[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finalizes the draft guidance for industry entitled ``Time and Extent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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