[Federal Register Volume 64, Number 130 (Thursday, July 8, 1999)]
[Notices]
[Pages 36886-36887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17331]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-1938]


Review of Guidances for Industry on the Development of Generic 
Drug Products; Development and Use of FDA Guidance Documents; Request 
for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

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SUMMARY:  The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research (CDER), Office of Generic Drugs (OGD) is 
providing notice to drug manufacturers on its plans for reviewing 
policy and procedure guides (PPG's) and other existing OGD documents 
that provide guidance on the development of generic drug products. This 
effort is being undertaken consistent with the agency's good guidance 
practices (GGP's) policy. The goal of this long-term effort is to 
identify documents that need to be revised, reformatted to fit the GGP 
policy, or withdrawn because they are no longer current. OGD hopes this 
process will result in guidances for industry that better reflect the 
current thinking of the agency on generic drug development. OGD also is 
seeking input from the public on topics for future guidance 
development.

DATES:  Written comments by September 7, 1999. General comments on 
agency guidance documents are welcome at any time.

ADDRESSES:  Copies of agency guidance documents can be obtained on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written comments to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Rita R. Hassall, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5845.

SUPPLEMENTARY INFORMATION:  In the Federal Register of February 27, 
1997 (62 FR 8961), FDA published a notice explaining its policy for 
guidance document development, issuance, and use. The notice included 
an agency document entitled ``Good Guidance Practices'' (GGP's), which 
sets forth agency policies and procedures for developing, issuing, and 
using guidance documents.
    Since the early 1990's, OGD has developed and issued more than 40 
PPG's to provide information to industry on the development of generic 
drug products and to set forth procedures for the review of generic 
drug applications. In addition, other guidance has been provided in the 
form of letters and other communications to industry. OGD is 
undertaking a long-term effort to review all of its guidances and 
identify those that need to be revised, those that need to be 
reformatted for consistency with GGP's, and those that need to be 
withdrawn because they are no longer current. As an initial step in 
this process, OGD is planning to withdraw a number of drug-specific 
bioequivalence guidances that are outdated and no longer reflect the 
current thinking of the agency. Guidances that are being withdrawn 
include the following:

 
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              Guidance                         Date of Issuance
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Alprazolam (tablets)                 November 27, 1992
Bumetanide (tablets)                 April 23, 1993
Captopril (tablets)                  May 13, 1993
Carbidopa and Levodopa (tablets)     June 19, 1992
Cefaclor (capsules and suspension)   April 23, 1993
Diflunisal (tablets)                 May 16, 1992
Diltiazem Hydrochloride (tablets)    May 16, 1992
Flurbiprofen (tablets)               June 8, 1995 (2d Revision)
Gemfibrozil (tablets and capsules)   June 15, 1992 (Revision)
Guanabenz Acetate (tablets)          April 23, 1993
Hydroxychloroquine Sulfate           December 28, 1995
 (tablets)
Indapamide (tablets)                 April 23, 1993
Ketoprofen (capsules)                April 23, 1993
Leucovorin Calcium (tablets)         August 4, 1988 (Revision)
Medroxyprogesterone Acetate          September 17, 1987 (Revision)
 (tablets)
Metoprolol Tartrate (tablets)        June 12, 1992
Nadolol (tablets)                    May 16, 1992
Naproxen (tablets)                   June 8, 1995 (Revision)
Nortriptyline Hydrochloride          June 12, 1992
 (capsules)
Pentoxifylline (extended-release     December 22, 1995
 tablets)
Pindolol (tablets)                   April 23, 1993
Piroxicam (capsules)                 June 15, 1992
Ranitidine Hydrochloride (tablets)   April 23, 1993
Trazodone Hydrochloride (tablets)    April 30, 1988 (Revision)
------------------------------------------------------------------------

It is possible that some of the remaining drug-specific guidances on 
bioavailability and bioequivalence also will be withdrawn after they 
are reassessed. However, several CDER guidances currently under 
development will serve as core guidances on bioavailability and 
bioequivalence once they have been finalized, and they will replace the 
product-specific guidances. On rare occasions, the agency may wish to 
provide bioavailability and bioequivalence guidance for specific drug 
products, and these will be developed and issued consistent with the 
agency's GGP policy.
    The agency welcomes public comment on its efforts to review 
existing guidances related to the development of generic drugs and 
revise, reformat, or withdraw them as appropriate. The agency also is 
requesting public comment on topics for future guidance development 
regarding generic drugs.
    This information is being issued consistent with FDA's GGP's. It 
does not

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create or confer any rights for or on any person and does not operate 
to bind FDA or the public.
    Interested persons may submit written comments 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. Received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: June 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-17331 Filed 7-7-99; 8:45 am]
BILLING CODE 4160-01-F