New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction, 33698-33699 [2013-13331]

Download as PDF 33698 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations a.5. Ralstonia solanacearum, race 3, biovar 2; a.6. Raythayibactor toxicus [this bacterium is identified on the APHIS ‘‘select agents’’ list (see the Related Controls paragraph for this ECCN), but is not identified on the Australia Group (AG) ‘‘List of Plant Pathogens for Export Control’’]. b. Fungi, as follows: b.1. Colletotrichum kahawae (Colletotrichum coffeanum var. virulans); b.2. Cochliobolus miyabeanus (Helminthosporium oryzae); b.3. Microcyclus ulei (syn. Dothidella ulei); b.4. Puccinnia graminis ssp. graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. Puccinia graminis f. sp. tritici]); b.5. Puccinia striiformis (syn. Puccinia glumarum); b.6. Magnaporthe oryzae (Pyricularia oryzae); b.7. Peronosclerospora philippinensis (Peronosclerospora sacchari); b.8. Sclerophthora rayssiae var. zeae; b.9. Synchytrium endobioticum; b.10. Tilletia indica; b.11. Thecaphora solani; b.12. Phoma glycinicola (formerly Pyrenochaeta glycines) [this fungus is identified on the APHIS ‘‘select agents’’ list (see the Related Controls paragraph for this ECCN), but is not identified on the Australia Group (AG) ‘‘List of Plant Pathogens for Export Control’’]. c. Viruses, as follows: c.1. Andean potato latent virus (Potato Andean latent tymovirus); c.2. Potato spindle tuber viroid. 10. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN 1C360 is removed. ■ 11. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN 1C991 is amended under the List of Items Controlled section by revising the fourth sentence in the ‘‘Related Definitions’’ paragraph and by revising paragraph a. in the ‘‘Items’’ paragraph to read as follows: ■ 1C991 Vaccines, immunotoxins, medical products, diagnostic and food testing kits, as follows (see List of Items Controlled). TKELLEY on DSK3SPTVN1PROD with RULES * * * * * List of Items Controlled Unit: * * * Related Controls: * * * Related Definitions: * * * Biological toxins in any other configuration, including bulk shipments, or for any other end-uses are controlled by ECCN 1C351. * * * Items: a. Vaccines against items controlled by ECCN 1C351, 1C352, 1C353 or 1C354. * * * VerDate Mar<15>2010 * * 16:07 Jun 04, 2013 Jkt 229001 12. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN 1E001 is amended by revising the ECCN heading and by revising the ‘‘Control(s)’’ language for ‘‘Country Chart—CB Column 1’’ in the License Requirements section to read as follows: ■ 1E001 ‘‘Technology’’ according to the General Technology Note for the ‘‘Development’’ or ‘‘Production’’ of items controlled by 1A001.b, 1A001.c, 1A002, 1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008, 1A101, 1B (except 1B999), or 1C (except 1C355, 1C980 to 1C984, 1C988, 1C990, 1C991, 1C995 to 1C999). License Requirements Reason for Control: NS, MT, NP, CB, RS, AT Country chart Control(s) * * * CB applies to ‘‘technology’’ for items controlled by 1C351, 1C352, 1C353, or 1C354. * * * * * CB Column 1. * * respectively, and adding a new paragraph f. to read as follows: 2B352 Equipment capable of use in handling biological materials, as follows (see List of Items Controlled). * * * * * List of Items Controlled Unit: * * * Related Controls: * * * Related Definitions: * * * Items: * * * * * f. Spray-drying equipment capable of drying toxins or pathogenic microorganisms having all of the flowing characteristics: f.1. A water evaporation capacity of ≥ 0.4 kg/h and ≤ 400 kg/h; f.2. The ability to generate a typical mean product particle size of ≤ 10 micrometers with existing fittings or by minimal modification of the spray-dryer with atomization nozzles enabling generation of the required particle size; and f.3. Capable of being sterilized or disinfected in situ. * * * * * Dated: May 29, 2013. Kevin J. Wolf, Assistant Secretary for Export Administration. License Requirements Note: * * * [FR Doc. 2013–13270 Filed 6–4–13; 8:45 am] * BILLING CODE 3510–33–P * * * * 13. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN 1E351 is amended by revising the ECCN heading and by revising the ‘‘Control(s)’’ language for ‘‘Country Chart—CB Column 1’’ in the License Requirements section to read as follows: ■ 1E351 ‘‘Technology’’ according to the ‘‘General Technology Note’’ for the disposal of chemicals or microbiological materials controlled by 1C350, 1C351, 1C352, 1C353, or 1C354. Country chart Control(s) CB applies to ‘‘technology’’ for the disposal of items controlled by 1C351, 1C352, 1C353, or 1C354. * * * * * * CB Column 1. * * * 14. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2—Materials Processing, ECCN 2B352 is amended under the ‘‘Items’’ paragraph in the List of Items Controlled section by redesignating paragraphs f. through h. as paragraphs g. through i., ■ PO 00000 Frm 00010 Fmt 4700 Food and Drug Administration 21 CFR Part 522 [Docket No. FDA–2013–N–0002] New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction AGENCY: Sfmt 4700 Food and Drug Administration, HHS. ACTION: License Requirements Reason for Control: CB, AT * DEPARTMENT OF HEALTH AND HUMAN SERVICES Correcting amendments. SUMMARY: The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations. DATES: This rule is effective June 5, 2013. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug E:\FR\FM\05JNR1.SGM 05JNR1 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, ghaibel@fda.hhs.gov. The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013 (78 FR 25182). FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, 21 CFR part 522 is corrected by making the following correcting amendment. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 2. In § 522.558, revise paragraph (a) to read as follows: ■ § 522.558 Dexmedetomidine. (a) Specifications. Each milliliter of solution contains 0.1 or 0.5 milligrams dexmedetomidine hydrochloride. * * * * * Dated: May 31, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013–13331 Filed 6–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF STATE 22 CFR Part 41 employment that would otherwise allow them to change status to A classification. This rule is being promulgated to allow family members of employees of bilateral missions to work at international organizations in a visa status that reflects their position with the international organization. DATES: This rule is effective June 5, 2013. FOR FURTHER INFORMATION CONTACT: Lauren A. Prosnik, Legislation and Regulations Division, Visa Services, Department of State, 2401 E Street NW., Room L–603D, Washington, DC 20520– 0106, (202) 663–1260. SUPPLEMENTARY INFORMATION: Why is the Department promulgating this rule? Currently, 22 CFR 41.22(b) requires that an alien entitled to classification as an A–1 or A–2 nonimmigrant must be classified as such, even those who are also eligible for another nonimmigrant classification. This rule will allow an A–1 or A–2 derivative applicant who works for an international organization to be classified as G–1, G–2, G–3, or G–4 nonimmigrant. Additionally, this rule amends 22 CFR 41.24(b)(4) to clarify that an immediate family member of a principal alien classifiable G–1 or G–2, G–3 or G–4 who has employment authorization may maintain G classification, even if employment obtained after entry would allow them to be classified under INA 101(a)(15)(A). With this change, family members of diplomats assigned to the United States will be able to accept employment with international organizations and obtain visas that reflect their status as employees of such organizations, rather than as diplomatic dependents. Inability to obtain G visas has posed an impediment to the employment of some individuals in this category. Regulatory Findings [Public Notice 8348] State Department. ACTION: Final rule. Administrative Procedure Act This regulation involves a foreign affairs function of the United States and, therefore, in accordance with 5 U.S.C. 553(a)(1), is not subject to the rulemaking procedures set forth at 5 U.S.C. 553. This rule permits qualified immediate family members of A–1 or A–2 nonimmigrants to be independently classified as G–1, G–2, G–3, or G–4 nonimmigrants. It also clarifies that immediate family members of G–1, G– 2, G–3, and G–4 nonimmigrants who have employment authorization may remain in G classification upon gaining Regulatory Flexibility Act/Executive Order 13272: Small Business Because this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with the RIN 1400–AD21 Visas: Classification of Immediate Family Members as G Nonimmigrants AGENCY: TKELLEY on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 33699 Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department certifies that this rule will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and import markets. Executive Order 12866 The Department of State has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866 and has determined that the benefits of this regulation outweigh any cost. The Department does not consider this rule to be an economically significant action within the scope of section 3(f)(1) of the Executive Order since it is not likely to have an annual effect on the economy of $100 million or more or to adversely affect in a material way the economy, a sector of the economy, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities. Executive Orders 12372 and 13132: Federalism This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The rule will not have federalism implications warranting the application of Executive Orders 12372 and 13132. E:\FR\FM\05JNR1.SGM 05JNR1

Agencies

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33698-33699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13331]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2013-N-0002]


New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; 
Monensin; and Tylosin; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendments.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document amending the animal drug regulations to reflect approval 
actions for new animal drug applications and abbreviated new animal 
drug applications during March 2013 that appeared in the Federal 
Register of April 30, 2013. FDA is correcting the approved strengths of 
dexmedetomidine hydrochloride injectable solution. This correction is 
being made to improve the accuracy of the animal drug regulations.

DATES: This rule is effective June 5, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug

[[Page 33699]]

Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, 
ghaibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is 
correcting a document amending the animal drug regulations to reflect 
approval actions for new animal drug applications and abbreviated new 
animal drug applications during March 2013 that appeared in the Federal 
Register of April 30, 2013 (78 FR 25182). FDA is correcting the 
approved strengths of dexmedetomidine hydrochloride injectable 
solution. This correction is being made to improve the accuracy of the 
animal drug regulations.

List of Subjects in 21 CFR Part 522

    Animal drugs.

    Therefore, 21 CFR part 522 is corrected by making the following 
correcting amendment.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.558, revise paragraph (a) to read as follows:


Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains 0.1 or 0.5 
milligrams dexmedetomidine hydrochloride.
* * * * *

    Dated: May 31, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-13331 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.