Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
ICR 201311-0910-005
OMB: 0910-0672
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0672 can be found here:
Investigational New Drug
Safety Reporting Requirements for Human Drug and Biological
Products and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans
Extension without change of a currently approved collection
The information collection is intended
to improve the utility of investigational new drug safety reports,
expedite FDA's review of critical safety information, better
protect human subjects enrolled in clinical trials, and harmonize
safety reporting requirements internationally.
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.