[Federal Register: October 27, 2003 (Volume 68, Number 207)]
[Page 61222-61223]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 61222]]



Food and Drug Administration

[Docket No. 1999D-1938]

Review and Revision of Guidances for Industry on the Development 
of Generic Drug Products; Development and Use of Food and Drug 
Administration Guidance Documents; Update and Withdrawal of Guidances

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; update and withdrawal of guidances.


SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research (CDER), Office of Generic Drugs (OGD) is 
updating drug manufacturers on OGD efforts to review policy and 
procedure guides (PPGs) and other existing OGD documents that provide 
guidance on the development of generic drug products. We are also 
announcing the withdrawal of a list of PPGs that have become obsolete 
or have been replaced with other guidances or agency directives 
(manuals for policy and procedures (MaPPs)).

DATES: General comments on agency guidance documents are welcome at any 

ADDRESSES: Copies of agency guidance documents can be obtained on the 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-

SUPPLEMENTARY INFORMATION: Since the early 1990s, OGD has developed and 
issued more than 40 PPGs 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 
    On July 8, 1999, the agency announced in the Federal Register (64 
FR 36886) 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 the agency's good guidance practices 
regulation (GGP) (21 CFR 10.115), and those that need to be withdrawn 
because they are no longer current. As an initial step in that process, 
OGD withdrew a number of drug-specific bioequivalence guidances and a 
number of labeling guidances that were outdated and no longer reflected 
the current thinking of the agency.
    This notice has a twofold purpose: (1) It updates manufacturers on 
the status of OGD efforts to review existing guidances, and (2) it 
announces the withdrawal of 30 PPGs that are obsolete.
    The PPGs that are being withdrawn are listed below. In each case, 
the reason for the withdrawal has been provided in parentheses.
    [sbull] 1-89 ``Correspondence Practices'' (The guidance ``Major, 
Minor, and Telephone Amendments to Abbreviated New Drug Applications'' 
describes current correspondence practices.)
    [sbull] 3-89 ``Handling Telephone Inquiries on Status of Processing 
from Applicants or Their Representatives'' (MAPP 5020.1 has been issued 
on this topic.)
    [sbull] 4-89 ``Microbiology Consults'' (It is no longer needed as 
OGD has its own microbiology staff.)
    [sbull] 6-89 ``Not Approvable Actions for ANDA\1\ and AADA\2\ 
Supplements'' (The guidance ``Major, Minor, and Telephone Amendments to 
Abbreviated New Drug Applications'' describes current correspondence 

    \1\ ANDA means Abbreviated New Drug Application.
    \2\ AADA means Abbreviated Antibiotic Drug Application.

    [sbull] 8-89 ``Changes in the Labeling of ANDAs Subsequent to 
Revision of Innovator Labeling'' (The guidance ``Revising ANDA Labeling 
Following Revision of the RLD\3\ Labeling'' addresses this topic.)

    \3\ RLD means Reference Listed Drug.

    [sbull] 9-89 ``Delivery of Documents to the Office of Generic 
Drug's Document Room; Providing Requested Documents to Messengers and 
Other Representatives of ANDA/AADA Applicants'' (This describes 
interactions with messengers and other representatives that have been 
overtaken by advances in technology. See also guidance ``Major, Minor, 
and Telephone Amendments to Abbreviated New Drug Applications'' for 
information on current correspondence practices.)
    [sbull] 10-89 ``Meetings With Pharmaceutical Firm Employees or 
Their Representatives'' (This is addressed in CDER MAPP 4512.1.)
    [sbull] 11-89 ``Shredding of Carbons and Draft Reviews and 
Letters'' (This has been overtaken by advances in technology.)
    [sbull] 12-89 ``Number of Manufacturing Sites Permitted in an ANDA 
or AADA'' (This was superceded by the guidance ``Variations in Drug 
Products that May Be Included in a Single ANDA.'')
    [sbull] 13-89 ``Testing Requirements Applicable to Finished Dosage 
Forms Manufactured Outside the United States'' (This material will be 
incorporated into the center's guidance on ``Stability Testing of Drug 
Substances and Drug Products,'' which issued as a draft in June 1998.)
    [sbull] 14-89 ``Signatory Concurrence and Agreement on Final Typed 
Reviews and Letters and Other Items in the Administrative File'' (This 
is addressed by MaPP 4151.1.)
    [sbull] 16-90 First in-First Reviewed Policies'' (This was 
superseded by PPG 38-93, then addressed by MaPP 5240.3.)
    [sbull] 18-90 ``Requests for Expedited Review of Supplements to 
Approved ANDAs and AADAs'' (This became MaPP 5240.1.)
    [sbull] 19-90 ``Availability of Labeling Guidance'' (This became 
MaPP 5230.1.)
    [sbull] 20-90 ``Variations in Solid Oral Dosage Forms and 
Injectables That Can Be Included Within a Single ANDA'' (The guidance 
``Variations in Drug Products that May be Included in a Single ANDA'' 
was issued on this topic.)
    [sbull] 21-90 ``First In-First Reviewed Policy and Exceptions 
Applied to Supplemental Applications'' (This was superseded by PPG 38-
93, then addressed by MaPP 5240.3.)
    [sbull] 24-90 ``Improvement by the Applicant of Unreviewed Original 
ANDA and AADA Submissions'' (This is no longer needed given existence 
of form OGD uses to receive applications. See ``ANDA Checklist for 
Completeness and Acceptability of an Application,'' http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ogd/anda_checklist.doc.
    [sbull] 25-90 ``Removal of Work-Related Materials from the Division 
at the End of Employment'' (This is covered by existing CDER exit 
    [sbull] 26-90 ``Reference to Type I DMF's \4\ in ANDAs and AADAs'' 
(This is obsolete as type I DMFs are no longer used.)

    \4\ DMF means Drug Master Files.

    [sbull] 27-90 ``Acceptance for Filing and Review of AADAs Absent 
Approval of the Referenced Bulk Antibiotic'' (This became MaPP 5240.2; 
the MaPP was then withdrawn with repeal of section 507 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 357).)
    [sbull] 30-91 ``Organization of an ANDA and an AADA'' (This is 
addressed in the guidance for industry ``Organization of an ANDA.'')
    [sbull] 32-92 ``Reaffirmation of Expiration Dating Period for 
Abbreviated Applications'' (This is addressed by MaPP 5226.1.)

[[Page 61223]]

    [sbull] 33-92 ``Consistent Container Information in an Abbreviated 
Application'' (This is addressed by MaPP 5225.2.)
    [sbull] 34-92 ``Implementation of the Fraud, Untrue Statements of 
Material Facts, Bribery and Illegal Gratuities Final Policy'' (Revised 
October 3, 1992 (An agency-level policy addresses this topic.)
    [sbull] 35-92 ``Revision of Exhibit Batch Requirements for 
Abbreviated Antibiotic Drug Applications'' (This became MaPP 5223.1; 
the MaPP was then withdrawn with repeal of section 507 of the act.)
    [sbull] 36-92 ``Submission of an Investigational New Drug 
Application to the Office of Generic Drugs'' (This is addressed by MaPP 
    [sbull] 37-92 ``Management of Office and Center Committees'' (This 
was previously withdrawn per memo dated February 14, 1997, because of 
center committee reorganization.)
    [sbull] 38-93 ``Restatement of the Office of Generic Drugs First 
In-First Reviewed Policy and Modifications of the Exceptions to the 
Policy Regarding Minor Amendments'' (This is addressed by MaPP 5240.3.)
    [sbull] 40-94 ``Scoring Configuration of Generic Drug Products'' 
(This is addressed by MaPP 5223.2.)
    [sbull] 41-95 ``Packaging of Test Batches'' (This is addressed by 
MaPP 5225.1.)
    A number of other PPGs and other OGD documents are undergoing 
revision. Some of them will be issued as MaPPs; others will be revised 
and reissued in the form of guidances for industry consistent with the 
GGP regulation.
    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 is also 
requesting public comment on topics for future guidance development 
regarding generic drugs.
    This information is being issued consistent with FDA's GGPs. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written comments. Two copies of any 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. Received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: October 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26964 Filed 10-24-03; 8:45 am]