Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties, 73590-73591 [2014-29046]
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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0073]
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.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies 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. 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 9, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our estimate of the
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
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 Derived From New Plant
Varieties,’’ which is available on FDA’s
Web site 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 FD&C Act.
Description of Respondents:
Respondents to this collection of
information include developers of new
plant varieties intended for food use.
FDA estimates the burden of this
collection as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Activity
FDA form No.
Initial consultation ...............
Final consultation ................
None ...................................
FDA 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.
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19:07 Dec 10, 2014
Jkt 235001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\11DEN1.SGM
11DEN1
Total hours
Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
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 (CVM) and its
Center for Food Safety and Applied
Nutrition (CFSAN) 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:07 Dec 10, 2014
Jkt 235001
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: December 8, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29046 Filed 12–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1960]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies 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
revisions to Forms FDA 3500, 3500A,
and 3500B used in the FDA Medical
Products Reporting Program.
DATES: Submit either electronic or
written comments on the collection of
information by February 9, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
73591
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: 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.
MedWatch: The FDA Medical Products
Reporting Program—(OMB Control
Number 0910–0291)—Extension
I. Background
To ensure the marketing of safe and
effective products, postmarketing
adverse outcomes and product problems
must be reported for all FDA-regulated
human healthcare products, including
drugs (prescription, nonprescription,
and compounded), biologics, medical
devices, dietary supplements and other
special nutritional products (e.g. infant
formula and medical foods), and
cosmetics. In addition, FDA has
E:\FR\FM\11DEN1.SGM
11DEN1
]]>Agencies
[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73590-73591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29046]
[[Page 73590]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0073]
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies 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. 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 9, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our estimate of the 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
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 Derived From New
Plant Varieties,'' which is available on FDA's Web site 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 FD&C Act.
Description of Respondents: Respondents to this collection of
information include developers of new plant varieties intended for food
use.
FDA estimates the burden of this collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation...................... None........................ 20 2 40 4 160
Final consultation........................ FDA 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.
[[Page 73591]]
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 (CVM) and its
Center for Food Safety and Applied Nutrition (CFSAN) 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.
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: December 8, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29046 Filed 12-10-14; 8:45 am]
BILLING CODE 4164-01-P
