[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Notices]               
[Page 17563-17564]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-89]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0117]

 
Draft Guidance for Industry on Orally Disintegrating Tablets; 
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availability of a draft guidance for industry entitled ``Orally 
Disintegrating Tablets.'' The draft guidance provides pharmaceutical 
manufacturers of new and generic drug products with an agency 
perspective on the definition of an orally disintegrating tablet (ODT) 
and also provides recommendations to applicants who would like to 
designate a proposed product as an ODT.

DATES:  Submit written or electronic comments on the draft guidance by 
June 8, 2007. 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.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: Frank O. Holcombe, Jr., Center for 
Drug Evaluation and Research (HFD-600), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-276-9310.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Orally Disintegrating Tablets.'' The draft guidance provides 
pharmaceutical manufacturers of new and generic drug products with an 
agency perspective on the definition of an ODT and also provides 
recommendations to applicants who would like to designate proposed 
products as ODTs.

[[Page 17564]]

    In an effort to develop drug products that are more convenient to 
use and to address potential issues of patient compliance for certain 
product indications and patient populations, pharmaceutical 
manufacturers have developed products that can be ingested simply by 
placing them on the tongue. The products are designed to disintegrate 
or dissolve rapidly on contact with saliva, thus eliminating the need 
for chewing the tablet, swallowing an intact tablet, or taking the 
tablet with water. This mode of administration was initially expected 
to be beneficial to pediatric and geriatric patients, to people with 
conditions related to impaired swallowing, and for treatment of 
patients when compliance may be difficult (e.g., for psychiatric 
disorders).
    As firms started developing additional products using different 
technology and formulations, many of these later products exhibited 
wide variation in product characteristics from the initial products. 
Because this shift in product characteristics can affect a product's 
suitability for particular uses, the agency developed this guidance for 
industry.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on orally 
disintegrating tablets. 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 regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, 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. Received comments may be seen 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
.fda.gov/ohrms/dockets/default.htm.

    Dated: March 30, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6509 Filed 4-6-07; 8:45 am]

BILLING CODE 4160-01-S