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need only return those records that must ■ Par. 10. Section 901.31 is amended by Approved: March 2, 2011. be attached to the client’s required revising paragraphs (a) and (c) to read as Carolyn Zimmerman, forms under ERISA and the Internal follows: Chairman, Joint Board for the Enrollment of Revenue Code. The enrolled actuary, Actuaries. § 901.31 Grounds for suspension or however, must provide the client with termination of enrollment. [FR Doc. 2011–7573 Filed 3–29–11; 11:15 am] reasonable access to review and copy BILLING CODE 4810–25–P any additional records of the client (a) Failure to satisfy requirements for retained by the enrolled actuary under enrollment. The enrollment of an actuary may be terminated if it is found State law that are necessary for the DEPARTMENT OF HEALTH AND that the actuary did not satisfy the client to comply with his or her HUMAN SERVICES obligations under ERISA and the eligibility requirements set forth in Internal Revenue Code. § 901.11 or § 901.12. Food and Drug Administration (2) For purposes of this section, * * * * * records of the client include all (c) Disreputable conduct. The 21 CFR Parts 510, 520, 522, 524, and documents or written or electronic enrollment of an actuary may be 558 materials provided to the enrolled suspended or terminated if it is found [Docket No. FDA–2011–N–0160] actuary, or obtained by the enrolled that the actuary has, at any time after actuary in the course of the enrolled he/she applied for enrollment, engaged Animal Drugs, Feeds, and Related actuary’s representation of the client, in any conduct set forth in § 901.12(f) or Products; Withdrawal of Approval of that preexisted the retention of the other conduct evidencing fraud, New Animal Drug Applications; enrolled actuary by the client. The term dishonesty, or breach of trust. Such Chorionic Gonadotropin; Cuprimyxin; ‘‘records of the client’’ also includes other conduct includes, but is not Diethylcarbamazine; Levamisole; materials that were prepared by the limited to, the following: Nitrofurazone; Phenylbutazone; client or a third party (not including an * * * * * Pyrantel; Tylosin; Tylosin and employee or agent of the enrolled ■ Sulfamethazine actuary) at any time and provided to the Par. 11. Section 901.32 is amended by enrolled actuary with respect to the revising the last sentence to read as AGENCY: Food and Drug Administration, subject matter of the representation. The follows: HHS. term ‘‘records of the client’’ also includes § 901.32 Receipt of information ACTION: Final rule; technical any return, claim for refund, schedule, concerning enrolled actuaries. amendment. affidavit, appraisal or any other document prepared by the enrolled * * * If any other person has SUMMARY: The Food and Drug actuary, or his or her employee or agent, information of any such violation, he/ Administration (FDA) is amending the that was presented to the client with she may make a report thereof to the animal drug regulations by removing respect to a prior representation if such Executive Director. those portions that reflect approval of 13 document is necessary for the taxpayer ■ Par. 12. Section 901.47 is amended by new animal drug applications (NADAs). to comply with his or her current revising the last sentence to read as In a notice published elsewhere in this obligations under ERISA and the follows: issue of the Federal Register, FDA is Internal Revenue Code. The term withdrawing approval of these NADAs. ‘‘records of the client’’ does not include § 901.47 Transcript. DATES: This rule is effective April 11, any return, claim for refund, schedule, * * * Copies of exhibits introduced 2011. affidavit, appraisal or any other at the hearing or at the taking of FOR FURTHER INFORMATION CONTACT: John document prepared by the enrolled depositions will be supplied to parties Bartkowiak, Center for Veterinary actuary or the enrolled actuary’s firm, upon the payment of a reasonable fee Medicine (HFV–212), Food and Drug employees or agents if the enrolled (31 U.S.C. 9701). Administration, 7519 Standish Pl., actuary is withholding such document ■ Par. 13. Section 901.72 is added to Rockville, MD 20855, 240–276–9079, pending the client’s performance of its e-mail: [email protected]. contractual obligation to pay fees with read as follows: SUPPLEMENTARY INFORMATION: The respect to such document. § 901.72 Additional rules. sponsors of the 13 approved NADAs * * * * * The Joint Board may, in notice or listed in table 1 have requested that (l) The rules of this section apply to other guidance of general applicability, FDA withdraw approval because the all actuarial services and related acts provide additional rules regarding the products are no longer manufactured or performed on or after May 2, 2011. enrollment of actuaries. marketed.

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

21 CFR section NADA No. product affected Sponsor (established name of drug) (sponsor’s drug labeler code)

Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ NADA 093–029, UNITOP Cream (cuprimyxin) ...... 524.520 (063238). 07054–1298. Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, NADA 097–981, TYLAN 40 Sulfa-G Premix (tylosin phos- 558.630 (016968). MN 55318. phate/sulfamethazine). Abraxis Pharmaceutical Products, Division of Abraxis Bio- NADA 100–840, Chorionic Gonadotropin for Injection 522.1081 (063323). science, 6133 River Rd., suite 500, Rosemont, IL 60018. (chorionic gonadotropin). Furst-McNess Co., Freeport, IL 61032 ...... NADA 100–991, McNess Custom Premix L200 (tylosin 558.625 (010439). phosphate). Fort Dodge Animal Health, Division of Wyeth Holdings, a NADA 101–079 TRAMISOL–10% Pig Wormer (levamisole) Not codified (000856). wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017. Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 NADA 101–905, Mill Co-Medicator TY–10 (tylosin phos- 558.625 (017139). phate). Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 NADA 101–906, Mill Co-Medicator TS–40 Premix (tylosin 558.630 (017139). phosphate/sulfamethazine). Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL NADA 102–824,Phenylbutazone Tablets (phenylbutazone) 520.1720a (055246). 32514. Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN NADA 108–487, DEC Tabs (diethylcarbamazine citrate) .... 520.622a (015579). 56011. Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN NADA 108–863, DEC Chewable Tabs (diethylcarbamazine 520.622c (015579). 56011. citrate). Furst-McNess Co., Freeport, IL 61032 ...... NADA 140–820, TYLAN 40 Sulfa-G Premix (tylosin phos- 558.630 (010439). phate/sulfamethazine). Furst-McNess Co., Freeport, IL 61032 ...... NADA 140–825, BANMINTH Intermediate Premix (pyrantel 558.485 (010439). tartrate). Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY NADA 140–910, NFZ Wound Powder (nitrofurazone) ...... 524.1580c (050749). 40511.

In a notice published elsewhere in 21 CFR Parts 520, 522, and 524 Authority: 21 U.S.C. 360b. this issue of the Federal Register, FDA Animal drugs. ■ gave notice that approval of NADAs 93– 4. In § 520.622a, remove and reserve 029, 97–981, 100–840, 100–991, 101– 21 CFR Part 558 paragraph (a)(1); in paragraph (a)(5), ‘‘ 079, 101–905, 101–906, 102–824, 108– Animal drugs, Animal feeds. remove 000081’ and in its place add ‘‘No. 000061’’; and revise paragraph 487, 108–863, 140–820, 140–825, and Therefore, under the Federal Food, (b)(2) to read as follows: 140–910, and all supplements and Drug, and Cosmetic Act and under amendments thereto, is withdrawn, authority delegated to the Commissioner § 520.622a Diethylcarbamazine citrate effective April 11, 2011. As provided in of Food and Drugs and redelegated to tablets. the regulatory text of this document, the the Center for Veterinary Medicine, 21 * * * * * animal drug regulations are amended to CFR parts 510, 520, 522, 524, and 558 reflect these withdrawals of approval are amended as follows: (b) * * * and a current format. (2) Limitations. Federal law restricts Following these changes of PART 510—NEW ANIMAL DRUGS this drug to use by or on the order of sponsorship, Abraxis Pharmaceutical a licensed veterinarian. Products, Furst-McNess Co., Roche ■ 1. The authority citation for 21 CFR Vitamins, Inc., Waterloo Mills Co., and part 510 continues to read as follows: ■ 5. In § 520.622c, remove and reserve Wendt Laboratories, Inc., are no longer Authority: 21 U.S.C. 321, 331, 351, 352, paragraph (b)(1); remove reserved the sponsors of an approved 353, 360b, 371, 379e. paragraph (b)(7); and revise paragraph application. Accordingly, 21 CFR (c)(3) to read as follows: § 510.600 [Amended] 510.600(c) is being amended to remove the entries for these firms. ■ 2. In § 510.600, in the table in § 520.622c Diethylcarbamazine citrate This rule does not meet the definition paragraph (c)(1), remove the entries for chewable tablets. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because ‘‘Abraxis Pharmaceutical Products’’, * * * * * it is a rule of ‘‘particular applicability.’’ ‘‘Furst-McNess Co.’’, ‘‘Roche Vitamins, (c) * * * Therefore, it is not subject to the Inc.’’, ‘‘Waterloo Mills Co.’’, and ‘‘Wendt congressional review requirements in 5 Laboratories, Inc.’’; and in the table in (3) Limitations. Federal law restricts U.S.C. 801–808. paragraph (c)(2), remove the entries for this drug to use by or on the order of ‘‘010439’’, ‘‘015579’’, ‘‘017139’’, ‘‘063238’’, a licensed veterinarian. List of Subjects and ‘‘063323’’. § 520.1720a [Amended] 21 CFR Part 510 PART 520—ORAL DOSAGE FORM ■ 6. In § 520.1720a, remove and reserve Administrative practice and NEW ANIMAL DRUGS procedure, Animal drugs, Labeling, paragraph (b)(4). Reporting and recordkeeping ■ 3. The authority citation for 21 CFR requirements. part 520 continues to read as follows:

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PART 522—IMPLANTATION OR DEPARTMENT OF JUSTICE and only microgram amounts are INJECTABLE DOSAGE FORM NEW required to produce overt ANIMAL DRUGS Drug Enforcement Administration hallucinations. It induces a heightened awareness of sensory input that is ■ 7. The authority citation for 21 CFR 21 CFR Part 1310 accompanied by an enhanced sense of part 522 continues to read as follows: [Docket No. DEA–320F] clarity, but reduced ability to control what is experienced. Authority: 21 U.S.C. 360b. RIN 1117–AB24 Illicit Production of LSD § 522.1081 [Amended] Control of Ergocristine, a Chemical Precursor Used in the Illicit LSD has been manufactured illegally ■ 8. In paragraph (b)(2) of § 522.1081, Manufacture of Lysergic Acid since the 1960s. A limited number of remove ‘‘Nos. 058639 and 063323’’ and Diethylamide, as a List I Chemical chemists, probably less than a dozen, in its place add ‘‘No. 058639’’. are believed to be manufacturing nearly AGENCY: Drug Enforcement all of the LSD available in the United PART 524—OPHTHALMIC AND Administration (DEA), Department of States. Clandestine laboratory operators TOPICAL DOSAGE FORM NEW Justice. must adhere to precise and complex ANIMAL DRUGS ACTION: Final rule. production procedures, and production SUMMARY: of LSD is relatively difficult. ■ 9. The authority citation for 21 CFR This rulemaking finalizes a February 24, 2010, Notice of Proposed part 524 continues to read as follows: LSD has historically been produced Rulemaking in which DEA proposed to from lysergic acid, which is made from Authority: 21 U.S.C. 360b. control the chemical precursor ergotamine or ergonovine, substances ergocristine as a List I chemical under derived from an ergot fungus on rye, or § 524.520 [Removed] the Controlled Substances Act (CSA). from lysergic acid amide, a chemical ■ 10. Remove § 524.520. Clandestine laboratories are using this found in morning glory seeds. chemical as a substitute for the List I § 524.1580c [Amended] chemicals ergotamine and ergonovine to Movement to Ergocristine as LSD illicitly manufacture the schedule I Precursor and Largest LSD Laboratory ■ 11. In paragraph (b) of § 524.1580c, controlled substance lysergic acid Ever Seized by DEA remove ‘‘Nos. 000010, 000069, and diethylamide (LSD). Because of the existing CSA 050749’’ and in its place add ‘‘Nos. This rule is being finalized as regulatory controls on the LSD 000010 and 000069’’. proposed. Therefore, handlers of precursors lysergic acid, lysergic acid ergocristine shall be subject to the amide, ergotamine, and ergonovine, PART 558—NEW ANIMAL DRUGS FOR chemical regulatory provisions of the clandestine laboratory operators have USE IN ANIMAL FEEDS CSA and its implementing regulations. sought uncontrolled sources of This rulemaking does not establish a precursor material for the production of ■ 12. The authority citation for 21 CFR threshold for domestic and international LSD. This has led to the illicit part 558 continues to read as follows: transactions of ergocristine. As such, all utilization of the precursor chemical transactions involving ergocristine, Authority: 21 U.S.C. 360b, 371. ergocristine as a direct substitute for regardless of size, shall be regulated. § 558.485 [Amended] This rulemaking also specifies that ergotamine and ergonovine for the illicit chemical mixtures containing production of LSD. In fact, the largest ■ 13. In § 558.485, in paragraph (b)(3), ergocristine will not be exempt from clandestine LSD laboratory ever seized remove ‘‘010439’’. regulatory requirements at any by DEA utilized ergocristine as the LSD precursor. Recipes documenting § 558.625 [Amended] concentration. Therefore, all transactions of chemical mixtures procedures for utilizing ergocristine in LSD synthesis are easily found on the ■ 14. In § 558.625, remove and reserve containing any quantity of ergocristine Internet. paragraphs (b)(42) and (b)(45). shall be regulated and subject to control under the CSA. Availability of the Precursor Chemical § 558.630 [Amended] DATES: This rulemaking becomes effective May 2, 2011. Persons seeking DEA has determined that ergocristine ■ 15. In § 558.630, remove and reserve registration must apply on or before is readily available from commercial paragraph (b)(4); and in paragraph May 2, 2011 to continue their business chemical suppliers. DEA has identified (b)(5), remove ‘‘010439,’’ and ‘‘016968,’’. pending final action by DEA on their at least three suppliers of ergocristine, of Dated: March 25, 2011. application. which one distributor is located domestically; the other two are based in Leslie Kux, FOR FURTHER INFORMATION CONTACT: Germany and the Czech Republic. Acting Assistant Commissioner for Policy. Christine A. Sannerud, PhD, Chief, Drug [FR Doc. 2011–7560 Filed 3–30–11; 8:45 am] and Chemical Evaluation Section, Office This rule implements both domestic BILLING CODE 4160–01–P of Diversion Control, Drug Enforcement and import/export controls on Administration, 8701 Morrissette Drive, ergocristine (and its salts). As noted in Springfield, VA 22152; telephone: (202) the February 24, 2010, Notice of 307–7183. Proposed Rulemaking (75 FR 8287), SUPPLEMENTARY INFORMATION: such controls are deemed necessary for law enforcement to identify domestic Background and international transactions in Lysergic acid diethylamide (LSD) is a ergocristine, due to growing concerns synthetic schedule I hallucinogen. It is regarding its use for the illicit the most potent hallucinogen known manufacture of LSD.

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