This document contains corrections to final regulations (T.D. 9604, 2012-52 I.R.B. 730) that were published in the Federal Register on Friday, December 7, 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act.
Natalie Payne, Michael Beker, or Stephanie Bland, at (202) 622-3130 (not a toll-free number).
The final regulations (T.D. 9604) that are the subject of this correction is under section 4191 of the Internal Revenue Code.
As published, the final regulations (T.D. 9604) contain errors that may prove to be misleading and are in need of clarification.
Accordingly, the final regulations (T.D. 9604), that are the subject of FR Doc. 2012-29628, are corrected as follows:
1. On page 72925, column 1, in the preamble, under the paragraph heading “Background”, second full paragraph of the column, lines 2 through 9, the language “regulations identified two issues that the IRS and the Treasury Department will study further and on which the IRS and the Treasury Department have requested additional comments. Those issues are discussed later in this preamble. Comments with regard to those issues should be submitted in” is corrected to read “regulations identified one issue that the IRS and the Treasury Department will study further and on which the IRS and the Treasury Department have requested additional comments. That issue is discussed later in this preamble. Comments with regard to that issue should be submitted in”.
2. On page 72926, column 2, in the preamble, under the paragraph heading “Humanitarian Use Devices”, line 6 from the bottom of the column, the language “excluding HUDs from the definition of ” is corrected to read “excluding HUDs from the definition of a”.
3. On page 72927, column 3, under the paragraph heading “Nonexclusivity of Factors”, line 4 from the bottom of the column, the language “the final regulations include seven” is corrected to read “the final regulations include eight”
4. On page 72928, column 2, under the paragraph heading “Cost”, line 6 from the bottom of the column, the language “used in hospitals, doctors offices and” is corrected to read “used in hospitals, doctors’ offices and”.
5. On page 72929, column 2, under the paragraph heading “Documents Submitted for FDA Notification or Approval”, line 3 from the top of the column, the language “by the general public for individual use.” is corrected to read “by the general public at retail for individual use.”
6. On page 72929, column 3, under the paragraph heading “Capped Rental Devices”, first full paragraph of the column, line 2, the language “in consultation with the Center for” is corrected to read “in consultation with the Centers for”.
7. On page 72930, column 2, under the paragraph heading “A. Proposed Regulations”, line 6, the language “of taxable medical device to the FDA’s” is corrected to read “of a taxable medical device to the FDA’s”.
8. On page 72931, column 1, under the paragraph heading “Installment Sales, Leases, and Long-Term Contracts”, line 3 from the bottom of the column, the language “Payments made pursuant to a contract” is corrected to read “Payments made on or after January 1, 2013, pursuant to a contract”.
9. On page 72932, column 2, under the paragraph heading “Consolidated Form 637 Registration”, line 3, the language “effectuate tax-free sales. Several” is corrected to read “effectuate tax-free sales for further manufacture or export. Several”.
LaNita VanDyke,The Internal Revenue Bulletin is produced and published by the Internal Revenue Service and contains IRS pronouncements affecting tax analysis under the Code and the Regulations, including but not limited to Revenue Procedures, Revenue Rulings, Notices and Announcements. Access the IRS site at https://www.irs.gov/help/irsgov-accessibility for information concerning accessibility of IRS materials. While every effort has been made to ensure that the IRB database files available through the TouchTax application are accurate, those using TouchTax for legal research should verify their results against the printed versions of the IRBs available from the IRS.