New Animal Drugs for Minor Use and Minor Species, 18685-18686 [2012-7532]

Download as PDF Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Rules and Regulations pmangrum on DSK3VPTVN1PROD with RULES § 230.500 Use of Regulation D. Users of Regulation D (§§ 230.500 et seq.) should note the following: (a) Regulation D relates to transactions exempted from the registration requirements of section 5 of the Securities Act of 1933 (the Act) (15 U.S.C.77a et seq., as amended). Such transactions are not exempt from the antifraud, civil liability, or other provisions of the federal securities laws. Issuers are reminded of their obligation to provide such further material information, if any, as may be necessary to make the information required under Regulation D, in light of the circumstances under which it is furnished, not misleading. (b) Nothing in Regulation D obviates the need to comply with any applicable state law relating to the offer and sale of securities. Regulation D is intended to be a basic element in a uniform system of federal-state limited offering exemptions consistent with the provisions of sections 18 and 19(c) of the Act (15 U.S.C. 77r and 77(s)(c)). In those states that have adopted Regulation D, or any version of Regulation D, special attention should be directed to the applicable state laws and regulations, including those relating to registration of persons who receive remuneration in connection with the offer and sale of securities, to disqualification of issuers and other persons associated with offerings based on state administrative orders or judgments, and to requirements for filings of notices of sales. (c) Attempted compliance with any rule in Regulation D does not act as an exclusive election; the issuer can also claim the availability of any other applicable exemption. For instance, an issuer’s failure to satisfy all the terms and conditions of rule 506 (§ 230.506) shall not raise any presumption that the exemption provided by section 4(2) of the Act (15 U.S.C. 77d(2)) is not available. (d) Regulation D is available only to the issuer of the securities and not to any affiliate of that issuer or to any other person for resales of the issuer’s securities. Regulation D provides an exemption only for the transactions in which the securities are offered or sold by the issuer, not for the securities themselves. (e) Regulation D may be used for business combinations that involve sales by virtue of rule 145(a) (§ 230.145(a)) or otherwise. (f) In view of the objectives of Regulation D and the policies underlying the Act, Regulation D is not available to any issuer for any transaction or chain of transactions that, VerDate Mar<15>2010 14:15 Mar 27, 2012 Jkt 226001 although in technical compliance with Regulation D, is part of a plan or scheme to evade the registration provisions of the Act. In such cases, registration under the Act is required. (g) Securities offered and sold outside the United States in accordance with Regulation S (§ 230.901 through 905) need not be registered under the Act. See Release No. 33–6863. Regulation S may be relied upon for such offers and sales even if coincident offers and sales are made in accordance with Regulation D inside the United States. Thus, for example, persons who are offered and sold securities in accordance with Regulation S would not be counted in the calculation of the number of purchasers under Regulation D. Similarly, proceeds from such sales would not be included in the aggregate offering price. The provisions of this paragraph (g), however, do not apply if the issuer elects to rely solely on Regulation D for offers or sales to persons made outside the United States. § 230.501 [Amended] 6. In § 230.501 introductory text, remove the reference to ‘‘§§ 230.501– 230.508’’ and add in its place ‘‘§ 230.500 et seq. of this chapter’’. ■ § 230.502 [Amended] 18685 Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 78j–1, 78k, 78k–1, 78l, 78m, 78n, 78n–1, 78o, 78o–4, 78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a–20, 80a–23, 80a–29, 80a–37, 80b– 3, 80b–4, 80b–11, and 7201 et seq.; 18 U.S.C. 1350, 12 U.S.C. 5221(e)(3), and Pub. L. 111– 203, § 939A, 124 Stat. 1376, (2010) unless otherwise noted. * * § 242.101 * * * [Amended] 11. In § 242.101(b)(10)(i), remove the reference to ‘‘§ 230.501 through § 230.508’’ and add in its place ‘‘§ 230.500 et seq’’. ■ § 242.102 [Amended] 12. In § 242.102(b)(7)(i), remove the reference to ‘‘§ 230.501 through § 230.508’’ and add in its place ‘‘§ 230.500 et seq’’. ■ § 242.104 [Amended] 13. In § 242.104(j)(2)(i), remove the reference to ‘‘§ 230.501 through § 230.508’’ and add in its place ‘‘§ 230.500 et seq’’. ■ Dated: March 23, 2012. Elizabeth M. Murphy, Secretary. 7. In § 230.502 introductory text, remove the reference to ‘‘§§ 230.501– 230.508’’ and add in its place ‘‘§ 230.500 et seq. of this chapter’’. [FR Doc. 2012–7446 Filed 3–27–12; 8:45 am] PART 240—GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934 HEALTH AND HUMAN SERVICES DEPARTMENT ■ 8. The general authority citation for Part 240 continues to read, in part, as follows: BILLING CODE 8011–01–P Food and Drug Administration ■ Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 78j–1, 78k, 78k–1, 78l, 78m, 78n, 78n–1, 78o, 78o–4, 78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a–20, 80a–23, 80a–29, 80a–37, 80b– 3, 80b–4, 80b–11, and 7201 et seq.; 18 U.S.C. 1350, 12 U.S.C. 5221(e)(3), and Pub. L. 111– 203, § 939A, 124 Stat. 1376, (2010) unless otherwise noted. * * * § 240.15g–1 * * 9. In § 240.15g–1(c), remove the reference to ‘‘17 CFR 230.501–230.508’’ and add in its place ‘‘17 CFR 230.500 et seq’’. ■ PART 242—REGULATION M 10. The general authority citation for Part 242 continues to read, in part, as follows: PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 New Animal Drugs for Minor Use and Minor Species CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2011, on page 96, in § 516.20, (b)(2) is revised to read as follows: § 516.20 Content and format of a request for MUMS-drug designation. * [Amended] ■ 21 CFR Part 516 * * * * (b) * * * (2) The name and address of the sponsor; the name of the sponsor’s primary contact person and/or permanent-resident U.S. agent including title, address, and telephone number; the established name (and proprietary name, if any) of the active pharmaceutical ingredient of the drug; and the name and address of the source E:\FR\FM\28MRR1.SGM 28MRR1 18686 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Rules and Regulations of the active pharmaceutical ingredient of the drug. * * * * * [FR Doc. 2012–7532 Filed 3–27–12; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 Apportionment of Tax Items Among the Members of a Controlled Group of Corporations CFR Correction In Title 26 of the Code of Federal Regulations, Part 1(§ 1.1551 to End of Part 1), revised as of April 1, 2011, on page 24, in § 1.1561–2, paragraphs (c) through (f) are added to read as follows: § 1.1561–2 Special rules for allocating reductions of certain section 1561(a) taxbenefit items. pmangrum on DSK3VPTVN1PROD with RULES * * * * * (c) Accumulated earnings credit. The component members of a controlled group of corporations are permitted to allocate the amount of the accumulated earnings credit unequally if they have an apportionment plan in effect. (d) [Reserved] (e) Short taxable years not including a December 31st date—(1) General rule. If a corporation has a short taxable year not including a December 31st date and, after applying the rules of section 1561(b) and paragraph (e)(2)(i) of this section, it qualifies as a component member of the group with respect to its short taxable year (short-year member), then, for purposes of subtitle A of the Internal Revenue Code, the amount of any tax-benefit item described in section 1561(b) allocated to that component member’s short taxable year shall be the amount specified in section 1561(a) for that item, divided by the number of corporations which are component members of that group on the last day of that component member’s short taxable year. The component members of such group may not apportion, by an apportionment plan, an amount of such tax-benefit item to any short-year member that differs from equal apportionment of that item. (2) Additional rules. For purposes of paragraph (e)(1) of this section— (i) Section 1563(b) shall be applied as if the last day of the taxable year of a short-year member were substituted for December 31st; and (ii) The term short taxable year does not refer to any portion of a tax year of a corporation for which its income is VerDate Mar<15>2010 16:30 Mar 27, 2012 Jkt 226001 required to be included in a consolidated return pursuant to § 1.1502–76(b). (3) Calculation of the additional tax. A short-year member (as defined in paragraph (e)(1) of this section) for its short taxable year calculates its additional tax liability imposed by section 11(b)(1) only on its own income, and therefore the subsequent calculation of the additional tax liability with regard to the remaining members of the group will not include the income of this short-year member. (4) Calculation of the alternative minimum tax. If a component member has a tax year of less than 12 months, whether or not such tax year includes a December 31st date, see section 443(d) for the annualization method required for calculating the alternative minimum tax. (5) Examples. The provisions of this paragraph (e) may be illustrated by the following examples: Example 1. Formation of a new member of a controlled group— (i) Facts. On January 2, 2007, corporation X transfers cash to newly formed corporation Y (which begins business on that date) and receives all of the stock of Y in return. X also owns all of the stock of corporation Z on each day of 2006 and 2007. X, Y and Z have an apportionment plan in effect, apportioning the 15 percent taxbracket amount as follows: 40% ($20,000) to each of X and Y and 20% ($10,000) to Z. X, Y and Z each file a separate return with respect to the group’s December 31st, 2007 testing date. X is on a calendar tax year and Z is on a fiscal tax year ending on March 31. Y adopts a fiscal year ending on June 30 and timely files a tax return for its short taxable year beginning on January 2, 2007, and ending on June 30, 2007. (ii) Y’s short taxable year. On June 30, 2007, Y is a component member of a parentsubsidiary controlled group of corporations composed of X, Y and Z. Pursuant to paragraph (e)(1) of this section, the group may not apportion any amount of the 15 percent tax bracket to Y’s short taxable year ending on June 30, 2007. Rather, Y is entitled to exactly 1⁄3 of such bracket amount, or $16,667. (iii) The members’ subsequent tax years. On December 31st, 2007, X, Y and Z are component members of a parent-subsidiary controlled group of corporations. For their tax years that include December 31st, 2007 (X’s calendar year ending December 31st, 2007, Z’s fiscal year ending March 31, 2008 and Y’s fiscal year ending June 30, 2008), X, Y and Z apportion among themselves the full amount of all of the applicable tax brackets pursuant to their apportionment plan. For example, 40% of the 15 percent tax-bracket amount, or $20,000, was apportioned to each of X and Y, and the remaining 10%, or $10,000, was apportioned to Z. Example 2. Allocating a tax bracket to the short taxable year of a liquidated member of a controlled group— (i) Facts. On January 1, 2007, corporation P owns all of the stock of PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 corporations S1, S2 and S3 (the P group). Each of these four component members of the P group, with respect to the group’s December 31st, 2007 testing date, files its separate return on a calendar year basis. These members have an apportionment plan in effect (the P group plan) under which S1 and S2 are each entitled to 40% of the 15 percent tax-bracket amount ($20,000), and P and S3 are each entitled to 10% of the 15 percent tax-bracket amount ($5,000). On May 31, 2007, S1 liquidates and therefore files a return for the short taxable year beginning on January 1, 2007, and ending on May 31, 2007. On July 31, 2007, S2 liquidates and therefore files a return for the short taxable year beginning on January 1, 2007 and ending on July 31, 2007. P and S3 each file a return for their 2007 calendar tax years. (ii) Apportionment of the 15 percent tax bracket to S1 for its short taxable year. On May 31, 2007, S1 is a component member of the P group composed of P, S1, S2 and S3. Pursuant to paragraph (e)(1) of this section, the group may not apportion any amount of the 15 percent tax bracket to S1’s short taxable year ending on June 30, 2007. Rather, S1 is entitled to exactly 1⁄4 of such bracket amount, or $12,500. (iii) Apportionment of the 15 percent tax bracket to S2 for its short taxable year. On July 31, 2007, S2 is a component member of the P group composed of P, S2 and S3. Pursuant to paragraph (e)(1) of this section, the group may not apportion any amount of the 15 percent tax bracket to S2’s short taxable year ending on June 30, 2007. Rather, S2 is entitled to exactly 1⁄4 of such bracket amount, or $16,667. (iv) Apportionment of the 15 percent tax bracket to P and S3 for each of their calendar tax years. On December 31st, 2007, P and S3 are component members of the P group. Accordingly, for P and S3’s 2007 calendar tax year, they are each apportioned $25,000 of the 15 percent tax bracket, pursuant to the applicable P group plan. Example 3. Liquidation of member after its transfer to another controlled group— (i) Facts. The facts are the same as in Example 2, except that P, on April 30, 2007, sold all of the stock of S2 to the M–N controlled group. At the time of the sale, M and N are both unrelated to any members of the P group. As in Example 2, S2 liquidates on July 31, 2007, and therefore files a tax return for its short taxable year beginning on January 1, 2007, and ending on July 31, 2007. Pursuant to the sales agreement, the N–M group timely notified P that S2 had liquidated. (ii) Controlled group analysis. On April 30, 2007, the date of the sale of S2, the P group reasonably expected that S2 would be treated as an excluded member with respect to its December 31st, 2007 testing date. On that April 30th date, S2 had been a member of the P group for less than one-half the number of days of what it expected would be a full 2007 calendar tax year preceding December 31st, 2007 (120 days (January 1–April 30) out of 364 days (January 1–December 30)). Yet, as a result of S2’s subsequent liquidation by the M–N group prior to December 31st, 2007, S2 became a component member of the P group with respect to the P group’s December 31st, 2007 testing date. With respect to that E:\FR\FM\28MRR1.SGM 28MRR1

Agencies

[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Rules and Regulations]
[Pages 18685-18686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7532]


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HEALTH AND HUMAN SERVICES DEPARTMENT

Food and Drug Administration

21 CFR Part 516


New Animal Drugs for Minor Use and Minor Species

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 500 to 599, 
revised as of April 1, 2011, on page 96, in Sec.  516.20, (b)(2) is 
revised to read as follows:


Sec.  516.20  Content and format of a request for MUMS-drug 
designation.

* * * * *
    (b) * * *
    (2) The name and address of the sponsor; the name of the sponsor's 
primary contact person and/or permanent-resident U.S. agent including 
title, address, and telephone number; the established name (and 
proprietary name, if any) of the active pharmaceutical ingredient of 
the drug; and the name and address of the source

[[Page 18686]]

of the active pharmaceutical ingredient of the drug.
* * * * *
[FR Doc. 2012-7532 Filed 3-27-12; 8:45 am]
BILLING CODE 1505-01-D
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