[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