NDA Data Submission Agreement (DSA)

NDAR Data Access Request

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0925-0667 can be found here:

Documents and Forms

Document Name Document Type
Form 1 NDA Data Submission Agreement (DSA) Form and Instruction
1 NDA Data Submission Agreement NDA Data Submission Agreement_0925-0667_August 2019_Clean (1).docx Form and Instruction

Information Collection (IC) Details

IC Title:	NDA Data Submission Agreement (DSA)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

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	1	NDA Data Submission Agreement	NDA Data Submission Agreement_0925-0667_August 2019_Clean (1).docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title: Records of Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public Health Service, HHS/PHS/NIH/OD	FR Citation: 67 FR 60742

Number of Respondents: 250	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	250	250
Annual IC Time Burden (Hours)	375	375
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.