[Federal Register: June 4, 2003 (Volume 68, Number 107)]
[Proposed Rules]
[Page 33429]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn03-40]
[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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