[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77724-77725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30086]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry on Diabetes Mellitus--Evaluating 
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 
Diabetes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Diabetes Mellitus--
Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat 
Type 2 Diabetes.'' This guidance makes recommendations about how to 
demonstrate that a new antidiabetic therapy to treat type 2 diabetes is 
not associated with an unacceptable increase in cardiovascular risk. We 
are issuing this guidance for immediate implementation to ensure that 
relevant issues related to minimizing cardiovascular risk are 
considered by all sponsors who have ongoing drug development programs 
for type 2 diabetes.

DATES: Submit written or electronic 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. 
Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit

[[Page 77725]]

electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Mary Parks, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, rm. 3362, Silver Spring, MD 20993-0002, 301-796-2290.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Diabetes Mellitus--Evaluating Cardiovascular Risk in New 
Antidiabetic Therapies to Treat Type 2 Diabetes.'' Diabetes mellitus is 
associated with an increased risk of cardiovascular disease. Reducing 
long-term cardiovascular complications in patients with diabetes should 
be an important goal of disease management. There are compelling data 
in patients with type 2 diabetes supporting a reduced risk of 
microvascular complications with improved long-term glycemic control. 
This guidance makes recommendations about how to demonstrate that a new 
antidiabetic therapy to treat type 2 diabetes is not associated with an 
unacceptable increase in cardiovascular risk.
    On March 3, 2008, FDA issued the draft guidance for industry 
entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic 
Biologics for Treatment and Prevention'' (73 FR 11420). On July 1 and 
2, 2008, the Endocrinologic and Metabolic Drugs Advisory Committee met 
to discuss the role of cardiovascular assessment in the premarketing 
and postmarketing settings for drugs and therapeutic biologics 
developed for the treatment of type 2 diabetes mellitus. After 
considering the discussion at this meeting as well as other available 
data and information, we have determined that concerns about 
cardiovascular risk should be more thoroughly addressed during drug 
development. We are issuing this guidance to ensure that our 
recommendations reach all sponsors who may submit applications for 
approval of drugs to treat type 2 diabetes mellitus.
    We are issuing this level 1 guidance for immediate implementation, 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). FDA is not seeking comment before implementing this guidance 
because of the need to immediately notify sponsors with ongoing 
development programs of the need to address cardiovascular risk in 
ongoing drug development programs. If FDA receives comments on this 
guidance, it will consider the comments and incorporate final 
recommendations into the final version of the March 2008 draft 
guidance.
    This guidance represents the agency's current thinking on 
evaluating cardiovascular risk in new antidiabetic therapies to treat 
type 2 diabetes. 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. The 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 Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
0910-0014, and the collections of information in 21 CFR part 314 have 
been approved under 0910-0001.

III. 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 Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. 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.regulations.gov.

    Dated: December 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30086 Filed 12-17-08; 11:15 am]
BILLING CODE 4160-01-S