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Federal Register / Vol. 71, No.

245 / Thursday, December 21, 2006 / Rules and Regulations 76599

Form 10–QSB for a fiscal year ending on or after 305), Food and Drug Administration,
* * * * * December 15, 2007 but before December 5630 Fishers Lane, rm. 1061, Rockville,
15, 2008. MD 20852.
Part I—Financial Information (b) This temporary Item 8A(T) will To ensure more timely processing of
Item 3A(T). Controls and Procedures expire on June 30, 2009. comments, FDA is no longer accepting
* * * * * comments submitted to the agency by e-
(a) Furnish the information required mail. FDA encourages you to continue
by Items 307 and 308T of Regulation S– Dated: December 15, 2006.
to submit electronic comments by using
B (17 CFR 228.307 and 228.308T) with By the Commission.
the Federal eRulemaking Portal or the
respect to a quarterly report that the Nancy M. Morris, agency Web site, as described in the
small business issuer is required to file Secretary. Electronic Submissions portion of this
for a fiscal year ending on or after [FR Doc. E6–21781 Filed 12–20–06; 8:45 am] paragraph.
December 15, 2007 but before December BILLING CODE 8011–01–P Instructions: All submissions received
15, 2008. must include the agency name and
(b) This temporary Item 3A(T) will Docket No. 2000N–1596 for this
expire on June 30, 2009. DEPARTMENT OF HEALTH AND rulemaking. All comments received will
* * * * * HUMAN SERVICES be posted without change to http://
■ 19. Form 10–K (referenced in www.fda.gov/ohrms/dockets/
§ 249.310) is amended by adding Food and Drug Administration default.htm, including any personal
temporary Item 9A(T) to Part II information provided. For additional
following Item 9A. 21 CFR Part 101 information on submitting comments,
The addition reads as follows: [Docket No. 2000N–1596] see the ‘‘Comments’’ heading of the
Note: The text of Form 10–K does not, and SUPPLEMENTARY INFORMATION section of
this amendment will not, appear in the Code Uniform Compliance Date for Food this document.
of Federal Regulations. Labeling Regulations Docket: For access to the docket to
read background documents or
Form 10–K AGENCY: Food and Drug Administration, comments received, go to http://
HHS. www.fda.gov/ohrms/dockets/
* * * * *
ACTION: Final rule. default.htm and insert the docket
Part II number found in brackets in the
SUMMARY: The Food and Drug
* * * * * heading of this document, into the
Administration (FDA) is establishing
‘‘Search’’ box and follow the prompts
Item 9A(T). Controls and Procedures January 1, 2010, as the uniform
and/or go to the Division of Dockets
compliance date for food labeling
(a) If the registrant is neither a large Management, 5630 Fishers Lane, rm.
regulations that are issued between
accelerated filer nor an accelerated filer 1061, Rockville, MD 20852.
January 1, 2007, and December 31, 2008.
as those terms are defined in § 240.12b– FOR FURTHER INFORMATION CONTACT:
FDA periodically announces uniform
2 of this chapter, furnish the Louis B. Brock, Center for Food Safety
compliance dates for new food labeling
information required by Items 307 and and Applied Nutrition (HFS–24), Food
requirements to minimize the economic
308T of Regulation S–K (17 CFR and Drug Administration, 5100 Paint
impact of label changes. On March 14,
229.307 and 229.308T) with respect to Branch Pkwy., College Park, MD 20740,
2005, FDA established January 1, 2008,
an annual report that the registrant is 301–436–2378.
as the uniform compliance date for food
required to file for a fiscal year ending SUPPLEMENTARY INFORMATION: FDA
labeling regulations that issued between
on or after December 15, 2007 but before periodically issues regulations requiring
March 14, 2005, and December 31, 2006.
December 15, 2008. changes in the labeling of food. If the
(b) This temporary Item 9A(T) will DATES: This rule is effective December
21, 2006. Submit written or electronic effective dates of these labeling changes
expire on June 30, 2009. were not coordinated, the cumulative
comments by March 6, 2007.
* * * * * economic impact on the food industry
ADDRESSES: You may submit comments,
■ 20. Form 10–KSB (referenced in of having to respond separately to each
identified by Docket No. 2000N–1596,
§ 249.310b) is amended by adding change would be substantial. Therefore,
by any of the following methods:
temporary Item 8A(T) to Part II after the agency periodically has announced
Item 8A. Electronic Submissions uniform compliance dates for new food
The addition reads as follows: labeling requirements (see, e.g., the
Submit electronic comments in the
Note: The text of Form 10–KSB does not, following ways: Federal Registers of October 19, 1984
and this amendment will not, appear in the • Federal eRulemaking Portal: http:// (49 FR 41019), December 24, 1996 (61
Code of Federal Regulations. www.regulations.gov. Follow the FR 67710), December 27, 1996 (61 FR
instructions for submitting comments. 68145), December 23, 1998 (63 FR
Form 10–KSB • Agency Web site: http:// 71015), November 20, 2000 (65 FR
* * * * * www.fda.gov/dockets/ecomments. 69666), and December 31, 2002 (67 FR
Follow the instructions for submitting 79851)). Use of a uniform compliance
Part II date provides for an orderly and
comments on the agency Web site.
* * * * * economical industry adjustment to new
Written Submissions labeling requirements by allowing
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Item 8A(T). Controls and Procedures Submit written submissions in the sufficient lead time to plan for the use
(a) Furnish the information required following ways: of existing label inventories and the
by Items 307 and 308T of Regulation S– • FAX: 301–827–6870. development of new labeling materials.
B (17 CFR 228.307 and 228.308T) with • Mail/Hand delivery/Courier [For This policy serves consumers’ interests
respect to an annual report that the paper, disk, or CD-ROM submissions]: as well because the cost of multiple
small business issuer is required to file Division of Dockets Management (HFA– short-term label revisions that would

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76600 Federal Register / Vol. 71, No. 245 / Thursday, December 21, 2006 / Rules and Regulations

otherwise occur would likely be passed expenditure that would meet or exceed labeling regulations that require changes
on to consumers in the form of higher this amount. in the labeling of food products and that
prices. FDA has analyzed this final rule in publish after January 1, 2007, and before
The agency has determined under 21 accordance with the principles set forth December 31, 2008. Those regulations
CFR 25.30(k) that this action is of a type in Executive Order 13132. FDA has will specifically identify January 1,
that does not individually or determined that the rule does not 2010, as their compliance date. All food
cumulatively have a significant effect on contain policies that have substantial products subject to the January 1, 2010,
the human environment. Therefore, direct effects on the States, on the compliance date must comply with the
neither an environmental assessment relationship between the National appropriate regulations when initially
nor an environmental impact statement Government and the States, or on the introduced into interstate commerce on
is required. distribution of power and or after January 1, 2010. If any food
This final rule contains no collections responsibilities among the various labeling regulation involves special
of information. Therefore, clearance by levels of government. Accordingly, the circumstances that justify a compliance
the Office of Management and Budget agency has concluded that the rule does date other than January 1, 2010, the
(OMB) under the Paperwork Reduction not contain policies that have agency will determine for that
Act of 1995 is not required. federalism implications as defined in regulation an appropriate compliance
FDA has examined the impacts of the the Executive order and, consequently, date, which will be specified when the
final rule under Executive Order 12866 a federalism summary impact statement final regulation is published.
and the Regulatory Flexibility Act (5 is not required.
This action is not intended to change Dated: December 13, 2006.
U.S.C. 601–612), and the Unfunded Jeffrey Shuren,
existing requirements for compliance
Mandates Reform Act of 1995 (Public Assistant Commissioner for Policy.
dates contained in final rules published
Law 104–4). Executive Order 12866
before January 1, 2007. Therefore, all [FR Doc. E6–21902 Filed 12–20–06; 8:45 am]
directs agencies to assess all costs and
final FDA regulations published in the BILLING CODE 4160–01–S
benefits of available regulatory
Federal Register before January 1, 2007,
alternatives and, when regulation is
will still go into effect on the date stated
necessary, to select regulatory DEPARTMENT OF HEALTH AND
in the respective final rule.
approaches that maximize net benefits The agency generally encourages HUMAN SERVICES
(including potential economic, industry to comply with new labeling
environmental, public health and safety, regulations as quickly as feasible, Indian Health Service
and other advantages; distributive however. Thus, when industry members
impacts; and equity). The agency voluntarily change their labels, it is 25 CFR Part 900
believes that this final rule is not a appropriate that they incorporate any
significant regulatory action under the new requirements that have been Contracts Under the Indian Self-
Executive order. published as final regulations up to that Determination and Education
The establishment of a uniform time. Assistance Act; Change of Address for
compliance date does not in itself lead In rulemaking that began with the Civilian Board of Contract Appeals
to costs or benefits. We will assess the publication of a proposal on April 15,
costs and benefits of the uniform AGENCY: Indian Health Service, HHS.
1996 (61 FR 16422), and ended with a
compliance date in the regulatory final rule on December 24, 1996, FDA ACTION: Final rule; change of address.
impact analyses of the labeling rules provided notice and an opportunity for
that take effect at that date. The Indian Health Service is revising
comment on the practice of establishing its regulations governing contracts
The Regulatory Flexibility Act uniform compliance dates by issuance under the Indian Self-Determination
requires agencies to analyze regulatory of a final rule announcing the date. and Education Assistance Act to reflect
options that would minimize any Receiving no comments objecting to this a change of address due to a move for
significant economic impact of a rule on practice, FDA finds any further the Civilian Board of Contract Appeals
small entities. Because the final rule rulemaking unnecessary for (CBCA).
does not impose compliance costs on establishment of the uniform
small entities, the agency certifies that DATES: This rule change is effective
compliance date. Nonetheless, under 21
the final rule will not have a significant December 21, 2006.
CFR 10.40(e) (1), FDA is providing an
economic impact on a substantial opportunity for comment on whether FOR FURTHER INFORMATION CONTACT:
number of small entities. this uniform compliance date should be Hankie Ortiz, Director, Division of
Section 202(a) of the Unfunded modified or revoked. Regulatory Affairs, Records Access, and
Mandates Reform Act of 1995 requires Interested persons may submit to the Policy Liaison, Indian Health Service,
that agencies prepare a written Division of Dockets Management (see 801 Thompson Avenue, Suite 450,
statement, which includes an ADDRESSES), written or electronic Rockville, Maryland 20852, Telephone
assessment of anticipated costs and comments regarding this document. (301) 443–1116.
benefits, before proposing ‘‘any rule that Submit a single copy of electronic SUPPLEMENTARY INFORMATION:
includes any Federal mandate that may comments or two paper copies of any
result in the expenditure by State, local, I. Background
mailed comments, except that
and tribal governments, in the aggregate, individuals may submit one paper copy. Regulations promulgated by the
or by the private sector, of $100,000,000 Comments are to be identified with the Indian Health Service to govern the
or more (adjusted annually for inflation) docket number found in brackets in the administration of contracts under the
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in any one year.’’ The current threshold heading of this document. Received Indian Self-Determination and
after adjustment for inflation is $115 comments may be seen in the Division Education Assistance Act reference an
million, using the most current (2003) of Dockets Management between 9 a.m. address for the Interior Board of
Implicit Price Deflator for the Gross and 4 p.m., Monday through Friday. Contract Appeals (IBCA). Effective
Domestic Product. FDA does not expect The new uniform compliance date January 6, 2007, the Interior Board of
this final rule to result in any 1-year will apply only to final FDA food Contract Appeals will be consolidated

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