[Federal Register Volume 73, Number 42 (Monday, March 3, 2008)]
[Notices]
[Page 11420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3974]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0118]


Draft Guidance for Industry on Diabetes Mellitus: Developing 
Drugs and Therapeutic Biologics for Treatment and Prevention; 
Availability

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availability of a draft guidance for industry entitled ``Diabetes 
Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and 
Prevention.'' The draft guidance provides recommendations for industry 
for developing drugs and therapeutic biologics for the prevention and 
treatment of diabetes mellitus. Because diabetes mellitus has reached 
epidemic proportions in the United States, FDA recognizes the need for 
new products that can be used as part of a comprehensive treatment 
strategy in the treatment and prevention of diabetes. In addition to 
the draft guidance, FDA plans to convene a public advisory committee 
meeting to specifically discuss new approaches for the development of 
products for the treatment of diabetes, with particular emphasis on the 
design and implementation of studies to assess long-term cardiovascular 
risks and benefits of these new products. FDA plans to announce the 
meeting date in a future issue of the Federal Register.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by May 2, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://www.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ilan Irony, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, rm. 3100, Silver Spring, MD 20993-0002, 301-796-2290.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic 
Biologics for Treatment and Prevention.'' Although a number of drugs 
are available for the treatment of type 1 and type 2 diabetes, many 
patients remain inadequately controlled, and thus are exposed to a 
higher risk of long-term complications. This draft guidance provides 
recommendations on the following topics related to the treatment of 
type 1 and type 2 diabetes mellitus:
     Diabetes-specific preclinical studies;
     Different study designs in different phases of drug 
development for both type 1 and type 2 diabetes;
     Study endpoints in the assessment of pharmacokinetic/
pharmacodynamic profiles and for efficacy and safety assessment in 
treating patients with diabetes;
     Study population considerations in different phases of 
development;
     Sample sizes;
     Study duration; and
     Specific statistical issues related to development of 
drugs and biologics intended for the treatment of diabetes.
    The draft guidance also provides recommendations regarding the 
development of products for the prevention of both type 1 and type 2 
diabetes.
    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 the 
treatment and prevention of diabetes mellitus. 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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

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: February 25, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3974 Filed 2-29-08; 8:45 am]
BILLING CODE 4160-01-S