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: 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Rules and Regulations 55029 

PART 65—[AMENDED] 

■ 1. The authority citation for part 65 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp., p. 376. 

§ 65.4 [Amended] 

■ 2. The tables published under the 

authority of § 65.4 are amended as 

shown below: 

State and County Location 

Dates and name of newspaper where notice was 

published 

Chief executive officer of community Effective date of 

modification 

Community 

No. 

Connecticut: 

Litchfield ....... Town of 

Harwinton.

September 6, 2005, September 13, 2005, The 

Register Citizen.

Ms. Marie Knudsen, Town of 

Harwinton First Selectman, 

Harwinton Town Hall, 100 Bentley 

Drive, Harwinton, Connecticut 

06791.

Dec. 13, 2005 ............ 090147 B 

Litchfield ....... Town of Litchfield September 6, 2005, September 13, 2005, The 

Register Citizen.

Mr. Leo Paul, Town of Litchfield First 

Selectman, Town Offices, 74 West 

Street, P.O. Box 488, Litchfield, 

Connecticut 06759.

Dec. 13, 2005 ............ 090047 B 

Litchfield ....... City of Torrington September 6, 2005, September 13, 2005, The 

Register Citizen.

The Honorable Owen J. Quinn, 

Mayor of the City of Torrington, 

Municipal Building, 140 Main 

Street, Torrington, Connecticut 

06790.

Dec. 13, 2005 ............ 095081 B 

Pennsylvania: 

Chester ......... Township of 

Atglen.

August 11, 2005, August 

18, 2005, Daily Local 

News.

The Honorable Wesley Vincent, 

Mayor of the Borough of Atglen, 

P.O. Box 250, Atglen, Pennsylvania 19310.

Nov. 17, 2005 ............ 420273 D 

Lancaster ...... Township of 

Sadsbury.

August 11, 2005, August 

18, 2005, Parkesburg 

Post Ledger.

Mr. N. Eugene Lammey, Chairman 

of the Township of Sadsbury 

Board of Supervisors, 7182 White 

Oak Road, Christiana, Pennsylvania 17509.

Nov. 17, 2005 ............ 421782 E 

Chester ......... Township of West 

Sadsbury.

August 11, 2005, August 

18, 2005, Parkesburg 

Post Ledger.

Mr. James Landis, Chairman of the 

Township of West Sadsbury 

Board of Supervisors, 6400 N. 

Moscow Road, Parkesburg, Pennsylvania 19365.

Nov. 17, 2005 ............ 422281 D 

(Catalog of Federal Domestic Assistance No. 

83.100, ‘‘Flood Insurance’’) 

Dated: September 14, 2005. 

David I. Maurstad, 

Acting Director, Mitigation Division, 

Emergency Preparedness and Response 

Directorate. 

[FR Doc. 05–18729 Filed 9–19–05; 8:45 am] 

BILLING CODE 9110–12–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

Changes in Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency (FEMA), 

Emergency Preparedness and Response 

Directorate, Department of Homeland 

Security. 

ACTION: Final rule. 

SUMMARY: Modified Base (1% annual 

chance) Flood Elevations (BFEs) are 

finalized for the communities listed 

below. These modified elevations will 

be used to calculate flood insurance 

premium rates for new buildings and 

their contents. 

DATES: The effective dates for these 

modified BFEs are indicated on the 

following table and revise the Flood 

Insurance Rate Map(s) (FIRMs) in effect 

for each listed community prior to this 

date. 

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: FEMA 

makes the final determinations listed 

below of modified BFEs for each 

community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Mitigation Division 

Director of the Emergency Preparedness 

and Response Directorate has resolved 

any appeals resulting from this 

notification. 

The modified BFEs are not listed for 

each community in this notice. 

However, this rule includes the address 

of the Chief Executive Officer of the 

community where the modified base 

flood elevation determinations are 

available for inspection. 

The modifications are made pursuant 

to Section 206 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).