[Federal Register Volume 68, Number 107 (Wednesday, June 4, 2003)]
[Proposed Rules]
[Page 33429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13914]



[[Page 33429]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 343

[Docket No. 77N-0941]
RIN 0910-AA01


Internal Analgesic, Antipyretic, and Antirheumatic Drug Products 
for Over-the-Counter Human Use; Proposed Amendment of the Tentative 
Final Monograph, and Related Labeling; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
September 2, 2003, the comment period on the agency's proposal to amend 
the tentative final monograph (TFM) for over-the-counter (OTC) internal 
analgesic, antipyretic, and antirheumatic (IAAA) drug products to 
include ibuprofen as a generally recognized safe and effective 
analgesic/antipyretic active ingredient for OTC use and to amend its 
regulations to include consistent allergy warnings for OTC IAAA drug 
products containing nonsteroidal antiinflammatory active ingredients. 
The proposal was published in the Federal Register of August 21, 2002 
(67 FR 54139). FDA is taking this action in response to a request for 
an extension of 90 days for the submission of comments on the proposed 
rule. The comment period for this information closed on November 19, 
2002.

DATES: Submit written or electronic comments by September 2, 2003.

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.

FOR FURTHER INFORMATION CONTACT: Ida I. Yoder, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 21, 2002 (67 FR 54139), FDA 
published a proposed rule to amend the TFM for OTC IAAA drug products 
to include ibuprofen as a generally recognized safe and effective 
analgesic/antipyretic active ingredient for OTC use and to amend its 
regulations to include consistent allergy warnings for OTC IAAA drug 
products that contain nonsteroidal antiinflammatory active ingredients.
    The proposed rule was in response to a citizen petition and a 
comment to that petition and is part of FDA's ongoing review of OTC 
drug products. Based on the information submitted and other relevant 
information, FDA determined that ibuprofen in a 200-milligram (mg) 
tablet formulation for use in adults and children 12 years of age and 
older, at a maximum daily dose of 1,200 mg, qualifies as safe and 
effective for inclusion in an OTC drug monograph when labeled with 
adequate warnings and directions for use. Therefore, FDA proposed to 
include ibuprofen 200 mg, in tablet formulation, in 21 CFR 343.10(g) as 
a safe and effective ingredient for the relief of pain and fever in 
adults and children 12 years of age and older and to include specific 
warnings and directions for use in 21 CFR 343.50(c) and (d).
    The agency also tentatively concluded that, for consistency, the 
``Allergy alert'' and additional allergy warning statements required 
for certain OTC NSAID IAAA drug products should be extended to all such 
products, whether marketed under an OTC drug monograph or an NDA/ANDA. 
These standardized allergy alert and warning statements (in proposed 
Sec.  201.324) would provide the following information:
    (a) ``Allergy alert: [insert name of active ingredient (first 
letter of first word for ingredient in uppercase)] may cause a severe 
allergic reaction which may include:
    [sbull] hives.
    [sbull] facial swelling.
    [sbull] asthma (wheezing).
    [sbull] shock''.
    (b) ``Do not use if you have ever had an allergic reaction to any 
other pain reliever/fever reducer'' (This statement appears as the 
first warning under the subheading ``Do not use.'')
    (c) ``Stop use and ask a doctor if an allergic reaction occurs. 
Seek medical help right away.'' (These statements appear as the first 
warning under the subheading ``Stop use and ask a doctor if.'')
    On October 11, 2002, FDA received a request (Ref. 1) for an 
extension of 90 days for submission of comments on the proposed rule. 
The comment stated that it had delayed its response to the proposal so 
that consideration could be given to the impact of FDA's 
Nonprescription Drug Advisory Committee (NDAC) discussions on the 
labeling of all OTC IAAA drug products, including ibuprofen, at its 
September 19 and 20, 2002, meeting. Therefore, the comment stated that 
it needed additional time to evaluate and comment on labeling 
suggestions that arose from the NDAC meeting and to review the 
preclinical and clinical safety data that the agency used to support 
label warning statements. Further, the comment stated that it was 
considering conducting consumer research on information relevant to 
crafting an appropriate OTC label for these products.
    FDA has carefully considered the request and acknowledges that 
additional time may be beneficial to fully evaluate and respond to the 
issues. FDA considers an extension of time for comments to be in the 
public interest. Therefore, the agency is providing additional time for 
comments by reopening the comment period for 90 days from the date of 
this notice.

II. Request for Comments

    Three copies of all written comments are to be submitted. 
Individuals submitting written comments or anyone submitting electronic 
comments may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document and may 
be accompanied by a supporting memorandum or brief. Received comments 
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Reference

    The following reference is on display in the Dockets Management 
Branch (see ADDRESSES) and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday.
    1. Comment No. EXT1.

    Dated: May 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13914 Filed 6-3-03; 8:45 am]
BILLING CODE 4160-01-S