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, 17868-17869 [E9-8773]
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17868
Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–8818 Filed 4–16–09; 8:45 am]
BILLING CODE 4150–30–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
mstockstill on PROD1PC66 with NOTICES
AGENCY: Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice of meeting.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold a meeting,
to be held by teleconference. This
meeting will be equivalent to an inperson meeting and will be open to the
public. Pre-registration is required for
both public attendance by phone as well
as public comment. Any individual who
wishes to attend the meeting and/or
participate in the public comment
session should e-mail nvpo@hhs.gov.
DATES: The Committee will meet by
teleconference on May 7, 2009, from 3
p.m. to 4:30 p.m., Eastern Daylight Time
(EDT).
ADDRESSES: The meeting will occur by
teleconference. To attend, please call 1–
800–369–1957, passcode ‘‘NVAC’’.
International callers must dial 1–630–
395–0286.
FOR FURTHER INFORMATION CONTACT: Ms.
Andrea Krull, Public Health Advisor,
National Vaccine Program Office,
Department of Health and Human
Services, Room 715–H, Hubert H.
Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
Phone: (202) 690–5566; Fax: (202) 260–
1165; e-mail: nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The National
Vaccine Advisory Committee was
established to provide advice and make
recommendations to the Director of the
National Vaccine Program, on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
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16:13 Apr 16, 2009
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This is a special meeting of the
NVAC. Discussions will surround the
draft recommendations on the draft ISO
Scientific Agenda contained in the
document titled ‘‘NVAC Vaccine Safety
Working Group Draft Report’’ prepared
at the request of the Assistant Secretary
for Health by the Committee’s Vaccine
Safety Working Group. The NVAC
Vaccine Safety Working Group was
initially established to (1) undertake and
coordinate a scientific review of the
draft Centers for Disease Control and
Prevention (CDC) Immunization Safety
Office (ISO) Scientific Agenda, and (2)
review the current vaccine safety
system. The draft report may be found
at https://www.hhs.gov/nvpo/nvac/
reports.html. The draft ISO Scientific
Agenda can be found at: https://
www.cdc.gov/vaccinesafety/00_pdf/
draft_agenda_recommendations_
080404.pdf and the addendum at https://
www.cdc.gov/vaccinesafety/00_pdf/
draft_recommendations_add_080410.
pdf. The Committee will review the
draft document and discuss the
proposed recommendations in
preparation for an upcoming vote on
these recommendations at the June 2009
NVAC meeting.
For this special meeting, members of
the public are invited to attend by
teleconference via a toll-free call-in
phone number. The call-in number will
be operator assisted to provide members
of the public the opportunity to provide
comments to the Committee. Public
participation and ability to comment
will be limited to space and time
available. Public comment will be
limited to no more than three minutes
per speaker. Pre-registration is required
for both public attendance and
comment. Individuals who plan to
attend and need special assistance, such
as accommodation for hearing
impairment or other reasonable
accommodations, should notify the
designated contact person at least one
week prior to the meeting.
Any members of the public who wish
to have printed material distributed to
NVAC should submit materials to the
Executive Secretary, NVAC, through the
contact person listed above prior to
close of business April 30, 2009. A draft
agenda and any additional materials
will be posted on the NVAC Vaccine
Safety Working Group Web site (https://
www.hhs.gov/nvpo/nvac/) prior to the
meeting.
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Dated: April 14, 2009.
Raymond A. Strikas,
Medical Officer, National Vaccine Program
Office, U.S. Department of Health and Human
Services.
[FR Doc. E9–8825 Filed 4–16–09; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Solicitation for Nominations for
Members of the U.S. Preventive
Services Task Force (USPSTF)
Correction
In notice document E9–8040
beginning on page 16408 in the issue of
Friday, April 10, 2009, make the
following corrections:
1. On page 16409, in the first column,
in the fifth line from the top,
‘‘indMduals’’ should read
‘‘individuals’’.
2. On the same page, in the ADDRESSES
section, in the eighth and ninth lines,
‘‘https://dreamless.keenspot.com/
comic.rss’’ should read
‘‘uspstaskforce@ahrq.hhs.gov’’.
3. On the same page, in the FOR
FURTHER INFORMATION CONTACT section,
in the second line,
‘‘uspstaskforce@ahrg.hhs.gov’’ should
read ‘‘uspstaskforce@ahrq.hhs.gov’’.
4. On the same page, in the last full
paragraph, in the second line from the
bottom, ‘‘https://
preventiveservices.ahrg.gov’’ should
read ‘‘https://
preventiveservices.ahrq.gov’’.
[FR Doc. Z9–8040 Filed 4–16–09; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0657]
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
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E:\FR\FM\17APN1.SGM
17APN1
17869
Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices
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 May 18,
2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0583. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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—
(OMB Control Number 0910–0583)—
Extension
Since May 29, 1992 (57 FR 22984),
when FDA issued a policy statement on
foods derived from new plant varieties,
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
guidance entitled ‘‘Recommendations
for the Early Food Safety Evaluation of
New Non-Pesticidal Proteins Produced
by New Plant Varieties Intended for
Food Use’’ 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. The 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.
The respondents to this collection of
information are developers of new plant
varieties intended for food use.
In the Federal Register of January 9,
2009 (74 FR 906), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
First four data components
20
1
20
4
80
Two other data components
20
1
20
16
320
Total
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1 There
400
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates the annual total hour
burden for this collection of information
to be 400 hours. This estimate is based
on early food safety evaluations
submitted in the past 3 years. FDA’s
estimate of the time that it would take
a respondent to prepare the data
components of the early food safety
evaluation submission is based on the
agency’s experience with similar
submissions.
Completing an early food safety
evaluation for a new protein from a new
plant variety is a one-time burden (one
evaluation per new protein). Based on
its experience over the past 3 years,
FDA estimates that approximately 20
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 in such a way (e.g., on such
a small scale, or in such isolated
VerDate Nov<24>2008
16:13 Apr 16, 2009
Jkt 217001
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.
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
PO 00000
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Sfmt 4703
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 assemble 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: April 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8773 Filed 4–16–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\17APN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 73 (Friday, April 17, 2009)]
[Notices]
[Pages 17868-17869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8773]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0657]
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
[[Page 17869]]
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 May 18,
2009.
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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0583.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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--(OMB Control Number 0910-0583)--Extension
Since May 29, 1992 (57 FR 22984), when FDA issued a policy
statement on foods derived from new plant varieties, 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 guidance entitled ``Recommendations for
the Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use'' 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. The 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.
The respondents to this collection of information are developers of
new plant varieties intended for food use.
In the Federal Register of January 9, 2009 (74 FR 906), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per
Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components 20 1 20 4 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Two other data components 20 1 20 16 320
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates the annual total hour burden for this collection of
information to be 400 hours. This estimate is based on early food
safety evaluations submitted in the past 3 years. FDA's estimate of the
time that it would take a respondent to prepare the data components of
the early food safety evaluation submission is based on the agency's
experience with similar submissions.
Completing an early food safety evaluation for a new protein from a
new plant variety is a one-time burden (one evaluation per new
protein). Based on its experience over the past 3 years, FDA estimates
that approximately 20 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 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.
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
assemble 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: April 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8773 Filed 4-16-09; 8:45 am]
BILLING CODE 4160-01-S
