Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, 24315-24317 [2018-11281]
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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Joint Commission’s requirements
are equivalent to the CLIA requirements
at §§ 493.801 through 493.865.
C. Subpart J—Facility Administration
for Nonwaived Testing
The Joint Commission’s requirements
are equal to the CLIA requirements at
§§ 493.1100 through 493.1105.
D. Subpart K—Quality System for
Nonwaived Testing
The Joint Commission requirements
are as or more stringent than the CLIA
requirements at §§ 493.1200 through
493.1299. For instance, the Joint
Commission has control procedure
requirements for all waived complexity
testing performed.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that Joint
Commission requirements are
equivalent to the CLIA requirements at
§§ 493.1403 through 493.1495 for
laboratories that perform moderate and
high complexity testing.
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F. Subpart Q—Inspections
We have determined that the Joint
Commission requirements are
equivalent to the CLIA requirements at
§§ 493.1771 through 493.1780.
G. Subpart R—Enforcement Procedures
The Joint Commission meets the
requirements of subpart R to the extent
that it applies to accreditation
organizations. The Joint Commission
policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
accreditation. When appropriate, the
Joint Commission will deny, suspend,
or revoke accreditation in a laboratory
accredited by the Joint Commission and
report that action to us within 30 days.
The Joint Commission also provides an
appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that the Joint
Commission laboratory enforcement and
appeal policies are as or more stringent
than the requirements of part 493
subpart R as they apply to accreditation
organizations.
IV. Federal Validation Inspections and
Continuing Oversight
The Federal validation inspections of
laboratories accredited by the Joint
Commission may be conducted on a
representative sample basis or in
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response to substantial allegations of
noncompliance (that is, complaint
inspections). The outcome of those
validation inspections, performed by
CMS or our agents, or the state survey
agencies, will be our principal means
for verifying that the laboratories
accredited by the Joint Commission
remain in compliance with CLIA
requirements. This federal monitoring is
an ongoing process.
V. Removal of Approval as an
Accrediting Organization
VI. Collection of Information
Requirements
This notice does not impose any
information collection and record
keeping requirements subject to the
Paperwork Reduction Act (PRA).
Consequently, it does not need to be
reviewed by the Office of Management
and Budget (OMB) under the authority
of the PRA. The requirements associated
with the accreditation process for
clinical laboratories under the CLIA
program, codified in 42 CFR part 493
subpart E, are currently approved by
OMB under OMB reapproval number
0938–0686.
VII. Executive Order 12866 Statement
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
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Dated: May 16, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–11330 Filed 5–24–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0438]
Our regulations provide that we may
rescind the approval of an accreditation
organization, such as that of the Joint
Commission, for cause, before the end of
the effective date of the approval period.
If we determine that the Joint
Commission has failed to adopt,
maintain and enforce requirements that
are equal to, or more stringent than, the
CLIA requirements, or that systemic
problems exist in its monitoring,
inspection or enforcement processes, we
may impose a probationary period, not
to exceed 1 year, in which the Joint
Commission would be allowed to
address any identified issues. Should
the Joint Commission be unable to
address the identified issues within that
timeframe, we may, in accordance with
the applicable regulations, revoke Joint
Commission’s deeming authority under
CLIA.
Should circumstances result in our
withdrawal of the Joint Commission’s
approval, we will publish a notice in the
Federal Register explaining the basis for
removing its approval.
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Agency Information Collection
Activities; Proposed Collection;
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 Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s
procedures for early food safety
evaluation of new non-pesticidal
proteins produced by new plant
varieties intended for food use,
including bioengineered food plants.
DATES: Submit either electronic or
written comments on the collection of
information by July 24, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 24, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 24, 2018. 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:
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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0438 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Early
Food Safety Evaluation of New NonPesticidal Proteins Produced by New
Plant Varieties Intended for Food Use.’’
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.
• 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
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18:28 May 24, 2018
Jkt 241001
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
PO 00000
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of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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’’ 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 material from that plant
variety.
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 in people or animals. 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
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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
communicating with us about the safety
evaluation.
Interested persons may use Form FDA
3666 to transmit their submissions 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/
ElectronicSubmissionsGateway/
default.htm), paper format, or as
electronic files on physical media with
a paper signature page. FDA uses this
information to evaluate the food safety
of 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.
FDA estimates the burden of this
collection of information as follows:
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 a 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 (https://
www.fda.gov/ForIndustry/
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Category
FDA Form No.
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
First four data components ......................
Two other data components ....................
3666
3666
6
6
1
1
6
6
4
16
24
96
Total ..................................................
........................
........................
........................
........................
........................
120
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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 × 6 responses).
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis that can be performed using
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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
a 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 burden for this collection of
information to be 120 hours.
Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11281 Filed 5–24–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Advisory Commission on Childhood
Vaccines
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Advisory Committee
meeting.
AGENCY:
SUMMARY: In accordance with the
Federal Advisory Committee Act, this
PO 00000
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notice announces that the Advisory
Commission on Childhood Vaccines
(ACCV) will hold a public meeting. This
meeting will be open to the public.
DATES: Friday, June 15, 2018, from 10:00
a.m. to 2:00 p.m. ET.
ADDRESSES: The meeting is a
teleconference and webinar. The
conference call-in number is 1–800–
988–0218; passcode: 9302948. The
webinar link is https://
hrsa.connectsolutions.com/accv/.
Participants should call and connect 15
minutes prior to the meeting in order for
logistics to be set up. If you have never
attended an Adobe Connect meeting,
please test your connection using the
following URL: https://
hrsa.connectsolutions.com/common/
help/en/support/meeting_test.htm and
get a quick overview by following URL:
https://www.adobe.com/go/connectpro_
overview.
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Principal Staff Liaison,
Division of Injury Compensation
Programs (DICP), Healthcare Systems
Bureau (HSB), HRSA, 5600 Fishers
Lane, Room 08N146B, Rockville,
Maryland 20857; phone: (301) 443–
6593; or email: aherzog@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Background: The ACCV advises the
Secretary on the implementation of the
Vaccine Injury Compensation Program
(VICP). Other activities of the ACCV
include: Recommending changes to the
Vaccine Injury table, at its own
initiative or as the result of the filing of
a petition; advising the Secretary on
implementing section 2127 of the Public
Health Service Act (PHS Act) regarding
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]]>Agencies
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24315-24317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11281]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0438]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's procedures for early food safety evaluation of new non-pesticidal
proteins produced by new plant varieties intended for food use,
including bioengineered food plants.
DATES: Submit either electronic or written comments on the collection
of information by July 24, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 24, 2018. 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:
[[Page 24316]]
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'''' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0438 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Early Food Safety Evaluation of
New Non-Pesticidal Proteins Produced by New Plant Varieties Intended
for Food Use.'' 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.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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'' 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
material from that plant variety.
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 in people or animals.
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
[[Page 24317]]
communicating with us about the safety evaluation.
Interested persons may use Form FDA 3666 to transmit their
submissions 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 a 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
(https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm), paper format, or as electronic files on physical media
with a paper signature page. FDA uses this information to evaluate the
food safety of 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of
Category FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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First four data components.............................. 3666 6 1 6 4 24
Two other data components............................... 3666 6 1 6 16 96
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Total............................................... .............. .............. .............. .............. .............. 120
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\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 that 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
a 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 burden for this collection of information to
be 120 hours.
Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11281 Filed 5-24-18; 8:45 am]
BILLING CODE 4164-01-P
