GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information

ICR 201610-0910-007

OMB: 0910-0754

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-10-24
ICR Details
0910-0754 201610-0910-007
Historical Active 201309-0910-005
HHS/FDA CDER
GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information
Extension without change of a currently approved collection   No
Regular
Approved without change 01/23/2017
Retrieve Notice of Action (NOA) 10/24/2016
  Inventory as of this Action Requested Previously Approved
01/31/2020 36 Months From Approved 01/31/2017
25 0 30
2,500 0 3,000
0 0 0

This information collection request supports agency guidance regarding "Dear Healthcare Provider" Letters. Respondents to the collection are manufacturers and distributors of drugs for which such a letter is required under 21 CFR part 200.5. The burden reflects the estimated time associated with the coordination and preparation of these letters with respondents so that they may be issued accordingly. The letters communicate new and important information about prescription drug and biological products (drugs).

None
None

Not associated with rulemaking

  81 FR 12734 03/10/2016
81 FR 72808 10/21/2016
No

1
IC Title Form No. Form Name
GFI: Dear Healthcare Provider Letter; Improving Communication of Important Safety Information

  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 25 30 0 0 -5 0
Annual Time Burden (Hours) 2,500 3,000 0 0 -500 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Fewer respondents to the collection has lowered the agency burden estimate. This is discussed at Q15 of the supporting statement.

$22,000
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
10/24/2016


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