[Federal Register Volume 67, Number 228 (Tuesday, November 26, 2002)]
[Rules and Regulations]
[Pages 70691-70692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 90N-0056]
RIN 0910-AA74


Aluminum in Large and Small Volume Parenterals Used in Total 
Parenteral Nutrition; Amendment; Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is further delaying 
until January 26, 2004, the effective date of a final rule published in 
the Federal Register of January 26, 2000 (65 FR 4103) (aluminum final 
rule), and originally scheduled to become effective on January 26, 
2001. In the Federal Register of January 26, 2001 (66 FR 7864), the 
agency delayed the effective date of the aluminum final rule until 
January 26, 2003. The aluminum final rule imposes certain requirements 
for aluminum-containing large volume parenterals (LVPs), small volume 
parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total 
parenteral nutrition (TPN). FDA is delaying the effective date of the 
aluminum final rule to allow time for the agency to finalize an 
amendment to the aluminum final rule. The agency is also amending the 
aluminum final rule to change to January 26, 2004, the date that limits 
the use of historical levels to determine the maximum level of aluminum 
in SVPs and PBPs; this date corresponds to the effective date of the 
aluminum final rule, which is delayed until January 26, 2004, by this 
document.

DATES: This final rule is effective December 26, 2002. The effective 
date for Sec.  201.323 (21 CFR 201.323), added at 65 FR 4103, January 
26, 2000, is delayed until January 26, 2004.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: On January 26, 2000, FDA published final 
regulations at Sec.  201.323 imposing certain requirements for 
aluminum-containing LVPs, SVPs, and PBPs used in TPN (65 FR 4103). The 
aluminum final rule was originally scheduled to become effective on 
January 26, 2001. In the Federal Register of January 26, 2001 (66 FR 
7864), the agency published a notice delaying the effective date until 
January 26, 2003.
    In the Federal Register of August 12, 2002 (67 FR 52429), FDA 
published a proposed rule to amend Sec.  201.323. The proposed rule 
would permit SVPs and PBPs containing 25 micrograms per liter ([mu]g/L) 
or less of aluminum to be labeled with the statement ``Contains no more 
than 25 [mu]g/L of aluminum'', instead of stating the exact amount of 
aluminum they contain. Because there is insufficient time to finalize 
this proposed amendment before January 26, 2003, when Sec.  201.323 is 
scheduled to become effective, the agency is delaying the effective 
date of Sec.  201.323 until January 26, 2004.
    The agency is also amending Sec.  201.323(c)(3) of the aluminum 
final rule to reflect the fact that the effective date is now being 
extended to January 26, 2004. Section 201.323(c)(3) provides that a 
manufacturer may state the maximum level of aluminum in terms of 
historical levels, but only until completion of production of the first 
five batches after January 26, 2001, the date by which manufacturers 
were to have submitted supplements describing the validated assay 
method used to determine aluminum content. Because manufacturers now 
have until January 26, 2004, to submit supplements, this final rule is 
changing the date in Sec.  201.323(c)(3) to reflect the fact that the 
effective date of the aluminum final rule has been extended to January 
26, 2004.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment 
comes within the good cause exceptions in 5 U.S.C. 553(b)(3)(B) in that 
obtaining public comment is impracticable, unnecessary, and contrary to 
the public interest. The agency is delaying the effective date of Sec.  
201.323 because the agency has proposed to amend Sec.  201.323. Given 
the imminence of the effective date of current Sec.  201.323, seeking 
prior public comment on this delay is impracticable, as well as 
contrary to the public interest in the orderly issuance and 
implementation of regulations. Notice and comment procedures in this 
instance would create uncertainty, confusion, and undue financial 
hardship because, during the time that the agency would be proposing to 
extend the effective date for Sec.  201.323, those companies affected 
would have to be preparing to relabel to comply with the January 26, 
2003, effective date. In accordance with 21 CFR 10.40(e)(1), FDA is 
providing an opportunity for comment on which this delay should be 
modified or revoked.
    FDA has examined the impacts of this delay of effective date under 
Executive Order 12866. Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory

[[Page 70692]]

alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). The agency believes that this action 
is consistent with the regulatory philosophy and principles identified 
in the Executive order. This action will ease the burden on industry of 
compliance with Sec.  201.323 by giving manufacturers more time to 
relabel affected products. Thus, this action is not a significant 
action as defined by the Executive order.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
201 is amended as follows:

PART 201--LABELING

    1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
    2. Section 201.323(c)(3) is amended by removing the date ``2001'' 
and adding in its place the date ``2004''.

    Dated: November 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-29924 Filed 11-25-02; 8:45 am]
BILLING CODE 4160-01-S