9608 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Proposed Rules 

(i) Collects, analyzes, or maintains 

information that solely relates to 

transactions or experiences between the 

person and a consumer; and 

(ii) Provides the information 

described in paragraph (i)(2)(i) of this 

section to an affiliate. 

(3) Exception for furnishing 

information to a consumer reporting 

entity. Consumer reporting does not 

include the activities of a person to the 

extent that a person provides 

information that solely relates to 

transactions or experiences between a 

consumer and the person, or the affiliate 

of such person, to another person that 

is engaged in consumer reporting. 

(4) Exception for providing 

information to be used solely in a 

decision regarding employment, 

government licensing, or residential 

leasing or tenancy. Consumer reporting 

does not include the activities of a 

person to the extent that a person 

provides consumer report or other 

account information that is used or 

expected to be used solely in any 

decision regarding the offering or 

provision of a product or service that is 

not a consumer financial product or 

service, including a decision for 

employment, government licensing, or a 

residential lease or tenancy involving a 

consumer. 

(j) Larger participant means a 

nonbank covered person that meets a 

test under § 1090.102, and for the period 

provided in § 1090.103 of this part. 

(k) Nonbank covered person means, 

except for persons described in sections 

1025(a) and 1026(a) of the Act: 

(1) Any person that engages in 

offering or providing a consumer 

financial product or service; and 

(2) Any affiliate of a person described 

in paragraph (k)(1) of this section if such 

affiliate acts as a service provider to 

such person. 

(l) Person means an individual, 

partnership, company, corporation, 

association (incorporated or 

unincorporated), trust, estate, 

cooperative organization, or other 

entity. 

(m) Supervision or supervisory 

activity means the Bureau’s exercise, or 

intended exercise, of supervisory 

authority by initiating or undertaking an 

examination, or requiring a report of a 

person pursuant to section 1024 of the 

Act. 

§ 1090.102 Covered markets and tests for 

determining larger participants of those 

markets. 

(a) Consumer debt collection. A 

nonbank covered person that offers or 

provides consumer debt collection is a 

larger participant of the consumer debt 

collection market if the person’s annual 

receipts resulting from consumer debt 

collection are more than $10 million. 

(b) Consumer reporting. A nonbank 

covered person that offers or provides 

consumer reporting is a larger 

participant of the consumer reporting 

market if the person’s annual receipts 

resulting from consumer reporting are 

more than $7 million. 

§ 1090.103 Status as larger participant 

subject to supervision. 

A person qualifying as a larger 

participant under § 1090.102 shall not 

cease to be a larger participant under 

this part until two years from the first 

day of the tax year in which the person 

last met the applicable test under 

§ 1090.102. 

§ 1090.104 Determination of status as a 

larger participant. 

(a) If a nonbank covered person 

receives a written communication from 

the Bureau initiating a supervisory 

activity, such person may respond by 

asserting that the person does not meet 

the definition of a larger participant of 

a market covered by this part within 30 

days of the date of the communication. 

Such response must be sent to the 

Assistant Director by electronic 

transmission at the address included in 

the communication and must include an 

affidavit setting forth an explanation of 

the basis for the person’s assertion that 

it does not meet the definition of larger 

participant of a market covered by this 

part and therefore is not subject to the 

Bureau’s supervisory authority under 

section 1024 of the Act. In addition, a 

person may include with the response 

copies of any records, documents, or 

other information on which the person 

relied to make the assertion. 

(b) A person shall be deemed to have 

waived the right, at any time that it may 

dispute that it qualifies as a larger 

participant, to rely on any argument, 

records, documents, or other 

information that it fails to submit to the 

Assistant Director under paragraph (a) 

of this section. A person who fails to 

respond to the Bureau’s written 

communication within 30 days will be 

deemed to have acknowledged that it is 

a larger participant. 

(c) The Assistant Director shall review 

the affidavit, any attached records, 

documents, or other information 

submitted pursuant to paragraph (a) of 

this section, and any other information 

the Assistant Director deems relevant, 

and thereafter send by electronic 

transmission to the person a statement 

setting forth the Bureau’s conclusion as 

to whether the person meets the 

definition of a larger participant of a 

market covered by this part. 

(d) At any time, including prior to 

issuing the written communication 

referred to in paragraph (a) of this 

section, the Assistant Director may 

require that a person provide to the 

Bureau such records, documents, and 

information as the Assistant Director 

may deem appropriate to determine 

whether a person qualifies as a larger 

participant. Persons must provide the 

requisite records, documents, and other 

information to the Bureau within the 

time period specified in the request. 

(e) The Assistant Director, in her or 

his discretion, may modify any 

timeframe prescribed by this section on 

his or her own initiative or for good 

cause shown. 

Dated: February 8, 2012. 

Richard Cordray, 

Director, Consumer Financial Protection 

Bureau. 

[FR Doc. 2012–3775 Filed 2–16–12; 8:45 am] 

BILLING CODE 4810–AM–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 177 

[Docket No. FDA–2012–F–0031] 

American Chemistry Council; Filing of 

Food Additive Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of petition. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that the American Chemistry Council 

(ACC) has filed a petition proposing that 

the food additive regulations be 

amended to no longer provide for the 

use of polycarbonate (PC) resins in 

infant feeding bottles and spill-proof 

cups designed to help train babies to 

drink from cups because these uses have 

been abandoned. PC resins are formed 

by the condensation of 4,4′- 

isopropylenediphenol (i.e., Bisphenol A 

(BPA)), and carbonyl chloride or 

diphenyl carbonate. 

DATES: Submit either electronic or 

written comments by April 17, 2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–F– 

0031 by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

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Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Proposed Rules 9609 

• 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 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–F–0031. 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: 

Vanee Komolprasert, Center for Food 

Safety and Applied Nutrition (HFS– 

275), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 240–402–1217. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 409(b)(5) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 348(b)(5)), notice 

is given that a food additive petition 

(FAP 1B4783) has been filed by the 

American Chemistry Council (ACC), 700 

Second St. NE., Washington, DC 20002. 

The petition proposes to amend the food 

additive regulations in 21 CFR 177.1580 

to no longer permit the use of PC resins 

in infant feeding bottles (‘‘baby bottles’’) 

and spill-proof cups designed to help 

train babies to drink from cups (‘‘sippy 

cups’’) because these uses have been 

abandoned. Polycarbonate resins are 

formed by the condensation of 4,4′- 

isopropylenediphenol (i.e., BPA), and 

carbonyl chloride or diphenyl 

carbonate. 

II. Abandonment 

Under section 409(i) of the FD&C Act, 

FDA ‘‘shall by regulation prescribe the 

procedure by which regulations under 

the foregoing provisions of this section 

may be amended or repealed, and such 

procedure shall conform to the 

procedure provided in this section for 

the promulgation of such regulations.’’ 

FDA’s regulations specific to 

administrative actions for food additives 

provide as follows: ‘‘The Commissioner, 

on his own initiative or on the petition 

of any interested person, pursuant to 

part 10 of this chapter, may propose the 

issuance of a regulation amending or 

repealing a regulation pertaining to a 

food additive or granting or repealing an 

exception for such additive.’’ (21 CFR 

171.130(a)). These regulations further 

provide: ‘‘Any such petition shall 

include an assertion of facts, supported 

by data, showing that new information 

exists with respect to the food additive 

or that new uses have been developed 

or old uses abandoned, that new data 

are available as to toxicity of the 

chemical, or that experience with the 

existing regulation or exemption may 

justify its amendment or appeal. New 

data shall be furnished in the form 

specified in 21 CFR 171.1 and 171.100 

for submitting petitions.’’ (21 CFR 

171.130(b)). Under these regulations, a 

petitioner may propose that FDA amend 

a food additive regulation if the 

petitioner can demonstrate that there are 

‘‘old uses abandoned’’ for the relevant 

food additive. Such abandonment must 

be complete for any intended uses in the 

U.S. market. While section 409 of the 

FD&C Act and § 171.130 also provide for 

amending or revoking a food additive 

regulation based on safety, an 

amendment or revocation based on 

abandonment is not based on safety, but 

is based on the fact that regulatory 

authorization is no longer necessary for 

the use of that food additive. 

Abandonment may be based on the 

abandonment of certain authorized food 

additive uses for a substance (e.g., if a 

substance is no longer used in certain 

product categories), or on the 

abandonment of all authorized food 

additive uses of a substance (e.g., if a 

substance is no longer being 

manufactured). If a petition seeks an 

amendment to a food additive 

regulation based on the abandonment of 

certain uses of the food additive, such 

uses must be adequately defined so that 

both the scope of the abandonment and 

any amendment to the food additive 

regulation are clear. 

The ACC petition contains public 

information and information collected 

from companies that produce PC resins 

to support the claim that baby bottles 

and sippy cups containing PC resins are 

no longer being introduced into the U.S. 

market and that manufacturers of baby 

bottles and sippy cups have abandoned 

the use of PC resins in making these 

products. The petition contains the 

results of an industry poll showing that 

the PC resin manufacturers, which 

represent over 97 percent of worldwide, 

global PC resin production capacity, are 

no longer, to their knowledge, selling PC 

resins to be used in the manufacture of 

baby bottles and sippy cups intended 

for import into the United States or sale 

in the U.S. market. 

FDA expressly requests comments on 

ACC’s proposal that FDA amend the 

food additive regulations to no longer 

permit the use of PC resins in baby 

bottles and sippy cups. For the purposes 

of this petition, FDA considers ‘‘sippy 

cups’’ to mean spill-resistant training 

cups, including their closures and lids, 

intended for use by babies or toddlers. 

As noted, the basis for the proposed 

amendment is that the use of PC resins 

in the manufacture of baby bottles and 

sippy cups has been abandoned. 

Accordingly, FDA requests comments 

that address whether these uses of PC 

resins have been abandoned, such as 

information on whether baby bottles or 

sippy cups containing PC resins are 

currently being introduced or delivered 

for introduction into the U.S. market. 

Further, FDA requests comments on 

whether the uses that are the subject of 

ACC’s petition (baby bottles and sippy 

cups) have been adequately defined. 

FDA is not currently aware of 

information that would suggest 

continued use of PC resins in the 

manufacture of baby bottles and sippy 

cups. FDA is providing the public 60 

days to submit comments. 

The Agency is not requesting 

comments on the safety of these uses of 

PC resins because, as discussed 

previously in this document, such 

information is not relevant to 

abandonment, which is the basis of the 

proposed action. Any comments 

addressing the safety of PC resins or 

containing safety information on these 

resins will not be considered in FDA’s 

evaluation of this petition. Separate 

from FDA’s consideration of this 

petition, FDA is actively assessing the 

safety of BPA (see 75 FR 17145, April 

5, 2010). Interested persons with safety 

information that has not previously 

been submitted to FDA on the use of PC 

resins may provide that information to 

Docket No. FDA–2010–N–0100. 

Although this docket is no longer 

accepting electronic comments, written 

comments will be accepted by FDA’s 

Division of Dockets Management (see 

ADDRESSES). 

The Agency has determined under 21 

CFR 25.32(m) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

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9610 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Proposed Rules 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: February 13, 2012. 

Dennis M. Keefe, 

Director, Office of Food Additive Safety, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. 2012–3744 Filed 2–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2012–M–0076] 

Gastroenterology-Urology Devices; 

Reclassification of Sorbent 

Hemoperfusion Devices for the 

Treatment of Poisoning and Drug 

Overdose; Effective Date of 

Requirement for Premarket Approval 

for Sorbent Hemoperfusion Devices To 

Treat Hepatic Coma and Metabolic 

Disturbances 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify the sorbent hemoperfusion 

system, a preamendments class III 

device, into class II (special controls) for 

the treatment of poisoning and drug 

overdose, and to require the filing of a 

premarket approval application (PMA) 

or a notice of completion of a product 

development protocol (PDP) for the 

treatment of hepatic coma and 

metabolic disturbances. FDA is 

identifying the proposed special 

controls that the Agency believes will 

reasonably ensure the safety and 

effectiveness of the device for the 

treatment of poisoning and drug 

overdose. 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 the devices to 

meet the statute’s approval requirements 

and the benefits to the public from the 

use of the devices. In addition, FDA is 

announcing the opportunity for 

interested persons to request that the 

Agency change the classification of any 

of the devices mentioned in this 

document based on new information. 

This action implements certain statutory 

requirements. 

DATES: Submit either electronic or 

written comments by May 17, 2012. 

Submit requests for a change in 

classification by March 5, 2012. See 

section XVIII of this document for the 

proposed effective date of a final rule 

based on this proposed rule. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–M– 

0076, 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 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–M–0076 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, 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: 

Melissa Burns, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1646, Silver Spring, 

MD 20993, 301–796–5616, 

melissa.burns@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

A. Requirement for Premarket Approval 

Application 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended by the 

Medical Device Amendments (the 1976 

amendments) (Pub. L. 94–295), the Safe 

Medical Devices Act of 1990 (SMDA) 

(Pub. L. 101–629), Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115), the 

Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA) 

(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 

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