2011-3476. 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.

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 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: [phone], or e-mailed to [e-mail]. 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

Activity	FDA Form No.	Number of respondents	Annual frequency per response	Total annual responses	Hours per response	Total hours
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 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:

• 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 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 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.