Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information

ICR 201309-0910-005

OMB: 0910-0754

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-12-04
IC Document Collections
ICR Details
0910-0754 201309-0910-005
Historical Active
HHS/FDA 20501
Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 12/13/2013
Retrieve Notice of Action (NOA) 09/13/2013
  Inventory as of this Action Requested Previously Approved
12/31/2016 36 Months From Approved
30 0 0
3,000 0 0
0 0 0

This information collection request estimates the third-party disclosure burden for preparing letters of important new information about prescription drug and biological products (drugs). These letters communicate new information promptly to health care practitioners involved in prescribing or dispensing a drug, or in caring for patients who receive a drug.

None
None

Not associated with rulemaking

  75 FR 69449 11/12/2010
78 FR 41064 07/09/2013
Yes

1
IC Title Form No. Form Name
Mailing of Important Information About Drugs - 21 CFR 200.5

  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 30 0 0 30 0 0
Annual Time Burden (Hours) 3,000 0 0 3,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new collection of information.

$19,488
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@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.
09/13/2013


© 2024 OMB.report | Privacy Policy