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
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0754 can be found here:
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)
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.
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.