[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Notices]
[Pages 33164-33165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0197]


Guidance for Industry on Drug Products Containing Ensulizole, 
Hypromellose, Meradimate, Octinoxate, and Octisalate--Labeling 
Enforcement Policy; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Drug Products 
Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and 
Octisalate--Labeling Enforcement Policy.'' This guidance discusses how 
FDA plans to exercise its enforcement discretion after September 1, 
2002, with regard to drug products whose labeling does not use the 
established names for ensulizole, hypromellose, meradimate, octinoxate, 
and octisalate.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Wayne Mitchell, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA is announcing the availability of a guidance for industry 
entitled ``Drug Products Containing Ensulizole, Hypromellose, 
Meradimate, Octinoxate, and Octisalate--Labeling Enforcement Policy.'' 
This guidance explains that the agency intends to exercise enforcement 
discretion by not initiating any enforcement action, until September 1, 
2003, based on a firm's failure to bring its products' labeling into 
compliance with the United State Pharmacopeia (USP) monograph title 
changes for ensulizole, hypromellose, meradimate, octinoxate, and 
octisalate, as required by section 502(e)(1)(A)(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352(e)(1)(A)(i)).
    As explained in detail in the guidance, a series of events has lead 
to the development of the guidance. These events include USP monograph 
title changes, changes to the FDA's monograph for over-the-counter 
(OTC) sunscreen drug products, and the receipt of two petitions 
regarding these changes and their effective date (September 1, 2002).
    We are issuing this level 1 guidance for immediate implementation, 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The guidance represents the agency's current thinking on this 
issue. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative

[[Page 33165]]

approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
addresses) written or electronic comments on the guidance. Two paper 
copies of any mailed comments are to be submitted, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13828 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S