[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Notices]
[Page 79371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32195]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1584]


Draft Guidance for Industry on Labeling OTC Human Drug Products--
Submitting Requests for Exemptions and Deferrals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Labeling OTC 
Human Drug Products--Submitting Requests for Exemptions and 
Deferrals.'' The draft guidance is intended to provide information on 
procedures for requesting an exemption or deferral in accordance with 
the final rule that established standardized format and content 
requirements for the labeling of over-the-counter (OTC) human drug 
products.

DATES: Submit written comments on the draft guidance by February 20, 
2001. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Labeling OTC Human Drug 
Products--Submitting Requests for Exemptions and Deferrals.'' This is 
one of a series of guidances intended to help manufacturers, packers, 
and distributors implement the final rule establishing standardized 
format and content requirements for the labeling of all OTC drug 
products. Once finalized, these guidances will supersede all other 
statements, feedback, and correspondence provided by the agency on 
these matters since the issuance of the final rule.
    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule establishing standardized format and content 
requirements for the labeling of all OTC drug products, including drug-
cosmetic products. This rule is intended to standardize labeling for 
all OTC human drug products to help consumers read and understand the 
product labeling and use these products safely and effectively.
    This draft document is intended to provide guidance on the format 
and procedures for submitting requests for exemptions and deferrals 
from the requirements of the rule.
    This draft guidance is being issued consistent with FDA's good 
guidance regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
The draft guidance represents the agency's current thinking on 
exemptions and deferral procedures related to the labeling of OTC human 
drug products (21 CFR part 201). It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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. The draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 4, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32195 Filed 12-18-00; 8:45 am]
BILLING CODE 4160-01-F