[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Notices]
[Pages 68697-68698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4809]


Draft Guidance for Industry on Applications Covered by Section 
505(b)(2); 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availability of a draft guidance for industry entitled ``Applications 
Covered by Section 505(b)(2).'' A section 505(b)(2) application is a 
new drug application (NDA) for which one or more of the investigations 
relied upon by the applicant for approval were not conducted by or for 
the applicant and for which the applicant has not obtained a right of 
reference or use from the person by or for whom the investigations were 
conducted. This draft guidance also provides information on procedures 
for submitting an application for approval of a change from an approved 
drug.

DATES: Written comments on the draft guidance may be submitted by 
February 7, 2000. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), 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 Submit written comments on the draft guidance 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 Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Khyati N. Roberts, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6779.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Applications Covered by Section 
505(b)(2).'' Section 505 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 355) describes three types of NDA's: (1) An 
application that contains full reports of investigations of safety and 
effectiveness (section 505(b)(1) of the act); (2) an application that 
contains full reports of investigations of safety and effectiveness but 
where at least one of those reports required for approval was not 
conducted by or for the applicant or for which the applicant has not 
obtained a right of reference (section 505(b)(2) of the act); or (3) an 
application that contains information to show that the proposed product 
is identical in active ingredient, dosage form, strength, route of 
administration, labeling, quality, performance characteristics, and 
intended use, among other things, as a previously approved product 
(section 505(j) of the act).
    Section 505(b)(2) of the act was added to the act by the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman 
amendments). It explicitly allows FDA to rely, for approval of an NDA, 
on data not developed by the applicant. Section 505(b)(2) and (j) of 
the act replaced FDA's paper NDA policy, which had permitted an 
applicant to rely on studies published in the scientific literature to 
demonstrate the safety and effectiveness of duplicates of certain post-
1962 pioneer drug products (46 FR 27396, May 19, 1981). Enactment of 
the generic drug approval provision of the Hatch-Waxman amendments 
ended the need for approvals of duplicate drugs through the paper NDA 
process. Specifically, section 505(j) of the act allows for approval of 
duplicates of approved NDA's on the basis of chemistry and 
bioequivalence data. Section 505(b)(2) of the act allows for approval 
of applications other than those for duplicate products.

[[Page 68698]]

    This draft guidance identifies the types of applications that can 
be submitted under section 505(b)(2) of the act. A section 505(b)(2) 
application is an NDA submitted under section 505(b)(1) of the act and 
approved under section 505(c) of the act. This draft guidance also 
provides further information and amplification of information stated at 
21 CFR 314.54.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on section 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, regulations, or both.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). Two copies 
of any 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 may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: November 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-31698 Filed 12-7-99; 8:45 am]
BILLING CODE 4160-01-F