Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling, 18338-18339 [E6-5219]
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Federal Register / Vol. 71, No. 69 / Tuesday, April 11, 2006 / Notices
an independent audit in accordance
with OMB Circular A–133.
VII. Agency Contacts
Administrative and Budgetary
Requirements
For information related to
administrative and budgetary
requirements, contact Karen Campbell
in the OPHS Office of Grants
Management, 1101 Wootton Parkway,
Suite 550, Rockville, MD 20852; by
phone at 240–453–8822, or by email at
kcampbell@osophs.dhhs.gov.
Program Requirements
For information related to family
planning program requirements, contact
the Regional Program Consultant for
Family Planning in PHS Region VI
(Arkansas, Louisiana, New Mexico,
Oklahoma, Texas)—Evelyn Glass, by
phone at 214–767–3088, or by email at
eglass@osophs.dhhs.gov.
VIII. Other Information
There will be an opportunity for a
technical assistance conference call to
be held within one month after
publication of this Notice in the Federal
Register. For more information
regarding this opportunity, including
date, registration information, and how
to join the call, please consult the OPA
Web site at https://opa.osophs.dhhs.gov.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to: Research Center and
Occupational Safety and Health Training
Projects Grants, PAR–05–126.
FOR FURTHER INFORMATION CONTACT:
Charles N. Rafferty, Ph.D., Designated
Federal Official, National Institute for
Occupational Safety and Health, CDC,
1600 Clifton Road, NE, Mailstop E–74,
Atlanta, GA 30333, Telephone Number
404–498–2582.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: April 5, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–5241 Filed 4–10–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 29, 2006.
Alma L. Golden,
Deputy Assistant Secretary for Population
Affairs.
[FR Doc. E6–5262 Filed 4–10–06; 8:45 am]
Food and Drug Administration
[Docket No. 2006N–0130]
BILLING CODE 4150–34–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling;
Trans Fatty Acids in Nutrition Labeling
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
AGENCY:
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panels (SEP): Research
Center and Occupational Safety and
Health Training Projects Grants, PAR–
05–126
wwhite on PROD1PC61 with NOTICES
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): Research Center and
Occupational Safety and Health Training
Projects Grants, PAR–05–126.
Time And Date: 10 a.m.–12 p.m., April 25,
2006 (Closed).
Place: Teleconference.
VerDate Aug<31>2005
19:37 Apr 10, 2006
Jkt 208001
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
the information collection requirements
of FDA’s regulations requiring that trans
fatty acids be declared in the Nutrition
Facts panel of conventional foods and
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
dietary supplements on a separate line
without a percent Daily Value (%DV).
Submit written or electronic
comments on the collection of
information by June 12, 2006.
DATES:
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\11APN1.SGM
11APN1
18339
Federal Register / Vol. 71, No. 69 / Tuesday, April 11, 2006 / Notices
Food Labeling; Trans Fatty Acids in
Nutrition Labeling—21 CFR
101.9(c)(2)(ii) and 101.36(b)(2) (OMB
Control Number 0910–0515)—Extension
Section 403(q) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 343(q)) establishes the
requirements for nutrition labeling of
foods. In particular, section 403(q)(1)(A)
and (q)(1)(B) require that the label or
labeling of a food bear nutrition
information on the amount of nutrients
present in a product. Section 403(q)(2)
of the act permits FDA to require
information about nutrients not
specified in section 403(q)(1) if that
additional information will assist
consumers in maintaining healthy
dietary practices. Section 403(q)(5)(F) of
the act specifies the nutrition
information that must be on the label or
labeling of dietary supplements. Under
these provisions of the act, FDA issued
regulations in § 101.9(c)(2) (21 CFR
101.9(c)(2)) that require information on
the amounts of fat and certain fatty
acids in food products to be disclosed
in the Nutrition Facts panel. Similarly,
FDA issued regulations in § 101.36(b)
(21 CFR 101.36(b)) that specify the
nutrition information that must be on
the label or labeling of dietary
supplements. In particular,
§§ 101.9(c)(2)(ii) and 101.36(b)(2)
require that the amount of trans fatty
acids present in a food, including
dietary supplements, must be declared
on the nutrition label of conventional
foods and dietary supplements on a
separate line immediately under the line
for the declaration of saturated fat.
Description of Respondents: Persons
and businesses, including small
businesses.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
101.9(c)(2)(ii)
Annual Frequency
per
Response
Total Annual
Responses
Hours per
Response
Total Hours
10,490
27
278,100
2
556,200
$155,200
910
32
29,500
2
59,000
$16,500
615,200
101.36(b)(2)
$171,700
Totals
wwhite on PROD1PC61 with NOTICES
1There
Total Operating
Costs
are no capital costs or maintenance costs associated with this collection of information.
FDA believes that the burden
associated with the disclosure of trans
fatty acid information on labels or in
labeling food and dietary supplement
products is largely a one-time burden
created by the need for firms to revise
the labels for those existing products
that contain trans fatty acids.
FDA estimated that there were
approximately 10,490 firms producing
food products and 910 firms producing
dietary supplement products that,
because they contain trans fatty acids,
were affected by §§ 101.9 and 101.36.
The agency estimated that these firms
needed to revise approximately 278,100
food labels and 29,500 dietary
supplement labels, although only about
25 percent of these label changes would
have to be made earlier than the firms
planned. Because these firms were
already disclosing information on total
fat, saturated fat, and other significant
nutrients on their product labels, based
upon its knowledge of food and dietary
supplement labeling, FDA estimated
that firms would require less than 2
hours per product to comply with the
nutrition labeling requirements of
§§ 101.9 and 101.36.
Multiplying the total number of
responses by the hours per response
gives the total hours. FDA estimated
operating costs by combining testing
and relabeling costs ($44.9 million +
$126.8 million). This total was then
apportioned between §§ 101.9 and
101.36 according to the proportion of
responses for each section. Based on the
VerDate Aug<31>2005
19:37 Apr 10, 2006
Jkt 208001
labeling cost model, FDA expected that,
with a compliance period of over 2
years, 75 percent of firms will
coordinate labeling revisions required
by the trans fat final rule with other
planned labeling changes for their
products.
Dated: April 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–5219 Filed 4–10–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0136]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Interstate Shellfish
Dealers Certificate
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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
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
Form FDA 3038, Interstate Shellfish
Dealers Certificate.
DATES: Submit written or electronic
comments on the collection of
information by June 12, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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 Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[Federal Register Volume 71, Number 69 (Tuesday, April 11, 2006)]
[Notices]
[Pages 18338-18339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5219]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0130]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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 the information collection
requirements of FDA's regulations requiring that trans fatty acids be
declared in the Nutrition Facts panel of conventional foods and dietary
supplements on a separate line without a percent Daily Value (%DV).
DATES: Submit written or electronic comments on the collection of
information by June 12, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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 Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
[[Page 18339]]
Food Labeling; Trans Fatty Acids in Nutrition Labeling--21 CFR
101.9(c)(2)(ii) and 101.36(b)(2) (OMB Control Number 0910-0515)--
Extension
Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 343(q)) establishes the requirements for nutrition
labeling of foods. In particular, section 403(q)(1)(A) and (q)(1)(B)
require that the label or labeling of a food bear nutrition information
on the amount of nutrients present in a product. Section 403(q)(2) of
the act permits FDA to require information about nutrients not
specified in section 403(q)(1) if that additional information will
assist consumers in maintaining healthy dietary practices. Section
403(q)(5)(F) of the act specifies the nutrition information that must
be on the label or labeling of dietary supplements. Under these
provisions of the act, FDA issued regulations in Sec. 101.9(c)(2) (21
CFR 101.9(c)(2)) that require information on the amounts of fat and
certain fatty acids in food products to be disclosed in the Nutrition
Facts panel. Similarly, FDA issued regulations in Sec. 101.36(b) (21
CFR 101.36(b)) that specify the nutrition information that must be on
the label or labeling of dietary supplements. In particular, Sec. Sec.
101.9(c)(2)(ii) and 101.36(b)(2) require that the amount of trans fatty
acids present in a food, including dietary supplements, must be
declared on the nutrition label of conventional foods and dietary
supplements on a separate line immediately under the line for the
declaration of saturated fat.
Description of Respondents: Persons and businesses, including small
businesses.
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 Total Operating
21 CFR Section Respondents per Response Responses Response Total Hours Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.9(c)(2)(ii) 10,490 27 278,100 2 556,200 $155,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.36(b)(2) 910 32 29,500 2 59,000 $16,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 615,200 $171,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or maintenance costs associated with this collection of information.
FDA believes that the burden associated with the disclosure of
trans fatty acid information on labels or in labeling food and dietary
supplement products is largely a one-time burden created by the need
for firms to revise the labels for those existing products that contain
trans fatty acids.
FDA estimated that there were approximately 10,490 firms producing
food products and 910 firms producing dietary supplement products that,
because they contain trans fatty acids, were affected by Sec. Sec.
101.9 and 101.36. The agency estimated that these firms needed to
revise approximately 278,100 food labels and 29,500 dietary supplement
labels, although only about 25 percent of these label changes would
have to be made earlier than the firms planned. Because these firms
were already disclosing information on total fat, saturated fat, and
other significant nutrients on their product labels, based upon its
knowledge of food and dietary supplement labeling, FDA estimated that
firms would require less than 2 hours per product to comply with the
nutrition labeling requirements of Sec. Sec. 101.9 and 101.36.
Multiplying the total number of responses by the hours per response
gives the total hours. FDA estimated operating costs by combining
testing and relabeling costs ($44.9 million + $126.8 million). This
total was then apportioned between Sec. Sec. 101.9 and 101.36
according to the proportion of responses for each section. Based on the
labeling cost model, FDA expected that, with a compliance period of
over 2 years, 75 percent of firms will coordinate labeling revisions
required by the trans fat final rule with other planned labeling
changes for their products.
Dated: April 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5219 Filed 4-10-06; 8:45 am]
BILLING CODE 4160-01-S
