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12454 Federal Register / Vol. 73, No.

46 / Friday, March 7, 2008 / Notices

will continue to list the drug products written or electronic comments on the right of reference to such information or
listed in this document in the draft guidance by May 6, 2008. by relying on the finding of safety and
‘‘Discontinued Drug Product List’’ ADDRESSES: Submit written requests for effectiveness for a listed drug and
section of the Orange Book. The single copies of the draft guidance to the establishing a clinical bridge to that
‘‘Discontinued Drug Product List’’ Division of Drug Information (HFD– listed drug. This draft guidance pertains
identifies, among other items, drug 240), Center for Drug Evaluation and to new formulations containing
products that have been discontinued Research, Food and Drug previously approved drug substances
from marketing for reasons other than Administration, 5600 Fishers Lane, only and does not address the safety
safety or effectiveness. Rockville, MD 20857. Send one self- evaluation of excipients.
Approved ANDAs that refer to the addressed adhesive label to assist that
NDAs listed in this document are This draft guidance is being issued
office in processing your requests.
unaffected by the discontinued Submit written comments on the draft consistent with FDA’s good guidance
marketing of the products subject to guidance to the Division of Dockets practices regulation (21 CFR 10.115).
those NDAs. Additional ANDAs for the Management (HFA–305), Food and Drug The draft guidance, when finalized, will
products may also be approved by the Administration, 5630 Fishers Lane, rm. represent the agency’s current thinking
agency if they comply with relevant 1061, Rockville, MD 20852. Submit on the safety evaluation of reformulated
legal and regulatory requirements. If electronic comments to http:// drug products, including products
FDA determines that labeling for these www.regulations.gov. See the intended for administration by an
drug products should be revised to meet SUPPLEMENTARY INFORMATION section for alternate route. It does not create or
current standards, the agency will electronic access to the draft guidance confer any rights for or on any person
advise ANDA applicants to submit such document. and does not operate to bind FDA or the
labeling. FOR FURTHER INFORMATION CONTACT: Paul public. An alternative approach may be
Dated: February 29, 2008. Brown, Center for Drug Evaluation and used if such approach satisfies the
Jeffrey Shuren, Research, Food and Drug requirements of the applicable statutes
Assistant Commissioner for Policy. Administration, 10903 New Hampshire and regulations.
[FR Doc. E8–4469 Filed 3–6–08; 8:45 am] Ave., Bldg. 22, rm. 5172, Silver Spring, II. Comments
BILLING CODE 4160–01–S MD 20993–0002, 301–796–0856.
SUPPLEMENTARY INFORMATION: Interested persons may submit to the
Division of Dockets Management (see
I. Background
DEPARTMENT OF HEALTH AND ADDRESSES) written or electronic
HUMAN SERVICES FDA is announcing the availability of comments regarding this document.
a draft guidance for industry and review Submit a single copy of electronic
Food and Drug Administration staff entitled ‘‘Nonclinical Safety comments or two paper copies of any
Evaluation of Reformulated Drug mailed comments, except that
[Docket No. FDA–2008–D–0142] Products and Products Intended for individuals may submit one paper copy.
Administration by an Alternate Route.’’
Comments are to be identified with the
Draft Guidance for Industry and This draft guidance is intended for
docket number found in brackets in the
Review Staff on Nonclinical Safety individuals or organizations and review
heading of this document. Received
Evaluation of Reformulated Drug staff in the Center for Drug Evaluation
Products and Products Intended for and Research involved in the comments may be seen in the Division
Administration by an Alternate Route; development and review of new of Dockets Management between 9 a.m.
Availability formulations of products containing and 4 p.m., Monday through Friday.
previously approved drug substances Please note that on January 15, 2008,
AGENCY: Food and Drug Administration, and proposals for existing formulations the FDA Web site transitioned to the
HHS. to be used in a new route of Federal Dockets Management System
ACTION: Notice. administration. This draft guidance (FDMS). FDMS is a Government-wide,
assumes that the drug substance has electronic docket management system.
SUMMARY: The Food and Drug
already been used in an approved drug Electronic submissions will be accepted
Administration (FDA) is announcing the product. It outlines the nonclinical
availability of a draft guidance for by FDA through FDMS only.
information generally recommended to
industry and review staff entitled support the development of a new III. Electronic Access
‘‘Nonclinical Safety Evaluation of formulation containing a previously
Reformulated Drug Products and Persons with access to the Internet
approved drug substance.
Products Intended for Administration This draft guidance also provides may obtain the document at either
by an Alternate Route.’’ The draft nonclinical evaluation information for http://www.fda.gov/cder/guidance/
guidance provides recommendations formulations intended for use by new index.htm or http://www.fda.gov/
concerning development of safety routes of administration even if there is ohrms/dockets/default.htm.
profiles to support approval of no change in the composition of the Dated: February 29, 2008.
reformulated drug products and formulation. Although this situation
products proposed for use by a route of Jeffrey Shuren,
does not represent a reformulation, it is
administration for which the product Assistant Commissioner for Policy.
appropriate in this case to reevaluate the
was not previously approved. toxicity information using [FR Doc. E8–4481 Filed 3–6–08; 8:45 am]
DATES: Although you can comment on considerations outlined in the draft BILLING CODE 4160–01–S
sroberts on PROD1PC70 with NOTICES

any guidance at any time (see 21 CFR guidance.


10.115(g)(5)), to ensure that the agency This draft guidance does not absolve
considers your comment on this draft the sponsor from providing complete
guidance before it begins work on the nonclinical information for a drug
final version of the guidance, submit product, either directly or through a

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