55026 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Rules and Regulations 

security. No other available alternative 

is believed to be as satisfactory, and 

thus, this action is recommended. 

Regulatory Flexibility Certification 

In accordance with the Regulatory 

Flexibility Act of 1980 (5 U.S.C. 605(b)), 

the NRC certifies that this rule will not, 

if issued, have a significant economic 

impact on a substantial number of small 

entities. This direct final rule affects 

only the licensing and operation of 

nuclear power plants, independent 

spent fuel storage facilities, and TN. The 

companies that own these plants do not 

fall within the scope of the definition of 

‘‘small entities’’ set forth in the 

Regulatory Flexibility Act or the Small 

Business Size Standards set out in 

regulations issued by the Small 

Business Administration at 13 CFR part 

121. 

Backfit Analysis 

The NRC has determined that the 

backfit rule (10 CFR 50.109 or 10 CFR 

72.62) does not apply to this direct final 

rule because this amendment does not 

involve any provisions that would 

impose backfits as defined. Therefore, a 

backfit analysis is not required. 

Congressional Review Act 

In accordance with the Congressional 

Review Act of 1996, the NRC has 

determined that this action is not a 

major rule and has verified this 

determination with the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget. 

List of Subjects in 10 CFR Part 72 

Administrative practice and 

procedure, Criminal penalties, 

Manpower training programs, Nuclear 

materials, Occupational safety and 

health, Penalties, Radiation protection, 

Reporting and recordkeeping 

requirements, Security measures, Spent 

fuel, Whistleblowing. 

■ For the reasons set out in the 

preamble and under the authority of the 

Atomic Energy Act of 1954, as amended; 

the Energy Reorganization Act of 1974, 

as amended; and 5 U.S.C. 552 and 553; 

the NRC is adopting the following 

amendments to 10 CFR part 72. 

PART 72—LICENSING 

REQUIREMENTS FOR THE 

INDEPENDENT STORAGE OF SPENT 

NUCLEAR FUEL, HIGH-LEVEL 

RADIOACTIVE WASTE, AND 

REACTOR-RELATED GREATER THAN 

CLASS C WASTE 

■ 1. The authority citation for part 72 

continues to read as follows: 

Authority: Secs. 51, 53, 57, 62, 63, 65, 69, 

81, 161, 182, 183, 184, 186, 187, 189, 68 Stat. 

929, 930, 932, 933, 934, 935, 948, 953, 954, 

955, as amended, sec. 234, 83 Stat. 444, as 

amended (42 U.S.C. 2071, 2073, 2077, 2092, 

2093, 2095, 2099, 2111, 2201, 2232, 2233, 

2234, 2236, 2237, 2238, 2282); sec. 274, Pub. 

L. 86–373, 73 Stat. 688, as amended (42 

U.S.C. 2021); sec. 201, as amended, 202, 206, 

88 Stat. 1242, as amended, 1244, 1246 (42 

U.S.C. 5841, 5842, 5846); Pub. L. 95–601, sec. 

10, 92 Stat. 2951 as amended by Pub. L. 102–

486, sec. 7902, 106 Stat. 3123 (42 U.S.C. 

5851); sec. 102, Pub. L. 91–190, 83 Stat. 853 

(42 U.S.C. 4332); secs. 131, 132, 133, 135, 

137, 141, Pub. L. 97–425, 96 Stat. 2229, 2230, 

2232, 2241, sec. 148, Pub. L. 100–203, 101 

Stat. 1330–235 (42 U.S.C. 10151, 10152, 

10153, 10155, 10157, 10161, 10168); sec. 

1704, 112 Stat. 2750 (44 U.S.C. 3504 note). 

Section 72.44(g) also issued under secs. 

142(b) and 148(c),(d), Pub. L. 100–203, 101 

Stat. 1330–232, 1330–236 (42 U.S.C. 

10162(b), 10168(c),(d)). Section 72.46 also 

issued under sec. 189, 68 Stat. 955 (42 U.S.C. 

2239); sec. 134, Pub. L. 97–425, 96 Stat. 2230 

(42 U.S.C. 10154). Section 72.96(d) also 

issued under sec. 145(g), Pub. L. 100–203, 

101 Stat. 1330–235 (42 U.S.C. 10165(g)). 

Subpart J also issued under secs. 2(2), 2(15), 

2(19), 117(a), 141(h), Pub. L. 97–425, 96 Stat. 

2202, 2203, 2204, 2222, 2224 (42 U.S.C. 

10101, 10137(a), 10161(h)). Subparts K and L 

are also issued under sec. 133, 98 Stat. 2230 

(42 U.S.C. 10153) and sec. 218(a), 96 Stat. 

2252 (42 U.S.C. 10198). 

■ 2. In § 72.214, Certificate of 

Compliance 1004 is revised to read as 

follows: 

§ 72.214 List of approved spent fuel 

storage casks. 

* * * * * 

Certificate Number: 1004. 

Initial Certificate Effective Date: 

January 23, 1995. 

Amendment Number 1 Effective Date: 

April 27, 2000. 

Amendment Number 2 Effective Date: 

September 5, 2000. 

Amendment Number 3 Effective Date: 

September 12, 2001. 

Amendment Number 4 Effective Date: 

February 12, 2002. 

Amendment Number 5 Effective Date: 

January 7, 2004. 

Amendment Number 6 Effective Date: 

December 22, 2003. 

Amendment Number 7 Effective Date: 

March 2, 2004. 

Amendment Number 8 Effective Date: 

December 5, 2005. 

SAR Title: Final Safety Analysis 

Report for the Standardized NUHOMS

Horizontal Modular Storage System for 

Irradiated Nuclear Fuel. 

Docket Number: 72–1004. 

Certificate Expiration Date: January 

23, 2015. 

Model Number: NUHOMS–24P, 

–52B, –61BT, –32PT, –24PHB, and 

–24PTH. 

* * * * * 

Dated at Rockville, Maryland, this 1st day 

of September 2005. 

For the Nuclear Regulatory Commission. 

Luis A. Reyes, 

Executive Director for Operations. 

[FR Doc. 05–18662 Filed 9–19–05; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 872 

[Docket No. 2005N–0338] 

Medical Devices; Dental Devices; 

Classification of Oral Rinse to Reduce 

the Adhesion of Dental Plaque 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

oral rinse to reduce the adhesion of 

dental plaque device into class II 

(special controls). The special control 

that will apply to the device is the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Oral Rinse to Reduce the Adhesion of 

Dental Plaque.’’ The agency is 

classifying the device into class II 

(special controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. Elsewhere in 

this issue of the Federal Register, FDA 

is publishing a notice of availability of 

a guidance document that is the special 

control for this device. 

DATES: This rule is effective October 20, 

2005. The reclassification was effective 

March 28, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Robert Betz, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–827–5283, ext. 125. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

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

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to previously marketed 

devices by means of premarket 

notification procedures in section 510(k) 

of the act (21 U.S.C. 360(k)) and 21 CFR 

part 807 of FDA’s regulations. 

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a document in the Federal 

Register announcing such classification 

(section 513(f)(2) of the act). 

In accordance with section 513(f)(1) of 

the act, FDA issued an order on January 

14, 2005, classifying the Decapinol Oral 

Rinse into class III, because it was not 

substantially equivalent to a device that 

was introduced or delivered for 

introduction into interstate commerce 

for commercial distribution before May 

28, 1976, or a device which was 

subsequently reclassified into class I or 

class II. On January 24, 2005, Sinclair 

Pharmaceuticals submitted a petition 

requesting classification of the 

Decapinol Oral Rinse under section 

513(f)(2) of the act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1). 

In accordance with 513(f)(2) of the 

act, FDA reviewed the petition in order 

to classify the device under the criteria 

for classification set forth in 513(a)(1) of 

the act. Devices are to be classified into 

class II if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that Decapinol Oral 

Rinse can be classified into class II with 

the establishment of special controls. 

FDA believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name oral rinse to reduce the adhesion 

of dental plaque and is identified as a 

device intended to reduce the presence 

of bacterial plaque on teeth and oral 

mucosal surfaces by physical means. 

The device type includes those devices 

that act by reducing the attachment and 

inhibiting the growth of bacterial 

plaque. 

FDA has identified the following risks 

to health associated specifically with 

this type of device: (1) Ineffective 

plaque reduction, (2) alteration of oral 

flora, (3) adverse tissue reaction, (4) 

toxicity, and (5) improper use. The class 

II special controls guidance document 

aids in mitigating potential risks by 

providing recommendations on material 

characterization; validation of 

performance characteristics; testing and 

control methods; biocompatibility 

testing; and labeling. Therefore, on 

March 28, 2005, FDA issued an order to 

the petitioner classifying the device into 

Class II. FDA is codifying this device by 

adding § 872.5580. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for oral rinse to reduce the 

adhesion of dental plaque will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance, or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirements under 510(k) of the act, if 

FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. For this type 

of device, however, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of this type of device and, therefore, the 

device is not exempt from premarket 

notification requirements. Thus, persons 

who intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the oral rinse to reduce the 

adhesion of dental plaque they intend to 

market. 

II. Environmental Impact 

The agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). 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). The 

agency believes that this final rule is not 

a significant regulatory action as defined 

by the Executive order and so it is not 

subject to review under the Executive 

Order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of this 

device into class II will relieve 

manufacturers of the device of the cost 

of complying with the premarket 

approval requirements of section 515 of 

the act (21 U.S.C. 360e), and may permit 

small potential competitors to enter the 

marketplace by lowering their costs, the 

agency certifies that the final rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $115 

million, using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Paperwork Reduction Act of 1995 

FDA concludes that this final rule 

contains no collections of information. 

Therefore, clearance by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520) is not 

required. 

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

FDA also concludes that the special 

controls guidance document contains 

information collection provisions that 

are subject to review and clearance by 

OMB under the PRA. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a notice announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Oral Rinse to 

Reduce the Adhesion of Dental Plaque’’; 

the notice contains an analysis of the 

paperwork burden for the guidance. 

V. Reference 

The following reference has 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. Petition from Sinclair 

Pharmaceuticals, dated January 24, 

2005. 

List of Subjects in 21 CFR Part 872 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 872 is 

amended as follows: 

PART 872—DENTAL DEVICES 

■ 1. The authority citation for 21 CFR 

part 872 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 872.5580 is added to 

subpart F to read as follows: 

§ 872.5580 Oral rinse to reduce the 

adhesion of dental plaque. 

(a) Identification. The device is 

assigned the generic name oral rinse to 

reduce the adhesion of dental plaque 

and is identified as a device intended to 

reduce the presence of bacterial plaque 

on teeth and oral mucosal surfaces by 

physical means. The device type 

includes those devices that act by 

reducing the attachment and inhibiting 

the growth of bacterial plaque. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Oral Rinse to Reduce the Adhesion of 

Dental Plaque.’’ See § 872.1(e) for the 

availability of this guidance document. 

Dated: September 9, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–18656 Filed 9–19–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket No. FEMA–D–7579] 

Changes in Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency (FEMA), 

Emergency Preparedness and Response 

Directorate, Department of Homeland 

Security. 

ACTION: Interim rule. 

SUMMARY: This interim rule lists 

communities where modification of the 

Base (1% annual chance) Flood 

Elevations (BFEs) is appropriate because 

of new scientific or technical data. New 

flood insurance premium rates will be 

calculated from the modified BFEs for 

new buildings and their contents. 

DATES: These modified BFEs are 

currently in effect on the dates listed in 

the table and revise the Flood Insurance 

Rate Map(s) (FIRMs) in effect prior to 

this determination for each listed 

community. 

From the date of the second 

publication of these changes in a 

newspaper of local circulation, any 

person has ninety (90) days in which to 

request through the community that the 

Director reconsider the changes. The 

modified elevations may be changed 

during the 90-day period. 

ADDRESSES: The modified BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: 

Doug Bellomo, P.E., Hazard 

Identification Section, Emergency 

Preparedness and Response Directorate, 

FEMA, 500 C Street SW., Washington, 

DC 20472, (202) 646–2903. 

SUPPLEMENTARY INFORMATION: The 

modified BFEs are not listed for each 

community in this interim rule. 

However, the address of the Chief 

Executive Officer of the community 

where the modified BFE determinations 

are available for inspection is provided. 

Any request for reconsideration must 

be based upon knowledge of changed 

conditions, or upon new scientific or 

technical data. 

The modifications are made pursuant 

to section 201 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4105, 

and are in accordance with the National 

Flood Insurance Act of 1968, 42 U.S.C. 

4001 et seq., and with 44 CFR part 65. 

For rating purposes, the currently 

effective community number is shown 

and must be used for all new policies 

and renewals. 

The modified BFEs are the basis for 

the floodplain management measures 

that the community is required to either 

adopt or to show evidence of being 

already in effect in order to qualify or 

to remain qualified for participation in 

the National Flood Insurance Program 

(NFIP). 

These modified elevations, together 

with the floodplain management criteria 

required by 44 CFR 60.3, are the 

minimum that are required. They 

should not be construed to mean that 

the community must change any 

existing ordinances that are more 

stringent in their floodplain 

management requirements. The 

community may at any time enact 

stricter requirements of its own, or 

pursuant to policies established by other 

Federal, State or regional entities. 

The changes in BFEs are in 

accordance with 44 CFR 65.4. 

National Environmental Policy Act. 

This rule is categorically excluded from 

the requirements of 44 CFR part 10, 

Environmental Consideration. No 

environmental impact assessment has 

been prepared. 

Regulatory Flexibility Act. The 

Mitigation Division Director of the 

Emergency Preparedness and Response 

Directorate certifies that this rule is 

exempt from the requirements of the 

Regulatory Flexibility Act because 

modified BFEs are required by the Flood 

Disaster Protection Act of 1973, 42 

U.S.C. 4105, and are required to 

maintain community eligibility in the 

NFIP. No regulatory flexibility analysis 

has been prepared. 

Regulatory Classification. This 

interim rule is not a significant 

regulatory action under the criteria of 

section 3(f) of Executive Order 12866 of 

September 30, 1993, Regulatory 

Planning and Review, 58 FR 51735. 

Executive Order 12612, Federalism. 

This rule involves no policies that have 

federalism implications under Executive 

Order 12612, Federalism, dated October 

26, 1987. 

Executive Order 12778, Civil Justice 

Reform. This rule meets the applicable 

standards of section 2(b)(2) of Executive 

Order 12778. 

List of Subjects in 44 CFR Part 65 

Flood insurance, Floodplains, 

Reporting and recordkeeping 

requirements. 

■ Accordingly, 44 CFR part 65 is 

amended to read as follows: