Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Proposed Experimental Study of Trans Fat Claims on Foods, 75554-75555 [E6-21317]
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Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
reasonable cost. The objectives of
competitive bidding include:
(1) To implement competitive bidding
programs for certain covered items of
DMEPOS and associated services in
select areas;
(2) to assure beneficiary access to
quality DMEPOS as a result of the
program;
(3) to reduce the amount Medicare
pays for DMEPOS and create a payment
structure under competitive bidding
that is more reflective of a competitive
market;
(4) to limit the financial burden on
beneficiaries by reducing their out-ofpocket expenses for DMEPOS they
obtain through the program; and,
(5) to contract with suppliers who
conduct business in a manner that is
beneficial for the program and Medicare
beneficiaries.
Contract suppliers will be selected
from the suppliers that have the lowest
bids and that meet all relevant program
requirements. Suppliers bidding above
the winning price are to be excluded
from the Medicare market; however,
multiple winners must be awarded in
each site. The forms associated with this
collection of information will collect all
of the relevant information needed for
processing bids.
Following the publication of the 60day Federal Register notice (71 FR
26546), we received a considerable
number of public comments.
Commenters discussed a variety of
topics, ranging from the general
requirements of the forms to the
availability of instructions for
completing the forms. After reviewing
the comments, we revised the
information collection request (ICR) to
clarify the issues raised by the public.
In addition, instructions for completing
the forms are complete and available for
public viewing. Form Number: CMS–
10169 (OMB#: 0938–NEW); Frequency:
Reporting—Every three years; Affected
Public: Business or other for-profit, Notfor-profit institutions, and the Federal
government; Number of Respondents:
23,973; Total Annual Responses:
23,973; Total Annual Hours: 1,088,164.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Written comments and
recommendations for the proposed
VerDate Aug<31>2005
15:47 Dec 14, 2006
Jkt 211001
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: December 7, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–21436 Filed 12–14–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0037]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Proposed
Experimental Study of Trans Fat
Claims on Foods
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 January 16,
2007.
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.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Proposed Experimental Study of Trans
Fat Claims on Foods—(OMB Control
Number 0910–0533—Reinstatement)
FDA is requesting OMB approval of a
proposed experimental study of trans fat
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
claims on food products intended to
help FDA’s Center for Food Safety and
Applied Nutrition formulate decisions
and policies affecting labeling
requirements for trans fat claims on
foods.
In the Federal Register of July 11,
2003 (68 FR 41507), FDA issued an
advance notice of proposed rulemaking
entitled ‘‘Food Labeling: Trans Fatty
Acids in Nutrition Labeling; Consumer
Research to Consider Nutrient Content
and Health Claims and Possible
Footnote or Disclosure Statements,’’
which requested comments about
possible disclosure requirements to
accompany nutrient content claims
about trans fatty acids that could help
consumers make heart-healthy food
choices. The proposed experimental
study will evaluate the ability of several
such disclosure requirements to help
consumers make heart-healthy food
choices. The results of the proposed
experimental study will provide
empirical support for possible policy
decisions about the need for such
disclosures and the appropriate form
they should take.
FDA or its contractor will collect and
use information gathered from Internet
panel samples to evaluate how
consumers understand and respond to
possible disclosure requirements for
trans fat content claims. The distinctive
features of Internet panel and shopping
mall methodologies for the purpose of
the proposed experimental study are
that they allow for controlled visual
presentation of study materials,
experimental manipulation of study
materials, and the random assignment of
subjects to condition. Experimental
manipulation of labels and random
assignment to condition makes it
possible to estimate the effects of the
various possible disclosure
requirements while controlling for
individual differences. Random
assignment ensures that mean
differences between conditions can be
tested using well-known techniques
such as analysis of variance or
regression analysis to yield statistically
valid estimates of treatment effect size.
The proposed study will be conducted
with a convenience sample drawn from
a large, national consumer panel with
about one million households.
Participants will be adults, age 18 and
older, who are recruited for a study
about foods and food labels. Each
participant will be randomly assigned to
1 of the 144 experimental conditions
consisting of fully crossing 8 disclosure
conditions, 3 product types, 3 fatty acid
profiles and 2 prior knowledge
conditions.
E:\FR\FM\15DEN1.SGM
15DEN1
75555
Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
FDA will use the information from the
proposed experimental study to
evaluate regulatory policy options. The
agency often lacks empirical data about
how consumers understand and
respond to statements they might see in
product labeling. The information
gathered from this proposed
experimental study will be used by the
agency to assess likely consumer
responses to various disclosure
requirements for nutrient content
claims.
In the Federal Register of February 6,
2006 (71 FR 6076), FDA published a 60–
day notice requesting public comment
on the information collection that will
take place as part of the experimental
study. FDA received one letter in
response to the notice, containing
multiple comments.
(Comment 1) One comment stated
that the organization concurs with the
objectives of the study and believes the
information from this study will be
useful to FDA in developing labeling
policy to assist consumers with
interpretation of trans fat claims in food
labeling. Another comment suggested
that FDA change the labels used to
describe the three fatty acid profiles in
the study (‘‘good profile,’’ ‘‘medium
profile,’’ and ‘‘poor profile’’) because
these descriptors were seen as overly
negative. The comment recommended
alternative language (‘‘low profile,’’
‘‘medium profile’’ and ‘‘high profile’’) as
a way to ensure that the products are
not characterized as ‘‘good foods’’ or
‘‘bad foods.’’
(Response) This suggestion has been
implemented. The terminology
suggested in the comment adequately
conveys the intended profile
differences.
(Comment 2) One comment critiqued
the draft Full Information treatment
language. The comment criticized the
one-page summary because it : (1) Did
not identify calories in the discussion of
fat as a major source of energy and (2)
did not relate the calorie contribution of
fat to that of carbohydrates and protein.
The comment also criticized the
information about sources of trans fat
because it omitted mention of natural
sources of trans fat in the diet, which
the comment suggested would help
ensure factually correct and balanced
information about sources of trans in
the diet. The comment questioned the
value of stating that trans fat extends
shelflife and has desirable taste
characteristics since many saturated fat
sources are relatively shelf stable and
have desirable taste characteristics.
(Response) FDA agrees and has
revised the Full Information treatment
to incorporate these concerns. Calories
and other sources of energy are now
mentioned in the introductory passage.
Natural sources of trans fat are now
mentioned and the similarity between
trans fat and saturated fat in terms of
shelflife and taste are now addressed.
The revised draft will be included in the
study pretest and further revisions will
be made if FDA determines they are
needed based upon pretest results.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
40
1
40
.25
10
2,880
Study
1
2,880
.25
720
Total
730
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21317 Filed 12–14–06; 8:45 am]
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
BILLING CODE 4160–01–S
DATES:
Fax written comments on the
collection of information by January 16,
2007.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2006N–0197]
mstockstill on PROD1PC61 with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Food Facilities Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
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.
ADDRESSES:
Food and Drug Administration
ACTION:
Total Hours
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
VerDate Aug<31>2005
15:47 Dec 14, 2006
Jkt 211001
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.230
through 1.235 (OMB Control Number
0910–0502)—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 415 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 350d), which requires
domestic and foreign facilities that
manufacture, process, pack, or hold
food for human or animal consumption
in the United States to register with
FDA. Sections 1.230 through 1.235 (21
CFR 1.230 through 1.235) set forth the
procedures for registration of food
facilities. Information provided to FDA
under these regulations will help the
agency to notify quickly the facilities
that might be affected by a deliberate or
accidental contamination of the food
supply.
Description of respondents: The
respondents to this information
collection include owners, operators, or
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 71, Number 241 (Friday, December 15, 2006)]
[Notices]
[Pages 75554-75555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21317]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0037]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Proposed Experimental
Study of Trans Fat Claims on Foods
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 January
16, 2007.
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.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Proposed Experimental Study of Trans Fat Claims on Foods--(OMB Control
Number 0910-0533--Reinstatement)
FDA is requesting OMB approval of a proposed experimental study of
trans fat claims on food products intended to help FDA's Center for
Food Safety and Applied Nutrition formulate decisions and policies
affecting labeling requirements for trans fat claims on foods.
In the Federal Register of July 11, 2003 (68 FR 41507), FDA issued
an advance notice of proposed rulemaking entitled ``Food Labeling:
Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider
Nutrient Content and Health Claims and Possible Footnote or Disclosure
Statements,'' which requested comments about possible disclosure
requirements to accompany nutrient content claims about trans fatty
acids that could help consumers make heart-healthy food choices. The
proposed experimental study will evaluate the ability of several such
disclosure requirements to help consumers make heart-healthy food
choices. The results of the proposed experimental study will provide
empirical support for possible policy decisions about the need for such
disclosures and the appropriate form they should take.
FDA or its contractor will collect and use information gathered
from Internet panel samples to evaluate how consumers understand and
respond to possible disclosure requirements for trans fat content
claims. The distinctive features of Internet panel and shopping mall
methodologies for the purpose of the proposed experimental study are
that they allow for controlled visual presentation of study materials,
experimental manipulation of study materials, and the random assignment
of subjects to condition. Experimental manipulation of labels and
random assignment to condition makes it possible to estimate the
effects of the various possible disclosure requirements while
controlling for individual differences. Random assignment ensures that
mean differences between conditions can be tested using well-known
techniques such as analysis of variance or regression analysis to yield
statistically valid estimates of treatment effect size. The proposed
study will be conducted with a convenience sample drawn from a large,
national consumer panel with about one million households.
Participants will be adults, age 18 and older, who are recruited
for a study about foods and food labels. Each participant will be
randomly assigned to 1 of the 144 experimental conditions consisting of
fully crossing 8 disclosure conditions, 3 product types, 3 fatty acid
profiles and 2 prior knowledge conditions.
[[Page 75555]]
FDA will use the information from the proposed experimental study
to evaluate regulatory policy options. The agency often lacks empirical
data about how consumers understand and respond to statements they
might see in product labeling. The information gathered from this
proposed experimental study will be used by the agency to assess likely
consumer responses to various disclosure requirements for nutrient
content claims.
In the Federal Register of February 6, 2006 (71 FR 6076), FDA
published a 60-day notice requesting public comment on the information
collection that will take place as part of the experimental study. FDA
received one letter in response to the notice, containing multiple
comments.
(Comment 1) One comment stated that the organization concurs with
the objectives of the study and believes the information from this
study will be useful to FDA in developing labeling policy to assist
consumers with interpretation of trans fat claims in food labeling.
Another comment suggested that FDA change the labels used to describe
the three fatty acid profiles in the study (``good profile,'' ``medium
profile,'' and ``poor profile'') because these descriptors were seen as
overly negative. The comment recommended alternative language (``low
profile,'' ``medium profile'' and ``high profile'') as a way to ensure
that the products are not characterized as ``good foods'' or ``bad
foods.''
(Response) This suggestion has been implemented. The terminology
suggested in the comment adequately conveys the intended profile
differences.
(Comment 2) One comment critiqued the draft Full Information
treatment language. The comment criticized the one-page summary because
it : (1) Did not identify calories in the discussion of fat as a major
source of energy and (2) did not relate the calorie contribution of fat
to that of carbohydrates and protein. The comment also criticized the
information about sources of trans fat because it omitted mention of
natural sources of trans fat in the diet, which the comment suggested
would help ensure factually correct and balanced information about
sources of trans in the diet. The comment questioned the value of
stating that trans fat extends shelflife and has desirable taste
characteristics since many saturated fat sources are relatively shelf
stable and have desirable taste characteristics.
(Response) FDA agrees and has revised the Full Information
treatment to incorporate these concerns. Calories and other sources of
energy are now mentioned in the introductory passage. Natural sources
of trans fat are now mentioned and the similarity between trans fat and
saturated fat in terms of shelflife and taste are now addressed. The
revised draft will be included in the study pretest and further
revisions will be made if FDA determines they are needed based upon
pretest results.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Pretest 40 1 40 .25 10
----------------------------------------------------------------------------------------------------------------
Study 2,880 1 2,880 .25 720
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 730
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21317 Filed 12-14-06; 8:45 am]
BILLING CODE 4160-01-S
