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

ICR 201911-0910-007

OMB: 0910-0754

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0754 201911-0910-007
Active 201610-0910-007
HHS/FDA CDER
Dear Health Care Provider Letters; Improving Communication of Important Safety Information
Extension without change of a currently approved collection   No
Regular
Approved without change 12/31/2019
Retrieve Notice of Action (NOA) 12/06/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 01/31/2020
13 0 25
1,300 0 2,500
159,094 0 0

This information collection request supports agency regulations at 21 CFR part 200.5 and the associated agency guidance regarding "Dear Healthcare Provider" Letters. Respondents to the collection are manufacturers and distributors of drugs for which such a letter would be required as provided for in our regulations. The letters communicate important information about prescription drug and biological products (drugs).

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  84 FR 42929 08/19/2019
84 FR 64541 11/22/2019
Yes

1
IC Title Form No. Form Name
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 13 25 0 0 -12 0
Annual Time Burden (Hours) 1,300 2,500 0 0 -1,200 0
Annual Cost Burden (Dollars) 159,094 0 0 0 159,094 0
No
No
The information collection reflects an adjustment. We have reduced the number of respondents by 17, which results in a corresponding decrease to the annual burden hours by 1,200 and the annual number of disclosures by 12.

$35,000
No
    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.
12/06/2019


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