Agency Information Collection Activities; Proposed Collection; Comment Request; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products, 3711-3712 [05-1395]
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Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection information; (c) the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: January 18, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–1398 Filed 1–25–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0012]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; 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 an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a voluntary consumer survey entitled
‘‘Allergen Labeling of Food Products
Consumer Preference Survey’’ and an
experimental study entitled
‘‘Experimental Study on Allergen
Labeling of Food Products.’’
DATES: Submit written or electronic
comments on the collection of
information by March 28, 2005.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
3711
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 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.
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
No. of
Respondents
Questionnaire
Screener
Total Annual
Responses
Hours per
Response
Total Hours
35,000
19:33 Jan 25, 2005
Jkt 205001
PO 00000
1
35,000
.0055
193
30
Pre-test
VerDate jul<14>2003
Annual Frequency
per Response
1
30
.167
5
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\26JAN1.SGM
26JAN1
3712
Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Questionnaire
Survey
Annual Frequency
per Response
1,000
Total Annual
Responses
1
Hours per
Response
1,000
Total Hours
.167
Total
1There
167
365
are no capital costs or operating 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.
Experimental Study on Allergen
Labeling of Food Products
As previously above, 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 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 approximately 600,000 people who
will be screened (through self-report) for
food allergy, and food allergy caregiver
status. Participation in the allergen
experimental study is voluntary.
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
No. of
Respondents
Questionnaire
Screener
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
600,000
1
600,000
.0028
1,680
30
1
30
.167
5
9,000
1
9,000
.167
1,503
Pre-test
Experiment
Total
1There
Total Hours
3,188
are no capital costs or operating 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Food and Drug Administration
DATES:
Dated: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1395 Filed 1–25–05; 8:45 am]
[Docket No. 2003D–0386]
BILLING CODE 4160–01–S
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry on Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
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
VerDate jul<14>2003
19:33 Jan 25, 2005
Jkt 205001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by February
25, 2005.
The Office of Management
and Budget (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:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3711-3712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1395]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0012]
Agency Information Collection Activities; Proposed Collection;
Comment Request; 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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on a voluntary consumer survey
entitled ``Allergen Labeling of Food Products Consumer Preference
Survey'' and an experimental study entitled ``Experimental Study on
Allergen Labeling of Food Products.''
DATES: Submit written or electronic comments on the collection of
information by March 28, 2005.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. All comments should be identified with
the docket number found in brackets in the heading of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 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.
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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Questionnaire Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Screener 35,000 1 35,000 .0055 193
----------------------------------------------------------------------------------------------------------------
Pre-test 30 1 30 .167 5
----------------------------------------------------------------------------------------------------------------
[[Page 3712]]
Survey 1,000 1 1,000 .167 167
----------------------------------------------------------------------------------------------------------------
Total 365
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating 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.
Experimental Study on Allergen Labeling of Food Products
As previously above, 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 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 approximately 600,000 people who will be screened (through self-
report) for food allergy, and food allergy caregiver status.
Participation in the allergen experimental study is voluntary.
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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Questionnaire Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Screener 600,000 1 600,000 .0028 1,680
----------------------------------------------------------------------------------------------------------------
Pre-test 30 1 30 .167 5
----------------------------------------------------------------------------------------------------------------
Experiment 9,000 1 9,000 .167 1,503
----------------------------------------------------------------------------------------------------------------
Total 3,188
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating 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: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1395 Filed 1-25-05; 8:45 am]
BILLING CODE 4160-01-S
