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, 58487-58488 [2015-24620]

Download as PDF 58487 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices James Seligman, Co-Chair Irma Arispe Janet Collins Hazel Dean Joseph Henderson Christine Kosmos Alan Kotch Jennifer Parker Judith Qualters Kalwant Smagh 202–395–7285, or emailed to oira_ submission@omb.eop.gov. 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, PRAStaff@ fda.hhs.gov. 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. Dated: September 24, 2015. Veronica Kennedy, Acting Director, Division of the Executive Secretariat, Office of the Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2015–24650 Filed 9–28–15; 8:45 am] BILLING CODE 4163–18–P 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. 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: SUMMARY: 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 Category FDA Form No. Number of responses per respondent Number of respondents Average burden per response Total annual responses Total hours asabaliauskas on DSK5VPTVN1PROD with NOTICES First four data components ...................... Two other data components .................... 3666 3666 6 6 1 1 6 6 4 16 24 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 VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 with early food safety evaluations. Completing an early food safety evaluation for a new protein from a new PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 plant variety is a one-time burden (one evaluation per new protein). Many developers of novel plants may choose E:\FR\FM\29SEN1.SGM 29SEN1 58488 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 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 crosspollination 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 × 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 × 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2014–M–2375, FDA– 2015–M–0909, FDA–2015–M–0199, FDA– 2015–M–0200, FDA–2015–M–0201, FDA– 2015–M–0228, FDA–2015–M–0266, FDA– 2015–M–0267, FDA–2015–M–0431, FDA– 2015–M–0502, FDA–2015–M–0690, FDA– 2015–M–0738, FDA–2015–M–0910] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers SUMMARY: Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–5576. SUPPLEMENTARY INFORMATION: I. Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from January 1, 2015, through March 31, 2015. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES PMA No., Docket No. Applicant Trade name P980040/S049, FDA–2014–M–2375 ........ Abbott Medical Optics, Inc. ..................... P140010, FDA–2015–M–0199 ................. Medtronic, Inc. ........................................ P130019, FDA–2015–M–0201 ................. P130025, FDA–2015–M–0200 ................. P060001/S020, FDA–2015–M–0228 ........ EnteroMedics, Inc. .................................. Koning Corp. ........................................... ev3, Inc. .................................................. H140001, FDA–2015–M–0267 ................. ABIOMED, Inc. ........................................ TECNIS® multifocal 1-piece intraocular lens. IN.PACTTM AdmiralTM Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter. Maestro® Rechargeable System ............ Koning Breast CT (Model CBCT 1000) .. ´ ´ ProtegeTM GPS Self-Expanding Peripheral Stent System. Impella RP System ................................. VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1 Approval date 12/17/2014 12/30/2014 1/14/2015 1/14/2015 1/21/2015 1/23/2015

Agencies

[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58487-58488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.

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

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