Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, 7048-7051 [E6-1806]
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Federal Register / Vol. 71, No. 28 / Friday, February 10, 2006 / Notices
3,800; Total Annual Responses: 3,800;
Total Annual Hours: 608,000.
To obtain copies of the supporting
statement and any related forms for
these paperwork collections referenced
above, access CMS Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB Desk Officer at
the address below, no later than 5 p.m.
on March 13, 2006. OMB Human
Resources and Housing Branch,
Attention: Carolyn Lovett, CMS Desk
Officer, New Executive Office Building,
Room 10235, Washington, DC 20503.
Dated: February 3, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–1819 Filed 2–9–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–359, 360, R–55;
CMS–368, R–144; and CMS–643]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
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AGENCY:
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minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Comprehensive
Outpatient Rehabilitation Facility
(CORF) Eligibility and Survey Forms
and Information Collection
Requirements at 42 CFR 485.56, 485.58,
485.60, 485.64, 485.66 and 410.105;
Use: In order for a provider to
participate in the Medicare program as
a CORF, a provider must meet the
Federal conditions of participation. The
form CMS–359 is utilized as an
application for facilities wishing to
participate in the Medicare/Medicaid
program as CORFs. This form initiates
the process of obtaining a decision as to
whether the conditions of participation
are met. The form CMS–360 is an
instrument used by the State survey
agency to record data collected in order
to determine the provider compliance
with individual conditions of
participation and to report it to the
Federal government; Form Numbers:
CMS–359, 360, R–55 (OMB#: 0938–
0267); Frequency: Reporting—On
occasion; Affected Public: State, Local,
or Tribal government and Business or
other for-profit; Number of
Respondents: 630; Total Annual
Responses: 630; Total Annual Hours:
300,046.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: State Medicaid
Drug Rebate; Use: Section 1927 of the
Social Security Act requires each State
Medicaid agency to report quarterly
prescription drug utilization
information to drug manufacturers and
to the Centers for Medicare and
Medicaid Services. As part of this
information, the State Medicaid
agencies are required to report the total
Medicaid rebate amount they claim they
are owed by each drug manufacturer for
each covered prescription drug product
each quarter; Form Numbers: CMS–368,
R–144 (OMB#: 0938–0582); Frequency:
Reporting—Quarterly; Affected Public:
State, Local, or Tribal government;
Number of Respondents: 51; Total
Annual Responses: 204; Total Annual
Hours: 9,389.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Hospice Survey
and Deficiencies Report Form and
Supporting Regulations at 42 CFR
442.30 and 488.26; Use: In order to
participate in the Medicare program, a
hospice must meet certain Federal
health and safety conditions of
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participation. This form is used by State
surveyors to record data about a
hospice’s compliance with these
conditions of participation in order to
initiate the certification or
recertification process; Form Number:
CMS–643 (OMB#: 0938–0379);
Frequency: Reporting—Annually;
Affected Public: Not-for-profit
institutions and Business or other forprofit; Number of Respondents: 2,293;
Total Annual Responses: 475; Total
Annual Hours: 238.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on April 11, 2006.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—A,
Attention: Melissa Musotto (CMS–359,
360, R–55; CMS–368, R–144; and CMS–
643) Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
Dated: January 31, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–1820 Filed 2–9–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0369]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recommendations
for the Early Food Safety Evaluation of
New Non-Pesticidal Proteins Produced
by New Plant Varieties Intended for
Food Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
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Federal Register / Vol. 71, No. 28 / Friday, February 10, 2006 / Notices
rmajette on PROD1PC67 with NOTICES1
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by March 13,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
Recommendations for the Early Food
Safety Evaluation of New NonPesticidal Proteins Produced by New
Plant Varieties Intended for Food Use
Since 1992, when FDA issued its
Statement of Policy: Foods Derived from
New Plant Varieties (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 early in the
development process to discuss possible
scientific and regulatory issues that
might arise. The current guidance
continues to foster early communication
by encouraging developers to submit to
FDA their evaluation of the food safety
of their new protein. Such
communication helps to ensure that any
potential food safety issues regarding a
new protein in a new plant variety are
resolved early in development, prior to
any possible inadvertent introduction
into the food supply of material from
that plant variety.
FDA believes that any food safety
concern related to such material
entering the food supply would be
limited to the potential that a new
protein in food from the plant variety
could cause an allergic reaction in
susceptible individuals or could be a
toxin. This guidance describes the
procedures for early food safety
evaluation of new proteins in new plant
varieties, including bioengineered food
plants, and the procedures for
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communicating with FDA about the
safety evaluation.
In the Federal Register of November
24, 2004 (69 FR 68381), FDA published
a notice of availability with a 60-day
comment period requesting public
comment on the collection of
information in FDA’s draft guidance
document titled, ‘‘Guidance for
Industry: Recommendations for the
Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use.’’
Nonresponsive comments
FDA received approximately 5,000
letters in response to the November 24,
2004, notice. However, many of these
letters contained comments that were
not responsive to the PRA questions.
For example, several comments
expressed the following opinions: The
collection of information was
insufficient to ensure safety; the agency
might not be able to commit sufficient
resources to performing early food
safety reviews without having to
redirect resources from other tasks; the
decision should not be left to the
developer regarding when to submit an
early food safety evaluation to the
agency; and the objectivity and
scientific expertise of the individuals
reviewing the information may be
inadequate.
(Response) These comments are
general comments directed to the
adequacy of the guidance, rather than
specific comments relevant to the
collection of information; therefore,
these non-responsive comments will not
be addressed in this document.
Responsive comments
FDA received several letters with
specific comments responsive to the
comment request concerning the
proposed information collection in the
notice. The comments and FDA’s
responses follow.
(Comment 1) Several comments were
supportive of the information collection,
stating that the information collection
was necessary for FDA to fulfill
statutory requirements to protect the
safety of the food supply. Relevant to
the minimization of burden, several of
these comments also noted that the
information collection was
appropriately limited in scope to
prevent duplicative submissions among
Federal agencies.
(Response) These comments provide
support for the utility of the information
collection and confirm that the
collection will not result in a
duplicative information collection
among Federal agencies.
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(Comment 2) One comment suggested
that FDA should minimize the burden
on developers by referencing in the
guidance the availability of public
protein databases that could be useful in
the evaluation of allergen or toxin
homology.
(Response) FDA does not want to
reference or list the various databases
because to do so would imply that FDA
is endorsing any or all of them. FDA
finds that there are several databases in
the public domain that are easily
obtained through the internet, are
known in the scientific community, and
are in common use by developers of
bioengineered crops.
(Comment 3) One comment suggested
that FDA could minimize the burden of
the proposed collection of information
by clarifying that a weight of the
evidence approach is applied to the
assessment of potential allergenicity of
a new protein. The comment further
suggested that alternative methods and
protocols be considered in the
evaluation of the allergenicity of new
proteins.
(Response) FDA’s guidance does not
state that a weight of the evidence
approach will be applied to the
evaluation. The guidance describes a
case-by-case evaluation that recognizes
that different pieces of information may
have varying importance for the food
safety evaluation depending on the
characteristics of the protein. As stated
in the guidance, developers are free to
use alternative approaches in their
evaluations. The comment fails to
explain how a weight of the evidence
approach would reduce the burden
under the PRA.
(Comment 4) One comment suggested
as an approach to minimize burden on
developers that FDA treat highly similar
proteins as a family of proteins, if they
differ only by a few amino acids but
retain the same function, rather than
evaluating each protein individually,
though the comment further suggests
that certain aspects of a protein may be
evaluated individually.
(Response) FDA notes that the
guidance is intended to consider
specific proteins, not protein families.
FDA further notes that even small
changes in amino acid sequence may
alter a protein, and these small
differences could also have implications
for food safety. However, if there is
relevant information contained in a
previous submission, that information
can be incorporated by reference into a
current submission for a new protein
evaluation.
(Comment 5) One comment suggested
as a means of minimizing burden of the
proposed collection of information that
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FDA provide standard forms or formats
for certain elements of the submission
(e.g., bioinformatics reports). The
comment also suggested minimizing
burden by making greater use of
electronic submissions.
(Response) FDA has considered the
use of standardized forms or formats
and at this time does not believe that
their use would reduce the burden of
the information collection. The use of
standardized forms could discourage
alternative approaches for the
presentation of data in an evaluation
that might more clearly or thoroughly
set forth the data. Developers will have
access to the forms and formats used by
previous submitters and are free to use
them; thus, at this time we do not
perceive a need for a standardized form.
Based on its experience in evaluation of
submissions FDA will in the future
revisit whether the use of standardized
forms and formats would be
advantageous to developers.
With respect to electronic
submissions, FDA states in the guidance
that electronic submissions are
acceptable, but one paper copy is also
requested. Efforts are underway at FDA
to convert in the future to a submission
process that is entirely electronic.
(Comment 6) One comment stated
that a way to enhance the quality,
utility, and clarity of the information to
be collected is to follow guidance
available from the Codex Alimentarius.
Although the comment did not specify
which guidance from the Codex
Alimentarius FDA should follow, FDA
believes that the comment is referring to
the Codex Alimentarius ‘‘Guideline for
the Conduct of Food Safety Assessment
of Foods Derived from RecombinantDNA Plants’’ (CAC/GL 45–2003) (the
Codex Plant Guideline), containing
‘‘Annex: Assessment of Possible
Allergenicity’’ (the Codex Allergenicity
Annex). The comment also stated that
FDA should make Codex guidance a
mandatory part of its guidance.
(Response) FDA agrees in part and
disagrees in part. FDA notes that its
recommendations in this guidance are
consistent with the approach
recommended in the Codex Plant
Guideline. In fact, FDA references the
Codex Plant Guideline as a resource to
be consulted by a developer in
evaluating the food safety of a new
protein. However, FDA notes that the
Codex Plant Guideline addresses a
broad range of issues associated with
food safety assessment of food derived
from bioengineered plants. While FDA’s
guidance is consistent with the Codex
Plant Guideline, it does not address the
entire broad range of issues as that
document. FDA’s guidance is focused
on the food safety issues that might arise
from the intermittent, low-level
presence of material from a plant being
developed for food and feed use. FDA
believes that any potential risk from the
intermittent, low level presence of such
material in the food supply would be
limited to the food safety of the new
proteins. FDA references the Codex
Plant Guideline, paragraphs 34–43
under Expressed Substances (nonnucleic acid substances) and the Codex
Allergenicity Annex, for that component
of the safety review.
FDA disagrees with the comment’s
suggestion that the agency make the
Codex Plant Guideline a mandatory part
of its guidance. While FDA believes that
the Codex Plant Guideline and the
Codex Allergenicity Annex are useful
documents, it recognizes that other
approaches may also be appropriate.
(Comment 7) One comment stated
that while the information to be
collected is essential and important for
FDA to obtain, the information is
inadequate to fulfill FDA’s ‘‘stated and
mandated goals,’’ and therefore it is of
questionable utility.
(Response) FDA disagrees. The
guidance is properly focused on the
food safety assessment of a new protein
produced in a new plant variety when
there might be a low level, intermittent
presence of material from a plant being
developed for food. Although the
commenter would like more
information to be presented for FDA
review at this stage, FDA notes that
more information is not necessary
because the information that the
guidance recommends a developer
collect and present to FDA as part of a
food safety evaluation of a protein is
adequate for the specific assessment that
FDA is making at this stage. FDA
recommends that a broader scope of
information be presented to FDA for
review at subsequent evaluation stages.
For example, when a developer utilizes
the recommendations articulated in
FDA’s guidance entitled, ‘‘Consultation
Procedures for New Plant Varieties’’
(available at https://www.cfsan.fda.gov/
~lrd/consulpr.html), FDA expects that
significantly more information will be
presented during the consultation.
(Comment 8) Several comments
challenged the accuracy of FDA’s
estimate of the burden of the proposed
collection of information. These
comments opined that FDA should
collect more extensive information than
what is proposed in the guidance, and
they concluded, therefore, that FDA had
underestimated the burden of the
proposed information collection. The
comments did not challenge the
accuracy of the burden estimate for the
information as proposed in the
guidance.
(Response) FDA notes that the
comments did not challenge the
accuracy of FDA’s estimate, rather they
challenged what FDA recommends in
the guidance. FDA believes that the
estimate of the burden of the proposed
collection of information is accurate.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency per
Response
No. of Respondents
First four data
components
Two other data
components
Total
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1There
Total Annual
Responses
Hours Per Response
Total Hours
20
1
20
4
80
20
1
20
16
320
400
are no capital costs or operating and maintenance costs associated with this collection of information.
One Time Burden
Completing an early food safety
evaluation for a new protein from a new
plant variety will be a one-time burden
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(one evaluation per new protein). FDA
cannot know how many developers will
choose to complete an early food safety
evaluation for their new plant protein.
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Many developers of novel plants may
choose not to submit an evaluation
because the field testing of a plant
containing a new protein is conducted
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Federal Register / Vol. 71, No. 28 / Friday, February 10, 2006 / Notices
in such a way (e.g., on such a small
scale, or in such isolated conditions,
etc.) that cross-pollination with
traditional crops or commingling of
plant material is not likely to be an
issue. Also, other developers may have
previously communicated with FDA
about the food safety of a new plant
protein, for example, when the same
protein was expressed in a different
crop.
FDA scientists predict that this draft
guidance will generate about 20 to 150
early food safety evaluations yearly.
While there is uncertainty as to the
number of developers who will choose
to submit an evaluation, FDA estimates
that the annual number of early food
safety evaluations will be closer to the
lower bound estimate of 20 evaluations
rather than the upper bound estimate of
150 evaluations. This estimation is
supported by the fact that on average
there have been nine initial
biotechnology consultations per year.
An initial biotechnology consultation
has traditionally been the first
discussion between a developer and
FDA about a food made from a new
bioengineered plant variety; it is usually
bioengineered varieties of plants that are
the subject of a consultation with FDA.
Evaluation Components
appropriate in vitro assays (protein
digestibility study).
The paperwork burden of these two
data components consists of the time it
takes the company to put together the
information on these two data
components to submit to FDA. We
estimate that these two data components
will take 16 hours to complete (8 hours
for each component). In Table 1 of this
document, row 2 shows that for 20
evaluations, the total burden for these
two data components is 320 hours.
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Dated: February 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1806 Filed 2–9–06; 8:45 am]
Financial Disclosure by Clinical
Investigators—(OMB Control Number
0910–0396)—Extension
Respondents are sponsors of
marketing applications that contain
clinical data from studies covered by the
regulations. These sponsors represent
pharmaceutical, biologic and medical
device firms. The applicant will incur
reporting costs in order to comply with
the final rule. Applicants will be
required to submit, for example, the
complete list of clinical investigators for
each covered study, not employed by
the applicant and/or sponsor of the
covered study, and either certify to the
absence of certain financial
arrangements with clinical investigators
or disclose the nature of those
arrangements to FDA and the steps
taken by the applicant or sponsor to
minimize the potential for bias. The
clinical investigator will have to supply
information regarding financial interests
or payments held in the sponsor of the
covered study. FDA has said that it has
no preference as to how this information
is collected from investigators and that
sponsors/applicants have the flexibility
to collect the information in the most
efficient and least burdensome manner
that will be effective. FDA estimated
that the total reporting costs of sponsors
would be less than $450,000 annually.
Costs could also occur after a marketing
application is submitted if FDA
determines that the financial interests of
an investigator raise significant
questions about the integrity of the data.
FDA estimates the burden of this
collection of information as follows:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0296]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Financial
Disclosure by Clinical Investigators
AGENCY:
Food and Drug Administration,
HHS.
The early food safety evaluation for
new proteins includes six main data
components. Four of these data
components are easily and quickly
obtainable, having to do with the
identity and source of the protein. FDA
estimates that completing these data
components will take about 4 hours per
evaluation. In table 1 of this document,
row 1 shows that for 20 evaluations, the
total burden for these 4 data
components is 80 hours.
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis which can be performed using
publicly available databases. The other
data component involves ‘wet’ lab work
to assess the new protein’s stability and
the resistance of the protein to
enzymatic degradation using
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 13,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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,
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
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54.4(a)(1) and (a)(2)
Annual Frequency
per Response
Total Annual
Responses
Hours Per Response
1,000
1
1,000
5
5,000
100
1
100
20
2,000
46,000
.25
11,500
.1
11,500
54.4(a)(3)
54.4
Total
1There
Total Hours
18,500
are no capital cost or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 71, Number 28 (Friday, February 10, 2006)]
[Notices]
[Pages 7048-7051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1806]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0369]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recommendations for
the Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of
[[Page 7049]]
information has been submitted to the Office of Management and Budget
(OMB) for review and clearance under the Paperwork Reduction Act of
1995 (the PRA).
DATES: Fax written comments on the collection of information by March
13, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
Recommendations for the Early Food Safety Evaluation of New Non-
Pesticidal Proteins Produced by New Plant Varieties Intended for Food
Use
Since 1992, when FDA issued its Statement of Policy: Foods Derived
from New Plant Varieties (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 early in
the development process to discuss possible scientific and regulatory
issues that might arise. The current guidance continues to foster early
communication by encouraging developers to submit to FDA their
evaluation of the food safety of their new protein. Such communication
helps to ensure that any potential food safety issues regarding a new
protein in a new plant variety are resolved early in development, prior
to any possible inadvertent introduction into the food supply of
material from that plant variety.
FDA believes that any food safety concern related to such material
entering the food supply would be limited to the potential that a new
protein in food from the plant variety could cause an allergic reaction
in susceptible individuals or could be a toxin. This guidance describes
the procedures for early food safety evaluation of new proteins in new
plant varieties, including bioengineered food plants, and the
procedures for communicating with FDA about the safety evaluation.
In the Federal Register of November 24, 2004 (69 FR 68381), FDA
published a notice of availability with a 60-day comment period
requesting public comment on the collection of information in FDA's
draft guidance document titled, ``Guidance for Industry:
Recommendations for the Early Food Safety Evaluation of New Non-
Pesticidal Proteins Produced by New Plant Varieties Intended for Food
Use.''
Nonresponsive comments
FDA received approximately 5,000 letters in response to the
November 24, 2004, notice. However, many of these letters contained
comments that were not responsive to the PRA questions. For example,
several comments expressed the following opinions: The collection of
information was insufficient to ensure safety; the agency might not be
able to commit sufficient resources to performing early food safety
reviews without having to redirect resources from other tasks; the
decision should not be left to the developer regarding when to submit
an early food safety evaluation to the agency; and the objectivity and
scientific expertise of the individuals reviewing the information may
be inadequate.
(Response) These comments are general comments directed to the
adequacy of the guidance, rather than specific comments relevant to the
collection of information; therefore, these non-responsive comments
will not be addressed in this document.
Responsive comments
FDA received several letters with specific comments responsive to
the comment request concerning the proposed information collection in
the notice. The comments and FDA's responses follow.
(Comment 1) Several comments were supportive of the information
collection, stating that the information collection was necessary for
FDA to fulfill statutory requirements to protect the safety of the food
supply. Relevant to the minimization of burden, several of these
comments also noted that the information collection was appropriately
limited in scope to prevent duplicative submissions among Federal
agencies.
(Response) These comments provide support for the utility of the
information collection and confirm that the collection will not result
in a duplicative information collection among Federal agencies.
(Comment 2) One comment suggested that FDA should minimize the
burden on developers by referencing in the guidance the availability of
public protein databases that could be useful in the evaluation of
allergen or toxin homology.
(Response) FDA does not want to reference or list the various
databases because to do so would imply that FDA is endorsing any or all
of them. FDA finds that there are several databases in the public
domain that are easily obtained through the internet, are known in the
scientific community, and are in common use by developers of
bioengineered crops.
(Comment 3) One comment suggested that FDA could minimize the
burden of the proposed collection of information by clarifying that a
weight of the evidence approach is applied to the assessment of
potential allergenicity of a new protein. The comment further suggested
that alternative methods and protocols be considered in the evaluation
of the allergenicity of new proteins.
(Response) FDA's guidance does not state that a weight of the
evidence approach will be applied to the evaluation. The guidance
describes a case-by-case evaluation that recognizes that different
pieces of information may have varying importance for the food safety
evaluation depending on the characteristics of the protein. As stated
in the guidance, developers are free to use alternative approaches in
their evaluations. The comment fails to explain how a weight of the
evidence approach would reduce the burden under the PRA.
(Comment 4) One comment suggested as an approach to minimize burden
on developers that FDA treat highly similar proteins as a family of
proteins, if they differ only by a few amino acids but retain the same
function, rather than evaluating each protein individually, though the
comment further suggests that certain aspects of a protein may be
evaluated individually.
(Response) FDA notes that the guidance is intended to consider
specific proteins, not protein families. FDA further notes that even
small changes in amino acid sequence may alter a protein, and these
small differences could also have implications for food safety.
However, if there is relevant information contained in a previous
submission, that information can be incorporated by reference into a
current submission for a new protein evaluation.
(Comment 5) One comment suggested as a means of minimizing burden
of the proposed collection of information that
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FDA provide standard forms or formats for certain elements of the
submission (e.g., bioinformatics reports). The comment also suggested
minimizing burden by making greater use of electronic submissions.
(Response) FDA has considered the use of standardized forms or
formats and at this time does not believe that their use would reduce
the burden of the information collection. The use of standardized forms
could discourage alternative approaches for the presentation of data in
an evaluation that might more clearly or thoroughly set forth the data.
Developers will have access to the forms and formats used by previous
submitters and are free to use them; thus, at this time we do not
perceive a need for a standardized form. Based on its experience in
evaluation of submissions FDA will in the future revisit whether the
use of standardized forms and formats would be advantageous to
developers.
With respect to electronic submissions, FDA states in the guidance
that electronic submissions are acceptable, but one paper copy is also
requested. Efforts are underway at FDA to convert in the future to a
submission process that is entirely electronic.
(Comment 6) One comment stated that a way to enhance the quality,
utility, and clarity of the information to be collected is to follow
guidance available from the Codex Alimentarius. Although the comment
did not specify which guidance from the Codex Alimentarius FDA should
follow, FDA believes that the comment is referring to the Codex
Alimentarius ``Guideline for the Conduct of Food Safety Assessment of
Foods Derived from Recombinant-DNA Plants'' (CAC/GL 45-2003) (the Codex
Plant Guideline), containing ``Annex: Assessment of Possible
Allergenicity'' (the Codex Allergenicity Annex). The comment also
stated that FDA should make Codex guidance a mandatory part of its
guidance.
(Response) FDA agrees in part and disagrees in part. FDA notes that
its recommendations in this guidance are consistent with the approach
recommended in the Codex Plant Guideline. In fact, FDA references the
Codex Plant Guideline as a resource to be consulted by a developer in
evaluating the food safety of a new protein. However, FDA notes that
the Codex Plant Guideline addresses a broad range of issues associated
with food safety assessment of food derived from bioengineered plants.
While FDA's guidance is consistent with the Codex Plant Guideline, it
does not address the entire broad range of issues as that document.
FDA's guidance is focused on the food safety issues that might arise
from the intermittent, low-level presence of material from a plant
being developed for food and feed use. FDA believes that any potential
risk from the intermittent, low level presence of such material in the
food supply would be limited to the food safety of the new proteins.
FDA references the Codex Plant Guideline, paragraphs 34-43 under
Expressed Substances (non-nucleic acid substances) and the Codex
Allergenicity Annex, for that component of the safety review.
FDA disagrees with the comment's suggestion that the agency make
the Codex Plant Guideline a mandatory part of its guidance. While FDA
believes that the Codex Plant Guideline and the Codex Allergenicity
Annex are useful documents, it recognizes that other approaches may
also be appropriate.
(Comment 7) One comment stated that while the information to be
collected is essential and important for FDA to obtain, the information
is inadequate to fulfill FDA's ``stated and mandated goals,'' and
therefore it is of questionable utility.
(Response) FDA disagrees. The guidance is properly focused on the
food safety assessment of a new protein produced in a new plant variety
when there might be a low level, intermittent presence of material from
a plant being developed for food. Although the commenter would like
more information to be presented for FDA review at this stage, FDA
notes that more information is not necessary because the information
that the guidance recommends a developer collect and present to FDA as
part of a food safety evaluation of a protein is adequate for the
specific assessment that FDA is making at this stage. FDA recommends
that a broader scope of information be presented to FDA for review at
subsequent evaluation stages. For example, when a developer utilizes
the recommendations articulated in FDA's guidance entitled,
``Consultation Procedures for New Plant Varieties'' (available at
https://www.cfsan.fda.gov/~lrd/consulpr.html), FDA expects that
significantly more information will be presented during the
consultation.
(Comment 8) Several comments challenged the accuracy of FDA's
estimate of the burden of the proposed collection of information. These
comments opined that FDA should collect more extensive information than
what is proposed in the guidance, and they concluded, therefore, that
FDA had underestimated the burden of the proposed information
collection. The comments did not challenge the accuracy of the burden
estimate for the information as proposed in the guidance.
(Response) FDA notes that the comments did not challenge the
accuracy of FDA's estimate, rather they challenged what FDA recommends
in the guidance. FDA believes that the estimate of the burden of the
proposed collection of information is accurate.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual
No. of Respondents Response Responses Hours Per Response Total Hours
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First four data components 20 1 20 4 80
Two other data components 20 1 20 16 320
Total ......................... ......................... .................... .................... 400
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
One Time Burden
Completing an early food safety evaluation for a new protein from a
new plant variety will be a one-time burden (one evaluation per new
protein). FDA cannot know how many developers will choose to complete
an early food safety evaluation for their new plant protein. Many
developers of novel plants may choose not to submit an evaluation
because the field testing of a plant containing a new protein is
conducted
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in such a way (e.g., on such a small scale, or in such isolated
conditions, etc.) that cross-pollination with traditional crops or
commingling of plant material is not likely to be an issue. Also, other
developers may have previously communicated with FDA about the food
safety of a new plant protein, for example, when the same protein was
expressed in a different crop.
FDA scientists predict that this draft guidance will generate about
20 to 150 early food safety evaluations yearly. While there is
uncertainty as to the number of developers who will choose to submit an
evaluation, FDA estimates that the annual number of early food safety
evaluations will be closer to the lower bound estimate of 20
evaluations rather than the upper bound estimate of 150 evaluations.
This estimation is supported by the fact that on average there have
been nine initial biotechnology consultations per year. An initial
biotechnology consultation has traditionally been the first discussion
between a developer and FDA about a food made from a new bioengineered
plant variety; it is usually bioengineered varieties of plants that are
the subject of a consultation with FDA.
Evaluation Components
The early food safety evaluation for new proteins includes six main
data components. Four of these data components are easily and quickly
obtainable, having to do with the identity and source of the protein.
FDA estimates that completing these data components will take about 4
hours per evaluation. In table 1 of this document, row 1 shows that for
20 evaluations, the total burden for these 4 data components is 80
hours.
Two data components ask for original data to be generated. One data
component consists of a bioinformatics analysis which can be performed
using publicly available databases. The other data component involves
`wet' lab work to assess the new protein's stability and the resistance
of the protein to enzymatic degradation using appropriate in vitro
assays (protein digestibility study).
The paperwork burden of these two data components consists of the
time it takes the company to put together the information on these two
data components to submit to FDA. We estimate that these two data
components will take 16 hours to complete (8 hours for each component).
In Table 1 of this document, row 2 shows that for 20 evaluations, the
total burden for these two data components is 320 hours.
Dated: February 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1806 Filed 2-9-06; 8:45 am]
BILLING CODE 4160-01-S
