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 March

30, 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 ``Evaluation of Proposed Over-the-Counter (OTC) Label Format

Comprehension,'' (Study A). This document announces the availability of

the data and frequency tabulations that summarize the Study A data and

reopens the comment period for the OTC rulemaking proceeding to allow

an opportunity for comment on Study A.

DATES: Submit written comments on Study A by March 30, 1998.

ADDRESSES: Submit written comments on the information collected in

Study A to the Dockets Management Branch (HFA-305), ATTN: Study A, 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 better 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 Format Comprehension, 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). In the Federal

Register of December 30, 1997 (62 FR 67770), the agency requested

comments specifically related to Study B. The data and frequency

tabulations for Study A are now available.

In Study A, consumers were invited to view examples of OTC label

designs. Respondents were asked questions designed to measure knowledge

and attitudes about OTC drug products, as well as decisions about

proper use of the products. The agency is now seeking comments on the

data developed under Study A, including the participants' responses on

the comprehension elements measured for the specific label designs

viewed. The comments on Study A will be included in the agency's

deliberations on developing a final, standardized OTC labeling format

regulation.

Interested persons may, on or before March 30, 1998, submit written

comments on the data developed under Study A 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 A, 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 previously.

Dated: February 4, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-3625 Filed 2-12-98; 8:45 am]

BILLING CODE 4160-01-F