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Gatekeeper Reviews
Testing Communications on Biological Products
OMB: 0910-0687
IC ID: 211697
OMB.report
HHS/FDA
OMB 0910-0687
ICR 201405-0910-019
IC 211697
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0687 can be found here:
2014-12-04 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Gatekeeper Reviews
Agency IC Tracking Number:
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 393(d)(2)(D) (To search for a specific CFR, visit the
Code of Federal Regulations.
)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
400
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
400
0
400
0
0
0
Annual IC Time Burden (Hours)
200
0
200
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
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.