[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Rules and Regulations]
[Pages 55527-55528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 447

[CMS-2175-CN]
RIN 0938-AM20


Medicaid Program; Time Limitation on Price Recalculations and 
Recordkeeping Requirements Under the Drug Rebate Program; Correction

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule; correction.

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SUMMARY: This document corrects the effective date of a final rule with 
comment period published in the Federal Register on August 29, 2003 (68 
FR 51912). That rule finalizes separately, in an accelerated timeframe, 
two specific provisions of the September 19, 1995 proposed rule. It 
establishes new recordkeeping requirements for drug manufacturers under 
the Medicaid drug rebate program. It also sets forth a 3-year time 
limitation during which manufacturers must report changes to average 
manufacturer price and best price for purposes of reporting data to us. 
In addition, it announces the pressing need for codification of 
fundamental recordkeeping requirements. It also announces our intention 
to continue to work on finalizing the complete drug

[[Page 55528]]

rebate regulation for the Medicaid drug rebate program. This document 
corrects the effective date.

EFFECTIVE DATE: The effective date of the August 29, 2003 final rule 
(68 FR 51912) amending 42 CFR part 447 is corrected from October 1, 
2003 to January 1, 2004.

FOR FURTHER INFORMATION CONTACT: Marge Watchorn, (410) 786-4361.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 29, 2003, we published in the Federal Register a final 
rule with comment period entitled, ``Medicaid Program; Time Limitation 
on Price Recalculations and Recordkeeping Requirements Under the Drug 
Rebate Program.'' The rule establishes requirements for recordkeeping 
and time limits on price recalculations. The effective date of these 
requirements as stated in the August 2003 rule is October 1, 2003.
    The Office of Management and Budget (OMB) declared that the August 
2003 final rule is a major rule. Thus, we should have given January 1, 
2004 as the effective date in accordance with 5 U.S.C. 801(a)(4). 
However, we erroneously incorporated an incorrect effective date of 
October 1, 2003. We have identified and corrected that error in the 
``Correction of Errors'' section below.

II. Correction of Errors

    In FR Doc. 03-21548 of August 29, 2003 (68 FR 51917), make the 
following correction:
    [sbull] On page 51912, in column one, in the ``Dates'' section, 
remove ``October 1, 2003'' and replace it with ``January 1, 2004.''

III. Waiver of Notice of Proposed Rulemaking and Delay of the Effective 
Date

    We ordinarily publish a general notice of proposed rulemaking in 
the Federal Register and invite prior public comment on a proposed 
rule. Final rules generally have a 30-day or longer prospective 
effective date. However, this document merely provides a correction to 
the effective date of the final rule with comment published on August 
29, 2003. This correction is being made based on OMB's decision that 
the August 2003 final rule is a major rule. Thus, we should have given 
January 1, 2004 as the effective date in accordance with 5 U.S.C. 
801(a)(4). However, we erroneously incorporated an incorrect effective 
date of October 1, 2003. It would be impracticable, unnecessary and 
contrary to the public interest to publish a proposed rule and solicit 
comments since this document is technical in nature and does not impose 
new limits on the substantive rights of the industry or the public. 
Similarly, given the imminence of the effective date, it would serve no 
useful purpose to further delay the effective date of this technical 
correction. Therefore, to the extent that 5 U.S.C. 553 applies to this 
action, we find good cause to waive notice and comment procedures and 
our usual delay in the effective date.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

    Dated: September 24, 2003.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 03-24550 Filed 9-25-03; 8:45 am]
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