Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 47719 

1 15 U.S.C. 77a et seq. 

2 15 U.S.C. 78a et seq. 

3 15 U.S.C. 77aaa et seq. 

DATES: Effective Dates: 0901 UTC, 

October 22, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Colby Abbott, Airspace and Rules 

Group, Office of System Operations 

Airspace and AIM, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

History 

On November 3, 1994, a final rule for 

Airspace Docket No. 94–ASW–12, was 

published in the Federal Register (59 

FR 55030), changing the time of 

designation for Restricted Areas R– 

5103A, R–5103B, R–5103C, and R– 

5103D at McGregor, NM. In that rule, 

the preamble discussion stated the time 

of designation was being changed from 

the existing time of designation, ‘‘0700– 

2000 local time; other times by 

NOTAM’’ to ‘‘0700–2000 local time, 

Monday–Friday; other times by 

NOTAM’’ to lessen the burden on the 

public and accurately reflect their actual 

time of use. However, in the regulatory 

language, the time of designation was 

published as ‘‘0700–2000 local time, 

Monday–Friday, other times by 

NOTAM’’. Having changed the semicolon between the days of the week and 

NOTAM provision to a comma 

unintentionally linked the NOTAM 

provision to the days of the week listed 

in the legal description only. The 

unintended consequence of this error is 

that the NOTAM provision does not 

apply to Saturdays or Sundays, as it did 

previous to that final rule. Had a semicolon been published in the regulatory 

text between the days of the week and 

the NOTAM provision, the ‘‘other times 

by NOTAM’’ provision would apply 

daily. 

Subsequent to the rule published 

November 3, 1994, (59 FR 55030), a 

second rule affecting R–5103A, R– 

5103B, R–5103C, and R–5103D was 

published December 13, 2004, (69 FR 

72113), Airspace Docket No. 04–ASW– 

11, FAA Docket No. FAA–2004–17773. 

This second rule modified the 

boundaries and designated altitudes for 

Restricted Areas R–5103A, R–5103B, 

and R–5103C, and revoked R–5103D to 

allow the U.S. Army to activate the 

restricted areas in a manner that was 

more consistent with the actual 

utilization of the airspace. As a result of 

this action, the correction to Restricted 

Area R–5103D is not necessary as it no 

longer exists. 

Based on the original intent of the 

final rule published November 3, 1994, 

and subsequently modified by a second 

final rule published December 13, 2004, 

the NOTAM provisions for R–5103A, R– 

5103B, and R–5103C should be 

applicable daily, outside the 0700–2000 

local time, Monday through Friday, 

published hours currently listed in that 

final rule. This action corrects that error 

by amending the time of designation for 

R–5103A, R–5103B, and R–5103C to 

read, ‘‘0700–2000 local time, Monday– 

Friday; other times by NOTAM’’. 

List of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

Correction to Final Rule 

■ Accordingly, pursuant to the authority 

delegated to me, the legal description as 

published in the Federal Register on 

November 3, 1994 (59 FR 55030), 

Airspace Docket 94–ASW–12, and 

incorporated by reference in 14 CFR 73, 

is corrected as follows: 

§ 73.51 [Amended] 

■ On page 55031, correct the airspace 

description for the time of designation 

for Restricted Areas R–5103A, R–5103B, 

and R–5103C, to read as follows: 

* * * * * 

R–5103A McGregor, NM [Amended] 

By removing the current ‘‘Time of 

designation. 0700–2000 local time, MondayFriday, other times by NOTAM.’’ and 

substituting the following: ‘‘Time of 

designation. 0700–2000 local time MondayFriday; other times by NOTAM.’’ 

R–5103B McGregor, NM [Amended] 

By removing the current ‘‘Time of 

designation. 0700–2000 local time, MondayFriday, other times by NOTAM.’’ and 

substituting the following: ‘‘Time of 

designation. 0700–2000 local time MondayFriday; other times by NOTAM.’’ 

R–5103C McGregor, NM [Amended] 

By removing the current ‘‘Time of 

designation. 0700–2000 local time, MondayFriday, other times by NOTAM.’’ and 

substituting the following: ‘‘Time of 

designation. 0700–2000 local time MondayFriday; other times by NOTAM.’’ 

* * * * * 

Issued in Washington, DC, on August 27, 

2009. 

Ellen Crum, 

Acting Manager, Airspace and Rules Group. 

[FR Doc. E9–21263 Filed 9–16–09; 8:45 am] 

BILLING CODE 4910–13–P 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR parts 230, 240 and 260 

[Release Nos. 33–9063; 34–60663; 39–2467; 

File No. S7–02–09] 

RIN 3235–AK26 

Extension of Temporary Exemptions 

for Eligible Credit Default Swaps To 

Facilitate Operation of Central 

Counterparties To Clear and Settle 

Credit Default Swaps 

AGENCY: Securities and Exchange 

Commission. 

ACTION: Interim final temporary rules; 

extension. 

SUMMARY: We are adopting amendments 

to the expiration dates in our interim 

final temporary rules that provide 

exemptions under the Securities Act of 

1933, the Securities Exchange Act of 

1934, and the Trust Indenture Act of 

1939 for certain credit default swaps in 

order to facilitate the operation of one 

or more central counterparties for those 

credit default swaps. Under the 

amendments, the expiration dates of the 

interim final temporary rules will be 

extended to November 30, 2010. 

DATES: Effective Date: This rule is 

effective September 17, 2009, and the 

expiration dates for the interim final 

temporary rules and amendments 

published January 22, 2009 (74 FR 3967) 

is extended from September 25, 2009 to 

November 30, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Amy M. Starr, Senior Special Counsel, 

or Sebastian Gomez Abero, Attorney, 

Office of Chief Counsel, Division of 

Corporation Finance, at (202) 551–3500, 

U.S. Securities and Exchange 

Commission, 100 F Street, NE., 

Washington, DC 20549–3628. 

SUPPLEMENTARY INFORMATION: We are 

adopting amendments to the following 

rules: interim final temporary Rule 239T 

and Rule 146 under the Securities Act 

of 1933 (‘‘Securities Act’’),1 interim final 

temporary Rule 12a–0T and Rule 12h– 

1(h)T under the Securities Exchange Act 

of 1934 (‘‘Exchange Act’’),2 and interim 

final temporary Rule 4d–11T under the 

Trust Indenture Act of 1939 (‘‘Trust 

Indenture Act’’).3

I. Background 

In January 2009, we adopted interim 

final temporary Rule 239T and a 

temporary amendment to Rule 146 

under the Securities Act, interim final 


cprice-sewell on DSK2BSOYB1PROD with RULES
47720 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 

4See Exchange Act Release No. 59246 (Jan. 14, 

2009). 

5 15 U.S.C. 78q–1. 

6See 7 U.S.C. 1a(12). 

7See Exchange Act Release Nos. 59164 and 59165 

(Dec. 24, 2008). 

8 15 U.S.C. 78e and 78f. 

9For a discussion of concerns related to the 

market in CDS, and the development of the 

exemptive orders and interim temporary rules, see 

Exchange Act Release No. 59246 (Jan. 14, 2009). 

10See Exchange Act Release No. 59527 (Mar. 6, 

2009), 74 FR 10791 (Mar. 12, 2009) (temporary 

exemption for ICE U.S. Trust LLC). 

11See Historical Daily Volume Report—ICE Trust 

U.S., available at https://www.theice.com/ 

marketdata/reports/ 

ReportCenter.shtml?reportId=26. 

12See Testimony of Mark Lenczowski, Managing 

Director and Assistant General Counsel at JPMorgan 

Chase & Co., to the Senate Agriculture Committee 

(June 4, 2009) (In his testimony, Mr. Lenczowski 

indicated, in the context of CDS clearing by ICE 

Trust, that ‘‘[c]learing is a highly transparent 

process. * * *’’). 

13As of June 30, 2009, ICE Trust had reduced the 

notional amount of CDS open interest, or net 

exposure, from over $1.3 trillion to $168.5 billion 

by clearing trades and netting positions. See, 

Quarterly Report on Form 10–Q for the quarter 

ended June 30, 2009 (filed on August 5, 2009). ICE 

Trust also has a guarantee fund that provides 

additional protection in the event of a clearing 

participant default. See Exchange Act Release No. 

59527, supra Note 10. 

14See Exchange Act Release No. 60373 (July 23, 

2009) (temporary exemption for Eurex Clearing 

AG); Exchange Act Release No. 60372 (July 23, 

2009) (temporary exemption for ICE Clear Europe 

Limited); Exchange Act Release No. 59578 (Mar. 13, 

2009) (temporary exemption for Chicago Mercantile 

Exchange Inc.); and Exchange Act Release No. 

59164 (Dec. 24, 2008) (temporary exemption for 

LIFFE A&M and LCH.Clearnet Ltd.). LIFFE A&M 

and LCH.Clearnet Ltd., to whom we granted 

exemptive orders in December 2008, indicated that 

they will suspend their plans to clear CDS. See, 

Alastair Marsh, NYSE Liffe and LCH.Clearnet close 

CDS clearing service (Aug. 12, 2009), available at 

http://www.risk.net/public/ 

showPage.html?page=867491. 

15See Christine Birkner, CDS Clearing Battle (Buy 

Side vs. Sell Side), Futures (July 1, 2009) (‘‘A 

spokesperson for CME Group says, ‘We continue to 

work with buy and sell participants to demonstrate 

the value of our offering.’ ’’). 

16See Press Release, IntercontinentalExchange, 

ICE Clear Europe Clears Euro 51 Billion in Third 

Week of European CDS Processing; Announces New 

CDS Clearing Member (Aug. 17, 2009), available at 

http://ir.theice.com/ 

releasedetail.cfm?ReleaseID=403509. See also, Press 

Release, Eurex Clearing AG, Eurex Credit Clear 

Clears First Single Name CDS Worldwide (Aug. 28, 

2009), available at http://www.eurexclearing.com/ 

about/press/press_647_en.html. 

17See, e.g., Derivatives Trading Integrity Act of 

2009 (S. 272) (introduced by Senator Tom Harkin 

in January 2009); The Derivatives Markets 

Transparency and Accountability Act (H.R. 977) 

(introduced by Representative Collin Peterson in 

February 2009); Authorizing the Regulation of 

Swaps Act (S. 961) (introduced by Senator Carl 

Levin and Senator Susan Collins in May 2009); 

Treasury’s framework for regulatory reform 

(released in June 2009); Derivative Trading 

Accountability and Disclosure Act (H.R. 3300) 

(introduced by Representative Michael McMahon in 

July 2009); Description of Principles for OTC 

Derivatives Legislation (announced by 

Representative Barney Frank and Representative 

Collin Peterson in July 2009); Senator Charles 

Schumer’s announcement that he is drafting a bill 

establishing central trade repositories for OTC 

derivatives markets (August 2009); and Over-theCounter Derivatives Markets Act of 2009 (prepared 

by Treasury and sent to Congress in August 2009). 

18See Press Release, Bank for International 

Settlements, CPSS–IOSCO working group on the 

review of the ‘‘Recommendations for Central 

Counterparties’’ (July 20, 2009), available at http: 

//www.bis.org/press/p090720.htm. 

19 ‘‘Where necessary, the working group will 

propose guidance on how CCPs for OTC derivatives 

may meet the standards set out by the 

recommendations and will identify any areas in 

which the recommendations might be strengthened 

or expanded to better address risks associated with 

the central clearing of OTC derivatives. Participants 

in the working group include representatives of the 

central banks that are members of the CPSS, 

representatives of the securities regulators that are 

members of the IOSCO Technical Committee, and 

representatives of the International Monetary Fund 

and the World Bank.’’ Id. 

20See letters from the Yale Law School Capital 

Markets and Financial Instruments Clinic (March 

23, 2009) and from IDX Capital (March 23, 2009). 

21The public comments we received are available 

for inspection in the Commission’s Public 

Reference Room at 100 F St., NE., Washington, DC 

20549 in File No. S7–02–09. They are also available 

online at http://www.sec.gov/comments/s7-02-09/ 

s70209.shtml. 

temporary Rules 12a–10T and 12h– 

1(h)T under the Exchange Act, and 

interim final temporary Rule 4d–11T 

under the Trust Indenture Act 

(collectively, the ‘‘Interim Final 

Temporary Rules’’).4 We adopted these 

rules in connection with temporary 

exemptive orders we issued to a clearing 

agency acting as a central counterparty 

(‘‘CCP’’), which exempted the CCP from 

the requirement to register as a clearing 

agency under Section 17A of the 

Exchange Act 5 solely to perform the 

functions of a clearing agency for certain 

credit default swap (‘‘CDS’’) 

transactions. The exemptive orders also 

exempted certain eligible contract 

participants 6 and others from certain 

Exchange Act requirements with respect 

to certain CDS.7 Also at that time, we 

temporarily exempted any exchange 

that effects transactions in certain CDS 

from the requirements under Sections 5 

and 6 of the Exchange Act 8 to register 

as a national securities exchange, and 

any broker or dealer that effects 

transactions on an exchange in certain 

CDS from the requirements of Section 5 

of the Exchange Act. 

The Interim Final Temporary Rules, 

and the temporary exemptive orders we 

provided under the Exchange Act, were 

intended to facilitate the operation of 

one or more CCPs that clear and settle 

CDS transactions while enabling us to 

provide oversight to the CDS market.9

Since the adoption of the interim final 

rules, only one CCP, ICE U.S. Trust LLC 

(‘‘ICE Trust’’), has been actively engaged 

as a CCP in clearing CDS transactions in 

the U.S. in accordance with our 

exemptions.10 As of August 28, 2009, 

ICE Trust had cleared more than 22,800 

CDS transactions with a notional value 

of $1.9 trillion.11 We believe that the 

clearing of CDS transactions by ICE 

Trust has contributed and we anticipate 

will continue to contribute to increased 

transparency 12 and the reduction of 

systemic risk in the CDS market.13

We also granted exemptive orders to 

four other CCPs to clear CDS, two of 

which were approved in July 2009.14

The Chicago Mercantile Exchange, to 

whom we granted an exemptive order in 

March 2009, has indicated that it 

continues to work with buy and sell 

participants in the CDS market to 

promote its CCP.15 ICE Clear Europe 

Limited (‘‘ICE Europe’’) and Eurex 

Clearing AG (‘‘Eurex’’) have begun 

clearing CDS transactions in Europe.16

Since the adoption of the Interim 

Final Temporary Rules, a number of 

legislative initiatives relating to the 

regulation of derivatives, including 

CDS, have been introduced by members 

of Congress and recommended by the 

United States Department of the 

Treasury (‘‘Treasury’’).17 Congress has 

not yet taken definitive action with 

respect to any of the legislative 

initiatives or the Treasury proposals. 

Separately, in July 2009, the Committee 

on Payment and Settlement Systems 

(‘‘CPSS’’) and the Technical Committee 

of the International Organization of 

Securities Commissions (‘‘IOSCO’’) 

established a working group to review 

the application of the CPSS–IOSCO 

Recommendations for Central 

Counterparties (‘‘Recommendations’’) 

with respect to OTC derivatives.18 The 

Recommendations set out standards for 

risk management of CCPs. The working 

group plans to identify key issues that 

can arise when a CCP provides central 

clearing services for OTC derivatives 

transactions.19

At the time of adoption of the Interim 

Final Temporary Rules, we requested 

comment on various aspects of the rule 

provisions. We received a total of 15 

letters, only two of which commented 

specifically on the interim temporary 

final rules. Those two letters generally 

supported allowing CCPs to clear and 

settle CDS transactions in accordance 

with the terms of the Interim Final 

Temporary Rules; but neither of the 

commenters specifically addressed the 

duration of the Interim Final Temporary 

Rules and temporary amendments.20

The other commenters raised issues not 

directly related to this rulemaking.21


cprice-sewell on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 47721 

22See Section III, infra, for a discussion of why 

the extension of time is necessary. 

23See 17 CFR 230.239T(d). 

24For purposes of Securities Act Rule 239T, 

‘‘eligible contract participant’’ has the same 

meaning as in Section 1a(12) of the Commodity 

Exchange Act (the ‘‘CEA’’), as in effect on the date 

of adoption of Rule 239T, except that the term does 

not include a person who is an ‘‘eligible contract 

participant’’ pursuant to Section 1a(12)(C) of the 

CEA. 17 CFR 230.239T(a)(2). 

25We note that among the conditions of the 

exemptions, or representations in the exemptive 

requests on which we are relying, from clearing 

registration are that: (1) Information is available 

about the terms of the CDS, the creditworthiness of 

the CCP or any guarantor, and the clearing and 

settlement process for the CDS; and (2) the 

reference entity, the issuer of the reference security, 

or the reference security is one of the following: an 

entity reporting under the Exchange Act, providing 

Securities Act Rule 144A(d)(4) information, or 

about which financial information is otherwise 

publicly available; a foreign private issuer that has 

securities listed outside the United States and has 

its principal trading market outside the United 

States; a foreign sovereign debt security; an assetbacked security, as defined in Regulation AB [17 

CFR 229.1100], issued in a registered transaction 

with publicly available distribution reports; an 

asset-backed security issued or guaranteed by 

Fannie Mae, Freddie Mac or the Government 

National Mortgage Association; or indexes in which 

80 percent or more of the index’s weight is 

comprised of these reference entities or reference 

securities. See, e.g., Exchange Act Release No. 

59527, supra Note 10. 26 17 CRF 230.239T(c). 27This provision is similar to the condition in the 

Securities Act exemption in Rule 238 for 

standardized options [17 CFR 230.238] and in 

Securities Act Section 2(a)(3) [15 U.S.C. 77b(a)(3)] 

relating to security futures products. 

28 17 CFR 230.146(c)T. State securities regulation 

of covered securities generally is limited under 

Section 18(b). Under Section 18(b)(3), covered 

securities are securities offered and sold to qualified 

purchasers, as defined by the Commission. 

29 15 U.S.C. 78l(a). 

30 17 CFR 240.12h–1(h)T; 15 U.S.C. 78l(g). 

31Rule 4d–11T. The Trust Indenture Act applies 

to debt securities sold through the use of the mails 

or interstate commerce. Section 304 of the Trust 

Indenture Act exempts from the Act a number of 

securities and transactions. Section 304(a) of the 

Trust Indenture Act exempts securities that are 

exempt under Securities Act Section 3(a), but does 

not exempt from the Trust Indenture Act securities 

that are exempt by Commission rule. Accordingly, 

while Securities Act Rule 239T exempts the offer 

and sale of eligible CDS satisfying certain 

conditions from all the provisions of the Securities 

Act (other than Section 17(a)), the Trust Indenture 

Act would continue to apply. 

The Interim Final Temporary Rules 

expire on September 25, 2009. We have 

determined that it is necessary and 

appropriate to extend the expiration 

date of the Interim Final Temporary 

Rules to November 30, 2010.22

II. Discussion of the Final Temporary 

Rules 

We are adopting amendments to the 

Interim Final Temporary Rules to 

extend the expiration date of each of the 

rules to November 30, 2010. We are not 

making any other changes to the Interim 

Final Temporary Rules. 

A. Securities Act Rule 239T and Rule 

146 

Securities Act Rule 239T exempts 

from all provisions of the Securities Act, 

except the anti-fraud provisions of 

Section 17(a), certain CDS (‘‘eligible 

CDS’’) 23 that are offered and sold only 

to ‘‘eligible contract participants,’’ 24

and that are being or will be issued or 

cleared by a CCP satisfying the 

conditions set forth in the CCP 

exemptions, or registered as a clearing 

agency under Section 17A of the 

Exchange Act (‘‘Registered or Exempt 

CCP’’). Hence, under Securities Act Rule 

239T, the offer and sale of eligible CDS 

are exempt from the registration 

requirements of the Securities Act if the 

eligible CDS is or will be issued or 

cleared by a Registered or Exempt CCP, 

and offered and sold only to an eligible 

contract participant. Communications 

used in connection with such offers and 

sales are not subject to Section 12(a)(2) 

liability under the Securities Act. 

Securities Act Rule 239T assures the 

availability of information to buyers and 

sellers of CDS due to certain 

information conditions in the CCP 

exemptive orders.25

As we noted in January 2009, absent 

this exemption, the Securities Act may 

require registration of the offer and sale 

of eligible CDS that are or will be issued 

or cleared by a Registered or Exempt 

CCP. Without also exempting the offers 

and sales of the eligible CDS by a 

Registered or Exempt CCP from the 

registration requirements of the 

Securities Act and the Exchange Act 

and the provisions of the Trust 

Indenture Act, we believe that the CCPs 

would not be able to operate in the 

manner contemplated by the Exchange 

Act exemptive orders. In addition, the 

Securities Act, Exchange Act and Trust 

Indenture Act exemptions are intended 

to encourage market participants to 

clear their CDS through the CCPs. 

Securities Act Rule 239T also 

provides that any offer or sale of an 

eligible CDS that is or will be issued or 

cleared by a Registered or Exempt CCP 

by or on behalf of the issuer of a 

security, an affiliate of such issuer, or an 

underwriter, if such security is 

delivered in settlement or whose value 

is used to determine the amount of the 

settlement obligation, will constitute a 

‘‘contract for sale of,’’ ‘‘sale of,’’ ‘‘offer 

for sale,’’ or ‘‘offer to sell’’ such security 

under Section 2(a)(3) of the Securities 

Act.26 This provision is intended to 

ensure that an eligible CDS that is or 

will be issued or cleared by a Registered 

or Exempt CCP cannot be used by an 

issuer, affiliate of an issuer or 

underwriter to circumvent the 

registration requirements of Section 5 

with respect to an issuer’s security for 

such eligible CDS.27 As a result, a 

transaction by such persons in an 

eligible CDS that is or will be issued or 

cleared by a Registered or Exempt CCP 

having such securities of the issuer also 

is a transaction in the issuer’s securities 

that must be registered under the 

Securities Act, unless an exemption 

from registration is available. 

We also adopted on an interim final 

temporary basis an amendment to 

Securities Act Rule 146. Under the 

temporary amendment to Rule 146, 

eligible contract participants that are 

sold eligible CDS in reliance on interim 

final temporary Securities Act Rule 

239T are defined as ‘‘qualified 

purchasers’’ under Section 18(b)(3) of 

the Securities Act and thereby such 

eligible CDS that are or will be issued 

or cleared by a Registered or Exempt 

CCP are considered ‘‘covered securities’’ 

under Section 18 of the Securities Act 

and exempt from state blue sky laws.28

B. Exchange Act Rule 12a–10T and Rule 

12h–1(h)T 

In January 2009, we also adopted two 

Interim Final Temporary Rules relating 

to Exchange Act registration of eligible 

CDS that are or have been issued or 

cleared by a Registered or Exempt CCP. 

Exchange Act Rule 12a–10T exempts 

eligible CDS that are or have been 

issued or cleared by a Registered or 

Exempt CCP from the provisions of 

Section 12(a) of the Exchange Act under 

certain conditions.29 Exchange Act Rule 

12h–1(h)T exempts eligible CDS that are 

or have been issued or cleared by a 

Registered or Exempt CCP from the 

provisions of Section 12(g) of the 

Exchange Act under certain 

conditions.30

C. Trust Indenture Act Rule 4d–11T 

We also adopted a rule under Section 

304(d) of the Trust Indenture Act that 

exempts any eligible CDS, as defined in 

Securities Act Rule 239T and offered 

and sold in reliance on Securities Act 

Rule 239T, from having to comply with 

the provisions of the Trust Indenture 

Act.31

III. Amendment of Expiration Date of 

Interim Final Temporary Rules 

In January 2009, we adopted the 

interim final rules on a temporary basis 

until September 25, 2009 because we 

anticipated that this date would provide 

us with adequate time to evaluate the 

availability of the exemptions 

applicable to CDS CCPs and nonexcluded CDS, and whether any 

conditions or provisions of such 


cprice-sewell on DSK2BSOYB1PROD with RULES
47722 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 

32See Section III of Exchange Act Release No. 

59246 (Jan. 14, 2009). 

33See Harrington and Leising, supra note 15 

(quoting Theo Lubke, an official with the Federal 

Reserve Bank of New York responsible for the 

central bank’s efforts to curb risk in the CDS market, 

as stating that ‘‘A competitive [CCP clearing] 

environment, at least in the short run, is beneficial. 

We don’t want the first mover to be the winner just 

because they’re the first mover. We would like to 

see real choice in the market for a period of time 

to determine which is the better mousetrap.’’). See 

also, Financial Services: Cost of Trading Going 

Down, Survey Finds, Europolitics (July 17, 2009) 

(citing European Commissioner Charlie McCreevy, 

‘‘I particularly welcome the [European Commission] 

study’s findings concerning the decreases in costs 

for trading and clearing and to some extent also for 

settlement services since 2006. This confirms the 

positive impact on competition of the Markets in 

Financial Instruments Directive and the code of 

conduct on clearing and settlement.’’). 

34 5 U.S.C. 553(b). 

35 5 U.S.C. 553(b)(B). 

36This finding also satisfies the requirements of 

5 U.S.C. 808(2), allowing the rule amendment to 

become effective notwithstanding the requirement 

of 5 U.S.C. 801 (if a Federal agency finds that notice 

and public comment are ‘‘impractical, unnecessary 

or contrary to the public interest,’’ a rule ‘‘shall take 

effect at such time as the Federal agency 

promulgating the rule determines’’). 

37 5 U.S.C. 553(d). 

38 5 U.S.C. 553(d)(3). 

39 44 U.S.C. 3501 et seq. 

40 44 U.S.C. 3507(d) and 5 CFR 1320.11. 

exemptions should be modified. At the 

time we adopted the Interim Final 

Temporary Rules, we indicated that we 

could act to extend the expiration date 

of such rules.32

We have now determined that it is 

necessary to extend the expiration date 

of the Interim Final Temporary Rules for 

the following reasons. First, we adopted 

the interim final rules to foster the 

development of CCPs by providing 

exemptions from certain regulatory 

provisions that might otherwise prevent 

them from engaging in such activities in 

the manner contemplated by the 

exemptive orders. To date, there has 

been only one CCP (ICE Trust) that has 

begun to clear and settle CDS 

transactions in the U.S. and two CCPs 

(ICE Europe and Eurex) that have begun 

to clear and settle CDS transactions in 

Europe. Extending the expiration date of 

our Interim Final Temporary Rules 

would not only allow ICE Trust, ICE 

Europe and Eurex to continue to clear 

and settle CDS transactions, it would 

also enable other CCPs to start clearing 

and settling CDS transactions in the 

manner contemplated by the exemptive 

orders. Competition among CCPs 

clearing CDS transactions could give 

participants more choice for their 

trading needs and may reduce clearing 

fees.33 In addition, the extension would 

give us more time to evaluate the rule 

and assess its effect on the CDS market 

and the market participants. As 

reflected in the CPSS–IOSCO 

Recommendations, our fellow regulators 

around the world are also thinking 

about how to address the risks 

associated with the central clearing of 

OTC derivatives, and this remains an 

open and current topic of discussion for 

all securities regulators. Finally, 

Treasury has delivered financial 

regulatory reform proposals to Congress, 

and several bills to regulate derivatives 

and the derivatives markets have been 

introduced in Congress. 

Absent an exemption, the offer and 

sale of eligible CDS that are or will be 

issued or cleared by a Registered or 

Exempt CCP may have to be registered 

under the Securities Act, the eligible 

CDS that have been so issued or cleared 

may have to be registered as a class 

under the Exchange Act, and the 

provisions of the Trust Indenture Act 

may need to be complied with. We 

believe that the Interim Final 

Temporary Rules have facilitated and 

anticipate that they will continue to 

facilitate the use by eligible contract 

participants of CDS CCPs. Absent an 

extension of the expiration date of the 

interim final rules, we believe that the 

CCPs would not be able to operate in the 

manner contemplated by the exemptive 

orders. We note that the expiration dates 

of certain of these exemptive orders 

currently extend until April 23, 2010. 

We are, therefore, adopting amendments 

to each of the interim final rules to 

extend the expiration date of the rules 

to November 30, 2010. Extending the 

expiration dates for this length of time 

will allow us to continue to monitor the 

development and operation of CCPs in 

the CDS market under the current, 

evolving regulatory and legislative 

environment. 

IV. Certain Administrative Law Matters 

Section 553(b) of the Administrative 

Procedure Act (‘‘APA’’) 34 generally 

requires an agency to publish notice of 

a proposed rule making in the Federal 

Register. This requirement does not 

apply, however, if the agency ‘‘for good 

cause finds (and incorporates the 

finding and a brief statement of reasons 

therefor in the rules issued) that notice 

and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest.’’ 35 The 

Commission finds good cause to act 

immediately to extend the expiration 

date of the Interim Final Temporary 

Rules. When we adopted the rules in 

January of this year, we sought 

sufficient time to evaluate the 

appropriateness of the exemptions and 

the role of CCPs in the CDS market. 

Since that time, we have granted orders 

to four additional CDS CCPs exempting 

them from the requirement to register as 

a clearing agency under Section 17A of 

the Exchange Act. Two of these orders 

were granted as recently as July 2009, 

and one CCP has started to clear CDS 

transactions in the U.S. and two have 

begun clearing CDS in Europe. In 

addition, there have been a number of 

recent and still developing legislative 

and regulatory initiatives relating to the 

regulation of derivatives, including 

CDS. Finally, we note that commenters 

had an opportunity to comment on the 

length of the temporary rules in January 

of this year and that this extension is of 

a limited duration. Therefore, we 

believe there is good cause to extend the 

exemption until November 30, 2010 and 

find that notice and solicitation of 

comment on the extension to be 

impracticable, unnecessary, or contrary 

to the public interest.36

The APA also generally requires that 

an agency publish an adopted rule in 

the Federal Register 30 days before it 

becomes effective.37 However, this 

requirement does not apply if the 

agency finds good cause not to delay the 

effective date.38 For similar reasons to 

those explained above, the Commission 

finds good cause not to delay the 

effective date. 

V. Paperwork Reduction Act 

The Interim Final Temporary Rules 

do not impose any new ‘‘collections of 

information’’ within the meaning of the 

Paperwork Reduction Act of 1995 

(‘‘PRA’’),39 nor do they create any new 

filing, reporting, recordkeeping, or 

disclosure reporting requirements for a 

CCP that is or will be issuing or clearing 

eligible CDS. Accordingly, we did not 

submit the Interim Final Temporary 

Rules to the Office of Management and 

Budget for review in accordance with 

the PRA.40 We requested comment on 

whether our conclusion that there are 

no collections of information is correct, 

and we did not receive any comment. 

The extension of the expiration dates 

does not change our analysis. 

VI. Cost-Benefit Analysis 

In January 2009, we adopted the 

Interim Final Temporary Rules under 

the Securities Act, the Exchange Act 

and the Trust Indenture Act that exempt 

eligible CDS that are or will be issued 

or cleared by a Registered or Exempt 

CCP and offered and sold only to 

eligible contract participants from all 

provisions of the Securities Act, other 

than the Section 17(a) anti-fraud 

provision, as well as from the 

registration requirements under Section 


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Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 47723 

41See Section I, supra, for additional discussion 

of developments in this area since the adoption of 

the Interim Final Temporary Rules. 

42See Semiannual OTC derivatives statistics at 

end-December 2008, Bank for International 

Settlements (‘‘BIS’’), available at http:// 

www.bis.org/statistics/otcder/dt1920a.pdf. 

43CDSs were initially created to meet the demand 

of banking institutions looking to hedge and 

diversify the credit risk attendant with their lending 

activities. However, other financial institutions 

such as insurance companies, pension funds, 

securities firms and hedge funds have entered the 

CDS market. 

44See Karen Brettell, Banks to submit 95 pct of 

eligible CDS for clearing (Sep. 1, 2009), available at 

http://www.reuters.com/article/euRegulatoryNews/

idUSN0150814420090901?pageNumber=1&virtual

BrandChannel=10522. 

45See e.g., Exchange Act Release No. 59527, 

supra Note 10 (our exemptions require that the 

CCPs provide us with, among other things, access 

to conduct on-site inspections of facilities, records 

and personnel). 

46See Testimony of Mark Lenczowski, supra Note 

12. 

47See e.g., Exchange Act Release No. 59527, 

supra Note 26. 

48See IntercontinentalExchange, supra Note 13. 

49See, e.g., Securities Act Section 3(a)(14) [15 

U.S.C. 77c(a)(14)], Securities Act Rule 238 [17 CFR 

230.238]; Exchange Act Section 12(a) [15 U.S.C. 

78l], and Exchange Act Rule 12h–1(d) and (e) [17 

CFR 240.12h–1(d) and (e)]. 50 17 CFR 230.238. 

12 of the Exchange Act and from the 

provisions of the Trust Indenture Act. 

The Interim Final Temporary Rules 

were intended to facilitate the operation 

of one or more CCPs to act as a clearing 

agency in the CDS market to reduce 

some of the risks in the CDS market. 

Today, we are adopting amendments to 

such rules to extend their expiration 

date to November 30, 2010. 

Since the adoption of the Interim 

Final Temporary Rules, one CCP (ICE 

Trust) has been actively engaged as a 

CCP in clearing CDS transactions in the 

U.S. in accordance with terms of the 

exemptive orders, and two other CCPs 

(ICE Europe and Eurex) have begun 

clearing CDS transactions in Europe. In 

addition, a number of legislative 

initiatives relating to the regulation of 

derivatives, including CDS, have been 

introduced by members of Congress and 

recommended by the United States 

Department of the Treasury.41

Extending the expiration dates of the 

Interim Final Temporary Rules for this 

length of time will allow us to continue 

to monitor the development and 

operation of CCPs in the CDS market 

under the current, evolving regulatory 

and legislative environment. 

A CDS is a bilateral contract between 

two parties, known as counterparties. 

The value of this financial contract is 

based on underlying obligations of a 

single entity, or on a particular security 

or other debt obligation, or an index of 

several such entities, securities, or 

obligations. The obligation of a seller to 

make payment under a CDS contract is 

triggered by a default or other credit 

event as to such entity or entities or 

such security or securities. Investors 

may use CDS for a variety of reasons, 

including to offset or insure against risk 

in their fixed-income portfolios, to take 

synthetic positions in bonds or in 

segments of the debt market as 

represented by an index, or to capitalize 

on the volatility in credit spreads during 

times of economic uncertainty. In recent 

years, CDS market volumes have rapidly 

increased.42 This growth has coincided 

with a significant rise in the types and 

number of entities participating in the 

CDS market.43

In a CCP arrangement, both parties 

entering a CDS novate their trades to the 

CCP, and the CCP stands in as the 

counterparty to all parties of the CDS it 

clears. Through this novation process, 

the counterparty risk of a CDS is 

effectively concentrated in the CCP. 

A. Benefits 

We are extending the termination date 

of the Interim Final Temporary Rules 

that provide exemptions from certain 

provisions of the Securities Act, the 

Exchange Act and the Trust Indenture 

Act, subject to certain conditions 

described in the CCP exemptive orders 

and in the exemptions themselves to 

further facilitate the operation of CCPs 

in the CDS market. The conditions and 

representations in the CCP exemptive 

orders and exemptions require that 

information be available about the terms 

of the CDS, the creditworthiness of the 

CCP or any guarantor, and the clearing 

and settlement process for the CDS. 

Additionally, the conditions require that 

financial information about the 

reference entity, the issuer of the 

reference security, or the reference 

security be publicly available. We 

believe that the Interim Final 

Temporary Rules and the exemptions 

under the Exchange Act, have facilitated 

and we anticipate will continue to 

facilitate the operation of CCPs 44 while 

enabling us to provide oversight to the 

non-excluded CDS market.45 We believe 

that the operation of at least one CCP 

over the last six months in accordance 

with our exemptions has increased 

transparency,46 increased available 

information about exposures to 

particular reference entities or reference 

securities,47 and reduced risks to 

participants in the market for CCPcleared CDS.48 Not extending the 

termination date could cause significant 

disruptions in this market. Therefore, 

we believe this extension provides 

important benefits. 

Absent an exemption, the offer and 

sale of eligible CDS that are and will be 

issued or cleared by a Registered or 

Exempt CCP would have to be registered 

under the Securities Act, the eligible 

CDS that are or have been issued or 

cleared by a Registered or Exempt CCP 

would have to be registered as a class 

under the Exchange Act, and the 

provisions of the Trust Indenture Act 

would apply. We believe that the 

Interim Final Temporary Rules 

exempting the registration of eligible 

CDS issued or cleared by a Registered or 

Exempt CCP under certain conditions 

have facilitated and we anticipate will 

continue to facilitate the use by eligible 

contract participants of CDS CCPs. 

Without also exempting the offers and 

sales of eligible CDS issued or cleared 

by a Registered or Exempt CCP from the 

registration requirements of the 

Securities Act and the Exchange Act 

and the provisions of the Trust 

Indenture Act, we believe that the CCPs 

would not be able to operate in the 

manner contemplated by the exemptive 

orders. 

The interim final temporary 

exemptions treat eligible CDS issued or 

cleared by a Registered or Exempt CCP 

under the Securities Act and the 

Exchange Act in the same manner as 

certain other types of derivative 

contracts, such as security futures 

products and standardized options.49 A 

Registered or Exempt CCP issuing or 

clearing eligible CDS benefits from the 

temporary exemptions because it does 

not have to file registration statements 

with us covering the offer and sale of 

the eligible CDS. The registration form 

most applicable to a CCP is a Form 

S–20, which is the form that is used by 

options clearing houses that do not 

qualify for our exemption in Securities 

Act Rule 238 50 from registering the offer 

and sale of standardized options. If a 

CCP is not required to register the offer 

and sale of eligible CDS (on Form S–20, 

for example), it would not have to incur 

the costs of such registration, including 

legal and accounting costs. Some of 

these costs, of course, such as the costs 

of obtaining audited financial 

statements, may still be incurred as a 

result of the operations of the entity as 

a CCP and the regulatory oversight of 

the central counterparty operations. In 

addition, if any of the CCPs are entities 

that are subject to the periodic reporting 

requirements of the Exchange Act, the 

cost of filing a registration statement 

covering the eligible CDS would be 

lessened further as the information 

regarding the CCP already would be 

prepared. The availability of exemptions 

under the Securities Act, the Exchange 


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47724 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 

51 15 U.S.C. 78j(b). 

52 15 U.S.C. 77k and 77l. 

53See 15 U.S.C. 77q and 15 U.S.C. 78j(b). 

54 15 U.S.C. 78w(a)(2). 

55 15 U.S.C. 77b(b). 

56 15 U.S.C. 78c(f). 

Act, and the Trust Indenture Act also 

would mean that CCPs would not incur 

the costs of preparing disclosure 

documents describing eligible CDS and 

from preparing indentures and 

arranging for the services of a trustee. 

B. Costs 

The Interim Final Temporary Rules 

exempting offers and sales of eligible 

CDS that are or will be issued or cleared 

by a Registered or Exempt CCP have 

facilitated and we anticipate will 

continue to facilitate the use by eligible 

contract participants of CDS CCPs that 

are the subject of exemptive orders at 

some costs to the CCP or investors. 

Absent an exemption, a CCP may 

have to file a registration statement 

covering the offer and sale of the eligible 

CDS, may have to satisfy the applicable 

provisions of the Trust Indenture Act, 

and may have to register the class of 

eligible CDS that it has issued or cleared 

under the Exchange Act, which would 

provide investors with civil remedies in 

addition to antifraud remedies. While a 

CCP registration statement covering 

eligible CDS (or the offer and sale of 

such eligible CDS) may provide certain 

information about the CCP, CDS 

contract terms, and the identification of 

reference entities or reference securities, 

it would not necessarily provide the 

type of information necessary to assess 

the credit risk of the reference entity or 

reference security. Further, while a CCP 

registration statement would provide 

information to the CDS market 

participants, as well as to the market as 

a whole, a condition of the clearing 

agency exemption in the exemptive 

orders is that the CCPs make their 

audited financial statements and other 

information about themselves publicly 

available. 

We recognize that a consequence of 

the exemptions has been and will 

continue to be the unavailability of 

certain remedies under the Securities 

Act and the Exchange Act and certain 

protections under the Trust Indenture 

Act. While an investor would be able to 

pursue an antifraud action in 

connection with the purchase and sale 

of eligible CDS under Exchange Act 

Section 10(b),51 it would not be able to 

pursue civil remedies under Sections 11 

or 12 of the Securities Act.52 We could 

still pursue an antifraud action in the 

offer and sale of eligible CDS issued or 

cleared by a CCP.53 We believe that the 

incremental costs from the extension of 

the expiration date of the Interim Final 

Temporary Rules will be minimal 

because the amendments are merely an 

extension of such Interim Final 

Temporary Rules and such extension 

will not affect the information and 

remedies available to investors as a 

result of the Interim Final Temporary 

Rules. 

VII. Consideration of Impact on the 

Economy, Burden on Competition and 

Promotion of Efficiency, Competition 

and Capital Formation 

Section 23(a)(2) of the Exchange 

Act 54 requires us, when adopting rules 

under the Exchange Act, to consider the 

impact that any new rule would have on 

competition. Section 23(a)(2) prohibits 

us from adopting any rule that would 

impose a burden on competition not 

necessary or appropriate in furtherance 

of the purposes of the Exchange Act. In 

addition, Section 2(b) 55 of the Securities 

Act and Section 3(f) 56 of the Exchange 

Act require us, when engaging in 

rulemaking where we are required to 

consider or determine whether an action 

is necessary or appropriate in the public 

interest, to also consider whether the 

action will promote efficiency, 

competition, and capital formation. 

The Interim Final Temporary Rules 

we are extending today exempt eligible 

CDS issued or cleared by a Registered or 

Exempt CCP from all provisions of the 

Securities Act, other than the Section 

17(a) antifraud provision, as well as 

from the registration requirements 

under Section 12 of the Exchange Act 

and the provisions of the Trust 

Indenture Act. Because these interim 

final temporary exemptions are 

available to any Registered or Exempt 

CCP offering and selling eligible CDS, 

we do not believe that the exemptions 

impose a burden on competition. 

Although only one CCP is currently 

clearing and settling CDS in the U.S., we 

believe the extension will increase the 

opportunity for other CCPs to compete 

in the marketplace. We also believe that 

the ability to settle CDS through CCPs 

has improved and we anticipate will 

continue to improve the transparency of 

the CDS market and provide greater 

assurance to participants as to the 

capacity of the eligible CDS 

counterparty to perform its obligations 

under the eligible CDS. ICE Trust, for 

example, makes available on its Web 

site information about open interests, or 

net exposure, volume and pricing of 

CDS transactions. We believe that 

increased transparency in the CDS 

market could help to decrease further 

market turmoil and thereby facilitate the 

capital formation process. 

VIII. Regulatory Flexibility Act 

Certification 

The Commission certified pursuant to 

5 U.S.C. 605(b) that the Interim Final 

Temporary Rules would not have a 

significant economic impact on a 

substantial number of small entities. 

The Interim Final Temporary Rules 

exempt eligible CDS that are or will be 

issued or cleared by a Registered or 

Exempt CCP. None of the entities that 

are eligible to meet the requirements of 

the exemption from registration under 

Section 17A is a small entity. We 

received no comments on the 

certification. 

IX. Statutory Authority and Text of the 

Rules and Amendments 

The amendments described in this 

release are being adopted under the 

authority set forth in Sections 18, 19 

and 28 of the Securities Act; Sections 

12(h), 23(a) and 36 of the Exchange Act; 

and Section 304(d) of the Trust 

Indenture Act. 

List of Subjects in 17 CFR Parts 230, 

240 and 260 

Reporting and recordkeeping 

requirements, Securities. 

Text of the Rules and Amendments 

■ Accordingly, we are temporarily 

amending 17 CFR parts 230, 240, and 

260 as follows and the expiration date 

for the interim final temporary rules 

published January 22, 2009 (74 FR 3967) 

is extended from September 25, 2009, to 

November 30, 2010. 

PART 230—GENERAL RULES AND 

REGULATIONS, SECURITIES ACT OF 

1933 

■ 1. The authority citation for Part 230 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77b, 77c, 77d, 77f, 

77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, 78c, 78d, 

78j, 78l, 78m, 78n, 78o, 78t, 78w, 78ll(d), 

78mm, 80a–8, 80a–24, 80a–28, 80a–29, 80a– 

30, and 80a–37, unless otherwise noted. 

* * * * * 

§§ 230.146 and 230.239 [Amended] 

■ 2. In § 230.146(c)T, in the last 

sentence, remove the words ‘‘September 

25, 2009’’ and add, in their place, the 

words ‘‘November 30, 2010’’. 

■ 3. In § 230.239T(e), remove the words 

‘‘September 25, 2009’’ and add, in their 

place, the words ‘‘November 30, 2010’’. 


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Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 47725 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 4. The authority citation for Part 240 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p, 

78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a– 

20, 80a–23, 80a–29, 80a–37, 80b–3, 80b–4, 

80b–11, and 7201 et seq.; and 18 U.S.C. 1350, 

unless otherwise noted. 

* * * * * 

§§ 240.12a–10T and 240.12h–1 [Amended] 

■ 5. In § 240.12a–10T(b), remove the 

words ‘‘September 25, 2009’’ and add, 

in their place, the words ‘‘November 30, 

2010’’. 

■ 6. In § 240.12h–1(h)T, in the last 

sentence, remove the words ‘‘September 

25, 2009’’ and add, in their place, the 

words ‘‘November 30, 2010’’. 

PART 260—GENERAL RULES AND 

REGULATIONS, TRUST INDENTURE 

ACT OF 1939 

■ 7. The authority citation for Part 260 

continues to read as follows: 

Authority: 15 U.S.C. 77eee, 77ggg, 77nnn, 

77sss, 78ll(d), 80b–3, 80b–4, and 80b–11. 

§ 260.4d–11T [Amended] 

■ 8. Section 260.4d–11T is amended by 

removing the words ‘‘September 25, 

2009’’ and adding, in their place, the 

words ‘‘November 30, 2010’’ in the last 

sentence. 

September 14, 2009. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. E9–22389 Filed 9–16–09; 8:45 am] 

BILLING CODE 8010–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Fomepizole 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of an abbreviated new 

animal drug application (ANADA) filed 

by Synerx Pharma, LLC. The ANADA 

provides for the veterinary prescription 

use of fomepizole injectable solution as 

an antidote for ethylene glycol 

(antifreeze) poisoning in dogs. 

DATES: This rule is effective September 

17, 2009. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Synerx 

Pharma, LLC, 100 N. State St., 

Newtown, PA 18940–2048, filed 

ANADA 200–472 that provides for 

veterinary prescription use of 

Fomepizole for Injection as an antidote 

for ethylene glycol (antifreeze) 

poisoning in dogs. Synerx Pharma, 

LLC’s Fomepizole for Injection is 

approved as a generic copy of Paladin 

Laboratories’ ANTIZOL–VET 

(fomepizole), approved under NADA 

141–075. The ANADA is approved as of 

2009, and the regulations are amended 

in 21 CFR 522.1004 to reflect the 

approval. 

In addition, Synerx Pharma, LLC, is 

not currently listed in the animal drug 

regulations as a sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to add 

entries for this sponsor. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

FDA has determined under 21 CFR 

25.33 that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510 and 522 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), alphabetically add an 

entry for ‘‘Synerx Pharma, LLC’’; and in 

the table in paragraph (c)(2), 

numerically add an entry for ‘‘068882’’ 

to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Synerx Pharma, LLC, 100 

N. State St., Newtown, 

PA 18940–2048 

068882 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

068882 Synerx Pharma, LLC, 100 

N. State St., Newtown, 

PA 18940–2048 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. In § 522.1004, revise paragraph (b) 

to read as follows: 

§ 522.1004 Fomepizole. 

* * * * * 


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