[Federal Register: March 10, 2004 (Volume 69, Number 47)]
[Rules and Regulations]
[Page 11309-11310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr04-10]
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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]
BILLING CODE 4160-01-S