Oral Dosage Form New Animal Drugs; Tylosin, 59023-59024 [2011-24461]

Download as PDF Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Rules and Regulations erowe on DSK2VPTVN1PROD with RULES results will not vary from one lab or manufacturer to another. Such variation would be likely if labs or manufacturers were able to use different ignition sources that have similar physical properties but different burning characteristics. The amendment to the Standard is reasonable, technologically practicable, and appropriate. The revision to the ignition source provision is based on technical research conducted by NIST, which established that the SRM cigarette is capable of providing reliable and reproducible results in flammability testing of mattresses and mattress pads. SRM 1196 represents an equivalent, safety-neutral ignition source for use in testing to establish compliance with the Standard. The amendment to the Standard is limited to fabrics, related materials, and products that present an unreasonable risk. The revision of the ignition source provision will not make any changes to the products to which the Standard applies. Voluntary standards. There is no applicable voluntary standard for mattresses. We are amending an existing federal mandatory standard. Relationship of benefits to costs. Revising the ignition source provision in the Standard to specify SRM 1196 will allow testing to the Standard to continue without interruption, will maintain the effectiveness of the Standard, and will not significantly increase testing costs to manufacturers and importers of mattresses and mattress pads. Thus, there is a reasonable relationship between benefits and costs of the amendment. Both expected benefits and costs are likely to be small. The likely effect on testing costs would be minor, approximately one-third to one cent per mattress produced under those tests. Least burdensome requirement. No other alternative would allow the Standard’s level of safety and effectiveness to continue. Thus, the revision to the ignition source provision specifying SRM 1196 imposes the least burdensome requirement that would adequately reduce the risk of injury. K. Conclusion For the reasons discussed above, the Commission finds that revising the ignition source provision in the Standard (16 CFR part 1632) to specify SRM 1196 as the ignition source is needed to adequately protect the public against the unreasonable risk of the occurrence of fire leading to death, injury, and significant property damage. The Commission also finds that the amendment to the Standard is VerDate Mar<15>2010 14:40 Sep 22, 2011 Jkt 223001 59023 reasonable, technologically practicable, and appropriate. The Commission further finds that the amendment is limited to the fabrics, related materials, and products that present such unreasonable risks. DEPARTMENT OF HEALTH AND HUMAN SERVICES L. References [Docket No. FDA–2011–N–0003] 1. Gann, R.G., and Hnetkovsky E.J., Modification of ASTM E 2187 for Measuring the Ignition Propensity of Conventional Cigarettes, Technical Note 1627, National Institute of Standards and Technology, Gaithersburg, MD, 20899, 2009. 2. Directorate for Economic Analysis Report, Final Regulatory Analysis: Smoldering Ignition Source Technical Amendment to the Flammability Standard for Mattresses and Mattress Pads (16 CFR part 1632). Oral Dosage Form New Animal Drugs; Tylosin List of Subjects in 16 CFR Part 1632 Consumer protection, Flammable materials, Labeling, Mattresses and mattress pads, Records, Textiles, Warranties. For the reasons given above, the Commission amends 16 CFR part 1632 as follows: PART 1632—STANDARD FOR THE FLAMMABILITY OF MATTRESSES AND MATTRESS PADS (FF 4–72, AMENDED) 1. The authority citation for part 1632 continues to read as follows: ■ Authority: 15 U.S.C. 1193, 1194; 15 U.S.C. 2079(b). 2. Section 1632.4(a)(2) is revised to read as follows: ■ § 1632.4 Mattress test procedure. (a) * * * (2) Ignition source. The ignition source shall be a Standard Reference Material cigarette (SRM 1196), available for purchase from the National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899. * * * * * Dated: September 20, 2011. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 2011–24482 Filed 9–22–11; 8:45 am] BILLING CODE 6355–01–P PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 Food and Drug Administration 21 CFR Part 520 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The ANADA provides for use of tylosin tartrate soluble powder in chickens, turkeys, swine, and honey bees. DATES: This rule is effective September 23, 2011. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8197, e-mail: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200–455 for use of TYLOMED– WS (tylosin tartrate), a water soluble powder, in chickens, turkeys, swine, and honey bees. The abbreviated application is approved as of July 5, 2011, and the regulations are amended in 21 CFR 520.2640 to reflect the approval and to make minor revisions that will improve accuracy of the regulations. A summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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. E:\FR\FM\23SER1.SGM 23SER1 59024 Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Rules and Regulations List of Subjects in 21 CFR Part 520 Animal drugs. 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 part 520 is amended as follows: Dated: September 20, 2011. Bernadette Dunham, Director, Center for Veterinary Medicine. Frank Supik, Senior Counsel, at (202) 874–6638 or frank.supik@fms.treas.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2011–24461 Filed 9–22–11; 8:45 am] PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Fiscal Service 1. The authority citation for 21 CFR part 520 continues to read as follows: 31 CFR Part 210 I. Proposed Rulemaking We issued a Notice of Proposed Rulemaking (NPRM) on May 14, 2010, requesting comment on a number of proposed amendments to title 31 CFR part 210 (Part 210). 75 FR 27239. Part 210 governs the use of the ACH Network by Federal agencies. The ACH Network is a nationwide electronic fund transfer (EFT) system that provides for the interbank clearing of electronic credit and debit transactions and for the exchange of payment-related information among participating financial institutions. Part 210 incorporates the ACH Rules adopted by NACHA, with certain exceptions. From time to time we amend Part 210 in order to address changes that NACHA periodically makes to the ACH Rules or to revise the regulation as otherwise appropriate. ■ BILLING CODE 4160–01–P DEPARTMENT OF THE TREASURY RIN 1510–AB24 Authority: 21 U.S.C. 360b. 2. In § 520.2640, add paragraph (b)(3); and revise paragraphs (a), (b)(1), (b)(2), (d)(2)(ii), (d)(3)(ii)(A), (d)(3)(ii)(B), and (d)(3)(iii) to read as follows: ■ erowe on DSK2VPTVN1PROD with RULES § 520.2640 Tylosin. (a) Specifications. Each container of soluble powder contains tylosin tartrate equivalent to either 100 or 256 grams tylosin base. (b) * * * (1) No. 000986 for use of a 100-gram jar as in paragraph (d) of this section. (2) No. 016592 for use of a 100-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section. (3) No. 061623 for use of a 100- or 256-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section. * * * * * (d) * * * (2) * * * (ii) Indications for use. For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin. * * * * * (3) * * * (ii) * * * (A) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate medicated feed; and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate medicated feed. (B) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae. (iii) Limitations. Prepare a fresh solution daily. Do not administer within 48 hours of slaughter. As indicated in paragraph (d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi)(c) of this chapter. * * * * * VerDate Mar<15>2010 14:40 Sep 22, 2011 Jkt 223001 Federal Government Participation in the Automated Clearing House AGENCY: Financial Management Service, Fiscal Service, Treasury. ACTION: Final rule. SUMMARY: The Department of the Treasury, Financial Management Service (FMS) is issuing this final rule which amends our regulation governing the use of the Automated Clearing House (ACH) network by Federal agencies. The rule adopts, with some exceptions, the 2009 ACH Rules published by NACHA—The Electronic Payments Association (NACHA) as the rules governing the use of the ACH Network by Federal agencies. Among other things, the final rule includes new requirements to identify all international payment transactions using a new Standard Entry Class Code and to include certain information in the ACH record sufficient to allow the receiving financial institution to identify the parties to the transaction and to allow screening to comply with requirements administered by the Office of Foreign Assets Control (OFAC). In addition, the rule requires financial institutions to provide limited accountrelated customer information related to the reclamation of post-death benefit payments as permitted under the Payment Transactions Integrity Act of 2008. It also allows Federal payments to be delivered to pooled or master accounts established by nursing facilities for residents of those facilities or held by religious orders whose members have taken vows of poverty. DATES: October 24, 2011. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 24, 2011. FOR FURTHER INFORMATION CONTACT: Bill Brushwood, Director of the Settlement Services Division, at (202) 874–1251 or bill.brushwood@fms.treas.gov; Natalie H. Diana, Senior Counsel, at (202) 874– 6680 or natalie.diana@fms.treas.gov; or PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 International ACH Transactions In the NPRM, we proposed to incorporate in Part 210 some, but not all, of the changes that NACHA adopted in 2007 and 2008, as reflected in the 2009 ACH Rules book. Those changes include requirements to identify all international payment transactions using a new Standard Entry Class Code and to include in the ACH record certain information sufficient to allow the receiving financial institution to identify the parties to the transaction and the path of the transaction. Effective September 18, 2009, the ACH Rules required Originating Depository Financial Institutions (ODFIs) and Gateway Operators to identify all international payment transactions transmitted via the ACH Network for any portion of the money trail with a new Standard Entry Class Code for International ACH Transactions (IAT). IAT transactions must include the specific data elements defined within the Bank Secrecy Act’s (BSA) ‘‘Travel Rule’’ so that all parties to the transaction have the information necessary to comply with U.S. law, including the laws administered by OFAC. Previously, many payments that are international in nature were being introduced as domestic transactions into the U.S. ACH Network through correspondent banking relationships, making it difficult for processing depository financial institutions to identify them for purposes of complying with U.S. law. NACHA’s IAT Standard Entry Class Code classifies international payments based on the geographical location of the financial institutions or E:\FR\FM\23SER1.SGM 23SER1

Agencies

[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Rules and Regulations]
[Pages 59023-59024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]


Oral Dosage Form New Animal Drugs; Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original abbreviated new 
animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The 
ANADA provides for use of tylosin tartrate soluble powder in chickens, 
turkeys, swine, and honey bees.

DATES: This rule is effective September 23, 2011.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group, Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-455 for use of TYLOMED-WS 
(tylosin tartrate), a water soluble powder, in chickens, turkeys, 
swine, and honey bees. The abbreviated application is approved as of 
July 5, 2011, and the regulations are amended in 21 CFR 520.2640 to 
reflect the approval and to make minor revisions that will improve 
accuracy of the regulations.
    A summary of safety and effectiveness data and information 
submitted to support approval of this application may be seen in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m., Monday through Friday.
    The Agency has determined under 21 CFR 25.33 that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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.

[[Page 59024]]

List of Subjects in 21 CFR Part 520

    Animal drugs.

    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 part 520 is 
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.


0
2. In Sec.  520.2640, add paragraph (b)(3); and revise paragraphs (a), 
(b)(1), (b)(2), (d)(2)(ii), (d)(3)(ii)(A), (d)(3)(ii)(B), and 
(d)(3)(iii) to read as follows:


Sec.  520.2640  Tylosin.

    (a) Specifications. Each container of soluble powder contains 
tylosin tartrate equivalent to either 100 or 256 grams tylosin base.
    (b) * * *
    (1) No. 000986 for use of a 100-gram jar as in paragraph (d) of 
this section.
    (2) No. 016592 for use of a 100-gram jar or pouch as in paragraphs 
(d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of 
this section.
    (3) No. 061623 for use of a 100- or 256-gram jar or pouch as in 
paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and 
(d)(4) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For maintaining weight gain and feed 
efficiency in the presence of infectious sinusitis associated with 
Mycoplasma gallisepticum sensitive to tylosin.
* * * * *
    (3) * * *
    (ii) * * *
    (A) For the treatment and control of swine dysentery associated 
with Brachyspira hyodysenteriae when followed immediately by tylosin 
phosphate medicated feed; and for the control of porcine proliferative 
enteropathies (PPE, ileitis) associated with Lawsonia intracellularis 
when followed immediately by tylosin phosphate medicated feed.
    (B) For the treatment and control of swine dysentery associated 
with Brachyspira hyodysenteriae.
    (iii) Limitations. Prepare a fresh solution daily. Do not 
administer within 48 hours of slaughter. As indicated in paragraph 
(d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated 
feed as in Sec.  558.625(f)(1)(vi)(c) of this chapter.
* * * * *

    Dated: September 20, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-24461 Filed 9-22-11; 8:45 am]
BILLING CODE 4160-01-P

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