[Federal Register Volume 69, Number 47 (Wednesday, March 10, 2004)]
[Rules and Regulations]
[Pages 11309-11310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 2003N-0417]


Application of 30-Month Stays on Approval of Abbreviated New Drug 
Applications and Certain New Drug Applications Containing a 
Certification That a Patent Claiming the Drug Is Invalid or Will Not Be 
Infringed; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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SUMMARY: 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).

DATES: This rule is effective March 10, 2004.

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.

SUPPLEMENTARY INFORMATION:

1. Background

    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,

[[Page 11310]]

known 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)).

List of Subjects in 21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

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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:

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

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1. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 356, 
356a, 356b, 356c, 371, 374, 379e.


Sec.  314.52  [Amended]

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2. Section 314.52 is amended by removing paragraph (a)(3) and 
redesignating paragraph (a)(4) as paragraph (a)(3).


Sec.  314.95  [Amended]

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3. Section 314.95 is amended by removing paragraph (a)(3) and 
redesignating paragraph (a)(4) as paragraph (a)(3) .

    Dated: March 1, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5407 Filed 3-9-04; 8:45 am]
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