[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Pages 13132-13133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06069]



Food and Drug Administration

[Docket No. FDA-2010-D-0073]

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 (PRA).

DATES: Fax written comments on the collection of information by April 
26, 2018.

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: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0704. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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 

OMB Control Number 0910-0704--Extension

    This information collection supports the above captioned Agency 
guidance document. FDA recommends that producers who use biotechnology 
in the manufacture or development of foods and food ingredients work 
cooperatively with FDA to ensure that products derived through 
biotechnology are safe and comply with all applicable legal 
requirements and has instituted a voluntary consultation process with 
industry. To facilitate this process the Agency has issued a guidance 
entitled, ``Guidance on Consultation Procedures: Foods Derived From New 
Plant Varieties,'' which is available on our website at https://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation 
process for the evaluation of information on new plant varieties 
provided by developers. The Agency believes this consultation process 
will help ensure that human food and animal feed safety issues or other 
regulatory issues (e.g., labeling) are resolved prior to commercial 
distribution. Additionally, 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 Federal Food, Drug, and Cosmetic 
Act (FD&C Act).
    In the Federal Register of December 13, 2017 (82 FR 58619), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. Two comments were received 
in response to the notice. Overall, the comments supported FDA's need 
for the information collection and neither comment suggested revising 
our estimate of the associated burden. However, both comments reminded 
us that significant resources were invested into developing data upon 
which respondents rely to bring information to FDA regarding the 
development of foods derived from new plant varieties. All the more 
reason, the comments said, FDA should identify mechanisms by which it 
can better incorporate its experience over time and, where possible, 
implement more efficient, streamlined review processes for those 
products similar to those the Agency has reviewed in the past. The 
comments recommended FDA compare efficiencies with a process at the 
U.S. Department of Agriculture regarding the review of agricultural 
biotechnology products. We appreciate this suggestion. FDA strives to 
allocate its limited resources in ways that maximize protection to the 
public health and facilitate compliance with existing regulatory 
requirements implemented to do so. We also look for ways in which we 
might coordinate our efforts with those by other agencies who share 
these objectives.
    Both comments also included the suggestion that FDA develop a less 
redundant review process (such as reciprocity if no material 
differences are identified) that better coordinates expertise across 
the Center for Food Safety and Nutrition (CFSAN) and the Center for 
Veterinary Medicine (CVM) into a single, efficient review. We 
appreciate this suggestion as well and, as discussed in the guidance, 
note the following:
    [FDA's] Office of Premarket Approval of the CFSAN and the Office of 
Surveillance and Compliance of the CVM have established a Biotechnology 
Evaluation Team (BET) to facilitate, and to ensure consistency in the 
process by which firms consult under the 1992 policy and inform FDA 
regarding the marketing of bioengineered foods and food ingredients 
derived from new plant varieties including those developed using rDNA 
techniques. The BET oversees the consultation process, identifies 
regulatory and scientific issues that need to be addressed, and once 
all relevant issues have been adequately addressed, brings the 
consultation to closure.
    At the same time, we have shared the comments received in response 
to this notice under the PRA with the BET. Consistent with our Good 
Guidance Practice regulations (21 CFR 10.115), FDA welcomes comments on 
our guidance documents at any time.
    In consideration of these comments, we have retained the currently 
approved burden estimated associated with the information collection, 
which is as follows:

[[Page 13133]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                             Number of                        Average
                        Activity                           FDA form No.      Number of    responses  per   Total  annual    burden per      Total hours
                                                                            respondents     respondent       responses       response
Initial consultation....................................            None              20               2              40               4             160
Final consultation......................................            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.

    Our estimate is based on the information collection activities 
discussed below.
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 the guidance, 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.
    FDA estimates that CVM and CFSAN jointly received an average of 40 
initial consultations per year in the last 3 years via telephone, 
email, or written letter. Based on this information, we expect to 
receive no more than 40 annually in the next 3 years.
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 developed 
a form that prompts a developer to include certain elements in the 
final consultation in a standard format: Form FDA 3665 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 
    We base our estimate of the average time to prepare a submission on 
informal contact with firms that made one or more biotechnology 
consultation submission under the voluntary biotechnology consultation 
process. As such, we estimate the average time to prepare a submission 
for final consultation to be 150 hours.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06069 Filed 3-26-18; 8:45 am]