Information Collection

NDA Data Submission Agreement (DSA)

IC 228274 under ICR 202110-0925-002 · OMB 0925-0667.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 1 NDA Data Submission Agreement (DSA)	Form and Instruction
1 NDA Data Submission Agreement Attachment B_Revised clean copy of NDA Data Submission Agreement.docx	Form and Instruction
1 NDA Data Submission Agreement Attachment B_Revised clean copy of NDA Data Submission Agreement.docx	Form and Instruction

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:

table that charts list of 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	Attachment B_Revised clean copy of NDA Data Submission Agreement.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: 300

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	300	300
Annual IC Time Burden (Hours)	450	450
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.