Agency Information Collection Activities; Proposed Collection; Comment Request; Gluten-Free Labeling of Food Products Experimental Study, 9822-9823 [E9-4766]
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9822
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
FDA received no submissions under
§ 660.36, however FDA is using the
estimate of one protocol submission in
the event one is submitted in the future.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2008, which totaled
6,314, for the various submission
requirements of samples and protocols
for the licensed biological products. The
rate of final actions is not expected to
change significantly in the next few
years. The hours per response are based
on information provided by industry.
The burden estimates provided by
industry ranged from 1 to 5.5 hours.
Under § 610.2, the hours per response
are based on the average of these
estimates and rounded to 3 hours.
Under the remaining regulations, the
hours per response are based on the
higher end of the estimate (rounded to
5 or 6 hours) since more information is
generally required to be submitted in
the other protocols than under § 610.2.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
Respondents
21 CFR Section
610.2
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
65
95.5
6,208
3
18,624
660.6(b)
2
44
88
5
440
660.36(a)(2) and (b)
1
1
1
6
6
660.46(b)
1
17
17
5
85
Total
69
1 There
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0083]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Gluten-Free
Labeling of Food Products
Experimental Study
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a voluntary consumer study entitled
‘‘Gluten-Free Labeling of Food Products
Experimental Study.’’
DATES: Submit written or electronic
comments on the collection of
information by May 5, 2009.
VerDate Nov<24>2008
16:20 Mar 05, 2009
Jkt 217001
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: 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
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
ADDRESSES:
BILLING CODE 4160–01–S
ACTION:
19,155
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4750 Filed 3–5–09; 8:45 am]
AGENCY:
6,314
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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.
Gluten-Free Labeling of Food Products
Experimental Study
Under section 903(b)(2) of the Federal
Food, Drug, and Cosmetic 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 an experimental
study about gluten-free labeling of food
products. The Gluten-Free Labeling of
Food Products Experimental Study will
collect information from both
consumers who have celiac disease or
gluten intolerance and those who do not
have either condition. The purpose of
the study is to gauge perceptions of
characteristics related to claims of
‘‘gluten-free’’ and allowed variants (e.g.,
‘‘free of gluten,’’ ‘‘without gluten,’’ ‘‘no
gluten’’), in addition to other types of
statements (e.g., ‘‘made in a gluten-free
facility’’ or ‘‘not made in a facility that
processes gluten-containing foods’’) on
the food label. The study will also
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06MRN1
9823
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
assess consumer understanding of
‘‘gluten-free’’ claims on foods that are
naturally free of gluten, and gauge
consumer reaction to a product carrying
a gluten claim concurrently with a
statement about the amount of gluten
the product contains.
The data will be collected over the
Internet from samples derived from two
sources: (1) A membership list from a
celiac disease special interest
organization and (2) an online consumer
panel. Participation in the study is
voluntary.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
Respondents
Questionnaire
Screener
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
6,000
1
6,000
0.0055
33
140
1
140
.167
23.38
5,000
1
5,000
.167
835
Pretest
Experiment
Total
891.38
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Approximately 6,000 respondents
will be screened. We estimate that it
will take a respondent 20 seconds
(0.0055 hours) to complete the screening
questions, for a total of 33 hours. A
pretest will be conducted with 140
participants; we estimate that it will
take a respondent 10 minutes (0.167
hours) to complete the pretest, for a total
of 23.38 hours. Five thousand adults
will complete the experiment. We
estimate that it will take a respondent
10 minutes (0.167 hours) to complete
the entire experiment, for a total of 835
hours. Thus, the total estimated burden
is 891.38 hours. FDA’s burden estimate
is based on prior experience with
consumer experiments that are similar
to this proposed experiment.
Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4766 Filed 3–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0105]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ARRANON
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Total Hours
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ARRANON and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
VerDate Nov<24>2008
16:20 Mar 05, 2009
Jkt 217001
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions 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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the drug product. Although only a
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of Patents
and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product ARRANON
(nelarabine). ARRANON is indicated for
the treatment of patients with T-cell
acute lymphoblastic leukemia and Tcell lymphoblastic lymphoma whose
disease has not responded to or has
relapsed following treatment with at
least two chemotherapy regimens.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
ARRANON (U.S. Patent No. 5,424,295)
from,SmithKline Beecham Corp. (DBA
GlaxoSmithKline), and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated April 28, 2008, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of ARRANON
represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ARRANON is 4,163 days. Of this time,
3,980 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
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]]>Agencies
[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Notices]
[Pages 9822-9823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0083]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Gluten-Free Labeling of Food Products Experimental
Study
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a voluntary consumer study entitled
``Gluten-Free Labeling of Food Products Experimental Study.''
DATES: Submit written or electronic comments on the collection of
information by May 5, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: 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 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.
Gluten-Free Labeling of Food Products Experimental Study
Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic 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 an experimental study about gluten-free labeling of food
products. The Gluten-Free Labeling of Food Products Experimental Study
will collect information from both consumers who have celiac disease or
gluten intolerance and those who do not have either condition. The
purpose of the study is to gauge perceptions of characteristics related
to claims of ``gluten-free'' and allowed variants (e.g., ``free of
gluten,'' ``without gluten,'' ``no gluten''), in addition to other
types of statements (e.g., ``made in a gluten-free facility'' or ``not
made in a facility that processes gluten-containing foods'') on the
food label. The study will also
[[Page 9823]]
assess consumer understanding of ``gluten-free'' claims on foods that
are naturally free of gluten, and gauge consumer reaction to a product
carrying a gluten claim concurrently with a statement about the amount
of gluten the product contains.
The data will be collected over the Internet from samples derived
from two sources: (1) A membership list from a celiac disease special
interest organization and (2) an online consumer panel. Participation
in the study is voluntary.
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
Questionnaire Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Screener 6,000 1 6,000 0.0055 33
----------------------------------------------------------------------------------------------------------------
Pretest 140 1 140 .167 23.38
----------------------------------------------------------------------------------------------------------------
Experiment 5,000 1 5,000 .167 835
----------------------------------------------------------------------------------------------------------------
Total ................. .................... ................. ................. 891.38
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Approximately 6,000 respondents will be screened. We estimate that
it will take a respondent 20 seconds (0.0055 hours) to complete the
screening questions, for a total of 33 hours. A pretest will be
conducted with 140 participants; we estimate that it will take a
respondent 10 minutes (0.167 hours) to complete the pretest, for a
total of 23.38 hours. Five thousand adults will complete the
experiment. We estimate that it will take a respondent 10 minutes
(0.167 hours) to complete the entire experiment, for a total of 835
hours. Thus, the total estimated burden is 891.38 hours. FDA's burden
estimate is based on prior experience with consumer experiments that
are similar to this proposed experiment.
Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4766 Filed 3-5-09; 8:45 am]
BILLING CODE 4160-01-S
