New Animal Drugs; Change of Sponsor's Name, 23066-23067 [E8-9328]

Download as PDF 23066 Federal Register / Vol. 73, No. 83 / Tuesday, April 29, 2008 / Rules and Regulations FETRA, be promulgated and administered without regard to the Paperwork Reduction Act. Federal Register on June 24, 1983 (48 FR 29115). Executive Order 12612 This rule does not have Federalism implications that warrant the preparation of a Federalism Assessment. This rule will not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various levels of government. E-Government Act Compliance Executive Order 12988 List of Subjects in 7 CFR Part 1463 This final rule has been reviewed under Executive Order 12988. This final rule is not retroactive and it does not preempt State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. Before any judicial action may be brought regarding the provisions of this rule the administrative appeal provisions of 7 CFR parts 11 and 780 must be exhausted. Agriculture, Agricultural commodities, Acreage allotments, Marketing quotas, Price support programs, Tobacco, Tobacco Transition Program. Federal Assistance Program PART 1463—2005–2014 TOBACCO TRANSITION PROGRAM The title and number of the Federal assistance program as found in the Catalog of Federal Domestic Assistance, to which this rule applies, are: Commodity Loans and Purchases— 10.051. This rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandates Reform Act (UMRA) for State, local, and tribal government or the private sector. In addition, CCC was not required to publish a notice of proposed rulemaking for this rule. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) Section 642(c) of FETRA requires that the Secretary use the authority in section 808 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) (SBREFA), which allows an agency to forgo SBREFA’s usual 60-day Congressional Review delay of the effective date of a major regulation if the agency finds that there is a good cause to do so. Accordingly, this rule is effective on the date of publication in the Federal Register. jlentini on PROD1PC65 with RULES Paperwork Reduction Act These regulations are exempt from the requirements of the Paperwork Reduction Act (44 U.S.C. Chapter 35), as specified in section 642(b) of FETRA, which provides that these regulations, which are necessary to implement 16:32 Apr 28, 2008 Jkt 214001 Signed at Washington, DC, April 23, 2008. Teresa C. Lasseter, Executive Vice President, Commodity Credit Corporation. [FR Doc. E8–9295 Filed 4–28–08; 8:45 am] BILLING CODE 3410–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 For the reasons provided above, amend part 1463 of title 7 of the Code of Federal Regulation as follows: New Animal Drugs; Change of Sponsor’s Name Chapter XIV—Commodity Credit Corporation, Department of Agriculture HHS. I 1. The authority citation for part 1463 continues to read as follows: I Authority: 7 U.S.C. 714b and 714c; and Title VI of Pub. L. 108–357. 2. Amend § 1463.3 by revising the definition of CCC’s point of contact to read as follows: I Unfunded Mandates VerDate Aug<31>2005 CCC is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. the provisions of § 1463.6, as determined by the Deputy Administrator, Farm Service Agency. * * * * * § 1463.3 Definitions. * * * * * CCC’s point of contact means, for items physically sent to CCC, ‘‘Fibers, Peanuts, and Tobacco Analysis Group, Economic and Policy Analysis Staff, Farm Service Agency, United States Department of Agriculture (USDA), STOP 0515, Room 3720–S, 1400 Independence Avenue, SW., Washington, DC 20250–0515’’ unless otherwise specified by CCC through actual notice. * * * * * 3. Amend § 1463.8 by redesignating paragraphs (b)(8) and (b)(9) as paragraphs (b)(9) and (b)(10), respectively, and adding a new paragraph (b)(8) to read as follows: I § 1463.8 Notification of assessments. * * * * * (b) * * * (8) Beginning with the 2nd quarter of 2008, or as soon as practicable thereafter, the applied market share for that quarter of each other manufacturer and importer, for the applicable class of tobacco product of those manufacturers and importers that have provided such information to CCC in accordance with PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 AGENCY: ACTION: Food and Drug Administration, Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Halocarbon Laboratories, Division of Halocarbon Products Corp., to Halocarbon Products Corp. DATES: This rule is effective April 29, 2008. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Halocarbon Laboratories, Division of Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ 07661, has informed FDA that it has changed its name to Halocarbon Products Corp. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. FDA is also correcting the sponsor’s address in the regulation. 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 in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to E:\FR\FM\29APR1.SGM 29APR1 Federal Register / Vol. 73, No. 83 / Tuesday, April 29, 2008 / Rules and Regulations the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600 in the table in paragraph (c)(1), revise the entry for ‘‘Halocarbon Laboratories’’; and in the table in paragraph (c)(2), revise the entry for ‘‘012164’’ to read as follows: I § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Firm name and address * * * Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661. * * * Drug labeler code * 012164 * * * (2) * * * Drug labeler code * 012164 * * * Firm name and address * * * Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661. * * * Dated: April 16, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–9328 Filed 4–28–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF STATE 22 CFR Parts 40 and 41 [Public Notice: 6202] Visas: Documentation of Nonimmigrants Under the Immigration and Nationality Act, as Amended Department of State. Final rule. AGENCY: jlentini on PROD1PC65 with RULES ACTION: SUMMARY: This final rule amends the Department of State’s regulations related to application for a nonimmigrant visa, to offer a completely electronic application procedure as an alternative to submission of the Form DS–156. DATES: This rule is effective on April 29, 2008. FOR FURTHER INFORMATION CONTACT: Charles Robertson, Legislation and VerDate Aug<31>2005 16:32 Apr 28, 2008 Jkt 214001 Regulations Division, Visa Services, Department of State, Washington, DC 20520–0106, (202) 663–1202, e-mail (robertsonce3@state.gov). SUPPLEMENTARY INFORMATION: Why is the Department promulgating this rule? The Government Paperwork Elimination Act (GPEA 1998) requires that, when possible, Federal agencies use electronic forms, electronic filing, and electronic signatures to conduct agency business with the public. For this reason, the Department of State developed and introduced an electronic application process for nonimmigrant visas to eventually replace the current application process, which depends on a paper form (Form DS–156, and other forms when required, such as the Form DS–157 and Form DS–158). The first step was to offer an electronic visa application form (EVAF) as a voluntary alternative way of obtaining and preparing the Form DS–156. While the nonimmigrant visa applicant could obtain and prepare the Form DS–156 electronically, he or she was required to sign the Form DS–156 manually. On October 1, 2006, the EVAF was made mandatory worldwide wherever possible. Now, while the Department will continue to accept the EVAF (electronic Form DS–156) where necessary, it proposes to eventually eliminate the Form DS–156 entirely and replace it with the Form DS–160, an electronic form designed to be completed and signed electronically. What effect does the electronic application process have on the nonimmigrant visa applicant? The procedure is the same for the nonimmigrant visa applicant except that he or she will not be required to print and sign a form to take to the visa interview. All information entered into the Form DS–160 will be available to the consular officer at the time of the interview, thus simplifying the process from the point of the view of the applicant. The applicant is required to sign the Form DS–160 electronically. How does the applicant sign the Form DS–160 electronically? The applicant will be required to click on the box designated ‘‘Sign Application’’ found within the certification section of the application. How does the consular officer identify the applicant who has submitted an electronic application (Form DS–160)? Photos, passports and fingerscans collected as part of the application process will identify the applicant. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 23067 How does the applicant certify that the information in the Form DS–160 is correct? By signing the Form DS–160 electronically (i.e., clicking on the ‘‘Sign Application’’ box), the applicant certifies that the information provided is correct. Is an electronic signature binding on a nonimmigrant visa applicant? Yes. The electronic signature (i.e., the click on the ‘‘Sign Application’’ box) indicates that the applicant is familiar with and intends to be bound by the statements contained in the application and has answered all questions truthfully, under penalty of perjury. Can a third party prepare the Form DS– 160? While a third party may assist the applicant in preparing the Form DS– 160, the applicant must electronically sign the application himself or herself. The applicant must identify in the application any third party who has assisted in the preparation of the Form DS–160. Regulatory Findings 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 rule making procedures set forth at 5 U.S.C. 553. 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 at sections 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with section 605(b) of the 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. This regulates individual aliens who seek consideration for nonimmigrant visas and does not affect any small entities, as defined in 5 U.S.C. 601(6). The Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995 (UFMA), Public Law 104–4, 109 Stat. 48, 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 E:\FR\FM\29APR1.SGM 29APR1

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[Federal Register Volume 73, Number 83 (Tuesday, April 29, 2008)]
[Rules and Regulations]
[Pages 23066-23067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor's name from Halocarbon 
Laboratories, Division of Halocarbon Products Corp., to Halocarbon 
Products Corp.

DATES: This rule is effective April 29, 2008.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Halocarbon Laboratories, Division of 
Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River 
Ridge, NJ 07661, has informed FDA that it has changed its name to 
Halocarbon Products Corp. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c) to reflect these changes. FDA is also 
correcting the sponsor's address in the regulation.
    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 in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to

[[Page 23067]]

the Center for Veterinary Medicine, 21 CFR part 510 is amended as 
follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600 in the table in paragraph (c)(1), revise the entry 
for ``Halocarbon Laboratories''; and in the table in paragraph (c)(2), 
revise the entry for ``012164'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Halocarbon Products Corp., 887 Kinderkamack   012164
 Rd., River Edge, NJ 07661.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
012164                       Halocarbon Products Corp., 887 Kinderkamack
                              Rd., River Edge, NJ 07661.
                                * * * * *
------------------------------------------------------------------------


    Dated: April 16, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-9328 Filed 4-28-08; 8:45 am]
BILLING CODE 4160-01-S
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