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, 40312-40315 [2016-14584]
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Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
To be eligible to receive a formula
grant under Section 307 (a) of the Older
Americans Act (OAA) of 1965, as
amended, each State Unit on Aging
(SUA) is required to develop a State
Plan on Aging that conforms to
requirements and priorities outlined by
the Assistant Secretary for Aging. Such
plans are required, by statute, to be
completed by each state and territory
every two, three or four years. States
with current two- or three-year plans
may request an extension, or may
amend their current plans if needed;
however, at the end of a four-year plan,
states must develop a new plan. There
is no statutory authority to extend a
plan beyond a four-year period.
State plans must address key
objectives and focus areas as articulated
by the Assistant Secretary for Aging.
Objectives and focus areas may change
periodically in accordance with the
evolution of policies and practices
pertaining to the provision of home and
community-based supportive services to
older adults and their family caregivers.
Additionally, state plans must include
specific assurances that the state will
carry out certain activities in accordance
with the OAA. Finally, states are
required to develop (or revise) and
submit an Intrastate Funding Formula
(IFF), detailing how Federal funds made
available under the OAA will be
disbursed throughout the state. The
information submitted to ACL/AoA via
the state plan is used for Federal
oversight of Title III and VII programs,
ensuring that OAA funds are serving as
a base for a broader system of long-term
services and supports for older adults in
the state and that funds are being
targeted in accordance with the
requirements of the Act.
With respect to targeting, LGBT
advocates are urging ACL to require
states, in their state plans, to provide
assurances that they will assess all
groups that may be eligible for
designation as a ‘‘greatest social need’’
population and expressly include LGBT
older adults as one of those groups
whose needs must be assessed by the
State Unit on Aging. Additionally, the
recently reauthorized OAA directs the
Assistant Secretary for Aging to issue
guidance for conducting outreach to,
and serving, Holocaust survivors. In this
regard, ACL wants to know whether the
targeting guidance as articulated on
pages 5–6 of the template is feasible and
likely to ensure maximum inclusion of
all populations of seniors, including
older American Indians, LGBT seniors,
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Holocaust survivors living in the U.S.,
and other isolated groups of older
adults. To that end, comments are
specifically requested on the extent to
which the direction provided is
sufficient for states to fully assess the
existence of, and develop plans for
serving, these individuals and their
families. If commenters believe the
proposed direction is insufficient, this
solicitation requests comments
containing the specific guidance desired
as well as the practical means and data
available to implement said guidance,
direction and requirements for states.
When completed annually by ACL/
AoA staff, the template presented here
for comment will yield a Program
Instruction containing the necessary
information states need to develop and
submit their state plans on aging. ACL/
AoA estimates the burden of this data
collection as follows: approximately one
third (1⁄3) of the 56 State Units on Aging
(or approximately 18 states per year)
submit a new state plan in a given year.
Estimates as to the amount of time it
takes to prepare and submit a state plan
vary greatly. Recent feedback from states
indicates that, on average, it takes a state
approximately 750 hours to prepare and
submit a state plan on aging. The
proposed Program Instruction template
may be found on the ACL Web site for
review at: https://www.aoa.acl.gov/AoA_
Programs/OAA/Aging_Network/pi/PITemplate.aspx.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 21,
2016.
Dated: June 14, 2016.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
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 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.
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
[FR Doc. 2016–14612 Filed 6–20–16; 8:45 am]
BILLING CODE 4154–01–P
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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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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 0910–0660. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
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Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
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
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. 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
40313
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 January 28,
2016 (81 FR 4923), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received two
comments in response, both of which
supported the collection of information
by FDA to ensure that farms are in
compliance with the FD&C Act and
regulations, and that adequate control
measures for prevention of SE are being
implemented.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper
Number of
recordkeepers 2
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).
Prevention Plan Design, § 118.10(a)(1) ........
Cleaning
and
Disinfection
Records,
§ 118.10(a)(3)(iii).
Total annual
records
Average burden per
recordkeeping
2,600
343
52
52
135,200
17,836
.5 (30 minutes)
.5 (30 minutes)
67,600
8,918
331
6,308
5,965
7
23
1
2,317
145,084
5,965
8.3
.25 (15 minutes)
.5 (30 minutes)
19,231
36,271
2,983
331
1
331
4,731
1
9,462
300
331
10
3,310
4,731
.5 (30 minutes)
2,366
52
492,024
.5 (30 minutes)
246,012
1
1
300
331
20
.5 (30 minutes)
6,000
166
Total hours .............................................
1 There
2 Some
Total hours
392,857
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.
include requirements for pullet and layer houses.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
3 Calculations
We are basing 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
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number of layer and pullet houses
affected by part 118. We assume that
those farms that are operating according
to recognized industry or State quality
assurance plans are already largely in
compliance with the plan design and
recordkeeping provisions discussed in
this section, and therefore are not
experiencing additional costs to comply
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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
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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.
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
percent tests 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 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
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
× 0.5 hour).
We assume that records of testing,
diversion, and treatment under
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§ 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 × 0.5 hour).
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 × 8.3 hours).
We estimate that all 1,577 pullet and
4,731 layer houses not currently testing
(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 employs a
random sampling method, implying an
average of 23 samples per house. Thus,
we estimate that 6,308 recordkeepers
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 takes
approximately 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 × 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 × 0.5 hour).
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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
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 × 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 × 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 × 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
300 new farm registrations annually and
we assume that this reflects 300 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 6,000 hours
(300 × 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 × 0.5 hour).
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
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 ...
300
30
1
1
300
30
2.3
1
690
30
Total ............................................
..............................
........................
........................
........................
........................
720
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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).
2 The
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 300 registrations or updates per year
over the next 3 years. Based on the
number of cancellations previously
received, we estimate that we will
receive approximately 30 cancellations
per year over the next 3 years.
We estimate 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 690 hours
(300 × 2.3 hours).
We estimate cancelling a registration,
on average, requires a 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 calculated to be 30 hours
(30 cancellations × 1 hour).
Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–14584 Filed 6–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2016–N–1593]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Accessories
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
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information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by July 21,
2016.
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 ‘‘Medical Device Accessories.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Device Accessories—OMB
Control Number 0910–NEW
The draft guidance encourages
manufacturers and other parties to
utilize the process defined in section
513(f)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to request
risk- and regulatory control-based
classifications of new types of
accessories. This process provides a
pathway to class I or class II
classification for accessory devices for
which general controls, or general and
special controls, provide a reasonable
assurance of safety and effectiveness,
but for which there is no legally
marketed predicate device.
In accordance with section 513(f)(2) of
the FD&C Act, manufacturers and other
parties may submit a de novo requesting
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FDA to make a classification
determination for the accessory device
according to the criteria in section
513(a)(1) of the FD&C Act. The de novo
must include a description of the device
and detailed information and reasons
for any recommended classification (see
section 513(f)(2)(A)(v) of the FD&C Act).
In the Federal Register of January 20,
2015 (80 FR 2710), FDA published a 60day notice requesting public comment
on the proposed collection of
information. We received a total of 12
comments on the guidance. Of these the
following were related to the
information collection:
Two comments raised concerns
regarding the possible difficulties for
manufacturers to submit a de novo for
new accessories and for risk- and
regulatory control-based classification of
accessories that were approved under
the premarket approval application
(PMA) for the parent medical devices.
One comment questioned whether FDA
considered the possible ‘‘practical and
economic impact’’ of the proposed
definition of ‘‘accessories’’ that may
result in manufacturers being obligated
to list some components as accessories
for FDA’s registration and listing
process. The second comment
anticipates that ‘‘few companies are
likely to pursue this route given the
associated costs and minimal advantage
in time to market.’’ Neither comment
specifically discusses the potential PRA
burden hours of voluntarily submitting
a de novo application; however, it may
be inferred that this could impact their
resources under the PRA for submitting
a de novo.
Also, FDA is not proposing to limit or
remove any mechanism that currently
exists for manufacturers to obtain
marketing authorization for accessories.
De novos are typically less burdensome
than PMAs for the purpose of
classifying a new accessory.
Furthermore, if a manufacturer wishes
for an accessory to remain in the same
regulatory class as the parent device,
that manufacturer may continue to
submit the accessory for clearance or
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]]>Agencies
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40312-40315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14584]
-----------------------------------------------------------------------
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) 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 July
21, 2016.
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 0910-0660.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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.
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
[[Page 40313]]
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 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. 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 January 28, 2016 (81 FR 4923), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments in response, both
of which supported the collection of information by FDA to ensure that
farms are in compliance with the FD&C Act and regulations, and that
adequate control measures for prevention of SE are being implemented.
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. 118.10(a)(3)(iv) 2,600 52 135,200 .5 (30 minutes) 67,600
Testing, Diversion, and Treatment Records, 343 52 17,836 .5 (30 minutes) 8,918
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. 118.10(a)(3)(v) 6,308 23 145,084 .25 (15 minutes) 36,271
\3\.
Testing, Diversion, and Treatment Records, 5,965 1 5,965 .5 (30 minutes) 2,983
Sec. 118.10(a)(3)(v) through (viii)
(negative) \3\.
Prevention Plan Review and Modifications, Sec. 331 1 331 10 3,310
118.10(a)(4).
Chick and Pullet Procurement Records, Sec. 4,731 1 4,731 .5 (30 minutes) 2,366
118.10(a)(2).
Rodent and Other Pest Control, Sec. 9,462 52 492,024 .5 (30 minutes) 246,012
118.10(a)(3)(ii), and Biosecurity Records,
Sec. 118.10(a)(3)(i).
Prevention Plan Design, Sec. 118.10(a)(1)... 300 1 300 20 6,000
Cleaning and Disinfection Records, Sec. 331 1 331 .5 (30 minutes) 166
118.10(a)(3)(iii).
---------------------------------------------------------------------------------------------------------
Total hours............................... 392,857
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
We are basing 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 are operating
according to recognized industry or State quality assurance plans are
already largely in compliance with the plan design and recordkeeping
provisions discussed in this section, and therefore are not
experiencing 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
[[Page 40314]]
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
percent tests 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 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 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 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 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 x 8.3
hours).
We estimate that all 1,577 pullet and 4,731 layer houses not
currently testing (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
employs a random sampling method, implying an average of 23 samples per
house. Thus, we estimate that 6,308 recordkeepers 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 takes
approximately 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 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 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 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 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 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 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 300 new farm registrations annually and we
assume that this reflects 300 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 6,000 hours (300 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 x 0.5 hour).
[[Page 40315]]
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Description and 21 CFR section FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates, Sec. 118.11... Form FDA 3733 \2\........... 300 1 300 2.3 690
Cancellations, Sec. 118.11.............. Form FDA 3733............... 30 1 30 1 30
-------------------------------------------------------------------------------------------------------------
Total................................. ............................ .............. .............. .............. .............. 720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 300
registrations or updates per year over the next 3 years. Based on the
number of cancellations previously received, we estimate that we will
receive approximately 30 cancellations per year over the next 3 years.
We estimate 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 690 hours (300 x 2.3 hours).
We estimate cancelling a registration, on average, requires a
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
calculated to be 30 hours (30 cancellations x 1 hour).
Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14584 Filed 6-20-16; 8:45 am]
BILLING CODE 4164-01-P
