83 FR 49108 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 189 (September 28, 2018)

Page Range		49108-49109
FR Document		2018-21148

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.

Federal Register, Volume 83 Issue 189 (Friday, September 28, 2018)

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49108-49109]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-21148]

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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 oira_submission@omb.eop.gov. 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,
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/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

Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49109

a specific new protein produced by a In the Federal Register of May 25, but did not respond to any of the four
new plant variety. 2018 (83 FR 24315), we published a 60- information collection topics solicited
Description of Respondents: The day notice requesting public comment and is therefore not addressed.
respondents to this collection of on the proposed collection of We therefore estimate the burden for
information are developers of new plant information. One comment was received the information collection as follows:
varieties intended for food use.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Category Form FDA No. responses per annual burden per Total hours
respondents respondent responses 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 consists of the time it takes the company ADDRESSES: Requests for copies of the
collection since our last request for to assemble the information on these patent applications, inquiries, and
OMB approval, we have made no two data components and include it in comments relating to the contemplated
adjustments to our burden estimate. The an NPC. We estimate that completing Exclusive Patent License should be
estimated number of annual responses these data components will take about directed to: Andrew Burke, Senior
and average burden per response are 16 hours per NPC. We estimate the Technology Transfer Manager, NCI
based on our experience with early food reporting burden for the two other data Technology Transfer Center, 9609
safety evaluations. Completing an early components to be 96 hours (16 hours × Medical Center Drive, Rm. 1E530, MSC
food safety evaluation for a new protein 6 responses). Thus, we estimate the total 9702, Bethesda, MD 20892–9702 (for
from a new plant variety is a one-time annual hour burden for this collection business mail), Rockville, MD 20850–
burden (one evaluation per new of information to be 120 hours. 9702; Telephone: (240) 276–5484;
protein). Many developers of novel Dated: September 25, 2018. Facsimile: (240) 276–5504; Email:
plants may choose not to submit an andy.burke@nih.gov.
Leslie Kux,
evaluation because the field testing of a SUPPLEMENTARY INFORMATION:
plant containing a new protein is Associate Commissioner for Policy.
conducted in such a way (e.g., on such [FR Doc. 2018–21148 Filed 9–27–18; 8:45 am] Intellectual Property
a small scale, or in such isolated BILLING CODE 4164–01–P
Group A
conditions, etc.) that cross-pollination
with traditional crops or commingling E–028–2015: Anti-Mutated KRAS T Cell
of plant material is not likely to be an DEPARTMENT OF HEALTH AND Receptors
issue. Also, other developers may have HUMAN SERVICES 1. U.S. Provisional Patent Application
previously communicated with us about 62/084,654, filed November 26, 2014
National Institutes of Health
the food safety of a new plant protein, (E–028–2015–0–US–01);
for example, when the same protein was Prospective Grant of an Exclusive 2. International Patent Application
expressed in a different crop. Patent License: Development and PCT/US2015/062269, filed November
We estimate the annual number of Commercialization of Cell Therapies 24, 2015 (E–028–2015–1–PCT–01);
NPCs submitted by developers will be 3. Australian Patent Application
for Cancer
six or fewer. The early food safety 2015353720, filed May 18, 2017 (E–028–
evaluation for new proteins includes six AGENCY: National Institutes of Health, 2015–1–AU–02);
main data components. Four of these HHS. 4. Canadian Patent Application
data components are easily and quickly 2968399, filed May 18, 2017 (E–028–
obtainable, having to do with the ACTION: Notice.
2015–1–CA–03);
identity and source of the protein. We 5. Chinese Patent Application
SUMMARY: The National Cancer Institute,
estimate that completing these data 201580070673.7, filed June 23, 2017 (E–
an institute of the National Institutes of
components will take about 4 hours per 028–2015–1–CN–04);
Health, Department of Health and
NPC. We estimate the reporting burden 6. European Patent Application
Human Services, is contemplating the
for the first four data components to be 15807756.0 filed June 23, 2017 (E–028–
grant of an Exclusive Patent License to
24 hours (4 hours × 6 responses). 2015–1–EP–05);
Two data components ask for original practice the inventions embodied in the
7. Israeli Patent Application 252258,
data to be generated. One data Patents and Patent Applications listed
filed May 14, 2017 (E–028–2015–1–IL–
component consists of a bioinformatics in the SUPPLEMENTARY INFORMATION
06);
analysis which can be performed using section of this Notice to Tailored
8. Japanese Patent Application
publicly available databases. The other Therapeutics, LLC. (‘‘Tailored’’), located
527874/2017, filed May 24, 2017 (E–
amozie on DSK3GDR082PROD with NOTICES1

data component involves ‘‘wet’’ lab in Potomac, MD.
028–2015–1–JP–07);
work to assess the new protein’s DATES: Only written comments and/or 9. Korean Patent Application 2017–
stability and the resistance of the applications for a license which are 7017289, filed June 23, 2017 (E–028–
protein to enzymatic degradation using received by the National Cancer 2015–1–KR–08);
appropriate in vitro assays (protein Institute’s Technology Transfer Center 10. Mexican Patent Application MX/
digestibility study). The paperwork on or before October 15, 2018 will be a/2017/006865, filed May 25, 2017 (E–
burden of these two data components considered. 028–2015–1–MX–09);

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Document Created: 2018-09-28 01:23:42
Document Modified: 2018-09-28 01:23:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by October 29, 2018.
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]
FR Citation		83 FR 49108

83 FR 49108 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 189 (September 28, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration