[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Rules and Regulations]
[Page 15559-15564]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-3]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004P-0294]
Food Labeling: Health Claims; Dietary Noncariogenic Carbohydrate
Sweeteners and Dental Caries
AGENCY: Food and Drug Administration, HHS.
[[Page 15560]]
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
decision to authorize the use of a health claim regarding the
association between sucralose and the nonpromotion of dental caries.
Based on its review of evidence described in the proposed rule and
comments submitted on the proposed rule, the agency has concluded that
sucralose does not promote dental caries. Therefore, the agency has
decided to amend the regulation that authorizes a health claim
regarding noncariogenic carbohydrate sweeteners to include sucralose.
DATES: This final rule is effective March 29, 2006.
FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD, 20740-3835, 301-436-1450.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 13, 2005 (70 FR 25496), the agency
published a proposed rule to amend Sec. 101.80 (21 CFR 101.80), the
regulation which authorizes a health claim regarding the relationship
between noncariogenic carbohydrate sweeteners and dental caries, to
include sucralose, a non-nutritive sweetener food ingredient. Under
403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 343(r)(3)(B)(i)), FDA issued this proposed rule in response
to a petition filed under section 403(r)(4) of the act (21 U.S.C.
343(r)(4)). Section 403(r)(3)(B)(i) of the act states that the
Secretary of Health and Human Services (Secretary) (and, by delegation,
FDA) shall issue a regulation authorizing a health claim only if the
Secretary determines, based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner which is consistent with generally recognized
scientific procedures and principles), that there is significant
scientific agreement, among experts qualified by scientific training
and experience to evaluate such claims, that the claim is supported by
such evidence (see also 21 CFR 101.14(c)). Section 403(r)(4) of the act
sets out the procedures that FDA is to follow upon receiving a health
claim petition.
On April 2, 2004, McNeil Nutritionals, of Brunswick, NJ (the
petitioner) submitted a petition requesting that the agency amend Sec.
101.80 to include the non-nutritive sweetener sucralose as one of the
substances eligible to bear the dental caries health claim (Ref. 1).
FDA filed the petition for comprehensive review in accordance with
section 403(r)(4) of the act on July 9, 2004.
FDA considered the scientific evidence presented in the petition as
part of its review of the scientific literature on sucralose and dental
caries, as well as information previously considered by the agency on
the etiology of dental caries and the effects of slowly fermentable
carbohydrates. The agency summarized this evidence in the proposed rule
(70 FR 25496 at 25498 to 25499). Based on the available evidence, FDA
concluded that dental caries is a disease for which the U.S. population
is at risk; sucralose is a food because it contributes taste and other
technical effects listed in 21 CFR 170.3(o) to food; the use of
sucralose as a non-nutritive sweetener in food is safe and lawful; and
there is significant scientific agreement among qualified experts that
sucralose does not promote dental caries (70 FR 25496 at 25499).
Consequently, FDA proposed amending Sec. 101.80 (the sucralose
proposed rule) to broaden the health claim to include sucralose as an
additional noncariogenic carbohydrate sweetener eligible for the health
claim.
II. Summary of Comments and the Agency's Response
The agency received four responses, each containing one or more
comments, to the sucralose proposed rule. Two responses were from
individual consumers, one from an industry trade organization, and the
other from the petitioner. One consumer comment had no relevance to the
proposed amendment, and the other consumer comment opposed a health
claim for this non-nutritive sweetener but provided little specific
information. The industry trade organization and the petitioner agreed
with the proposed amendment without providing grounds for this support
other than those grounds already provided by FDA in the preamble to the
sucralose proposed rule. The petitioner also made several comments
regarding FDA's evaluation of the evidence, which are discussed in
detail in comments 1 to 4 of this section II.
(Comment 1) The petitioner commented that it was inappropriate for
FDA to refer to sucralose-based sugar substitute products by brand
names in the preamble; specifically in regards to statements about
specific SPLENDA sugar substitute products not meeting the eligibility
criteria of Sec. 101.80(c)(2)(iii). The petitioner noted that the
SPLENDA brand name did not appear in the petition and thus FDA's
conclusions should have referred to the eligibility of sucralose-based
sugar substitute formulations generically. The petitioner further noted
that SPLENDA brand name product formulations can be changed and may in
the future meet Sec. 101.80(c)(2)(iii) eligibility criteria.
(Response) The petition cites dental plaque pH studies conducted
with sucralose-based formulations representative of commercially
marketed SPLENDA sugar substitute products. FDA discussed these
products in the preamble to clarify that although the petition included
plaque pH data representative of these products, FDA was concluding
that the available evidence did not support the eligibility of these
sucralose-based formulations for the health claim. FDA referred to
these formulations by their specific product names (i.e., SPLENDA
Granular, and SPLENDA Packet) for the sake of convenience. The
amendment to Sec. 101.80 provides for the use of the dental caries
health claim in food labeling of sucralose-containing products in
general and does not prohibit the use of the health claim in labeling
of any SPLENDA brand name product that meets Sec. 101.80(c)(2)(iii)
eligibility criteria.
(Comment 2) The petitioner commented that FDA incorrectly concluded
that the use of the dental caries health claim in the labeling of
SPLENDA Granular would not be appropriate. The petitioner asserted that
the petition contains insufficient information to warrant this
conclusion. FDA had concluded that evidence contained in the petition
does not demonstrate that SPLENDA Granular would prevent plaque pH from
falling below 5.7 when measured, as specified in Sec.
101.80(c)(2)(iii)(C), by the indwelling electrode method (70 FR 24596
at 25500). The petition included data on the impact of SPLENDA Granular
on plaque pH as measured by the micro-touch method, a measurement
method different from the indwelling electrode method specified in
Sec. 101.80(c)(2)(iii)(C). The petitioner also asserted in this
comment that the tests conducted involved the equivalent of two
servings of SPLENDA Granular, rather than one, and that this was not
taken into consideration by the FDA.
(Response) FDA agrees that a more appropriate conclusion would have
been that the submitted evidence is insufficient to establish the
eligibility of the sucralose-maltodextrin formulation for the claim,
rather than concluding that the available evidence shows the use of the
dental caries health claim in
[[Page 15561]]
labeling of SPLENDA Granular would not be appropriate. However, this
discussion does not bear on the amendment to Sec. 101.80 in the final
rule because the amendment addresses sucralose, not specific SPLENDA
brand products.
(Comment 3) The petitioner objected to FDA specifically identifying
SPLENDA Packet as not eligible for use of the dental caries claim
because the product does not meet the definition for ``sugar free.''
The petitioner noted that SPLENDA Packet could in the future be
reformulated using nonfermentable bulking agents in order to be ``sugar
free,'' or to lower the level of dextrose in each packet in order to
meet the ``sugar free'' criterion. Furthermore, the petitioner asserted
that the plaque pH performance criterion is a more important test than
is the ``sugar free'' standard in the health claim requirements, adding
that if plaque pH is not lowered below 5.7 by the indwelling pH method,
then it should not matter how much sugar the product contains on a per
serving basis.
(Response) The preamble of the proposed rule explicitly stated that
this specific sucralose formulation, for which the petitioner submitted
plaque pH data, was not being included in our consideration and stated
the reason for our decision. FDA believes that we correctly decided to
exclude the sucralose formulation in question, but we agree that our
comment applies only to that formulation, which was tested in the
submitted studies, and not to the SPLENDA Packet brand name. In any
case, the petition did not request any amendment to the regulation with
respect to the ``sugar free'' requirement. Furthermore, FDA does not
rank the importance of the various eligibility criteria in assessing
whether the food in question can make the claim, as each of the
requirements listed in Sec. 101.80(c), including the ``sugar free''
standard, must be met for the claim to be made.
(Comment 4) The petitioner commented that the evidence submitted in
the petition demonstrates that sucralose is not fermented at all, and
therefore FDA's conclusion that sucralose is ``minimally fermented''
and ``not fermented by oral bacteria to an extent sufficient to lower
dental plaque pH * * *'' is inconsistent with the available evidence.
(Response) FDA considers it a difficult task to demonstrate
conclusively that sucralose would not be fermented to any extent by any
species of oral bacteria. FDA's decision to add sucralose to the dental
caries health claim does not turn on a distinction between ``minimally
fermented'' or ``not fermented.'' The amount of sucralose, an intense
sweetener, used per serving is in milligram amounts. Even if sucralose
were fermented by oral bacteria, considering the amount of sucralose
involved, the complete and rapid fermentation of the amount of
sucralose contained in one serving would likely not contribute
significantly to a change in plaque pH. Thus, whether sucralose is
``minimally fermented'' or ``not fermented'' does not affect our
decision to authorize this amendment to the dental caries health claim.
Given the information discussed in the preamble to the proposed
rule and the absence of contrary information in the comments, FDA is
adopting as a final rule, without change, the proposed amendment of
Sec. 101.80 to include sucralose as a substance eligible for the
dental caries health claim.
III. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule. No new information or
comments have been received that would affect the agency's previous
determination that there is no significant impact on the human
environment and that an environmental impact statement is not required.
IV. Analysis of Impacts
A. Regulatory Impact Analysis
FDA has examined the economic implications of this final rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including the following: Having an annual effect on the
economy of $100 million, adversely affecting a sector of the economy in
a material way, adversely affecting competition, or adversely affecting
jobs. A regulation is also considered a significant regulatory action
if it raises novel legal or policy issues. We have determined that this
final rule is not a significant regulatory action as defined by
Executive Order 12866.
FDA identified the following three options regarding this petition:
(1) Deny the petition; (2) add sucralose to the dental caries health
claim using the standards previously applied for making that claim; or
(3) add sucralose to the dental caries health claim using different
standards from those standards previously applied for making that
claim, so that the claim could be applied to products such as SPLENDA
Granular and SPLENDA Packet. This final rule will affect the following
three sets of stakeholders: Consumers, producers using sucralose, and
producers not using sucralose. We will evaluate each of the three
options with respect to their effect on each of these three sets of
stakeholders.
Option one: FDA's denial of the petition would mean no change in
the dental caries health claim. This option generates no new costs and
benefits and is the point of comparison for all other options.
Producers using sucralose would not change labels to provide more
information on sucralose and dental caries. Producers not using
sucralose would not be affected by changes in the information given to
consumers about sucralose and dental caries or changes in the relative
prices of sweeteners or products using sweeteners. Consumers would
continue to experience dental caries unaffected by information on
sucralose and dental caries.
If we deny the petition, then the state of treatment of dental
caries would not be affected. Dental caries is the most common chronic
childhood disease and 94 percent of adults have either untreated decay
or fillings in the crowns of their teeth, with an average of 22
affected surfaces, according to the National Oral Health Survey, part
of the National Health and Nutrition Examination Survey (Ref. 2). The
cost of dental caries includes the costs of dental treatment as well as
the value of lost productivity and pain and suffering associated with
dental caries. The following are several risk factors for developing
dental caries: Genetic factors, eating behaviors, types and
characteristics of foods eaten, and dental hygiene (Ref. 3).
Specifically, consumption of dietary sugars and starches have been
linked to development of dental caries.
Option two (final rule): The option chosen by the agency permits
producers who use sucralose to place the dental caries health claim in
their labeling under certain conditions. If these producers decide to
do so they will have to pay to redesign and replace their labels. If
they make this choice, then their choice reveals that they value the
ability to place the health claim on their products more highly than
they value the cost they must bear to make the
[[Page 15562]]
labeling change. Producers who use sucralose are better off under
option two than under option one because under option two they have
additional ways to market their products to consumers.
This option (under certain conditions) permits producers who use
sucralose to give consumers more information about sucralose and dental
carries. Some consumers may find this information valuable to them
while choosing products. As stated previously, FDA has determined that
this information has sufficient scientific support, and when provided
in labeling under certain conditions is truthful and not misleading to
consumers. Consumption of products containing sucralose, such as gum
and soft drinks, can reduce the risk of dental caries. This would lead
to benefits in reduced expenditures and other health costs related to
dental caries. It is possible that the health claim could draw some
consumers to choose foods that are more expensive. If they make this
choice, they reveal that they value the more expensive products more
highly than they value the additional expenditure. It is also possible
that the prices of products containing sucralose may rise and cause
some consumers to seek other, less expensive products with less
protection against dental caries. If they make this choice, they reveal
that they value the less expensive products more highly than the
increased probability of bearing the consequences of dental caries.
Regardless of their choices, consumers are better off under option two
than under option one because they can have more information related to
their health and can make the choices that seem best to them.
If the agency under certain conditions permits producers who use
sucralose to place the dental caries health claim in their labeling,
products that do not contain sucralose may be affected. Some producers
may be hurt if consumers choose to stop consuming their products and
instead consume products containing sucralose. Some producers may be
helped if changes in the prices of products using sucralose make their
products look less expensive to consumers. Producers not using
sucralose will be affected differently depending on the type of product
that they produce, and it is impossible to tell beforehand how the
approval of this health claim will affect different producers.
Some producers not now using sucralose may decide to reformulate
their products to contain sucralose. Substitution of sucralose for
sugars in some foods, such as gum and soft drinks can reduce the risk
of dental caries. This reformulation would lead to benefits to
consumers in reduced costs associated with dental caries. If some
producers choose to reformulate their products, they reveal that they
value the ability to place the health claim on their products more
highly than they value the cost of reformulating their products.
Whatever the effects of this option on producers not using sucralose,
they will be the result of the product choices made by consumers who
respond to the new information and make the choices that seem best to
them.
Option three: This option would relax some of the restrictions
imposed by the agency in option two so that the claim could be applied
to products such as SPLENDA Granular and SPLENDA Packet. Option three
would use different standards for approving this claim than previously
applied to other products.
Option three would give producers using sucralose more
opportunities to make the health claim than under option two. If, when
given this option, producers decide to make the claims, they would have
to pay to redesign and replace their labels, and they could decide to
change more labels than under option two. However, if they voluntarily
make this choice, they reveal that they value the ability to place the
health claim on their product more highly than they value the cost of
the label change regardless of how many labels they would change.
Therefore, producers who use sucralose are better off under option
three than under option two because they have additional opportunities
for marketing their products to consumers using the health claim.
Option three makes producers using sucralose better off while
making consumers worse off. As stated previously, the intended use of
SPLENDA Granular is in the preparation of foods likely to lower plaque
pH below 5.7 when measured by the indwelling electrode method. It also
is designed to be used in the cooking and baking of many foods
containing starch. Because foods containing starch are associated with
increased plaque acidity and thus increased risk of dental caries,
consumers would not benefit from seeing the health claim on products
such as SPLENDA Granular. Also, as stated previously, SPLENDA Packet
contains dextrose, and therefore is not ``sugar free'' and may promote
tooth decay. Therefore, consumers would be made worse off under option
three than under option two. Having the health claim on these
additional types of products may mislead consumers and undo some of the
benefit (reduced dental caries) of allowing the claim on products
containing sucralose that meet the conditions set forth by the agency.
For producers not using sucralose, the effect of option three is
generally the same as for option two, though allowing the claim to
appear on more products would likely make for larger effects.
We can conclude that the final rule option chosen by the agency
(option two) is better for society than option one because the impact
on consumers and on producers using sucralose is positive and the
impact on producers not using sucralose is indeterminate and depends
only on choices made by better informed consumers. We can also conclude
that the final rule option chosen by the agency (option two) is better
for society than option three because under option three any advantage
to producers using sucralose comes at the disadvantage of consumers.
The petition also raises the issue of the effect the increased use
of sucralose could have on weight loss in the U.S. population. We have
not addressed that issue here because the products involved and the
amounts consumed are so small that a health claim relating sucralose to
reduced dental caries would not have an impact big enough to cause a
noticeable change in weight.
B. Regulatory Flexibility Analysis
We have examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant impact on a substantial number of small
entities, the Regulatory Flexibility Act requires the agency to analyze
regulatory options that would minimize the economic impact of the rule
on small entities.
As previously explained, this final rule will not generate any
compliance costs for any small entities, because it does not require
small entities to undertake any new activity. No small business will
choose to use the dental caries health claim authorized by this rule
unless it believes that doing so will increase private benefits by more
than it increases private costs. Accordingly, we certify that this
final rule will not have a significant impact on a substantial number
of small entities. Under the Regulatory Flexibility Act, no further
analysis is required.
C. Unfunded Mandates
Title II of the Unfunded Mandates Reform Act of 1995 (Public Law
104-4) requires that agencies prepare a written statement of
anticipated costs and benefits before issuing any final rule that may
result in the expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of
[[Page 15563]]
$115,000,000 or more (adjusted annually for inflation) in any 1 year.
The Unfunded Mandates Reform Act does not require FDA to prepare a
statement of costs and benefits for this rule, because the rule is not
expected to result in any 1 year expenditure that would exceed
$115,000,000.
V. Paperwork Reduction Act
FDA concludes that the labeling provisions of this final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food
labeling health claim on the association between sucralose and the
nonpromotion of dental caries is a ``public disclosure of information
originally supplied by the Federal Government to the recipient for the
purpose of disclosure to the public.'' (5 CFR 1320.3(c)(2)).
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
will have a preemptive effect on State law. Section 4 (a) of the
Executive Order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a) of the act (21 U.S.C.
343-1(a)) provides that:
(a)* * * no State or political subdivision of a State may
directly or indirectly establish under any authority or continue in
effect as to any food in interstate commerce -- * * *
(5) any requirement respecting any claim of the type described
in section 403(r)(1) made in the label or labeling of food that is
not identical to the requirement of section 403(r). * * *
Currently, this provision operates to preempt States from imposing
health claim labeling requirements concerning sucralose and reduced
risk of dental caries because no such requirement had been imposed by
FDA under section 403(r) of the act. This final rule amends existing
food labeling regulations to add sucralose as an eligible noncariogenic
carbohydrate sweetener to the dietary noncariogenic carbohydrate
sweeteners and dental caries health claim. Although this rule would
have a preemptive effect, in that it would preclude States from issuing
any health claim labeling requirements for sucralose and reduced risk
of dental caries that are not identical to those required by this final
rule, this preemptive effect is consistent with what Congress set forth
in section 403A of the act. Section 403A(a)(5) of the act displaces
both State legislative requirements and State common law duties.
Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in
part and concurring in judgment); id. at 510 (O'Connor, J., joined by
Rehnquist, C. J., Scalia, J., and Thomas, J., concurring in part and
dissenting in part); Cipollone v. Liggett Group, Inc., 505 U.S. 504,
521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., joined by
Thomas, J., concurring in judgment in part and dissenting in part).
FDA believes that the preemptive effect of the final rule would be
consistent with Executive Order 13132. Section 4(e) of the Executive
Order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' FDA
provided the States with an opportunity for appropriate participation
in this rulemaking when it sought input from all stakeholders through
publication of the proposed rule in the Federal Register on May 13,
2005 (70 FR 25496). FDA received no comments from any states on the
proposed rulemaking.
In addition, on December 23, 2005, FDA's Division of Federal and
State Relations provided notice by fax and email transmission to State
health commissioners, State agriculture commissioners, food program
directors, and drug program directors as well as FDA field personnel of
FDA's intended amendment to add sucralose as a sweetener to the
noncariogenic carbohydrate sweeteners and dental caries health claim
(21 CFR 101.80). The notice provided the States with further
opportunity for input on the rule. It advised the States of the
publication of the proposed rule and encouraged State and local
governments to review the notice and to provide any comments to the
docket (docket number 2004P-0294), opened in the May 13, 2005, Federal
Register notice, by a date 30 days from the date of the notice (i.e.,
by January 23, 2006), or to contact certain named individuals. FDA
received no comments in response to this notice. The notice has been
filed in the above numbered docket.
In conclusion, the agency believes that it has complied with all of
the applicable requirements under the Executive Order and has
determined that the preemptive effects of this rule are consistent with
Executive Order 13132.
VII. References
The following references have been placed on display in the
Division of Dockets Management, (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and
may be seen by interested persons between 9 a.m. and 4 p.m., Monday
through Friday.
1. McNeil Nutritionals, ``Petition to Amend the Regulation for
21 CFR Sec. 101.80 to Authorize a Noncariogenicity Dental Health
Claim for Sucralose,'' CP-1, Docket No. 2004P-0294, April 2, 2004.
2. U.S. Department of Health and Human Services, National
Institute of Dental and Craniofacial Research, ``Results of National
Oral Health Survey Released'' (press release), Rockville MD, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hhs.gov/news/press/1996pres/960311.html
, March 11, 1996.
3. U.S. Department of Health and Human Services, National
Institute of Dental and Craniofacial Research, ``Oral Health in
America: A Report of the Surgeon General,'' executive summary
(monograph on the Internet), Rockville MD, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nidcr.nih.gov/AboutNIDCR/SurgeonGeneral/ExecutiveSummary.htm
, May 2000.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. Section 101.80 is amended by adding (c)(2)(ii)(C) and (e)(1)(v) to
read as follows:
Sec. 101.80 Health claims: dietary noncariogenic carbohydrate
sweeteners and dental caries.
* * * * *
(c) * * *
(2) * * *
(ii) * * *
(C) Sucralose.
* * * * *
(e) * * *
(1) * * *
(v) Frequent eating of foods high in sugars and starches as
between-meal snacks can promote tooth decay. Sucralose, the sweetening
ingredient
[[Page 15564]]
used to sweeten this food, unlike sugars, does not promote tooth decay.
* * * * *
Dated: March 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3007 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S