Section 361.1, which governs the use
of radioactive drugs for basic scientific research, sets forth
regulations regarding the establishment and composition of
radioactive drug research committees (RDRCs) and their role in
approving and monitoring basic research studies utilizing
radiopharmaceuticals. No basic research study involving any
administration fo a radioactive drug to research subjects is
permitted without the authorization of an FDA approved RDRC. The
types of research that may be undertaken with a radiopharmaceutical
drug are specified in the regulation and include studies of
metabolism, human physiology, pathophysiology, or
biochemistry.
US Code:
21
USC 361 Name of Law: Prescription Drugs for Human Use Generally
regognized as safe and effective and Not Misbranded
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.