52426 Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Rules and Regulations 

1See Dodd-Frank Wall Street Reform and 

Consumer Protection Act of 2010, Public Law 111– 

203, 124 Stat. 1376 (2010). The text of the DoddFrank Act may be accessed at http://www.cftc.gov/ 

LawRegulation/OTCDERIVATIVES/index.htm. 

2Pursuant to section 701 of the Dodd-Frank Act, 

Title VII may be cited as the ‘‘Wall Street 

Transparency and Accountability Act of 2010.’’ 

3 7 U.S.C. 1 et seq. 

4 7 U.S.C. 2(c)(2)(D). 

5 7 U.S.C. 2(c)(2)(D)(i). 

6 7 U.S.C. 6(a) (prohibition against off-exchange 

contracts of sale of a commodity for future 

delivery). 

7 7 U.S.C. 6(b) (regulation of foreign boards of 

trade with United States participants). 

8 7 U.S.C. 6b (prohibition against fraud). 

9 7 U.S.C. 2(c)(2)(D)(iii). 

10 7 U.S.C. 2(c)(2)(D)(ii)(III)(aa). 

11The Commission has not adopted any 

regulations permitting a longer actual delivery 

period for any commodity pursuant to new CEA 

section 2(c)(2)(D)(ii)(III)(aa). Accordingly, the 28- 

day actual delivery period set forth in this provision 

remains applicable to all commodities. 

12Retail Commodity Transactions Under 

Commodity Exchange Act, 76 FR 77670 (Dec. 14, 

2011). 

13The comment file may be accessed at http://

comments.cftc.gov/PublicComments/

CommentList.aspx?id=1124. 

14National Futures Association (NFA). 

15 Dillon Gage Group (DGG) and Monex Deposit 

Company and its affiliate (MDC). 

16 J.B. Grossman P.A. (JBG), Greenberg Traurig, 

LLP (GBT), and Rothgerber Johnson & Lyons LLP 

(RJL). 

17National Energy Markets Association (NEM), 

Retail Energy Supply Association (RESA), and 

Commercial Energy Working Group (CEWG). 

18Constellation NewEnergy, Inc., Green 

Mountain Energy Company, Direct Energy Services, 

LLC, Exelon Energy Company, Reliant Energy Retail 

Holdings, LLC, Liberty Power Corporation, and 

Champion Energy Services, LLC. 

Issued in College Park, Georgia, on August 

16, 2013. 

Kip B. Johns, 

Manager, Operations Support Group, Eastern 

Service Center, Air Traffic Organization. 

[FR Doc. 2013–20512 Filed 8–22–13; 8:45 am] 

BILLING CODE 4910–13–P 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Part 1 

RIN 3038–AD64 

Retail Commodity Transactions Under 

Commodity Exchange Act 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Interpretation. 

SUMMARY: On December 14, 2011, the 

Commodity Futures Trading 

Commission (‘‘Commission’’ or 

‘‘CFTC’’) issued in the Federal Register 

an interpretation (‘‘Interpretation’’) 

regarding the meaning of the term 

‘‘actual delivery,’’ as set forth in the 

Commodity Exchange Act. The 

Commission also requested public 

comment on whether the Interpretation 

accurately construed the statutory 

language. In response to the comments 

received, the Commission has 

determined to clarify its Interpretation. 

DATES: Effective August 23, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Rosemary Hollinger, Regional Counsel, 

Division of Enforcement, 312–596–0538, 

rhollinger@cftc.gov, or Martin B. White, 

Assistant General Counsel, Office of the 

General Counsel, 202–418–5129, 

mwhite@cftc.gov, Commodity Futures 

Trading Commission, Three Lafayette 

Centre, 1155 21st Street NW., 

Washington, DC 20581. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 21, 2010, President Obama 

signed the Dodd-Frank Wall Street 

Reform and Consumer Protection Act 

(‘‘Dodd-Frank Act’’).1 Title VII of the 

Dodd-Frank Act 2 amended the 

Commodity Exchange Act (‘‘CEA’’) 3 to 

establish a comprehensive new 

regulatory framework for swaps and 

security-based swaps. The legislation 

was enacted to reduce risk, increase 

transparency, and promote market 

integrity within the financial system by, 

among other things: (1) Providing for the 

registration and comprehensive 

regulation of swap dealers and major 

swap participants; (2) imposing clearing 

and trade execution requirements on 

standardized derivative products; (3) 

creating robust recordkeeping and realtime reporting regimes; and (4) 

enhancing the Commission’s 

rulemaking and enforcement authorities 

with respect to, among others, all 

registered entities and intermediaries 

subject to the Commission’s oversight. 

In addition, section 742(a) of the 

Dodd-Frank Act amends section 2(c)(2) 

of the CEA to add a new subparagraph, 

section 2(c)(2)(D) of the CEA,4 entitled 

‘‘Retail Commodity Transactions.’’ New 

CEA section 2(c)(2)(D) broadly applies 

to any agreement, contract, or 

transaction in any commodity that is 

entered into with, or offered to (even if 

not entered into with), a non-eligible 

contract participant or non-eligible 

commercial entity on a leveraged or 

margined basis, or financed by the 

offeror, the counterparty, or a person 

acting in concert with the offeror or 

counterparty on a similar basis.5 New 

CEA section 2(c)(2)(D) further provides 

that such an agreement, contract, or 

transaction shall be subject to CEA 

sections 4(a),6 4(b),7 and 4b 8 as if the 

agreement, contract, or transaction was 

a contract of sale of a commodity for 

future delivery.9

New CEA section 2(c)(2)(D) excepts 

certain transactions from its application. 

In particular, new CEA section 

2(c)(2)(D)(ii)(III)(aa) 10 excepts a contract 

of sale that results in actual delivery 

within 28 days or such other longer 

period as the Commission may 

determine by rule or regulation based 

upon the typical commercial practice in 

cash or spot markets for the commodity 

involved.11

On December 14, 2011, the 

Commission issued an Interpretation 

inviting public comment on whether its 

stated interpretation of the term ‘‘actual 

delivery,’’ as used in new CEA section 

2(c)(2)(D)(ii)(III)(aa), accurately 

construes the statutory language.12 The 

Commission received several public 

comments on the Interpretation. After 

thoroughly reviewing those comments, 

the Commission has determined to 

clarify its Interpretation in response to 

the comments received. 

II. Summary of Comments 

A. Comments Generally 

The Commission received 13 

comments in response to its 

Interpretation.13 The comments 

included 11 comment letters that 

addressed the Interpretation. These 11 

comment letters were submitted by 

entities representing a broad range of 

interests, including a self-regulatory 

organization,14 precious metals dealers 

and depository companies,15 law 

firms,16 trade associations comprised of 

energy producers and suppliers,17 and 

electricity and natural gas suppliers.18

Of the 11 comment letters addressing 

the Interpretation, two voiced general 

support for the Interpretation. For 

example, NFA stated: 

NFA fully supports the Commission’s 

proposed interpretation of the term [actual 

delivery] and believes that it is consistent 

with the statutory language. 

The comment letter submitted by 

DGG expressed its appreciation of the 

Commission’s efforts to ‘‘curtail any 

fraudulent retail commodity 

transactions occurring by unscrupulous 

actors.’’ DGG further urged the 

Commission to consider delivery of 

precious metals to affiliates of the seller, 

but not to the seller itself, as 

constituting actual delivery under new 

CEA section 2(c)(2)(D)(ii)(III)(aa), stating 

that ‘‘[w]hile we understand the CFTC’s 

desire to ensure, among other things, 

that the seller actually has the 

commodity to deliver, an affiliate of one 

of the limited types of depositories 

described in Example 2 [of the 

Interpretation] are unlikely to be the 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Rules and Regulations 52427 

19 76 FR 77670, 77672 (Dec. 14, 2011). 

20 Id. 

seller ‘fraudsters’ Senator Lincoln had 

in mind.’’ 

Two of the comment letters submitted 

by law firms generally did not support 

the Interpretation. GBT stated that 

neither the Dodd-Frank Act nor its 

legislative history indicated Congress’s 

desire to limit the depositories to which 

actual delivery could be made, and JBG 

voiced its view that delivery in the 

context of precious and industrial 

metals requires only transfer of title to 

metal, not physical delivery of metal. 

The third comment letter submitted 

by a law firm, RJL, was submitted on 

behalf of precious metals dealers. RJL 

requested clarification of when the 

Commission will consider the 28 days 

in new CEA section 2(c)(2)(D)(ii)(III)(aa) 

to begin and urged the Commission to 

allow for delivery of precious metals to 

additional depositories beyond those 

described in the Interpretation. RJL also 

requested clarification, as did MDC, a 

retail precious metals dealer, of whether 

the offset of a precious metals purchase 

prior to transfer of title to the customer 

and delivery of the precious metals to a 

depository within 28 days would cause 

the original purchase to become a 

prohibited transaction under new CEA 

section 2(c)(2)(D). 

Finally, four of the comment letters 

were submitted by energy suppliers or 

trade associations comprised of energy 

producers and suppliers, and they 

generally requested clarification of 

whether new CEA section 2(c)(2)(D) 

and/or its exceptions apply to the sale 

and delivery of physical energy 

commodities, such as electricity and 

natural gas, to industrial, commercial, 

and/or retail customers on a recurring 

basis. For example, NEMA requested: 

that the Commission clarify that the type of 

transactions which its retail energy marketer 

members typically enter into with residential 

and commercial customers, in which they 

contract with the customer to provide 

physical energy supply (electricity or natural 

gas) for terms that regularly in the course of 

business contemplate delivery of the physical 

energy commodity in excess of 28 days, were 

not intended and should not be interpreted 

to constitute ‘retail commodity transactions’ 

under the Act. 

B. Specific Comments 

1. Functional Approach and Relevant 

Factors 

Significantly, no commenters 

criticized, expressed disagreement with, 

or questioned the underlying foundation 

for the Commission’s approach in 

determining whether ‘‘actual delivery’’ 

has occurred, as set forth in the 

Interpretation: ‘‘The determination of 

whether ‘actual delivery’ has occurred 

within the meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa) requires 

consideration of evidence regarding 

delivery beyond the four corners of 

contract documents;’’ and ‘‘in 

determining whether actual delivery has 

occurred within 28 days, the 

Commission will employ a functional 

approach and examine how the 

agreement, contract, or transaction is 

marketed, managed, and performed, 

instead of relying solely on language 

used by the parties in the agreement, 

contract, or transaction.’’ 19 Further, no 

comment letters criticized, expressed 

disagreement with, or questioned the 

relevant factors the Commission 

enumerated in the Interpretation: 

Ownership, possession, title, and 

physical location of the commodity 

purchased or sold, both before and after 

execution of the agreement, contract, or 

transaction; the nature of the 

relationship between the buyer, seller, 

and possessor of the commodity 

purchased or sold; and the manner in 

which the purchase or sale is recorded 

and completed.20 Accordingly, the 

Commission will assess whether any 

given transaction results in actual 

delivery within the meaning of new 

CEA section 2(c)(2)(D)(ii)(III)(aa) by 

employing the functional approach and 

considering the factors set forth in the 

Interpretation. 

2. When the 28-Day Period Begins 

In response to the comment from RJL, 

the Commission is clarifying when it 

will consider the 28-day period in new 

CEA section 2(c)(2)(D)(ii)(III)(aa) to 

begin. The Commission has determined 

that the most practical point at which to 

begin counting the 28 days is the date 

on which the agreement, contract, or 

transaction is entered into. This 

approach is consistent with the 

functional approach the Commission 

will take in determining whether actual 

delivery has occurred, and it should 

provide industry participants and the 

public with a readily ascertainable date 

for determining whether actual delivery 

has occurred within the meaning of new 

CEA section 2(c)(2)(D)(ii)(III)(aa). 

3. Interpretation Examples 

The Interpretation included five 

examples to illustrate how the 

Commission would determine whether 

actual delivery has occurred within the 

meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa), and several 

comment letters urged the Commission 

to allow for delivery of commodities to 

depositories beyond those described in 

Example 2 or expressed disagreement 

with any limitation imposed on 

acceptable depositories or the precise 

form of delivery. The Commission has 

considered these comments and has 

determined to clarify the intent behind 

these examples. 

The examples are non-exclusive and 

are included to provide the public with 

guidance on how the Commission will 

apply the relevant factors enumerated in 

the Interpretation in making its 

determination of whether actual 

delivery has occurred within the 

meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa). Examples 1 and 2 

do not encompass all scenarios in which 

the Commission may determine that 

actual delivery has occurred, nor do 

Examples 3, 4, and 5 encompass all 

scenarios in which the Commission may 

determine that actual delivery has not 

occurred. Specifically, with regard to 

Example 2, the Commission may 

determine that actual delivery has 

occurred if a commodity is delivered to 

an affiliate of the seller or is already 

physically located at a depository, so 

long as the commodity is otherwise 

delivered in accordance with the 

methods described in Example 2, if a 

careful consideration of the other 

relevant factors enumerated in the 

Interpretation demonstrates that the 

purported delivery is not simply a sham 

and that actual delivery has occurred 

within the meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa). Conversely, the 

Commission may determine that actual 

delivery has not occurred if a 

commodity is purportedly delivered to 

an affiliate of the seller, but the 

Commission is unable to obtain 

sufficient assurances within a 

reasonable period of time that the 

purported delivery is not simply a 

sham. 

4. Offsetting of Transactions 

Two commenters, in response to 

Example 5 of the Interpretation, 

requested clarification of whether the 

offset of a precious metals purchase 

prior to transfer of title to the customer 

and delivery of the precious metals to a 

depository within 28 days would cause 

the original purchase to become a 

prohibited transaction under new CEA 

section 2(c)(2)(D). After careful 

consideration of this comment, the 

Commission has determined that 

Example 5 accurately illustrates the 

Commission’s views of whether actual 

delivery will have occurred under the 

circumstances described in Example 5. 

However, the Commission recognizes 

that a customer may request to cancel a 

purchase of a commodity prior to actual 

delivery of the commodity within 28 

days due to extraordinary market 


emcdonald on DSK67QTVN1PROD with RULES
52428 Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Rules and Regulations 

21 7 U.S.C. 2(c)(2)(D)(ii)(III)(bb). 

22 7 U.S.C. 1a(27). 

23 7 U.S.C. 1a(47)(B)(ii). 

24See, e.g., Statutory Interpretation Concerning 

Forward Transactions, 55 FR 39188 (Sept. 25, 1990) 

(‘‘Brent Interpretation’’). 

25Based on Examples 1 and 2, an agreement, 

contract, or transaction that results in ‘‘physical 

delivery’’ within the meaning of section 

1.04(a)(2)(i)–(iii) of the Model State Commodity 

Code would ordinarily result in ‘‘actual delivery’’ 

under new CEA section 2(c)(2)(D)(ii)(III)(aa), absent 

other evidence indicating that the purported 

delivery is a sham. See Model State Commodity 

Code § 1.04(a)(2)(i)–(iii), Comm. Fut. L. Rep. 

Archive (CCH) ¶ 22,568 (Apr. 5, 1985). Conversely, 

an agreement, contract, or transaction that does not 

result in ‘‘physical delivery’’ within the meaning of 

section 1.04(a)(2)(i)–(iii) of the Model State 

Commodity Code is highly unlikely to result in 

‘‘actual delivery’’ under new CEA section 

2(c)(2)(D)(ii)(III)(aa). 

circumstances. Accordingly, the 

Commission will not prosecute a seller 

for permitting such a cancellation, 

provided that the seller does so only on 

limited occasions and at the customer’s 

request, and further provided that the 

customer does not enter into a 

subsequent transaction within three 

business days of such cancellation. 

5. Energy Producers and Suppliers 

Four comment letters requested 

clarification of whether new CEA 

section 2(c)(2)(D) and/or any of its 

exceptions apply to the sale and 

delivery of physical energy commodities 

to industrial, commercial, and/or retail 

customers on a recurring basis. 

Specifically, under the scenario 

described in these comment letters, 

energy firms enter into fixed price 

contracts with customers to supply 

electricity or natural gas to the 

customer’s residence or business for a 

period of one or more years. The 

customer consumes the electricity or 

natural gas and subsequently pays for 

that usage, along with all applicable 

taxes, on a periodic basis. The 

Commission is not of the view that new 

CEA section 2(c)(2)(D) applies to this 

scenario, particularly in light of the fact 

that the customer regularly receives 

delivery of and consumes the physical 

energy commodity over the term of the 

contract and periodically pays for that 

usage. 

III. Commission Interpretation of 

‘‘Actual Delivery’’ 

In consideration of the foregoing, the 

Commission issues the following 

interpretation to inform the public of 

the Commission’s views as to the 

meaning of the term ‘‘actual delivery’’ as 

used in new CEA section 

2(c)(2)(D)(ii)(III)(aa) and to provide the 

public with guidance on how the 

Commission intends to assess whether 

any given transaction results in actual 

delivery within the meaning of the 

statute. This interpretation does not 

address the meaning or scope of new 

CEA section 2(c)(2)(D)(ii)(III)(bb) 21 or 

any exception to new CEA section 

2(c)(2)(D) other than new CEA section 

2(c)(2)(D)(ii)(III)(aa). Similarly, this 

interpretation does not address the 

meaning or scope of contracts of sale of 

a commodity for future delivery, the 

forward contract exclusion from the 

term ‘‘future delivery’’ set forth in CEA 

section 1a(27),22 or the forward contract 

exclusion from the term ‘‘swap’’ set 

forth in CEA section 1a(47)(B)(ii).23 Nor 

does this interpretation alter any 

statutory interpretation or statement of 

Commission policy relating to the 

forward contract exclusion.24

In the view of the Commission, the 

determination of whether ‘‘actual 

delivery’’ has occurred within the 

meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa) requires 

consideration of evidence regarding 

delivery beyond the four corners of 

contract documents. This interpretation 

of the statutory language is based on 

Congress’s use of the word ‘‘actual’’ to 

modify ‘‘delivery’’ and on the legislative 

history of new CEA section 

2(c)(2)(D)(ii)(III)(aa) described above. 

Consistent with this interpretation of 

the statutory language, in determining 

whether actual delivery has occurred 

within 28 days of the date the 

agreement, contract, or transaction is 

entered into, the Commission will 

employ a functional approach and 

examine how the agreement, contract, or 

transaction is marketed, managed, and 

performed, instead of relying solely on 

language used by the parties in the 

agreement, contract, or transaction. This 

approach best accomplishes Congress’s 

intent when it enacted section 742(a) of 

the Dodd-Frank Act and gives full 

meaning to Congress’s term ‘‘actual 

delivery.’’ 

Relevant factors in this determination 

include the following: Ownership, 

possession, title, and physical location 

of the commodity purchased or sold, 

both before and after execution of the 

agreement, contract, or transaction, 

including all related documentation; the 

nature of the relationship between the 

buyer, seller, and possessor of the 

commodity purchased or sold; and the 

manner in which the purchase or sale is 

recorded and completed. The 

Commission provides the following 

non-exclusive examples to illustrate 

how it will determine whether actual 

delivery has occurred within the 

meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa). The Commission 

may also determine that actual delivery 

has occurred in circumstances beyond 

those described in the first two 

examples if it can readily determine 

within a reasonable period of time that 

the purported delivery is not simply a 

sham and that actual delivery has 

occurred within 28 days within the 

meaning of new CEA section 

2(c)(2)(D)(ii)(III)(aa). 

Example 1: Actual delivery will have 

occurred if, within 28 days, the seller has: (1) 

Physically delivered the entire quantity of 

the commodity purchased by the buyer, 

including any portion of the purchase made 

using leverage, margin, or financing, into the 

possession of the buyer; and (2) has 

transferred title to that quantity of the 

commodity to the buyer. 

Example 2: Actual delivery will have 

occurred if, within 28 days, the seller has: (1) 

Physically delivered the entire quantity of 

the commodity purchased by the buyer, 

including any portion of the purchase made 

using leverage, margin, or financing, whether 

in specifically segregated or fungible bulk 

form, into the possession of a depository 

other than the seller and its parent company, 

partners, agents, and other affiliates, that is: 

(a) A financial institution as defined by the 

CEA; (b) a depository, the warrants or 

warehouse receipts of which are recognized 

for delivery purposes for any commodity on 

a contract market designated by the 

Commission; or (c) a storage facility licensed 

or regulated by the United States or any 

United States agency; and (2) has transferred 

title to that quantity of the commodity to the 

buyer.25

Example 3: Actual delivery will not have 

occurred if, within 28 days, a book entry is 

made by the seller purporting to show that 

delivery of the commodity has been made to 

the buyer and/or that a sale of a commodity 

has subsequently been covered or hedged by 

the seller through a third party contract or 

account, but the seller has not, in accordance 

with the methods described in Example 1 or 

2, physically delivered the entire quantity of 

the commodity purchased by the buyer, 

including any portion of the purchase made 

using leverage, margin, or financing, and 

transferred title to that quantity of the 

commodity to the buyer, regardless of 

whether the agreement, contract, or 

transaction between the buyer and seller 

purports to create an enforceable obligation 

on the part of the seller, or a parent company, 

partner, agent, or other affiliate of the seller, 

to deliver the commodity to the buyer. 

Example 4: Actual delivery will not have 

occurred if, within 28 days, the seller has 

purported to physically deliver the entire 

quantity of the commodity purchased by the 

buyer, including any portion of the purchase 

made using leverage, margin, or financing, in 

accordance with the method described in 

Example 2, and transfer title to that quantity 

of the commodity to the buyer, but the title 

document fails to identify the specific 

financial institution, depository, or storage 

facility with possession of the commodity, 

the quality specifications of the commodity, 

the identity of the party transferring title to 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Rules and Regulations 52429 

the commodity to the buyer, and the 

segregation or allocation status of the 

commodity. 

Example 5: Actual delivery will not have 

occurred if, within 28 days, an agreement, 

contract, or transaction for the purchase or 

sale of a commodity is rolled, offset, or 

otherwise netted with another transaction or 

settled in cash between the buyer and the 

seller, but the seller has not, in accordance 

with the methods described in Example 1 or 

2, physically delivered the entire quantity of 

the commodity purchased by the buyer, 

including any portion of the purchase made 

using leverage, margin, or financing, and 

transferred title to that quantity of the 

commodity to the buyer, regardless of 

whether the agreement, contract, or 

transaction between the buyer and seller 

purports to create an enforceable obligation 

on the part of the seller, or a parent company, 

partner, agent, or other affiliate of the seller, 

to deliver the commodity to the buyer. 

Issued in Washington, DC, on August 20, 

2013, by the Commission. 

Christopher J. Kirkpatrick, 

Deputy Secretary of the Commission. 

Appendix to Retail Commodity 

Transactions Under Commodity 

Exchange Act—Commission Voting 

Summary 

On this matter, Chairman Gensler and 

Commissioners Chilton, O’Malia, and Wetjen 

voted in the affirmative. No Commissioners 

voted in the negative. 

[FR Doc. 2013–20617 Filed 8–22–13; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 175 

Indirect Food Additives: Adhesives 

and Components of Coatings 

CFR Correction 

In Title 21 of the Code of Federal 

Regulations, Parts 170 to 199, revised as 

of April 1, 2013, on page 196, in 

§ 175.320, in paragraph (c), in the first 

sentence, revise ‘‘tables 1 and 2 of 

§ 176.17(c)’’ to read ‘‘tables 1 and 2 of 

§ 176.170(c)’’. 

[FR Doc. 2013–20702 Filed 8–22–13; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, and 558 

[Docket No. FDA–2013–N–0839] 

New Animal Drugs; Withdrawal of 

Approval of New Animal Drug 

Applications; Diethylcarbamazine; 

Nicarbazin; Penicillin 

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 

withdrawal of approval of three new 

animal drug applications (NADAs) at 

the sponsors’ request because the 

products are no longer manufactured or 

marketed. 

DATES: This rule is effective September 

3, 2013. 

FOR FURTHER INFORMATION CONTACT: 

David Alterman, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6843, 

email: david.alterman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Phibro 

Animal Health Corp., 65 Challenger Rd., 

3d Floor, Ridgefield Park, NJ 07660 has 

requested that FDA withdraw approval 

of NADA 098–371 for use of nicarbazin, 

penicillin, and roxarsone in 3-way, 

combination drug Type C medicated 

feeds for broiler chickens and NADA 

098–374 for use of nicarbazin and 

penicillin in 2-way, combination drug 

Type C medicated feeds for broiler 

chickens because the products are no 

longer manufactured or marketed. 

Accordingly, 21 CFR 558.366 and 

558.460 are being amended to reflect the 

withdrawal of approval. 

R. P. Scherer North America, P.O. Box 

5600, Clearwater, FL 33518 has 

requested that FDA withdraw approval 

of NADA 123–116 for 

Diethylcarbamazine Citrate Capsules 

used in dogs for the prevention of 

heartworm disease because the product 

is no longer manufactured or marketed. 

Accordingly, 21 CFR 520.622d is being 

amended to reflect the withdrawal of 

approval. 

Following this withdrawal of 

approval, R. P. Scherer North America 

is no longer the sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to remove 

the entries for these firms. 

Elsewhere in this issue of the Federal 

Register, FDA gave notice that approval 

of NADA 098–371, NADA 098–374, and 

NADA 123–116, and all supplements 

and amendments thereto, is withdrawn. 

As provided in the regulatory text of 

this document, the animal drug 

regulations are amended to reflect these 

voluntary withdrawals of approval. 

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 520 

Animal drugs. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

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, 520, and 558 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. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entry for 

‘‘R. P. Scherer North America’’; and in 

the table in paragraph (c)(2), remove the 

entry for ‘‘011014’’. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

§ 520.622d [Removed] 

■ 4. Remove § 520.622d. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 5. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.366 [Amended] 

■ 6. In § 558.366, in the table in 

paragraph (d), in the entry for ‘‘90.8 to 

181.6 (0.01 to 0.02 pct)’’, remove the 


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