0583 GFI Safety Eval New Plant Variety SSA 2018 Ext

United States Food and Drug Administration
Recommendations for the Early Food Safety Evaluation
of New Non-Pesticidal Proteins Produced by New Plant Varieties
Intended for Food Use
OMB Control No. 0910-0583
SUPPORTING STATEMENT Part A. Justification
1. Circumstances Making the Collection of Information Necessary
The Food and Drug Administration (FDA) encourages developers of new plant varieties,
including those varieties that are developed through biotechnology, to consult with FDA
early in the development process to discuss possible scientific and regulatory issues that
might arise (see 57 FR 22984). The guidance entitled, “Recommendations for the Early
Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties
Intended for Food Use,” fosters early communication by encouraging developers to submit
to FDA their evaluation of the food safety of their new protein. Such communication
helps ensure that any potential food safety issues regarding a new protein in a new plant
variety are resolved early in development, prior to any possible inadvertent introduction
into the food supply. FDA believes that any food safety concern related to such material
entering the food supply would be limited to the potential that a new protein in food from
the plant variety could cause an allergic reaction in susceptible individuals or could be a
toxin. The guidance describes the procedures for early food safety evaluation of new
proteins produced by new plant varieties, including bioengineered food plants, and the
procedures for communicating with FDA about the safety evaluation.
Respondents may use Form FDA 3666 to transmit submissions to the Office of Food
Additive Safety in the Center for Food Safety and Applied Nutrition. Form FDA 3666,
available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350010.pdf,
is entitled, “Early Food Safety Evaluation of a New Non-Pesticidal Protein Produced by a
New Plant Variety (New Protein Consultation)” and may be used in lieu of a cover letter
for a New Protein Consultation (NPC). Form FDA 3666 prompts the respondent to
include certain elements of a NPC in standard format and helps the respondent organize the
submission to focus on the information needed for FDA’s safety review. The form, and
elements prepared as attachments to the form, may be submitted in electronic format via
the Electronic Submission Gateway (ESG), or may be submitted in paper format, or as
electronic files on physical media with paper signature page.
Accordingly, FDA is requesting an extension of approval for the information collection
provisions found in the guidance entitled, “Recommendations for the Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for
Food Use,” and in Form FDA 3666.

2. Purpose and Use of the Information Collection
FDA reviews NPCs to ensure that foods are safe, wholesome, sanitary, and properly labeled,
in accordance with its legislative mandates: Section 903 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. Section 393), as well as the authority found in the
food additive provisions in sections 201(s) and 409 of the FD&C Act (21 U.S.C. Sections
321(s) and 348) and in the adulterated food provisions in section 402 of the FD&C Act (21
U.S.C. Section 342).
Description of Respondents: The respondents to this collection of information are
developers of new plant varieties intended for food use. Respondents are from the private
sector (for-profit businesses, as well as not-for-profit institutions).
3. Use of Improved Information Technology and Burden Reduction
Form FDA 3666, and elements prepared as attachments to the form, may be submitted in
electronic format via the ESG, or may be submitted in paper format, or as electronic files on
physical media with paper signature page. The agency estimates that all the NPCs (100%)
will be submitted electronically.
4. Efforts to Identify Duplication and Use of Similar Information
FDA procedures seek to prevent duplicative collection of information. FDA makes
submissions of NPCs, and FDA's responses thereto, easily accessible to the public via the
internet. If a protein has been evaluated in a NPC and no safety concerns are identified, we
would not expect an additional NPC to be submitted if the same protein is introduced into
another plant species. Also, if a protein has previously been reviewed as part of a
biotechnology consultation (approved by OMB under control number 0910-0704) and there
were no safety concerns identified, we would not expect the submission of a NPC for such a
protein.
Additionally, FDA continues to work with the U.S. Environmental Protection Agency
(EPA) and the U.S. Department of Agriculture (USDA) to eliminate areas of duplicate data
collection and evaluation. Under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136 et seq.), EPA has authority to regulate all pesticides, regardless of
how they are made or their mode of action. FDA’s NPC applies to non-pesticidal proteins
and is not duplicative with EPA responsibilities. Meanwhile, many plants developed using
recombinant DNA (rDNA) technology are considered “regulated articles” under regulations
of USDA’s Animal and Plant Health Inspection Service (APHIS) (7 CFR Part 340), which
regulates the introduction of certain “genetically engineered” plants into the environment. A
developer must obtain authorization from APHIS to field test such crops and, depending on
the nature of the crop, a developer files either a permit application or a notification. In
contrast, FDA requests a submission of data and information concerning the food safety of a
specific new protein produced in a new plant variety. Therefore, although a submission to
APHIS would include some information, such as the name of the company and the identity

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of the protein, which would be included in the information requested by FDA in a NPC, the
submission is not duplicative.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that five percent (40%) of respondents are small businesses. FDA’s NPC
minimizes the reporting burden on all businesses, including small businesses, by providing
that the developer submits a summary of data and information, rather than the data and
information itself. There is no burden to respondents for developing the data and
information that underlie the new protein evaluation because respondents would have
already generated such data and information to ensure that the protein is safe and is in
compliance with all applicable requirements of the FD&C Act.
FDA aids small businesses in complying with its requirements through the agency’s
Regional Small Business Representatives and through the scientific and administrative
staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. The data in a NPC are submitted only once for
each specific new protein and therefore cannot be collected less frequently.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in
the Federal Register of May 25, 2018 (83 FR 24315). One comment was received outside of
the scope of the information collection topics solicited, and therefore is not addressed.
9. Explanation of Any Payment or Gift to Respondents
No gifts or payments are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
FDA believes that, in most cases, neither the existence of a NPC, nor most or all of its
content, would satisfy the criteria for exemption from disclosure. However, information
submitted to FDA in a NPC may contain trade secret and commercial confidential
information. As a result, all files are maintained in a secured area. Form FDA 3666, its
instructions, and related guidance, provide instructions for assisting FDA with protecting
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confidential information. A submitter may choose to provide a redacted copy of the NPC,
identifying that information that the submitter views as trade secret or as confidential
commercial or financial information. Only information that is releasable under the
agency’s regulations in 21 CFR part 20 would be released to the public. This information
is also safeguarded by Section 301(j) of the FD&C Act and would be protected from
disclosure under the Freedom of Information Act (FOIA) under sections 552(a) and (b) (5
U.S.C. 552(a) and (b)). At this time, we do not proactively disclose the submission of a
NPC until after the submitter completes the consultation procedure. After the
consultation is complete, we place on the FDA Internet site a redacted copy of the NPC
and an electronic version of the agency response to the submitter
(https://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/Submissions/ucm2225
95.htm).
This ICR does not request any personally identifiable information nor does this ICR
include a form that requires a Privacy Act Statement.
11. Justification for Sensitive Questions
This information collection does not ask questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:

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GFI Section
VI: Format for
Submission
First four data
components
Two other data
components
Total

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Table 1.--Estimated Annual Reporting Burden
No. of
No. of
FDA Form
Total
2
Respondents
Responses
per
Annual
No.
Respondent
Responses
3666
6
1
6
3666

6

1

Average
Burden per
Response
4

Total
Hours

16

96

6

24

120

There are no capital costs or operating and maintenance costs associated with this collection of information.
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Form FDA 3666 may be submitted electronically via the ESG.

The estimates provided for this collection of information are based on FDA’s experience
with its early food safety evaluation submission program. Based on our review, we
received 12 NPCs during the 5-year period from 2005 through 2009, for an average of
2.4 NPCs per year. However, during the last extension period, we saw a decrease in the
number of NPCs submitted by developers, with no NPCs submitted in 2010 through
2014. More recently, FDA received 4 NPCs in the first 4 months of 2015 and 2 NPCs
from 2016 through 2017. By combining an average of these figures together with our
observations, we expect the total number of annual NPC submissions to be 6 or fewer and
the total hourly burden to be 120 hours.
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The early food safety evaluation for new proteins includes six main data components.
Four of these data components are easily and quickly obtainable, having to do with the
identity and source of the protein. FDA estimates that completing these four data
components will take about 4 hours per NPC and thus we estimate the reporting burden is
24 hours (4 hours x 6 responses), as reflected in Table 1 row 1 above. At the same time,
two data components ask for original data to be generated, where one component consists
of a bioinformatics analysis which can be performed using publicly available databases.
The other component involves “wet” lab work to assess the new protein’s stability and the
resistance of the protein to enzymatic degradation using appropriate in vitro assays (protein
digestibility study). FDA estimates that completing these two data components will take
about 16 hours per NPC and thus we estimate the reporting burden is 96 hours (16 hours x
6 responses), as reflected in Table 1 row 2 above.
As requested in part III of Form FDA 3666, section 5, submissions may incorporate by
reference information from a previous submission to FDA (biotechnology notification file
(BNF), new protein consultation (NPC), generally recognized as safe (GRAS) notice,
GRAS affirmation petition, food additive petition, and food master file). These collections
of information have been approved by OMB under the following control numbers:





biotechnology consultation procedures are approved under OMB Control No.
0910-0704;
new protein consultations are approved under this collection, OMB Control No.
0910-0583;
GRAS notices and affirmation petitions are approved under OMB Control No.
0910-0342; and
food additive petitions and food master files are approved under OMB
Control No. 0910-0016.

12b. Annualized Cost Burden Estimate
Gathering the information for the NPC and providing it to the agency requires a team of
employees, which may include toxicologists, chemists, and lawyers. FDA estimates that the
average hourly wage for these employees is equivalent to a GS-14/Step-1 in the locality pay
area of Washington- Baltimore in 2018, approximately $54.91/hour. Doubling this wage to
account for overhead costs, FDA estimates the average hourly cost to respondents to be
$109.82/hour. Thus, the overall estimated cost incurred by the respondents is $13,178 (120
burden hours x $109.82/hour = $13,178.40, rounded to $13,178). In addition, while FDA
does not charge for the use of the ESG, FDA requires respondents to obtain a public key
infrastructure (PKI) certificate in order to set up the account. This can be obtained in-house
or outsourced by purchasing a public key certificate that is valid for 1 to 3 years. The
certificate typically costs from $20-$30.

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Category
First four data
components
Nurses
Total

Table 2 – Burden Costs
Total Burden
Hourly Wage Rate
Total Respondent
Hours
Costs
24
$109.82
$2,635.68
96

$109.82

$10,542.72
$13,178.40

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
FDA estimates that the staffing burden for review of a NPC is 80 hours per submission. We
estimate that we will receive approximately 6 NPCs annually. Thus, we estimate 480 hours
will be needed to review NPC submissions annually. FDA estimates the annual cost to the
Federal government to be 480 hours at rate of $60.40/hour, the GS-13/Step-10 rate for the
Washington- Baltimore locality pay area for the year 2018 (480 hours x $60.40/hour =
$28,992. To account for overhead, this cost is increased by 100%, making the total
estimated annual cost to the Federal government $57,984.
15. Explanation for Program Changes or Adjustments
This collection is a renewal without changes as the burden has not changed from the burden
shown in the current inventory. Based on a review of the information collection since our
last request for OMB approval, we have made no adjustments to our burden estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
No statistics from the information obtained from this data collection will be published.
However, as noted above in Section 10, we do not proactively disclose the submission of a
NPC until after the submitter completes the consultation procedure. After the consultation
is complete, we place on the FDA Internet site the redacted copy of the NPC and an
electronic version of the agency response to the submitter
(https://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/Submissions/ucm2225
95.htm).

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the
information collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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