Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties, 58619-58621 [2017-26794]
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
Recommendations.’’ This draft guidance
is intended to convey to drug
manufacturers FDA’s recommendations
on how certain drug products should be
labeled regarding gluten, a matter of
interest to individuals with celiac
disease. Some individuals with celiac
disease have faced difficulty when
trying to determine whether specific
drug products contain gluten.
Confronted by uncertainty, some
patients may forego important
medication rather than risk an adverse
reaction to gluten. Thus, even if gluten
is not present at levels that would harm
a typical individual with celiac disease,
that individual may be harmed through
uncertainty and lack of information.
Celiac disease is an immune-based
reaction to dietary gluten that primarily
affects the small intestine in susceptible
individuals; unmanaged celiac disease
can lead to serious health
complications. Approximately 1 percent
of the U.S. population has celiac disease
(Binder, 2015, ‘‘Disorders of
Absorption,’’ in Harrison’s Principles of
Internal Medicine, 19th ed.). It is
characterized by ongoing inflammation
of part of the lining of the small
intestine that generally heals if foods
containing gluten are excluded from the
diet and returns if they are
reintroduced. This guidance encourages
drug manufacturers to have accurate
information about their products’ gluten
content available so they can respond to
questions from consumers and health
care professionals. Manufacturers
should pay attention to possible sources
of gluten in their products, consider
specifications when appropriate, and
consider the impact of changes in
ingredient sources or formulations on
gluten content.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on Gluten in Drug Products and
Associated Labeling Recommendations.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information discussed in
VerDate Sep<11>2014
18:53 Dec 12, 2017
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the draft guidance have been approved
by OMB under the following control
numbers:
OMB control number 0910–0001:
Submitting to FDA labeling in NDAs
and ANDAs, including amendments to
pending NDAs and ANDAs,
supplements to approved NDAs and
ANDAs, and annual reports; OMB
control number 0910–0572: Designing,
testing, and revising prescription drug
product labeling; OMB control number
0910–0340: Designing, testing, and
revising Drug Facts labeling for OTC
drugs, including submitting labeling to
FDA for OTC monograph drugs; OMB
control number 0910–0139:
Recordkeeping requirements in CGMPs;
OMB control number 0910–0393:
Preparing and revising Medication
Guides; and OMB control number 0910–
0338: Submitting to FDA labeling in
BLAs, including amendments to
pending BLAs, supplements to
approved BLAs, and annual reports.
The recommended labeling statement
in this draft guidance, ‘‘Contains no
ingredient made from a glutencontaining grain (wheat, barley, or rye)’’
is information provided by FDA to
applicants and manufacturers for
disclosure to the public and therefore
does not constitute a collection of
information under 5 CFR 1320.3(c)(2).
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26828 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6455]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Consultation Procedures: Foods
Derived From New Plant Varieties
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00032
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58619
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s
consultation procedures for foods
derived from new plant varieties,
including the information collection
provisions in the guidance entitled,
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties,’’ and in Form FDA 3665
entitled, ‘‘Final Consultation For Food
Derived From a New Plant Variety
(Biotechnology Final Consultation),’’
which developers may use to prepare
the final consultation in a standard
format.
DATES: Submit either electronic or
written comments on the collection of
information by February 12, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 12,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 12, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–6455 for ‘‘Guidance on
Consultation Procedures: Foods Derived
from New Plant Varieties.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the 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,
PO 00000
Frm 00033
Fmt 4703
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when appropriate, and other forms of
information technology.
Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties
OMB Control Number 0910–0704—
Extension
This information collection supports
the above captioned Agency guidance
document. 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 Derived From New Plant
Varieties,’’ which is available on our
website at https://www.fda.gov/Food
Guidances. 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 Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
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 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 in
compliance with all requirements of the
FD&C Act (57 FR 22984 at 22985).
Description of Respondents:
Respondents to this collection of
information include developers of new
plant varieties intended for food use.
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
No. of
responses
per
respondent
Total annual
responses
Average
burden per
response
Activity
FDA Form No.
Initial consultation ....................................
Final consultation .....................................
None ..............
3665 ...............
20
12
2
1
40
12
4
150
160
1,800
Total ..................................................
........................
........................
........................
........................
........................
1,960
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have retained the currently
approved burden estimate for this
information collection and discuss the
information collection activities below.
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.
sradovich on DSK3GMQ082PROD with NOTICES
Total hours
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.
We base our estimate of the average
time to prepare a submission on
informal contact with firms that made
one or more biotechnology consultation
submission under the voluntary
biotechnology consultation process. As
such, we estimate the average time to
prepare a submission for final
consultation to be 150 hours.
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26794 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
18:53 Dec 12, 2017
Jkt 244001
PO 00000
Food and Drug Administration
[Docket No. FDA–2014–N–0345]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Drug Product Communications as
Used by the Food and Drug
Administration
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 January 12,
2018.
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 0910–0695. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7729, PRAStaff@
fda.hhs.gov.
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
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58619-58621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26794]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6455]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's consultation procedures for foods derived from new plant
varieties, including the information collection provisions in the
guidance entitled, ``Guidance on Consultation Procedures: Foods Derived
From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final
Consultation For Food Derived From a New Plant Variety (Biotechnology
Final Consultation),'' which developers may use to prepare the final
consultation in a standard format.
DATES: Submit either electronic or written comments on the collection
of information by February 12, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 12, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact
[[Page 58620]]
information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-6455 for ``Guidance on Consultation Procedures: Foods
Derived from New Plant Varieties.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the 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.
Guidance on Consultation Procedures: Foods Derived From New Plant
Varieties
OMB Control Number 0910-0704--Extension
This information collection supports the above captioned Agency
guidance document. 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 Derived From New
Plant Varieties,'' which is available on our website at https://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 Federal Food, Drug, and Cosmetic
Act (the FD&C Act).
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 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 in compliance with all requirements of the FD&C Act (57 FR
22984 at 22985).
Description of Respondents: Respondents to this collection of
information include developers of new plant varieties intended for food
use.
[[Page 58621]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Average
Activity FDA Form No. No. of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation.................... None.......................... 20 2 40 4 160
Final consultation...................... 3665.......................... 12 1 12 150 1,800
---------------------------------------------------------------------------------------------------------------
Total............................... .............................. .............. .............. .............. .............. 1,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have retained the currently approved burden estimate for this
information collection and discuss the information collection
activities below.
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.
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.
We base our estimate of the average time to prepare a submission on
informal contact with firms that made one or more biotechnology
consultation submission under the voluntary biotechnology consultation
process. As such, we estimate the average time to prepare a submission
for final consultation to be 150 hours.
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26794 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P
