[Federal Register Volume 62, Number 118 (Thursday, June 19, 1997)]
[Proposed Rules]
[Pages 33379-33380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16066]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 330, and 358
[Docket Nos. 96N-0420, 92N-454A, 90P-0201, and 95N-0259]
RIN 0910-AA79
Over-the-Counter Human Drugs; Proposed Labeling Requirements;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to October
6, 1997, the period for comments for the notice of proposed rulemaking
on over-the-counter (OTC) labeling requirements that was
[[Page 33380]]
published in the Federal Register of February 27, 1997 (62 FR 9024).
The document proposed to establish a standardized format for the
labeling of OTC drug products. The document supersedes the agency's
proposed rule regarding the use of interchangeable terms, published in
the Federal Register of March 4, 1996 (61 FR 8460), and responds to the
comments that were submitted to FDA as a result of that proposal
(Docket No. 92N-454A). The document also proposes to preempt State and
local rules that establish different or additional format or content
requirements than those in the proposed rule. FDA is extending the
comment period of the proposed rule in response to two manufacturers'
associations requests to extend the period for comments to allow
interested persons adequate time to assess and respond to the proposal.
Elsewhere in this issue of the Federal Register the agency is also
announcing that the Nonprescription Drugs Advisory Committee will meet
to discuss proposed labeling requirements for OTC drug product
labeling.
DATES: Written comments by October 6, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Cazemiro R. Martin, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2222.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 27, 1997
(62 FR 9024), FDA published a notice of proposed rulemaking to
establish a standardized format for the labeling of OTC drug products.
Interested persons were given until June 27, 1997, to submit comments
on the proposal.
In the proposal, the agency indicated that because the design and
format of labeling information varies considerably among OTC drug
products, consumers often have difficulty reading and understanding the
information presented on OTC drug product labeling. The proposal is
intended to enable consumers to better read and understand OTC drug
product labeling and to apply this information to the safe and
effective use of OTC drug products. The agency had also tentatively
determined that to ensure that OTC drug product labeling conveys all
material information to the consumer, and that the labeling conveys
this information in a manner that is likely to be read and understood
by the consumer, State and local rules that would establish different
or additional format or content requirements than those in the proposed
rule should be preempted.
FDA has received requests from two manufacturers' associations to
extend the comment period to permit industry and other interested
parties additional time to respond to the proposed labeling
requirements. One association requested a 90-day extension of the
comment period until September 25, 1997, for the following reasons: (1)
To comment on the economic and possible environmental impact of the
proposed rule; (2) to obtain, analyze, collate, and summarize data from
a survey of OTC drug manufacturers to determine the actual cost and the
time involved in major label revisions; (3) to prepare model or
prototype labels to illustrate the effect of the proposed rule and to
develop solutions to problems that may be encountered; and (4) to
provide the agency with quality comments in response to the recently
published proposal. The comment added that the proposal is the most
far-reaching for, and will have the most universal effect on, OTC drug
products of any rule published in the last 20 years.
The other association requested a 120-day extension to the comment
period until October 25, 1997, because the proposal would require
extensive relabeling of its member companies' products. The comment
indicated that additional time is essential to form industry consensus
to support useful comments to the agency and to ascertain the long
range implication of the labeling proposal for the entire industry and
for cosmetic-drug products in particular. The comment also mentioned
that the first opportunity for its board of directors to make a
recommendation on the labeling proposal would not occur until September
30, 1997. Therefore, the extension request of 120 days is dictated by
the scheduling of the meeting of its board and the time needed
subsequent to the board meeting to complete comments on the proposed
rule.
Recognizing the scope of the proposed labeling requirements on OTC
drug products, the agency provided in the February 27, 1997, proposal a
comment period of 120 days until June 27, 1997, rather than the 90-day
comment period generally provided, to address many of the labeling
issues proposed. The agency continues to work closely with a number of
companies, associations, and other interested parties, in an effort to
improve OTC drug labeling readability and understandability. Based on
the far-reaching effect the proposal will have on OTC drug labeling and
the reasons provided by the two manufacturers' associations, the agency
believes that an extension of the comment period is appropriate.
Therefore, the agency is providing an extension of the period for
comment until October 6, 1997.
Interested persons may, on or before October 6, 1997, submit to
the Dockets Management Branch (address above) written comments on the
proposed OTC labeling requirements. Three copies of any comments are to
be submitted, except that individuals may submit one copy. Comments are
to be identified with the docket numbers found in brackets in the
heading of this document. Received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 13, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16066 Filed 6-18-97; 8:45 am]
BILLING CODE 4160-01-F
