80 FR 8663 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 32 (February 18, 2015)

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8663-8664]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03207]



[[Page 8663]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
20, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0704. 
Also include the FDA 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, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance on Consultation Procedures: Foods Derived From New Plant 
Varieties--(OMB Control No. 0910-0704)--(Extension)

    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 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.
    In the Federal Register of December 11, 2014 (79 FR 73590), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received; however, it was 
not responsive to the information collection topics solicited in the 
notice and is not, therefore, addressed in this document.
    FDA estimates the burden of this collection as follows:

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

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.

[[Page 8664]]

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: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03207 Filed 2-17-15; 8:45 am]
BILLING CODE 4164-01-P