[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74734-74736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25752]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6455]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Consultation Procedures: Foods Derived From New Plant 
Varieties

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 
pertaining to FDA consultation procedures for foods derived from new 
plant varieties, including information collection provisions in the 
guidance entitled, ``Guidance on Consultation Procedures: Foods Derived 
From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final 
Consultation For Food Derived From a New Plant Variety (Biotechnology 
Final Consultation),'' which developers may use to prepare the final 
consultation in a standard format.

DATES: Submit either electronic or written comments on the collection 
of information by January 22, 2021.

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 January 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 22, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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-2017-N-6455 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Consultation Procedures: Foods 
Derived From New Plant Varieties.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-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, 240-402-7500.

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. 3501-3521), 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.

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    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.

Consultation Procedures: Foods Derived From New Plant Varieties

OMB Control Number 0910-0704--Extension

    This information collection supports FDA's consultation procedures 
for foods derived from new plant varieties, as discussed and included 
in Agency guidance, and in Form FDA 3665. We recommend that producers 
who use biotechnology in the manufacture or development of foods and 
food ingredients work cooperatively with FDA to ensure that products 
derived through biotechnology are safe and comply with all applicable 
legal requirements and have instituted a voluntary consultation process 
with industry. To facilitate this process, the Agency issued a guidance 
entitled, ``Guidance on Consultation Procedures: Foods Derived From New 
Plant Varieties,'' which is available on our website at https://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation 
process for the evaluation of information on new plant varieties 
provided by developers. The Agency believes this consultation process 
will help ensure that human and animal food safety issues or other 
regulatory issues (e.g., labeling) are resolved prior to commercial 
distribution. Additionally, such communication will help to ensure that 
any potential food safety issues regarding a new plant variety are 
resolved during development and will help to ensure that all market 
entry decisions by the industry are made consistently and in full 
compliance with the standards of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act).
    Since 1992, when FDA issued its ``Statement of Policy: Foods 
Derived From New Plant Varieties'' (the 1992 policy) (57 FR 22984, May 
29, 1992), we have encouraged developers of new plant varieties, 
including those varieties that are developed through biotechnology, to 
consult with FDA during the plant development process to discuss 
possible scientific and regulatory issues that might arise. In the 1992 
policy, we explained that under the FD&C Act developers of new foods 
(in this document food refers to both human and animal food) have a 
responsibility to ensure that the foods they offer to consumers are 
safe and in compliance with all requirements of the FD&C Act (57 FR 
22984 at 22985).
    Description of Respondents: Respondents to this collection of 
information include developers of new plant varieties intended for food 
use.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                        Activity                           Form FDA No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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Initial consultation....................................            None              20               2              40               4             160
Final consultation......................................            3665              12               1              12             150           1,800
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           1,960
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\1\ There are no 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.

Initial Consultations

    Initial consultations are generally a one-time burden, although a 
developer might return more than once to discuss additional issues 
before submitting a final consultation. As noted in the guidance, we 
encourage developers to consult early in the development phase of their 
products, and as often as necessary. Historically, firms developing a 
new genetically engineered plant variety intended for food use have 
generally initiated consultation with FDA early in the process of 
developing such a variety, even though there is no legal obligation for 
such consultation. These consultations have made FDA aware of foods and 
food ingredients before these products are distributed commercially and 
have provided FDA with the information necessary to address any 
potential questions regarding the safety, labeling, or regulatory 
status of the food or food ingredient. As such, these consultations 
have aided both industry and the Agency in exercising their mutual 
responsibilities under the FD&C Act.
    We estimate that the Center for Veterinary Medicine and the Center 
for Food Safety and Applied Nutrition jointly received an average of 40 
requests for initial consultations per year in the last 3 years via 
email, or written letter. Based on this information, we expect to 
receive no more than 40 annually for a total of 160 hours for initial 
consultations.

Final Consultations

    Final consultations are a one-time burden. At some stage in the 
process of research and development, a developer will have accumulated 
the information that the developer believes is adequate to ensure that 
food derived from the new plant variety is safe and that it 
demonstrates compliance with the relevant provisions of the FD&C Act. 
The developer will then be able to conclude any ongoing consultation 
with FDA. The developer submits to FDA a summary of the safety and 
nutritional assessment that has been conducted about the genetically 
engineered food intended to be introduced into commercial distribution. 
We evaluate the submission to ensure that all potential safety and 
regulatory questions have been addressed. We have developed a form that 
prompts a developer to include certain elements in the final 
consultation in a standard format: Form FDA 3665 entitled, ``Final 
Consultation for Food Derived From a New Plant Variety (Biotechnology 
Final Consultation).'' The form and its elements that would be prepared 
as

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attachments to the form can be submitted in electronic format.
    We base our estimate of the average time to prepare a submission on 
informal contact with firms that made one or more biotechnology 
consultation submission under the voluntary biotechnology consultation 
process. We estimate the average time to prepare a submission for final 
consultation to be 150 hours. With an estimated 12 annual submissions, 
the total will be 1,800 hours for final consultations.
    The total estimated burden for this collection of information is 
1,960 hours.

    Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25752 Filed 11-20-20; 8:45 am]
BILLING CODE 4164-01-P


