Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions, 11309-11312 [2019-05757]
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Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
Our estimated burden for the
information collection reflects a
decrease of 27 responses and 27 records,
and a corresponding overall decrease of
108,000 hours. We attribute this
adjustment to a decrease in the average
number of submissions we received
over the last few years.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05759 Filed 3–25–19; 8:45 am]
BILLING CODE 4164–01–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.
jbell on DSK30RV082PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 28, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 28, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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Electronic Submissions
11309
comments only as a written/paper
submission. You should submit two
Submit electronic comments in the
copies total. One copy will include the
following way:
• Federal eRulemaking Portal: https:// information you claim to be confidential
with a heading or cover note that states
www.regulations.gov. Follow the
‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments.
CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically,
Agency will review this copy, including
including attachments, to https://
the claimed confidential information, in
www.regulations.gov will be posted to
its consideration of comments. The
the docket unchanged. Because your
second copy, which will have the
comment will be made public, you are
claimed confidential information
solely responsible for ensuring that your
redacted/blacked out, will be available
comment does not include any
for public viewing and posted on
confidential information that you or a
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third party may not wish to be posted,
both copies to the Dockets Management
such as medical information, your or
Staff. If you do not wish your name and
anyone else’s Social Security number, or
contact information to be made publicly
confidential business information, such
available, you can provide this
as a manufacturing process. Please note
information on the cover sheet and not
that if you include your name, contact
in the body of your comments and you
information, or other information that
must identify this information as
identifies you in the body of your
‘‘confidential.’’ Any information marked
comments, that information will be
as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov.
except in accordance with 21 CFR 10.20
• If you want to submit a comment
and other applicable disclosure law. For
with confidential information that you
more information about FDA’s posting
do not wish to be made available to the
of comments to public dockets, see 80
public, submit the comment as a
FR 56469, September 18, 2015, or access
written/paper submission and in the
the information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper
fdsys/pkg/FR-2015-09-18/pdf/2015Submissions’’ and ‘‘Instructions’’).
23389.pdf.
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
follows:
received, go to https://
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
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docket number, found in brackets in the
Management Staff (HFA–305), Food and
heading of this document, into the
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Dockets Management
• For written/paper comments
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management
Rockville, MD 20852.
Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
well as any attachments, except for
Domini Bean, Office of Operations,
information submitted, marked and
Food and Drug Administration, Three
identified, as confidential, if submitted
White Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Instructions: All submissions received Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
must include the Docket No. FDA–
fda.hhs.gov.
2013–N–0297 for ‘‘Agency Information
SUPPLEMENTARY INFORMATION: Under the
Collection Activities; Proposed
PRA (44 U.S.C. 3501–3520), Federal
Collection; Comment Request;
Agencies must obtain approval from the
Prevention of Salmonella Enteritidis in
Office of Management and Budget
Shell Eggs During Production;
(OMB) for each collection of
Recordkeeping and Registration
information they conduct or sponsor.
Provisions.’’ Received comments, those
‘‘Collection of information’’ is defined
filed in a timely manner (see
ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
and, except for those submitted as
or requirements that members of the
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov public submit reports, keep records, or
provide information to a third party.
or at the Dockets Management Staff
Section 3506(c)(2)(A) of the PRA (44
between 9 a.m. and 4 p.m., Monday
U.S.C. 3506(c)(2)(A)) requires Federal
through Friday.
Agencies to provide a 60-day notice in
• Confidential Submissions—To
the Federal Register concerning each
submit a comment with confidential
proposed collection of information,
information that you do not wish to be
including each proposed extension of an
made publicly available, submit your
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Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
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) (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,
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
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
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.
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).
Prevention Plan Design, § 118.10(a)(1) .........................
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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
9,462
1
52
4,731
492,024
350
1
350
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E:\FR\FM\26MRN1.SGM
0.5 (30 minutes)
0.5 (30 minutes)
20 ........................
26MRN1
2,366
246,012
7,000
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
11311
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
Cleaning and Disinfection Records, § 118.10(a)(3)(iii) ...
331
1
331
Total .........................................................................
........................
........................
........................
1 There
2 Some
0.5 (30 minutes)
.............................
Total hours
166
393,857
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.
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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
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.
Prevention plan review and
modifications (§ 118.10(a)(4)) also need
to be performed every time a house tests
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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).
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
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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
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
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§ 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
2 FDA
Registrations or Updates, § 118.11 .........
Cancellations, § 118.11 ............................
Total ..................................................
Number of
respondents
Form
Number of
responses per
respondent
Average burden
per response
Total annual
responses
Total hours
3733
FDA 3733
350
30
1
1
350
30
2.3
1
805
30
........................
........................
........................
........................
........................
835
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).
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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 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.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05757 Filed 3–25–19; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Appointment to the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
SUMMARY: The U.S. Department of
Health and Human Services (HHS) is
soliciting nominations of individuals
who are interested in being considered
for appointment to the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council) as a voting member or as a
non-voting liaison representative
member from an organization and/or
interest group. Nominations from
qualified individuals who wish to be
considered for appointment to either
member category of the Advisory
Council are currently being accepted.
Nominations must be received
no later than 5:00 p.m. ET on May 10,
2019.
DATES:
Information on how to
submit a nomination is on the Advisory
Council website, https://www.hhs.gov/
ash/carb/.
ADDRESSES:
PO 00000
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Fmt 4703
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FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, Designated Federal
Officer, Presidential Advisory Council
on Combating Antibiotic-Resistant
Bacteria, Office of the Assistant
Secretary for Health, U.S. Department of
Health and Human Services, Room
L133, Switzer Building, 330 C. St. SW,
Washington, DC 20201. Phone: (202)
690–5566; email: CARB@hhs.gov. The
Advisory Council charter may be
accessed online at https://www.hhs.gov/
ash/carb/. The charter includes detailed
information about the Advisory
Council’s purpose, function, and
structure.
Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees. The Advisory
Council will provide advice,
information, and recommendations to
the Secretary of HHS regarding
programs and policies intended to:
Preserve the effectiveness of antibiotics
by optimizing their use; advance
research to develop improved methods
for combating antibiotic resistance and
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11309-11312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05757]
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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.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 28, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0297 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prevention of Salmonella
Enteritidis in Shell Eggs During Production; Recordkeeping and
Registration Provisions.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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
[[Page 11310]]
existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
With respect to the following collection of information, FDA
invites 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) (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, 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 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Number of Average burden
Description and 21 CFR section recordkeepers records per Total annual per Total hours
\2\ recordkeeper records recordkeeping
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Refrigeration Records, Sec. 2,600 52 135,200 0.5 (30 67,600
118.10(a)(3)(iv). minutes).
Testing, Diversion, and 343 52 17,836 0.5 (30 8,918
Treatment Records, Sec. minutes).
118.10(a)(3)(v) through (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 (15 36,271
118.10(a)(3)(v) \3\. minutes).
Testing, Diversion, and 5,965 1 5,965 0.5 (30 2,983
Treatment Records, Sec. minutes).
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 4,731 1 4,731 0.5 (30 2,366
Records, Sec. 118.10(a)(2). minutes).
Rodent and Other Pest Control, 9,462 52 492,024 0.5 (30 246,012
Sec. 118.10(a)(3)(ii), and minutes).
Biosecurity Records, Sec.
118.10(a)(3)(i).
Prevention Plan Design, Sec. 350 1 350 20............. 7,000
118.10(a)(1).
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Cleaning and Disinfection 331 1 331 0.5 (30 166
Records, Sec. minutes).
118.10(a)(3)(iii).
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Total...................... .............. .............. .............. ............... 393,857
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\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 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 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
[[Page 11312]]
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\
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Number of
Description and 21 CFR section Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Registrations or Updates, Sec. 118.11................. \2\ FDA 3733 350 1 350 2.3 805
Cancellations, Sec. 118.11............................ FDA 3733 30 1 30 1 30
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Total............................................... .............. .............. .............. .............. .............. 835
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\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: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05757 Filed 3-25-19; 8:45 am]
BILLING CODE 4164-01-P
