Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48053 

Paperwork Reduction Act Burden Statement 

(p) A federal agency may not conduct or 

sponsor, and a person is not required to 

respond to, nor shall a person be subject to 

a penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork Reduction 

Act unless that collection of information 

displays a current valid OMB Control 

Number. The OMB Control Number for this 

information collection is 2120–0056. Public 

reporting for this collection of information is 

estimated to be approximately 5 minutes per 

response, including the time for reviewing 

instructions, completing and reviewing the 

collection of information. All responses to 

this collection of information are mandatory. 

Comments concerning the accuracy of this 

burden and suggestions for reducing the 

burden should be directed to the FAA at: 800 

Independence Ave., SW., Washington, DC 

20591, Attn: Information Collection 

Clearance Officer, AES–200. 

Alternative Methods of Compliance 

(AMOCs) 

(q)(1) The Manager, Atlanta 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. 

Related Information 

(r) For more information about this AD, 

contact Carl Gray, Aerospace Engineer, 

Airframe Branch, ACE–117A, FAA, Atlanta 

Aircraft Certification Office (ACO), 1701 

Columbia Avenue, College Park, Georgia 

30337; phone: 404–474–5554; fax: 404–474– 

5606; e-mail: Carl.W.Gray@faa.gov. 

(s) For service information identified in 

this AD, contact Lockheed Martin 

Corporation/Lockheed Martin Aeronautics 

Company, Airworthiness Office, Dept. 6A0M, 

Zone 0252, Column P–58, 86 S. Cobb Drive, 

Marietta, Georgia 30063; phone: 770–494– 

5444; fax: 770–494–5445; e-mail: 

ams.portal@lmco.com; Internet http:// 

www.lockheedmartin.com/ams/tools/ 

TechPubs.htm. 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. 

Issued in Renton, Washington, on July 29, 

2011. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2011–19968 Filed 8–5–11; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1130 

[CPSC Docket No. CPSC–2011–0053] 

Consumer Registration of Durable 

Infant or Toddler Products 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: In accordance with section 

104(d) of the Consumer Product Safety 

Improvement Act of 2008 (‘‘CPSIA’’) the 

Consumer Product Safety Commission 

(‘‘Commission,’’ ‘‘CPSC,’’ or ‘‘we’’) 

issued a final consumer product safety 

rule requiring manufacturers of durable 

infant or toddler products to establish a 

consumer registration program. The 

Commission is proposing an 

amendment to clarify and correct some 

of the requirements of the rule. 

DATES: Written comments must be 

received by October 24, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2011– 

0053, 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. 

To ensure timely processing of 

comments, the Commission is no longer 

accepting comments submitted by 

electronic mail (e-mail), except through 

http://www.regulations.gov. 

Written Submissions 

Submit written submissions in the 

following way: 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions), 

preferably in five copies, to: Office of 

the Secretary, Consumer Product Safety 

Commission, Room 820, 4330 East West 

Highway, Bethesda, MD 20814; 

telephone (301) 504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change, including any personal 

identifiers, contact information, or other 

personal information provided to http:// 

www.regulations.gov. Do not submit 

confidential business information, trade 

secret information, or other sensitive or 

protected information electronically. 

Such information should be submitted 

in writing. 

Docket: For access to the docket to 

read background documents or 

comments received go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Celestine T. Kiss, Project Manager, 

Division of Human Factors, Directorate 

for Engineering Sciences, Consumer 

Product Safety Commission, 4330 East 

West Highway, Bethesda, MD 20814; 

telephone (301) 504–7739; 

ckiss@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

On December 29, 2009, we published 

a final rule requiring manufacturers of 

durable infant or toddler products to: (1) 

Provide with each product a postagepaid consumer registration form; (2) 

keep records of consumers who register 

such products with the manufacturer; 

and (3) permanently place the 

manufacturer’s name and contact 

information, model name and number, 

and the date of manufacture on each 

such product. 74 FR 68668. The rule 

specified formatting and text 

requirements for the registration forms. 

Subsequently, we published a 

correction notice on February 22, 2010. 

75 FR 7550. Since December 29, 2010, 

registration forms have been required 

for all durable infant or toddler products 

covered by the rule. 

Some manufacturers and testing 

laboratories have brought to our 

attention the need to clarify or correct 

certain aspects of the rule. We are 

proposing this amendment for that 

purpose. 

We note that, although manufacturers 

of durable infant or toddler products 

must comply with the registration 

requirements, they are not required to 

have a third party testing laboratory 

‘‘test’’ their product’s compliance with 

the registration requirements. 

B. Proposed Clarifications and 

Corrections 

1. Simplifying the Provisions for the 

Format and Text of Registration Forms 

(Proposed § 1130.6) 

The rule specifies requirements for 

the format of registration forms in 

§ 1130.6 and requirements for the text of 

registration forms in § 1130.7. Given the 

geometry of the registration forms, 

which have four surfaces (front, back, 

top, and bottom), we believe that it is 

confusing to explain the requirements in 

this way. Therefore, the proposed 

amendment would eliminate this 

framework, essentially collapsing the 

requirements from §§ 1130.6 and 1130.7 

into one section and clarifying them. 

Proposed § 1130.6 would describe the 

registration form more clearly, moving 

logically from the front top of the form 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48054 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

to the front bottom of the form, to the 

back top of the form, and ending with 

the back bottom of the form. We believe 

that structuring the requirements this 

way will also align the text more closely 

with the illustration of the registration 

form in Figures 1 and 2. We are not 

eliminating any of the requirements for 

the registration forms but proposing to 

organize the requirements more clearly. 

Restructuring the rule would require 

several corresponding changes. For 

example, the proposed rule would, in 

essence, combine the existing §§ 1130.6 

and 1130.7 into a revised § 1130.6. The 

proposal would then renumber existing 

§§ 1130.8 and 1130.9 as §§ 1130.7 and 

1130.8 respectively. Thus, any other 

sections in part 1130 that refer to 

§§ 1130.6 through 1130.9 (such as 

§ 1130.3(a)(2), which refers to § 1130.9) 

would, themselves, need to be amended 

to reflect the renumbered sections. 

2. Clarifying the Required Font Size 

(Proposed § 1130.6(b)(2)) 

Currently, § 1130.6(c) requires that 

registration forms use 12-point and 10- 

point type. Manufacturers and testing 

labs have reported confusion concerning 

the physical size required for the type. 

The dictionary defines a ‘‘point’’ as 1/ 

72 of an inch. However, according to 

font charts, font sizes used in printing 

do not follow this formula and are 

actually smaller than this measurement. 

To settle this confusion, the proposed 

amendment would specify the physical 

measurement of the type, rather than 

refer to ‘‘point.’’ For example, instead of 

requiring ‘‘12-point’’ type, the proposed 

amendment would require ‘‘0.12-inch 

(3.0 mm) type.’’ This change would be 

made in proposed § 1130.6(b)(2). 

3. Changes To Clarify That Consumers 

Should Return the Bottom Part of the 

Form Only (Proposed § 1130.6(c)(1) and 

(d)(1)) 

The rule requires firms to provide a 

form at least the size of two standard 

postcards connected together by a 

perforated line so that the two portions 

can be separated. The consumer retains 

the top portion which contains a 

statement of the purpose of the card and 

the manufacturer’s contact information. 

According to several manufacturers, 

consumers have been confused about 

what they need to return to the 

manufacturer, and some consumers 

have been sending in the entire form or 

the top portion of the form only. 

Currently, § 1130.7(b) requires that 

the back of the top portion of the form 

state the manufacturer’s name and 

contact information (a U.S. mailing 

address, a telephone number, toll-free, if 

available), among other things. The 

example shown in Figure 1 of the rule 

shows this information to be center 

justified, which makes this look like a 

mailing address. 

To resolve this confusion, proposed 

§ 1130.6(d)(1)(i) would specify that the 

manufacturer’s name and contact 

information on the top portion of the 

form is to be stated in sentence format 

and appear underneath the heading: 

‘‘Manufacturer’s Contact Information.’’ 

In Figure 2 of the proposed amendment, 

the order of the manufacturer’s contact 

information and the model name, model 

number, and manufacture date would be 

reversed from the order in the original 

Figure 2. This would place the 

manufacturer’s contact information on 

top and further decrease the likelihood 

that a consumer would return the top 

part of the form. 

In addition, proposed 

§ 1130.6(d)(1)(ii) would add a new 

provision requiring that just above the 

perforation line, each form must state in 

capital letters: ‘‘KEEP THIS TOP PART 

FOR YOUR RECORDS. FILL OUT AND 

RETURN BOTTOM PART.’’ 

Finally, the proposed amendment 

would revise the wording in the 

purpose statement to clarify that 

consumers should mail the bottom part 

of the form. Currently, § 1130.7(a) and 

Figure 1 state: ‘‘please complete and 

mail this card.’’ Proposed § 1130.6(c)(1) 

and proposed Figure 1 would state: 

‘‘please complete and mail the bottom 

part of this card.’’ 

4. Omitting Manufacturer’s Name on the 

Back Bottom of the Form (Proposed 

§ 1130.6(d)(2)) 

Currently, § 1130.7(d), as corrected in 

February 2010, requires that the bottom 

back portion of the form state the 

manufacturer’s name with the product 

information. However, the illustration 

in Figure 2 of the rule does not show the 

manufacturer’s name in this location. 

Some manufacturers have pointed out 

that there is limited space on this part 

of the form, and they have suggested 

that omitting the manufacturer’s name 

would allow more space for the 

consumer’s information. Others have 

indicated that the manufacturer’s name 

may be useful on the back of the form 

when they use a third party to process 

the registration cards. Because the front 

of the bottom portion of the form will 

always have the manufacturer’s name 

even when they use a third party to 

process the card, we believe it is not 

necessary to include the manufacturer’s 

name at this location of the form. 

However, the Commission will allow a 

manufacturer to include its name on the 

back portion of the card if it wants to 

do so and further seeks comments on 

whether some additional latitude is 

necessary to assist firms using a third 

party vendor to process their 

registration cards. 

Proposed § 1130.6(d)(2) would omit 

the requirement, currently in 

§ 1130.7(d), that the manufacturer’s 

name be stated along with the product 

information at the back bottom portion 

of the form. It would continue to allow 

a manufacturer to include its name on 

the card should it choose to do so. 

5. Identifying a Third Party That Is 

Processing the Forms (Proposed 

§ 1130.6(c)(2)) 

Currently, § 1130.6(b)(3) requires that 

the registration form be pre-addressed 

‘‘with the manufacturer’s name and 

mailing address where registration 

information is to be collected.’’ As 

discussed in the preamble to the final 

rule (74 FR at 68670), a manufacturer is 

allowed to contract with a third party 

who would be responsible for 

maintaining the registration 

information. Some manufacturers have 

asked whether the third party’s name 

could appear in the mailing information 

on the form in these circumstances. 

Proposed § 1130.6(c)(2) would specify 

that, if a manufacturer uses a third party 

to process the registration forms, the 

third party’s name may be included as 

a ‘‘c/o’’ on the form. 

6. Clarifying the Location Where 

Registration Information Is To Be 

Maintained (Proposed § 1130.8(d)) 

Several manufacturers have asked 

whether the consumer registration 

information they receive must be 

maintained at a location in the United 

States. The rule does not specifically 

address this issue. 

Because so much data and 

information is kept electronically and 

can be retrieved quickly, we do not 

believe it is necessary to require that 

registration information be maintained 

in the United States. However, 

manufacturers must be able to access 

the information when requested. 

Therefore, proposed § 1130.8(d) would 

state that registration records shall be 

made available within 24 hours of a 

request by CPSC. 

7. Correcting Text Requirement for 

Purpose Statement To Match Figure 1 

(Proposed § 1130.6(c)(1)) 

Currently, § 1130.7(a) provides, in 

part, that: ‘‘The front top portion of each 

form shall state ‘PRODUCT 

REGISTRATION FOR SAFETY ALERT 

OR RECALL. We will use the 

information provided on this card to 

contact you only if there is a safety alert 

or recall for this product. We will not 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48055 

sell, rent, or share your personal 

information. To register your product, 

please complete and mail this card or 

visit our online registration at http:// 

www.websitename.com.’’’ There are two 

discrepancies between the wording of 

the text and the illustration in Figure 1. 

To make the text and Figure 1 

consistent, proposed § 1130.6(c)(1) 

would make two changes to the text. 

The word ‘‘ONLY’’ would be added at 

the end of the first sentence, and 

‘‘http//’’ would be deleted from the Web 

site name. 

C. Effective Date 

This proposed amendment would 

clarify and correct several provisions of 

the consumer registration rule. It would 

not alter the substantive requirements of 

the existing rule. We recognize that 

manufacturers may have an existing 

inventory of registration forms. Because 

the proposed changes to the forms are 

minor and would not affect safety, we 

believe that it is appropriate to allow 

sufficient time for manufacturers to use 

their existing stock of registration forms 

before they must meet the amended 

requirements. Thus, we propose that 

this amendment would take effect 12 

months after publication of a final rule. 

Until the proposed amendment takes 

effect, we would consider registration 

forms that meet either the existing rule 

or the proposed amendment to be in 

compliance. 

D. Regulatory Flexibility Analysis or 

Certification 

The Regulatory Flexibility Act 

(‘‘RFA’’) generally requires that agencies 

review proposed rules for their potential 

economic impact on small entities, 

including small businesses. However, 

section 104(d)(1) of the CPSIA removes 

this requirement for the rule 

implementing the CPSIA’s consumer 

registration provision. Consequently, no 

regulatory flexibility analysis or 

certification is necessary for this 

proposed amendment clarifying and 

correcting the consumer registration 

rule. Moreover, the proposed changes 

are minor and would not alter the 

impact that the registration rule has on 

small entities. 

E. Paperwork Reduction Act 

Section 104(d)(1) of the CPSIA also 

excludes the consumer registration rule 

from requirements of the Paperwork 

Reduction Act, 44 U.S.C. sections 3501 

through 3520. Consequently, no 

Paperwork Reduction Act analysis is 

necessary for this proposed amendment 

clarifying and correcting the consumer 

registration rule. Moreover, the 

proposed changes are minor and would 

not alter any collection of information 

required under the registration rule. 

F. Environmental Considerations 

The Commission’s regulations 

provide a categorical exemption for the 

Commission’s rules from any 

requirement to prepare an 

environmental assessment or an 

environmental impact statement as they 

‘‘have little or no potential for affecting 

the human environment.’’ 16 CFR 

1021.5(c)(2). This proposed amendment 

falls within the categorical exemption. 

List of Subjects in 16 CFR 1130 

Administrative practice and 

procedure, Business and industry, 

Consumer protection, Reporting and 

recordkeeping requirements. 

Accordingly, we propose to amend 16 

CFR part 1130 as follows: 

PART 1130—REQUIREMENTS FOR 

CONSUMER REGISTRATION OF 

DURABLE INFANT OR TODDLER 

PRODUCTS 

1. The authority citation for part 1130 

continues to read as follows: 

Authority: 15 U.S.C. 2056a, 2065(b). 

§ 1130.3 [Amended] 

2. In § 1130.3(a)(2), remove ‘‘§ 1130.9’’ 

and add in its place ‘‘§ 1130.8’’. 

3. Section 1130.5 is amended as 

follows: 

a. In § 1130.5 (a), remove ‘‘and 

1130.7’’. 

b. In § 1130.5 (f), remove ‘‘1130.7(a)’’ 

and add, in its place ‘‘1130.6(c)(1)’’. 

4. Revise § 1130.6 to read as follows: 

§ 1130.6 Requirements for format and text 

of registration forms. 

(a) Size of form. The form shall be at 

least the size of two standard post cards 

connected with perforation for later 

separation, so that each of the two 

portions is at least 31⁄2 inches high x 5 

inches wide x 0.007 inches thick. 

(b) Layout of form—(1) General. The 

form shall consist of four parts: top and 

bottom, divided by perforations for easy 

separation, and front and back. 

(2) Font size and typeface. The 

registration form shall use bold black 

typeface. The size of the type shall be 

at least 0.12 in (3.0 mm) for the purpose 

statement required in § 1130.6(c)(1), and 

no less than 0.10 in (2.5 mm) for the 

other information in the registration 

form. The title of the purpose statement 

and the retention statement required in 

§ 1130.6(d)(2) shall be in all capitals. All 

other information shall be in capital and 

lowercase type. 

(c) Front of form—(1) Top front of 

form: Purpose statement. The top 

portion of the front of each form shall 

state: ‘‘PRODUCT REGISTRATION FOR 

SAFETY ALERT OR RECALL ONLY. 

We will use the information provided 

on this card to contact you only if there 

is a safety alert or recall for this product. 

We will not sell, rent, or share your 

personal information. To register your 

product, please complete and mail the 

bottom part of this card, or visit our 

online registration at: http:// 

www.websitename.com.’’ Manufacturers 

that do not have a Web site may provide 

an e-mail address and state at the end 

of the purpose statement: ‘‘To register 

your product, please complete and mail 

the bottom part of this card, or e-mail 

your contact information, the model 

name and number, and date of 

manufacture of the product, as provided 

on this card, to: name@firmname.com.’’ 

(2) Bottom front of form: 

Manufacturer’s mailing address. The 

bottom portion of the front of each form 

shall be pre-addressed and postage-paid 

with the manufacturer’s name and 

mailing address where registration 

information is to be collected. If a 

manufacturer uses a third party to 

process registration forms, the third 

party’s name may be included as a ‘‘c/o’’ 

(‘‘in care of’’) in the address on the form. 

(d) Back of the form—(1) Top back of 

form— 

(i) Product information and 

manufacturer’s identification. The top 

portion of the back of each form shall 

state: ‘‘Manufacturer’s Contact 

Information’’ and provide the 

manufacturer’s name and contact 

information (a U.S. mailing address 

displayed in sentence format, website 

address, a telephone number, toll-free, if 

available), product model name and 

number (or other identifier as described 

in § 1130.4(a)(1) and (2)), and 

manufacture date of the product. A 

rectangular box shall be placed around 

the model name, model number, and 

manufacture date. 

(ii) Retention statement. On the back 

of each form, just above the perforation 

line, the form shall state: ‘‘KEEP THIS 

TOP PART FOR YOUR RECORDS. FILL 

OUT AND RETURN BOTTOM PART.’’ 

(2) Bottom back of form. 

(i) Consumer information. The bottom 

portion of the back of each form shall 

have blocks for the consumer to provide 

his/her name, address, telephone 

number, and e-mail address. These 

blocks shall be 5 mm wide and 7 mm 

high, with as many blocks as possible to 

fill the width of the card allowing for 

normal printing practices. 

(ii) Product information. The 

following product information shall be 

provided on the bottom portion of the 

back of each form below the blocks for 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48056 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

consumer information printed directly 

on the form or on a pre-printed label 

that is applied to the form: the model 

name and number (or other identifier as 

described in § 1130.4(a)(1) and (2)), and 

the date of manufacture of the product. 

A rectangular box shall be placed 

around the model name, model number, 

and manufacture date. A manufacturer 

may include its name on the bottom 

portion of the back of the form if they 

choose to do so. 

5. Remove § 1130.7. 

6. Redesignate §§ 1130.8 and 1130.9 

as §§ 1130.7 and 1130.8, respectively. 

7. In newly redesignated § 1130.8, add 

new paragraph (d) to read as follows: 

§ 1130.8 Recordkeeping and notification 

requirements. 

* * * * * 

(d) Records required under this 

section shall be made available within 

24 hours, upon the request of any 

officer, employee, or agent acting on 

behalf of the Consumer Product Safety 

Commission. 

7. Revise Figure 1 to part 1130 to read 

as follows: 

FIGURE 1 TO PART 1130—FRONT OF 

REGISTRATION FORM 

BILLING CODE 6355–01–P 


emcdonald on DSK2BSOYB1PROD with PROPOSALSEP08AU11.173</GPH>
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48057 

FIGURE 1 TO PART 1130—FRONT OF 

REGISTRATION FORM 

8. Revise Figure 2 as follows: 


emcdonald on DSK2BSOYB1PROD with PROPOSALSEP08AU11.174</GPH>
48058 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

FIGURE 2 TO PART 1130—BACK OF 

REGISTRATION FORM 

Dated: August 2, 2011. 

Todd A. Stevenson, 

Secretary, U.S. Consumer Product Safety 

Commission. 

[FR Doc. 2011–19912 Filed 8–5–11; 8:45 am] 

BILLING CODE 6355–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2011–N–0505] 

Effective Date of Requirement for 

Premarket Approval for Cardiovascular 

Permanent Pacemaker Electrode 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the following class III 

preamendments device: Cardiovascular 

permanent pacemaker electrode. The 

Agency is also summarizing its 

proposed findings regarding the degree 

of risk of illness or injury designed to 

be eliminated or reduced by requiring 

this device to meet the statute’s 

approval requirements and the benefits 

to the public from the use of the device. 

In addition, FDA is announcing the 

opportunity for interested persons to 

request that the Agency change the 

classification of the cardiovascular 

permanent pacemaker electrode based 

on new information. This action 

implements certain statutory 

requirements. 

DATES: Submit either electronic or 

written comments by November 7, 2011. 

Submit requests for a change in 

classification by August 23, 2011. FDA 

intends that, if a final rule based on this 

proposed rule is issued, anyone who 

wishes to continue to market the device 

will need to submit a PMA within 90 

days of the effective date of the final 

rule. Please see section XI of this 

document for the proposed effective 

date of any final rule that may publish 

based on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0505, 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 ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, 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–2011–N–0505 for this 

rulemaking. 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(s), 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: 

Elias Mallis, Food and Drug 

Administration, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 1538, 

Silver Spring, MD 20993–0002, 301– 

796–6216. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (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 (the SMDA) (Pub. L. 101–629), and 

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 (Pub. L. 108– 

214), and the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), establish a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three categories 

(classes) of devices, reflecting the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval unless and 

until the device is 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 

FD&C Act, to a predicate device that 

does not require premarket approval. 

The Agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and 21 CFR part 807. 

A preamendments device that has 

been classified into class III may be 

marketed by means of premarket 

notification procedures (510(k) process) 

without submission of a PMA until FDA 

issues a final regulation under section 

515(b) of the FD&C Act (21 U.S.C. 

360e(b)) requiring premarket approval. 

Section 515(b)(1) of the FD&C Act (21 

U.S.C. 360e(b)(1)) establishes the 

requirement that a preamendments 

device that FDA has classified into class 

III is subject to premarket approval. A 

preamendments class III device may be 

commercially distributed without an 

approved PMA or a notice of 

completion of a PDP until 90 days after 

FDA issues a final rule requiring 

premarket approval for the device, or 30 

months after final classification of the 

device under section 513 of the FD&C 

Act, whichever is later. Also, a 

preamendments device subject to the 

rulemaking procedure under section 

515(b) of the FD&C Act is not required 

to have an approved investigational 


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