2.10: Biologics License Application (BLA)

Field 21: Submission Type

• Original: An application for which FDA has never issued an approval letter.
• Labeling Supplement: A supplemental application for labeling changes to an approved product as described under 21 CFR 314.70 and 21 CFR 601.12 that does not otherwise qualify as another type of supplement (e.g., Efficacy, CMC, REMS).
• CMC Supplement: A supplemental application for chemistry, manufacturing, and control (CMC) changes to an approved product as described under 21 CFR 314.70, 21 CFR 314.71, 21 CFR 314.72, and 21 CFR 601.12, including CMC supplements with corresponding labeling changes.
• Efficacy Supplement: A supplemental application for changes to an approved product from among the following changes: new or modified indication; new or revised dose or dosing regimen; new route of administration; comparative efficacy claim naming another product; significant alteration in the patient population; switch of marketing status from prescription to over-the-counter use; traditional approval of a product originally approved under Subpart H (Accelerated Approval) or Subpart I (Animal Rule); labeling or manufacturing change requiring clinical data for approval.
• Annual Report: See 21 CFR 314.81(b)(2) for NDAs and 21 CFR 601.12(d) for BLAs.
• Product Correspondence: Any communication or general correspondence related to an application (e.g., routine administrative changes, donor re-entry requests, lot distribution reports, license reissuance requests, meeting requests) that is not an amendment to a pending application. Provide a description of the content or intent of the Product Correspondence in Field 27 (Reasons for the Submission).
• REMS Assessment Methodologies and Study Protocols: A submission containing information on methodological approaches and study protocols use to assess a REMS program.
• REMS Assessment Report: A submission containing information and data to support if the goal of each strategy is being met; modifications to the REMS or revisions to the REMS assessment plan are needed, including the timing of the REMS assessments; and whether the REMS is still necessary to ensure the benefits outweigh the risks of the drug.
• REMS Supplement: A supplemental application proposing a new Risk Evaluation and Mitigation strategy (REMS) or modifications (major and/or minor) to an approved REMS.
• Post Marketing Requirements or Commitments: A submission containing information related to post marketing requirements or commitments (e.g., nonclinical protocol, final study report).
• Periodic Safety Report: Periodic reports (Periodic Adverse Drug Experience Reports (PADERs)) of adverse drug or biological product experience as described under 21 CFR 314.80(c)(2), 21 CFR 314.98, and 21 CFR 600.80(c)(2), including those in Periodic Safety Update Report (PSUR) format.
• Request for Proprietary Name Review: A submission containing a request for proprietary name review.
• Human Factors (Specify Type): Select check box and specify what type of HF information is being submitted in “Specify Type” (e.g. HF Protocol, HF Study Report, Use-Related Risk Analysis, Justification for no HF Validation Study, Comparative Analysis, etc.).
• Other (specify): State the submission type if it is not one of the previous submission types listed above (e.g., formal dispute resolution request, REMS revisions). If this box is checked, provide the Reasons for the Submission in Field 27.

Field 30 (application contents)

This section contains items 1 through 20 which is a checklist that should be used to indicate the types of information contained within a particular application or submission.

1. Index
2. Labelling
3. Summary
4. Chemistry Section
   1. Chemistry, manufacturing, and controls information
   2. Samples
   3. Methods validation package
5. Nonclinical pharmacology and toxicology section
6. Human pharmacokinetics and bioavailability section
7. Clinical microbiology section
8. Clinical data section
9. Safety update report
10. Statistical section
11. Case report tabulations
12. Case report forms
13. Patent information
14. A patent certification
15. Establishment description
16. Debarment certification
17. Field copy certification
18. User Fee Cover Sheet
19. Financial Disclosure information
20. Other

A complete index or table of contents should immediately follow the Form FDA 356h and, if applicable, a User Fee Cover Sheet (Forms FDA 3397, 3792, or 3794). Note that the CFR references are provided for most items in order to indicate what type of information should or must be submitted in each section. For further information, the applicant may consult the guidance documents that are available from the Agency. Please note, selecting Field 30, item 15 indicates the complete Biological Products establishment description is included at Field 28.