[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9020-9022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0390] (formerly Docket No. 2004N-0503)


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

[[Page 9021]]

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 
18, 2011.

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 e-mailed to <a href="/cdn-cgi/l/email-protection#0c63657e6d537f796e61657f7f6563624c63616e2269637c226b637a"><span class="__cf_email__" data-cfemail="d0bfb9a2b18fa3a5b2bdb9a3a3b9bfbe90bfbdb2feb5bfa0feb7bfa6">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-New and 
title ``Guidance on Consultation Procedures: Foods Derived From New 
Plant Varieties.'' Also include the FDA docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Number 0910-NEW)

I. Background

    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 has long regarded it to be a prudent practice for producers who 
use biotechnology in the manufacture or development of foods and food 
ingredients to work cooperatively with FDA to ensure that products 
derived through biotechnology are safe and comply with all applicable 
legal requirements. Consequently, FDA instituted a voluntary 
consultation process with industry. The guidance on Consultation 
Procedures: From New Plant Varieties (originally published in 1996 and 
revised October 1997; the updated version is available on FDA's Web 
site at http://www.fda.gov/FoodGuidances) fosters communication by 
encouraging developers to submit to FDA their evaluation of the food 
safety of their new plant variety. 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 February 18, 2010 (75 FR 7274), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter, containing multiple 
comments, in response to the notice. One comment expressed strong 
support for the consultation procedures, generally.
    (Comment 1) One comment noted with appreciation that Form FDA 3665 
will provide a standardized format and an ability to provide electronic 
information.
    (Response) FDA agrees. As discussed elsewhere in this document, the 
new form will prompt developers to submit to FDA certain information in 
a standard format. In addition, the form and attachments can be 
submitted in an electronic format. FDA believes that use of the form 
and electronic submission will facilitate both the preparation and 
review of the submission because it organizes the information necessary 
to support the safety of the food derived from the new plant variety. 
FDA also expects that use of the form will decrease the overall 
paperwork burden on respondents.
    (Comment 2) Another comment noted that the use of the new form and 
electronic submission of data and information for FDA's use should 
assure the protection of proprietary data and information submitted to 
FDA.
    (Response) The submission to FDA may contain trade secret and 
commercial confidential information. Only information that is 
releasable under 21 CFR part 20 would be released to the public. This 
information is also safeguarded by section 301(j) of the FD&C Act (21 
U.S.C. 331(j)) and would be protected from disclosure under sections 
552(a) and (b) of the Freedom of Information Act (5 U.S.C. 552(a) and 
(b)).
    FDA estimates the burden of this collection of information as 
follows:

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

II. 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 its guidance to 
industry, 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

[[Page 9022]]

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.
    Generally, for an initial consultation, a developer requests a 
meeting by sending FDA a letter with an agenda. A mutually convenient 
time is arranged and the developer comes to discuss their product. In 
preparation for a meeting, a developer might prepare written materials 
or a slide presentation to discuss their product under development. A 
meeting between the developer and FDA typically lasts between 1 and 2 
hours. As a result of such a meeting, FDA establishes a file called a 
biotechnology notification file, or BNF, to collect all documentation 
and communication regarding the bioengineered plant. For example, FDA 
typically places information such as the developer's letter, agenda, 
and any written materials (such as copies of a slide presentation) in a 
BNF, as well as any memorandum FDA prepares as a record of the meeting. 
FDA has not issued any recommendations as to the format for these types 
of materials (e.g., there is no form associated with requesting a 
meeting).
    Depending on the introduced trait, the experience the developer has 
had with the kind of modification being considered, and their 
familiarity with the consultation procedures, a developer might choose 
to do a final consultation without an initial consultation.

III. 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 recently 
developed a form that prompts a developer to include certain elements 
in the final consultation in a standard format. New Form FDA 3665 is 
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.
    The summary information of the safety and nutritional assessment 
for a new plant variety submitted to FDA (on the form and in 
attachments to the form) includes the following information:
    <bullet> The name of the bioengineered food and the crop from which 
it is derived;
    <bullet> A description of the various applications or uses of the 
bioengineered food, including animal feed uses;
    <bullet> Information concerning the sources, identities, and 
functions of introduced genetic material;
    <bullet> Information on the purpose or intended technical effect of 
the modification, and its expected effect on the composition or 
characteristic properties of the food or feed;
    <bullet> Information concerning the identity and function of 
expression products encoded by the introduced genetic material, 
including an estimate of the concentration of any expression product in 
the bioengineered crop or food derived therefrom;
    <bullet> Information regarding any known or suspected allergenicity 
and toxicity of expression products and the basis for concluding that 
foods containing the expression products can be safely consumed;
    <bullet> Information comparing the composition or characteristics 
of the bioengineered food to that of food derived from the parental 
variety or other commonly consumed varieties of the same crop with 
special emphasis on important nutrients, and toxicants that occur 
naturally in the food;
    <bullet> A discussion of the available information that addresses 
whether the potential for the food derived from a bioengineered plant 
to induce an allergic response has been altered by the genetic 
modification; and
    <bullet> Any other information relevant to the safety and 
nutritional assessment of the bioengineered food.
    In 2001, FDA contacted 5 firms that had made one or more 
biotechnology consultation submissions under the 1996 procedures. FDA 
asked each of these firms for an estimate of the hourly burden to 
prepare a submission under the voluntary biotechnology consultation 
process. Three of these firms subsequently provided the requested 
information. Based on this information, FDA estimated that the average 
time to prepare a submission for final consultation under the 1996 
procedures is 150 hours (69 FR 68381, November 24, 2004). The 
availability of the form, and the opportunity to provide the 
information in electronic format, could reduce this estimate. However, 
as a conservative approach for the purpose of this analysis, FDA is 
assuming that the availability of the form and the opportunity to 
submit the information in electronic format will have no effect on the 
average time to prepare a submission for final consultation under the 
1996 procedures.

    Dated: February 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3476 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P


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