80 FR 35370 - Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 118 (June 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 118 (June 19, 2015)
| Page Range | 35370-35372 | |
| FR Document | 2015-15078 |
[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)] [Notices] [Pages 35370-35372] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15078] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0438] Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use 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 must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants. DATES: Submit either electronic or written comments on the collection of information by August 18, 2015. 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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, we are publishing this notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our estimate of the [[Page 35371]] 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. Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (OMB Control Number 0910- 0583)--Extension Since May 29, 1992, when we issued a policy statement on foods derived from new plant varieties, we have encouraged developers of new plant varieties, including those varieties that are developed through biotechnology, to consult with us early in the development process to discuss possible scientific and regulatory issues that might arise (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,'' continues to foster early communication by encouraging developers to submit to us their evaluation of the food safety of their new protein. Such communication helps to 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 of the new protein. We believe 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 us about the safety evaluation. Interested persons may use Form FDA 3666 to transmit their submission to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition. Form FDA 3666 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 a submitter to include certain elements of a NPC in a standard format and helps the respondent organize their submission to focus on the information needed for our safety review. The form, and elements that would be prepared as attachments to the form, may be submitted in electronic format via the Electronic Submission Gateway, or may be submitted in paper format, or as electronic files on physical media with paper signature page. The information is used by us to evaluate the food safety of a specific new protein produced by a new plant variety. Description of Respondents: The respondents to this collection of information are developers of new plant varieties intended for food use. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Category FDA Form No. Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- First four data components............. Form FDA 3666............. 6 1 6 4 24 Two other data components.............. Form FDA 3666............. 6 1 6 16 96 ---------------------------------------------------------------------------------------------------------------- Total.............................. .......................... ............... ............... ............... ............... 120 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated number of annual responses and average burden per response are based on our experience with early food safety evaluations. Completing an early food safety evaluation for a new protein from a new plant variety is a one-time burden (one evaluation per new protein). Many developers of novel plants may choose not to submit an evaluation because the field testing of a plant containing a new protein is conducted in such a way (e.g., on such a small scale, or in such isolated conditions, etc.) that cross-pollination with traditional crops or commingling of plant material is not likely to be an issue. Also, other developers may have previously communicated with us about the food safety of a new plant protein, for example, when the same protein was expressed in a different crop. For purposes of this extension request, we are re-evaluating our estimate of the annual number of responses that we expect to receive in the next 3 years. 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, we received 4 NPCs in the first 4 months of 2015. Based on an approximate average from the years 2005 through 2009, and our experience in 2015, we are revising our estimate of the annual number of NPCs submitted by developers to be 6 or fewer. 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. We estimate that completing these data components will take about 4 hours per NPC. We estimate the reporting burden for the first four data components to be 24 hours (4 hours x 6 responses). Two data components ask for original data to be generated. One data component consists of a bioinformatics analysis which can be performed using publicly available databases. The other data 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). The paperwork burden of these two data components consists of the time it takes the company to assemble the information on these two data components and include it in a NPC. We estimate that completing these data components will take about 16 hours per NPC. We estimate the reporting burden for the two other data components to be 96 hours (16 hours x 6 responses). Thus, we estimate the total annual hour burden for this collection of information to be 120 hours. [[Page 35372]] Dated: June 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-15078 Filed 6-18-15; 8:45 am] BILLING CODE 4164-01-P
![35370 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Number of responses Total annual Average
Number of responses Total annual
Activity non- per non- burden per Total hours
respondents per responses respondents non- responses response
respondent respondent
2015–2016 Data Collection (Healthcare Facili-
ties)—Completion of Sections 1 and 3 ......... 400 1 400 .................... .................... .................... 2.5 1,000
2015–2016 Data Collection (Schools)—Com-
pletion of Sections 1 and 3 ........................... 400 1 400 .................... .................... .................... 2 800
2015–2016 Data Collection (Retail Food
Stores)—Completion of Sections 1 and 3 ..... 400 1 400 .................... .................... .................... 3 1,200
2015–2016 Data Collection-Completion of Sec-
tion 2—All Facility Types ............................... 1,200 1 1,200 .................... .................... .................... 0.5 600
2017–2018 Data Collection-Entry Refusals—
All Facility Types ........................................... .................... .................... .................... 24 1 24 0.08 1.92
(5 minutes)
Total Hours ................................................ .................... .................... .................... .................... .................... .................... .................... 3,601.92
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References Dated: June 15, 2015. information to http://
Leslie Kux, www.regulations.gov. Submit written
The following references have been Associate Commissioner for Policy. comments on the collection of
placed on display in the Division of [FR Doc. 2015–15077 Filed 6–18–15; 8:45 am] information to the Division of Dockets
Dockets Management (see ADDRESSES) BILLING CODE 4164–01–P Management (HFA–305), Food and Drug
and may be seen by interested persons Administration, 5630 Fishers Lane, Rm.
between 9 a.m. and 4 p.m., Monday 1061, Rockville, MD 20852. All
through Friday, and are available DEPARTMENT OF HEALTH AND comments should be identified with the
electronically at http://regulations.gov. HUMAN SERVICES docket number found in brackets in the
1. ‘‘Report of the FDA Retail Food Program heading of this document.
Food and Drug Administration FOR FURTHER INFORMATION CONTACT: FDA
Database of Foodborne Illness Risk Factors
(2000).’’ Available at: http://www.fda.gov/ [Docket No. FDA–2012–N–0438] PRA Staff, Office of Operations, Food
downloads/Food/FoodSafety/ and Drug Administration, 8455
RetailFoodProtection/ Agency Information Collection Colesville Rd., COLE–14526, Silver
FoodborneIllnessandRiskFactorReduction/ Activities; Proposed Collection; Spring, MD 20993–0002, PRAStaff@
RetailFoodRiskFactorStudies/ Comment Request; Early Food Safety fda.hhs.gov.
ucm123546.pdf. Evaluation of New Non-Pesticidal
SUPPLEMENTARY INFORMATION: Under the
2. ‘‘FDA Report on the Occurrence of Proteins Produced by New Plant
PRA (44 U.S.C. 3501–3520), Federal
Foodborne Illness Risk Factors in Selected Varieties Intended for Food Use
Agencies must obtain approval from the
Institutional Foodservice, Restaurant, and AGENCY: Food and Drug Administration, Office of Management and Budget
Retail Food Store Facility Types (2004).’’
HHS. (OMB) for each collection of
Available at: http://www.fda.gov/downloads/
ACTION: Notice. information they conduct or sponsor.
Food/GuidanceRegulation/
‘‘Collection of information’’ is defined
RetailFoodProtection/ SUMMARY: The Food and Drug in 44 U.S.C. 3502(3) and 5 CFR
FoodborneIllnessRiskFactorReduction/ Administration (FDA) is announcing an 1320.3(c) and includes Agency requests
UCM423850.pdf opportunity for public comment on the or requirements that members of the
3. ‘‘FDA Report on the Occurrence of proposed collection of certain
Foodborne Illness Risk Factors in Selected
public submit reports, keep records, or
information by the Agency. Under the provide information to a third party.
Institutional Foodservice, Restaurant, and Paperwork Reduction Act of 1995 (the
Retail Food Store Facility Types (2009).’’
Section 3506(c)(2)(A) of the PRA (44
PRA), Federal Agencies must publish a U.S.C. 3506(c)(2)(A)) requires Federal
Available at: http://www.fda.gov/downloads/ notice in the Federal Register
Food/FoodSafety/RetailFoodProtection/ Agencies to provide a 60-day notice in
concerning each proposed collection of the Federal Register concerning each
FoodborneIllnessandRiskFactorReduction/ information, including each proposed
RetailFoodRiskFactorStudies/ proposed collection of information,
extension of an existing collection of including each proposed extension of an
UCM224682.pdf.
information, and allow 60 days for existing collection of information,
4. FDA National Retail Food Team. ‘‘FDA
public comment in response to the before submitting the collection to OMB
Trend Analysis Report on the Occurrence of
notice. This notice solicits comments on for approval. To comply with this
Foodborne Illness Risk Factors in Selected
the information collection provisions of requirement, we are publishing this
Institutional Foodservice, Restaurant, and
FDA’s procedures for early food safety notice of the proposed collection of
Retail Food Store Facility Types (1998–
evaluation of new non-pesticidal information set forth in this document.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
2008).’’ Available at: http://www.fda.gov/
downloads/Food/FoodSafety/
proteins produced by new plant With respect to the following
RetailFoodProtection/
varieties intended for food use, collection of information, we invite
FoodborneIllnessandRiskFactorReduction/ including bioengineered food plants. comments on these topics: (1) Whether
RetailFoodRiskFactorStudies/ DATES: Submit either electronic or the proposed collection of information
UCM224152.pdf. written comments on the collection of is necessary for the proper performance
5. FDA Food Code. Available at: http:// information by August 18, 2015. of our functions, including whether the
www.fda.gov/FoodCode. ADDRESSES: Submit electronic information will have practical utility;
comments on the collection of (2) the accuracy of our estimate of the
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![35372 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
Dated: June 15, 2015. availability of a draft guidance entitled health’’ (section 403(w)(7) of the FD&C
Leslie Kux, ‘‘Draft Guidance for Industry: Food Act).
Associate Commissioner for Policy. Allergen Labeling Exemption Petitions The guidance is being issued
[FR Doc. 2015–15078 Filed 6–18–15; 8:45 am] and Notifications’’ and gave interested consistent with FDA’s good guidance
BILLING CODE 4164–01–P
parties an opportunity to submit practices regulation (21 CFR 10.115).
comments on the draft guidance at any This guidance represents the current
time and comments on the proposed thinking of FDA on Food Allergen
DEPARTMENT OF HEALTH AND collection of information by September Labeling Exemption Petitions and
HUMAN SERVICES 25, 2014. We received several comments Notifications. It does not create or
and revised the guidance accordingly. confer any rights for or on any person
Food and Drug Administration The Food Allergen Labeling and and is not binding on FDA or the public.
Consumer Protection Act of 2004 You can use an alternative approach if
[Docket No. FDA–2014–D–0052]
(FALCPA) (Title II of Pub. L. 108–282) it satisfies the requirements of
Food Allergen Labeling Exemption amended the FD&C Act by defining the applicable statutes and regulations.
Petitions and Notifications; Guidance term ‘‘major food allergen’’ and stating II. Paperwork Reduction Act of 1995
for Industry; Availability that foods regulated under the FD&C Act
This guidance contains information
are misbranded unless they declare the
AGENCY: Food and Drug Administration, collection provisions that are subject to
presence of each major food allergens on
HHS. review by the Office of Management and
the product label using the common or
ACTION: Notice. Budget (OMB) under the Paperwork
usual name of that major food allergen.
Reduction Act of 1995 (44 U.S.C. 3501–
Section 201(qq) of the FD&C Act (21
SUMMARY: The Food and Drug 3520). The collection of information in
U.S.C. 321(qq)) now defines a major
Administration (‘‘FDA’’ or ‘‘we’’) is this guidance was approved under OMB
food allergen as ‘‘[m]ilk, egg, fish (e.g.,
announcing the availability of a control number 0910–0792.
bass, flounder, or cod), Crustacean
guidance for industry entitled ‘‘Food
shellfish (e.g., crab, lobster, or shrimp), III. Comments
Allergen Labeling Exemption Petitions
tree nuts (e.g., almonds, pecans, or Interested persons may submit either
and Notifications.’’ This guidance
walnuts), wheat, peanuts, and electronic comments regarding the
explains FDA’s current thinking on the
soybeans’’ and also as a food ingredient guidance to http://www.regulations.gov
preparation of regulatory submissions
that contains protein derived from such or written comments to the Division of
for obtaining exemptions for ingredients
foods. The definition excludes any Dockets Management (see ADDRESSES). It
from the labeling requirements for major
highly refined oil derived from a major is only necessary to send one set of
food allergens in the Federal Food,
food allergen and any ingredient comments. Identify comments with the
Drug, and Cosmetic Act (FD&C Act)
derived from such highly refined oil. docket number found in brackets in the
through submission of either a petition
or a notification. In some cases, the production of an heading of this document. Received
ingredient derived from a major food comments may be seen in the Division
DATES: Submit either electronic or
allergen may eliminate the allergenic of Dockets Management between 9 a.m.
written comments on Agency guidances proteins in that derived ingredient such
at any time. and 4 p.m., Monday through Friday, and
that it is not a risk for food allergic will be posted to the docket at http://
ADDRESSES: Submit written requests for individuals. In addition, a major food www.regulations.gov.
single copies of the guidance to the allergen may be used as an ingredient or
Office of Nutrition, Labeling and Dietary as a component of an ingredient such IV. Electronic Access
Supplements, Center for Food Safety that the level of allergenic protein in Persons with access to the Internet
and Applied Nutrition (HFS–820), Food finished food products does not cause may obtain the document at either
and Drug Administration, 5100 Paint an allergic response that presents a risk http://www.fda.gov/FoodGuidances or
Branch Pkwy., College Park, MD 20740. for food allergic individuals. Therefore, http://www.regulations.gov. Use the
Send two self-addressed adhesive labels FALCPA provides two mechanisms FDA Web site listed in the previous
to assist that office in processing your through which such ingredients may sentence to find the most current
request. See the SUPPLEMENTARY become exempt from the labeling version of the guidance.
INFORMATION section for electronic requirement of section 403(w)(1) of the Dated: June 16, 2015.
access to the guidance. FD&C Act (21 U.S.C. 343(w)(1)). An
Submit electronic comments on the Leslie Kux,
ingredient may obtain an exemption
guidance to http://www.regulations.gov. Associate Commissioner for Policy.
through submission and approval of a
Submit written comments to the [FR Doc. 2015–15119 Filed 6–18–15; 8:45 am]
petition containing scientific evidence
Division of Dockets Management (HFA– that demonstrates that the ingredient BILLING CODE 4164–01–P
305), Food and Drug Administration, ‘‘does not cause an allergic response
5630 Fishers Lane, rm. 1061, Rockville, that poses a risk to human health’’
MD 20852. DEPARTMENT OF HEALTH AND
(section 403(w)(6) of the FD&C Act).
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT: Alternately, an ingredient may become
Richard Bonnette, Center for Food and exempt through submission of a Food and Drug Administration
Applied Nutrition (HFS–255), Food and notification containing scientific
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Drug Administration, 5100 Paint Branch evidence showing that the ingredient [Docket No. FDA–2015–N–0001]
Pkwy., College Park, MD 20740, 240– ‘‘does not contain allergenic protein’’ or
Announcement of Food and Drug
402–1235. that there has been a previous
Administration Demo Day for the 2014
SUPPLEMENTARY INFORMATION: determination through a premarket
Food and Drug Administration Food
approval process under section 409 of
I. Background Safety Challenge; Public Meeting
the FD&C Act (21 U.S.C. 348) that the
In the Federal Register of May 8, 2014 ingredient ‘‘does not cause an allergic AGENCY: Food and Drug Administration,
(79 FR 26435), we announced the response that poses a risk to human HHS.
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Document Created: 2018-02-22 11:10:42
Document Modified: 2018-02-22 11:10:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by August 18, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 35370 |
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