[Federal Register Volume 66, Number 36 (Thursday, February 22, 2001)]
[Notices]
[Pages 11175-11176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0059]


Draft Guidance for Industry on Separate Marketing Applications 
and Definition of Clinical Data for Purposes of Assessing User Fees; 
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availability of a draft guidance for industry entitled ``Separate 
Marketing Applications and Clinical Data for Purposes of Assessing User 
Fees.'' This draft guidance revises a procedural guidance entitled 
``Attachment E--Interim Guidance: Separate Marketing Applications and 
Clinical Data for Purposes of Assessing User Fees Under the User Fee 
Act of 1992'' issued in July 1993 (the July 1993 interim guidance), 
which provided guidance on the agency's policy on ``bundling'' 
applications and a definition of ``clinical data'' for user fee 
purposes. This draft guidance deletes two appendices in the July 1993 
interim guidance and directs readers to the agency publication entitled 
``Approved Drug Products with Therapeutic Equivalence Evaluations'' 
(the Orange Book) for a listing of routes of administration and dosage 
forms.

DATES: Submit written comments on this draft guidance by March 26, 
2001. General comments 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ADDRESSES: Copies of this draft guidance for industry are available on 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 and http:/www.fda.gov/cder/pdufa/default.htm. Submit written requests for single copies of 
the draft guidance entitled ``Separate Marketing Applications and 
Clinical Data for Purposes of Assessing User Fees'' to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
or to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
The document may also be obtained by fax by calling the FAX Information 
System at 1-888-CBER-FAX or 301-827-3844. Send one self-addressed 
adhesive label to assist the office in processing your request. 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:
    Michael D. Jones, Center for Drug Evaluation and Research (HFD-5), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-2041, FAX 301-827-5562, or
    Carla A. Vincent, Center for Biologics Evaluation and Research 
(HFM-110), 1401 Rockville Pike, Rockville, MD 20852, 301-827-3503, FAX 
301-827-2875.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Separate Marketing Applications 
and Clinical Data for Purposes of Assessing User Fees.'' This draft 
guidance revises the July 1993 interim guidance.
    The agency is deleting from the 1993 interim guidance the list of 
routes of administration in appendix A and dosage forms in appendix B.
    FDA is deleting appendices A and B so that the guidance reflects 
current agency policy, as developed over the past few years (see Docket 
Nos. 93P-0421, 95P-0262, 96P-0317, and 96P-0459). Among other things, 
in the review of abbreviated new drug applications, the Center for Drug 
Evaluation and Research generally has not considered different 
mechanisms of release, particularly for suppository, delayed, and 
controlled release products, as different dosage forms.

[[Page 11176]]

    Instead, the draft guidance refers readers to the Orange Book 
appendix C, ``Uniform Terms.'' Although the Orange Book appendix C is 
not binding on the agency or industry, it does serve as informal 
guidance on what the ``same'' or ``identical'' dosage form or route of 
administration would be.
    The draft guidance also updates the July 1993 interim guidance for 
consistency with the agency's good guidance practices (GGP's) 
regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). The agency 
anticipates making additional revisions to this procedural guidance in 
the future.
    This Level 1 draft guidance is being issued consistent with FDA's 
GGP's. The draft guidance represents the agency's current thinking on 
this topic. 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. The draft guidance will be updated 
as appropriate.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance at any time. 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 are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: February 13, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4311 Filed 2-21-01; 8:45 am]
BILLING CODE 4160-01-F