[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60504-60505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0438] (Formerly 2004D-0027)


Guidance for Industry on Time and Extent Applications for 
Nonprescription Drug Products; 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 ``Time and Extent 
Applications for Nonprescription Drug Products.'' This guidance 
describes a two-step process on how to request that a new condition be 
added to the over-the-counter (OTC) drug monograph system. The process 
includes submitting a time and extent application (TEA) to determine 
whether a condition is eligible for inclusion in the OTC drug monograph 
system and, if the condition is found to be eligible, submitting safety 
and effectiveness data. This guidance is designed to clarify the TEA 
process and what happens after a TEA is submitted. This guidance 
finalizes the draft guidance for industry entitled ``Time and Extent 
Applications'' published in the Federal Register on February 10, 2004 
(69 FR 6309).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ruth E. Scroggs, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5488, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Time and Extent Applications for Nonprescription Drug 
Products.'' This guidance provides information about how to request 
that a new condition be added to the OTC drug monograph system. The OTC 
drug monograph system was established to evaluate the safety and 
effectiveness of all OTC drug products marketed in the United States 
before May 11, 1972, that were not marketed under approved new drug 
applications (NDAs) and all OTC drug products 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 
FD&C Act). In 1972, FDA began its OTC drug review to evaluate eligible 
OTC drug products by categories or classes (e.g., antacids, skin 
protectants), rather than on a product-by-product basis, and to develop 
``conditions'' under which classes of OTC drug products are generally 
recognized as safe and effective (GRASE) and not misbranded.
    FDA publishes these conditions, including active ingredients, 
labeling, and other general conditions under which a class of OTC drug 
products is considered GRASE, in the Federal Register in the form of 
OTC drug monographs. Final monographs are codified in 21 CFR parts 331 
through 358. Manufacturers seeking to market an OTC drug product 
covered by an OTC drug monograph need not obtain FDA approval before 
marketing if their drug product meets the conditions in part 330 (21 
CFR part 330) and the applicable final monograph (Sec.  330.1).
    Before Sec.  330.14 went into effect in 2002, there was no formal 
process to add OTC drug products that had not been marketed in the 
United States before May 11, 1972, to the OTC drug monograph system. 
Interested persons were required to obtain premarketing approval under 
section 505 of the FD&C Act (21 U.S.C. 355) if they wanted to introduce 
into the United States an OTC drug product that had been marketed 
solely in a foreign country. Companies also were required to obtain 
premarketing approval to market OTC drug products 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 drug products as GRASE and not misbranded. The final 
rule provided a process for establishing that certain OTC drug 
products, which previously required premarketing approval under section 
505 of the FD&C Act to be marketed, were eligible to be considered for 
inclusion in the OTC drug monograph system. Under the regulation in 
Sec.  330.14, an applicant must first submit a TEA to show that the 
drug product is eligible for inclusion in the OTC drug monograph system 
by showing that the drug product has been marketed ``to a material 
extent'' and ``for a material time.'' If FDA determines that the 
condition meets the time and extent eligibility criteria, FDA publishes 
a notice of eligibility in the Federal Register, and the applicant and 
other interested parties have the opportunity to submit safety and 
effectiveness data to FDA for evaluation. This two-step process allows 
applicants to demonstrate that eligibility criteria are met before 
expending resources to prepare safety and effectiveness data.
    In the Federal Register of February 10, 2004, FDA announced the 
availability of the draft guidance for industry entitled ``Time and 
Extent Applications.'' FDA received comments on the draft guidance, 
considered those comments, and revised the guidance as appropriate. The 
finalized TEA guidance announced in this document replaces the February 
2004 draft guidance. This guidance is designed to clarify the TEA 
process. We are providing this guidance because we have received 
inquiries from the public regarding the TEA process.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on TEAs. 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork

[[Page 60505]]

Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in Sec.  330.14 have been approved under OMB control number 
0910-0688. The collections of information in 21 CFR part 25 and the 
guidance for industry entitled ``Environmental Assessment of Human Drug 
and Biologics Applications,'' which are referenced in the guidance 
announced in this document, are approved under OMB control number 0910-
0322.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25118 Filed 9-28-11; 8:45 am]
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