This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
Final rule, technical amendment.
The Food and Drug Administration (FDA) is revoking certain sections of its regulation concerning 30-month stays of approval of abbreviated new drug applications (ANDAs) and certain new drug applications (NDAs) that contain a certification that a patent claiming the drug is invalid or will not be infringed. This action is taken in response to the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 signed December 8, 2003. Title XI, Access to Affordable Pharmaceuticals, contains provisions that supersede sections of the regulation. This action will result in the revocation of 21 CFR 314.52(a)(3) and 21 CFR 314.95(a)(3).
This rule is effective March 10, 2004.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy and Planning (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360.End Further Info End Preamble Start Supplemental Information
In the Federal Register of June 18, 2003 (68 FR 36676), we (FDA) issued a final rule that amended our patent submission and listing requirements. The final rule revised the regulations regarding the effective date of approval for ANDAs and certain other NDAs, Start Printed Page 11310known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDAs and 505(b)(2) applications effective for 30 months if the applicant has certified that a patent claiming the drug is invalid or will not be infringed and the patent owner or NDA holder then sues the applicant for patent infringement. The final rule stated that there was only one opportunity for a 30-month stay of the approval date of each ANDA and 505(b)(2) application. The final rule also clarified the types of patents that must and must not be submitted to FDA and revised the declaration that NDA applicants must submit to FDA regarding patents to help ensure that NDA applicants submit only appropriate patents. The final rule became effective on August 18, 2003.
On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) was signed into law. Title XI, Access to Affordable Pharmaceuticals, subtitle A, section 1101 (Public Law 108-173) contains provisions that supersede sections of the regulation issued in the June 18, 2003, final rule (68 FR 36676). The new statutory provisions address the effective date of approval for certain ANDAs and 505(b)(2) applications and prohibit approval for 30 months if the applicant has certified that a patent claiming the drug is invalid or will not be infringed, and the patent owner or NDA holder then sues the applicant for patent infringement. The effective date of these provisions was made retroactive to August 18, 2003. The new statutory provisions address the applicability of 30-month stays in approval of certain ANDAs and 505(b)(2) applications in a different manner than our final rule, which was issued under statutory language now superseded.
Therefore, certain regulations issued in the final rule published on June 18, 2003 (68 FR 36676) are superseded by the new statutory provisions. The affected sections of the regulation are 21 CFR 314.52(a)(3) and 21 CFR 314.95(a)(3) that stay the effective date of approval for certain ANDAs and 505(b)(2) applications for 30 months in certain situations.
In accordance with the new statutory provisions, we are revoking the applicable sections of the regulation. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)).Start List of Subjects
List of Subjects in 21 CFR Part 314
- Administrative practice and procedure
- Confidential business information
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR 314 is amended as follows:End Amendment Part Start Part
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUGEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 314 continues to read as follows:End Amendment Part
2. Section 314.52 is amended by removing paragraph (a)(3) and redesignating paragraph (a)(4) as paragraph (a)(3).End Amendment Part
3. Section 314.95 is amended by removing paragraph (a)(3) and redesignating paragraph (a)(4) as paragraph (a)(3) .End Amendment Part Start Signature
Dated: March 1, 2004.
Assistant Commissioner for Policy.
[FR Doc. 04-5407 Filed 3-9-04; 8:45 am]
BILLING CODE 4160-01-S