Product Jurisdiction and Combination Products

ICR 202010-0910-010

OMB: 0910-0523

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2020-10-27
Justification for No Material/Nonsubstantive Change
2020-10-27
Supporting Statement A
2019-11-07
IC Document Collections
IC ID
Document
Title
Status
6241
Modified
ICR Details
0910-0523 202010-0910-010
Historical Active 201910-0910-004
HHS/FDA OC
Product Jurisdiction and Combination Products
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 10/30/2020
Retrieve Notice of Action (NOA) 10/27/2020
  Inventory as of this Action Requested Previously Approved
12/31/2022 12/31/2022 12/31/2022
192 0 56
3,112 0 1,344
0 0 0

The ICR collects information from sponsors who wish to obtain a determination from the Agency classification and primary jurisdiction of a medical product. Sponsors submit information as provided in Agency regulations regarding combination products, including description of the product, proposed use or indications, description of all known modes of action, etc. The information submitted is reviewed so that a classification and jurisdiction determination can be made.

US Code: 21 USC 301 Name of Law: FFDCA
  
None

Not associated with rulemaking

  84 FR 34188 07/17/2019
84 FR 61064 11/12/2019
No

1
IC Title Form No. Form Name
Request for designation

  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 192 56 0 0 136 0
Annual Time Burden (Hours) 3,112 1,344 0 0 1,768 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
FDA is discontinuing the collection of information associated with control no. 0910-0845 and is proposing to consolidate it here with similar collection activity. This results in an adjustment of 136 additional responses and 1,768 additional hours annually.

$139,395
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
10/27/2020


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