[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]
[DOCID:fr03mr04-23]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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]
BILLING CODE 4160-01-S