This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

55023 

Vol. 70, No. 181 

Tuesday, September 20, 2005 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 72 

RIN 3150–AH77 

List of Approved Spent Fuel Storage 

Casks: Standardized NUHOMS 32PT, 

–24PHB, and –24PTH Revision 8 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Direct final rule. 

SUMMARY: The Nuclear Regulatory 

Commission (NRC) is amending its 

regulations revising the Transnuclear, 

Inc., Standardized NUHOMS System 

listing within the ‘‘List of approved 

spent fuel storage casks’’ to include 

Amendment No. 8 to Certificate of 

Compliance Number (CoC No.) 1004. 

Amendment No. 8 to the Standardized 

NUHOMS System CoC will add a new 

spent fuel storage and transfer system, 

designated the NUHOMS–24PTH 

System, and modify the NUHOMS– 

32PT and –24PHB dry shielded canister 

designs. 

DATES: The final rule is effective 

December 5, 2005, unless significant 

adverse comments are received by 

October 20, 2005. A significant adverse 

comment is a comment where the 

commenter explains why the rule would 

be inappropriate, including challenges 

to the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. If the 

rule is withdrawn, timely notice will be 

published in the Federal Register. 

ADDRESSES: You may submit comments 

by any one of the following methods. 

Please include the following number 

(RIN 3150–AH77) in the subject line of 

your comments. Comments on 

rulemakings submitted in writing or in 

electronic form will be made available 

for public inspection. Because your 

comments will not be edited to remove 

any identifying or contact information, 

the NRC cautions you against including 

personal information such as social 

security numbers and birth dates in 

your submission. 

Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

E-mail comments to: SECY@nrc.gov. If 

you do not receive a reply e-mail 

confirming that we have received your 

comments, contact us directly at (301) 

415–1966. You may also submit 

comments via the NRC’s rulemaking 

Web site at http://ruleforum.llnl.gov. 

Address questions about our rulemaking 

Web site to Carol Gallagher (301) 415– 

5905; e-mail cag@nrc.gov. Comments 

can also be submitted via the Federal 

eRulemaking Portal http:// 

www.regulations.gov. 

Hand deliver comments to: 11555 

Rockville Pike, Rockville, Maryland 

20852, between 7:30 a.m. and 4:15 p.m. 

Federal workdays (telephone (301) 415– 

1966). 

Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at (301) 

415–1101. 

Publicly available documents related 

to this rulemaking may be viewed 

electronically on the public computers 

located at the NRC’s Public Document 

Room (PDR), O–1F21, One White Flint 

North, 11555 Rockville Pike, Rockville, 

Maryland. Selected documents, 

including comments, can be viewed and 

downloaded electronically via the NRC 

rulemaking Web site at http:// 

ruleforum.llnl.gov. 

Publicly available documents created 

or received at the NRC after November 

1, 1999, are available electronically at 

the NRC’s Electronic Reading Room at 

http://www.nrc.gov/NRC/ADAMS/ 

index.html. From this site, the public 

can gain entry into the NRC’s 

Agencywide Document Access and 

Management System (ADAMS), which 

provides text and image files of NRC’s 

public documents. If you do not have 

access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS, contact the NRC 

PDR Reference staff at 1–800–397–4209, 

301–415–4737, or by e-mail to 

pdr@nrc.gov. An electronic copy of the 

proposed CoC, Technical Specifications 

(TS), and preliminary safety evaluation 

report (SER) can be found under 

ADAMS Accession No. ML051610554. 

CoC No. 1004, the revised TS, the 

underlying SER for Amendment No. 8, 

and the Environmental Assessment 

(EA), are available for inspection at the 

NRC PDR, 11555 Rockville Pike, 

Rockville, MD. Single copies of these 

documents may be obtained from Jayne 

M. McCausland, Office of Nuclear 

Material Safety and Safeguards, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, telephone 

(301) 415–6219, e-mail jmm2@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jayne M. McCausland, telephone (301) 

415–6219, e-mail jmm2@nrc.gov, of the 

Office of Nuclear Material Safety and 

Safeguards, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 218(a) of the Nuclear Waste 

Policy Act of 1982, as amended 

(NWPA), requires that ‘‘[t]he Secretary 

[of the Department of Energy (DOE)] 

shall establish a demonstration program, 

in cooperation with the private sector, 

for the dry storage of spent nuclear fuel 

at civilian nuclear power reactor sites, 

with the objective of establishing one or 

more technologies that the [Nuclear 

Regulatory] Commission may, by rule, 

approve for use at the sites of civilian 

nuclear power reactors without, to the 

maximum extent practicable, the need 

for additional site-specific approvals by 

the Commission.’’ Section 133 of the 

NWPA states, in part, that ‘‘[t]he 

Commission shall, by rule, establish 

procedures for the licensing of any 

technology approved by the 

Commission under Section 218(a) for 

use at the site of any civilian nuclear 

power reactor.’’ 

To implement this mandate, the NRC 

approved dry storage of spent nuclear 

fuel in NRC-approved casks under a 

general license by publishing a final 

rule in 10 CFR part 72 entitled, ‘‘General 

License for Storage of Spent Fuel at 

Power Reactor Sites’’ (55 FR 29181; July 

18, 1990). This rule also established a 

new subpart L within 10 CFR part 72, 

entitled ‘‘Approval of Spent Fuel 

Storage Casks’’ containing procedures 

and criteria for obtaining NRC approval 

of spent fuel storage cask designs. The 

NRC subsequently issued a final rule on 

December 22, 1994 (59 FR 65898), that 

approved the Standardized NUHOMS

System (NUHOMS–24P and –52B) 

cask designs and added them to the list 

of NRC-approved cask designs in 

55024 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Rules and Regulations 

§ 72.214 as CoC No. 1004. Amendments 

3, 5, and 6, respectively, added the 

–61BT, –32PT, and –24PHB designs to 

the Standardized NUHOMS System. 

Discussion 

On September 19, 2003, and as 

supplemented on January 22, April 21, 

May 28, July 6, August 16, September 

17, September 23, October 8, October 

11, October 26, November 29, 2004, and 

January 14, March 15, June 10, and July 

20, 2005, the certificate holder, 

Transnuclear, Inc. (TN), submitted an 

application to the NRC to amend CoC 

No. 1004 to add a new spent fuel storage 

and transfer system, designated the 

NUHOMS–24PTH System, and to 

modify the NUHOMS–32PT and 

–24PHB dry shielded canister (DSC) 

designs. The NUHOMS–24PTH System 

consists of new or modified 

components: (1) The –24PTH DSC; (2) a 

new –24PTH DSC basket design; (3) a 

modified horizontal storage module 

(HSM), designated the HSM–H; and (4) 

a modified transfer cask (TC), 

designated the OS 197FC TC. The 

NUHOMS–24PTH System is designed 

to store fuel with maximum average 

burnup of up to 62 gigawatts-day/metric 

ton of uranium (GWd/MTU); maximum 

average initial enrichment of 5.0 weight 

percent; minimum cooling time of 3.0 

years; and maximum heat load of 40.8 

kilowatts (kW) per DSC. TS 1.2.18 and 

Table 1–1l are augmented to restrict the 

–24PTH DSC basket heat loading 

patterns to those analyzed in the Safety 

Analysis Report (SAR), and TS 1.2.17c 

is revised to delete the use of air for 

blowdown of the –24PTH DSC before 

drying operations. The changes to the 

–32PT and –24PHB systems include: (1) 

Revising the –32PT DSC Fuel 

Specification and Fuel Qualification 

Tables to include low enrichment and 

reconstituted fuel; (2) revising the 

–32PT DSC Fuel Specification Tables to 

show minimum boron loading 

concentration; (3) expanding the 

authorized contents for the –24PHB 

DSC; (4) revising the TC/DSC handling 

and lifting height specifications in TS 

1.2.10 and 1.2.13; and (5) clarifying DSC 

surface contamination actions in TS 

1.2.12. No other changes to the 

Standardized NUHOMS System cask 

design were requested in this 

application. The NRC staff performed a 

detailed safety evaluation of the 

proposed CoC amendment request and 

found that an acceptable safety margin 

is maintained. In addition, the NRC staff 

has determined that there continues to 

be reasonable assurance that public 

health and safety and the environment 

will be adequately protected. 

This direct final rule revises the 

Standardized NUHOMS System cask 

design listing in § 72.214 by adding 

Amendment No. 8 to CoC No. 1004. The 

amendment consists of changes to the 

TS as described above. The particular 

TS which are changed are identified in 

the NRC staff’s SER for Amendment No. 

8. 

The amended Standardized 

NUHOMS System, when used in 

accordance with the conditions 

specified in the CoC, the TS, and NRC 

regulations, will meet the requirements 

of part 72; thus, adequate protection of 

public health and safety will continue to 

be ensured. 

Discussion of Amendments by Section 

Section 72.214 List of Approved Spent 

Fuel Storage Casks 

Certificate No. 1004 is revised by 

adding the effective date of Amendment 

Number 8. 

Procedural Background 

On May 25, 2005, a direct final rule 

(70 FR 29931) and companion proposed 

rule (70 FR 30015) were published in 

the Federal Register, to revise the cask 

system listing for the TN Standardized 

NUHOMS System, by adding 

Amendment No. 8 to the list of 

approved spent fuel storage casks in 10 

CFR 72.214. After the rules were 

published, staff became aware of needed 

changes in the TS associated with the 

CoC, and on July 15, 2005, the NRC 

withdrew the direct final rule (70 FR 

40879) and the proposed rule (70 FR 

40924). This direct final rule includes 

the original Amendment No. 8 changes, 

the revised TS 1.2.17c and 1.2.18, Table 

1–1l, and additional changes, as 

discussed above. These additional 

changes were originally to be addressed 

as a subsequent amendment. However, 

the withdrawal of the May 25, 2005, 

package allowed the staff to combine 

this information into Amendment No. 8. 

This results in a more effective and 

efficient use of resources. 

This rule is limited to the changes 

contained in Amendment No. 8 to CoC 

No. 1004 and does not include other 

aspects of the Standardized NUHOMS

System design. The NRC is using the 

‘‘direct final rule procedure’’ to issue 

this amendment because it represents a 

limited and routine change to an 

existing CoC that is expected to be 

noncontroversial. Adequate protection 

of public health and safety continues to 

be ensured. The amendment to the rule 

will become effective on December 5, 

2005. However, if the NRC receives 

significant adverse comments by 

October 20, 2005, then the NRC will 

publish a document that withdraws this 

action and will address the comments 

received in response to the proposed 

amendments published elsewhere in 

this issue of the Federal Register. A 

significant adverse comment is a 

comment where the commenter 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. A 

comment is adverse and significant if: 

(1) The comment opposes the rule and 

provides a reason sufficient to require a 

substantive response in a notice-andcomment process. For example, in a 

substantive response: 

(a) The comment causes the NRC staff 

to reevaluate (or reconsider) its position 

or conduct additional analysis; 

(b) The comment raises an issue 

serious enough to warrant a substantive 

response to clarify or complete the 

record; or 

(c) The comment raises a relevant 

issue that was not previously addressed 

or considered by the NRC staff. 

(2) The comment proposes a change 

or an addition to the rule, and it is 

apparent that the rule would be 

ineffective or unacceptable without 

incorporation of the change or addition. 

(3) The comment causes the NRC staff 

to make a change (other than editorial) 

to the CoC or TS. 

These comments will be addressed in 

a subsequent final rule. The NRC will 

not initiate a second comment period on 

this action. 

Voluntary Consensus Standards 

The National Technology Transfer Act 

of 1995 (Pub. L. 104–113) requires that 

Federal agencies use technical standards 

that are developed or adopted by 

voluntary consensus standards bodies 

unless the use of such a standard is 

inconsistent with applicable law or 

otherwise impractical. In this direct 

final rule, the NRC revises the 

Standardized NUHOMS System cask 

design listed in § 72.214 (List of NRCapproved spent fuel storage cask 

designs). This action does not constitute 

the establishment of a standard that 

establishes generally applicable 

requirements. 

Agreement State Compatibility 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997, and 

published in the Federal Register on 

September 3, 1997 (62 FR 46517), this 

rule is classified as Compatibility 

Category ‘‘NRC.’’ Compatibility is not 

required for Category ‘‘NRC’’

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Rules and Regulations 55025 

regulations. The NRC program elements 

in this category are those that relate 

directly to areas of regulation reserved 

to the NRC by the Atomic Energy Act of 

1954, as amended (AEA), or the 

provisions of Title 10 of the Code of 

Federal Regulations. Although an 

Agreement State may not adopt program 

elements reserved to NRC, it may wish 

to inform its licensees of certain 

requirements via a mechanism that is 

consistent with the particular State’s 

administrative procedure laws but does 

not confer regulatory authority on the 

State. 

Plain Language 

The Presidential Memorandum dated 

June 1, 1998, entitled ‘‘Plain Language 

in Government Writing,’’ directed that 

the Government’s writing be in plain 

language. The NRC requests comments 

on this direct final rule specifically with 

respect to the clarity and effectiveness 

of the language used. Comments should 

be sent to the address listed under the 

heading ADDRESSES above. 

Finding of No Significant 

Environmental Impact: Availability 

Under the National Environmental 

Policy Act of 1969, as amended, and the 

NRC regulations in subpart A of 10 CFR 

part 51, the NRC has determined that 

this rule is not a major Federal action 

significantly affecting the quality of the 

human environment and, therefore, an 

environmental impact statement is not 

required. The rule amends the CoC for 

the Standardized NUHOMS System 

within the list of approved spent fuel 

storage casks that power reactor 

licensees can use to store spent fuel at 

reactor sites under a general license. 

The amendment adds a new spent fuel 

storage and transfer system, designated 

the NUHOMS–24PTH System, and 

modifies the NUHOMS–32PT and 

–24PHB DSC designs. The NUHOMS–

24PTH System consists of new or 

modified components: (1) The –24PTH 

DSC; (2) a new –24PTH DSC basket 

design; (3) a modified horizontal storage 

module, designated the HSM–H; and (4) 

a modified transfer cask, designated the 

OS 197FC TC. The NUHOMS–24PTH 

System is designed to store fuel with 

maximum average burnup of up to 62 

GWd/MTU; maximum average initial 

enrichment of 5.0 weight percent; 

minimum cooling time of 3.0 years; and 

maximum heat load of 40.8 kW per 

DSC. TS 1.2.18 and Table 1–1l are 

augmented to restrict the –24PTH DSC 

basket heat loading patterns to those 

analyzed in the SAR, and TS 1.2.17c is 

revised to delete the use of air for 

blowdown of the –24PTH DSC before 

drying operations. The changes to the 

–32PT and –24PHB systems include: (1) 

Revising the –32PT DSC Fuel 

Specification and Fuel Qualification 

Tables to include low enrichment and 

reconstituted fuel; (2) revising the 

–32PT DSC Fuel Specification Tables to 

show minimum boron loading 

concentration; (3) expanding the 

authorized contents for the –24PHB 

DSC; (4) revising the TC/DSC handling 

and lifting height specifications in TS 

1.2.10 and 1.2.13; and (5) clarifying DSC 

surface contamination actions in TS 

1.2.12. The EA and finding of no 

significant impact on which this 

determination is based are available for 

inspection at the NRC Public Document 

Room, 11555 Rockville Pike, Rockville, 

MD. Single copies of the EA and finding 

of no significant impact are available 

from Jayne M. McCausland, Office of 

Nuclear Material Safety and Safeguards, 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555–0001, telephone 

(301) 415–6219, e-mail jmm2@nrc.gov. 

Paperwork Reduction Act Statement 

This direct final rule does not contain 

a new or amended information 

collection requirement subject to the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). Existing 

requirements were approved by the 

Office of Management and Budget, 

Approval Number 3150–0132. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

Regulatory Analysis 

On July 18, 1990 (55 FR 29181), the 

NRC issued an amendment to 10 CFR 

part 72 to provide for the storage of 

spent nuclear fuel under a general 

license in cask designs approved by the 

NRC. Any nuclear power reactor 

licensee can use NRC-approved cask 

designs to store spent nuclear fuel if it 

notifies the NRC in advance, spent fuel 

is stored under the conditions specified 

in the cask’s CoC, and the conditions of 

the general license are met. A list of 

NRC-approved cask designs is contained 

in § 72.214. On December 22, 1994 (59 

FR 65898), the NRC issued an 

amendment to part 72 that approved the 

Standardized NUHOMS System 

(NUHOMS–24P and –52B) by adding it 

to the list of NRC-approved cask designs 

in § 72.214. Amendments 3, 5, and 6, 

respectively, added the –61BT, –32PT, 

and –24PHB designs to the 

Standardized NUHOMS System. On 

September 19, 2003, and as 

supplemented on January 22, April 21, 

May 28, July 6, August 16, September 

17, September 23, October 8, October 

11, October 26, November 29, 2004, and 

January 14, March 15, June 10, and July 

20, 2005, the certificate holder, TN, 

submitted an application to the NRC to 

amend CoC No. 1004 to add a new spent 

fuel storage and transfer system, 

designated the NUHOMS–24PTH 

System, and to modify the NUHOMS

–32PT and –24PHB DSC designs. The 

NUHOMS–24PTH System consists of 

new or modified components: (1) The 

–24PTH DSC; (2) a new –24PTH DSC 

basket design; (3) a modified horizontal 

storage module, designated the HSM–H; 

and (4) a modified transfer cask, 

designated the OS 197FC TC. The 

NUHOMS–24PTH System is designed 

to store fuel with maximum average 

burnup of up to 62 GWd/MTU; 

maximum average initial enrichment of 

5.0 weight percent; minimum cooling 

time of 3.0 years; and maximum heat 

load of 40.8 kW per DSC. TS 1.2.18 and 

Table 1–1l are augmented to restrict the 

–24PTH DSC basket heat loading 

patterns to those analyzed in the SAR, 

and TS 1.2.17c is revised to delete the 

use of air for blowdown of the –24PTH 

DSC prior to drying operations. The 

changes to the –32PT and –24PHB 

systems include: (1) Revising the –32PT 

DSC Fuel Specification and Fuel 

Qualification Tables to include low 

enrichment and reconstituted fuel; (2) 

revising the –32PT DSC Fuel 

Specification Tables to show minimum 

boron loading concentration; (3) 

expanding the authorized contents for 

the –24PHB DSC; (4) revising the TC/ 

DSC handling and lifting height 

specifications in TS 1.2.10 and 1.2.13; 

and (5) clarifying DSC surface 

contamination actions in TS 1.2.12. 

The alternative to this action is to 

withhold approval of this amended cask 

system design and issue an exemption 

to each general license. This alternative 

would cost both the NRC and the 

utilities more time and money because 

each utility would have to pursue an 

exemption. 

Approval of the direct final rule will 

eliminate this problem and is consistent 

with previous NRC actions. Further, the 

direct final rule will have no adverse 

effect on public health and safety. This 

direct final rule has no significant 

identifiable impact or benefit on other 

Government agencies. Based on this 

discussion of the benefits and impacts 

of the alternatives, the NRC concludes 

that the requirements of the direct final 

rule are commensurate with the NRC’s 

responsibilities for public health and 

safety and the common defense and 

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