Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, 49108-49109 [2018-21148]
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49108
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Irradiation in the Production, Processing, and Handling of Food ...........................................................................
State Enforcement Notifications ..............................................................................................................................
Veterinary Feed Directive ........................................................................................................................................
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................
Quality Facility Attestation .......................................................................................................................................
Administrative Practices and Procedures; Formal Evidentiary Public Hearing ......................................................
Regulations Under the Federal Import Milk Act ......................................................................................................
Medical Device Reporting ........................................................................................................................................
Animal Food Labeling; Declaration of Certifiable Color Additives ..........................................................................
Evaluation of the Food and Drug Administration’s Fresh Empire Multicultural Youth Tobacco Prevention Campaign .....................................................................................................................................................................
National Agriculture and Food Defense Strategy Survey .......................................................................................
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–21209 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0438]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Early Food Safety
Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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: Fax written comments on the
collection of information by October 29,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0583. Also
include the FDA docket number found
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:22 Sep 27, 2018
Jkt 244001
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use
OMB Control Number 0910–0583—
Extension
Since May 29, 1992, when FDA
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,’’
(available at https://www.fda.gov/Food/
GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/
ucm096156.htm) continues to foster
early communication by encouraging
developers to submit to us their
evaluation of the food safety of their
new protein. Such communication
helps to ensure that any potential food
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0186
0910–0275
0910–0363
0910–0796
0910–0854
0910–0191
0910–0212
0910–0437
0910–0721
7/31/2021
7/31/2021
7/31/2021
7/31/2021
7/31/2021
8/31/2021
8/31/2021
8/31/2021
8/31/2021
0910–0788
0910–0855
8/31/2021
8/31/2021
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
recommended 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. Form FDA 3666 is entitled,
‘‘Early Food Safety Evaluation of a New
Non-Pesticidal Protein Produced by a
New Plant Variety (New Protein
Consultation),’’ (https://www.fda.gov/
downloads/AboutFDA/ReportsManuals
Forms/Forms/UCM350010.pdf) and may
be used in lieu of a cover letter for a
New Protein Consultation (NPC). 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
that would be prepared as attachments
to the form, may be submitted in
electronic format via the Electronic
Submission Gateway, or may be
submitted in paper format, or as
electronic files on physical media with
paper signature page. The information is
used by us to evaluate the food safety of
E:\FR\FM\28SEN1.SGM
28SEN1
49109
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
a specific new protein produced by a
new plant variety.
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 May 25,
2018 (83 FR 24315), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
but did not respond to any of the four
information collection topics solicited
and is therefore not addressed.
We therefore estimate the burden for
the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Category
Total
annual
responses
Average
burden per
response
Total hours
First four data components ......................
Two other data components ....................
3666
3666
6
6
1
1
6
6
4
16
24
96
Total ..................................................
........................
........................
........................
........................
........................
120
1 There
amozie on DSK3GDR082PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Form FDA No.
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 no
adjustments to our burden estimate. The
estimated number of annual responses
and average burden per response are
based on our experience with early food
safety evaluations. Completing an early
food safety evaluation for a new protein
from a new plant variety is a one-time
burden (one evaluation per new
protein). Many developers of novel
plants may choose not to submit an
evaluation because the field testing of a
plant containing a new protein is
conducted in such a way (e.g., on such
a small scale, or in such isolated
conditions, etc.) that cross-pollination
with traditional crops or commingling
of plant material is not likely to be an
issue. Also, other developers may have
previously communicated with us about
the food safety of a new plant protein,
for example, when the same protein was
expressed in a different crop.
We estimate the annual number of
NPCs submitted by developers will be
six or fewer. The early food safety
evaluation for new proteins includes six
main data components. Four of these
data components are easily and quickly
obtainable, having to do with the
identity and source of the protein. We
estimate that completing these data
components will take about 4 hours per
NPC. We estimate the reporting burden
for the first four data components to be
24 hours (4 hours × 6 responses).
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis which can be performed using
publicly available databases. The other
data component involves ‘‘wet’’ lab
work to assess the new protein’s
stability and the resistance of the
protein to enzymatic degradation using
appropriate in vitro assays (protein
digestibility study). The paperwork
burden of these two data components
VerDate Sep<11>2014
19:22 Sep 27, 2018
Jkt 244001
consists of the time it takes the company
to assemble the information on these
two data components and include it in
an NPC. We estimate that completing
these data components will take about
16 hours per NPC. We estimate the
reporting burden for the two other data
components to be 96 hours (16 hours ×
6 responses). Thus, we estimate the total
annual hour burden for this collection
of information to be 120 hours.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, Rm. 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240) 276–5484;
Facsimile: (240) 276–5504; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
[FR Doc. 2018–21148 Filed 9–27–18; 8:45 am]
Intellectual Property
BILLING CODE 4164–01–P
Group A
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cell Therapies
for Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this Notice to Tailored
Therapeutics, LLC. (‘‘Tailored’’), located
in Potomac, MD.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before October 15, 2018 will be
considered.
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
E–028–2015: Anti-Mutated KRAS T Cell
Receptors
1. U.S. Provisional Patent Application
62/084,654, filed November 26, 2014
(E–028–2015–0–US–01);
2. International Patent Application
PCT/US2015/062269, filed November
24, 2015 (E–028–2015–1–PCT–01);
3. Australian Patent Application
2015353720, filed May 18, 2017 (E–028–
2015–1–AU–02);
4. Canadian Patent Application
2968399, filed May 18, 2017 (E–028–
2015–1–CA–03);
5. Chinese Patent Application
201580070673.7, filed June 23, 2017 (E–
028–2015–1–CN–04);
6. European Patent Application
15807756.0 filed June 23, 2017 (E–028–
2015–1–EP–05);
7. Israeli Patent Application 252258,
filed May 14, 2017 (E–028–2015–1–IL–
06);
8. Japanese Patent Application
527874/2017, filed May 24, 2017 (E–
028–2015–1–JP–07);
9. Korean Patent Application 2017–
7017289, filed June 23, 2017 (E–028–
2015–1–KR–08);
10. Mexican Patent Application MX/
a/2017/006865, filed May 25, 2017 (E–
028–2015–1–MX–09);
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49108-49109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21148]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0438]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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: Fax written comments on the collection of information by October
29, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 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.
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food Use
OMB Control Number 0910-0583--Extension
Since May 29, 1992, when FDA 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,'' (available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm096156.htm) continues to foster early communication by encouraging
developers to submit to us their evaluation of the food safety of their
new protein. 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 recommended 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. Form FDA 3666 is entitled, ``Early Food
Safety Evaluation of a New Non-Pesticidal Protein Produced by a New
Plant Variety (New Protein Consultation),'' (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350010.pdf) and may be
used in lieu of a cover letter for a New Protein Consultation (NPC).
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 that would be prepared as attachments to the form, may be
submitted in electronic format via the Electronic Submission Gateway,
or may be submitted in paper format, or as electronic files on physical
media with paper signature page. The information is used by us to
evaluate the food safety of
[[Page 49109]]
a specific new protein produced by a new plant variety.
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 May 25, 2018 (83 FR 24315), we published
a 60-day notice requesting public comment on the proposed collection of
information. One comment was received but did not respond to any of the
four information collection topics solicited and is therefore not
addressed.
We therefore estimate the burden for the information collection as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Category Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components.............................. 3666 6 1 6 4 24
Two other data components............................... 3666 6 1 6 16 96
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 no adjustments to our burden
estimate. The estimated number of annual responses and average burden
per response are based on our experience with early food safety
evaluations. Completing an early food safety evaluation for a new
protein from a new plant variety is a one-time burden (one evaluation
per new protein). Many developers of novel plants may choose not to
submit an evaluation because the field testing of a plant containing a
new protein is conducted in such a way (e.g., on such a small scale, or
in such isolated conditions, etc.) that cross-pollination with
traditional crops or commingling of plant material is not likely to be
an issue. Also, other developers may have previously communicated with
us about the food safety of a new plant protein, for example, when the
same protein was expressed in a different crop.
We estimate the annual number of NPCs submitted by developers will
be six or fewer. The early food safety evaluation for new proteins
includes six main data components. Four of these data components are
easily and quickly obtainable, having to do with the identity and
source of the protein. We estimate that completing these data
components will take about 4 hours per NPC. We estimate the reporting
burden for the first four data components to be 24 hours (4 hours x 6
responses).
Two data components ask for original data to be generated. One data
component consists of a bioinformatics analysis which can be performed
using publicly available databases. The other data component involves
``wet'' lab work to assess the new protein's stability and the
resistance of the protein to enzymatic degradation using appropriate in
vitro assays (protein digestibility study). The paperwork burden of
these two data components consists of the time it takes the company to
assemble the information on these two data components and include it in
an NPC. We estimate that completing these data components will take
about 16 hours per NPC. We estimate the reporting burden for the two
other data components to be 96 hours (16 hours x 6 responses). Thus, we
estimate the total annual hour burden for this collection of
information to be 120 hours.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21148 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P
