
[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73590-73591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29046]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0073]


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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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. 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 9, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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

    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 Federal Food, Drug, and Cosmetic 
Act (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 are in 
compliance with all requirements of the FD&C Act (57 FR 22984 at 
22985).
    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 FDA's Web site at http://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 FD&C Act.
    Description of Respondents: Respondents to this collection of 
information include developers of new plant varieties intended for food 
use.
    FDA estimates the burden of this collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of                        Average
                 Activity                           FDA form No.             Number 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........................  FDA 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.


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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 (CVM) and its 
Center for Food Safety and Applied Nutrition (CFSAN) 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.
    Upon implementation of the collection, FDA contacted five firms 
that had made one or more biotechnology consultation submissions. We 
asked each of these firms for an estimate of the hourly burden to 
prepare a submission under the voluntary biotechnology consultation 
process. Based on information provided by the three firms who 
responded, we estimate the average time to prepare a submission for 
final consultation to be 150 hours.

    Dated: December 8, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29046 Filed 12-10-14; 8:45 am]
BILLING CODE 4164-01-P


