[Federal Register: February 10, 2004 (Volume 69, Number 27)]
[Page 6309-6310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004D-0277]

Draft Guidance for Industry on Time and Extent Applications; 

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availability of a draft guidance for industry entitled ``Time and 
Extent Applications.'' This guidance is being written to assist those 
persons interested in adding a new condition to the over-the-counter 
(OTC) drug monograph system. A time and extent application (TEA) can be 
submitted for FDA to determine whether a condition is eligible to be 
considered for inclusion in an OTC drug monograph. This guidance is 
designed to clarify issues concerning the TEA in an effort to 
facilitate the application process.

DATES: Submit written or electronic comments on the draft guidance by 
April 12, 2004. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 

[[Page 6310]]

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draft guidance to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the draft guidance document.

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


I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Time and Extent Applications.'' The OTC drug monograph 
system was established to evaluate the safety and effectiveness of all 
OTC drug products for the following reasons: (1) Marketed in the United 
States before May 11, 1972, that were not covered by new drug 
applications (NDAs), and (2) covered by ``safety'' NDAs that were 
marketed in the United States before enactment of the 1962 drug 
amendments to the Federal Food, Drug, and Cosmetic Act (the act). In 
1972, FDA began its OTC drug review of the following procedures: (1) To 
evaluate OTC drugs by categories or classes (e.g., antacids, skin 
protectants), rather than on a product-by-product basis, and (2) to 
develop ``conditions'' under which classes of OTC drugs are generally 
recognized as safe and effective (GRAS/E) and not misbranded.
    FDA publishes these conditions in the Federal Register in the form 
of OTC drug monographs, which consist primarily of active ingredients, 
labeling, and other general requirements. Final monographs for OTC 
drugs that are GRAS/E and not misbranded are codified in part 330 (21 
CFR part 330). Manufacturers seeking to market an OTC drug covered by 
an OTC drug monograph need not obtain FDA approval before marketing.
    Previously, interested persons had to prepare and submit an NDA if 
they wanted to introduce into the United States an OTC drug condition 
that had been marketed solely in a foreign country. Companies also had 
to submit an NDA if their OTC drug products were initially marketed in 
the United States after the OTC drug review began in 1972. In the 
Federal Register of January 23, 2002 (67 FR 3060), FDA published a 
final rule that amended the OTC drug review procedures in part 330 and 
included additional criteria and procedures for classifying OTC drugs 
as GRAS/E and not misbranded. The final rule provided procedures for 
conditions that previously required an NDA for those conditions to 
become eligible for inclusion in the OTC drug monograph system. This 
final rule stated that an applicant must first submit a TEA to show 
marketing ``to a material extent'' and ``for a material time.'' Once 
FDA has determined eligibility, safety and effectiveness data would be 
submitted and evaluated. This two-step process allows applicants to 
demonstrate that eligibility criteria are met before expending 
resources to prepare safety and effectiveness data.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (GGPs) regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent the agency's current thinking 
on time and extent applications. 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 approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed 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 Division of Dockets Management 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www

    Dated: January 29, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-2729 Filed 2-9-04; 8:45 am]