[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Rules and Regulations]
[Pages 13066-13067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6447]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 77N-094W]


Over-the-Counter Drug Products Containing Analgesic/Antipyretic 
Active Ingredients for Internal Use; Required Alcohol Warning; Final 
Rule; Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; compliance date.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
compliance date of October 22, 1999, for the regulation that published 
in the Federal Register of October 23, 1998 (63 FR 56789). The 
regulation established warning statements that advise consumers with a 
history of heavy alcohol use to consult a physician for advice about 
the use of OTC internal analgesic/antipyretic drug products. The 
compliance date applies to all affected OTC drug products, whether 
marketed with or without an approved application. FDA is taking this 
action in response to correspondence and a citizen petition requesting 
more time to relabel these products.

DATES: 21 CFR 201.322, published on October 23, 1998 (63 FR 56789), is 
effective April 23, 1999; but compliance is not required until October 
22, 1999.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2307.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 14, 1997 (62 FR 61041), FDA 
published a proposed amendment of part 201 (21 CFR part 201) to 
establish alcohol warnings for all OTC drug products labeled for adult 
use containing internal analgesic/antipyretic active ingredients. The 
agency stated that it may change the wording of the proposed warnings 
or not require them as a result of comments filed in response to the 
proposal. Because it wished to encourage the voluntary use of the 
proposed warning statements, the agency advised that manufacturers 
would be given ample time after publication of a final rule to use up 
any labeling printed in conformance with the proposal (62 FR 61041 at 
61052).
    In the Federal Register of October 23, 1998 (63 FR 56789), FDA 
issued a final rule amending part 201 and establishing in Sec. 201.322 
a required alcohol warning for OTC drug products containing internal 
analgesic/antipyretic active ingredients. The final rule requires 
manufacturers to add certain new warnings for any OTC drug product, 
labeled for adult use, containing any internal analgesic/antipyretic 
active ingredients (including, but not limited to, acetaminophen, 
aspirin, carbaspirin calcium, choline salicylate, ibuprofen, 
ketoprofen, magnesium salicylate, naproxen sodium, and sodium 
salicylate) alone or in combination and marketed with or without an 
approved application. The wording of the warnings in the final rule was 
different than the wording in the proposal. The final rule specified an 
effective date of April 23, 1999, for any OTC drug product subject to 
this section.

II. Summary of Comments Received

    In response to the final rule, the agency received several comments 
(Ref. 1) and a citizen petition (Ref. 2) requesting more time to 
implement the new required alcohol warnings and a mechanism by which 
manufacturers may petition the agency for a variance or extension of 
time to comply with the regulation's 6-month implementation date. The 
comments were submitted by several large manufacturers of brand name 
OTC internal analgesic/antipyretic drug products and a manufacturer of 
a large number of private label OTC internal analgesic/antipyretic drug 
products. The comments stated that relabeling procedures generally take 
longer than the 6 months provided for in the final rule and that the 
companies simply lack the needed manpower and equipment to comply by 
April 23, 1999.
    The comments added that the implementation period for the new rule 
must ensure that label integrity is not compromised or done 
haphazardly. The comments stated that 6 months is an insufficient 
period of time for a number of companies to accomplish the relabeling, 
and the short timeframe does not promote emphasis on labeling integrity 
and good manufacturing practice compliance. All of the comments 
expressed concern that numerous products could become unavailable and 
estimated significant loss of inventory if required to implement the 
labeling change by April 23, 1999.
    One comment requested permission to use up all existing supplies of 
labeling that contain the precise alcohol warning contained in an 
agency letter dated March 14, 1996 (Ref. 3). Another

[[Page 13067]]

comment, submitted by a manufacturer, stated that it would implement 
the new alcohol warnings by the effective date and that other affected 
companies should also be required to meet that date (Ref. 4).
    The agency held a public meeting on January 20, 1999 (Ref. 5), to 
hear the views of interested parties regarding the implementation date 
of the rule. At this meeting, one large private label manufacturer of 
internal analgesic/antipyretic drug products stated that it would not 
be able to meet the April 23, 1999, implementation date, and that if 
the deadline were not extended a real possibility existed that there 
would be a national shortage of certain products that it manufactures. 
Another manufacturer at the meeting stated that it would be able to 
comply by the implementation date.

III. The Agency's Response

    As stated in the final rule, the agency considers the lack of 
sufficient alcohol warnings to be a significant public health issue. 
However, additional information (Refs. 6 through 11) that the agency 
has obtained since publication of the final rule suggests that the 
agency may have underestimated the number of individual label changes 
that some manufacturers will have to make. This information also 
indicates that there may be a significantly greater disparity in the 
effect of the required labeling upon manufacturers than originally 
anticipated. For these reasons, FDA now believes that the original 6-
month implementation period would not provide adequate time for many 
manufacturers of affected products to relabel a significant number of 
their products and that strict adherence to the April 23, 1999, 
effective date might result in short-term shortages of some of these 
important OTC drug products, which are widely used by many consumers. 
Consequently, the agency believes that establishing a compliance date 
for the regulation, until October 22, 1999, will provide sufficient 
time for industry to implement the labeling revisions required for 
these OTC internal analgesic/antipyretic drug products.
    The agency does not believe that there should be an open-ended 
period, as one comment requested, to use up existing supplies of 
labeling that contain an alcohol warning that was implemented 
voluntarily in response to an agency letter dated March 14, 1996 (Ref. 
3). Rather, FDA believes that there should be a date certain after 
which all products initially introduced or initially delivered for 
introduction into interstate commerce contain the new warnings. 
Further, because of the importance of the alcohol warnings, the agency 
continues to encourage all affected manufacturers to bring their 
labeling into compliance with the final rule as promptly as possible.
    Because this document merely establishes a compliance date, FDA 
finds that notice and comment procedures are unnecessary and not in the 
public interest (5 U.S.C. 553(b) and (d)). Moreover, because of the 
need for the agency to publish this document before the original April 
23, 1999, effective date, notice and comment rulemaking would be 
impracticable for this document.

IV. Analysis of Impacts

    The economic impact of the final regulation was discussed in the 
final rule (63 FR 56789 at 56798 to 56799). This document will provide 
additional time for companies to relabel affected products and will 
reduce label obsolescence, as there will be additional time to use up 
more existing labeling. Thus, setting a compliance date of October 22, 
1999, should reduce the economic impact on industry significantly.
    FDA has examined the impacts of this final rule (establishment of 
the compliance date) under Executive Order 12866 and the Regulatory 
Flexibility Act (5 U.S.C. 601-612). Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
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 final 
rule is consistent with the regulatory philosophy and principles set 
out in the Executive Order. The final rule is not a significant 
regulatory action as defined by the Executive Order and so is not 
subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This final rule sets a compliance date, which will 
provide manufacturers additional time to use up existing product 
labeling. Accordingly, the agency certifies that the final rule will 
not have a significant economic impact on a substantial number of small 
entities. Therefore, under the Regulatory Flexibility Act, no further 
analysis is required.

V. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this document are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the 
labeling statements are a ``public disclosure of information originally 
supplied by the Federal government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)).

VI. Environmental Impact

    The agency has determined under 21 CFR 25.31(c) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. References

    The following references are on display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, and may be seen by interested parties 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Comment Nos. C20, C21, and C22, Docket No. 77N-094W, Dockets 
Management Branch.
    2. Comment No. CP1, Docket No. 77N-094W, Dockets Management 
Branch.
    3. Letter from D. Bowen, FDA, to R. Soller, Nonprescription Drug 
Manufacturers Association, Coded LET2, Docket No. 77N-094W, Dockets 
Management Branch.
    4. Comment No. C19, Docket No. 77N-094W, Dockets Management 
Branch.
    5. Comment No. MM, Docket No. 77N-094W, Dockets Management 
Branch.
    6. Letter from K. Rothschild, FDA, to D. Jespersen, Perrigo, 
coded LET3, Docket No. 77N-094W, Dockets Management Branch.
    7. Letter from K. Rothschild, FDA, to H. McCain, Whitehall-
Robins, coded LET4, Docket No. 77N-094W, Dockets Management Branch.
    8. Comment No. C23, Docket No. 77N-094W, Dockets Management 
Branch.
    9. Comment No. C24, Docket No. 77N-094W, Dockets Management 
Branch.
    10. Letter from K. Rothschild, FDA, to H. McCain, Whitehall-
Robins, coded LET5, Docket No. 77N-094W, Dockets Management Branch.
    11. Comment No. C25, Docket No. 77N-094W, Dockets Management 
Branch.

    Dated: March 11, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-6447 Filed 3-12-99; 12:40 pm]
BILLING CODE 4160-01-F