Information Collection

Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

IC 190521 under ICR 200908-0910-006 · OMB 0910-0838.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

IC Title:

Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

Agency IC Tracking Number:

Is this a Common Form?

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 600.80(g)(2)

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

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 5

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Requested	Program Change Due to New Statute
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	5	5
Annual IC Cost Burden (Dollars)	340	340

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.