17776 Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations 

need only return those records that must 

be attached to the client’s required 

forms under ERISA and the Internal 

Revenue Code. The enrolled actuary, 

however, must provide the client with 

reasonable access to review and copy 

any additional records of the client 

retained by the enrolled actuary under 

State law that are necessary for the 

client to comply with his or her 

obligations under ERISA and the 

Internal Revenue Code. 

(2) For purposes of this section, 

records of the client include all 

documents or written or electronic 

materials provided to the enrolled 

actuary, or obtained by the enrolled 

actuary in the course of the enrolled 

actuary’s representation of the client, 

that preexisted the retention of the 

enrolled actuary by the client. The term 

‘‘records of the client’’ also includes 

materials that were prepared by the 

client or a third party (not including an 

employee or agent of the enrolled 

actuary) at any time and provided to the 

enrolled actuary with respect to the 

subject matter of the representation. The 

term ‘‘records of the client’’ also includes 

any return, claim for refund, schedule, 

affidavit, appraisal or any other 

document prepared by the enrolled 

actuary, or his or her employee or agent, 

that was presented to the client with 

respect to a prior representation if such 

document is necessary for the taxpayer 

to comply with his or her current 

obligations under ERISA and the 

Internal Revenue Code. The term 

‘‘records of the client’’ does not include 

any return, claim for refund, schedule, 

affidavit, appraisal or any other 

document prepared by the enrolled 

actuary or the enrolled actuary’s firm, 

employees or agents if the enrolled 

actuary is withholding such document 

pending the client’s performance of its 

contractual obligation to pay fees with 

respect to such document. 

* * * * * 

(l) The rules of this section apply to 

all actuarial services and related acts 

performed on or after May 2, 2011. 

■ Par. 10. Section 901.31 is amended by 

revising paragraphs (a) and (c) to read as 

follows: 

§ 901.31 Grounds for suspension or 

termination of enrollment. 

(a) Failure to satisfy requirements for 

enrollment. The enrollment of an 

actuary may be terminated if it is found 

that the actuary did not satisfy the 

eligibility requirements set forth in 

§ 901.11 or § 901.12. 

* * * * * 

(c) Disreputable conduct. The 

enrollment of an actuary may be 

suspended or terminated if it is found 

that the actuary has, at any time after 

he/she applied for enrollment, engaged 

in any conduct set forth in § 901.12(f) or 

other conduct evidencing fraud, 

dishonesty, or breach of trust. Such 

other conduct includes, but is not 

limited to, the following: 

* * * * * 

■ Par. 11. Section 901.32 is amended by 

revising the last sentence to read as 

follows: 

§ 901.32 Receipt of information 

concerning enrolled actuaries. 

* * * If any other person has 

information of any such violation, he/ 

she may make a report thereof to the 

Executive Director. 

■ Par. 12. Section 901.47 is amended by 

revising the last sentence to read as 

follows: 

§ 901.47 Transcript. 

* * * Copies of exhibits introduced 

at the hearing or at the taking of 

depositions will be supplied to parties 

upon the payment of a reasonable fee 

(31 U.S.C. 9701). 

■ Par. 13. Section 901.72 is added to 

read as follows: 

§ 901.72 Additional rules. 

The Joint Board may, in notice or 

other guidance of general applicability, 

provide additional rules regarding the 

enrollment of actuaries. 

Approved: March 2, 2011. 

Carolyn Zimmerman, 

Chairman, Joint Board for the Enrollment of 

Actuaries. 

[FR Doc. 2011–7573 Filed 3–29–11; 11:15 am] 

BILLING CODE 4810–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, and 

558 

[Docket No. FDA–2011–N–0160] 

Animal Drugs, Feeds, and Related 

Products; Withdrawal of Approval of 

New Animal Drug Applications; 

Chorionic Gonadotropin; Cuprimyxin; 

Diethylcarbamazine; Levamisole; 

Nitrofurazone; Phenylbutazone; 

Pyrantel; Tylosin; Tylosin and 

Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations by removing 

those portions that reflect approval of 13 

new animal drug applications (NADAs). 

In a notice published elsewhere in this 

issue of the Federal Register, FDA is 

withdrawing approval of these NADAs. 

DATES: This rule is effective April 11, 

2011. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079, 

e-mail: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

sponsors of the 13 approved NADAs 

listed in table 1 have requested that 

FDA withdraw approval because the 

products are no longer manufactured or 

marketed. 


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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations 17777 

TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF 13 NADAS

Sponsor NADA No. product 

(established name of drug) 

21 CFR section 

affected 

(sponsor’s drug 

labeler code) 

Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 

07054–1298.

NADA 093–029, UNITOP Cream (cuprimyxin) .................... 524.520 (063238). 

Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, 

MN 55318.

NADA 097–981, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine).558.630 (016968). 

Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018.NADA 100–840, Chorionic Gonadotropin for Injection 

(chorionic gonadotropin).

522.1081 (063323). 

Furst-McNess Co., Freeport, IL 61032 ................................. NADA 100–991, McNess Custom Premix L200 (tylosin 

phosphate).

558.625 (010439). 

Fort Dodge Animal Health, Division of Wyeth Holdings, a 

wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., 

New York, NY 10017.

NADA 101–079 TRAMISOL–10% Pig Wormer (levamisole) Not codified (000856). 

Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 NADA 101–905, Mill Co-Medicator TY–10 (tylosin phosphate).558.625 (017139). 

Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 NADA 101–906, Mill Co-Medicator TS–40 Premix (tylosin 

phosphate/sulfamethazine).

558.630 (017139). 

Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 

32514.

NADA 102–824,Phenylbutazone Tablets (phenylbutazone) 520.1720a (055246). 

Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 

56011.

NADA 108–487, DEC Tabs (diethylcarbamazine citrate) .... 520.622a (015579). 

Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 

56011.

NADA 108–863, DEC Chewable Tabs (diethylcarbamazine 

citrate).

520.622c (015579). 

Furst-McNess Co., Freeport, IL 61032 ................................. NADA 140–820, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine).558.630 (010439). 

Furst-McNess Co., Freeport, IL 61032 ................................. NADA 140–825, BANMINTH Intermediate Premix (pyrantel 

tartrate).

558.485 (010439). 

Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 

40511.

NADA 140–910, NFZ Wound Powder (nitrofurazone) ........ 524.1580c (050749). 

In a notice published elsewhere in 

this issue of the Federal Register, FDA 

gave notice that approval of NADAs 93– 

029, 97–981, 100–840, 100–991, 101– 

079, 101–905, 101–906, 102–824, 108– 

487, 108–863, 140–820, 140–825, and 

140–910, and all supplements and 

amendments thereto, is withdrawn, 

effective April 11, 2011. As provided in 

the regulatory text of this document, the 

animal drug regulations are amended to 

reflect these withdrawals of approval 

and a current format. 

Following these changes of 

sponsorship, Abraxis Pharmaceutical 

Products, Furst-McNess Co., Roche 

Vitamins, Inc., Waterloo Mills Co., and 

Wendt Laboratories, Inc., are no longer 

the sponsors of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to remove 

the entries for these firms. 

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 Parts 520, 522, and 524 

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, 522, 524, 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 entries for 

‘‘Abraxis Pharmaceutical Products’’, 

‘‘Furst-McNess Co.’’, ‘‘Roche Vitamins, 

Inc.’’, ‘‘Waterloo Mills Co.’’, and ‘‘Wendt 

Laboratories, Inc.’’; and in the table in 

paragraph (c)(2), remove the entries for 

‘‘010439’’, ‘‘015579’’, ‘‘017139’’, ‘‘063238’’, 

and ‘‘063323’’. 

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. 

■ 4. In § 520.622a, remove and reserve 

paragraph (a)(1); in paragraph (a)(5), 

remove ‘‘000081’ and in its place add 

‘‘No. 000061’’; and revise paragraph 

(b)(2) to read as follows: 

§ 520.622a Diethylcarbamazine citrate 

tablets. 

* * * * * 

(b) * * * 

(2) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 5. In § 520.622c, remove and reserve 

paragraph (b)(1); remove reserved 

paragraph (b)(7); and revise paragraph 

(c)(3) to read as follows: 

§ 520.622c Diethylcarbamazine citrate 

chewable tablets. 

* * * * * 

(c) * * * 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

§ 520.1720a [Amended] 

■ 6. In § 520.1720a, remove and reserve 

paragraph (b)(4). 


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17778 Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 7. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.1081 [Amended] 

■ 8. In paragraph (b)(2) of § 522.1081, 

remove ‘‘Nos. 058639 and 063323’’ and 

in its place add ‘‘No. 058639’’. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 9. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

§ 524.520 [Removed] 

■ 10. Remove § 524.520. 

§ 524.1580c [Amended] 

■ 11. In paragraph (b) of § 524.1580c, 

remove ‘‘Nos. 000010, 000069, and 

050749’’ and in its place add ‘‘Nos. 

000010 and 000069’’. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 12. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

§ 558.485 [Amended] 

■ 13. In § 558.485, in paragraph (b)(3), 

remove ‘‘010439’’. 

§ 558.625 [Amended] 

■ 14. In § 558.625, remove and reserve 

paragraphs (b)(42) and (b)(45). 

§ 558.630 [Amended] 

■ 15. In § 558.630, remove and reserve 

paragraph (b)(4); and in paragraph 

(b)(5), remove ‘‘010439,’’ and ‘‘016968,’’. 

Dated: March 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7560 Filed 3–30–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–320F] 

RIN 1117–AB24 

Control of Ergocristine, a Chemical 

Precursor Used in the Illicit 

Manufacture of Lysergic Acid 

Diethylamide, as a List I Chemical 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: This rulemaking finalizes a 

February 24, 2010, Notice of Proposed 

Rulemaking in which DEA proposed to 

control the chemical precursor 

ergocristine as a List I chemical under 

the Controlled Substances Act (CSA). 

Clandestine laboratories are using this 

chemical as a substitute for the List I 

chemicals ergotamine and ergonovine to 

illicitly manufacture the schedule I 

controlled substance lysergic acid 

diethylamide (LSD). 

This rule is being finalized as 

proposed. Therefore, handlers of 

ergocristine shall be subject to the 

chemical regulatory provisions of the 

CSA and its implementing regulations. 

This rulemaking does not establish a 

threshold for domestic and international 

transactions of ergocristine. As such, all 

transactions involving ergocristine, 

regardless of size, shall be regulated. 

This rulemaking also specifies that 

chemical mixtures containing 

ergocristine will not be exempt from 

regulatory requirements at any 

concentration. Therefore, all 

transactions of chemical mixtures 

containing any quantity of ergocristine 

shall be regulated and subject to control 

under the CSA. 

DATES: This rulemaking becomes 

effective May 2, 2011. Persons seeking 

registration must apply on or before 

May 2, 2011 to continue their business 

pending final action by DEA on their 

application. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152; telephone: (202) 

307–7183. 

SUPPLEMENTARY INFORMATION: 

Background 

Lysergic acid diethylamide (LSD) is a 

synthetic schedule I hallucinogen. It is 

the most potent hallucinogen known 

and only microgram amounts are 

required to produce overt 

hallucinations. It induces a heightened 

awareness of sensory input that is 

accompanied by an enhanced sense of 

clarity, but reduced ability to control 

what is experienced. 

Illicit Production of LSD 

LSD has been manufactured illegally 

since the 1960s. A limited number of 

chemists, probably less than a dozen, 

are believed to be manufacturing nearly 

all of the LSD available in the United 

States. Clandestine laboratory operators 

must adhere to precise and complex 

production procedures, and production 

of LSD is relatively difficult. 

LSD has historically been produced 

from lysergic acid, which is made from 

ergotamine or ergonovine, substances 

derived from an ergot fungus on rye, or 

from lysergic acid amide, a chemical 

found in morning glory seeds. 

Movement to Ergocristine as LSD 

Precursor and Largest LSD Laboratory 

Ever Seized by DEA 

Because of the existing CSA 

regulatory controls on the LSD 

precursors lysergic acid, lysergic acid 

amide, ergotamine, and ergonovine, 

clandestine laboratory operators have 

sought uncontrolled sources of 

precursor material for the production of 

LSD. This has led to the illicit 

utilization of the precursor chemical 

ergocristine as a direct substitute for 

ergotamine and ergonovine for the illicit 

production of LSD. In fact, the largest 

clandestine LSD laboratory ever seized 

by DEA utilized ergocristine as the LSD 

precursor. Recipes documenting 

procedures for utilizing ergocristine in 

LSD synthesis are easily found on the 

Internet. 

Availability of the Precursor Chemical 

DEA has determined that ergocristine 

is readily available from commercial 

chemical suppliers. DEA has identified 

at least three suppliers of ergocristine, of 

which one distributor is located 

domestically; the other two are based in 

Germany and the Czech Republic. 

This rule implements both domestic 

and import/export controls on 

ergocristine (and its salts). As noted in 

the February 24, 2010, Notice of 

Proposed Rulemaking (75 FR 8287), 

such controls are deemed necessary for 

law enforcement to identify domestic 

and international transactions in 

ergocristine, due to growing concerns 

regarding its use for the illicit 

manufacture of LSD. 


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