Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD)

ICR 201706-0910-022

OMB: 0910-0845

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-07-25
IC Document Collections
IC ID
Document
Title
Status
227628 New
ICR Details
0910-0845 201706-0910-022
Historical Active
HHS/FDA OC
Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/25/2017
Retrieve Notice of Action (NOA) 07/26/2017
  Inventory as of this Action Requested Previously Approved
10/31/2020 36 Months From Approved
136 0 0
1,768 0 0
0 0 0

The ICR collects information from sponsors who wish to obtain a preliminary assessment (i.e., not legally binding) from the Agency regarding classification and primary jurisdiction of a medical product. Sponsors submit information as provided in Agency Pre-Request for Designation (Pre-RFD) Guidance 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 preliminary classification and jurisdiction assessment can be made.

None
None

Not associated with rulemaking

  82 FR 4351 01/13/2017
82 FR 32825 07/18/2017
No

1
IC Title Form No. Form Name
Pre-RFD Submissions/Meetings

  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 136 0 0 136 0 0
Annual Time Burden (Hours) 1,768 0 0 1,768 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
New collection

$330,915
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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.
07/26/2017


© 2021 OMB.report | Privacy Policy