Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 1155 

III. Publicly Available Documents 

The NRC has posted on 

www.regulations.gov for public 

availability the draft regulatory basis to 

strengthen and integrate onsite 

emergency response capabilities. This 

regulatory basis documents the reasons 

why the NRC determined rulemaking 

was the appropriate course of action to 

remedy a regulatory shortcoming. 

In addition, the NRC has posted 

preliminary proposed rule language 

related to this rulemaking as Appendix 

C of the draft regulatory basis. This 

preliminary proposed rule language 

contains one portion of the NRC’s 

proposed changes. This language does 

not represent a final NRC staff position 

nor has it been reviewed by the 

Commission. Therefore, the preliminary 

proposed rule language may undergo 

significant revision during the 

rulemaking process. 

The NRC is requesting formal public 

comments on the draft regulatory basis 

and the preliminary proposed rule 

language. The NRC may post additional 

materials, including other preliminary 

proposed rule language, to the Federal 

rulemaking Web site at 

www.regulations.gov, under Docket ID 

NRC–2012–0031. The Federal 

rulemaking Web site allows you to 

receive alerts when changes or additions 

occur in a docket folder. To subscribe: 

(1) Navigate to the docket folder (NRC– 

2012–0031); (2) click the ‘‘Email Alert’’ 

link; and (3) enter your email address 

and select how frequently you would 

like to receive emails (daily, weekly, or 

monthly). 

IV. Plain Writing 

The Plain Writing Act of 2010 (Pub. 

L. 111–274) requires Federal agencies to 

write documents in a clear, concise, 

well-organized manner that also follows 

other best practices appropriate to the 

subject or field and the intended 

audience. Although regulations are 

exempt under the Act, the NRC is 

applying the same principles to its 

rulemaking documents. Therefore, the 

NRC has written this document, 

including the preliminary proposed rule 

language, to be consistent with the Plain 

Writing Act. 

Dated at Rockville, Maryland, this 26th day 

of December, 2012. 

For the Nuclear Regulatory Commission. 

Sher Bahadur, 

Deputy Director, Division of Policy and 

Rulemaking, Office of Nuclear Reactor 

Regulation. 

[FR Doc. 2012–31706 Filed 1–7–13; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 61 

[NRC–2011–0012] 

RIN 3150–AI92 

Low-Level Waste Disposal 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Regulatory basis and 

preliminary rule language; second 

request for comment; correction. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is correcting a 

document appearing in the Federal 

Register on December 7, 2012 entitled, 

‘‘Low-Level Waste Disposal’’ that 

announced the availability of a 

regulatory basis document and 

requested comment on preliminary rule 

language. This action is necessary to 

correct the title and number used to 

access the regulatory basis document in 

the NRC’s Agencywide Documents 

Access and Management System 

(ADAMS). 

ADDRESSES: Please refer to Docket ID 

NRC–2011–0012 when contacting the 

NRC about the availability of 

information for this document. You may 

access information and comment 

submittals related to this document, 

which the NRC possesses and are 

publicly available, by any of the 

following methods: 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2011–0012. 

• ADAMS: You may access publicly 

available documents online in the NRC 

Library at http://www.nrc.gov/readingrm/adams.html. To begin the search, 

select ‘‘ADAMS Public Documents’’ and 

then select ‘‘Begin Web-based ADAMS 

Search.’’ For problems with ADAMS, 

please contact the NRC’s Public 

Document Room (PDR) reference staff at 

1–800–397–4209, 301–415–4737, or by 

email to pdr.resource@nrc.gov. The 

ADAMS accession number for each 

document referenced in this document 

(if that document is available in 

ADAMS) is provided the first time that 

a document is referenced. 

• NRC’s PDR: You may examine and 

purchase copies of public documents at 

the NRC’s PDR, Room O1–F21, One 

White Flint North, 11555 Rockville 

Pike, Rockville, Maryland 20852. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Carrera, Office of Federal and 

State Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone 301–415– 

1078, email Andrew.Carrera@nrc.gov. 

SUPPLEMENTARY INFORMATION: The NRC 

is correcting the accession number and 

title of the regulatory basis document 

that was referenced in a document the 

NRC published on December 7, 2012 (77 

FR 72997). The regulatory basis 

document has been further corrected to 

remove a reference to an unavailable 

document. 

On page 72997 of Federal Register 

document 2012–29527, published 

December 07, 2012 (77 FR 72997), in the 

third column, under the caption titled 

SUPPLEMENTARY INFORMATION, in the last 

paragraph of Section A, Accessing 

Information, under Section I, Accessing 

Information and Submitting Comments, 

‘‘Regulatory Analysis for Proposed 

Revisions to Low-Level Waste Disposal 

Requirement (10 CFR part 61)’’ is 

corrected to read ‘‘Regulatory Basis;’’ 

and ‘‘ML12306A480’’ is corrected to 

read ‘‘ML12356A242.’’ 

Dated at Rockville, Maryland, this 28th day 

of December, 2012. 

For the Nuclear Regulatory Commission. 

Kevin O’Sullivan, 

Acting Director, Division of 

Intergovernmental Liaison and Rulemaking, 

Office of Federal and State Materials and 

Environmental Management Programs. 

[FR Doc. 2012–31704 Filed 1–7–13; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2012–18033; Directorate 

Identifier 2004–CE–16–AD] 

RIN 2120–AA64 

Airworthiness Directives; Cessna 

Aircraft Company Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to revise an 

existing airworthiness directive (AD) 

that applies to all Cessna Aircraft 

Company (Cessna) Models 190, 195 (L– 

126A,B,C), 195A, and 195B airplanes 

that are equipped with certain inboard 

aileron hinge brackets. The existing AD 

currently requires you to repetitively 

inspect the affected inboard aileron 

hinge brackets for cracks or corrosion 

and replace them if cracks or corrosion 

is found. Replacement with aluminum 

brackets would terminate the need for 


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1156 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

the repetitive inspections. Since we 

issued AD 2004–21–08, the FAA, in 

recent months, has received reports of 

confusion between the casting number 

on the aileron hinge bracket and the part 

number (P/N) called out in the AD. This 

proposed AD would retain the actions of 

AD 2004–21–08 while requiring future 

compliance following a revised service 

bulletin that clarifies the casting 

numbers and part numbers to be 

inspected. We are proposing this AD to 

correct the unsafe condition on these 

products. 

DATES: We must receive comments on 

this proposed AD by February 22, 2013. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, 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: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this AD, contact Cessna Aircraft 

Company, Customer service, P.O. Box 

7706, Wichita, KS 67277; telephone: 

(316) 517–5800; fax: (316) 517–7271; 

email: 

customercare@cessna.textron.com; 

Internet: http:// 

www.cessnasupport.com. You may 

review copies of the referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, 

MO 64106. For information on the 

availability of this material at the FAA, 

call (816) 329–4148. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Management Facility 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 Office 

(phone: 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: Gary 

Park, Aerospace Engineer, Wichita ACO, 

FAA, 1801 Airport Road, Wichita, KS 

67209; phone: (316) 946–4123; fax: (316) 

946–4107; email: gary.park@faa.gov. 

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–2012–18033; Directorate Identifier 

2004–CE–16–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 because of 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 

On October 13, 2004, we issued AD 

2004–21–08, amendment 39–13828 (69 

FR 62396, October 26, 2004), for all 

Cessna Models 190, 195 (L–126A,B,C), 

195A, and 195B airplanes that are 

equipped with certain inboard aileron 

hinge brackets. That AD requires you to 

repetitively inspect the affected inboard 

aileron hinge brackets for cracks or 

corrosion and replace them if cracks or 

corrosion is found. Replacement with 

aluminum brackets would terminate the 

need for the repetitive inspections. 

AD 2004–21–08 (69 FR 62396, 

October 26, 2004) resulted from several 

reports of cracks and corrosion found on 

the magnesium aileron hinge brackets. 

Magnesium is known to be susceptible 

to corrosion. We issued AD 2004–21–08 

(69 FR 62396, October 26, 2004) to 

detect and correct corrosion damage to 

the inboard aileron hinge brackets. Such 

damage could result in the brackets 

cracking across the bearing boss and 

could lead to the aileron separating from 

the airplane with consequent reduced or 

loss of control. 

Actions Since Existing AD Was Issued 

Since we issued AD 2004–21–08 (69 

FR 62396, October 26, 2004), the FAA, 

in recent months, has received reports 

of confusion between the casting 

number on the aileron hinge bracket and 

the P/N called out in the AD. Due to this 

misunderstanding, proper inspections 

and/or replacement of the aileron hinge 

bracket may not be occurring following 

the AD. In one report, a service center 

provided an airworthiness compliance 

record stating ‘‘aileron hinge brackets 

are of a different part # than those 

specified in the note.’’ However, during 

a later inspection of the bracket, a crack 

was found through the bearing boss. 

Relevant Service Information 

We reviewed Cessna Aircraft 

Company Single Engine Service Bulletin 

SEB04–1, dated April 26, 2004, and 

Single Engine Service Bulletin SEB04– 

01, Revision 1, dated October 3, 2012. 

The service information describes 

procedures for: 

—Inspecting P/N 0322709 and P/N 

0322709–1 inboard aileron hinge 

brackets for cracks or corrosion; and 

—Replacing any bracket found cracked 

or corroded with a bracket that is 

FAA-approved and made from 

aluminum. 

Revision 1 of the service information 

adds casting numbers for the parts to be 

inspected and clarifies the inspection. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

Proposed AD Requirements 

This proposed AD would retain all 

requirements of AD 2004–21–08 (69 FR 

62396, October 26, 2004) while 

requiring future compliance following a 

revised service bulletin that clarifies the 

casting numbers and part numbers to be 

inspected. 

Change to Existing AD 

This proposed AD would retain all 

requirements of AD 2004–21–08 (69 FR 

62396, October 26, 2004). Since AD 

2004–21–08 was issued, the AD format 

has been revised, and certain paragraphs 

have been rearranged. As a result, the 

corresponding paragraph identifiers 

have changed in this proposed AD, as 

listed in the following table: 

REVISED PARAGRAPH IDENTIFIERS

Requirement in AD 

2004–21–08 

Corresponding 

requirement in this 

proposed AD 

paragraph (e)(1) paragraph (h) 

paragraph (e)(2) paragraph (i) 

paragraph (e)(3) paragraph (j) 

Costs of Compliance 

We estimate that this proposed AD 

affects 643 airplanes of U.S. registry. 

We estimate the following costs to 

comply with this proposed AD: 


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Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 1157 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product Cost on U.S. operators 

Inspection of the affected inboard aileron hinge brackets for cracks or 

corrosion.

1 work-hour × $85 per hour = $85 ........ Not Applicable ....... $85 1,180 airplanes × $85 = $54,655. 

The new requirements of this 

proposed AD add no additional 

economic burden. 

We estimate the following costs to do 

any necessary replacements that would 

be required based on the results of the 

proposed inspection. We have no way of 

determining the number of aircraft that 

might need these replacements: 

ON-CONDITION COSTS

Action Labor cost Parts cost Cost per 

product 

Replacement of left-hand (LH) brackets ...................... 3 work-hours × $85 per hour = $255 ........................... $1,999 $2,254 

Replacement of right-hand (RH) brackets .................... 3 work-hours × $85 per hour = $255 ........................... 1,592 1,847 

Replacement of LH and RH brackets .......................... 6 work-hours × $85 per hour = $510 ........................... 4,101 4,611 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

Section 106, describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701, 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We have determined that this 

proposed AD would not have federalism 

implications under Executive Order 

13132. This proposed AD would not 

have a substantial direct effect on the 

States, on the relationship between the 

national Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify that the proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under 

the DOT Regulatory Policies and 

Procedures (44 FR 11034, February 26, 

1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by 

removing airworthiness directive (AD) 

2004–21–08, Amendment 39–13828 (69 

FR 62396, October 26, 2004), and 

adding the following new AD: 

Cessna Aircraft Company: Docket No. FAA– 

2012–18033; Directorate Identifier 2004– 

CE–16–AD. 

(a) Comments Due Date 

The FAA must receive comments on this 

AD action by February 22, 2013. 

(b) Affected ADs 

This AD revises AD 2004–21–08, 

Amendment 39–13828. 

(c) Applicability 

This AD affects Models 190, 195 (L– 

126A,B,C), 195A, and 195B airplanes, all 

serial numbers, that are: 

(1) Certificated in any category; and 

(2) Equipped with at least one part number 

(P/N) 0322709 or P/N 0322709–1 inboard 

aileron hinge bracket. 

(d) Subject 

Joint Aircraft System Component (JASC)/ 

Air Transport Association (ATA) of America 

Code 2710, Aileron Control System. 

(e) Unsafe Condition 

This AD was prompted by reports of 

confusion between the casting number on the 

aileron hinge bracket and the part number 

called out in the AD. We are issuing this AD 

to correct the unsafe condition on these 

products. 

(f) Compliance 

Comply with this AD at the times specified 

following the procedures in Cessna Aircraft 

Company Single Engine Service Bulletin 

SEB04–01, Revision 1, dated October 3, 2012, 

unless already done. 

(g) Credit for Actions Accomplished in 

Accordance With Previous Service 

Information 

This paragraph provides credit for the 

actions required by paragraphs (h), (i), and (j) 

of this AD, if the actions were performed 

before the effective date of this AD using 

Cessna Aircraft Company Single Engine 

Service Bulletin SEB04–1, dated April 26, 

2004. All actions performed after the 

effective date of this AD will be required 

following Cessna Aircraft Company Single 

Engine Service Bulletin SEB04–01, Revision 

1, dated October 3, 2012. 


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1158 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

(h) Inspect Each P/N 0322709 and P/N 

0322709–1 Inboard Aileron Hinge Bracket or 

Any Other Bracket Made From Magnesium 

for Cracks or Corrosion 

Within the next 100 hours time-in-service 

(TIS) after November 30, 2004 (the effective 

date retained from AD 2004–21–08, 

Amendment 39–13828 (69 FR 62396, October 

26, 2004)), and repetitively thereafter at 

intervals not to exceed 100 hours TIS until 

each bracket is replaced with aluminum, 

inspect each P/N 0322709 and P/N 0322709– 

1 inboard aileron hinge bracket or any other 

bracket made from magnesium for cracks or 

corrosion. 

(i) Replace Any Cracked or Corroded 

Inboard Aileron Hinge Bracket 

Before further flight after any inspection 

where any cracked or corroded bracket is 

found, replace any cracked or corroded 

inboard aileron hinge. 

(1) If replacement is with an FAAapproved bracket made from magnesium, do 

the 100-hour TIS interval repetitive 

inspections as required in paragraph (h) of 

this AD. 

(2) If replacement is with an FAAapproved bracket that is made from 

aluminum, then no further inspections are 

necessary. These can be Cessna parts or nonCessna parts. 

(j) Terminating Action for the Repetitive 

Inspections 

(1) As terminating action for the repetitive 

inspections, you may replace all inboard 

aileron hinge brackets with FAA-approved 

brackets that are made from aluminum (as 

specified in paragraph (i)(2) of this AD) 

regardless if any corrosion or crack is found. 

(2) You may do this replacement at any 

time, but you must replace any corroded or 

cracked bracket before further flight after the 

applicable inspection where any corrosion or 

crack is found. 

(k) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Wichita Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in the 

Related Information section of this AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(3) All AMOCs approved for AD 2004–21– 

08 (69 FR 62396, October 26, 2004) are 

approved for this AD. 

(l) Related Information 

(1) For more information about this AD, 

contact Gary Park, Aerospace Engineer, 

Wichita ACO, FAA, 1801 Airport Road, 

Wichita, KS 67209; phone: (316) 946–4123; 

fax: (316) 946–4107; email: 

gary.park@faa.gov. 

(2) For service information identified in 

this AD, contact Cessna Aircraft Company, 

Customer Service, P.O. Box 7706, Wichita, 

KS 67277; telephone: (316) 517–5800; fax: 

(316) 517–7271; email: 

customercare@cessna.textron.com; Internet: 

http://www.cessnasupport.com. You may 

review copies of the referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, MO 

64106. For information on the availability of 

this material at the FAA, call (816) 329–4148. 

Issued in Kansas City, Missouri, on 

December 31, 2012. 

Earl Lawrence, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. 2013–00069 Filed 1–7–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 868 and 870 

[Docket No. FDA–2012–N–1174] 

Anesthesiology Devices; 

Reclassification of Membrane Lung for 

Long-Term Pulmonary Support; 

Redesignation as Extracorporeal 

Circuit and Accessories for Long-Term 

Pulmonary/Cardiac Support 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: On its own initiative, based 

on new information, the Food and Drug 

Administration (FDA) is proposing to 

reclassify membrane lung devices for 

long-term pulmonary support, a 

preamendments class III device, into 

class II (special controls) for conditions 

where imminent death is threatened by 

cardiopulmonary failure in neonates 

and infants or where cardiopulmonary 

failure results in the inability to separate 

from cardiopulmonary bypass following 

cardiac surgery. A membrane lung for 

long-term pulmonary support refers to 

the oxygenator component of an 

extracorporeal circuit used during longterm procedures, commonly referred to 

as extracorporeal membrane 

oxygenation (ECMO). Because circuit 

components used with the oxygenator 

are to be subject to the same regulatory 

controls, all of the device components 

used in an ECMO procedure are being 

considered in the scope of this proposed 

order, and the title and identification of 

the regulation will be revised 

accordingly to include extracorporeal 

circuit and accessories for long-term 

pulmonary/cardiac support. 

DATES: Submit either electronic or 

written comments on this proposed 

order by April 8, 2013. See section XI 

of this document for the proposed 

effective date of a final order based on 

this proposed order. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

1174, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following way: 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2012–N–1174 for this 

order. All comments received may be 

posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Angela Krueger, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1666, Silver Spring, 

MD 20993, 301–796–6380, 

angela.krueger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The FD&C Act, as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (FDAMA) (Pub. L. 105–115), the 

Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250), the Medical Devices Technical 

Corrections Act of 2004 (Pub. L. 108– 


srobinson on DSK4SPTVN1PROD with