21 CFR 315.4, 315.5, and 315.6 require
manufacturers of diagnostic radiopharmaceuticals to submit
information that demonstrates the safety and effectiveness of a new
diagnostic radiopharmaceutical or of a new indication for use of an
approved diagnostic radiopharmaceutical.
US Code:
21
USC 355 Name of Law: FD&C Act
PL:
Pub.L. 105 - 115 122 Name of Law: FDA Modernization Act of
1997
US Code: 42
USC 262 Name of Law: Public Health Service Act
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.