[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
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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
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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.
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
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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