GFI: Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling -Questions and Answers

ICR 201806-0910-008

OMB: 0910-0856

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0856 201806-0910-008
Active
HHS/FDA OC
GFI: Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling -Questions and Answers
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/14/2018
Retrieve Notice of Action (NOA) 06/14/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved
9,720 0 0
38,880 0 0
0 0 0

This information collection supports agency guidance. The guidance provides third-party disclosure recommendations firms should include in their drug and device labeling and prescription drug and restricted device advertising that contain information not found in the FDA-required labeling for their medical products but that are “consistent with the FDA-required labeling” (as that term is explained in the guidance) if they choose to publicly disseminate such materials.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 6575 01/19/2017
83 FR 27602 06/13/2018
No

1
IC Title Form No. Form Name
GFI: Medical Product Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers

  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 9,720 0 0 0 9,720 0
Annual Time Burden (Hours) 38,880 0 0 0 38,880 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$0
No
    No
    No
No
No
No
Uncollected
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.
06/14/2018


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