[Federal Register: March 3, 2004 (Volume 69, Number 42)]
[Proposed Rules]               
[Page 9982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 314

[Docket No. 2004N-0087]

Generic Drug Issues; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments.


SUMMARY:  The Food and Drug Administration (FDA) is requesting public 
comments on whether additional regulatory actions should be taken 
concerning the approval of abbreviated new drug applications (ANDAs). 
The agency is asking for comments because of recent statutory changes. 
The agency is not proposing any regulatory changes in this notice. The 
purpose of this notice is to identify a number of issues that the 
agency would like interested persons to address and to give interested 
persons an opportunity to submit comments on possible actions.

DATES: Submit written or electronic comments by May 3, 2004.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 200857. 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

FOR FURTHER INFORMATION CONTACT: Elaine Tseng, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5515 Security Lane, 
Rockville, MD 20852, 301-594-2041.


I. Background

    On December 8, 2003, President Bush signed into law the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Public Law 108-173). Title XI of MMA made changes to section 505(a), 
(b), and (j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
505(a), (b), and (j). In particular, Title XI of MMA made changes to 
the approval procedures for ANDAs.
    FDA is considering what additional regulatory steps, if any, are 
warranted in light of the statutory changes. The specific portions of 
the statute for which FDA seeks comment are Title XI of MMA's 
provisions concerning the 30-month stay of effectiveness period, 180-
day exclusivity, and bioavailability and bioequivalence. FDA seeks 
comments identifying issues contained in the relevant portions of Title 
XI of MMA, along with any suggestions for how to resolve those issues. 
FDA will consider these comments in assessing what regulatory actions 
might be appropriate.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written of electronic comment 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 
at 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.

    Dated: February 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4775 Filed 3-1-04; 8:45 am]