Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards, 26528-26530 [2021-10180]
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Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact She-Chia Chen
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10181 Filed 5–13–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0306]
Determination That OVIDE (Malathion)
Lotion, 0.5%, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that OVIDE (malathion)
lotion, 0.5%, was not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6272,
Silver Spring, MD 20993–0002, 240–
825–9944, Kaetochi.Okemgbo@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
OVIDE (malathion) lotion, 0.5%, is
the subject of NDA 018613, held by Taro
Pharmaceutical Industries, Ltd., and
initially approved on August 2, 1982.
OVIDE is indicated for patients infected
with Pediculus humanus capitis (head
lice and their ova) of the scalp hair.
In a letter dated August 19, 2019, Taro
Pharmaceutical Industries Ltd. notified
FDA that OVIDE (malathion) lotion,
0.5%, was being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Encube Ethicals Private Ltd.
submitted a citizen petition dated
March 19, 2021 (Docket No. FDA–2021–
P–0306), under 21 CFR 10.30,
requesting that the Agency determine
whether OVIDE (malathion) lotion,
0.5%, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
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Fmt 4703
Sfmt 4703
based on the information we have at this
time, FDA has determined under
§ 314.161 that OVIDE (malathion)
lotion, 0.5% was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that OVIDE
(malathion) lotion, 0.5%, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of OVIDE
(malathion) lotion, 0.5%, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list OVIDE (malathion)
lotion, 0.5%, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to this drug product. Additional ANDAs
for this drug product may also be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10166 Filed 5–13–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0341]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Safety;
Federal-State Food Regulatory
Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
E:\FR\FM\14MYN1.SGM
14MYN1
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
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 revision 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 associated with FDA’s
Federal-State Food Regulatory Program
Standards.
Submit either electronic or
written comments on the collection of
information by July 13, 2021.
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 July 13, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 13, 2021. 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:
khammond on DSKJM1Z7X2PROD with NOTICES
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:
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
• 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–
2021–N–0341 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Safety; Federal-State Food Regulatory
Program Standards.’’ 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
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26529
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:
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. 3501–3521), 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 revision 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.
Food Safety; Federal-State Food
Regulatory Program Standards
OMB Control Number 0910–0760—
Revision
This information collection supports
implementation of FDA’s Federal-State
Regulatory Program Standards, part of
our National Integrated Food Safety
System (IFSS) Programs and Initiatives.
For more information we invite you to
E:\FR\FM\14MYN1.SGM
14MYN1
26530
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
visit our website at: https://
www.fda.gov/federal-state-local-tribaland-territorial-officials/nationalintegrated-food-safety-system-ifssprograms-and-initiatives. In the United
States, Federal and State governments
work cooperatively to ensure the safety
of food intended for both human and
animal consumption. Part of this effort
includes developing and maintaining
uniform review criteria by which to
assess food safety. FDA has established
and maintains a number of program
standards aimed at improving the safety
evaluation for certain food products
including manufactured foods and
animal feed. Similarly, we are
establishing regulatory program
standards for eggs and have developed
the ‘‘Eggs Regulatory Program
Standards’’ (ERPS). The ERPS is
intended for use by State and local
regulatory officials and identifies ten
elements we believe are essential to the
effective regulatory assessment of egg
safety. States are encouraged to build
systems that are sustainable and
implement plans corresponding to the
IFSS.
In the course of their normal duties,
State, local, Territorial, and Tribal
governments collect information
pertaining to compliance with the
respective State, local, Territorial, and
tribal food safety requirements within
their jurisdictions. Although content
and format of the information collected
may vary, these activities are a usual
and customary part of routine regulatory
oversight. Respondents to the
information collection are State, local,
Territorial, Tribal, and Federal
regulatory agencies participating in
FDA’s Voluntary National Retail Food
Regulatory Program Standards
(information collection currently
approved under OMB control number
0910–0621). Consistent with the ERPS,
respondents will submit the following
information to FDA: (1) Program selfassessment; (2) risk factor study of the
regulated industry; and (3) independent
outside audit (verification audit).
The ERPS offers forms, worksheets,
and templates to help respondents
assess and meet the program elements
identified and discussed. Respondents
are not required to use the sample
collection instruments included in the
ERPS, however all data elements should
be submitted to FDA and supporting
documentation retained. The ERPS is
not intended to address any
performance appraisal processes that
any State, local, Territorial, or tribal
agency may use to evaluate its
employees’ performance. Funding
opportunities are available to
respondents who choose to implement
the ERPS, however these opportunities
are limited and contingent upon the
availability of funds, and to those
respondents who currently have an egg
inspection contract with FDA and thus
subject to auditing. A copy of the ERPS
has been posted to FDA–2021–N–0341
and is available at https://
www.regulations.gov.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Respondents; information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
State, Local, Territorial, and/or Tribal Governments; submission of data elements to FDA consistent with ERPS
10
10
100
500
500,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our experience with similar
information collection, we estimate an
initial 10 respondents will participate in
the ERPS, and assume an average of 500
hours is necessary for the attendant
recordkeeping and submission of data
elements to FDA. We expect
participation in the ERPS to increase.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10180 Filed 5–13–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2021–N–0408]
Modified Risk Tobacco Product
Application: Application for the IQOS 3
System Holder and Charger Submitted
by Philip Morris Products S.A.
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of a
modified risk tobacco product
application (MRTPA) for the IQOS 3
System Holder and Charger submitted
by Philip Morris Products S.A.
DATES: Electronic or written comments
on the application may be submitted
beginning May 14, 2021. FDA will
establish a closing date for the comment
period as described in section I.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Food and Drug Administration
AGENCY:
ACTION:
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
PO 00000
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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
E:\FR\FM\14MYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26528-26530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0341]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Safety; Federal-State Food Regulatory Program
Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of
[[Page 26529]]
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 revision 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
associated with FDA's Federal-State Food Regulatory Program Standards.
DATES: Submit either electronic or written comments on the collection
of information by July 13, 2021.
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 July 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 13, 2021. 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-2021-N-0341 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Safety; Federal-State Food
Regulatory Program Standards.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: 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 revision 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.
Food Safety; Federal-State Food Regulatory Program Standards
OMB Control Number 0910-0760--Revision
This information collection supports implementation of FDA's
Federal-State Regulatory Program Standards, part of our National
Integrated Food Safety System (IFSS) Programs and Initiatives. For more
information we invite you to
[[Page 26530]]
visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives. In the United States, Federal and State
governments work cooperatively to ensure the safety of food intended
for both human and animal consumption. Part of this effort includes
developing and maintaining uniform review criteria by which to assess
food safety. FDA has established and maintains a number of program
standards aimed at improving the safety evaluation for certain food
products including manufactured foods and animal feed. Similarly, we
are establishing regulatory program standards for eggs and have
developed the ``Eggs Regulatory Program Standards'' (ERPS). The ERPS is
intended for use by State and local regulatory officials and identifies
ten elements we believe are essential to the effective regulatory
assessment of egg safety. States are encouraged to build systems that
are sustainable and implement plans corresponding to the IFSS.
In the course of their normal duties, State, local, Territorial,
and Tribal governments collect information pertaining to compliance
with the respective State, local, Territorial, and tribal food safety
requirements within their jurisdictions. Although content and format of
the information collected may vary, these activities are a usual and
customary part of routine regulatory oversight. Respondents to the
information collection are State, local, Territorial, Tribal, and
Federal regulatory agencies participating in FDA's Voluntary National
Retail Food Regulatory Program Standards (information collection
currently approved under OMB control number 0910-0621). Consistent with
the ERPS, respondents will submit the following information to FDA: (1)
Program self-assessment; (2) risk factor study of the regulated
industry; and (3) independent outside audit (verification audit).
The ERPS offers forms, worksheets, and templates to help
respondents assess and meet the program elements identified and
discussed. Respondents are not required to use the sample collection
instruments included in the ERPS, however all data elements should be
submitted to FDA and supporting documentation retained. The ERPS is not
intended to address any performance appraisal processes that any State,
local, Territorial, or tribal agency may use to evaluate its employees'
performance. Funding opportunities are available to respondents who
choose to implement the ERPS, however these opportunities are limited
and contingent upon the availability of funds, and to those respondents
who currently have an egg inspection contract with FDA and thus subject
to auditing. A copy of the ERPS has been posted to FDA-2021-N-0341 and
is available at https://www.regulations.gov.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Respondents; information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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State, Local, Territorial, and/or Tribal Governments; submission of 10 10 100 500 500,000
data elements to FDA consistent with ERPS.........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our experience with similar information collection, we
estimate an initial 10 respondents will participate in the ERPS, and
assume an average of 500 hours is necessary for the attendant
recordkeeping and submission of data elements to FDA. We expect
participation in the ERPS to increase.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10180 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P
