[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Page 68379-68381]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 

    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 

                                     Table 1.--Estimated Reporting Burden\1\
                         No. of        Annual Frequency     Total Annual        Hours per
                      Respondents        per Response        Responses           Response         Total Hours
Initial                           20                  2                 40                  4                160
Final                             12                  1                 12                150              1,800
Annual one time burden hours                                                                               1,960
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

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 
    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]