Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations, 34353-34357 [E9-16869]
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Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices
be used to prepare ACF budget
submissions to Congress.
The American Recovery and
Reinvestment Act (ARRA) of 2009, (Pub.
L. 111–5) provides an additional $2
billion for the Child Care and
Development Fund to help States,
Territories, and Tribes provide child
care assistance to low income working
families. CCDF Program Instruction
(CCDF–ACF–PI–2009–03) provided
guidance on ARRA spending
requirements.
Section 1512 of the ARRA legislation
requires recipients to report quarterly
spending and performance data on the
public Web site, ‘‘Recovery.gov’’.
Federal agencies are required to collect
ARRA expenditure data and
performance data and these data must
be clearly distinguishable from the
regular CCDF (non-ARRA) funds. To
ensure transparency and accountability,
the ARRA authorizes Federal agencies
and grantees to track and report
separately on expenditures from funds
made available by the stimulus bill.
Office of Management and Budget
(OMB) guidance implementing the
ARRA legislation indicates that agencies
requiring additional information for
oversight should rely on existing
authorities and reflect these
requirements in their award terms and
conditions as necessary, following
existing procedures. Therefore, to
capture ARRA expenditures, the ACF–
696 has been modified (by the addition
of a column) for reporting ARRA
expenditure data. In addition, a new
data element will ask States and
Territories to estimate the number of
child service months funded with
ARRA dollars. The collection will not
duplicate other information.
Respondents: States and Territories.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden hours per
response
Total burden
hours
CCDF State and Territory Plan .......................................................................
56
4
5
1,120
Estimated Total Annual Burden
Hours: 1,120.
Additional Information:
ACF is requesting that 0MB grant a 90
day approval for this information
collection under procedures for
emergency processing by July 15, 2009.
A copy of this information collection,
with applicable supporting
documentation, may be obtained by
calling the Administration for Children
and Families, Reports Clearance Officer,
Robert Sargis at (202) 690–7275.
Comments and questions about the
information collection described above
should be directed to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for ACF, Office
of Management and Budget, Paperwork
Reduction Project, 725 17 Street, NW.,
Washington, DC 20503, FAX (202) 395–
6974.
Dated: June 6, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–16477 Filed 7–14–09; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on DSKD5P82C1PROD with NOTICES
[Docket No. FDA–2009–N–0296]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
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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
the information collection provisions in
FDA’s food labeling regulations and on
Form FDA 3570, ‘‘Model Small Business
Nutrition Labeling Exemption Notice,’’
which small businesses may use to
claim the small business exemption
from nutrition labeling.
DATES: Submit written or electronic
comments on the collection of
information by September 14, 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.
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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,
SUPPLEMENTARY INFORMATION:
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when appropriate, and other forms of
information technology.
Food Labeling Regulations—21 CFR
Parts 101, 102, 104, and 105 (OMB
Control Number 0910–0381)—Extension
FDA regulations require food
producers to disclose to consumers and
others specific information about
themselves or their products on the
label or labeling of their products.
Related regulations require that food
producers retain records establishing
the basis for the information contained
in the label or labeling of their products
and provide those records to regulatory
officials. Finally, certain regulations
provide for the submission of food
labeling petitions to FDA. FDA’s food
labeling regulations under parts 101,
102, 104, and 105 (21 CFR parts 101,
102, 104, and 105) were issued under
the authority of sections 4, 5, and 6 of
the Fair Packaging and Labeling Act (the
FPLA) (15 U.S.C. 1453, 1454, and 1455)
and under sections 201, 301, 402, 403,
409, 411, 701, and 721 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 321, 331, 342, 343, 348, 350,
371, and 379e). Most of these
regulations derive from section 403 of
the act, which provides that a food
product shall be deemed to be
misbranded if, among other things, its
label or labeling fails to bear certain
required information concerning the
food product, is false or misleading in
any particular, or bears certain types of
unauthorized claims. The disclosure
requirements and other collections of
information in the regulations in parts
101, 102, 104, and 105 are necessary to
ensure that food products produced or
sold in the United States are in
compliance with the labeling provisions
of the act and the FPLA.
Section 101.3 of FDA’s food labeling
regulations requires that the label of a
food product in packaged form bear a
statement of identity (i.e., the name of
the product), including, as appropriate,
the form of the food or the name of the
food imitated. Section 101.4 prescribes
requirements for the declaration of
ingredients on the label or labeling of
food products in packaged form. Section
101.5 requires that the label of a food
product in packaged form specify the
name and place of business of the
manufacturer, packer, or distributor
and, if the food producer is not the
manufacturer of the food product, its
connection with the food product.
Section 101.9 requires that nutrition
information be provided for all food
products intended for human
consumption and offered for sale, unless
an exemption in § 101.9(j) applies to the
product. Section 101.9(g)(9) also
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provides for the submission to FDA of
requests for alternative approaches to
nutrition labeling. Finally, § 101.9(j)(18)
provides for the submission to FDA of
notices from firms claiming the small
business exemption from nutrition
labeling. FDA has developed Form FDA
3570 to assist small businesses in
claiming the small business exemption
from nutrition labeling. The form
contains all the elements required by
§ 101.9(j)(18).
Section 101.10 requires that
restaurants provide nutrition
information, upon request, for any food
or meal for which a nutrient content
claim or health claim is made. Section
101.12(b) provides the reference amount
that is used for determining the serving
sizes for specific products, including
baking powder, baking soda, and pectin.
Section 101.12(e) provides that a
manufacturer that adjusts the reference
amount customarily consumed (RACC)
of an aerated food for the difference in
density of the aerated food relative to
the density of the appropriate
nonaerated reference food must be
prepared to show FDA detailed
protocols and records of all data that
were used to determine the densityadjusted RACC. Section 101.12(g)
requires that the label or labeling of a
food product disclose the serving size
that is the basis for a claim made for the
product if the serving size on which the
claim is based differs from the RACC.
Section 101.12(h) provides for the
submission of petitions to FDA to
request changes in the reference
amounts defined by regulation.
Section 101.13 requires that nutrition
information be provided in accordance
with § 101.9 for any food product for
which a nutrient content claim is made.
Under some circumstances, § 101.13
also requires the disclosure of other
types of information as a condition for
the use of a nutrient content claim. For
example, under § 101.13(j), if the claim
compares the level of a nutrient in the
food with the level of the same nutrient
in another ‘‘reference’’ food, the claim
must also disclose the identity of the
reference food, the amount of the
nutrient in each food, and the
percentage or fractional amount by
which the amount of the nutrient in the
labeled food differs from the amount of
the nutrient in the reference food. It also
requires that when this comparison is
based on an average of food products,
this information must be provided to
consumers or regulatory officials upon
request. Section 101.13(q)(5) requires
that restaurants document and provide
to appropriate regulatory officials, upon
request, the basis for any nutrient
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content claims they have made for the
foods they sell.
Section 101.14(d)(2) and (d)(3)
provides for the disclosure of nutrition
information in accordance with § 101.9
and, under some circumstances, certain
other information as a condition for
making a health claim for a food
product. Section 101.15 provides that, if
the label of a food product contains any
representation in a foreign language, all
words, statements, and other
information required by or under
authority of the act to appear on the
label shall appear thereon in both the
foreign language and in English. Section
101.22 contains labeling requirements
for the disclosure of spices, flavorings,
colorings, and chemical preservatives in
food products. Section 101.22(i)(4) sets
forth reporting and recordkeeping
requirements pertaining to certifications
for flavors designated as containing no
artificial flavor. Section 101.30 specifies
the conditions under which a beverage
that purports to contain any fruit or
vegetable juice must declare the
percentage of juice present in the
beverage and the manner in which the
declaration is to be made. Section
102.33 specifies the common or usual
name for beverages that contain fruit or
vegetable juice.
Section 101.36 requires that nutrition
information be provided for dietary
supplements offered for sale, unless an
exemption in § 101.36(h) applies.
Section 101.36(f)(2) cross-references the
provisions in § 101.9(g)(9) for the
submission to FDA of requests for
alternative approaches to nutrition
labeling. Also, § 101.36(h)(2) crossreferences the provisions in
§ 101.9(j)(18) for the submission of small
business exemption notices. As noted
previously, FDA has developed Form
FDA 3570 to assist small businesses in
claiming the small business exemption
from nutrition labeling. The form
contains all the elements required by
§ 101.36(h)(2).
Section 101.36(e) permits the
voluntary declaration of the quantitative
amount and the percent of Daily Value
of a dietary ingredient on a ‘‘per day’’
basis in addition to the required ‘‘per
serving’’ basis, if a dietary supplement
label recommends that the dietary
supplement be consumed more than
once per day.
Section 101.42 requests that food
retailers voluntarily provide nutrition
information for raw fruits, vegetables,
and fish at the point of purchase, and
§ 101.45 contains guidelines for
providing such information. Also,
§ 101.45(c) provides for the submission
of nutrient databases and proposed
nutrition labeling values for raw fruit,
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vegetables, and fish to FDA for review
and approval.
Sections 101.54, 101.56, 101.60,
101.61, and 101.62 specify information
that must be disclosed as a condition for
making particular nutrient content
claims. Section 101.67 provides for the
use of nutrient content claims for butter,
and cross-references requirements in
other regulations for ingredient
declaration (§ 101.4) and disclosure of
information concerning performance
characteristics (§ 101.13(d)). Section
101.69 provides for the submission of a
petition requesting that FDA authorize a
particular nutrient content claim by
regulation. Section 101.70 provides for
the submission of a petition requesting
that FDA authorize a particular health
claim by regulation. Section
101.77(c)(2)(ii)(D) requires the
disclosure of the amount of soluble fiber
per serving in the nutrition labeling of
a food bearing a health claim about the
relationship between soluble fiber and a
reduced risk of coronary heart disease.
Section 101.79(c)(2)(iv) requires the
disclosure of the amount of folate per
serving in the nutrition labeling of a
food bearing a health claim about the
relationship between folate and a
reduced risk of neural tube defects.
Section 101.100(d) provides that any
agreement that forms the basis for an
exemption from the labeling
requirements of section 403(c), (e), (g),
(h), (i), (k), and (q) of the act be in
writing and that a copy of the agreement
be made available to FDA upon request.
Section 101.100 also contains reporting
and disclosure requirements as
conditions for claiming certain labeling
exemptions (e.g., § 101.100(h)).
Section 101.105 specifies
requirements for the declaration of the
net quantity of contents on the label of
a food in packaged form and prescribes
conditions under which a food whose
label does not accurately reflect the
actual quantity of contents may be sold,
with appropriate disclosures, to an
institution operated by Federal, State, or
local government. Section 101.108
provides for the submission to FDA of
a written proposal requesting a
temporary exemption from certain
requirements of §§ 101.9 and 105.66 for
the purpose of conducting food labeling
experiments with FDA’s authorization.
Regulations in part 102 define the
information that must be included as
part of the statement of identity for
particular foods and prescribe related
labeling requirements for some of these
foods. For example, § 102.22 requires
that the name of a protein hydrolysate
shall include the identity of the food
source from which the protein was
derived.
Part 104, which pertains to nutritional
quality guidelines for foods, crossreferences several labeling provisions in
part 101 but contains no separate
information collection requirements.
Part 105 contains special labeling
requirements for hypoallergenic foods,
infant foods, and certain foods
represented as useful in reducing or
maintaining body weight.
The disclosure and other information
collection requirements in the
previously mentioned regulations are
placed primarily upon manufacturers,
packers, and distributors of food
products. Because of the existence of
exemptions and exceptions, not all of
the requirements apply to all food
producers or to all of their products.
Some of the regulations affect food
retailers, such as supermarkets and
restaurants.
The purpose of the food labeling
requirements is to allow consumers to
be knowledgeable about the foods they
purchase. Nutrition labeling provides
information for use by consumers in
selecting a nutritious diet. Other
information enables a consumer to
comparison shop. Ingredient
information also enables consumers to
avoid substances to which they may be
sensitive. Petitions or other requests
submitted to FDA provide the basis for
the agency to permit new labeling
statements or to grant exemptions from
certain labeling requirements.
Recordkeeping requirements enable
FDA to monitor the basis upon which
certain label statements are made for
food products and whether those
statements are in compliance with the
requirements of the act or the FPLA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—TOTAL ESTIMATED ANNUAL BURDEN1
21 CFR Section and Part/Form No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
101.3, 101.22, 102 and 104
25,000
1.03
25,750
.5
12,875
101.4, 101.22, 101.100, 102,
104 and 105
25,000
1.03
25,750
1
25,750
101.5
25,000
1.03
25,750
0.25
6,438
101.9, 101.13(n), 101.14(d)(3),
101.62, and 104
25,000
1.03
25,750
4
103,000
12
1
12
4
48
10,000
1
10,000
8
80,000
300,000
1.5
450,000
0.25
112,500
101.12(b)
29
2.3
67
1
67
101.12(e)
25
1
25
1
25
101.12(g)
5,000
1
5,000
1
5,000
101.12(h)
5
1
5
80
400
200
1
200
1
200
101.9(g)(9) and 101.36(f)(2)
101.9(j)(18) and 101.36(h)(2)/Form
FDA 3570
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101.10
101.13(d)(1) and 101.67
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TABLE 1.—TOTAL ESTIMATED ANNUAL BURDEN1—Continued
21 CFR Section and Part/Form No.
No. of
Respondents
101.13(j)(2), 101.13(k), 101.54,
101.56, 101.60, 101.61, and
101.62
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
5,000
1
5,000
1
5,000
101.13(q)(5)
300,000
1.5
450,000
0.75
337,500
101.14(d)(2)
300,000
1.5
450,000
0.75
337,500
160
10
1,600
8
12,800
25
1
25
1
25
1,500
5
7,500
1
7,500
101.36
300
40
12,000
4
48,000
101.36(e)
125
13
1,625
0.25
406
1,000
1
1,000
0.5
500
101.45(c)
5
4
20
4
80
101.69
3
1
3
25
75
101.70
5
1
5
80
400
1,000
1
1,000
0.25
250
100
1
100
0.25
25
1,000
1
1,000
1
1,000
25,000
1.03
25,750
0.5
12,875
1
1
1
40
40
101.15
101.22(i)(4)
101.30 and 102.33
101.42 and 101.45
101.79(c)(2)(i)(D)
101.79(c)(2)(iv)
101.100(d)
101.105 and 101.100(h)
101.108
Total
1There
1,110,279
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—TOTAL ESTIMATED ANNUAL BURDEN1
No. of
Recordkeepers
21 CFR Section
101.12(e)
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
25
1
25
1
25
101.13(q)(5)
300,000
1.5
450,000
0.75
337,500
101.14(d)(2)
300,000
1.5
450,000
0.75
337,500
101.22(i)(4)
25
1
25
1
25
1,000
1
1,000
1
1,000
100
1
100
1
100
101.100(d)(2)
101.105(t)
Total
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1There
676,150
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting and
recordkeeping burdens are based on
agency communications with industry
and FDA’s knowledge of and experience
with food labeling and the submission
of petitions and requests to the agency.
Where an agency regulation implements
an information collection requirement
in the act or the FPLA, only any
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additional burden attributable to the
regulation has been included in FDA’s
burden estimate.
No burden has been estimated for
those requirements where the
information to be disclosed is
information that has been supplied by
FDA. Also, no burden has been
estimated for information that is
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disclosed to third parties as a usual and
customary part of a food producer’s
normal business activities. Under 5 CFR
1320.3(c)(2), the public disclosure of
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public
is not a collection of information. Under
5 CFR 1320.3(b)(2), the time, effort, and
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financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
would occur in the normal course of
activities.
In this request for extension of OMB
approval under the PRA, FDA is
combining the burden hours associated
with OMB control numbers 0910–0395
(collection entitled ‘‘Food Labeling:
Nutrition Labeling of Dietary
Supplements on a ‘Per Day’ Basis’’) and
0910–0515 (collection entitled ‘‘Food
Labeling: Trans Fatty Acids in Nutrition
Labeling’’) with the burden hours
approved under OMB control number
0910–0381 (collection entitled ‘‘Food
Labeling Regulations’’).
Dated: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–16869 Filed 7–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Agency Recordkeeping/Reporting
Requirements Under Emergency
Review by the Office of Management
and Budget (OMB)
Title: Child Care and Development
Fund (CCDF) Financial Report, Form
ACF–696T (Tribes)
OMB No.: 0970–0195.
Description: Tribes use the Financial
Report Form ACF–696T to report Child
Care and Development Fund (CCDF)
expenditures. Authority to collect and
report this information is found in
Section 6580 of the Child Care and
Development Block Grant Act of 1990,
as revised. In addition to the Program
Reporting Requirements set forth in 45
CFR Part 98, Subpart H, the regulations
at 45 CFR 98.65(g) and 98.67(c)(1)
authorize the Secretary to require
financial reports as necessary.
Tribal grantees submit the ACF–696T
report on an annual basis on behalf of
the Tribal Lead Agency administering
the Child Care and Development Fund
(CCDF).
The American Recovery and
Reinvestment Act (ARRA) of 2009, (Pub.
L. 111–5) provides an additional $2
billion for the Child Care and
Development Fund to help States,
Territories, and Tribes provide child
care assistance to low income working
families. CCDF Program Instruction
(CCDF–ACF–PI–2009–03) provided
guidance on ARRA spending
requirements.
Section 1512 of the ARRA legislation
requires recipients to report quarterly
spending and performance data on the
public Web site, ‘‘Recovery.gov’’.
Federal agencies are required to collect
ARRA expenditure data and
performance data and these data must
be clearly distinguishable from the
regular CCDF (non-ARRA) funds. To
ensure transparency and accountability,
the ARRA requires Federal agencies and
grantees to track and report separately
on expenditures from funds made
available by the stimulus bill. Office of
Management and Budget (OMB)
guidance implementing the ARRA
legislation indicates that agencies
requiring additional information for
oversight should rely on existing
authorities and reflect these
requirements in their award terms and
conditions as necessary, following
existing procedures. Therefore, to
capture ARRA expenditures, the ACF
696T has been modified (by the addition
of two columns) for reporting ARRA
data. In addition, a new data element
will ask Tribes to estimate the number
of child service months funded with
ARRA dollars. The collection will not
duplicate other information.
Respondents: Tribal CCDF Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
CCDF Tribal Plan ............................................................................................
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Instrument
232
1
8
1,856
Estimated Total Annual Burden
Hours: 1,856.
Additional Information:
ACF is requesting that OMB grant a
90-day approval for this information
collection under procedures for
emergency processing by July 15, 2009.
A copy of this information collection,
with applicable supporting
documentation, may be obtained by
calling the Administration for Children
and Families, Reports Clearance Officer,
Robert Sargis at (202) 690–7275.
Comments and questions about the
information collection described above
should be directed to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for ACF, Office
of Management and Budget, Paperwork
Reduction Project, 725 Street, NW.,
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Washington, DC. 20503, FAX (202) 395–
6974.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 6, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–16478 Filed 7–14–09; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4184–01–M
PO 00000
[60Day–09–09CC]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Disease Control and
Prevention (CDC) is soliciting public
comment on the specific aspects of the
proposed information collection
described below. To request more
information on the proposed projects or
to obtain a copy of the data collection
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]]>Agencies
[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Pages 34353-34357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16869]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0296]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 the information collection
provisions in FDA's food labeling regulations and on Form FDA 3570,
``Model Small Business Nutrition Labeling Exemption Notice,'' which
small businesses may use to claim the small business exemption from
nutrition labeling.
DATES: Submit written or electronic comments on the collection of
information by September 14, 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, 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,
[[Page 34354]]
when appropriate, and other forms of information technology.
Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105 (OMB
Control Number 0910-0381)--Extension
FDA regulations require food producers to disclose to consumers and
others specific information about themselves or their products on the
label or labeling of their products. Related regulations require that
food producers retain records establishing the basis for the
information contained in the label or labeling of their products and
provide those records to regulatory officials. Finally, certain
regulations provide for the submission of food labeling petitions to
FDA. FDA's food labeling regulations under parts 101, 102, 104, and 105
(21 CFR parts 101, 102, 104, and 105) were issued under the authority
of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the
FPLA) (15 U.S.C. 1453, 1454, and 1455) and under sections 201, 301,
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371,
and 379e). Most of these regulations derive from section 403 of the
act, which provides that a food product shall be deemed to be
misbranded if, among other things, its label or labeling fails to bear
certain required information concerning the food product, is false or
misleading in any particular, or bears certain types of unauthorized
claims. The disclosure requirements and other collections of
information in the regulations in parts 101, 102, 104, and 105 are
necessary to ensure that food products produced or sold in the United
States are in compliance with the labeling provisions of the act and
the FPLA.
Section 101.3 of FDA's food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form. Section 101.5 requires that
the label of a food product in packaged form specify the name and place
of business of the manufacturer, packer, or distributor and, if the
food producer is not the manufacturer of the food product, its
connection with the food product. Section 101.9 requires that nutrition
information be provided for all food products intended for human
consumption and offered for sale, unless an exemption in Sec. 101.9(j)
applies to the product. Section 101.9(g)(9) also provides for the
submission to FDA of requests for alternative approaches to nutrition
labeling. Finally, Sec. 101.9(j)(18) provides for the submission to
FDA of notices from firms claiming the small business exemption from
nutrition labeling. FDA has developed Form FDA 3570 to assist small
businesses in claiming the small business exemption from nutrition
labeling. The form contains all the elements required by Sec.
101.9(j)(18).
Section 101.10 requires that restaurants provide nutrition
information, upon request, for any food or meal for which a nutrient
content claim or health claim is made. Section 101.12(b) provides the
reference amount that is used for determining the serving sizes for
specific products, including baking powder, baking soda, and pectin.
Section 101.12(e) provides that a manufacturer that adjusts the
reference amount customarily consumed (RACC) of an aerated food for the
difference in density of the aerated food relative to the density of
the appropriate nonaerated reference food must be prepared to show FDA
detailed protocols and records of all data that were used to determine
the density-adjusted RACC. Section 101.12(g) requires that the label or
labeling of a food product disclose the serving size that is the basis
for a claim made for the product if the serving size on which the claim
is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions to FDA to request changes in the reference
amounts defined by regulation.
Section 101.13 requires that nutrition information be provided in
accordance with Sec. 101.9 for any food product for which a nutrient
content claim is made. Under some circumstances, Sec. 101.13 also
requires the disclosure of other types of information as a condition
for the use of a nutrient content claim. For example, under Sec.
101.13(j), if the claim compares the level of a nutrient in the food
with the level of the same nutrient in another ``reference'' food, the
claim must also disclose the identity of the reference food, the amount
of the nutrient in each food, and the percentage or fractional amount
by which the amount of the nutrient in the labeled food differs from
the amount of the nutrient in the reference food. It also requires that
when this comparison is based on an average of food products, this
information must be provided to consumers or regulatory officials upon
request. Section 101.13(q)(5) requires that restaurants document and
provide to appropriate regulatory officials, upon request, the basis
for any nutrient content claims they have made for the foods they sell.
Section 101.14(d)(2) and (d)(3) provides for the disclosure of
nutrition information in accordance with Sec. 101.9 and, under some
circumstances, certain other information as a condition for making a
health claim for a food product. Section 101.15 provides that, if the
label of a food product contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the act to appear on the label shall appear thereon
in both the foreign language and in English. Section 101.22 contains
labeling requirements for the disclosure of spices, flavorings,
colorings, and chemical preservatives in food products. Section
101.22(i)(4) sets forth reporting and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavor. Section 101.30 specifies the conditions under which
a beverage that purports to contain any fruit or vegetable juice must
declare the percentage of juice present in the beverage and the manner
in which the declaration is to be made. Section 102.33 specifies the
common or usual name for beverages that contain fruit or vegetable
juice.
Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in Sec.
101.36(h) applies. Section 101.36(f)(2) cross-references the provisions
in Sec. 101.9(g)(9) for the submission to FDA of requests for
alternative approaches to nutrition labeling. Also, Sec. 101.36(h)(2)
cross-references the provisions in Sec. 101.9(j)(18) for the
submission of small business exemption notices. As noted previously,
FDA has developed Form FDA 3570 to assist small businesses in claiming
the small business exemption from nutrition labeling. The form contains
all the elements required by Sec. 101.36(h)(2).
Section 101.36(e) permits the voluntary declaration of the
quantitative amount and the percent of Daily Value of a dietary
ingredient on a ``per day'' basis in addition to the required ``per
serving'' basis, if a dietary supplement label recommends that the
dietary supplement be consumed more than once per day.
Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruits, vegetables, and fish at the point
of purchase, and Sec. 101.45 contains guidelines for providing such
information. Also, Sec. 101.45(c) provides for the submission of
nutrient databases and proposed nutrition labeling values for raw
fruit,
[[Page 34355]]
vegetables, and fish to FDA for review and approval.
Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify
information that must be disclosed as a condition for making particular
nutrient content claims. Section 101.67 provides for the use of
nutrient content claims for butter, and cross-references requirements
in other regulations for ingredient declaration (Sec. 101.4) and
disclosure of information concerning performance characteristics (Sec.
101.13(d)). Section 101.69 provides for the submission of a petition
requesting that FDA authorize a particular nutrient content claim by
regulation. Section 101.70 provides for the submission of a petition
requesting that FDA authorize a particular health claim by regulation.
Section 101.77(c)(2)(ii)(D) requires the disclosure of the amount of
soluble fiber per serving in the nutrition labeling of a food bearing a
health claim about the relationship between soluble fiber and a reduced
risk of coronary heart disease. Section 101.79(c)(2)(iv) requires the
disclosure of the amount of folate per serving in the nutrition
labeling of a food bearing a health claim about the relationship
between folate and a reduced risk of neural tube defects.
Section 101.100(d) provides that any agreement that forms the basis
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the act be in writing and that a copy of
the agreement be made available to FDA upon request. Section 101.100
also contains reporting and disclosure requirements as conditions for
claiming certain labeling exemptions (e.g., Sec. 101.100(h)).
Section 101.105 specifies requirements for the declaration of the
net quantity of contents on the label of a food in packaged form and
prescribes conditions under which a food whose label does not
accurately reflect the actual quantity of contents may be sold, with
appropriate disclosures, to an institution operated by Federal, State,
or local government. Section 101.108 provides for the submission to FDA
of a written proposal requesting a temporary exemption from certain
requirements of Sec. Sec. 101.9 and 105.66 for the purpose of
conducting food labeling experiments with FDA's authorization.
Regulations in part 102 define the information that must be
included as part of the statement of identity for particular foods and
prescribe related labeling requirements for some of these foods. For
example, Sec. 102.22 requires that the name of a protein hydrolysate
shall include the identity of the food source from which the protein
was derived.
Part 104, which pertains to nutritional quality guidelines for
foods, cross-references several labeling provisions in part 101 but
contains no separate information collection requirements.
Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in
reducing or maintaining body weight.
The disclosure and other information collection requirements in the
previously mentioned regulations are placed primarily upon
manufacturers, packers, and distributors of food products. Because of
the existence of exemptions and exceptions, not all of the requirements
apply to all food producers or to all of their products. Some of the
regulations affect food retailers, such as supermarkets and
restaurants.
The purpose of the food labeling requirements is to allow consumers
to be knowledgeable about the foods they purchase. Nutrition labeling
provides information for use by consumers in selecting a nutritious
diet. Other information enables a consumer to comparison shop.
Ingredient information also enables consumers to avoid substances to
which they may be sensitive. Petitions or other requests submitted to
FDA provide the basis for the agency to permit new labeling statements
or to grant exemptions from certain labeling requirements.
Recordkeeping requirements enable FDA to monitor the basis upon which
certain label statements are made for food products and whether those
statements are in compliance with the requirements of the act or the
FPLA.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Total Estimated Annual Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section and Part/Form No. Respondents per Response Responses Response Total Hours
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101.3, 101.22, 102 and 104 25,000 1.03 25,750 .5 12,875
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101.4, 101.22, 101.100, 102, 25,000 1.03 25,750 1 25,750
104 and 105
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101.5 25,000 1.03 25,750 0.25 6,438
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101.9, 101.13(n), 101.14(d)(3), 101.62, and 104 25,000 1.03 25,750 4 103,000
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101.9(g)(9) and 101.36(f)(2) 12 1 12 4 48
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101.9(j)(18) and 101.36(h)(2)/Form FDA 3570 10,000 1 10,000 8 80,000
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101.10 300,000 1.5 450,000 0.25 112,500
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101.12(b) 29 2.3 67 1 67
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101.12(e) 25 1 25 1 25
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101.12(g) 5,000 1 5,000 1 5,000
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101.12(h) 5 1 5 80 400
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101.13(d)(1) and 101.67 200 1 200 1 200
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101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, 5,000 1 5,000 1 5,000
and 101.62
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101.13(q)(5) 300,000 1.5 450,000 0.75 337,500
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101.14(d)(2) 300,000 1.5 450,000 0.75 337,500
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101.15 160 10 1,600 8 12,800
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101.22(i)(4) 25 1 25 1 25
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101.30 and 102.33 1,500 5 7,500 1 7,500
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101.36 300 40 12,000 4 48,000
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101.36(e) 125 13 1,625 0.25 406
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101.42 and 101.45 1,000 1 1,000 0.5 500
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101.45(c) 5 4 20 4 80
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101.69 3 1 3 25 75
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101.70 5 1 5 80 400
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101.79(c)(2)(i)(D) 1,000 1 1,000 0.25 250
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101.79(c)(2)(iv) 100 1 100 0.25 25
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101.100(d) 1,000 1 1,000 1 1,000
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101.105 and 101.100(h) 25,000 1.03 25,750 0.5 12,875
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101.108 1 1 1 40 40
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Total ................. ................. ................. ................. 1,110,279
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Total Estimated Annual Burden\1\
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No. of Annual Frequency per Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Record Total Hours
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101.12(e) 25 1 25 1 25
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101.13(q)(5) 300,000 1.5 450,000 0.75 337,500
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101.14(d)(2) 300,000 1.5 450,000 0.75 337,500
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101.22(i)(4) 25 1 25 1 25
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101.100(d)(2) 1,000 1 1,000 1 1,000
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101.105(t) 100 1 100 1 100
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Total ................. ....................... ................. ........... 676,150
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting and recordkeeping burdens are based
on agency communications with industry and FDA's knowledge of and
experience with food labeling and the submission of petitions and
requests to the agency. Where an agency regulation implements an
information collection requirement in the act or the FPLA, only any
additional burden attributable to the regulation has been included in
FDA's burden estimate.
No burden has been estimated for those requirements where the
information to be disclosed is information that has been supplied by
FDA. Also, no burden has been estimated for information that is
disclosed to third parties as a usual and customary part of a food
producer's normal business activities. Under 5 CFR 1320.3(c)(2), the
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
is not a collection of information. Under 5 CFR 1320.3(b)(2), the time,
effort, and
[[Page 34357]]
financial resources necessary to comply with a collection of
information are excluded from the burden estimate if the reporting,
recordkeeping, or disclosure activities needed to comply are usual and
customary because they would occur in the normal course of activities.
In this request for extension of OMB approval under the PRA, FDA is
combining the burden hours associated with OMB control numbers 0910-
0395 (collection entitled ``Food Labeling: Nutrition Labeling of
Dietary Supplements on a `Per Day' Basis'') and 0910-0515 (collection
entitled ``Food Labeling: Trans Fatty Acids in Nutrition Labeling'')
with the burden hours approved under OMB control number 0910-0381
(collection entitled ``Food Labeling Regulations'').
Dated: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16869 Filed 7-14-09; 8:45 am]
BILLING CODE 4160-01-S
