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55026 Federal Register / Vol. 70, No.

181 / Tuesday, September 20, 2005 / Rules and Regulations

security. No other available alternative Authority: Secs. 51, 53, 57, 62, 63, 65, 69, Dated at Rockville, Maryland, this 1st day
is believed to be as satisfactory, and 81, 161, 182, 183, 184, 186, 187, 189, 68 Stat. of September 2005.
thus, this action is recommended. 929, 930, 932, 933, 934, 935, 948, 953, 954, For the Nuclear Regulatory Commission.
955, as amended, sec. 234, 83 Stat. 444, as
Luis A. Reyes,
Regulatory Flexibility Certification amended (42 U.S.C. 2071, 2073, 2077, 2092,
2093, 2095, 2099, 2111, 2201, 2232, 2233, Executive Director for Operations.
In accordance with the Regulatory 2234, 2236, 2237, 2238, 2282); sec. 274, Pub. [FR Doc. 05–18662 Filed 9–19–05; 8:45 am]
Flexibility Act of 1980 (5 U.S.C. 605(b)), L. 86–373, 73 Stat. 688, as amended (42 BILLING CODE 7590–01–P
the NRC certifies that this rule will not, U.S.C. 2021); sec. 201, as amended, 202, 206,
if issued, have a significant economic 88 Stat. 1242, as amended, 1244, 1246 (42
impact on a substantial number of small U.S.C. 5841, 5842, 5846); Pub. L. 95–601, sec.
10, 92 Stat. 2951 as amended by Pub. L. 102– DEPARTMENT OF HEALTH AND
entities. This direct final rule affects 486, sec. 7902, 106 Stat. 3123 (42 U.S.C. HUMAN SERVICES
only the licensing and operation of 5851); sec. 102, Pub. L. 91–190, 83 Stat. 853
nuclear power plants, independent (42 U.S.C. 4332); secs. 131, 132, 133, 135, Food and Drug Administration
spent fuel storage facilities, and TN. The 137, 141, Pub. L. 97–425, 96 Stat. 2229, 2230,
companies that own these plants do not 2232, 2241, sec. 148, Pub. L. 100–203, 101 21 CFR Part 872
fall within the scope of the definition of Stat. 1330–235 (42 U.S.C. 10151, 10152,
10153, 10155, 10157, 10161, 10168); sec. [Docket No. 2005N–0338]
‘‘small entities’’ set forth in the
Regulatory Flexibility Act or the Small 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
Section 72.44(g) also issued under secs. Medical Devices; Dental Devices;
Business Size Standards set out in 142(b) and 148(c),(d), Pub. L. 100–203, 101 Classification of Oral Rinse to Reduce
regulations issued by the Small Stat. 1330–232, 1330–236 (42 U.S.C. the Adhesion of Dental Plaque
Business Administration at 13 CFR part 10162(b), 10168(c),(d)). Section 72.46 also
121. issued under sec. 189, 68 Stat. 955 (42 U.S.C. AGENCY: Food and Drug Administration,
2239); sec. 134, Pub. L. 97–425, 96 Stat. 2230 HHS.
Backfit Analysis (42 U.S.C. 10154). Section 72.96(d) also ACTION: Final rule.
The NRC has determined that the issued under sec. 145(g), Pub. L. 100–203,
101 Stat. 1330–235 (42 U.S.C. 10165(g)). SUMMARY: The Food and Drug
backfit rule (10 CFR 50.109 or 10 CFR
Subpart J also issued under secs. 2(2), 2(15), Administration (FDA) is classifying the
72.62) does not apply to this direct final 2(19), 117(a), 141(h), Pub. L. 97–425, 96 Stat.
rule because this amendment does not oral rinse to reduce the adhesion of
2202, 2203, 2204, 2222, 2224 (42 U.S.C.
involve any provisions that would 10101, 10137(a), 10161(h)). Subparts K and L
dental plaque device into class II
impose backfits as defined. Therefore, a are also issued under sec. 133, 98 Stat. 2230 (special controls). The special control
backfit analysis is not required. (42 U.S.C. 10153) and sec. 218(a), 96 Stat. that will apply to the device is the
2252 (42 U.S.C. 10198). guidance document entitled ‘‘Class II
Congressional Review Act Special Controls Guidance Document:
■ 2. In § 72.214, Certificate of Oral Rinse to Reduce the Adhesion of
In accordance with the Congressional Compliance 1004 is revised to read as
Review Act of 1996, the NRC has Dental Plaque.’’ The agency is
follows: classifying the device into class II
determined that this action is not a
major rule and has verified this § 72.214 List of approved spent fuel (special controls) in order to provide a
determination with the Office of storage casks. reasonable assurance of safety and
Information and Regulatory Affairs, * * * * * effectiveness of the device. Elsewhere in
Office of Management and Budget. Certificate Number: 1004. this issue of the Federal Register, FDA
Initial Certificate Effective Date: is publishing a notice of availability of
List of Subjects in 10 CFR Part 72 January 23, 1995. a guidance document that is the special
Administrative practice and Amendment Number 1 Effective Date: control for this device.
procedure, Criminal penalties, April 27, 2000. DATES: This rule is effective October 20,
Amendment Number 2 Effective Date: 2005. The reclassification was effective
Manpower training programs, Nuclear
September 5, 2000. March 28, 2005.
materials, Occupational safety and
Amendment Number 3 Effective Date: FOR FURTHER INFORMATION CONTACT:
health, Penalties, Radiation protection,
September 12, 2001. Robert Betz, Center for Devices and
Reporting and recordkeeping Amendment Number 4 Effective Date:
requirements, Security measures, Spent Radiological Health (HFZ–410), Food
February 12, 2002.
fuel, Whistleblowing. Amendment Number 5 Effective Date: and Drug Administration, 9200
January 7, 2004. Corporate Blvd., Rockville, MD 20850,
■ For the reasons set out in the
Amendment Number 6 Effective Date: 301–827–5283, ext. 125.
preamble and under the authority of the
Atomic Energy Act of 1954, as amended; December 22, 2003. SUPPLEMENTARY INFORMATION:
the Energy Reorganization Act of 1974, Amendment Number 7 Effective Date: I. Background
as amended; and 5 U.S.C. 552 and 553; March 2, 2004.
the NRC is adopting the following Amendment Number 8 Effective Date: In accordance with section 513(f)(1) of
amendments to 10 CFR part 72. December 5, 2005. the Federal Food, Drug, and Cosmetic
SAR Title: Final Safety Analysis Act (the act) (21 U.S.C. 360c(f)(1)),
PART 72—LICENSING Report for the Standardized NUHOMS devices that were not in commercial
REQUIREMENTS FOR THE Horizontal Modular Storage System for distribution before May 28, 1976, the
INDEPENDENT STORAGE OF SPENT Irradiated Nuclear Fuel. date of enactment of the Medical Device
NUCLEAR FUEL, HIGH-LEVEL Docket Number: 72–1004. Amendments of 1976 (the amendments),
RADIOACTIVE WASTE, AND Certificate Expiration Date: January generally referred to as postamendments
REACTOR-RELATED GREATER THAN 23, 2015. devices, are classified automatically by
CLASS C WASTE Model Number: NUHOMS–24P, statute into class III without any FDA
–52B, –61BT, –32PT, –24PHB, and rulemaking process. These devices
■ 1. The authority citation for part 72 –24PTH. remain in class III and require
continues to read as follows: * * * * * premarket approval, unless and until

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Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Rules and Regulations 55027

the device is classified or reclassified provide reasonable assurance of the neither an environmental assessment
into class I or II, or FDA issues an order safety and effectiveness of the device. nor an environmental impact statement
finding the device to be substantially The device is assigned the generic is required.
equivalent, in accordance with section name oral rinse to reduce the adhesion
of dental plaque and is identified as a III. Analysis of Impacts
513(i) of the act, to a predicate device
that does not require premarket device intended to reduce the presence FDA has examined the impacts of the
approval. The agency determines of bacterial plaque on teeth and oral final rule under Executive Order 12866
whether new devices are substantially mucosal surfaces by physical means. and the Regulatory Flexibility Act (5
equivalent to previously marketed The device type includes those devices U.S.C. 601–612), and the Unfunded
devices by means of premarket that act by reducing the attachment and Mandates Reform Act of 1995 (Pub. L.
notification procedures in section 510(k) inhibiting the growth of bacterial 104–4). Executive Order 12866 directs
of the act (21 U.S.C. 360(k)) and 21 CFR plaque. agencies to assess all costs and benefits
part 807 of FDA’s regulations. FDA has identified the following risks of available regulatory alternatives and,
Section 513(f)(2) of the act provides to health associated specifically with when regulation is necessary, to select
that any person who submits a this type of device: (1) Ineffective regulatory approaches that maximize
premarket notification under section plaque reduction, (2) alteration of oral net benefits (including potential
510(k) of the act for a device that has not flora, (3) adverse tissue reaction, (4) economic, environmental, public health
previously been classified may, within toxicity, and (5) improper use. The class and safety, and other advantages;
30 days after receiving an order II special controls guidance document distributive impacts; and equity). The
classifying the device in class III under aids in mitigating potential risks by agency believes that this final rule is not
section 513(f)(1) of the act, request FDA providing recommendations on material a significant regulatory action as defined
to classify the device under the criteria characterization; validation of by the Executive order and so it is not
set forth in section 513(a)(1) of the act. performance characteristics; testing and subject to review under the Executive
FDA shall, within 60 days of receiving control methods; biocompatibility Order.
testing; and labeling. Therefore, on
such a request, classify the device by The Regulatory Flexibility Act
March 28, 2005, FDA issued an order to
written order. This classification shall requires agencies to analyze regulatory
the petitioner classifying the device into
be the initial classification of the device. options that would minimize any
Class II. FDA is codifying this device by
Within 30 days after the issuance of an significant impact of a rule on small
adding § 872.5580.
order classifying the device, FDA must Following the effective date of this entities. Because classification of this
publish a document in the Federal final classification rule, any firm device into class II will relieve
Register announcing such classification submitting a 510(k) premarket manufacturers of the device of the cost
(section 513(f)(2) of the act). notification for oral rinse to reduce the of complying with the premarket
In accordance with section 513(f)(1) of adhesion of dental plaque will need to approval requirements of section 515 of
the act, FDA issued an order on January address the issues covered in the special the act (21 U.S.C. 360e), and may permit
14, 2005, classifying the Decapinol Oral controls guidance. However, the firm small potential competitors to enter the
Rinse into class III, because it was not need only show that its device meets the marketplace by lowering their costs, the
substantially equivalent to a device that recommendations of the guidance, or in agency certifies that the final rule will
was introduced or delivered for some other way provides equivalent not have a significant economic impact
introduction into interstate commerce assurance of safety and effectiveness. on a substantial number of small
for commercial distribution before May Section 510(m) of the act provides entities.
28, 1976, or a device which was that FDA may exempt a class II device Section 202(a) of the Unfunded
subsequently reclassified into class I or from the premarket notification Mandates Reform Act of 1995 requires
class II. On January 24, 2005, Sinclair requirements under 510(k) of the act, if that agencies prepare a written
Pharmaceuticals submitted a petition FDA determines that premarket statement, which includes an
requesting classification of the notification is not necessary to provide assessment of anticipated costs and
Decapinol Oral Rinse under section reasonable assurance of the safety and benefits, before proposing ‘‘any rule that
513(f)(2) of the act. The manufacturer effectiveness of the device. For this type includes any Federal mandate that may
recommended that the device be of device, however, FDA has result in the expenditure by State, local,
classified into class II (Ref. 1). determined that premarket notification and tribal governments, in the aggregate,
In accordance with 513(f)(2) of the is necessary to provide reasonable or by the private sector, of $100,000,000
act, FDA reviewed the petition in order assurance of the safety and effectiveness or more (adjusted annually for inflation)
to classify the device under the criteria of this type of device and, therefore, the in any one year.’’ The current threshold
for classification set forth in 513(a)(1) of device is not exempt from premarket after adjustment for inflation is $115
the act. Devices are to be classified into notification requirements. Thus, persons million, using the most current (2003)
class II if general controls, by who intend to market this type of device Implicit Price Deflator for the Gross
themselves, are insufficient to provide must submit to FDA a premarket Domestic Product. FDA does not expect
reasonable assurance of safety and notification, prior to marketing the this final rule to result in any 1-year
effectiveness, but there is sufficient device, which contains information expenditure that would meet or exceed
information to establish special controls about the oral rinse to reduce the this amount.
to provide reasonable assurance of the adhesion of dental plaque they intend to IV. Paperwork Reduction Act of 1995
safety and effectiveness of the device for market.
its intended use. After review of the FDA concludes that this final rule
information submitted in the petition, II. Environmental Impact contains no collections of information.
FDA determined that Decapinol Oral The agency has determined under 21 Therefore, clearance by the Office of
Rinse can be classified into class II with CFR 25.34(b) that this action is of a type Management and Budget (OMB) under
the establishment of special controls. that does not individually or the Paperwork Reduction Act of 1995
FDA believes these special controls, in cumulatively have a significant effect on (the PRA) (44 U.S.C. 3501–3520) is not
addition to general controls, will the human environment. Therefore, required.

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55028 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Rules and Regulations

FDA also concludes that the special DEPARTMENT OF HOMELAND Flood Insurance Act of 1968, 42 U.S.C.
controls guidance document contains SECURITY 4001 et seq., and with 44 CFR part 65.
information collection provisions that For rating purposes, the currently
are subject to review and clearance by Federal Emergency Management effective community number is shown
OMB under the PRA. Elsewhere in this Agency and must be used for all new policies
issue of the Federal Register, FDA is and renewals.
publishing a notice announcing the 44 CFR Part 65 The modified BFEs are the basis for
availability of the guidance document the floodplain management measures
[Docket No. FEMA–D–7579]
entitled ‘‘Class II Special Controls that the community is required to either
Guidance Document: Oral Rinse to Changes in Flood Elevation adopt or to show evidence of being
Reduce the Adhesion of Dental Plaque’’; Determinations already in effect in order to qualify or
the notice contains an analysis of the to remain qualified for participation in
paperwork burden for the guidance. AGENCY: Federal Emergency the National Flood Insurance Program
Management Agency (FEMA), (NFIP).
V. Reference Emergency Preparedness and Response These modified elevations, together
The following reference has been Directorate, Department of Homeland with the floodplain management criteria
placed on display in the Division of Security. required by 44 CFR 60.3, are the
Dockets Management (HFA–305), Food ACTION: Interim rule. minimum that are required. They
and Drug Administration, 5630 Fishers should not be construed to mean that
Lane, rm. 1061, Rockville, MD 20852, SUMMARY: This interim rule lists the community must change any
and may be seen by interested persons communities where modification of the existing ordinances that are more
between 9 a.m. and 4 p.m., Monday Base (1% annual chance) Flood stringent in their floodplain
through Friday. Elevations (BFEs) is appropriate because management requirements. The
1. Petition from Sinclair of new scientific or technical data. New community may at any time enact
Pharmaceuticals, dated January 24, flood insurance premium rates will be stricter requirements of its own, or
2005. calculated from the modified BFEs for pursuant to policies established by other
List of Subjects in 21 CFR Part 872 new buildings and their contents. Federal, State or regional entities.
DATES: These modified BFEs are The changes in BFEs are in
Medical devices. currently in effect on the dates listed in accordance with 44 CFR 65.4.
■ Therefore, under the Federal Food, the table and revise the Flood Insurance National Environmental Policy Act.
Drug, and Cosmetic Act and under Rate Map(s) (FIRMs) in effect prior to This rule is categorically excluded from
authority delegated to the Commissioner this determination for each listed the requirements of 44 CFR part 10,
of Food and Drugs, 21 CFR part 872 is community. Environmental Consideration. No
amended as follows: From the date of the second environmental impact assessment has
publication of these changes in a been prepared.
PART 872—DENTAL DEVICES Regulatory Flexibility Act. The
newspaper of local circulation, any
■ 1. The authority citation for 21 CFR person has ninety (90) days in which to Mitigation Division Director of the
part 872 continues to read as follows: request through the community that the Emergency Preparedness and Response
Director reconsider the changes. The Directorate certifies that this rule is
Authority: 21 U.S.C. 351, 360, 360c, 360e, exempt from the requirements of the
360j, 371. modified elevations may be changed
during the 90-day period. Regulatory Flexibility Act because
■ 2. Section 872.5580 is added to modified BFEs are required by the Flood
subpart F to read as follows: ADDRESSES: The modified BFEs for each
Disaster Protection Act of 1973, 42
community are available for inspection U.S.C. 4105, and are required to
§ 872.5580 Oral rinse to reduce the at the office of the Chief Executive
adhesion of dental plaque. maintain community eligibility in the
Officer of each community. The NFIP. No regulatory flexibility analysis
(a) Identification. The device is respective addresses are listed in the
assigned the generic name oral rinse to has been prepared.
table below. Regulatory Classification. This
reduce the adhesion of dental plaque FOR FURTHER INFORMATION CONTACT: interim rule is not a significant
and is identified as a device intended to Doug Bellomo, P.E., Hazard regulatory action under the criteria of
reduce the presence of bacterial plaque Identification Section, Emergency section 3(f) of Executive Order 12866 of
on teeth and oral mucosal surfaces by Preparedness and Response Directorate, September 30, 1993, Regulatory
physical means. The device type FEMA, 500 C Street SW., Washington, Planning and Review, 58 FR 51735.
includes those devices that act by DC 20472, (202) 646–2903. Executive Order 12612, Federalism.
reducing the attachment and inhibiting This rule involves no policies that have
SUPPLEMENTARY INFORMATION: The
the growth of bacterial plaque. federalism implications under Executive
(b) Classification. Class II (special modified BFEs are not listed for each
community in this interim rule. Order 12612, Federalism, dated October
controls). The special control is FDA’s
However, the address of the Chief 26, 1987.
guidance document entitled ‘‘Class II Executive Order 12778, Civil Justice
Special Controls Guidance Document: Executive Officer of the community
where the modified BFE determinations Reform. This rule meets the applicable
Oral Rinse to Reduce the Adhesion of standards of section 2(b)(2) of Executive
Dental Plaque.’’ See § 872.1(e) for the are available for inspection is provided.
Any request for reconsideration must Order 12778.
availability of this guidance document.
be based upon knowledge of changed List of Subjects in 44 CFR Part 65
Dated: September 9, 2005. conditions, or upon new scientific or
Linda S. Kahan, technical data. Flood insurance, Floodplains,
Deputy Director, Center for Devices and The modifications are made pursuant Reporting and recordkeeping
Radiological Health. to section 201 of the Flood Disaster requirements.
[FR Doc. 05–18656 Filed 9–19–05; 8:45 am] Protection Act of 1973, 42 U.S.C. 4105, ■ Accordingly, 44 CFR part 65 is
BILLING CODE 4160–01–S and are in accordance with the National amended to read as follows:

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