary.
FDA estimates that one respondent
will be affected annually. The
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 30
hours.
The guidance also refers to previously
approved information collections found
in FDA regulations. The collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120; and the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073.
In the Federal Register of March 5,
2019 (84 FR 7904), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping regarding reagents for detection of
specific novel influenza A viruses ..........................
1
2
2
15
30
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Manufactures are increasingly
adopting in silico methods
(computational analysis) for the
detection of specific novel Influenza A
viruses over traditional laboratory
techniques. Therefore, few
manufactures are using reagents for
detection of specific novel influenza A
viruses. Based on these industry trends,
we estimate a decrease in the number of
total annual records and a
corresponding decrease of 270 hours in
the total burden since our last OMB
approval.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
HHS.
[FR Doc. 2019–15160 Filed 7–16–19; 8:45 am]
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BILLING CODE 4164–01–P
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Food and Drug Administration
[Docket No. FDA–2013–N–0297]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prevention of
Salmonella Enteritidis in Shell Eggs
During Production; Recordkeeping and
Registration Provisions
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 16,
2019.
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_
SUMMARY:
PO 00000
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submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0660. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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) (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services to make and enforce
such regulations as ‘‘are necessary to
prevent the introduction, transmission,
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Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
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 (42 U.S.C. 264(a))). 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 (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.
Under part 118 (21 CFR part 118),
shell egg producers are required to
implement measures to prevent SE from
contaminating eggs on the farm and
from further growth during storage and
transportation. Shell egg producers also
are required to maintain records
concerning their compliance with part
118 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
(21 CFR 118.10) 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
(21 CFR 118.11) requires that each farm
covered by 21 CFR 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. We strongly
encourage electronic registration
because it is faster and more convenient.
The system can accept electronic
registrations 24 hours a day, 7 days a
week. A registering shell egg producer
receives 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 by mail or CD–ROM.
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
eggs to the table egg market, other than
directly to the consumer.
In the Federal Register of March 26,
2019 (84 FR 11309), we published a 60day notice requesting public comment
on the proposed collection of
information. Two comments were
received, however only one was
responsive to the four information
collection topics solicited. Specifically,
the comment suggested that farms could
save money by pooling samples while
conducting environmental testing,
proffering a 2015 research study. The
comment continued by suggesting that
the testing protocol be adjusted from
four 1,000-egg samples to two 1,000 egg
samples. We note, however, that testing
four 1,000-egg samples over an 8-week
period results in approximately a 95
percent probability that a positive egg
will be detected from a flock that is
producing SE-contaminated eggs with a
prevalence of 1 in 1,400, while testing
fewer than 4,000 eggs over a period of
8 weeks, as required by 21 CFR 118.7,
results in less than a 95 percent
probability that a positive egg would be
detected from a flock that is producing
SE-contaminated eggs at that rate. While
we are aware of the referenced research,
we decline to relax the current
requirements provided for under 21 CFR
118.7 and 118.8 as doing so may reduce
certain associated costs that would not
provide the same level of protection
necessary to ensure the public health.
The comment did not suggest a revision
to our estimated burden.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers 2
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Description and 21 CFR section
Refrigeration Records, § 118.10(a)(3)(iv) ....
Testing, Diversion, and Treatment Records,
§ 118.10(a)(3)(v) through (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) through (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).
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Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
2,600
343
52
52
135,200
17,836
0.5 (30 minutes) .............
0.5 (30 minutes) .............
67,600
8,918
331
6,308
5,965
7
23
1
2,317
145,084
5,965
8.3 ..................................
0.25 (15 minutes) ...........
0.5 (30 minutes) .............
19,231
36,271
2,983
331
1
331
10 ...................................
3,310
4,731
1
4,731
0.5 (30 minutes) .............
2,366
9,462
52
492,024
0.5 (30 minutes) .............
246,012
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34193
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers 2
Description and 21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Prevention Plan Design, § 118.10(a)(1) ......
Cleaning
and
Disinfection
Records,
§ 118.10(a)(3)(iii).
350
331
1
1
350
331
20 ...................................
0.5 (30 minutes) .............
7,000
166
Total .....................................................
..........................
..........................
..........................
........................................
393,857
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
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2 Some
We base our estimates for the
recordkeeping burden and the reporting
burden on our experience with similar
recordkeeping activities and the number
of registrations and cancellations
received in the past 3 years.
The number of recordkeepers
estimated in column 2 of table 1 is
drawn from estimates of the total
number of layer and pullet houses
affected by part 118. We assume that
those farms that were operating
according to recognized industry or
State quality assurance plans prior to
their compliance date under part 118
were already largely in compliance with
the plan design and recordkeeping
provisions discussed in this section, and
therefore did not experience additional
costs to comply with recordkeeping
provisions. We found that 59 percent of
farms with more than 50,000 layers are
members of State or industry quality
assurance plans. Fewer than 8 percent
of farms with fewer than 50,000 layers
are members of quality assurance plans.
Thus, we estimate the number of layer
farms incurring a new recordkeeping
burden because of part 118 to be 2,600,
and the number of houses affected to be
4,731.
Prevention plan design
(§ 118.10(a)(1)) records are kept on a per
farm basis, so we assume that new
prevention plan design is only
undertaken by new entrants to the
industry. Refrigeration records
(§ 118.10(a)(3)(iv)) are also 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)) are
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)) are also kept on a per
house basis, but only need to be kept in
the event that a layer house tests
environmentally positive for SE.
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Prevention plan review and
modifications (§ 118.10(a)(4)) also need
to be performed every time a house tests
positive, which we estimate that 7.0
percent test positive. Therefore, the
number of recordkeepers for these
provisions is calculated to be 331 (4,731
houses × 0.070) annually.
Records of testing, diversion, and
treatment (§ 118.10(a)(3)(v) through
(viii)) are kept on a per house basis and
include records on flocks from pullet
houses. We estimate that there are onethird 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 houses test positive
for SE. Annually, 343 layer and pullet
houses ((4,731 layer houses × 0.070) +
(4,731/3 pullet houses) × 0.0075)) are
expected to test positive and 5,965 are
expected to test negative ((4,731 layer
houses × 0.930) + (4,731/3 pullet
houses) × 0.9925)).
We assume that refrigeration records
are kept on a weekly basis on a per farm
basis under § 118.10(a)(3)(iv)). We
estimate that 2,600 recordkeepers
maintain 52 records each for a total of
135,200 records and that it takes
approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for refrigeration records is
calculated to be 67,600 hours (135,200
records × 0.5 hour).
We assume that records of testing,
diversion, and treatment under
§ 118.10(a)(3)(v) through (viii) are kept
weekly in the event a layer house tests
environmentally positive for SE. We
estimate that 343 layer and pullet
houses test positive and thus 343
recordkeepers maintain 52 records each
for a total of 17,836 records and that it
takes 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 calculated to be
8,918 hours (17,836 records × 0.5 hour).
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Given a positive environmental test
for SE, we estimate the weighted
average number of egg tests per house
under § 118.10(a)(3)(vii)) to be 7. We
estimate that 331 recordkeepers
maintain 7 records each for a total of
2,317 records and that it takes
approximately 8.3 hours per
recordkeeping. Thus, the total annual
burden for egg testing is calculated to be
19,231 hours (2,317 records × 8.3
hours).
We estimate that all 1,577 pullet and
4,731 layer houses not testing prior to
their compliance date under part 118
(6,308 recordkeepers) 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). We
estimate that roughly 50 percent of the
houses affected employ a row based
method and 50 percent employ a
random sampling method, implying an
average of 23 samples per house. The
time burden of sampling is estimated on
a per swab sample basis. We assume it
takes 15 minutes to collect and pack
each sample. Thus, the total annual
burden for environmental testing is
calculated to be 36,271 hours (145,084
records × 0.25 hour).
We estimate that records of testing,
diversion, and treatment under
§ 118.10(a)(3)(v) through (viii) are kept
annually in the event a layer house tests
environmentally negative for SE. We
estimate that 5,965 layer and pullet
houses test negative and thus 5,965
recordkeepers maintain 1 record of that
testing that takes 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 calculated to be
2,983 hours (5,965 records × 0.5 hour).
Prevention plan review and
modifications under § 118.10(a)(4)) need
to be performed every time a house tests
positive. We estimate that 331 layer
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houses test positive requiring plan
review and modifications and that it
takes 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 calculated to be 3,310
hours (331 records × 10 hours).
We estimate that chick and pullet
procurement records under
§ 118.10(a)(2) is kept roughly once
annually per layer house basis. We
estimate that 4,731 layer houses
maintain 1 record each and that it takes
approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for chick and pullet
procurement recordkeeping is
calculated to be 2,366 hours (4,731
records × 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) are kept weekly
on a per layer house basis. We assume
that 4,731 layer houses maintain a
weekly record under each provision.
Thus, we estimate 9,462 recordkeepers
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 records × 0.5 hour).
New prevention plan design required
by § 118.10(a)(1) is only undertaken by
new farms and records are kept on a per
farm basis. We estimate that there are
350 new farm registrations annually,
and we assume that this reflects 350
new farms requiring prevention plan
design. This is an increase from our
previous estimate based on new
registrations received. We estimate that
it takes 20 hours to complete this work.
Thus, the total annual burden for
prevention plan design is calculated to
be 7,000 hours (350 records × 20 hours).
Cleaning and disinfection
recordkeeping under § 118.10(a)(3)(iii)
needs to be performed every time a
house tests positive. We estimate that
331 layer houses test positive requiring
1 record each and that it takes
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 calculated to be 166 hours
(331 records × 0.5 hour).
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Description and 21 CFR section
Registrations or Updates,
§ 118.11.
Cancellations, § 118.11 ...............
Number of
respondents
Form
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
FDA 3733 2
350
1
350
2.3
805
FDA 3733
30
1
30
1
30
..........................
..........................
..........................
..........................
835
Total .....................................
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 the average
number of new shell egg producer
registrations and cancellations received
in the past 3 years under § 118.11. We
estimate that we will receive an average
of 350 registrations or updates per year
over the next 3 years and that it takes
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 calculated to be 805 hours
(350 respondents × 2.3 hours).
We estimate that we will receive 30
cancellations per year over the next 3
years and that cancelling a registration,
on average, requires a burden of 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 calculated to be
30 hours (30 cancellations × 1 hour).
We have increased our burden
estimate for the information collection
based on an increase in annual new
farm registrations.
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Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15162 Filed 7–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Population Affairs; Awards
Unsolicited Proposal for the CFDA
Number: 93.974
Office of Population Affairs,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Office of Population
Affairs (OPA) announces the award of a
single-source grant in response to an
unsolicited proposal from the
University of Northern Colorado,
Greely, Colorado. The proposal
submitted was not solicited either
formally or informally by any federal
government official.
FOR FURTHER INFORMATION CONTACT:
Diane Foley at diane.foley@hhs.gov or
by telephone at 240–453–8200.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Recipient: University of Northern
Colorado, Greely, Colorado.
Purpose of the Award: The purpose of
this grant is to expand the knowledge
base regarding cessation strategies that
adolescents and young adults use to
maintain their reproductive health. It
will provide valuable data on how
family planning services can
incorporate technology and cessation
counseling strategies in primary care
medical clinics and other clinic
workflows, including Title X clinics.
Amount of Award: $499,385 in
Federal Fiscal Year (FFY) 2019 funds
and estimated $500,000 in FFY 2020
funds subject to the enactment of
appropriations and availability of funds.
Project Period: July 15, 2019–July 14,
2021.
OPA performed an objective review of
the unsolicited proposal from the
University of Northern Colorado to
expand and evaluate the OPTIONS for
Integrated Health program. This
proposal builds on a previous study,
which is the only study in existence that
has scientifically demonstrated how the
Transtheoretical Model of Health
Behavior Change (Prochaska & Velicer)
works with sexually active adolescents
and young adults. This cutting edge
research identified the population of
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]]>Agencies
[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34191-34194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15162]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0297]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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
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 August
16, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0660.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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) (42 U.S.C. 264) authorizes the Secretary of
Health and Human Services to make and enforce such regulations as ``are
necessary to prevent the introduction, transmission,
[[Page 34192]]
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 (42 U.S.C. 264(a))). 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 (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.
Under part 118 (21 CFR part 118), shell egg producers are required
to implement measures to prevent SE from contaminating eggs on the farm
and from further growth during storage and transportation. Shell egg
producers also are required to maintain records concerning their
compliance with part 118 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 (21 CFR 118.10) 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 (21 CFR 118.11) requires
that each farm covered by 21 CFR 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.
We strongly encourage electronic registration because it is faster and
more convenient. The system can accept electronic registrations 24
hours a day, 7 days a week. A registering shell egg producer receives
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 by mail or CD-ROM.
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 eggs to the table egg market, other than directly to the
consumer.
In the Federal Register of March 26, 2019 (84 FR 11309), we
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received, however only one
was responsive to the four information collection topics solicited.
Specifically, the comment suggested that farms could save money by
pooling samples while conducting environmental testing, proffering a
2015 research study. The comment continued by suggesting that the
testing protocol be adjusted from four 1,000-egg samples to two 1,000
egg samples. We note, however, that testing four 1,000-egg samples over
an 8-week period results in approximately a 95 percent probability that
a positive egg will be detected from a flock that is producing SE-
contaminated eggs with a prevalence of 1 in 1,400, while testing fewer
than 4,000 eggs over a period of 8 weeks, as required by 21 CFR 118.7,
results in less than a 95 percent probability that a positive egg would
be detected from a flock that is producing SE-contaminated eggs at that
rate. While we are aware of the referenced research, we decline to
relax the current requirements provided for under 21 CFR 118.7 and
118.8 as doing so may reduce certain associated costs that would not
provide the same level of protection necessary to ensure the public
health. The comment did not suggest a revision to our estimated burden.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
Description and 21 CFR section recordkeepers records per Total annual Average burden per recordkeeping Total hours
\2\ recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refrigeration Records, Sec. 2,600 52 135,200 0.5 (30 minutes).......................... 67,600
118.10(a)(3)(iv).
Testing, Diversion, and Treatment 343 52 17,836 0.5 (30 minutes).......................... 8,918
Records, Sec. 118.10(a)(3)(v) through
(viii) (positive) \3\.
Egg Testing, Sec. 118.10(a)(3)(vii)... 331 7 2,317 8.3....................................... 19,231
Environmental Testing, Sec. 6,308 23 145,084 0.25 (15 minutes)......................... 36,271
118.10(a)(3)(v) \3\.
Testing, Diversion, and Treatment 5,965 1 5,965 0.5 (30 minutes).......................... 2,983
Records, Sec. 118.10(a)(3)(v) through
(viii) (negative) \3\.
Prevention Plan Review and 331 1 331 10........................................ 3,310
Modifications, Sec. 118.10(a)(4).
Chick and Pullet Procurement Records, 4,731 1 4,731 0.5 (30 minutes).......................... 2,366
Sec. 118.10(a)(2).
Rodent and Other Pest Control, Sec. 9,462 52 492,024 0.5 (30 minutes).......................... 246,012
118.10(a)(3)(ii), and Biosecurity
Records, Sec. 118.10(a)(3)(i).
[[Page 34193]]
Prevention Plan Design, Sec. 350 1 350 20........................................ 7,000
118.10(a)(1).
Cleaning and Disinfection Records, Sec. 331 1 331 0.5 (30 minutes).......................... 166
118.10(a)(3)(iii).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total............................... ............... ............... ............... .......................................... 393,857
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
We base our estimates for the recordkeeping burden and the
reporting burden on our experience with similar recordkeeping
activities and the number of registrations and cancellations received
in the past 3 years.
The number of recordkeepers estimated in column 2 of table 1 is
drawn from estimates of the total number of layer and pullet houses
affected by part 118. We assume that those farms that were operating
according to recognized industry or State quality assurance plans prior
to their compliance date under part 118 were already largely in
compliance with the plan design and recordkeeping provisions discussed
in this section, and therefore did not experience additional costs to
comply with recordkeeping provisions. We found that 59 percent of farms
with more than 50,000 layers are members of State or industry quality
assurance plans. Fewer than 8 percent of farms with fewer than 50,000
layers are members of quality assurance plans. Thus, we estimate the
number of layer farms incurring a new recordkeeping burden because of
part 118 to be 2,600, and the number of houses affected to be 4,731.
Prevention plan design (Sec. 118.10(a)(1)) records are kept on a
per farm basis, so we assume that new prevention plan design is only
undertaken by new entrants to the industry. Refrigeration records
(Sec. 118.10(a)(3)(iv)) are also 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)) are 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)) are
also kept on a per house basis, but 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)) also need to be
performed every time a house tests positive, which we estimate that 7.0
percent test positive. Therefore, the number of recordkeepers for these
provisions is calculated to be 331 (4,731 houses x 0.070) annually.
Records of testing, diversion, and treatment (Sec. 118.10(a)(3)(v)
through (viii)) are kept on a per house basis and include records on
flocks from pullet houses. We estimate 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 houses test positive
for SE. Annually, 343 layer and pullet houses ((4,731 layer houses x
0.070) + (4,731/3 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) + (4,731/3 pullet houses) x 0.9925)).
We assume that refrigeration records are kept on a weekly basis on
a per farm basis under Sec. 118.10(a)(3)(iv)). We estimate that 2,600
recordkeepers maintain 52 records each for a total of 135,200 records
and that it takes approximately 0.5 hour per recordkeeping. Thus, the
total annual burden for refrigeration records is calculated to be
67,600 hours (135,200 records x 0.5 hour).
We assume that records of testing, diversion, and treatment under
Sec. 118.10(a)(3)(v) through (viii) are kept weekly in the event a
layer house tests environmentally positive for SE. We estimate that 343
layer and pullet houses test positive and thus 343 recordkeepers
maintain 52 records each for a total of 17,836 records and that it
takes 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 calculated to be 8,918 hours (17,836 records x
0.5 hour).
Given a positive environmental test for SE, we estimate the
weighted average number of egg tests per house under Sec.
118.10(a)(3)(vii)) to be 7. We estimate that 331 recordkeepers maintain
7 records each for a total of 2,317 records and that it takes
approximately 8.3 hours per recordkeeping. Thus, the total annual
burden for egg testing is calculated to be 19,231 hours (2,317 records
x 8.3 hours).
We estimate that all 1,577 pullet and 4,731 layer houses not
testing prior to their compliance date under part 118 (6,308
recordkeepers) 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). We estimate that roughly 50 percent of the houses affected
employ a row based method and 50 percent employ a random sampling
method, implying an average of 23 samples per house. The time burden of
sampling is estimated on a per swab sample basis. We assume it takes 15
minutes to collect and pack each sample. Thus, the total annual burden
for environmental testing is calculated to be 36,271 hours (145,084
records x 0.25 hour).
We estimate that records of testing, diversion, and treatment under
Sec. 118.10(a)(3)(v) through (viii) are kept annually in the event a
layer house tests environmentally negative for SE. We estimate that
5,965 layer and pullet houses test negative and thus 5,965
recordkeepers maintain 1 record of that testing that takes
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 calculated to be 2,983 hours (5,965 records x 0.5 hour).
Prevention plan review and modifications under Sec. 118.10(a)(4))
need to be performed every time a house tests positive. We estimate
that 331 layer
[[Page 34194]]
houses test positive requiring plan review and modifications and that
it takes 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 calculated to be 3,310 hours (331 records x 10 hours).
We estimate that chick and pullet procurement records under Sec.
118.10(a)(2) is kept roughly once annually per layer house basis. We
estimate that 4,731 layer houses maintain 1 record each and that it
takes approximately 0.5 hour per recordkeeping. Thus, the total annual
burden for chick and pullet procurement recordkeeping is calculated to
be 2,366 hours (4,731 records 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)
are kept weekly on a per layer house basis. We assume that 4,731 layer
houses maintain a weekly record under each provision. Thus, we estimate
9,462 recordkeepers 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 records x 0.5 hour).
New prevention plan design required by Sec. 118.10(a)(1) is only
undertaken by new farms and records are kept on a per farm basis. We
estimate that there are 350 new farm registrations annually, and we
assume that this reflects 350 new farms requiring prevention plan
design. This is an increase from our previous estimate based on new
registrations received. We estimate that it takes 20 hours to complete
this work. Thus, the total annual burden for prevention plan design is
calculated to be 7,000 hours (350 records x 20 hours).
Cleaning and disinfection recordkeeping under Sec.
118.10(a)(3)(iii) needs to be performed every time a house tests
positive. We estimate that 331 layer houses test positive requiring 1
record each and that it takes 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 calculated to
be 166 hours (331 records x 0.5 hour).
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Description and 21 CFR section Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates, Sec. FDA 3733 \2\ 350 1 350 2.3 805
118.11.
Cancellations, Sec. 118.11......... FDA 3733 30 1 30 1 30
------------------------------------------------------------------------------------------------------------------
Total............................ ............................ ............... ............... ............... ............... 835
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 the average number of new shell egg
producer registrations and cancellations received in the past 3 years
under Sec. 118.11. We estimate that we will receive an average of 350
registrations or updates per year over the next 3 years and that it
takes 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 calculated to be 805 hours
(350 respondents x 2.3 hours).
We estimate that we will receive 30 cancellations per year over the
next 3 years and that cancelling a registration, on average, requires a
burden of 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 calculated to be 30
hours (30 cancellations x 1 hour).
We have increased our burden estimate for the information
collection based on an increase in annual new farm registrations.
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15162 Filed 7-16-19; 8:45 am]
BILLING CODE 4164-01-P
