# Presentation: 835998

## eCTD: Module 1from submission to reviewer

- Bronwyn Collier, B.S.N.
- Associate Director for Regulatory Affairs
- Center for Drug Evaluation and Research
- FDA

## Topics

- How information in Module 1 is used for
- Processing
- Assignment for review
- Application management
- eCTD TOC mapping to regulations/legislation
- Application of eCTD TOC headings/subheadings to Module 1 documents

## Module 1: Regional Documents

- Application status
- Sponsor information
- Entry to special regulatory programs
- Satisfies some regulatory requirements
- Guides response
- Document processing
- Facilitate review assignment

## From receipt to reviewer...

- Where to send your submission
- Providing identifying information for processing

## Document Processing

- Receive submission
- Date stamp
- Check for readability, application form, cover letter
- Data entry into tracking systems
- Review by RPM
- Data entry if corrections/additions needed
- Load into Electronic Document Room (EDR)
- Assignment to review team and any consultants

## Application/Submission Identity

*Module 1 is the only place where application administrative/identification information is provided in “machine readable” form*

## Where to send your eCTD

**FDA Electronic Submissions Gateway (ESG)**

**CBER Document Room**
**HFM-99, Suite 200N**
**1401 Rockville Pike**
**Rockville, MD 20862-1448**

**Office of Generic Drugs Document Room**
**HFD-600**
**Metro Park North II**
**7500 Standish Place**
**Rockville, MD  20855**

**CDER Central Document Room**
**Food and Drug Administration**
**Center for Drug Evaluation and Research**
**5901-B Ammendale Road**
**Beltsville, Maryland 20705-1266**

## US Mail & Courier Delivery

- Address to Central Document Room

## US Mail & Courier Delivery

- Resist the urge to send archive documents directly to the project manager or White Oak document room!

## Forms and Cover Letters

*Forms and cover letters should be considered “new” documents submitted to an application*

## Forms and Cover Letters

- Forms
- Fill out completely
- _[http://](http://www.fda.gov/opacom/morechoices/fdaforms/default.html)__[www.fda.gov/opacom/morechoices/fdaforms/default.html](http://www.fda.gov/opacom/morechoices/fdaforms/default.html)_
- Cover Letters
- Identification of application number
- Bold identification of submission content
- Brief description of submission content
- Any request for input on specific questions or issues
- Implementation date (e.g., new protocols, protocol changes, manufacturing changes)

## Cover letter: content identification

## Cover letter: content identification

## Submission & Receipt Dates

- Submission date
- Date on the form or cover letter, whichever is the latest
- Receipt date
- Physical media- date received in Document Room
- Gateway
- Official receipt time 8:00-4:30 EST
- Submissions received outside of official hours- next business day

## TOC Mapping

| CFR Citation |  | eCTD/STF Heading |  |  |
| --- | --- | --- | --- | --- |
| NUMBER | TITLE | MODULE | NUMBER | TITLE |
| 312.7(d) | Charging for and commercialization of investigational drugs | 1 | 1.12.2 | Request to Charge |
| 312.10 | Waivers | 1 | 1.12.5 | Request for a waiver |
| 312.23 (a)(1) | Cover sheet (Form FDA 1571) | 1 | 1.1.1 | Application form: FDA form 1571 |
| 312.23(a)(2) | Table of Contents | N/A | N/A | N/A |
| 314.50(h) | Patent Information | 1 | 1.3.5.1 | Patent Information |

## Module 1 Headings and Subheadings: What’s between the lines...

## Forms

- 1.1 Forms– not all forms are included in this section
- 3542 and 3542A (Patent certifications)
- 1572 (Investigator information)

## Requests & Supporting Documents

- 1.6.2 Meeting background materials
- A protocol may belong in Module 4 or 5
- 1.8 Special Protocol Assessment request
- Request- Module 1
- Protocol- Module 3, 4, or 5
- 1.10 Dispute Resolution
- Request- Module 1
- Supporting information may be in other modules

## Miscellaneous Information & Annual Reports

- 1.11 Information amendment- *use *_*only*_* for information that doesn’t fit into Modules 2-5*
- 1.13 Annual report
- Most parts will fit in Module 1
- A study report or a protocol amendment may belong in Module 4 or 5

## Labeling

- Targeted Product Profile (TPP)
- 1.14.4.1 Investigator’s Brochure
- SPL
- Must be placed in the SPL folder
- Link to the appropriate subheading in the TOC
- 1.14.1.3 Draft labeling text
- 1.14.2.3 Final labeling text

## What if there’s no available heading?

- Special Programs
- Accelerated Approval
- Priority Review cover
- Subpart E
- General Investigational Plan (outside of an Annual Report)

*Make use of the Cover Letter*

## Contact Information

- Gateway
- _[esgprep@fda.gov](mailto:esgprep@fda.gov)_
- eCTD
- _[esub@cder.fda.gov](mailto:esub@cder.fda.gov)_
- Regulatory questions
- _[Bronwyn.collier@fda.hhs.gov](mailto:Bronwyn.collier@fda.hhs.gov)_