Over-The-Counter Human Drugs; Proposed Labeling Requirements; Notice of Availability of Study Data and Reopening of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, and 358

[Docket No. 96N-0420]

Over-The-Counter Human Drugs; Proposed Labeling Requirements;

Notice of Availability of Study Data and Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period on specific data.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to

February 13, 1998 the comment period on specific data related to the

February 27, 1997, proposed rule to establish a standardized format for

the labeling of over-the-counter (OTC) drug products (62 FR 9024). As

part of that rulemaking proceeding, the agency collected data under a

study entitled ``Over-the-Counter (OTC) Label Format Preference, Study

B.'' (Study B). This document announces the availability of the data

and frequency tabulations that summarize the Study B data and reopens

the comment period for the OTC rulemaking proceeding to allow an

opportunity for comment on Study B.

DATES: Submit written comments on Study B by February 13, 1998.

ADDRESSES: Submit written comments on the information collected in

Study B to the Dockets Management Branch (HFA-305), ATTN: Study B, OTC

Drug Labeling Data Collection, Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kathryn J. Aikin, Food and Drug

Administration, Division of Drug Marketing, Advertising, and

Communications (HFD-40), 5600 Fishers Lane, Rockville, MD, 20857, 301-

827-2828, A[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of February 27, 1997

(62 FR 9024), FDA published a proposed rule intended to enable

consumers to read and understand OTC drug product labeling and to more

effectively apply the information in the labeling to the safe and

effective use of such products. An important element of FDA's proposed

rule is a standardized labeling format for OTC drug products.

After issuing the proposed rule, FDA published in the Federal

Register a notice under the Paperwork Reduction Act of 1995 announcing

the agency's intention to conduct four studies relating to OTC drug

products (62 FR 28482, May 23, 1997). The agency intends at this time

to use two of the studies (``Evaluation of Proposed Over-the-Counter

(OTC) Label Formats, Study A,'' and ``Over-the-Counter (OTC) Label

Format Preference, Study B'' ) in deliberations on developing a

standardized, easy to read and easy to understand, labeling format for

OTC drug products (see 62 FR 9024). The data and frequency tabulations

for one of these studies, Study B, are now available.

In Study B, consumers were invited to view examples and variations

of current OTC label designs. Respondents were asked to indicate their

preference for various designs and to evaluate labeling terminology and

graphics to help the agency understand how consumers interpret various

ways of communicating drug safety and drug effectiveness information.

The agency is now seeking comments on the data developed under Study B,

including the opinions of the respondents on the various labeling

format elements used in the Study. The comments on Study B will be

included in the agency's deliberations on developing a final,

standardized OTC labeling format regulation.

After the results for Study A are tabulated, the agency will

publish a notice in the Federal Register announcing when the data and

tabulations are available for viewing.

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Interested persons may, on or before February 13, 1998, submit

written comments on the data developed under Study B to the Dockets

Management Branch (address above). Two copies of any comments are to be

submitted, except that individuals may submit one copy. Comments are to

be identified with the docket number found in brackets in the heading

of this document and labeled ``ATTN: Study B, OTC Drug Labeling Data

Collection.'' The data, frequency tabulations, and received comments

may be seen in the office above between 9 a.m. and 4 p.m., Monday

through Friday. An electronic format of the data are available on the

internet at: www.fda.gov/CDER/ or can be obtained in electronic form

from the Dockets Management Branch at the address listed above.

Dated: December 19, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-33803 Filed 12-29-97; 8:45 am]

BILLING CODE 4160-01-F