Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Proposed Rules 2277 

APHIS. In the absence of data 

establishing the need for annual booster 

vaccinations, labeling must bear the 

following statement: ‘‘The need for 

annual booster vaccination has not been 

established for this product; 

consultation with a veterinarian is 

recommended.’’ 

* * * * * 

(j) All but very small final container 

labels for feline panleukopenia vaccines 

shall contain the following 

recommendations for use: 

(1) Killed virus vaccines. Vaccinate 

healthy cats with one dose, except that 

if the animal is less than 12 weeks of 

age, a second dose should be given at 12 

to 16 weeks of age. 

(2) Modified live virus vaccines. 

Vaccinate healthy cats with one dose, 

except that if the animal is less than 12 

weeks of age, a second dose should be 

given at 12 to 16 weeks of age. 

* * * * * 

(m) All labels for autogenous biologics 

must specify the name of the 

microorganism(s) or antigen(s) that they 

contain, and shall bear the following 

statement: ‘‘Potency and efficacy of 

autogenous biologics have not been 

established. This product is prepared for 

use only by or under the direction of a 

veterinarian or approved specialist.’’ 

* * * * * 

(o) All labels for conditionally 

licensed products shall bear the 

following statement: ‘‘This product 

license is conditional; efficacy and 

potency have not been fully 

demonstrated.’’ 

* * * * * 

PART 114—PRODUCTION 

REQUIREMENTS FOR BIOLOGICAL 

PRODUCTS 

9. The authority citation for part 114 

continues to read as follows: 

Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 

2.80, and 371.4. 

10. Section 114.11 is revised to read 

as follows: 

§ 114.11 Storage and handling. 

Biological products at licensed 

establishments must be protected at all 

times against improper storage and 

handling. Completed product must be 

kept under refrigeration at 35 to 46 °F 

(2 to 8 °C), unless the inherent nature 

of the product makes storage at different 

temperatures advisable, in which case, 

the proper storage temperature must be 

specified in the filed Outline of 

Production. All biological products to 

be shipped or delivered must be 

securely packed. 

Done in Washington, DC this 7th day of 

January 2011. 

John Ferrell, 

Deputy Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. 2011–648 Filed 1–12–11; 8:45 am] 

BILLING CODE 3410–34–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 72 

RIN 3150—AI89 

[NRC–2011–0002] 

List of Approved Spent Fuel Storage 

Casks: NUHOMS® HD System Revision 

1 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC or the Commission) 

is proposing to amend its spent fuel 

storage cask regulations by revising the 

Transnuclear, Inc. (TN) NUHOMS® HD 

System listing within the ‘‘List of 

Approved Spent Fuel Storage Casks’’ to 

include Amendment No. 1 to Certificate 

of Compliance (CoC) Number 1030. 

Amendment No. 1 would revise the 

definitions for Damaged Fuel Assembly 

and Transfer Operations; add 

definitions for Fuel Class and 

Reconstituted Fuel Assembly; add 

Combustion Engineering 16x16 class 

fuel assemblies as authorized contents; 

reduce the minimum off-normal 

ambient temperature from ¥20 °F to 

¥21 °F; expand the authorized contents 

of the NUHOMS® HD System to include 

pressurized water reactor fuel 

assemblies with control components; 

reduce the minimum initial enrichment 

of fuel assemblies from 1.5 weight 

percent uranium-235 to 0.2 weight 

percent uranium-235; clarify the 

requirements of reconstituted fuel 

assemblies; add requirements to qualify 

metal matrix composite neutron 

absorbers with integral aluminum 

cladding; clarify the requirements for 

neutron absorber tests; delete use of 

nitrogen for draining the water from the 

dry shielded canister (DSC), and allow 

only helium as a cover gas during DSC 

cavity water removal operations; and 

make corresponding changes to the 

technical specifications (TS). 

DATES: Comments on the proposed rule 

must be received on or before February 

14, 2011. 

ADDRESSES: Please include Docket ID 

NRC–2011–0002 in the subject line of 

your comments. For instructions on 

submitting comments and accessing 

documents related to this action, see 

Section I, ‘‘Submitting Comments and 

Accessing Information’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. You may submit 

comments by any one of the following 

methods. 

Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for documents filed under Docket ID 

NRC–2011–0002. Address questions 

about NRC dockets to Carol Gallagher, 

telephone: 301–492–3668, e-mail: 

Carol.Gallager@nrc.gov. 

Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

E-mail comments to: 

Rulemaking.Comments@nrc.gov. If you 

do not receive a reply e-mail confirming 

that we have received your comments, 

contact us directly at 301–415–1677. 

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– 

1677). 

Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at 301– 

415–1101. 

FOR FURTHER INFORMATION CONTACT: 

Gregory Trussell, Office of Federal and 

State Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone: 301–415– 

6445, e-mail: Gregory.Trussell@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments and Accessing 

Information 

Comments submitted in writing or in 

electronic form will be posted on the 

NRC Web site and on the Federal 

Rulemaking Web site, http:// 

www.regulations.gov. Because your 

comments will not be edited to remove 

any identifying or contact information, 

the NRC cautions you against including 

any information in your submission that 

you do not want to be publicly 

disclosed. The NRC requests that any 

party soliciting or aggregating comments 

received from other persons for 

submission to the NRC inform those 

persons that the NRC will not edit their 

comments to remove any identifying or 

contact information, and therefore, they 

should not include any information in 

their comments that they do not want 

publicly disclosed. 

You can access publicly available 

documents related to this document 

using the following methods: 

NRC’s Public Document Room (PDR): 

The public may examine and have 


srobinson on DSKHWCL6B1PROD with PROPOSALS
2278 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Proposed Rules 

copied for a fee publicly available 

documents at the NRC’s PDR, Room O– 

1F21, One White Flint North, 11555 

Rockville Pike, Rockville, Maryland. 

NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): Publicly available documents 

created or received at the NRC are 

available electronically at the NRC’s 

Electronic Reading Room at http:// 

www.nrc.gov/reading-rm/adams.html. 

From this page, the public can gain 

entry into 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’s PDR 

reference staff at 1–800–397–4209, 301– 

415–4737, or by e-mail to 

PDR.Resource@nrc.gov. 

Federal Rulemaking Web site: Public 

comments and supporting materials 

related to this proposed rule can be 

found at http://www.regulations.gov by 

searching on Docket ID NRC–2011– 

0002. 

For additional information, see the 

Direct Final Rule published in the Rules 

and Regulations section of this Federal 

Register. 

Procedural Background 

On May 6 and 7, 2010, respectively, 

a direct final rule (75 FR 24786) and 

companion proposed rule (75 FR 25120) 

were published in the Federal Register 

to revise the cask system listing for the 

TN NUHOMS® HD System by adding 

Amendment No. 1 to the list of 

approved spent fuel storage casks in 

Title 10 of the Code of Federal 

Regulations (10 CFR) 72.214. After the 

rules were published, the applicant 

identified that a certain TS for Boral 

characterization (TS 4.3.1, ‘‘Neutron 

Absorber Tests’’) was not written 

precisely and in a manner that could be 

readily and demonstrably implemented. 

On July 16, 2010, the NRC withdrew the 

direct final rule (75 FR 41369) and the 

companion proposed rule (75 FR 

41404).The applicant submitted revised 

language for TS 4.3.1 (and Final Safety 

Analysis Report (FSAR) sections 

incorporated into the TS by reference) 

on July 26 and August 24, 2010, which 

NRC staff reviewed and found to be 

acceptable. This proposed rule includes 

the original Amendment No. 1 changes 

and the revised TS 4.3.1 and FSAR 

sections incorporated into the TS by 

reference. 

This rule is limited to the changes 

contained in Amendment No. 1 to CoC 

No. 1030 and does not include other 

aspects of the NUHOMS® HD System 

design. Because NRC considers this 

action noncontroversial and routine, the 

NRC is publishing this proposed rule 

concurrently as a direct final rule in the 

Rules and Regulations section of this 

Federal Register. Adequate protection 

of public health and safety continues to 

be ensured. The direct final rule will 

become effective on March 29, 2011. 

However, if the NRC receives significant 

adverse comments on the direct final 

rule by February 14, 2011, then the NRC 

will publish a document that withdraws 

the direct final rule. If the direct final 

rule is withdrawn, the NRC will address 

the comments received in response to 

the proposed revisions in a subsequent 

final rule. Absent significant 

modifications to the proposed revisions 

requiring republication, the NRC will 

not initiate a second comment period on 

this action in the event the direct final 

rule is withdrawn. 

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, a 

substantive response is required when: 

(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 rule, CoC, or TS. 

For additional procedural information 

and the regulatory analysis, see the 

direct final rule published in the Rules 

and Regulations section of this Federal 

Register. 

List of Subjects in 10 CFR Part 72 

Administrative practice and 

procedure, Hazardous waste, Nuclear 

materials, Occupational safety and 

health, 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; the Nuclear Waste Policy 

Act of 1982, as amended, and 5 U.S.C. 

553; the NRC is proposing to adopt 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); 

sec. 651(e), Pub. L. 109–58, 119 Stat. 806–10 

(42 U.S.C. 2014, 2021, 2021b, 2111). 

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, 2244 (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 1030 is revised to read as 

follows: 

§ 72.214 List of approved spent fuel 

storage casks. 

* * * * * 

Certificate Number: 1030. 

Initial Certificate Effective Date: 

January 10, 2007. 

Amendment Number 1 Effective Date: 

March 29, 2011. 

SAR Submitted by: Transnuclear, Inc. 

SAR Title: Final Safety Analysis 

Report for the NUHOMS® HD 

Horizontal Modular Storage System for 

Irradiated Nuclear Fuel. 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Proposed Rules 2279 

Docket Number: 72–1030. 

Certificate Expiration Date: January 

10, 2027. 

Model Number: NUHOMS® HD– 

32PTH. 

* * * * * 

Dated at Rockville, Maryland this 13th day 

of December 2010. 

For the Nuclear Regulatory Commission. 

R.W. Borchardt, 

Executive Director for Operations. 

[FR Doc. 2011–644 Filed 1–12–11; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–1310; Directorate 

Identifier 2010–NM–067–AD] 

RIN 2120–AA64 

Airworthiness Directives; Empresa 

Brasileira de Aeronautica S.A. 

(EMBRAER) Model ERJ 170 and ERJ 

190 Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for the 

products listed above. This proposed 

AD results from mandatory continuing 

airworthiness information (MCAI) 

originated by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as: 

It has been reported during operational 

checks that some failures of the Escape Slide 

* * * installed on the forward passenger and 

service door have occurred which prevented 

the door from opening. 

* * * [T]his condition * * * could delay 

an emergency evacuation and increase the 

chance of injury to passengers and flight 

crew * * *. 

The proposed AD would require 

actions that are intended to address the 

unsafe condition described in the MCAI. 

DATES: We must receive comments on 

this proposed AD by February 28, 2011. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: (202) 493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–40, 1200 New Jersey 

Avenue, SE., Washington, DC, between 

9 a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

For service information identified in 

this proposed AD, contact Empresa 

Brasileira de Aeronautica S.A. 

(EMBRAER), Technical Publications 

Section (PC 060), Av. Brigadeiro Faria 

Lima, 2170–Putim–12227–901 Sa ̃o Jose 

dos Campos–SP—BRASIL; telephone 

+55 12 3927–5852 or +55 12 3309–0732; 

fax +55 12 3927–7546; e-mail 

distrib@embraer.com.br; Internet: http:// 

www.flyembraer.com. 

You may review copies of the 

referenced service information at the 

FAA, Transport Airplane Directorate, 

1601 Lind Avenue, SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, 

call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations office between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Operations 

office (telephone (800) 647–5527) is in 

the ADDRESSES section. Comments will 

be available in the AD docket shortly 

after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Kaulia, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone 

(425) 227–2848; fax (425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2010–1310; Directorate Identifier 

2010–NM–067–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD based on those comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

The Ageˆncia Nacional de Aviac ̧a ̃o 

Civil (ANAC), which is the aviation 

authority for Brazil, has issued Brazilian 

Airworthiness Directive 2009–11–01, 

dated November 30, 2009, applicable to 

Model ERJ 170 airplanes; and 

Airworthiness Directive 2009–08–02, 

dated August 18, 2009, applicable to 

Model ERJ 190 airplanes; (referred to 

after this as ‘‘the MCAI’’), to correct an 

unsafe condition for the specified 

products. 

MCAI 2009–11–01 states: 

It has been reported during operational 

checks that some failures of the Escape Slide 

P/N [part number] 4A4030–2 and P/N 

4A4030–4 installed on the forward passenger 

and service door have occurred which 

prevented the door from opening. 

Since this condition * * * could delay an 

emergency evacuation and increase the 

chance of injury to passengers and flight 

crew, a corrective action is required. 

MCAI 2009–08–02 states: 

It has been reported during operational 

checks some failures in the deployment of 

the Escape Slide P/N 104003–1 installed in 

the forward passenger and service door, 

preventing the door opening. 

Since this condition * * * could impede an 

emergency evacuation and increase the 

chance of injury to passengers and flight 

crew, a corrective action is required. 

The required actions include 

modifying the escape slides of the 

forward passenger and service doors, 

and doing boroscope inspections for 

damage of the aspirator body and inlet 

cross valve. Corrective actions include 

replacing the aspirator body. You may 

obtain further information by examining 

the MCAI in the AD docket. 

Relevant Service Information 

Goodrich Interiors has issued Service 

Bulletin 4A4030–25A379, dated August 

10, 2009, for Model ERJ 170 airplanes; 

and Service Bulletin 104003–25A380, 

Revision 2, dated July 7, 2009, for 

Model ERJ 190 airplanes. The actions 

described in this service information are 

intended to correct the unsafe condition 

identified in the MCAI. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 


srobinson on DSKHWCL6B1PROD with PROPOSALS