80 FR 58487 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 188 (September 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 188 (September 29, 2015)
| Page Range | 58487-58488 | |
| FR Document | 2015-24620 |
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)] [Notices] [Pages 58487-58488] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24620] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0438] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 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. DATES: Fax written comments on the collection of information by October 29, 2015. 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 0910-0583. Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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. In the Federal Register of June 19, 2015 (80 FR 35370), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. 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 Average Category FDA Form No. Number of responses per Total annual burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- First four data components.............................. 3666 6 1 6 4 24 Two other data components............................... 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 [[Page 58488]] 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 four 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 six 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. Dated: September 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24620 Filed 9-28-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58487
James Seligman, Co-Chair 202–395–7285, or emailed to oira_ entering the food supply would be
Irma Arispe submission@omb.eop.gov. All limited to the potential that a new
Janet Collins comments should be identified with the protein in food from the plant variety
Hazel Dean
Joseph Henderson
OMB control number 0910–0583. Also could cause an allergic reaction in
Christine Kosmos include the FDA docket number found susceptible individuals or could be a
Alan Kotch in brackets in the heading of this toxin. The guidance describes the
Jennifer Parker document. procedures for early food safety
Judith Qualters FOR FURTHER INFORMATION CONTACT: FDA evaluation of new proteins produced by
Kalwant Smagh new plant varieties, including
PRA Staff, Office of Operations, Food
Dated: September 24, 2015. and Drug Administration, 8455 bioengineered food plants, and the
Veronica Kennedy, Colesville Rd., COLE–14526, Silver procedures for communicating with us
Acting Director, Division of the Executive Spring, MD 20993–0002, PRAStaff@ about the safety evaluation.
Secretariat, Office of the Chief of Staff, fda.hhs.gov. Interested persons may use Form FDA
Centers for Disease Control and Prevention. 3666 to transmit their submission to the
SUPPLEMENTARY INFORMATION: In
[FR Doc. 2015–24650 Filed 9–28–15; 8:45 am] Office of Food Additive Safety in the
compliance with 44 U.S.C. 3507, FDA
BILLING CODE 4163–18–P
has submitted the following proposed Center for Food Safety and Applied
collection of information to OMB for Nutrition. Form FDA 3666 is entitled,
review and clearance. ‘‘Early Food Safety Evaluation of a New
DEPARTMENT OF HEALTH AND
Non-Pesticidal Protein Produced by a
HUMAN SERVICES Early Food Safety Evaluation of New New Plant Variety (New Protein
Non-Pesticidal Proteins Produced by Consultation),’’ and may be used in lieu
Food and Drug Administration New Plant Varieties Intended for Food of a cover letter for a New Protein
[Docket No. FDA–2012–N–0438] Use OMB Control Number 0910–0583— Consultation (NPC). Form FDA 3666
Extension prompts a submitter to include certain
Agency Information Collection
Since May 29, 1992, when we issued elements of a NPC in a standard format
Activities; Submission for Office of
a policy statement on foods derived and helps the respondent organize their
Management and Budget Review;
from new plant varieties, we have submission to focus on the information
Comment Request; Early Food Safety
encouraged developers of new plant needed for our safety review. The form,
Evaluation of New Non-Pesticidal
varieties, including those varieties that and elements that would be prepared as
Proteins Produced by New Plant
are developed through biotechnology, to attachments to the form, may be
Varieties Intended for Food Use
consult with us early in the submitted in electronic format via the
AGENCY: Food and Drug Administration, development process to discuss possible Electronic Submission Gateway, or may
HHS. scientific and regulatory issues that be submitted in paper format, or as
ACTION: Notice. might arise (57 FR 22984). The guidance electronic files on physical media with
entitled, ‘‘Recommendations for the paper signature page. The information is
SUMMARY: The Food and Drug Early Food Safety Evaluation of New used by us to evaluate the food safety of
Administration (FDA) is announcing Non-Pesticidal Proteins Produced by a specific new protein produced by a
that a proposed collection of New Plant Varieties Intended for Food new plant variety.
information has been submitted to the Use,’’ continues to foster early
Office of Management and Budget In the Federal Register of June 19,
communication by encouraging 2015 (80 FR 35370), FDA published a
(OMB) for review and clearance under developers to submit to us their
the Paperwork Reduction Act of 1995. 60-day notice requesting public
evaluation of the food safety of their comment on the proposed collection of
DATES: Fax written comments on the new protein. Such communication information. No comments were
collection of information by October 29, helps to ensure that any potential food received.
2015. safety issues regarding a new protein in
ADDRESSES: To ensure that comments on a new plant variety are resolved early in Description of Respondents: The
the information collection are received, development, prior to any possible respondents to this collection of
OMB recommends that written inadvertent introduction into the food information are developers of new plant
comments be faxed to the Office of supply of the new protein. varieties intended for food use.
Information and Regulatory Affairs, We believe that any food safety We estimate the burden of this
OMB, Attn: FDA Desk Officer, FAX: concern related to such material collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Category FDA Form No. responses per burden per Total hours
respondents responses
respondent response
First four data components ...................... 3666 6 1 6 4 24
Two other data components .................... 3666 6 1 6 16 96
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Total .................................................. ........................ ........................ ........................ ........................ ........................ 120
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of annual with early food safety evaluations. plant variety is a one-time burden (one
responses and average burden per Completing an early food safety evaluation per new protein). Many
response are based on our experience evaluation for a new protein from a new developers of novel plants may choose
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![58488 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices
not to submit an evaluation because the burden of these two data components Lane, Rm. 1061, Rockville, MD 20852.
field testing of a plant containing a new consists of the time it takes the company Please cite the appropriate docket
protein is conducted in such a way (e.g., to assemble the information on these number as listed in table 1 when
on such a small scale, or in such two data components and include it in submitting a written request. See the
isolated conditions, etc.) that cross- a NPC. We estimate that completing SUPPLEMENTARY INFORMATION section for
pollination with traditional crops or these data components will take about electronic access to the summaries of
commingling of plant material is not 16 hours per NPC. We estimate the safety and effectiveness.
likely to be an issue. Also, other reporting burden for the two other data FOR FURTHER INFORMATION CONTACT:
developers may have previously components to be 96 hours (16 hours × Melissa Torres, Center for Devices and
communicated with us about the food 6 responses). Thus, we estimate the total Radiological Health, Food and Drug
safety of a new plant protein, for annual hour burden for this collection Administration, 10903 New Hampshire
example, when the same protein was of information to be 120 hours. Ave., Bldg. 66, Rm. 1650, Silver Spring,
expressed in a different crop. Dated: September 23, 2015. MD 20993–0002, 301–796–5576.
For purposes of this extension
Leslie Kux, SUPPLEMENTARY INFORMATION:
request, we are re-evaluating our
estimate of the annual number of Associate Commissioner for Policy.
I. Background
responses that we expect to receive in [FR Doc. 2015–24620 Filed 9–28–15; 8:45 am]
the next 3 years. We received 12 NPCs BILLING CODE 4164–01–P In accordance with sections 515(d)(4)
during the 5-year period from 2005 and (e)(2) of the Federal Food, Drug, and
through 2009, for an average of 2.4 NPCs Cosmetic Act (the FD&C Act) (21 U.S.C.
per year. However, during the last DEPARTMENT OF HEALTH AND 360e(d)(4) and (e)(2)), notification of an
extension period, we saw a decrease in HUMAN SERVICES order approving, denying, or
the number of NPCs submitted by withdrawing approval of a PMA will
Food and Drug Administration continue to include a notice of
developers, with no NPCs submitted in
2010 through 2014. More recently, we [Docket Nos. FDA–2014–M–2375, FDA– opportunity to request review of the
received four NPCs in the first 4 months 2015–M–0909, FDA–2015–M–0199, FDA– order under section 515(g) of the FD&C
of 2015. Based on an approximate 2015–M–0200, FDA–2015–M–0201, FDA– Act. The 30-day period for requesting
average from the years 2005 through 2015–M–0228, FDA–2015–M–0266, FDA– reconsideration of an FDA action under
2015–M–0267, FDA–2015–M–0431, FDA– § 10.33(b) (21 CFR 10.33(b)) for notices
2009, and our experience in 2015, we
2015–M–0502, FDA–2015–M–0690, FDA– announcing approval of a PMA begins
are revising our estimate of the annual 2015–M–0738, FDA–2015–M–0910]
number of NPCs submitted by on the day the notice is placed on the
developers to be six or fewer. Medical Devices; Availability of Safety Internet. Section 10.33(b) provides that
The early food safety evaluation for and Effectiveness Summaries for FDA may, for good cause, extend this
new proteins includes six main data Premarket Approval Applications 30-day period. Reconsideration of a
components. Four of these data denial or withdrawal of approval of a
components are easily and quickly AGENCY: Food and Drug Administration, PMA may be sought only by the
obtainable, having to do with the HHS. applicant; in these cases, the 30-day
identity and source of the protein. We ACTION: Notice. period will begin when the applicant is
estimate that completing these data notified by FDA in writing of its
components will take about 4 hours per SUMMARY: The Food and Drug decision.
NPC. We estimate the reporting burden Administration (FDA) is publishing a The regulations provide that FDA
for the first four data components to be list of premarket approval applications publish a quarterly list of available
24 hours (4 hours × 6 responses). (PMAs) that have been approved. This safety and effectiveness summaries of
Two data components ask for original list is intended to inform the public of PMA approvals and denials that were
data to be generated. One data the availability of safety and announced during that quarter. The
component consists of a bioinformatics effectiveness summaries of approved following is a list of approved PMAs for
analysis which can be performed using PMAs through the Internet and the which summaries of safety and
publicly available databases. The other Agency’s Division of Dockets effectiveness were placed on the
data component involves ‘‘wet’’ lab Management. Internet from January 1, 2015, through
work to assess the new protein’s ADDRESSES: Submit written requests for March 31, 2015. There were no denial
stability and the resistance of the copies of summaries of safety and actions during this period. The list
protein to enzymatic degradation using effectiveness data to the Division of provides the manufacturer’s name, the
appropriate in vitro assays (protein Dockets Management (HFA–305), Food product’s generic name or the trade
digestibility study). The paperwork and Drug Administration, 5630 Fishers name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2015, THROUGH MARCH 31, 2015
PMA No., Docket No. Applicant Trade name Approval date
P980040/S049, FDA–2014–M–2375 ........ Abbott Medical Optics, Inc. ..................... TECNIS® multifocal 1-piece intraocular 12/17/2014
asabaliauskas on DSK5VPTVN1PROD with NOTICES
lens.
P140010, FDA–2015–M–0199 ................. Medtronic, Inc. ........................................ IN.PACTTM AdmiralTM Paclitaxel-coated 12/30/2014
Percutaneous Transluminal
Angioplasty Balloon Catheter.
P130019, FDA–2015–M–0201 ................. EnteroMedics, Inc. .................................. Maestro® Rechargeable System ............ 1/14/2015
P130025, FDA–2015–M–0200 ................. Koning Corp. ........................................... Koning Breast CT (Model CBCT 1000) .. 1/14/2015
P060001/S020, FDA–2015–M–0228 ........ ev3, Inc. .................................................. ProtégéTM GPS Self-Expanding Periph- 1/21/2015
eral Stent System.
H140001, FDA–2015–M–0267 ................. ABIOMED, Inc. ........................................ Impella RP System ................................. 1/23/2015
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Document Created: 2015-12-15 09:47:07
Document Modified: 2015-12-15 09:47:07
| 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 | Fax written comments on the collection of information by October 29, 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 58487 |
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