Furnishing Statements Required With Respect to Certain

Official source: Federal Register (GovInfo) (https://www.govinfo.gov/content/pkg/FR-1996-09-05/pdf/96-22592.pdf), retrieved 2026-10-03. U.S. Government work (17 U.S.C. § 105).

Federal Register / Vol. 61, No. 173 / Thursday, September 5, 1996 / Rules and Regulations 46719

Acrylic copolymers (CAS Reg. No. 30394–

86–6): Prepared by reaction of ethyl acrylate (CAS Reg. No. 140–88–5), methyl methacrylate (CAS Reg. No. 80–62–6), and methyacrylamide (CAS Reg. No. 79–39–0) blended with melamine-formaldehyde resin (CAS Reg. No. 68002–20–0). For use in coatings for polyethylene phthalate films complying with paragraph (a) of this section.

Dated: August 23, 1996. William K. Hubbard, Associate Commissioner for Policy Coordination.

[FR Doc. 96–22695 Filed 9–4–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs; Sulfadimethoxine/Ormetoprim Tablets

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 a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The approved NADA provides for oral use of sulfadimethoxine/ ormetoprim tablets in dogs for the treatment of certain bacterial skin and soft tissue infections (wounds and abscesses). The supplement adds the treatment of certain bacterial urinary tract infections. This product is limited to veterinary prescription use.

Dated: August 23, 1996. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

[FR Doc. 96–22694 Filed 9–4–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 602

[TD 8029]

Furnishing Statements Required With Respect to Certain Substitute Payments; Correction

AGENCY: Internal Revenue Services (IRS), Treasury.

ACTION: Correcting amendment.

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are the subject of this correction are under sections 6042, 6045 and 6049 of the Internal Revenue Code.

Need for Correction

The final regulations (TD 8029) omitted instructions to remove § 1.6045–2T and the entry for the OMB control number. It is the intent of this document to make these removals as of the publication of the final regulations.

List of Subjects

26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements.

26 CFR Part 602 Reporting and recordkeeping requirements.

Correcting Amendment to Regulations

Accordingly, 26 CFR parts 1 and 602 are corrected by making the following correcting amendments:

PART 1—INCOME TAXES

Paragraph 1. The authority citation for part 1 continues to read in part as follows:

SUMMARY: This document contains a correction to final regulations (TD 8029), which were published in the Federal Register on Wednesday, June 5, 1985 (50 FR 23676) relating to statements required to be furnished by brokers and information returns of brokers.

EFFECTIVE DATE: June 5, 1985.

FOR FURTHER INFORMATION CONTACT: Donna Welch, (202) 622–4910, (not a toll-free number).

EFFECTIVE DATE: September 5, 1996

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary Medicine (HFV–114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–594–1617.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed supplemental NADA 100– 929, which provides for oral use of Primor (sulfadimethoxine/ ormetoprim) tablets in dogs for the treatment of urinary tract infections caused by Escherichia coli, Staphylococcus spp., and Proteus mirabilis susceptible to the combination of sulfadimethoxine/ormetoprim in addition to its approved use for skin and soft tissue infections (wounds and abscesses) caused by strains of S. aureus and E. coli susceptible to sulfadimethoxine/ormetoprim. This product is limited to use by or on the order of a licensed veterinarian. The supplement is approved as of August 5, 1996, and the regulations are amended in 21 CFR 520.2220d to reflect the

approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of part 20 (21 CFR part 20) and § 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA–305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1–23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning August 5, 1996, because the supplement contains reports of new clinical or field investigations (other than bioequivalence or residue studies) essential to the approval and conducted or sponsored by the applicant. Marketing exclusivity applies only to use in treating urinary tract infections.

The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency’s finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

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

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

Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.2220d [Amended] 2. Section 520.2220d Sulfadimethoxine-ormetoprim tablets is amended in paragraph (c)(2) by adding the phrase ‘‘and urinary tract infections caused by Escherichia coli, Staphlococcus spp., and Proteus mirabilus ’’ after ‘‘ Escherichia coli ’’ .

46720 Federal Register / Vol. 61, No. 173 / Thursday, September 5, 1996 / Rules and Regulations

Authority: 26 U.S.C. 7805 * * *

§ 1.6045–2T [Removed] Par. 2. Section 1.6045–2T is removed.

PART 602—OMB CONTROL NUMBERS UNDER THE PAPERWORK REDUCTION ACT

Par. 3. The authority citation for part 602 continues to read as follows:

Authority: 26 U.S.C. 7805.

§ 602.101 [Amended] Par. 4. Section 602.101(c) is amended by removing the entry for § 1.6045–2T from the table. Cynthia E. Grigsby, Chief, Regulations Unit, Assistant Chief Counsel (Corporate).

[FR Doc. 96–22592 Filed 9–4–96; 8:45 a.m.]

BILLING CODE 4830–01–M

DEPARTMENT OF JUSTICE

28 CFR Part 0

[DEA–136C]

Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

AGENCY: Department of Justice.

ACTION: Final rule.

DATES: This amendment is effective October 7, 1996.

FOR FURTHER INFORMATION CONTACT: Caroll McBrine, M.D., Consultant, Regulations Staff (213A), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW, Washington DC 20420, (202) 273–7210.

SUPPLEMENTARY INFORMATION: As part of its first comprehensive review of the rating schedule since 1945, VA published a proposal to amend 38 CFR 4.96 and 4.97, which address the respiratory system. The proposal was published in the Federal Register of January 19, 1993 (58 FR 4962–69). Interested persons were invited to submit written comments on or before March 22, 1993. We received comments from Paralyzed Veterans of America, Disabled American Veterans, Veterans of Foreign Wars, the American Legion, several VA employees, and one member of the general public.

One commenter suggested a need for a zero percent level for all conditions.

On October 6, 1993, VA revised its regulation addressing the issue of zero percent evaluations (38 CFR 4.31) to authorize assignment of a zero percent evaluation for any disability in the rating schedule when minimum requirements for a compensable evaluation are not met. In general, that regulatory provision precludes the need for zero percent criteria for every condition. VA believes that it is useful to include a zero percent evaluation only if it is necessary to give the rating board clear and unambiguous instructions on rating where it might otherwise be unclear whether commonly occurring minor findings warrant a zero percent or higher evaluation.

One commenter suggested that the proposed revision would discriminate against veterans whose initial evaluations would be assigned under a new and deliberalized schedule.

Significant medical advances have occurred since the last comprehensive review of the rating schedule, and it is appropriate to take these advances into account in revising the rating schedule. Doing so is, in fact, one of the primary reasons for conducting this review. In our judgment, veterans will not be discriminated against by having their disabilities evaluated under criteria which reflect the effects of those medical advances. For veterans evaluated under the former criteria, Congress amended 38 U.S.C. 1155 to prohibit a reduction in a veteran’s disability rating because of a readjustment of the rating schedule

SUMMARY: Under delegated authority, the Deputy Administrator of the Drug Enforcement Administration (DEA), Department of Justice, is amending the Appendix to Subpart R of the Justice Department regulations to make a technical correction to reflect a change in the position classification series for DEA Diversion Investigators.

EFFECTIVE DATE: September 5, 1996.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537, Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: On October 1, 1995, Drug Enforcement Administration Diversion Investigators were converted from the Office of Personnel Management position classification series 1810 to series 1801. Section 3(b) of the Appendix to Subpart R is being amended to reflect that change by removing the reference to series 1810 and replacing it with series 1801. The Deputy Administrator certifies that this action will have no impact upon entities whose interests must be considered under the Regulatory Flexibility Act (5 U.S.C. 601). Pursuant to Executive Order 12866, this is not a

significant regulatory action since it relates only to the organization of functions within DEA. Accordingly, it has not been reviewed by the Office of Management and Budget and does not require certification under Executive Order 12778. This action has been analyzed in accordance with Executive Order 12616. It has been determined that this matter has no federalism implications which would require preparation of a federalism assessment.

List of Subjects in 28 CFR Part 0

Authority Delegations (Government Agencies), Organizations and functions (Government Agencies).

For the reasons set forth above, and pursuant to the authority vested in the Deputy Administrator of the Drug Enforcement Administration by 28 CFR 0.100 and 0.104, and 21 U.S.C. 871, title 28 of the Code of Federal Regulations, part 0, appendix to subpart R, Redelegation of Functions, is amended as follows:

PART 0—ORGANIZATION OF THE DEPARTMENT OF JUSTICE

The authority citation for part 0 continues to read as follows:

Authority: 5 U.S.C. 301: 28 U.S.C. 509, 510, 515–519.

In the Appendix to subpart R, Section 3(b) remove the words ‘‘series 1810’’ and replace them with the words ‘‘series 1801’’.

Dated: August 28, 1996. Stephen H. Greene, Deputy Administrator.

[FR Doc. 96–22707 Filed 9–4–96; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900–AE94

Schedule for Rating Disabilities; Respiratory System

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends that portion of the Department of Veterans Affairs (VA) Schedule for Rating Disabilities that addresses the Respiratory System. The intended effect of this action is to update the respiratory portion of the rating schedule to ensure that it uses current medical terminology and unambiguous criteria, and that it reflects medical advances which have occurred since the last review.