Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use, 60900-60902 [2024-16617]
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Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
food defense activities, if any, Federal
and/or SLTT agencies have completed
(or are planning on completing) from
2024 to 2028. Planning for the local,
territorial, and tribal information
collections will commence during this
period of renewal. The survey will
continue to be repeated approximately
every 2 to 4 years, as described in
section 108 of FSMA. The NAFDS
survey is being administered for the
purpose of monitoring progress in food
and agricultural defense by government
agencies.
A purposive sampling strategy is
employed, such that the government
agencies participating in food and
agricultural defense are asked to
respond to the voluntary survey. Food
defense leaders responsible for
conducting food defense activities
during a food emergency for their
jurisdiction are identified and will
receive an emailed invitation to
complete the survey online; they will be
provided with a web link to the survey.
The survey will be conducted
electronically on the FDA.gov web
portal, and results will be analyzed by
the interagency working group.
Description of Respondents:
Respondents to this collection are SLTT
government representatives (survey
respondents) who are food defense
leaders responsible for conducting food
defense activities during a food
emergency for their jurisdictions.
In the Federal Register of March 26,
2024 (89 FR 20980), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
SLTT Surveys ................................................................
500
1
500
0.33 (20 minutes)
165
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Office of Partnerships
reviewed the questionnaire and
provided the estimate of time to
complete the survey. The total burden is
based on our previous experiences
conducting surveys. Based on a review
of the information collection since our
last request for OMB approval, we have
made no adjustments to our burden
estimate.
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16616 Filed 7–26–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2024–N–0758]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Plant Varieties
Intended for Food Use
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
SUMMARY:
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0583. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
collection of information by August 28,
2024.
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
New Plant Varieties Intended for Food
Use
OMB Control Number 0910–0583—
Extension
This information collection supports
recommendations found in FDA
guidance pertaining to new plant
varieties intended for food use.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
I. Consultation Procedures: Foods
Derived From New Plant Varieties; Form
FDA 3665
The Agency guidance document
entitled ‘‘Consultation Procedures under
FDA’s 1992 Statement of Policy for
Foods Derived From New Plant
Varieties’’ (October 1997), which is
available on our website at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-consultationprocedures-under-fdas-1992-statementpolicy-foods-derived-new-plant,
describes our consultation process for
the evaluation of information on new
plant varieties provided by developers.
We believe this consultation process
will help ensure that human and animal
food safety issues or other regulatory
issues (e.g., labeling) are resolved prior
to commercial distribution.
Additionally, such communication will
help to ensure that any potential food
safety issues regarding a new plant
variety are resolved during development
and will help to ensure that market
entry decisions by the industry are
made consistently and in full
compliance with the standards of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
Since 1992, when we issued our
‘‘Statement of Policy: Foods Derived
From New Plant Varieties’’ (the 1992
policy) (57 FR 22984, May 29, 1992), we
have encouraged developers of new
plant varieties, including those varieties
that are developed through
biotechnology, to consult with us during
the plant development process to
discuss possible scientific and
E:\FR\FM\29JYN1.SGM
29JYN1
60901
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
regulatory issues that might arise. In the
1992 policy, we explained that under
the FD&C Act developers of new foods
(in this document food refers to both
human and animal food) have a
responsibility to ensure that the foods
they offer to consumers are safe and in
compliance with all requirements of the
FD&C Act. To initiate a New Plant
Variety consultation (also known as a
Biotechnology Notification File (BNF)),
developers are encouraged to
electronically submit their scientific
information and data following a stepby-step process to complete Form FDA
3665, assemble their notification, and
send fully electronic submissions to
FDA via the Center for Food Safety and
Applied Nutrition Online Submission
Module (COSM), which may be
accessed at https://www.fda.gov/food/
registration-food-facilities-and-othersubmissions/cfsan-online-submissionmodule-cosm. Firms that prefer to
submit a paper notification in a paper
format of their choosing or as electronic
files on physical media with a paper
signature page, have the option to do so;
however, Form FDA 3665 prompts a
notifier to input the elements of a BNF
in a standard format that we will be able
to review efficiently. Form FDA 3665
may be accessed at https://www.fda.gov/
about-fda/reports-manuals-forms/forms.
II. Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use; Form FDA 3666
Since we issued the 1992 policy on
foods derived from new plant varieties,
including those varieties that are
developed through biotechnology, we
have encouraged developers of new
plant varieties to consult with us early
in the development process to discuss
possible scientific and regulatory issues
that might arise. The guidance, entitled
‘‘Recommendations for the Early Food
Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use’’ (June
2006), which is available on our website
at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industryrecommendations-early-food-safetyevaluation-new-non-pesticidal-proteinsproduced, continues to foster early
communication by encouraging
developers to submit to us their
evaluation of the food safety of their
new proteins. Such communication
helps to ensure that any potential food
safety issues regarding a new protein in
a new plant variety are resolved early in
development, prior to any possible
inadvertent introduction into the food
supply of the new protein.
We believe that any food safety
concern related to such material
entering the food supply would be
limited to the potential that a new
protein in food from the plant variety
could cause an allergic reaction in
susceptible individuals or could be a
toxin. The guidance describes the
procedures for early food safety
evaluation of new proteins produced by
new plant varieties, including
biotechnology-derived food plants, and
the procedures for communicating with
us about the safety evaluation. To
initiate an Early Food Safety Evaluation
consultation (also known as a New
Protein Consultation (NPC)), developers
are encouraged to electronically submit
their scientific information and data
following a step-by-step process to
complete Form FDA 3666, assemble
their notification, and send fully
electronic submissions to FDA via
COSM, which may be accessed at
https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/
cfsan-online-submission-module-cosm.
Firms that prefer to submit a paper NPC
in a paper format of their choosing or as
electronic files on physical media with
a paper signature page, have the option
to do so; however, Form FDA 3666
prompts a notifier to input the elements
of an NPC in a standard format that we
will be able to review efficiently. Form
FDA 3666 may be accessed at https://
www.fda.gov/about-fda/reportsmanuals-forms/forms.
Description of Respondents: The
respondents to this collection of
information are developers of new plant
varieties intended for food use.
In the Federal Register of March 12,
2024 (89 FR 17854), we published a 60day notice soliciting comment on the
proposed collection of information.
Several comments were received. Most
comments indicated that the
information collected was necessary and
had practical utility which allows FDA
to make decisions regarding food safety
and protection of the public’s health.
Some of the comments also indicated
that the use of automation such as
electronic forms made the process of
submitting information much quicker
and smoother for the respondent. Two
comments received were not related to
the PRA and are therefore not discussed.
No adjustments to our burden estimates
were made in response to the public
comments.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Agency guidance
recommendations;
information collection
Form
FDA No.
Number of
responses per
respondent
Number of
respondents
Total
annual
responses
Average
burden per
response
Total
hours
Consultation Procedures: Foods Derived From New Plant Varieties
Initial consultation ....................................
Final consultation .....................................
None
3,665
30
12
2
1
60
12
4
150
240
1,800
ddrumheller on DSK120RN23PROD with NOTICES1
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Six data components ...............................
3,666
6
1
6
20
120
Total ..................................................
........................
........................
........................
78
........................
2,160
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made minor
adjustments to update our burden
estimate to reflect recent annual
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
response rates (increased initial
consultations under the New Plant
Variety consultation procedures) and to
clarify the total number of responses
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
under the Early Food Safety Evaluation
procedures.
E:\FR\FM\29JYN1.SGM
29JYN1
60902
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 23 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
August 28, 2024.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
SUMMARY:
[FR Doc. 2024–16617 Filed 7–26–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3248]
Fosun Pharma USA Inc., et al.;
Withdrawal of Approval of 23
Abbreviated New Drug Applications
AGENCY:
Notice.
Food and Drug Administration,
HHS.
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in table 1 have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Drug
ANDA 073462 ..
ANDA 079045 ..
Tolmetin Sodium capsule, Equivalent to (EQ) 400 milligrams
(mg) base.
Tolmetin Sodium tablet, EQ 200 mg base ...............................
Tolmetin Sodium tablet, EQ 600 mg base ...............................
Ketorolac Tromethamine injectable, 15 mg/milliliters (mL) and
30 mg/mL.
Milrinone Lactate injectable, EQ 1 mg base/mL .......................
Haloperidol Lactate injectable, EQ 5 mg base/mL ...................
Haloperidol Lactate injectable, EQ 5 mg base/mL ...................
Citalopram Hydrobromide tablet, EQ 10 mg base, EQ 20 mg
base, EQ 40 mg base.
Fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400
mg/200 mL (2 mg/mL).
Granisetron Hydrochloride (HCl) injectable, EQ 0.1 mg base/
mL (EQ 0.1 mg base/mL).
Bicalutamide tablet, 50 mg .......................................................
ANDA
ANDA
ANDA
ANDA
ANDA
Trifluoperazine HCl concentrate, EQ 10 mg base/mL ..............
Cyproheptadine HCl tablet, 4 mg .............................................
Phenylbutazone capsule, 100 mg .............................................
Pseudoephedrine HCl; Triprolidine HCl tablet, 60 mg; 2.5.mg
Levofloxacin tablet, 250 mg, 500 mg, 750 mg .........................
ANDA 073588 ..
ANDA 074002 ..
ANDA 075631 ..
ANDA
ANDA
ANDA
ANDA
076427
076791
076828
077040
..
..
..
..
ANDA 077947 ..
ANDA 078197 ..
085787
086808
087774
088602
090367
..
..
..
..
..
ANDA 091049 ..
Ceftriaxone Sodium injectable, EQ 250 mg base/vial, EQ 500
mg base/vial, EQ 1 gram (g) base/vial, EQ 2 g base/vial.
ANDA 091436 ..
ANDA 207032 ..
ANDA 207101 ..
Levofloxacin injectable, EQ 500 mg/20 mL (EQ 25 mg/mL) ....
Melphalan HCl injectable, EQ 50 mg base/vial ........................
Sumatriptan Succinate injectable, EQ 6 mg base/0.5 mL (EQ
12 mg base/mL).
Clobazam tablet, 10 mg and 20 mg .........................................
Chlorzoxazone tablet, 375 mg and 750 mg .............................
Methocarbamol solution, 1 g/10 mL (100 mg/mL) ....................
ANDA 211959 ..
ANDA 212053 ..
ANDA 215065 ..
ddrumheller on DSK120RN23PROD with NOTICES1
Applicant
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of August 28,
2024. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from table 1.
Introduction or delivery for introduction
into interstate commerce of products
listed in table 1 without an approved
new drug application or ANDA violates
sections 505(a) and 301(d) of the Federal
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204,
Princeton, NJ 08540.
Do.
Do.
Baxter Healthcare Corp., One Baxter Parkway, Deerfield, IL
60015.
Do.
Do.
Do.
Fosun Pharma USA Inc.
Baxter Healthcare Corp.
Do.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
Fosun Pharma USA Inc.
Do.
Do.
Do.
Celltrion USA, Inc., U.S. Agent for Celltrion, Inc., One
Evertrust Plaza, Suite 1207, Jersey City, NJ 07302.
EAS Consulting Group, LLC, U.S. Agent for Astral SteriTech
Pvt. Ltd., 1700 Diagonal Rd., Suite 750, Alexandria, VA
22314.
Baxter Healthcare Corp.
USWM, LLC, 4441 Springdale Rd., Louisville, KY 40241.
Baxter Healthcare Corp.
Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.
AptaPharma Inc., 1533 Union Ave., Pennsauken, NJ 08110.
Baxter Healthcare Corp.
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in table 1 that are in inventory
on August 28, 2024 may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
PO 00000
Frm 00048
Fmt 4703
Sfmt 9990
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16627 Filed 7–26–24; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60900-60902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16617]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0758]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Plant Varieties
Intended for Food Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 28, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0583. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
New Plant Varieties Intended for Food Use
OMB Control Number 0910-0583--Extension
This information collection supports recommendations found in FDA
guidance pertaining to new plant varieties intended for food use.
I. Consultation Procedures: Foods Derived From New Plant Varieties;
Form FDA 3665
The Agency guidance document entitled ``Consultation Procedures
under FDA's 1992 Statement of Policy for Foods Derived From New Plant
Varieties'' (October 1997), which is available on our website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-consultation-procedures-under-fdas-1992-statement-policy-foods-derived-new-plant, describes our consultation
process for the evaluation of information on new plant varieties
provided by developers. We believe this consultation process will help
ensure that human and animal food safety issues or other regulatory
issues (e.g., labeling) are resolved prior to commercial distribution.
Additionally, such communication will help to ensure that any potential
food safety issues regarding a new plant variety are resolved during
development and will help to ensure that market entry decisions by the
industry are made consistently and in full compliance with the
standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Since 1992, when we issued our ``Statement of Policy: Foods Derived
From New Plant Varieties'' (the 1992 policy) (57 FR 22984, May 29,
1992), we have encouraged developers of new plant varieties, including
those varieties that are developed through biotechnology, to consult
with us during the plant development process to discuss possible
scientific and
[[Page 60901]]
regulatory issues that might arise. In the 1992 policy, we explained
that under the FD&C Act developers of new foods (in this document food
refers to both human and animal food) have a responsibility to ensure
that the foods they offer to consumers are safe and in compliance with
all requirements of the FD&C Act. To initiate a New Plant Variety
consultation (also known as a Biotechnology Notification File (BNF)),
developers are encouraged to electronically submit their scientific
information and data following a step-by-step process to complete Form
FDA 3665, assemble their notification, and send fully electronic
submissions to FDA via the Center for Food Safety and Applied Nutrition
Online Submission Module (COSM), which may be accessed at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm. Firms that prefer to submit a
paper notification in a paper format of their choosing or as electronic
files on physical media with a paper signature page, have the option to
do so; however, Form FDA 3665 prompts a notifier to input the elements
of a BNF in a standard format that we will be able to review
efficiently. Form FDA 3665 may be accessed at https://www.fda.gov/about-fda/reports-manuals-forms/forms.
II. Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use; Form FDA 3666
Since we issued the 1992 policy on foods derived from new plant
varieties, including those varieties that are developed through
biotechnology, we have encouraged developers of new plant varieties to
consult with us early in the development process to discuss possible
scientific and regulatory issues that might arise. The guidance,
entitled ``Recommendations for the Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by New Plant Varieties Intended for
Food Use'' (June 2006), which is available on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recommendations-early-food-safety-evaluation-new-non-pesticidal-proteins-produced, continues to foster early communication
by encouraging developers to submit to us their evaluation of the food
safety of their new proteins. Such communication helps to ensure that
any potential food safety issues regarding a new protein in a new plant
variety are resolved early in development, prior to any possible
inadvertent introduction into the food supply of the new protein.
We believe that any food safety concern related to such material
entering the food supply would be limited to the potential that a new
protein in food from the plant variety could cause an allergic reaction
in susceptible individuals or could be a toxin. The guidance describes
the procedures for early food safety evaluation of new proteins
produced by new plant varieties, including biotechnology-derived food
plants, and the procedures for communicating with us about the safety
evaluation. To initiate an Early Food Safety Evaluation consultation
(also known as a New Protein Consultation (NPC)), developers are
encouraged to electronically submit their scientific information and
data following a step-by-step process to complete Form FDA 3666,
assemble their notification, and send fully electronic submissions to
FDA via COSM, which may be accessed at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm. Firms that prefer to submit a paper NPC in a
paper format of their choosing or as electronic files on physical media
with a paper signature page, have the option to do so; however, Form
FDA 3666 prompts a notifier to input the elements of an NPC in a
standard format that we will be able to review efficiently. Form FDA
3666 may be accessed at https://www.fda.gov/about-fda/reports-manuals-forms/forms.
Description of Respondents: The respondents to this collection of
information are developers of new plant varieties intended for food
use.
In the Federal Register of March 12, 2024 (89 FR 17854), we
published a 60-day notice soliciting comment on the proposed collection
of information. Several comments were received. Most comments indicated
that the information collected was necessary and had practical utility
which allows FDA to make decisions regarding food safety and protection
of the public's health. Some of the comments also indicated that the
use of automation such as electronic forms made the process of
submitting information much quicker and smoother for the respondent.
Two comments received were not related to the PRA and are therefore not
discussed. No adjustments to our burden estimates were made in response
to the public comments.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Agency guidance recommendations; information collection Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation Procedures: Foods Derived From New Plant Varieties
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation.................................... None 30 2 60 4 240
Final consultation...................................... 3,665 12 1 12 150 1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Six data components..................................... 3,666 6 1 6 20 120
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 78 .............. 2,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made minor adjustments to update our
burden estimate to reflect recent annual response rates (increased
initial consultations under the New Plant Variety consultation
procedures) and to clarify the total number of responses under the
Early Food Safety Evaluation procedures.
[[Page 60902]]
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16617 Filed 7-26-24; 8:45 am]
BILLING CODE 4164-01-P
