Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties, 13132-13133 [2018-06069]
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13132
Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
enumerated through their CMS
Certification Number (CCN). State
Medicaid agencies and CMS use the
provider’s tax identification number and
NPI or CCN combination in order to
make payment, validate payment
eligibility and detect and prevent
duplicate payments for EPs, eligible
hospitals and CAHs. Form Number:
CMS–10336 (OMB Control Number:
0938–1158); Frequency: Occasionally;
Affected Public: Private sector; Number
of Respondents: 214,694; Total Annual
Responses: 214,694; Total Annual
Hours: 2,034,740. (For policy questions
regarding this collection contact Steven
Johnson at (410) 786–3332).
Dated: March 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–06081 Filed 3–26–18; 8:45 am]
BILLING CODE 4120–01–P
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.
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by April 26,
2018.
DATES:
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.
amozie on DSK30RV082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
18:07 Mar 26, 2018
Jkt 244001
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, 301–796–5733, 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 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 (FD&C Act).
In the Federal Register of December
13, 2017 (82 FR 58619), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. Two
comments were received in response to
the notice. Overall, the comments
supported FDA’s need for the
information collection and neither
comment suggested revising our
estimate of the associated burden.
However, both comments reminded us
that significant resources were invested
into developing data upon which
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
respondents rely to bring information to
FDA regarding the development of foods
derived from new plant varieties. All
the more reason, the comments said,
FDA should identify mechanisms by
which it can better incorporate its
experience over time and, where
possible, implement more efficient,
streamlined review processes for those
products similar to those the Agency
has reviewed in the past. The comments
recommended FDA compare efficiencies
with a process at the U.S. Department of
Agriculture regarding the review of
agricultural biotechnology products. We
appreciate this suggestion. FDA strives
to allocate its limited resources in ways
that maximize protection to the public
health and facilitate compliance with
existing regulatory requirements
implemented to do so. We also look for
ways in which we might coordinate our
efforts with those by other agencies who
share these objectives.
Both comments also included the
suggestion that FDA develop a less
redundant review process (such as
reciprocity if no material differences are
identified) that better coordinates
expertise across the Center for Food
Safety and Nutrition (CFSAN) and the
Center for Veterinary Medicine (CVM)
into a single, efficient review. We
appreciate this suggestion as well and,
as discussed in the guidance, note the
following:
[FDA’s] Office of Premarket Approval
of the CFSAN and the Office of
Surveillance and Compliance of the
CVM have established a Biotechnology
Evaluation Team (BET) to facilitate, and
to ensure consistency in the process by
which firms consult under the 1992
policy and inform FDA regarding the
marketing of bioengineered foods and
food ingredients derived from new plant
varieties including those developed
using rDNA techniques. The BET
oversees the consultation process,
identifies regulatory and scientific
issues that need to be addressed, and
once all relevant issues have been
adequately addressed, brings the
consultation to closure.
At the same time, we have shared the
comments received in response to this
notice under the PRA with the BET.
Consistent with our Good Guidance
Practice regulations (21 CFR 10.115),
FDA welcomes comments on our
guidance documents at any time.
In consideration of these comments,
we have retained the currently approved
burden estimated associated with the
information collection, which is as
follows:
E:\FR\FM\27MRN1.SGM
27MRN1
13133
Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
FDA form No.
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
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.
Our estimate is based on the
information collection activities
discussed below.
amozie on DSK30RV082PROD with 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 CVM and 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
VerDate Sep<11>2014
18:07 Mar 26, 2018
Jkt 244001
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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06069 Filed 3–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0965]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Pharmacy Compounding
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Pharmacy Compounding Advisory
Committee (Committee), Division of
Advisory Committee Consultant
Management, Center for Drug
Evaluation and Research. The
SUMMARY:
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
Committee provides advice on
scientific, technical, and medical issues
concerning human drug compounding
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), and, as
required, any other product for which
FDA has regulatory responsibility, and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before May 29, 2018, will be given first
consideration for membership on the
Pharmacy Compounding Advisory
Committee. Nominations received after
May 29, 2018, will be considered for
nominations to the Committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002; 301–796–9001, Fax:
301–847–8533, email: PCAC@
fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
website by using the following link:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on the Pharmacy
Compounding Advisory Committee.
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13132-13133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06069]
-----------------------------------------------------------------------
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 (PRA).
DATES: Fax written comments on the collection of information by April
26, 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 [email protected]. 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (FD&C Act).
In the Federal Register of December 13, 2017 (82 FR 58619), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. Two comments were received
in response to the notice. Overall, the comments supported FDA's need
for the information collection and neither comment suggested revising
our estimate of the associated burden. However, both comments reminded
us that significant resources were invested into developing data upon
which respondents rely to bring information to FDA regarding the
development of foods derived from new plant varieties. All the more
reason, the comments said, FDA should identify mechanisms by which it
can better incorporate its experience over time and, where possible,
implement more efficient, streamlined review processes for those
products similar to those the Agency has reviewed in the past. The
comments recommended FDA compare efficiencies with a process at the
U.S. Department of Agriculture regarding the review of agricultural
biotechnology products. We appreciate this suggestion. FDA strives to
allocate its limited resources in ways that maximize protection to the
public health and facilitate compliance with existing regulatory
requirements implemented to do so. We also look for ways in which we
might coordinate our efforts with those by other agencies who share
these objectives.
Both comments also included the suggestion that FDA develop a less
redundant review process (such as reciprocity if no material
differences are identified) that better coordinates expertise across
the Center for Food Safety and Nutrition (CFSAN) and the Center for
Veterinary Medicine (CVM) into a single, efficient review. We
appreciate this suggestion as well and, as discussed in the guidance,
note the following:
[FDA's] Office of Premarket Approval of the CFSAN and the Office of
Surveillance and Compliance of the CVM have established a Biotechnology
Evaluation Team (BET) to facilitate, and to ensure consistency in the
process by which firms consult under the 1992 policy and inform FDA
regarding the marketing of bioengineered foods and food ingredients
derived from new plant varieties including those developed using rDNA
techniques. The BET oversees the consultation process, identifies
regulatory and scientific issues that need to be addressed, and once
all relevant issues have been adequately addressed, brings the
consultation to closure.
At the same time, we have shared the comments received in response
to this notice under the PRA with the BET. Consistent with our Good
Guidance Practice regulations (21 CFR 10.115), FDA welcomes comments on
our guidance documents at any time.
In consideration of these comments, we have retained the currently
approved burden estimated associated with the information collection,
which is as follows:
[[Page 13133]]
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...................................... 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.
Our estimate is based on the information collection activities
discussed 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 CVM and 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.
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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06069 Filed 3-26-18; 8:45 am]
BILLING CODE 4164-01-P
