Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use, 34765-34767 [2021-13953]
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Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices
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effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, BALVERSA
(erdafitinib) indicated for the treatment
of adult patients with locally advanced
or metastatic urothelial carcinoma that
has susceptible FGFR3 or FGFR2 genetic
alterations and progressed during or
following at least one line of prior
platinum-containing chemotherapy
including within 12 months of
neoadjuvant or adjuvant platinumcontaining chemotherapy. Patients are
selected for therapy based on an FDAapproved companion diagnostic for
BALVERSA. This indication is
approved under accelerated approval
based on tumor response rate.
Continued approval for this indication
may be contingent upon verification and
description of clinical benefit in
confirmatory trials. Subsequent to this
approval, the USPTO received a patent
term restoration application for
BALVERSA (U.S. Patent No. 8,895,601)
from Astex Therapeutics Ltd. and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
January 4, 2021, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
BALVERSA represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
BALVERSA is 2,179 days. Of this time,
1,972 days occurred during the testing
phase of the regulatory review period,
while 207 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under section
505(i) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(i))
VerDate Sep<11>2014
17:47 Jun 29, 2021
Jkt 253001
became effective: April 26, 2013. FDA has
verified the applicant’s claim that the date
the investigational new drug application
became effective was on April 26, 2013.
2. The date the application was initially
submitted with respect to the human drug
product under section 505 of the FD&C Act:
September 18, 2018. FDA has verified the
applicant’s claim that the new drug
application (NDA) for BALVERSA (NDA
212018) was initially submitted on
September 18, 2018.
3. The date the application was approved:
April 12, 2019. FDA has verified the
applicant’s claim that NDA 212018 was
approved on April 12, 2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 691 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13973 Filed 6–29–21; 8:45 am]
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34765
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1207]
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.
The Food and Drug
Administration (FDA, Agency, or we) 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 July 30,
2021.
SUMMARY:
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:
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—
Revision
This information collection supports
recommendations found in Agency
guidance pertaining to new plant
varieties intended for food use.
Respondents to the collection of
information are developers of new plant
varieties intended for food use.
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34766
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices
I. Consultation Procedures: Foods
Derived From New Plant Varieties;
Form FDA 3665
The Agency guidance document
entitled ‘‘Guidance on Consultation
Procedures: Foods Derived From New
Plant Varieties,’’ which is available on
our website at https://www.fda.gov/
FoodGuidances, 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 all 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 FDA issued its
‘‘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 FDA
during the plant development process to
discuss possible scientific and
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 (57 FR 22984 at 22985).
Respondents may use Form FDA 3665,
submitted via the Electronic
Submissions Gateway (https://
www.fda.gov/industry/electronicsubmissions-gateway), to request
consultation.
II. Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use; Form FDA 3666
Since May 29, 1992, when we issued
a policy statement 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 (57 FR 22984). The guidance
entitled ‘‘Recommendations for the
Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use’’ (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
bioengineered food plants, and the
procedures for communicating with us
about the safety evaluation.
Interested persons may use Form FDA
3666 to transmit their submission to the
Office of Food Additive Safety in the
Center for Food Safety and Applied
Nutrition (CFSAN). Form FDA 3666 is
entitled ‘‘Early Food Safety Evaluation
of a New Non-Pesticidal Protein
Produced by a New Plant Variety (New
Protein Consultation)’’ and may be used
in lieu of a cover letter for a New
Protein Consultation (NPC). The form
may be accessed at FDA’s web page for
forms (https://www.fda.gov/about-fda/
reports-manuals-forms/forms) using the
search term ‘‘3666.’’ To enable fieldfillable functionality of FDA forms, they
must be downloaded. Form FDA 3666
prompts a submitter to include certain
elements of an NPC in a standard format
and helps the respondent organize their
submission to focus on the information
needed for our safety review. The form,
and elements prepared as attachments
to the form, may be prepared using the
CFSAN Online Submission Module
(https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/
cfsan-online-submission-module-cosm).
Once the submission is prepared, it may
be submitted in electronic format via the
Electronic Submissions Gateway
(https://www.fda.gov/industry/
electronic-submissions-gateway), paper
format, or as electronic files on physical
media with paper signature page.
In the Federal Register of November
23, 2020 (85 FR 74734), we published a
60-day notice requesting public
comment on information collection
associated with the guidance document
‘‘Recommendations for the Early Food
Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use.’’ No
comments were received.
In the Federal Register of March 4,
2021 (86 FR 12688), we published a 60day notice requesting public comment
on information collection associated
with the guidance document ‘‘Early
Food Safety Evaluation of New NonPesticidal Proteins Produced by New
Plant Varieties Intended for Food Use.’’
No comments were received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Agency guidance recommendations;
information collection
Form FDA No.
Number of
responses per
respondent
Number of
responses
Average
burden per
response
Total annual
responses
Total hours
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Consultation Procedures: Foods Derived From New Plant Varieties
Initial consultation ....................................
Final consultation .....................................
None
3665
20
12
2
1
40
12
4
150
160
1,800
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
First four data components ......................
Two other data components ....................
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3666
3666
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1
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16
24
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Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices
34767
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Agency guidance recommendations;
information collection
Total ..................................................
1There
Form FDA No.
Number of
responses
Number of
responses per
respondent
........................
........................
........................
Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13953 Filed 6–29–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–2192; FDA–
2020–E–2194; FDA–2020–E–2195]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; OXBRYTA
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for OXBRYTA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 30, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
64
Average
burden per
response
........................
Total hours
2,080
are no capital costs or operating and maintenance costs associated with this collection of information.
For efficiency of Agency operations,
we are consolidating these related
information collections. We retain our
estimate of burden associated with the
individual collection activities but have
increased burden in OMB control
number 0910–0583 by 52 responses and
1,960 hours annually to reflect the
reorganization of the information
collection. Upon OMB approval of our
request, we intend to discontinue OMB
control number 0910–0704.
ACTION:
Total annual
responses
VerDate Sep<11>2014
17:47 Jun 29, 2021
Jkt 253001
December 27, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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 August 30,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 30, 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.
PO 00000
Frm 00055
Fmt 4703
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• 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 Nos. FDA–
2020–E–2192; FDA–2020–E–2194; and
FDA–2020–E–2195, for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
OXBRYTA.’’ 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 § 10.20 (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.
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]]>Agencies
[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34765-34767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13953]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1207]
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, Agency, or we) 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 July 30, 2021.
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--Revision
This information collection supports recommendations found in
Agency guidance pertaining to new plant varieties intended for food
use. Respondents to the collection of information are developers of new
plant varieties intended for food use.
[[Page 34766]]
I. Consultation Procedures: Foods Derived From New Plant Varieties;
Form FDA 3665
The Agency guidance document entitled ``Guidance on Consultation
Procedures: Foods Derived From New Plant Varieties,'' which is
available on our website at https://www.fda.gov/FoodGuidances,
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
all 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 FDA issued its ``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 FDA during the plant development process to discuss
possible scientific and 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 (57 FR
22984 at 22985). Respondents may use Form FDA 3665, submitted via the
Electronic Submissions Gateway (https://www.fda.gov/industry/electronic-submissions-gateway), to request consultation.
II. Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use; Form FDA 3666
Since May 29, 1992, when we issued a policy statement 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 (57
FR 22984). The guidance entitled ``Recommendations for the Early Food
Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use'' (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 bioengineered food plants,
and the procedures for communicating with us about the safety
evaluation.
Interested persons may use Form FDA 3666 to transmit their
submission to the Office of Food Additive Safety in the Center for Food
Safety and Applied Nutrition (CFSAN). Form FDA 3666 is entitled ``Early
Food Safety Evaluation of a New Non-Pesticidal Protein Produced by a
New Plant Variety (New Protein Consultation)'' and may be used in lieu
of a cover letter for a New Protein Consultation (NPC). The form may be
accessed at FDA's web page for forms (https://www.fda.gov/about-fda/reports-manuals-forms/forms) using the search term ``3666.'' To enable
field-fillable functionality of FDA forms, they must be downloaded.
Form FDA 3666 prompts a submitter to include certain elements of an NPC
in a standard format and helps the respondent organize their submission
to focus on the information needed for our safety review. The form, and
elements prepared as attachments to the form, may be prepared using the
CFSAN Online Submission Module (https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm). Once the submission is prepared, it may be submitted in
electronic format via the Electronic Submissions Gateway (https://www.fda.gov/industry/electronic-submissions-gateway), paper format, or
as electronic files on physical media with paper signature page.
In the Federal Register of November 23, 2020 (85 FR 74734), we
published a 60-day notice requesting public comment on information
collection associated with the guidance document ``Recommendations for
the Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use.'' No comments
were received.
In the Federal Register of March 4, 2021 (86 FR 12688), we
published a 60-day notice requesting public comment on information
collection associated with the guidance document ``Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use.'' No comments were received.
We estimate the burden of the information collection 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
responses respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation Procedures: Foods Derived From New Plant Varieties
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation.................................... None 20 2 40 4 160
Final consultation...................................... 3665 12 1 12 150 1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components.............................. 3666 6 1 6 4 24
Two other data components............................... 3666 6 1 6 16 96
-----------------------------------------------------------------------------------------------
[[Page 34767]]
Total............................................... .............. .............. .............. 64 .............. 2,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
1There are no capital costs or operating and maintenance costs associated with this collection of information.
For efficiency of Agency operations, we are consolidating these
related information collections. We retain our estimate of burden
associated with the individual collection activities but have increased
burden in OMB control number 0910-0583 by 52 responses and 1,960 hours
annually to reflect the reorganization of the information collection.
Upon OMB approval of our request, we intend to discontinue OMB control
number 0910-0704.
Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13953 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P
