[Federal Register Volume 69, Number 213 (Thursday, November 4, 2004)]
[Notices]
[Pages 64314-64315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0087]


Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and 
Approval of Abbreviated New Drug Applications and 505(b)(2) 
Applications Under Hatch-Waxman, as Amended by the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003--
Questions and Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Listed Drugs, 
30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under 
Hatch-Waxman, as Amended by the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003--Questions and Answers.'' 
This draft guidance follows the enactment of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) 
(MMA) on December 8, 2003. In part, this guidance satisfies FDA's 
obligation under that law to clarify the definition of ``listed drug'' 
for persons who wish to submit a change (i.e., an amendment or 
supplement) to an abbreviated new drug application (ANDA). The guidance 
explains when a change to an application should reference a drug 
different from the drug listed in the original ANDA, requiring the 
change to be made through an entirely new application.
    In addition to the definition of ``listed drug,'' the draft 
guidance clarifies certain other provisions of the MMA that 
significantly change the law that existed before the MMA's enactment. 
These include changes regarding 30-month stays and approval of ANDAs 
and new drug applications submitted under section 505(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (505(b)(2) applications). The 
draft guidance also explains the effective dates that apply to the 
MMA's provisions.

DATES: Submit written or electronic comments on the draft guidance by 
February 2, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Martin Shimer, Center for Drug 
Evaluation and Research (HFD-615), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855 301-827-5710.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Listed Drugs, 30-Month Stays, and Approval of ANDAs and 
505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003--
Questions and Answers.'' On December 8, 2003, the MMA was signed into 
law. Among other things, Title XI of that law, ``Access to Affordable 
Pharmaceuticals,'' states that guidance will be issued to define the 
term ``listed drug'' with respect to amendments and supplements to 
ANDAs. This guidance is necessary because the MMA specifies that, ``An

[[Page 64315]]

applicant may not amend or supplement an [ANDA] to seek approval of a 
drug referring to a different listed drug from the listed drug 
identified in the application as submitted to the Secretary'' (MMA, 
Title XI, section 1101(a)(1)(B)). In part, the draft guidance clarifies 
the definition of ``listed drug'' in the context of ANDAs as directed 
by the MMA. Portions of the guidance addressing ``listed drug'' are 
expected to be of use to sponsors who are contemplating submitting an 
amendment or supplement to an existing ANDA rather than submitting a 
new application. The draft guidance should aid these sponsors in 
determining when to reference a different listed drug and, thus, when 
to submit a new application rather than an amendment or supplement. A 
situation that is not considered in this guidance is that where a 
pending ANDA was submitted referencing a petition approved under 
section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 355(j)(2)(C)), and another application is approved for 
the product described in the petition before the pending ANDA is 
approved. FDA has not completed its analysis of this situation, and 
therefore the draft guidance does not cover it.
    In addition to the definition of ``listed drug,'' the draft 
guidance clarifies certain other significant changes made by the MMA to 
provisions of the act that were originally added by the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(Hatch-Waxman). These include changes made by the MMA with respect to 
the availability and termination of 30-month stays of approval on ANDAs 
and 505(b)(2) applications under section 505(j)(5)(B)(iii) and 
505(c)(3)(C) of the act, respectively, and to requirements for notice 
of patent certifications described by section 505(b)(2)(A)(iv) and 
505(j)(2)(A)(vii)(IV) of the act (paragraph IV certifications). The 
draft guidance also clarifies the applicability of certain changes made 
by the MMA regarding the period described by section 505(j)(5)(B)(iv) 
of the act during which ANDAs with paragraph IV certifications that 
were not the first to be submitted cannot be approved (180-day 
exclusivity). Finally, this guidance explains the effective dates that 
apply to the MMA's amendments. FDA is aware that these changes are 
complex and include significant departures from previous law. The 
agency therefore wishes to provide guidance to industry to clarify 
these amendments.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
definition of ``listed drug'' for amendments and supplements to ANDAs, 
and on 30-month stays and certain other matters related to the approval 
of ANDAs and 505(b)(2) applications. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24675 Filed 11-3-04; 8:45 am]
BILLING CODE 4160-01-S