U.S. Food and Drug Administration

Appendix A: Application Backlogs
(Overdue as of 12/31/99)

PDUFA (Based on PDUFA II commitment letter):
Application and Time Frame	Number Overdue As of 12/31/99
Review Priority NDAs within 6 months	0
Review Standard NDAs within 12 months	0
Review Standard NDAs within 10 months	N/A
Review Priority NDAs/PLAs/BLAs within 6 months	0
Review Standard NDAs/PLAs/BLAs within 12 months	0
Review Standard NDAs/PLAs/BLAs within 10 months	0
Review priority efficacy supplements within 6 months (CDER)	1
Review standard efficacy supplements within 12 months (CDER)	1
Review standard efficacy supplements within 10 months (CDER)	N/A
Review priority efficacy supplements within 6 months (CBER)	0
Review standard efficacy supplements within 12 months (CBER)	0
Review standard efficacy supplements within 10 months (CBER)	0
Review manufacturing supplements within 6 months (CDER)	1
Review manufacturing supplements within 4 months (CDER)	N/A
Review manufacturing supplements within 6 months (CBER)	1
Review manufacturing supplements within 4 months (CBER)	0

NON-PDUFA:
Application and Time Frame	Number Overdue As of 12/31/99
Review ANDAs within 180 days	74
Review PLAs/BLAs within 12 months (Internal time frame) (CBER)	0
Review PLA/BLA supplements within 12 months (Internal time frame)	14
Review PMAs within 180 days	2
Review PMA supplements within 180 days	6
Review 510(k)s within 90 days	0
Review food and color additive petitions within 360 days Goals are based on 360 days	56
Review NADAs & ANADAs within 180 days	22
Decide Fast Track Requests within 60 days	3
Review export applications for drugs and biologics within 30 days	0
Complete processing of generally recognized as safe (GRAS) notifications within time frame of final rule	N/A *
Review dietary ingredient notifications within 75 days	0
Review infant formula notifications within 90 days	0
Review health claim petitions within 100 days	0
Review nutrient content claim petitions within 100 days	0

N/A--Not available
*--Final rule still pending

Abbreviations Used in Table:

FDA Centers

CDER -- Center for Drug Evaluation and Research
CBER -- Center for Biologics Evaluation and Research

Marketing Applications:

NDA -- New Drug Application
PLA -- Product License Application
BLA -- Biologic License Application
ANDA -- Abbreviated New Drug Application
PMA --Premarket Approval Application (for a Medical Device)
510(k) --Premarket Notification (for a Medical Device)
NADA -- New Animal Drug Application
ANADA -- Abbreviated New Animal Drug Application

Appendix B: Sources for Additional Information

FDA's home page	www.fda.gov
FDAMA Plan For Statutory Compliance	www.fda.gov/oc/fdama/fdamapln/
Table of FDA's performance on goals specified in Plan	www.fda.gov/oc/fdama/fdamaplnresponse/rptgoalsFY99.html

Objective A: Maximize the availability and clarity of information about the process for review of applications and submissions.
Information on drug applications including forms, guidance, information for clinical investigators, organization, contacts, meetings	www.fda.gov/cder/regulatory/applications/
Guidance documents on the premarket approval process for devices	www.fda.gov/cdrh/databases.html
List of medical device product standards	www.fda.gov/cdrh/national.pdf
List of third party device reviewers	www.fda.gov/cdrh/thirdparty/
Information and requirements for review and approval of new animal drugs
Generic Animal Drugs and the Generic Animal Drug and Patent Term Restoration Act	www.fda.gov/cvm/gadaptra.html
Veterinary Master Files	www.fda.gov/cvm/FOI/vmf.htm

Objective B: Maximize the availability and clarity of information for consumers and patients concerning new products.
Take Time to Care	www.fda.gov/womens/tttc.html
Fight BAC	www.fightbac.org/
Food Safety Initiative 1999 Annual Report	www.cfsan.fda.gov/~dms/fsirp99.html
Clinical Trial Information	www.ClinicalTrials.gov
Patient participation in advisory committee decisions	www.fda.gov/oashi/patrep/patbroc.html
Food safety information	www.foodsafety.gov
CVM's Food Safety page	www.fda.gov/cvm/fsior.htm

Objective C: Implement inspection and postmarket monitoring provisions of this Act.
DeviceNet	www.fda.gov/cdrh/postsurv/medsun.html
Medwatch	www.fda.gov/medwatch/
Fight BAC	www.fightbac.org
Adverse events from Special Nutritionals	www.cfsan.fda.gov/~dms/aems.html
Adverse Drug Experience reporting	www.fda.gov/cvm/ade_cum.htm
Notices of Regulatory Activity letters to pharmaceutical companies
VICH	www.fda.gov/cvm/vich.html
Import Program	www.fda.gov/ora/import/ora_import_program.html

Objective D: Ensure access to needed scientific and technical expertise.
Moffett Center	www.iit.edu/~ncfs/
JIFSAN	www.jifsan.umd.edu
President's weekly radio addresses	ww.whitehouse.gov/library/
PQRI	www.pqri.org
Blood action plan	www.fda.gov/cber/blood/bap.htm
Tissue action plan	www.fda.gov/cber/tissue/tissue.htm
Xenotransplantation action plan	www.fda.gov/cber/xap/xap.htm
Biological device action plan	www.fda.gov/cber/dap/dap.htm
National Center for Toxicological Research	www.fda.gov/nctr/

Objective E: Establish mechanisms, by July 1, 1999, for meeting time periods for the review of all applications and submissions.
Mechanisms for meeting application review goals	www.fda.gov/ope/fdama/objEintro.html
PDUFA Performance Reports	www.fda.gov/oc/pdufa/reports.html

Table of Contents | Objectives (Part 1) | Objectives (Part 2) | Appendices

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