80 FR 8663 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 32 (February 18, 2015)

Page Range		8663-8664
FR Document		2015-03207

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.

Federal Register, Volume 80 Issue 32 (Wednesday, February 18, 2015)

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8663-8664]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-03207]

[[Page 8663]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

DATES: Fax written comments on the collection of information by March
20, 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 0910-0704.
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.

Guidance on Consultation Procedures: Foods Derived From New Plant
Varieties--(OMB Control No. 0910-0704)--(Extension)

Since 1992, when FDA issued its ``Statement of Policy: Foods
Derived from New Plant Varieties'' (the 1992 policy) (57 FR 22984, May
29, 1992), FDA has encouraged developers of new plant varieties,
including those varieties that are developed through biotechnology, to
consult with FDA during the plant development process to discuss
possible scientific and regulatory issues that might arise. In the 1992
policy, FDA explained that, under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), developers of new foods (in this document food
refers to both human food and animal feed) have a responsibility to
ensure that the foods they offer to consumers are safe and are in
compliance with all requirements of the FD&C Act (57 FR 22984 at
22985).
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 From New Plant
Varieties,'' which is available on FDA's Web site at http://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 FD&C Act.
Description of Respondents: Respondents to this collection of
information include developers of new plant varieties intended for food
use.
In the Federal Register of December 11, 2014 (79 FR 73590), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received; however, it was
not responsive to the information collection topics solicited in the
notice and is not, therefore, addressed in this document.
FDA estimates the burden of this collection as follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation...................... None........................ 20 2 40 4 160
Final consultation........................ FDA 3665.................... 12 1 12 150 1,800
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Total................................. ............................ .............. .............. .............. .............. 1,960
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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 its Center for Veterinary Medicine and its
Center for Food Safety and Applied Nutrition 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.

[[Page 8664]]

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
format.
Upon implementation of the collection, FDA contacted five firms
that had made one or more biotechnology consultation submissions. We
asked each of these firms for an estimate of the hourly burden to
prepare a submission under the voluntary biotechnology consultation
process. Based on information provided by the three firms who
responded, we estimate the average time to prepare a submission for
final consultation to be 150 hours.

Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03207 Filed 2-17-15; 8:45 am]
BILLING CODE 4164-01-P

8664 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices

Final Consultations food or offering such articles for importers for which she handled the
Final consultations are a one-time importation into the United States. FDA process of importing, and coordinating
burden. At some stage in the process of bases this order on a finding that Ms. with brokers to enter and bring in,
research and development, a developer Lin was convicted, as defined in the Chinese-origin honey into the United
will have accumulated the information FD&C Act, of three felony counts under States.
Federal law for conduct relating to the On or about December 13, 2009, Ms.
that the developer believes is adequate
importation into the United States of an Lin entered and introduced Chinese-
to ensure that food derived from the
article of food. Ms. Lin was given notice origin honey into the United States by
new plant variety is safe and that it
of the proposed debarment and an means of a false and fraudulent practice,
demonstrates compliance with the
opportunity to request a hearing within false statement, and fraudulent and false
relevant provisions of the FD&C Act.
the timeframe prescribed by regulation. papers, including Bureau of Customs
The developer will then be in a position
As of August 29, 2014 (30 days after and Border Protection (CBP) forms that
to conclude any ongoing consultation
receipt of the notice), Ms. Lin had not falsely declared that approximately four
with FDA. The developer submits to
responded. Ms. Lin’s failure to respond container loads of Chinese-origin honey
FDA a summary of the safety and with a declared value upon entry of
nutritional assessment that has been constitutes a waiver of her right to a
hearing concerning this action. approximately $92,822 was Chinese
conducted about the bioengineered food honey syrup. By so doing, Ms. Lin
that is intended to be introduced into DATES: This order is effective February
18, 2015. caused losses to the United States of
commercial distribution. FDA evaluates approximately $205,141 in uncollected
the submission to ensure that all ADDRESSES: Submit applications for
anti-dumping duties and honey
potential safety and regulatory questions termination of debarment to the
assessment fees, when in fact she knew
have been addressed. FDA has Division of Dockets Management (HFA–
the product was Chinese honey. This
developed a form that prompts a 305), Food and Drug Administration,
was in violation of 18 U.S.C. 542.
developer to include certain elements in 5630 Fishers Lane, Rm. 1061, Rockville, On or about December 13, 2009, Ms.
the final consultation in a standard MD 20852. Lin entered and introduced Chinese-
format: Form FDA 3665, entitled, ‘‘Final FOR FURTHER INFORMATION CONTACT: origin honey into the United States by
Consultation for Food Derived From a Kenny Shade, Division Of Enforcement, means of a false and fraudulent practice,
New Plant Variety (Biotechnology Final Office of Enforcement and Import false statement, and fraudulent and false
Consultation).’’ The form, and elements Operations, Office of Regulatory Affairs, papers, including CBP forms that falsely
that would be prepared as attachments Food and Drug Administration, 12420 declared that approximately three
to the form, can be submitted in Parklawn Dr. (ELEM4144), Rockville, container loads of Chinese-origin honey
electronic format. MD 20857, 301–796–4640. with a declared value upon entry of
Upon implementation of the SUPPLEMENTARY INFORMATION: approximately $69,617 was Chinese
collection, FDA contacted five firms that honey syrup. By so doing, Ms. Lin
had made one or more biotechnology I. Background
caused losses to the United States of
consultation submissions. We asked Section 306(b)(1)(C) of the FD&C Act approximately $153,855 in uncollected
each of these firms for an estimate of the (21 U.S.C. 335a(b)(1)(C)) permits FDA to anti-dumping duties and honey
hourly burden to prepare a submission debar an individual from importing an assessment fees, when in fact she knew
under the voluntary biotechnology article of food or offering such an article the product was Chinese honey. This
consultation process. Based on for import into the United States if FDA was in violation of 18 U.S.C. 542.
information provided by the three firms finds, as required by section On or about December 13, 2009, Ms.
who responded, we estimate the average 306(b)(3)(A) of the FD&C Act, that the Lin entered and introduced Chinese-
time to prepare a submission for final individual has been convicted of a origin honey into the United States by
consultation to be 150 hours. felony for conduct relating to the means of a false and fraudulent practice,
Dated: February 11, 2015. importation into the United States of false statement, and fraudulent and false
Leslie Kux, any food. papers, including CPB forms that falsely
On September 30, 2013, Ms. Lin was declared that approximately three
Associate Commissioner for Policy.
convicted, as defined in section container loads of Chinese-origin honey
[FR Doc. 2015–03207 Filed 2–17–15; 8:45 am]
306(l)(1)(B) of the FD&C Act, when the with a declared value upon entry of
BILLING CODE 4164–01–P U.S. District Court for the Northern approximately $69,617 was Chinese
District of Illinois accepted her plea of honey syrup. By so doing, Ms. Lin
guilty and entered judgment against her caused losses to the United States of
DEPARTMENT OF HEALTH AND
for the following offense: Three counts approximately $153,855 in uncollected
HUMAN SERVICES
of entry of goods into the United States anti-dumping duties and honey
Food and Drug Administration by means of false statements, in assessment fees, when in fact she knew
violation of 18 U.S.C. 542. the product was Chinese honey. This
[Docket No. FDA–2013–N–1484] FDA’s finding that debarment is was in violation of 18 U.S.C. 542.
appropriate is based on the felony Ms. Lin admitted that between 2009
Hung Yi Lin; Debarment Order convictions referenced herein. The and 2012, she caused up to 764
AGENCY: Food and Drug Administration, factual basis for these convictions is as shipping containers of Chinese-origin
HHS. follows: Ms. Lin owned and operated honey valued at approximately
emcdonald on DSK67QTVN1PROD with NOTICES

ACTION: Notice. KBB Express Inc., a freight forwarding $11,489,306 to be fraudulently imported
company located in South El Monte, CA and entered into the United States,
SUMMARY: The Food and Drug that provided nationwide thereby causing losses to the United
Administration (FDA or Agency) is transportation, delivery, and other States of as much as $39,203,144
issuing an order under the Federal logistical services for imported and through her fraudulent practices.
Food, Drug, and Cosmetic Act (FD&C entered merchandise, including As a result of her conviction, on July
Act) debarring Hung Yi Lin for a period Chinese-origin honey. Ms. Lin also 25, 2014, FDA sent Ms. Lin a notice by
of 12 years from importing articles of served as the U.S. agent for at least 12 certified mail proposing to debar her for

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Document Created: 2018-02-16 11:10:48
Document Modified: 2018-02-16 11:10:48

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 March 20, 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 8663

80 FR 8663 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 32 (February 18, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration