[Federal Register: February 16, 2005 (Volume 70, Number 31)]
[Page 7950-7951]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0355]

Scientific Considerations Related to Developing Follow-On Protein 
Products; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.


SUMMARY: The Food and Drug Administration (FDA) is reopening until

[[Page 7951]]

March 16, 2005, the comment period for the notice that appeared in the 
Federal Register of August 16, 2004 (69 FR 50386). In the notice, FDA 
announced a public workshop on scientific and technical considerations 
related to the development of follow-on protein pharmaceutical products 
and plans to develop draft guidance and requested comments related to 
developing and approving follow-on protein pharmaceutical products. The 
agency is taking this action in response to requests for an extension 
to allow interested persons additional time to submit comments.

DATES: Submit written and electronic comments by March 16, 2005.

ADDRESSES: Submit written comments on scientific topics related to 
follow-on protein products 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments

Evaluation and Research (HFD-121), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20852, 301-443-5089, e-mail: 
keith.webber@fda.gov, or Chris Joneckis, Center for Biologics 
Evaluation and Research (HFM-1), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20892, 301-827-2000, e-mail: 


I. Background

    In the Federal Register of August 16, 2004 (69 FR 50386), FDA 
published a notice with a 90-day comment period to request comments on 
the scientific and technological perspectives of manufacturers, 
academia, and other interested persons to determine the state of the 
science as it relates to protein characterization, production, and 
assessment of similarity.
    The agency has received requests for an extension of the comment 
period for the notice. In response to these requests, FDA has decided 
to reopen the comment period for the notice for an additional 30 days, 
until March 16, 2005.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this document. Two 
copies of mailed 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. Received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3027 Filed 2-11-05; 4:50 pm]