Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions
This is one in a series of guidance documents intended to assist sponsors making regulatory submissions to the Office of Orphan Products Development (OPD) in electronic format using the FDA Electronic Submissions Gateway (ESG) pathway or directly to OPD on physical media (e.g., CD-ROMs). This guidance discusses issues related to the electronic submission of requests for orphan-drug designation, humanitarian use device designation (HUD), and related submissions.
The goals of this guidance are to enhance the receipt, processing, review, and archiving of electronic submissions to OPD.
In October 2003, the Food and Drug Administration (FDA) issued the draft guidance for industry Providing Regulatory Submissions in Electronic Format — General Considerations. The General Considerations Guidance discusses issues common to all types of electronic regulatory submissions, such as acceptable file formats, physical media and submission procedures. As set forth under Part 11, Title 21, Code of Federal Regulations, for records submitted to the FDA, sponsors may elect to use electronic records in lieu of paper records, in whole or part, provided the requirements of Part 11 are met and the documents or parts of documents to be submitted have been identified by the FDA in public docket No. 92S-0251 as being the type of submission it is prepared to accept in electronic format.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.