[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58619-58621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26794]


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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; Guidance on 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 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 consultation procedures for foods derived from new plant 
varieties, including the 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 February 12, 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 February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 12, 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:
     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

[[Page 58620]]

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 ``Guidance on 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.
     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: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

Guidance on Consultation Procedures: Foods Derived From New Plant 
Varieties

OMB Control Number 0910-0704--Extension

    This information collection supports the above captioned Agency 
guidance document. FDA recommends 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 has instituted a voluntary consultation process with 
industry. To facilitate this process, the Agency has 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 food and animal feed 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), FDA has 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, FDA explained that, under the FD&C Act, developers of new foods 
(in this document food refers to both human food and animal feed) 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.

[[Page 58621]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                              No. of                          Average
                Activity                           FDA Form No.               No. of      responses  per   Total annual     burden per      Total hours
                                                                            respondents      respondent      responses       response
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Initial consultation....................  None..........................              20               2              40               4             160
Final consultation......................  3665..........................              12               1              12             150           1,800
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    Total...............................  ..............................  ..............  ..............  ..............  ..............           1,960
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have retained the currently approved burden estimate for this 
information collection and discuss the information collection 
activities below.
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, FDA 
encourages developers to consult early in the development phase of 
their products, and as often as necessary. Historically, firms 
developing a new bioengineered 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 served to make 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 provided assistance to both industry and the Agency 
in exercising their mutual responsibilities under the FD&C Act.
    FDA estimates that its Center for Veterinary Medicine and its 
Center for Food Safety and Applied Nutrition jointly received an 
average of 40 initial consultations per year in the last 3 years via 
telephone, email, or written letter. Based on this information, we 
expect to receive no more than 40 annually in the next 3 years.
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 in a position 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 
bioengineered food that is intended to be introduced into commercial 
distribution. FDA evaluates the submission to ensure that all potential 
safety and regulatory questions have been addressed. FDA has 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 elements that would 
be prepared as 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. As such, we estimate the average time to prepare a submission 
for final consultation to be 150 hours.

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26794 Filed 12-12-17; 8:45 am]
 BILLING CODE 4164-01-P


