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11420 Federal Register / Vol. 73, No.

42 / Monday, March 3, 2008 / Notices

and the number of requests, it may be DATES: Although you can comment on development of products for the
necessary to limit the time of each presenter. any guidance at any time (see 21 CFR prevention of both type 1 and type 2
Contact Person for More Information: 10.115(g)(5)), to ensure that the agency diabetes.
Claudine Johnson, Clerk, Lead Poisoning considers your comment on this draft This draft guidance is being issued
Prevention Branch, Division of
Environmental Emergency Health Services,
guidance before it begins work on the consistent with FDA’s good guidance
National Center for Environmental Health, final version of the guidance, submit practices regulation (21 CFR 10.115).
CDC, 4770 Buford Hwy., NE., Mailstop F–60, written or electronic comments on the The draft guidance, when finalized, will
Atlanta, GA 30341, Telephone: (770) 488– draft guidance by May 2, 2008. represent the agency’s current thinking
3629, Fax (770) 488–3635. ADDRESSES: Submit written requests for on the treatment and prevention of
The Director, Management Analysis and single copies of the draft guidance to the diabetes mellitus. It does not create or
Services Office, has been delegated the Division of Drug Information (HFD– confer any rights for or on any person
authority to sign Federal Register notices 240), Center for Drug Evaluation and and does not operate to bind FDA or the
pertaining to announcements of meetings and public. An alternative approach may be
Research, Food and Drug
other committee management activities, for
both CDC and the Agency for Toxic
Administration, 5600 Fishers Lane, used if such approach satisfies the
Substances and Disease Registry. Rockville, MD 20857. Send one self- requirements of the applicable statutes
addressed adhesive label to assist that and regulations.
Dated: February 27, 2008. office in processing your requests.
Diane Allen, II. Comments
Submit written comments on the draft
Acting Director, Management Analysis and guidance to the Division of Dockets Interested persons may submit to the
Services Office, Centers for Disease Control Management (HFA–305), Food and Drug Division of Dockets Management (see
and Prevention. Administration, 5630 Fishers Lane, rm. ADDRESSES) written or electronic
[FR Doc. E8–4085 Filed 2–29–08; 8:45 am] 1061, Rockville, MD 20852. Submit comments regarding this document.
BILLING CODE 4163–18–P electronic comments to http:// Submit a single copy of electronic See the comments or two paper copies of any
SUPPLEMENTARY INFORMATION section for mailed comments, except that
DEPARTMENT OF HEALTH AND electronic access to the draft guidance individuals may submit one paper copy.
HUMAN SERVICES document. Comments are to be identified with the
FOR FURTHER INFORMATION CONTACT: Ilan docket number found in brackets in the
Food and Drug Administration heading of this document. Received
Irony, Center for Drug Evaluation and
[Docket No. FDA–2008–D–0118] Research, Food and Drug comments may be seen in the Division
Administration, 10903 New Hampshire of Dockets Management between 9 a.m.
Draft Guidance for Industry on and 4 p.m., Monday through Friday.
Ave., Bldg. 22, rm. 3100, Silver Spring,
Diabetes Mellitus: Developing Drugs Please note that on January 15, 2008,
MD 20993–0002, 301–796–2290.
and Therapeutic Biologics for the FDA Web site transitioned to the
Treatment and Prevention; Availability Federal Dockets Management System
I. Background (FDMS). FDMS is a Government-wide,
AGENCY: Food and Drug Administration,
FDA is announcing the availability of electronic docket management system.
a draft guidance for industry entitled Electronic submissions will be accepted
ACTION: Notice. by FDA through FDMS only.
‘‘Diabetes Mellitus: Developing Drugs
SUMMARY: The Food and Drug and Therapeutic Biologics for Treatment III. Electronic Access
Administration (FDA) is announcing the and Prevention.’’ Although a number of
drugs are available for the treatment of Persons with access to the Internet
availability of a draft guidance for may obtain the document at either
industry entitled ‘‘Diabetes Mellitus: type 1 and type 2 diabetes, many
patients remain inadequately controlled,
Developing Drugs and Therapeutic index.htm or
Biologics for Treatment and and thus are exposed to a higher risk of
long-term complications. This draft ohrms/dockets/default.htm.
Prevention.’’ The draft guidance
provides recommendations for industry guidance provides recommendations on Dated: February 25, 2008.
for developing drugs and therapeutic the following topics related to the Jeffrey Shuren,
biologics for the prevention and treatment of type 1 and type 2 diabetes Assistant Commissioner for Policy.
treatment of diabetes mellitus. Because mellitus: [FR Doc. E8–3974 Filed 2–29–08; 8:45 am]
diabetes mellitus has reached epidemic • Diabetes-specific preclinical
proportions in the United States, FDA studies;
recognizes the need for new products • Different study designs in different
that can be used as part of a phases of drug development for both DEPARTMENT OF HEALTH AND
type 1 and type 2 diabetes; HUMAN SERVICES
comprehensive treatment strategy in the
• Study endpoints in the assessment
treatment and prevention of diabetes. In
of pharmacokinetic/pharmacodynamic Health Resources and Services
addition to the draft guidance, FDA profiles and for efficacy and safety
plans to convene a public advisory Administration
assessment in treating patients with
committee meeting to specifically diabetes;
discuss new approaches for the Organ Procurement and
• Study population considerations in Transplantation Network
development of products for the different phases of development;
treatment of diabetes, with particular • Sample sizes; AGENCY: Health Resources and Services
emphasis on the design and • Study duration; and Administration (HRSA), HHS.
rmajette on PROD1PC64 with NOTICES

implementation of studies to assess • Specific statistical issues related to ACTION: Request for information.
long-term cardiovascular risks and development of drugs and biologics
benefits of these new products. FDA intended for the treatment of diabetes. SUMMARY: HRSA, Healthcare Systems
plans to announce the meeting date in The draft guidance also provides Bureau, Division of Transplantation
a future issue of the Federal Register. recommendations regarding the (DoT) is in the process of information-

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