[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]
[Page 68379-68381]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for the Guidance on Consultation Procedures; Foods Derived
From New Plant Varieties.
DATES: Submit written or electronic comments on the collection of
information by January 24, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
[[Page 68380]]
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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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, including
each proposed extension of an existing 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.
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 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; Foods Derived From New Plant Varieties (Originally
published in 1996 and revised October 1997, the updated version is
available on FDA's Internet site at http://www.cfsan.fda.gov/lrd/consulpr.html
) 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
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Initial 20 2 40 4 160
consultation
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Final 12 1 12 150 1,800
consultation
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Annual one time burden hours 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, the
food industry generally has initiated consultation with FDA early in
the process of developing a new bioengineered plant variety, even
though there is no legal obligation to do so. 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.
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.
[[Page 68381]]
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.
Summary information of the safety and nutritional assessment for a
new plant variety submitted to FDA 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 five 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 is estimating that the
average time to prepare a submission for final consultation under the
1996 procedures is 150 hours.
Dated: November 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26048 Filed 11-19-04; 1:52 pm]
BILLING CODE 4160-01-S