83 FR 24315 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 102 (May 25, 2018)

Page Range		24315-24317
FR Document		2018-11281

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.

Federal Register, Volume 83 Issue 102 (Friday, May 25, 2018)

[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24315-24317]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11281]


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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.thefederalregister.org/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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
                        Category                           FDA Form 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 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

Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24315

B. Subpart H—Participation in response to substantial allegations of Dated: May 16, 2018.
Proficiency Testing for Laboratories noncompliance (that is, complaint Seema Verma,
Performing Nonwaived Testing inspections). The outcome of those Administrator, Centers for Medicare &
The Joint Commission’s requirements validation inspections, performed by Medicaid Services.
are equivalent to the CLIA requirements CMS or our agents, or the state survey [FR Doc. 2018–11330 Filed 5–24–18; 8:45 am]
at §§ 493.801 through 493.865. agencies, will be our principal means BILLING CODE 4120–01–P
for verifying that the laboratories
C. Subpart J—Facility Administration
accredited by the Joint Commission
for Nonwaived Testing DEPARTMENT OF HEALTH AND
remain in compliance with CLIA
The Joint Commission’s requirements requirements. This federal monitoring is HUMAN SERVICES
are equal to the CLIA requirements at an ongoing process.
§§ 493.1100 through 493.1105. Food and Drug Administration
V. Removal of Approval as an
D. Subpart K—Quality System for Accrediting Organization
[Docket No. FDA–2012–N–0438]
Nonwaived Testing
Our regulations provide that we may Agency Information Collection
The Joint Commission requirements Activities; Proposed Collection;
are as or more stringent than the CLIA rescind the approval of an accreditation
Comment Request; Early Food Safety
requirements at §§ 493.1200 through organization, such as that of the Joint
Evaluation of New Non-Pesticidal
493.1299. For instance, the Joint Commission, for cause, before the end of
Proteins Produced by New Plant
Commission has control procedure the effective date of the approval period.
Varieties Intended for Food Use
requirements for all waived complexity If we determine that the Joint
testing performed. Commission has failed to adopt, AGENCY: Food and Drug Administration,
maintain and enforce requirements that HHS.
E. Subpart M—Personnel for Nonwaived
Testing are equal to, or more stringent than, the ACTION: Notice.
CLIA requirements, or that systemic
We have determined that Joint problems exist in its monitoring, SUMMARY: The Food and Drug
Commission requirements are inspection or enforcement processes, we Administration (FDA or Agency) is
equivalent to the CLIA requirements at may impose a probationary period, not announcing an opportunity for public
§§ 493.1403 through 493.1495 for comment on the proposed collection of
to exceed 1 year, in which the Joint
laboratories that perform moderate and certain information by the Agency.
Commission would be allowed to
high complexity testing. Under the Paperwork Reduction Act of
address any identified issues. Should
F. Subpart Q—Inspections 1995 (PRA), Federal Agencies are
the Joint Commission be unable to
required to publish notice in the
We have determined that the Joint address the identified issues within that
Federal Register concerning each
Commission requirements are timeframe, we may, in accordance with proposed collection of information,
equivalent to the CLIA requirements at the applicable regulations, revoke Joint including each proposed extension of an
§§ 493.1771 through 493.1780. Commission’s deeming authority under existing collection of information, and
CLIA. to allow 60 days for public comment in
G. Subpart R—Enforcement Procedures
Should circumstances result in our response to the notice. This notice
The Joint Commission meets the
withdrawal of the Joint Commission’s solicits comments on the information
requirements of subpart R to the extent
approval, we will publish a notice in the collection provisions of FDA’s
that it applies to accreditation
Federal Register explaining the basis for procedures for early food safety
organizations. The Joint Commission
removing its approval. evaluation of new non-pesticidal
policy sets forth the actions the
proteins produced by new plant
organization takes when laboratories it VI. Collection of Information varieties intended for food use,
accredits do not comply with its Requirements including bioengineered food plants.
requirements and standards for
accreditation. When appropriate, the This notice does not impose any DATES: Submit either electronic or
Joint Commission will deny, suspend, information collection and record written comments on the collection of
or revoke accreditation in a laboratory keeping requirements subject to the information by July 24, 2018.
accredited by the Joint Commission and Paperwork Reduction Act (PRA). ADDRESSES: You may submit comments
report that action to us within 30 days. Consequently, it does not need to be as follows. Please note that late,
The Joint Commission also provides an reviewed by the Office of Management untimely filed comments will not be
appeals process for laboratories that and Budget (OMB) under the authority considered. Electronic comments must
have had accreditation denied, of the PRA. The requirements associated be submitted on or before July 24, 2018.
suspended, or revoked. with the accreditation process for The https://www.regulations.gov
We have determined that the Joint electronic filing system will accept
clinical laboratories under the CLIA
Commission laboratory enforcement and comments until midnight Eastern Time
program, codified in 42 CFR part 493
appeal policies are as or more stringent at the end of July 24, 2018. Comments
subpart E, are currently approved by
than the requirements of part 493 received by mail/hand delivery/courier
OMB under OMB reapproval number (for written/paper submissions) will be
subpart R as they apply to accreditation
organizations. 0938–0686. considered timely if they are
amozie on DSK3GDR082PROD with NOTICES1

VII. Executive Order 12866 Statement postmarked or the delivery service
IV. Federal Validation Inspections and acceptance receipt is on or before that
Continuing Oversight In accordance with the provisions of date.
The Federal validation inspections of Executive Order 12866, this notice was
laboratories accredited by the Joint Electronic Submissions
not reviewed by the Office of
Commission may be conducted on a Management and Budget. Submit electronic comments in the
representative sample basis or in following way:

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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24317

communicating with us about the safety UCM350010.pdf) and may be used in ElectronicSubmissionsGateway/
evaluation. lieu of a cover letter for a New Protein default.htm), paper format, or as
Interested persons may use Form FDA Consultation (NPC). Form FDA 3666 electronic files on physical media with
3666 to transmit their submissions to prompts a submitter to include certain a paper signature page. FDA uses this
the Office of Food Additive Safety in the elements of a NPC in a standard format information to evaluate the food safety
Center for Food Safety and Applied and helps the respondent organize their of a specific new protein produced by
Nutrition. Form FDA 3666 is entitled submission to focus on the information a new plant variety.
‘‘Early Food Safety Evaluation of a New needed for our safety review. The form, Description of Respondents: The
Non-Pesticidal Protein Produced by a and elements that would be prepared as respondents to this collection of
New Plant Variety (New Protein attachments to the form, may be information are developers of new plant
Consultation)’’ (https://www.fda.gov/ submitted in electronic format via the varieties intended for food use.
downloads/AboutFDA/ Electronic Submission Gateway (https:// FDA estimates the burden of this
ReportsManualsForms/Forms/ www.fda.gov/ForIndustry/ collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Category FDA Form No. responses per burden per Total hours
respondents responses
respondent 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 publicly available databases. The other notice announces that the Advisory
collection since our last request for data component involves ‘‘wet’’ lab Commission on Childhood Vaccines
OMB approval, we have made no work to assess the new protein’s (ACCV) will hold a public meeting. This
adjustments to our burden estimate. The stability and the resistance of the meeting will be open to the public.
estimated number of annual responses protein to enzymatic degradation using DATES: Friday, June 15, 2018, from 10:00
and average burden per response are appropriate in vitro assays (protein a.m. to 2:00 p.m. ET.
based on our experience with early food digestibility study). The paperwork ADDRESSES: The meeting is a
safety evaluations. Completing an early burden of these two data components teleconference and webinar. The
food safety evaluation for a new protein consists of the time it takes the company conference call-in number is 1–800–
from a new plant variety is a one-time to assemble the information on these 988–0218; passcode: 9302948. The
burden (one evaluation per new two data components and include it in webinar link is https://
protein). Many developers of novel a NPC. We estimate that completing hrsa.connectsolutions.com/accv/.
plants may choose not to submit an these data components will take about Participants should call and connect 15
evaluation because the field testing of a 16 hours per NPC. We estimate the minutes prior to the meeting in order for
plant containing a new protein is reporting burden for the two other data logistics to be set up. If you have never
conducted in such a way (e.g., on such components to be 96 hours (16 hours × attended an Adobe Connect meeting,
a small scale, or in such isolated 6 responses). Thus, we estimate the total please test your connection using the
conditions, etc.) that cross-pollination annual burden for this collection of following URL: https://
with traditional crops or commingling information to be 120 hours. hrsa.connectsolutions.com/common/
of plant material is not likely to be an Dated: May 9, 2018. help/en/support/meeting_test.htm and
issue. Also, other developers may have Leslie Kux, get a quick overview by following URL:
previously communicated with us about http://www.adobe.com/go/connectpro_
Associate Commissioner for Policy.
the food safety of a new plant protein, overview.
[FR Doc. 2018–11281 Filed 5–24–18; 8:45 am]
for example, when the same protein was FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
expressed in a different crop. Annie Herzog, Principal Staff Liaison,
We estimate the annual number of Division of Injury Compensation
NPCs submitted by developers will be DEPARTMENT OF HEALTH AND Programs (DICP), Healthcare Systems
six or fewer. The early food safety HUMAN SERVICES Bureau (HSB), HRSA, 5600 Fishers
evaluation for new proteins includes six Lane, Room 08N146B, Rockville,
main data components. Four of these Health Resources and Service Maryland 20857; phone: (301) 443–
data components are easily and quickly Administration 6593; or email: aherzog@hrsa.gov.
obtainable, having to do with the SUPPLEMENTARY INFORMATION:
identity and source of the protein. We Advisory Commission on Childhood Background: The ACCV advises the
estimate that completing these data Vaccines Secretary on the implementation of the
components will take about 4 hours per AGENCY: Health Resources and Service Vaccine Injury Compensation Program
amozie on DSK3GDR082PROD with NOTICES1

NPC. We estimate the reporting burden Administration (HRSA), Department of (VICP). Other activities of the ACCV
for the first four data components to be Health and Human Services (HHS). include: Recommending changes to the
24 hours (4 hours × 6 responses). Vaccine Injury table, at its own
ACTION: Notice of Advisory Committee
Two data components ask for original meeting. initiative or as the result of the filing of
data to be generated. One data a petition; advising the Secretary on
component consists of a bioinformatics SUMMARY: In accordance with the implementing section 2127 of the Public
analysis that can be performed using Federal Advisory Committee Act, this Health Service Act (PHS Act) regarding

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Document Created: 2018-05-25 02:12:55
Document Modified: 2018-05-25 02:12:55

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		Submit either electronic or written comments on the collection of information by July 24, 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 24315

83 FR 24315 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 102 (May 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration