Administrative Practices and Procedures; Formal Hearings

ICR 202005-0910-003

OMB: 0910-0191

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-05-31
ICR Details
0910-0191 202005-0910-003
Active 201805-0910-009
HHS/FDA OC
Administrative Practices and Procedures; Formal Hearings
Revision of a currently approved collection   No
Regular
Approved without change 07/07/2020
Retrieve Notice of Action (NOA) 06/01/2020
  Inventory as of this Action Requested Previously Approved
07/31/2023 36 Months From Approved 08/31/2021
1,096 0 227
9,720 0 5,194
0 0 0

This information collection supports Food and Drug Administration (FDA, the agency, us or we) regulations found in 21 CFR Part 10, 21 CFR Parts 12 through 16, and 21 CFR Part 19 (21 CFR §§ 10, 12-16, and 19). These regulations are established in accordance with the Administrative Procedures Act and implement administrative practice and procedures to give instructions to those conducting business with FDA.

US Code: 21 USC 371 Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 1169 01/09/2020
85 FR 29459 05/15/2020
Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,096 227 0 0 869 0
Annual Time Burden (Hours) 9,720 5,194 0 0 4,526 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects an overall increase to the collection by 4,526 hours and 869 responses annually resulting from consolidating related elements.

$305,510
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
06/01/2020


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