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U.S. Department of Health and Human Services

Regulatory Information

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Appendix D Application and Submission Review

The following is a summary description of the types of applications and submissions:

Original applications are generally submitted for new products or for new uses of food and color additives or for new food labeling claims.

Investigational new drug application (IND)--for drugs and biologics
New drug application (NDA)--human drug
Product license application (PLA)--biologics
Establishment license application (ELA)--biologics
Biologics license application (BLA)--combines PLA and ELA for biologics
Premarket application (PMA)--medical device
Food additive petition (FAP)
Color additive petition (CAP)
New animal drug application (NADA)
Nutrient Content Claim Petitions
Health Claim Petitions

510(k) applications (premarket notifications) are submitted to establish that a medical device is "substantially equivalent" to an already marketed device.

Generic drug applications generally are submitted to establish that a firm can manufacture a copy of a brand name drug.

Abbreviated new drug application (ANDA)
Abbreviated antibiotic drug application (AADA)
Abbreviated new animal drug application (ANADA)

Supplemental applications generally are submitted for changes in already approved products, including the addition of a new indication or changes in how a product is manufactured.

Efficacy supplements
Manufacturing supplements
Labeling supplements
Chemistry supplements
Other supplements

Other applications and submissions include investigational applications, fast track designation requests, notifications, and petitions.

Major Requirements--Application and Submission Review

PDUFA (Based on PDUFA II commitment letter):

Time Frame Relevant Statute FY 1999 Performance Plan Goal--Percentage of First Actions Within Time Frame FY 1997 Baseline (Estimate)--Percentage of First Actions Within Time Frame Number Overdue as of 9/30/98
Review Priority NDAs within 6 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 (b)
90 percent 100 percent 0
Review Standard NDAs within 12 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 (b)
90 percent 99 percent 0
Review Standard NDAs within 10 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 (b)
30 percent N/A N/A
Review Priority NDAs/PLAs/BLAs within 6 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 (b) for NDAs. None for PLAs/BLAs.
90 percent 100 percent 0
Review Standard NDAs/PLAs/BLAs within 12 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 (b) for NDAs. None for PLAs/BLAs.
90 percent 100 percent 0
Review Standard NDAs/PLAs/BLAs within 10 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 (b) for NDAs. None for PLAs/BLAs.
30 percent N/A N/A
Review priority efficacy supplements within 6 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements.
90 percent 100 percent 0
Review standard efficacy supplements within 12 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements.
90 percent 100 percent 2
Review standard efficacy supplements within 10 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements.
30 percent N/A N/A
Review priority efficacy supplements within 6 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements.
90 percent 100 percent 0
Review standard efficacy supplements within 12 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements.
90 percent 100 percent 0
Review standard efficacy supplements within 10 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements.
30 percent N/A N/A
Review manufacturing supplements within 6 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements.
90 percent 98 percent 21
Review manufacturing supplements within 4 months. (CDER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements.
30 percent N/A N/A
Review manufacturing supplements within 6 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements.
90 percent 98 percent 6
Review manufacturing supplements within 4 months. (CBER) Section 101(4) of FDAMA.
FD&C Act Sec. 505 for NDA supplements. None for PLAs/BLA supplements.
30 percent N/A N/A

 

Non-PDUFA:

Time Frame Relevant Statute FY 1999 Performance Plan Goal--Percentage of First Actions Within Time Frame FY 1997 Baseline (Estimate)--Percentage of First Actions Within Time Frame Number Overdue as of 9/30/98
Review ANDAs within 180 days. (CDER) FD&C Act Sec. 505(j) 60 percent 54 percent 142
Review Blood PLAs/BLAs within 12 months. (Internal time frame) (CBER) None 70 percent 83 percent 4
Review Blood PLA/BLA major supplements within 12 months. (Internal time frame) (CBER) None 70 percent N/A 0
Review Blood ELA major supplements within 12 months. (Internal time frame) (CBER) None 60 percent 98 percent 9
Review PMAs within 180 days. (CDRH) FD&C Act Sec. 515(d)(1)(A) 50 percent 65 percent 0
Review PMA supplements within 180 days. (CDRH) FD&C Act Sec. 515(d)(6) None 65 percent 0
Review 510(k)s within 90 days. (CDRH) FD&C Act Sec. 510(k) 90 percent 98 percent 0
Review Food and color additive petitions within 360 days (CFSAN) Goals are based on 360 days. FY 1997 baseline based on 180 days (statutory requirement).** FD&C Act Sec. 409 & Sec. 721 30 percent 24 percent (within 180 days)** 52
Review NADAs & ANADAs within 180 days. (CVM) FD&C Act Sec. 512(c)(1) None 75 percent 6
Decide Fast Track Requests within 60 days. (CDER and CBER) Section 112, FDAMA None N/A 1
Review export applications for drugs and biologics within 30 days. FD&C Act Sec. 801(e) & Sec. 802 None 100 percent 0
Complete processing of generally recognized as safe (GRAS) notifications within time frame of final rule. (CFSAN) FD&C Act Sec. 409 & Sec. 721 None N/A N/A
Review dietary ingredient notifications within 75 days. (CFSAN) Dietary Supplement Health and Education Act, Sec.8 None 100 percent 0
Review infant formula notifications within 90 days. (CFSAN) Infant Formula Act, Sec. 2 None 100 percent 0
Review health claim petitions within 100 days. (CFSAN) Nutrition Labeling and Education Act, Sec. 3 None 100 percent 0
Review nutrient content claim petitions within 100 days. (CFSAN) 21 USC 343(r) None 100 percent 0

These performance levels are based on funding in the proposed budget and therefore may change after the final budget is approved.

**For petitions received in FY 1996, using the previous petition review procedure, 24  percent of petitions received "first action" within 180 days. CFSAN re-engineered the petition review process in FY 1998 and redefined "first action." FY 1997 figures and FY 1999 and FY 2000 estimates are not directly comparable.

 

Other Applications and Submissions


CENTER(S)
NDA Labeling Supplement CDER, CBER
NDA Other Supplement CDER, CBER
ANDA Efficacy Supplement CDER, CBER
ANDA Manufacturing Supplement CDER, CBER
ANDA Labeling Supplement CDER, CBER
ANDA Other Supplement CDER, CBER
Product License Application (PLA)/Biologics License Application (BLA) CBER
PLA/BLA Labeling Supplement CBER
PLA/BLA Other Supplement CBER
Establishment Licensing Application (ELA) CBER
ELA Manufacturing Supplement CBER
ELA Other Supplement CBER
Investigational New Drug Application (IND) CDER, CBER
Investigational New Device Exemption (IDE) CDRH, CBER
NADA Manufacturing Supplement CVM
NADA Non-manufacturing Supplement CVM
NADA Other Supplement CVM
ANADA Supplements CVM
Investigational New Animal Drug Application (INADA) CVM
Abbreviated INADA CVM
Medicated Feed Application CVM
In Vivo Bioequivalence Waiver CVM
Color Certification CFSAN
Orphan Drug Designation CDER
Methadone Treatment Program Application CDER
Application for Variance Certificate for Products CDRH
Exemptions for Products Intended for U.S. Government Use CDRH
   
Small Business Notices CFSAN
   
Adverse Drug Experience Reports CDER
Export New Drug Application CDER
Initial Report for Listed Electronic Products CDRH
Report of Model Changes for Listed Electronic Products CDRH
Annual Reports for Listed Electronic Products CDRH
Certificates of Products for Export CDRH
Drug Experience Report CVM
Notification of Importation of INADA CVM
Notification of Exportation of INADA CVM
Low Acid and/or Acidified Canned Food Process Filing CFSAN
Infant Formula Exemptions CFSAN
Food Contact Substance Premarket Notification CFSAN
Nutrient Content Claim Based on Authoritative Statement by Scientific Body of the U.S. Government CFSAN
Health Claim Based on Authoritative Statement by Scientific Body of the U.S. Government CFSAN
GRAS Notifications CFSAN
Notification of Safety Assessment of Genetically Engineered Plants CFSAN
Structure / Function Claims (Dietary Supplements) CFSAN
   
Certificate of Free Sale CDER
Insulin Certification CDER
IND for Export CDER
ANDA Suitability Petition CBER
Lot Release Protocol CBER
Certificate of Exportability CBER
WHO Certificates CBER
Certificates to Foreign Governments CBER
Import-for-Export Requests CBER
IND for Export (312 Program) Requests CBER
Other Export Requests CBER
Export Approval Request CDRH
Plans for the Repair of Electronic Products CDRH
Temporary Marketing Permits CFSAN
Authorization to Use Edible Product from Animals Treatment with INADs CVM
Application for Export of Unapproved Animal Drugs CVM
   
Reclassification Petition CDRH
Reference Amount (Serving Size) Petitions CFSAN
Food Standard Petitions CFSAN
Investigational Food Additive Petition CVM
Investigational Food Additive Petition Supplements CVM
Abbreviated New Animal Drug Suitability Petition CVM
Food Additive Petition for Animal Food/Pet Food CVM
Food Additive Petition for Animal Food/Pet Food Supplements CVM
GRAS Petition Animal Feed/Pet Food CVM
GRAS Petition Animal Feed/Pet Food Supplements CVM
   
Drug Product Listings (OTC) CDER
Drug Registration Submissions CDER
Drug Product Listings (Prescription) CDER
   
Threshold of Regulation Exemption Request CFSAN
Request for Alternative Approach to Nutrition Labeling CFSAN

FDA Plan for Statutory Compliance