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74652 Federal Register / Vol. 70, No.

241 / Friday, December 16, 2005 / Rules and Regulations

introductory text, and the first sentence will grant an exception from the DEPARTMENT OF HEALTH AND
of paragraph (e)(i), remove ‘‘duplicate or limitations specified in § 422.103(e)(2) HUMAN SERVICES
corrected’’ and add in its place for replacement social security number
‘‘replacement.’’ cards representing a change in name or, Food and Drug Administration
■ b. In the third and fourth sentences of if you are an alien, a change to a
paragraph (a), the first sentence of restrictive legend shown on the card. 21 CFR Parts 510 and 558
paragraph (d) introductory text, and the (See § 422.103(e)(3) for the definition of
first sentence of paragraph (g), remove Animal Drugs, Feeds, and Related
a change to a restrictive legend.) Products; Withdrawal of Approval of
‘‘,duplicate, or corrected’’ and add in its
place ‘‘or replacement.’’ (b) Assisting in enumeration. We may New Animal Drug Applications
enter into an agreement with officials of
■ 4. Section 422.110 is revised to read AGENCY: Food and Drug Administration,
the Department of State and the
as follows: HHS.
Department of Homeland Security to
§ 422.110 Individual’s request for change assist us by collecting, as part of the ACTION: Final rule.
in record. immigration process, information to
SUMMARY: The Food and Drug
(a) Form SS–5. If you wish to change change the name or other personal Administration (FDA) is amending the
the name or other personal identifying identifying information you previously animal drug regulations by removing
information you previously submitted submitted in connection with an those portions that reflect approval of 15
in connection with an application for a application or request for a social new animal drug applications (NADAs)
social security number card, you must security number card. If your request is because the products are no longer
complete and sign a Form SS–5 except to change a name on the card or to manufactured or marketed. In a notice
as provided in paragraph (b) of this correct the restrictive legend on the card published elsewhere in this issue of the
section. You must prove your identity, to reflect a change in alien status, we Federal Register, FDA is withdrawing
and you may be required to provide may issue you a replacement card approval of the NADAs.
other evidence. (See § 422.107 for bearing the same number and the new DATES: This rule is effective December
evidence requirements.) You may obtain name or legend. We will grant an
a Form SS–5 from any local Social 27, 2005.
exception from the limitations specified FOR FURTHER INFORMATION CONTACT:
Security office or from one of the in § 422.103(e)(2) for replacement social
sources noted in § 422.103(b). You may Pamela K. Esposito, Center for
security number cards representing a Veterinary Medicine (HFV–212), Food
submit a completed request for change
change of name or, if you are an alien, and Drug Administration, 7519 Standish
in records to any Social Security office,
or, if you are outside the U.S., to the a change to a restrictive legend shown Pl., Rockville, MD 20855, 240–276–
Department of Veterans Affairs Regional on the card. (See § 422.103(e)(3) for the 9067, e-mail: pesposit@cvm.fda.gov.
Office, Manila, Philippines, or to any definition of a change to a restrictive SUPPLEMENTARY INFORMATION: The
U.S. Foreign Service post or U.S. legend.) following sponsors have requested that
military post. If your request is for a [FR Doc. 05–23962 Filed 12–15–05; 8:45 am] FDA withdraw approval of the 15
change of name on the card, we may BILLING CODE 4191–02–P NADAs listed in table 1 of this
issue you a replacement card bearing document because the products are no
the same number and the new name. We longer manufactured or marketed:

TABLE 1.
21 CFR Section
Affected (Sponsor
Sponsor NADA Number, Product (Drug) Drug Labeler
Code)

Bioproducts, Inc., 320 Springside Dr., Suite 300, NADA 119–063, Pyrantel Tartrate Ton Pack (pyrantel tartrate) 558.485 (051359)
Fairlawn, OH 44333–2435

Farmland Industries, Inc., Kansas City, MO NADA 138–656, BN Wormer—19.2 BANMINTH Premix (pyrantel tar- 558.485 (021676)
64116 trate)

I.M.S. Inc., 13619 Industrial Rd., Omaha, NE NADA 129–395, HYGROMIX 0.6 Premix (hygromycin B) 558.274 (050639)
68137
NADA 129–646, TYLAN 10 Sulfa-G (tylosin, sulfamethazine) 558.630 (050639)
NADA 136–601, Swine Guard BN (pyrantel tartrate) 558.485 (050639)

J. & R. Specialty Supply Co., 310 Second Ave., NADA 96–780, TYLAN 10; TYLAN 40 (tylosin) n/a (049768)
SW., P.O. Box 506, Waseca, MN 56093

Kerber Milling Co., Box 152, 1817 E. Main St., NADA 98–687, Hy-Test Hy-Boost TY 5 Medicated (tylosin) 558.625 (029341)
Emmetsburg, IA 50536

M & M Livestock Products Co., Eagle Grove, IA NADA 96–837, M & M Tylosin Premix (tylosin) 558.625 (026282)
50533

Nutra-Blend Corp., P.O. Box 485, Neosho, MO NADA 129–161, Nutra-Blend TYLAN 10 Sulfa Premix (tylosin, 558.630 (050568)
64850 sulfamethazine)
NADA 136–384, Swine Wormer-BN BANMINTH (pyrantel tartrate) 558.485 (050568)

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Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Rules and Regulations 74653

TABLE 1.—Continued
21 CFR Section
Affected (Sponsor
Sponsor NADA Number, Product (Drug) Drug Labeler
Code)

South St. Paul Feeds, Inc., 500 Farwell Ave., NADA 136–369, Custom Ban Wormer 9.6 (pyrantel tartrate) 558.485 (001800)
South St. Paul, MN 55075

Stockton Hay & Grain Co. NADA 49–462, Rainbrook Broiler Premix No. 1 (ampolium, arsanilic n/a (036541)
acid, ethopabate, penicillin G procaine, streptomycin)
NADA 91–646, Rainbow Broiler Base Concentrate (ampolium, baci- n/a (036541)
tracin zinc, ethopabate)
NADA 91–647, Rainbow Broiler Base Concentrate (ampolium, chlor- n/a (036541)
tetracycline, ethopabate)

Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des NADA 131–146, FLAVOMYCIN 0.4 (bambermycins) 558.95 (011490)
Moines, IA 50322

Following the withdrawal of approval paragraph (c)(2) by removing the entries DEPARTMENT OF JUSTICE
of these NADAs, Kerber Milling Co., M for ‘‘001800’’, ‘‘026282’’, ‘‘029341’’, and
& M Livestock Products Co., Nutra- ‘‘050568’’. Drug Enforcement Administration
Blend Corp., and South St. Paul Feeds,
Inc., are no longer sponsors of an PART 558—NEW ANIMAL DRUGS FOR 21 CFR Parts 1300 and 1308
approved application. Therefore, we are USE IN ANIMAL FEEDS
removing entries for these four sponsors [Docket No. DEA–264]
from 21 CFR 510.600(c). ■ 3. The authority citation for 21 CFR
As provided below, the animal drug part 558 continues to read as follows: RIN 1117–AA95
regulations are amended to reflect the Authority: 21 U.S.C. 360b, 371. Implementation of the Anabolic Steroid
withdrawal of approvals.
This rule does not meet the definition Control Act of 2004
§ 558.95 [Amended]
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because AGENCY: Drug Enforcement
it is a rule of ‘‘particular applicability.’’ ■ 4. Section 558.95 is amended by Administration (DEA), Department of
Therefore, it is not subject to the removing and reserving paragraph (a)(3). Justice.
congressional review requirements in 5 § 558.274 [Amended] ACTION: Final rule.
U.S.C. 801–808.
■ 5. Section 558.274 is amended in SUMMARY: The purpose of this
List of Subjects
paragraph (a)(4) by removing ‘‘, 043733, rulemaking is to conform the Drug
21 CFR Part 510 and 050639’’ and by adding in its place Enforcement Administration’s (DEA)
Administrative practice and ‘‘and 043733’’; and in the table in regulations to the provisions of the
procedure, Animal drugs, Labeling, paragraphs (c)(1)(i) and (c)(1)(ii) in the Anabolic Steroid Control Act of 2004.
Reporting and recordkeeping ‘‘Sponsor’’ column by removing ‘‘, Effective January 20, 2005, the Act
requirements. 050639’’. amended the Controlled Substances Act
(CSA) and replaced the existing
21 CFR Part 558 § 558.485 [Amended] definition of ‘‘anabolic steroid’’ with a
Animal drugs, Animal feeds. ■ 6. Section 558.485 is amended by new definition. This new definition
■ Therefore, under the Federal Food, removing and reserving paragraphs altered the basis for all future
Drug, and Cosmetic Act and under (b)(2) and (b)(4); and in paragraph (b)(3) administrative scheduling actions
authority delegated to the Commissioner by removing ‘‘, 049685, 050568, 050639, relating to the control of anabolic
of Food and Drugs and redelegated to and 051359’’ and by adding in its place steroids as Schedule III controlled
the Center for Veterinary Medicine, 21 ‘‘and 049685’’. substances by eliminating the
CFR parts 510 and 558 are amended as requirement to prove muscle growth.
follows: § 558.625 [Amended] Additionally, the Act lists 59 specific
substances as being anabolic steroids.
PART 510—NEW ANIMAL DRUGS ■ 7. Section 558.625 is amended by As such, these substances and their
removing and reserving paragraphs salts, esters and ethers are Schedule III
■ 1. The authority citation for 21 CFR (b)(22), (b)(31), (b)(52), and (b)(79). controlled substances. This rulemaking
part 510 continues to read as follows: amends 21 CFR Parts 1300 and 1308 to
§ 558.630 [Amended]
Authority: 21 U.S.C. 321, 331, 351, 352, reflect these changes.
353, 360b, 371, 379e. ■ 8. Section 558.630 is amended in The Act also amends the CSA by
paragraph (b)(10) by removing ‘‘, revising the language requiring
§ 510.600 [Amended] exclusion of certain over the counter
050568, 050639’’.
■ 2. Section 510.600 is amended in the products from regulation as controlled
Dated: December 7, 2005.
table in paragraph (c)(1) by removing substances. The Act clarifies that the
the entries for ‘‘Kerber Milling Co.’’, ‘‘M Stephen F. Sundlof, exclusionary language in 21 U.S.C.
& M Livestock Products Co.’’, ‘‘Nutra- Director, Center for Veterinary Medicine. 811(g)(1) pertains only to non-narcotic
Blend Corp.’’, and ‘‘South St. Paul [FR Doc. 05–24104 Filed 12–15–05; 8:45 am] ‘‘drugs’’ that may, under the Federal
Feeds, Inc.’’; and in the table in BILLING CODE 4160–01–S Food, Drug, and Cosmetic Act (FDCA),

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