[Federal Register Volume 67, Number 74 (Wednesday, April 17, 2002)]
[Notices]
[Page 18921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9364]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0363]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; MIFEPREX; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending to April 
26, 2002, the comment period for the regulatory review period 
determination for MIFEPREX, published in the Federal Register of 
January 25, 2002 (67 FR 3724). The agency is taking this action in 
response to a request for an extension.

DATES: Submit written or electronic comments on the regulatory review 
period determination for MIFEPREX by April 26, 2002.

ADDRESSES: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 2002 
(67 FR 3724), FDA published a document entitled ``Determination of 
Regulatory Review Period for Purposes of Patent Extension; MIFEPREX.'' 
The document set forth the determination of the regulatory review 
period for purposes of patent term extension for the human drug product 
MIFEPREX. The document announced that FDA determined that the 
applicable regulatory review period for MIFEPREX was 2,249 days, and 
that of this time, 593 days had occurred during the testing phase of 
the regulatory review period, while 1,656 days had occurred during the 
approval phase. The notice explained how these periods of time were 
derived.
    FDA received a letter dated March 22, 2002, from an attorney 
representing the Population Council (the patent holder) and others, 
requesting that the agency extend the comment period on the regulatory 
review period for 30 days, until April 26, 2002, explaining that 
additional time was needed to reach a licensing agreement. FDA has 
determined that it is appropriate to grant this request.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the regulatory review 
period determination for MIFEPREX on or before April 26, 2002. Three 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: March 27, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-9364 Filed 4-16-02; 8:45 am]
BILLING CODE 4160-01-S