Agency Information Collection Activities; Submission for Office of Management and Budget Review; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products, 24603-24605 [05-9328]
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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
VIII. Other Information
This and other CDC funding
opportunity announcements can be
found on the CDC Web site, Internet
address: https://www.cdc.gov. Click on
‘‘Funding’’ then ‘‘Grants and
Cooperative Agreements.’’
Dated: May 4, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–9273 Filed 5–9–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0012]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Allergen Labeling of Food Products
Consumer Preference Survey and
Experimental Study on Allergen
Labeling of Food Products
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.
Fax written comments on the
collection of information by June 9,
2005.
DATES:
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,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate jul<14>2003
16:17 May 09, 2005
Jkt 205001
Allergen Labeling of Food Products
Consumer Preference Survey
Under section 903(b)(2) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 393(b)(2)), FDA is authorized
to conduct research relating to foods
and to conduct educational and public
information programs relating to the
safety of the Nation’s food supply. FDA
is planning to conduct a consumer
survey about allergen labeling of food
products under this authority. The
Allergen Labeling of Food Products
Consumer Preference Survey will
collect information (see table 1 of this
document) to gauge the impact of
certain changes to the food label with
respect to information about allergenic
ingredients. This data collection is
needed to satisfy some of the
requirements of the Food Allergen
Labeling and Consumer Protection Act
(FALCPA) (Public Law 108–282, title II,
section 204.4), including the
requirement that FDA provide data on
consumer preferences in a report to
Congress. In particular, section 204.4 of
the FALCPA asks FDA to describe in the
report ‘‘* * *how consumers with food
allergies or the caretakers of consumers
would prefer that information about the
risk of cross-contact be communicated
on food labels as determined by using
appropriate survey mechanisms.’’ In
addition, the survey will address other
issues pertinent to allergen labeling
changes mandated by the FALCPA. The
data will be collected by means of a
pool of people who will be screened
(through self-report) for food allergy,
and food allergy caregiver status. A
balanced sample of 1,000 will be
selected. Participation in the survey is
voluntary.
Experimental Study on Allergen
Labeling of Food Products
As previously stated, under section
903(b)(2) of the act, FDA is authorized
to conduct research relating to foods
and to conduct educational and public
information programs relating to the
safety of the Nation’s food supply. FDA
is planning to conduct an experimental
study about allergen labeling of food
products under this authority. The
Experimental Study on Allergen
Labeling of Food Products will collect
information (see table 2 of this
document) to gauge the impact of
certain changes to the food label with
respect to information about allergenic
ingredients. This data collection is
needed to satisfy some of the
requirements of the FALCPA, including
the requirement that FDA provide data
on consumer preferences with regard to
allergen labeling in a report to Congress.
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
24603
In particular, section 204.4 of the
FALCPA asks FDA to describe in the
report ‘‘* * *how consumers with food
allergies or the caretakers of consumers
would prefer that information about the
risk of cross-contact be communicated
on food labels as determined by using
appropriate survey mechanisms.’’ The
allergen labeling experiment will
supplement data collected by the
Allergen Labeling of Food Products
Consumer Preference Survey. In
addition, the experiment will address
other issues pertinent to allergen
labeling changes mandated by the
FALCPA. The experimental study data
will be collected using an Internet panel
of people who will be screened (through
self-report) for food allergy, and food
allergy caregiver status. Participation in
the allergen experimental study is
voluntary.
In the Federal Register of January 26,
2005 (70 FR 3711), FDA published a 60day notice requesting public comment
on the information collection
provisions. FDA received two
comments, both from the same
consortium of food allergy interested
organizations: The American Academy
of Allergy, Asthma & Immunology
(AAAAI); the American College of
Allergy, Asthma & Immunology
(ACAAI); and The Food Allergy &
Anaphylaxis Network (FAAN). The
comments were identical and are
addressed in the following paragraphs.
The comments applauded FDA’s goals
for the research. The comments
suggested that to improve the quality of
the study and analysis, the agency
should do the following: (1) Consider
using FAAN’s membership rolls to draw
the samples, (2) screen the sampling
frame to maximize the likelihood of
recruiting truly food allergic
individuals, (3) acknowledge that some
households have multiple individuals
who are food allergic, (4) recognize that
some individuals do not have Internet
access, (5) consider using advisory
labeling that is currently found in the
marketplace, and (6) collaborate closely
with appropriate representatives from
their organizations.
The agency has considered the offer to
use FAAN’s membership rolls to draw
the study samples and has determined
that the high likelihood of bias would
render results not generalizable. The
agency does not agree that using
FAAN’s membership rolls will yield a
better sample than can be acquired by
using established Internet panels.
FDA will utilize two consumer
Internet panels to collect data for this
research. One of the advantages to using
Internet panels is the small ratio
between the cost of the research and the
E:\FR\FM\10MYN1.SGM
10MYN1
24604
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
quality of the data collected. Another
advantage is the minimal amount of
field time needed to collect the
information. This is an important
consideration because of the FALCPA
requirements for providing the
informational report to Congress. A
potential disadvantage of using Internet
panels for data collection is the risk that
the Internet panels’ constituency may
not adequately represent the general
population, lessening its potential to
provide generalizable data. A
description of each panel follows.
The Allergen Labeling of Food
Products Consumer Preference Survey
will utilize Knowledge Network’s (a
private research firm) Web-enabled
panel. Knowledge Network’s panel
consists of 40,000 households who have
agreed to participate in research studies
conducted through the Internet.
Knowledge Network’s Web-enabled
panel was constructed using random
digit dialing procedures rendering
samples drawn from them generalizable
to the general population. Both Internet
and Noninternet users were recruited.
Both groups received equipment that
allows them to participate in research
via the Internet.
The sample for the Experimental
Study on Allergen Labeling of Food
Products is Synovate, Inc.’s (a private
research firm) Internet panel. Synovate’s
panel consists of 500,000 households
who have agreed to participate in
research studies conducted through the
Internet. This panel was not constructed
using random digit dialing procedures
but rather by recruiting through
multiple media. The panel was designed
to closely match the general population
on major demographic characteristics.
The agency agrees that it is important
to implement rigorous screening
requirements in order to obtain samples
of truly food allergic individuals. Many
people believe that they have a food
allergy when, in fact, they have an
intolerance to a particular food or they
have celiac disease. While these two
conditions can produce symptoms that
are similar to those sometimes seen with
food allergies, the physiological
mechanisms producing the reactions are
entirely different. The agency has
designed a screener that all panel
members will receive in which they
would be asked first whether or not they
have a food allergy or if they regularly
prepare food for someone with a food
allergy, and then whether or not they
have been medically diagnosed as food
allergic. Then they are asked to state
which diagnosis method was used.
The agency agrees that some
households have multiple members who
are food allergic. As described
previously in the discussion on the
screener, Internet panel members are
asked whether or not they, or someone
for whom they regularly prepare food,
has a food allergy. The reason we made
the ‘‘prepare food for someone with a
food allergy’’ distinction is to be able to
categorize the respondent as a caregiver
to someone with a food allergy. It is
important to point out that the study
will also recruit individuals who do not
meet the criteria for food-allergic
individual or caregiver. The nonfood
allergic group will be analyzed
separately from the food allergic group.
The agency believes it is important to
acknowledge that the population of food
allergic individuals is not static and that
at any time someone can become a
member. These individuals must be able
to immediately use the food label to
determine whether or not it is safe for
them to consume the food.
The agency agrees that some
individuals do not have access to the
Internet. As discussed in the previous
paragraphs, the Internet panel that will
be used to draw the survey sample was
constructed using random digit dialing
procedures, and those without Internet
access were supplied with equipment
which allows them to access the
Internet and to participate in consumer
research.
The agency agrees that it is important
to use advisory labeling that is currently
found in the marketplace. The agency
has used the FAAN list of advisory
statements and another list created by
an informal market survey, and has
classified the statements into groupings
of similar statements. The statements
that appear most often in each of the
groupings were chosen for analysis in
the study.
The agency agrees that for the
research to be of the highest quality and
utility, collaboration with appropriate
representatives from AAAAI, ACAAI,
and FAAN is important and has already
implemented this collaboration.
FDA estimates the burden of the
Allergen Labeling of Food Products
Consumer Preference Survey collection
of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
Number of
Respondents
Screener
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
0.0055
Total Hours
500,000
1
500,000
Pretest
30
1
30
0.167
5
Survey
1,000
1
1,000
0.167
167
Total
2,750
2,922
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with consumer surveys
very similar to this proposed study.
FDA estimates the burden of the
Experimental Study on Allergen
Labeling of Food Products collection of
information as follows:
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
Number of
Respondents
Screener
VerDate jul<14>2003
Annual Frequency
per Response
40,000
16:17 May 09, 2005
Jkt 205001
PO 00000
Total Annual
Responses
1
Frm 00107
Fmt 4703
40,000
Sfmt 4703
E:\FR\FM\10MYN1.SGM
Hours per
Response
0.0055
10MYN1
Total Hours
220
24605
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Number of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
30
30
0.167
5
4,000
Experiment
1
1
4,000
0.167
668
Total
893
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here.
Dated: May 4, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9328 Filed 5–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Neurological
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 17, 2005, from 8:30 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Janet L. Scudiero,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1184, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512513. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will hear a
presentation on the FDA Critical Path
Initiative and a presentation by the
VerDate jul<14>2003
16:17 May 09, 2005
Jkt 205001
Office of Surveillance and Biometrics in
the Center for Devices and Radiological
Health outlining their responsibility for
the review of postmarket study design.
The committee will also hear an update
on the status of recent devices brought
before the committee. Subsequently, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for a
selective head cooling system intended
for use in infants 36 weeks of gestation
or older at risk for moderate to severe
hypoxic-ischemic encephalopathy (HIE)
to prevent or reduce the severity of HIE.
Background information for the topic,
including the agenda and questions for
the committee, will be available to the
public 1 business day before the
meeting on the Internet at https://
www.fda.gov/cdrh/panelmtg.html.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by June 3, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by June 3, 2005, and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
Williams at 240–276–0450, ext. 113 at
least 7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05–9296 Filed 5–9–05; 8:45am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 13 and 14, 2005, from 8
a.m. to 5:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Teresa A. Watkins,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, e-mail: watkinst@cder.fda.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512545. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On July 13, 2005, the
committee will discuss the implications
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24603-24605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9328]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0012]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Allergen Labeling of Food Products
Consumer Preference Survey and Experimental Study on Allergen Labeling
of Food Products
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.
DATES: Fax written comments on the collection of information by June 9,
2005.
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, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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.
Allergen Labeling of Food Products Consumer Preference Survey
Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research
relating to foods and to conduct educational and public information
programs relating to the safety of the Nation's food supply. FDA is
planning to conduct a consumer survey about allergen labeling of food
products under this authority. The Allergen Labeling of Food Products
Consumer Preference Survey will collect information (see table 1 of
this document) to gauge the impact of certain changes to the food label
with respect to information about allergenic ingredients. This data
collection is needed to satisfy some of the requirements of the Food
Allergen Labeling and Consumer Protection Act (FALCPA) (Public Law 108-
282, title II, section 204.4), including the requirement that FDA
provide data on consumer preferences in a report to Congress. In
particular, section 204.4 of the FALCPA asks FDA to describe in the
report ``* * *how consumers with food allergies or the caretakers of
consumers would prefer that information about the risk of cross-contact
be communicated on food labels as determined by using appropriate
survey mechanisms.'' In addition, the survey will address other issues
pertinent to allergen labeling changes mandated by the FALCPA. The data
will be collected by means of a pool of people who will be screened
(through self-report) for food allergy, and food allergy caregiver
status. A balanced sample of 1,000 will be selected. Participation in
the survey is voluntary.
Experimental Study on Allergen Labeling of Food Products
As previously stated, under section 903(b)(2) of the act, FDA is
authorized to conduct research relating to foods and to conduct
educational and public information programs relating to the safety of
the Nation's food supply. FDA is planning to conduct an experimental
study about allergen labeling of food products under this authority.
The Experimental Study on Allergen Labeling of Food Products will
collect information (see table 2 of this document) to gauge the impact
of certain changes to the food label with respect to information about
allergenic ingredients. This data collection is needed to satisfy some
of the requirements of the FALCPA, including the requirement that FDA
provide data on consumer preferences with regard to allergen labeling
in a report to Congress. In particular, section 204.4 of the FALCPA
asks FDA to describe in the report ``* * *how consumers with food
allergies or the caretakers of consumers would prefer that information
about the risk of cross-contact be communicated on food labels as
determined by using appropriate survey mechanisms.'' The allergen
labeling experiment will supplement data collected by the Allergen
Labeling of Food Products Consumer Preference Survey. In addition, the
experiment will address other issues pertinent to allergen labeling
changes mandated by the FALCPA. The experimental study data will be
collected using an Internet panel of people who will be screened
(through self-report) for food allergy, and food allergy caregiver
status. Participation in the allergen experimental study is voluntary.
In the Federal Register of January 26, 2005 (70 FR 3711), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received two comments, both from the same
consortium of food allergy interested organizations: The American
Academy of Allergy, Asthma & Immunology (AAAAI); the American College
of Allergy, Asthma & Immunology (ACAAI); and The Food Allergy &
Anaphylaxis Network (FAAN). The comments were identical and are
addressed in the following paragraphs.
The comments applauded FDA's goals for the research. The comments
suggested that to improve the quality of the study and analysis, the
agency should do the following: (1) Consider using FAAN's membership
rolls to draw the samples, (2) screen the sampling frame to maximize
the likelihood of recruiting truly food allergic individuals, (3)
acknowledge that some households have multiple individuals who are food
allergic, (4) recognize that some individuals do not have Internet
access, (5) consider using advisory labeling that is currently found in
the marketplace, and (6) collaborate closely with appropriate
representatives from their organizations.
The agency has considered the offer to use FAAN's membership rolls
to draw the study samples and has determined that the high likelihood
of bias would render results not generalizable. The agency does not
agree that using FAAN's membership rolls will yield a better sample
than can be acquired by using established Internet panels.
FDA will utilize two consumer Internet panels to collect data for
this research. One of the advantages to using Internet panels is the
small ratio between the cost of the research and the
[[Page 24604]]
quality of the data collected. Another advantage is the minimal amount
of field time needed to collect the information. This is an important
consideration because of the FALCPA requirements for providing the
informational report to Congress. A potential disadvantage of using
Internet panels for data collection is the risk that the Internet
panels' constituency may not adequately represent the general
population, lessening its potential to provide generalizable data. A
description of each panel follows.
The Allergen Labeling of Food Products Consumer Preference Survey
will utilize Knowledge Network's (a private research firm) Web-enabled
panel. Knowledge Network's panel consists of 40,000 households who have
agreed to participate in research studies conducted through the
Internet. Knowledge Network's Web-enabled panel was constructed using
random digit dialing procedures rendering samples drawn from them
generalizable to the general population. Both Internet and Noninternet
users were recruited. Both groups received equipment that allows them
to participate in research via the Internet.
The sample for the Experimental Study on Allergen Labeling of Food
Products is Synovate, Inc.'s (a private research firm) Internet panel.
Synovate's panel consists of 500,000 households who have agreed to
participate in research studies conducted through the Internet. This
panel was not constructed using random digit dialing procedures but
rather by recruiting through multiple media. The panel was designed to
closely match the general population on major demographic
characteristics.
The agency agrees that it is important to implement rigorous
screening requirements in order to obtain samples of truly food
allergic individuals. Many people believe that they have a food allergy
when, in fact, they have an intolerance to a particular food or they
have celiac disease. While these two conditions can produce symptoms
that are similar to those sometimes seen with food allergies, the
physiological mechanisms producing the reactions are entirely
different. The agency has designed a screener that all panel members
will receive in which they would be asked first whether or not they
have a food allergy or if they regularly prepare food for someone with
a food allergy, and then whether or not they have been medically
diagnosed as food allergic. Then they are asked to state which
diagnosis method was used.
The agency agrees that some households have multiple members who
are food allergic. As described previously in the discussion on the
screener, Internet panel members are asked whether or not they, or
someone for whom they regularly prepare food, has a food allergy. The
reason we made the ``prepare food for someone with a food allergy''
distinction is to be able to categorize the respondent as a caregiver
to someone with a food allergy. It is important to point out that the
study will also recruit individuals who do not meet the criteria for
food-allergic individual or caregiver. The nonfood allergic group will
be analyzed separately from the food allergic group. The agency
believes it is important to acknowledge that the population of food
allergic individuals is not static and that at any time someone can
become a member. These individuals must be able to immediately use the
food label to determine whether or not it is safe for them to consume
the food.
The agency agrees that some individuals do not have access to the
Internet. As discussed in the previous paragraphs, the Internet panel
that will be used to draw the survey sample was constructed using
random digit dialing procedures, and those without Internet access were
supplied with equipment which allows them to access the Internet and to
participate in consumer research.
The agency agrees that it is important to use advisory labeling
that is currently found in the marketplace. The agency has used the
FAAN list of advisory statements and another list created by an
informal market survey, and has classified the statements into
groupings of similar statements. The statements that appear most often
in each of the groupings were chosen for analysis in the study.
The agency agrees that for the research to be of the highest
quality and utility, collaboration with appropriate representatives
from AAAAI, ACAAI, and FAAN is important and has already implemented
this collaboration.
FDA estimates the burden of the Allergen Labeling of Food Products
Consumer Preference Survey collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual Frequency per Total Annual
Activity Respondents Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener 500,000 1 500,000 0.0055 2,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 30 1 30 0.167 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey 1,000 1 1,000 0.167 167
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 2,922
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on prior experience with consumer
surveys very similar to this proposed study.
FDA estimates the burden of the Experimental Study on Allergen
Labeling of Food Products collection of information as follows:
Table 2.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual Frequency per Total Annual
Activity Respondents Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener 40,000 1 40,000 0.0055 220
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 24605]]
Pretest 30 1 30 0.167 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experiment 4,000 1 4,000 0.167 668
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 893
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here.
Dated: May 4, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9328 Filed 5-9-05; 8:45 am]
BILLING CODE 4160-01-S
