[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7274-7276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3028]


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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; 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 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 ``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 written or electronic comments on the collection of 
information by April 19, 2010.

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

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 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. In the Federal 
Register of November 24, 2004 (69 FR 68379), FDA published a previous 
60-day notice requesting public comment on this proposed collection of 
information. FDA is publishing this notice to update comments. Comments 
previously submitted to the Division of Dockets Management do not need 
to be resubmitted because all such comments that are responsive to the 
comment request will be summarized and responded to in the Information 
Collection Request, i.e. 30-day notice, submitted to OMB.

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 act), 
developers of new foods (in this

[[Page 7275]]

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 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 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 of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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              FDA
 Activity    Form        No. of        Annual Frequency     Total Annual       Hours per         Total Hours
              No.      Respondents       per Response         Responses        Response
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Initial     None                  20                   2                40               4                   160
 consultat
 ion
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Final       FDA                   12                   1                12             150                 1,800
 consultat   3665
 ion
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,960
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

A. 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 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 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.

B. 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 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:
     The name of the bioengineered food and the crop from which 
it is derived;
     A description of the various applications or uses of the 
bioengineered food, including animal feed uses;
     Information concerning the sources, identities, and 
functions of introduced genetic material;
     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;
     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;
     Information regarding any known or suspected allergenicity 
and toxicity of expression products and the basis for

[[Page 7276]]

concluding that foods containing the expression products can be safely 
consumed;
     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;
     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
     Any other information relevant to the safety and 
nutritional assessment of the bioengineered food.
    In 2001, FDA contacted 5 firms that had made 1 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 68379 at 68381). 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 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3028 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S