Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling, 60157-60158 [E6-16840]
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rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 71, No. 197 / Thursday, October 12, 2006 / Notices
DOJ has agreed to represent the
employee, or
d. the United States Government is a
party to litigation or has an interest in
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
6. To assist a CMS contractor
(including, but not necessarily limited
to fiscal intermediaries and carriers) that
assists in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste, or abuse in such program.
7. To assist another Federal agency or
an instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud, waste, or
abuse in, a health benefits program
funded in whole or in part by Federal
funds, when disclosure is deemed
reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste, or abuse in such programs.
B. Additional Provisions Affecting
Routine Use Disclosures.
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164–512(a)(1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that an
individual could, because of the small
size, use this information to deduce the
identity of the beneficiary).
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POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored on computer
diskette and magnetic media.
RETRIEVABILITY:
Information can be retrieved by the
name, SSN, and/or HICN of claimant.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: the Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will transfer to and maintain in
an archival file for a total period not to
exceed 7 years. All claims-related
records are encompassed by the
document preservation order and will
be retained until notification is received
from DOJ.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Division of Appeals Policy,
Medicare Enrollment & Appeals Group,
Center for Beneficiary Choices, CMS,
PO 00000
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60157
Mail Stop C2–12–16, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
NOTIFICATION PROCEDURE:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, HICN, address, date of birth, and
gender, and for verification purposes,
the subject individual’s name (woman’s
maiden name, if applicable), and SSN.
Furnishing the SSN is voluntary, but it
may make searching for a record easier
and prevent delay.
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also specify the record contents being
sought. (These procedures are in
accordance with department regulation
45 CFR 5b.5(a)(2)).
CONTESTING RECORDS PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the records and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
Procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
Sources on information contained in
this records system is obtained from the
reconsideration requests made by or on
behalf of Medicare beneficiaries and
from inquiries from congressional
offices, health plans, providers, state
insurance commissioners, state
regulators, disenrollment surveys,
Medicare carriers or intermediaries, and
QIO records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E6–16852 Filed 10–11–06; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0130]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling;
Trans Fatty Acids in Nutrition Labeling
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\12OCN1.SGM
Notice.
12OCN1
60158
Federal Register / Vol. 71, No. 197 / Thursday, October 12, 2006 / Notices
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 November
13, 2006.
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 Management
Programs (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.
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 403(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 for dietary supplements, on
a separate line immediately under the
line for the declaration of saturated fat.
Respondents are expected to be
persons and businesses, including small
businesses.
In the Federal Register of April 11,
2006 (71 FR 18338), FDA published a
60-day notice requesting public
comment on the information collection
provisions. One comment was received
but unrelated to the information
collection.
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
Respondent
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
Total
rwilkins on PROD1PC63 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
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16:21 Oct 11, 2006
Jkt 211001
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
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: October 5, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–16840 Filed 10–11–06; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998D–0777] (formerly Docket
No. 98D–0777)
Guidance for Industry on Investigating
Out-of-Specification Test Results for
Pharmaceutical Production;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Investigating Out-ofSpecification (OOS) Test Results for
Pharmaceutical Production.’’ This
guidance provides information for the
pharmaceutical industry on how to
evaluate laboratory test results that fall
outside of specification limits. The
guidance is intended to provide clear
and consistent communication of
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Notices]
[Pages 60157-60158]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16840]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0130]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling; Trans
Fatty Acids in Nutrition Labeling
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 60158]]
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
November 13, 2006.
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 Management
Programs (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.
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 403(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 for dietary
supplements, on a separate line immediately under the line for the
declaration of saturated fat.
Respondents are expected to be persons and businesses, including
small businesses.
In the Federal Register of April 11, 2006 (71 FR 18338), FDA
published a 60-day notice requesting public comment on the information
collection provisions. One comment was received but unrelated to the
information collection.
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 Respondent 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 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: October 5, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16840 Filed 10-11-06; 8:45 am]
BILLING CODE 4160-01-S
