Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran, 65565-65566 [2010-27011]

Download as PDF Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Rules and Regulations Reservable liability Reserve requirement NET TRANSACTION ACCOUNTS: $0 to reserve requirement exemption amount ($10.7 million) ..................................................................... Over reserve requirement exemption amount ($10.7 million) and up to low reserve tranche ($58.8 million). Over low reserve tranche ($58.8 million) ..................................................................................................... 0 percent of amount. 3 percent of amount. $1,443,000 plus 10 percent of amount over $58.8 million. 0 percent. 0 percent. Nonpersonal time deposits ........................................................................................................................... Eurocurrency liabilities ................................................................................................................................. By order of the Board of Governors of the Federal Reserve System, acting through the Director of the Division of Monetary Affairs under delegated authority, October 21, 2010. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 2010–27014 Filed 10–25–10; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 556, and 558 [Docket No. FDA–2010–N–0002] AGENCY: Food and Drug Administration, HHS. ACTION: (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs. This rule is effective November 5, 2010. DATES: 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. FOR FURTHER INFORMATION CONTACT: Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran BILLING CODE 6210–01–P 65565 Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications SUMMARY: Fort Dodge Animal Health, a Division of Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 has requested that FDA withdraw approval of the eight NADAs listed in Table 1 of this document because they are no longer manufactured or marketed. SUPPLEMENTARY INFORMATION: TABLE 1 NADA No. Product NADA 11–141 ............ NADA 14–250 ............ NADA 34–536 ............ UNISTAT–2 Type A medicated article ........................................................ NOVASTAT Type A medicated article ........................................................ ALKOMIX Type A medicated article ........................................................... ALKOMIX–3 Type A medicated article ....................................................... NOVASTAT–3 Type A medicated article .................................................... NOVASTAT–W Soluble Powder ................................................................. UNISTAT–3 Type A medicated article ........................................................ TRAMISOL Type A medicated article ......................................................... TRAMISOL Type A medicated article ......................................................... erowe on DSK5CLS3C1PROD with RULES NADA NADA NADA NADA NADA 34–537 35–388 39–666 44–015 45–455 ............ ............ ............ ............ ............ In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 11– 141, 14–250, 34–536, 34–537, 35–388, 39–666, 44–015, and 45–455, and all supplements and amendments thereto, is withdrawn, effective November 5, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these 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. VerDate Mar<15>2010 14:00 Oct 25, 2010 Jkt 223001 Established name of drug(s) List of Subjects nitromide and sulfanitran. aklomide and sulfanitran. aklomide. aklomide, sulfanitran, and roxarsone. aklomide, sulfanitran, and roxarsone. aklomide and sulfanitran. nitromide, sulfanitran, and roxarsone. levamisole. levamisole. PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 21 CFR Part 520 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ Animal drugs. 21 CFR Part 556 Authority: 21 U.S.C. 360b. § 520.2320 Animal drugs, Foods. ■ 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 520, 556, and 558 are amended as follows: ■ PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 [Removed] 2. Remove § 520.2320. PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 3. The authority citation for 21 CFR part 556 continues to read as follows: ■ Authority: 21 U.S.C. 342, 360b, 371. § 556.30 ■ [Removed] 4. Remove § 556.30. E:\FR\FM\26OCR1.SGM 26OCR1 65566 Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Rules and Regulations § 556.220 ■ [Removed] 5. Remove § 556.220. § 556.680 ■ 501(c)(3). These regulations will affect sponsors of section 403(b) contracts, administrators, participants, and beneficiaries. [Removed] 6. Remove § 556.680. 7. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. § 558.4 [Amended] 8. In § 558.4, in paragraph (d), in the ‘‘Category I’’ table, remove the listing for ‘‘Aklomide’’; and in the ‘‘Category II’’ table, remove the listings for ‘‘Levamisole’’, ‘‘Nitromide’’ immediately followed in sequence by ‘‘Sulfanitran’’, ‘‘Nitromide’’ immediately followed in sequence by ‘‘Sulfanitran’’ and by ‘‘Roxarsone’’; ‘‘Sulfanitran’’ immediately followed in sequence by ‘‘Aklomide’’, and the two listings for ‘‘Sulfanitran’’ immediately followed in sequence by ‘‘Aklomide’’ and by ‘‘Roxarsone’’. ■ § 558.35 ■ [Removed] ■ ■ Concerning the regulations, John Tolleris at (202) 622–6060; concerning the regulations as applied to churchrelated entities, Sherri Edelman or Jason Levine at (202) 283–9634 (not toll-free numbers). SUPPLEMENTARY INFORMATION: The final regulations that are the subject of this correction are under section 403(b) of the Internal Revenue Code. Need for Correction As published, final regulations (TD 9340) contain errors that may prove to be misleading and are in need of clarification. Correction of Publication [Removed] Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments: ■ 11. Remove § 558.376. Dated: October 8, 2010. Bernadette Dunham, Director, Center for Veterinary Medicine. PART 1—INCOME TAXES [FR Doc. 2010–27011 Filed 10–25–10; 8:45 am] Paragraph 1. The authority citation for part 1 continues to read in part as follows: ■ BILLING CODE 4160–01–P DEPARTMENT OF THE TREASURY Authority: 26 U.S.C. 7805 * * * Par. 2. Section 1.403(b)–4 is amended by revising the third and fourth sentences of paragraph (c)(5) Example 12.(i) to read as follows: ■ Internal Revenue Service 26 CFR Part 1 [TD 9340] § 1.403(b)–4 RIN 1545–BB64 * Revised Regulations Concerning Section 403(b) Tax-Sheltered Annuity Contracts; Correction Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. AGENCY: This document contains corrections to final regulations (TD 9340) that were published in the Federal Register on Thursday, July 26, 2007 (72 FR 41128) providing updated guidance on section 403(b) contracts of public schools and tax-exempt organizations described in section erowe on DSK5CLS3C1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:00 Oct 25, 2010 Jkt 223001 * * (c) * * * (5) * * * Contribution limitations. * * Example 12. (i) * * * However, the $5,000 age 50 catch-up amount deferred in 2006 is disregarded for purposes of applying the limitation at paragraph (c)(3)(i)(C) of this section to determine the special section 403(b) catch-up amount. Thus, for 2007, only $80,000 of section 403(b) elective deferrals are taken into account in applying the limitation at paragraph (c)(3)(i)(C) of this section. * * * * * * * * (e) * * * (5) * * * See also § 1.403(b)–9(a)(5) for additional rules relating to annuities payable from a retirement income account. * * * * * ■ Par. 4. Section 1.403(b)–7 is amended by revising the fourth sentence of paragraph (b)(1) to read as follows: § 1.403(b)–7 benefits. § 1.403(b)–10 * * * * (b) * * * (3) Requirements for plan-to-plan transfers—(i) In general. * * * * * * * * LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. 2010–26979 Filed 10–25–10; 8:45 am] BILLING CODE 4830–01–P * * * * Par. 3. Section 1.403(b)–6 is amended by revising the last sentence of paragraph (e)(5) to read as follows: Fmt 4700 Sfmt 9990 Miscellaneous provisions. * ■ Frm 00004 Taxation of distributions and * * * * (b) * * * (1) * * * Thus, to the extent that a portion of a distribution (including a distribution from a designated Roth account) would be excluded from gross income if it were not rolled over, if that portion of the distribution is to be rolled over into an eligible retirement plan that is not an IRA, the rollover must be accomplished through a direct rollover of the entire distribution to a plan qualified under section 401(a) or a section 403(b) plan and that plan must agree to separately account for the amount not includible in income (so that a 60-day rollover to a plan qualified under section 401(a) or another section 403(b) plan is not available for this portion of the distribution). * * * * * * * * ■ Par. 5. Section 1.403(b)–10 is amended by revising the heading of paragraph (b)(3) and adding a heading to paragraph (b)(3)(i) to read as follows: * PO 00000 Timing of distributions and * Background Income taxes, Reporting and recordkeeping requirements. [Removed] 10. Remove § 558.315. § 558.376 FOR FURTHER INFORMATION CONTACT: List of Subjects in 26 CFR Part 1 9. Remove § 558.35. § 558.315 The correction is effective October 26, 2010, and is applicable on July 26, 2007. DATES: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS § 1.403(b)–6 benefits. E:\FR\FM\26OCR1.SGM 26OCR1

Agencies

[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Rules and Regulations]
[Pages 65565-65566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 556, and 558

[Docket No. FDA-2010-N-0002]


Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; 
Nitromide and Sulfanitran

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations by removing those portions that reflect approval of 
eight 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 November 5, 2010.

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: Fort Dodge Animal Health, a Division of 
Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d 
St., New York, NY 10017 has requested that FDA withdraw approval of the 
eight NADAs listed in Table 1 of this document because they are no 
longer manufactured or marketed.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
            NADA No.                    Product                       Established name of drug(s)
----------------------------------------------------------------------------------------------------------------
NADA 11-141....................  UNISTAT-2 Type A      nitromide and sulfanitran.
                                  medicated article.
NADA 14-250....................  NOVASTAT Type A       aklomide and sulfanitran.
                                  medicated article.
NADA 34-536....................  ALKOMIX Type A        aklomide.
                                  medicated article.   aklomide, sulfanitran, and roxarsone.
                                 ALKOMIX-3 Type A
                                  medicated article.
NADA 34-537....................  NOVASTAT-3 Type A     aklomide, sulfanitran, and roxarsone.
                                  medicated article.
NADA 35-388....................  NOVASTAT-W Soluble    aklomide and sulfanitran.
                                  Powder.
NADA 39-666....................  UNISTAT-3 Type A      nitromide, sulfanitran, and roxarsone.
                                  medicated article.
NADA 44-015....................  TRAMISOL Type A       levamisole.
                                  medicated article.
NADA 45-455....................  TRAMISOL Type A       levamisole.
                                  medicated article.
----------------------------------------------------------------------------------------------------------------

    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 11-141, 14-250, 34-536, 
34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and 
amendments thereto, is withdrawn, effective November 5, 2010. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these 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 520

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
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 520, 
556, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.2320  [Removed]

0
2. Remove Sec.  520.2320.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 360b, 371.


Sec.  556.30  [Removed]

0
4. Remove Sec.  556.30.

[[Page 65566]]

Sec.  556.220  [Removed]

0
5. Remove Sec.  556.220.


Sec.  556.680  [Removed]

0
6. Remove Sec.  556.680.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
7. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec.  558.4  [Amended]

0
8. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
remove the listing for ``Aklomide''; and in the ``Category II'' table, 
remove the listings for ``Levamisole'', ``Nitromide'' immediately 
followed in sequence by ``Sulfanitran'', ``Nitromide'' immediately 
followed in sequence by ``Sulfanitran'' and by ``Roxarsone''; 
``Sulfanitran'' immediately followed in sequence by ``Aklomide'', and 
the two listings for ``Sulfanitran'' immediately followed in sequence 
by ``Aklomide'' and by ``Roxarsone''.


Sec.  558.35  [Removed]

0
9. Remove Sec.  558.35.


Sec.  558.315  [Removed]

0
10. Remove Sec.  558.315.


Sec.  558.376  [Removed]

0
11. Remove Sec.  558.376.

    Dated: October 8, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-27011 Filed 10-25-10; 8:45 am]
BILLING CODE 4160-01-P

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