Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions, 2797-2800 [2022-00863]
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Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
Bldg., 725 17th St. NW, Rm. 10235,
Washington, DC 20503, Attn: OMB Desk
Officer for ACL.
FOR FURTHER INFORMATION CONTACT:
Peter Nye, Administration for
Community Living, Washington, DC
20201, (202) 795–7606 or
OILPPRAComments@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. The
Administration for Community Living
(ACL) is requesting approval to collect
data for information collection
requirements related to Centers for
Independent Living Program
Performance Report (CIL PPR) (0985–
0061). In the context of ACL, IL
programs are supported through funding
authorized by the Rehabilitation Act of
1973, as amended (The Act). Title VII,
chapter 1 of the Act states the current
purpose of the program is to ‘‘promote
a philosophy of independent living
including a philosophy of consumer
control, peer support, self-help, selfdetermination, equal access, and
individual and system advocacy, in
order to maximize the leadership,
empowerment, independence, and
productivity of individuals with
disabilities, and the integration and full
inclusion of individuals with
disabilities into the mainstream of
American society.’’
The CIL PPR is submitted annually by
all CILs receiving IL Part C funds. The
PPRs are used by ACL to assess
grantees’ compliance with title VII of
the Act, and with 45 CFR 1329 of the
Code of Federal Regulations and with
applicable provisions of the HHS
Regulations at 45 CFR part 75. The PPR
serves as the primary basis for ACL’s
monitoring activities in fulfillment of its
responsibilities under sections 706 and
722 of the Act. The PPR also enables
ACL to track performance outcomes and
efficiency measures of the CIL programs
with respect to the annual and longterm performance targets established in
compliance with GPRA. The PPR is also
used by ACL to design CIL and
Statewide Independent Living Council
training and technical assistance
programs authorized by section 711A
and section 721 of the Act.
The CARES Act PPR is submitted
annually by all CILs receiving CARES
Act funds. The CARES Act requires ACL
grantees that receive CARES Act
funding to report quarterly, to ACL and
to the Pandemic Response
Accountability Committee, ‘‘the total
amount of large covered funds that the
grantee received from ACL; the amount
of large covered funds received that
were expended or obligated for each
project or activity; a detailed list of all
projects or activities for which large
covered funds were expended or
obligated, including the name of the
project or activity; a description . . . ;
and the estimated number of jobs
created or retained by the project or
activity, where applicable; and detailed
information on any subcontracts or
Subgrants . . .’’ Coronavirus Aid,
Number of
respondents
Comments in Response to the 60-Day
Federal Register Notice
A notice was published in the Federal
Register on August 9, 2021 (Vol. 86,
Number 2021–16752; pp. 43549–43550).
We received no comments during the
60-day comment period.
Estimated Program Burden: ACL
estimates the burden of this collection
of information as follows: The twohundred ninety Part C CILs will
complete 353 CIL PPRs annually, and it
will take an estimated 35 hours per CIL
per CIL PPR for an estimated total of
12,355 hours. Two-hundred ninety CILs
will each complete CARES Act PPRs,
and it will take an estimated forty-six
hours per CIL per CARES Act PPR. The
two-hundred ninety Part C CILs will
take an estimated 13,340 hours to
complete CARES Act PPRs. The twohundred ninety Part C CILs will spend
an estimated 25,695 hours completing
CIL PPRs and CARES Act PPRs. These
burden estimates are based on ACL’s
estimate of the average time required to
collect the information collected in the
PPR and feedback from CILs on the time
needed to complete the PPR.
Responses
per
respondent
Hours per
response
Total Annual
burden hours
Respondent
Data collection activity
CILs ...................................................
CILs ...................................................
CIL PPR ...........................................
CARES Act PPR ..............................
353
290
1
1
35
46
12,355
13,340
CILs ...................................................
Total ..........................................
........................
2
81
25,695
Dated: January 12, 2022.
Alison Barkoff,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–00892 Filed 1–18–22; 8:45 am]
Food and Drug Administration
BILLING CODE 4154–01–P
[Docket No. FDA–2013–N–0297]
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Relief, and Economic Security Act,
Public Law 116–136, H.R. 748 15011(a–
b), 116th Cong. (2020).
The current version of the CIL PPR
(that includes the CARES Act PPR) that
OILP is requesting an extension for was
approved by OMB; the approval was
extended and will expire on January 31,
2022.
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:
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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.
SUMMARY:
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Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
Submit either electronic or
written comments on the collection of
information by March 21, 2022.
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 March 21,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 21, 2022. 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.
DATES:
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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
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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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, 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.
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
This information collection supports
Agency regulations in part 118 (21 CFR
part 118), Production, Storage, and
Transportation of Shell Eggs, and Form
FDA 3733, Shell Egg Producer
Registration Form. 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
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Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
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, shell egg producers
are required to implement measures to
prevent Salmonella Enteritidis (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 about 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, fax or CD–ROM.
For more information, we invite you to
visit our website at https://www.fda.gov/
food/registration-food-facilities-andother-submissions/shell-egg-producerregistration.
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
quickly notify 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers 2
Activity; 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 ............................................................................................
1 There
2 Some
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
4,731
9,462
1
1
52
331
4,731
492,024
10 ................................
0.5 (30 minutes) .........
0.5 (30 minutes) .........
3,310
2,366
246,012
350
331
1
1
350
331
20 ................................
0.5 (30 minutes) .........
7,000
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.
3 Calculations
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average
burden per
response
Activity; 21 CFR section
Form
Registrations or Updates; § 118.11 .......................................
Cancellations; § 118.11 .........................................................
FDA 3733 2 ........
FDA 3733 ..........
350
30
1
1
350
30
2.3
1
805
30
Total ...............................................................................
...........................
........................
........................
........................
........................
835
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 3733’’ refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is
available at https://www.access.fda.gov per § 118.11(b)(1).
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Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. Our
estimates for the recordkeeping burden
and the reporting burden are based on
our experience with similar
recordkeeping activities and the number
of registrations and cancellations
received in the past 3 years.
Dated: January 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00863 Filed 1–18–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the Public
Health Service Act and the Federal
Advisory Committee Act, this notice
announces that the Advisory Committee
on Heritable Disorders in Newborns and
Children (ACHDNC or Committee) has
scheduled a public meeting to be held
on Thursday, February 10, 2022, and
Friday, February 11, 2022. Information
about the ACHDNC and the agenda for
this meeting can be found on the
ACHDNC website at https://
www.hrsa.gov/advisory-committees/
heritable-disorders/.
DATES: Thursday, February 10, 2022,
from 10:00 a.m.–3:00 p.m. Eastern Time
(ET) and Friday, February 11, 2022,
from 10 a.m.–2:30 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required.
Please visit the ACHDNC website for
information on registration: https://
www.hrsa.gov/advisory-committees/
heritable-disorders/. The
deadline for registration is 12:00 p.m.
ET on February 9, 2022. Instructions on
how to access the meeting via webcast
will be provided upon registration.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Room 18W66, Rockville,
Maryland 20857; 301–443–0721; or
ACHDNC@hrsa.gov.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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ACHDNC
provides advice and recommendations
to the Secretary of Health and Human
Services (Secretary) on the development
of newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. The ACHDNC
reviews and reports regularly on
newborn and childhood screening
practices, recommends improvements in
the national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening on
the Recommended Uniform Screening
Panel (RUSP), following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in the comprehensive guidelines
supported by HRSA pursuant to section
2713 of the Public Health Service Act
(42 U.S.C. 300gg–13). Under this
provision, non-grandfathered group
health plans and health insurance
issuers offering non-grandfathered
group or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
During the February 10–11, 2022
meeting, ACHDNC will hear from
experts in the fields of public health,
medicine, heritable disorders, rare
disorders, and newborn screening.
Agenda items include the following:
(1) Final evidence-based review report
on the Mucopolysaccharidosis type II
(MPS II) condition nomination for
possible inclusion on the RUSP.
Following this report, the ACHDNC
expects to vote on whether to
recommend to the Secretary adding
MPS II to the RUSP.
(2) A presentation on phase two of the
evidence-based review for
Guanidinoacetate methyltransferase
(GAMT) deficiency.
(3) An update on the Krabbe disease
condition nomination.
(4) A possible vote on whether to
move Krabbe disease forward to full
evidence-based review.
(5) Overview of ACHDNC consumerfriendly resources.
(6) A presentation on healthy equity
in newborn screening.
The agenda for this meeting includes
a potential vote which may lead to a
decision to recommend a nominated
condition (MPS II) to the RUSP. As
SUPPLEMENTARY INFORMATION:
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noted in the agenda items, the
Committee may hold a vote on whether
or not to recommend a nominated
condition (Krabbe disease) to full
evidence-based review, and will hear
presentations on the evidence-based
review for Guanidinoacetate
methyltransferase deficiency, any of
which may lead to a recommendation to
add or not add a condition/conditions to
the RUSP at a future time.
Agenda items are subject to change as
priorities dictate. Information about the
ACHDNC, including a roster of members
and past meeting summaries, is also
available on the ACHDNC website listed
above.
Members of the public also will have
the opportunity to provide comments.
Public participants providing oral
comments may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Subject to change: Members of the
public registered to submit oral public
comments on MPS II are tentatively
scheduled to provide their statements
on Thursday, February 10, 2022.
Members of the public registered to
provide statements on all other newborn
screening related topics are tentatively
scheduled for Friday, February 11, 2022.
Requests to provide a written statement
or make oral comments to the ACHDNC
must be submitted via the registration
website by 12:00 p.m. ET on Friday,
February 4, 2022.
Individuals who need special
assistance or another reasonable
accommodation should notify Alaina
Harris at the address and phone number
listed above at least 10 business days
prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–00896 Filed 1–18–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Publication of the Trusted
Exchange Framework and Common
Agreement
Office of the National
Coordinator for Health Information
Technology, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
This notice fulfills an
obligation under the Public Health
Service Act (PHSA), which requires the
SUMMARY:
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2797-2800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00863]
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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.
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DATES: Submit either electronic or written comments on the collection
of information by March 21, 2022.
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 March 21, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 21, 2022. 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, 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
This information collection supports Agency regulations in part 118
(21 CFR part 118), Production, Storage, and Transportation of Shell
Eggs, and Form FDA 3733, Shell Egg Producer Registration Form. 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
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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, shell egg producers are required to implement
measures to prevent Salmonella Enteritidis (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 about 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, fax or CD-ROM. For more
information, we invite you to visit our website at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration.
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 quickly notify 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers \2\ recordkeeper records
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Refrigeration Records; Sec. 2,600 52 135,200 0.5 (30 minutes)....................... 67,600
118.10(a)(3)(iv).
Testing, Diversion, and Treatment Records; 343 52 17,836 0.5 (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. 6,308 23 145,084 0.25 (15 minutes)...................... 36,271
118.10(a)(3)(v) \3\.
Testing, Diversion, and Treatment Records; 5,965 1 5,965 0.5 (30 minutes)....................... 2,983
Sec. 118.10(a)(3)(v) through (viii)
(negative) \3\.
Prevention Plan Review and Modifications; 331 1 331 10..................................... 3,310
Sec. 118.10(a)(4).
Chick and Pullet Procurement Records; Sec. 4,731 1 4,731 0.5 (30 minutes)....................... 2,366
118.10(a)(2).
Rodent and Other Pest Control; Sec. 9,462 52 492,024 0.5 (30 minutes)....................... 246,012
118.10(a)(3)(ii), and Biosecurity Records,
Sec. 118.10(a)(3)(i).
Prevention Plan Design; Sec. 118.10(a)(1). 350 1 350 20..................................... 7,000
Cleaning and Disinfection Records; Sec. 331 1 331 0.5 (30 minutes)....................... 166
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.
Table 2--Estimated Annual Reporting Burden\1\
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Number of
Activity; 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. FDA 3733 \2\.................. 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).
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Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimates for the recordkeeping burden and the reporting
burden are based on our experience with similar recordkeeping
activities and the number of registrations and cancellations received
in the past 3 years.
Dated: January 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00863 Filed 1-18-22; 8:45 am]
BILLING CODE 4164-01-P
