Expanded Access Records - Initial

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0925-0586 can be found here:

Documents and Forms

Document Name Document Type
Form 5 Expanded Access Records - Initial Form and Instruction
5 Expanded Access Record Data Element Definitions (referen Attachment 3 - Expanded Access Record Data Element Definitions (Reference Document) and Data Entry Forms (Screenshots).pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Expanded Access Records - Initial	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	5	Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))	Attachment 3 - Expanded Access Record Data Element Definitions (Reference Document) and Data Entry Forms (Screenshots).pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 213	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	213	213
Annual IC Time Burden (Hours)	426	426
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.