10 CFR PART 35, AUTHORIZATION TO PREPARE RADIOPHARMACEUTICAL REAGENT KITS AND ELUTE RADIOPHARMACEUTICAL GENERATORS, USE OF RADIOPHARMACEUTICAL FOR THERAPY
ICR 199008-3150-001
OMB: 3150-0010
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 3150-0010 can be found here:
10 CFR PART 35, AUTHORIZATION
TO PREPARE RADIOPHARMACEUTICAL REAGENT KITS AND ELUTE
RADIOPHARMACEUTICAL GENERATORS, USE OF RADIOPHARMACEUTICAL FOR
THERAPY
THIS AMENDMENT TO 10 CFR 30 & 35
WOULD ALLOW NRC LICENSEES USING BYPRODUCT MATERIAL IN A
RADIOPHARMACEUTICAL FOR THEOPPEUTIC USE TO DEVIATE FROM THE PACKAGE
INSERT REGARDING INDICATIONS AND METHOD OF ADMINISTRATION IF
CERTAIN REQUIREMENTS ARE MET. RECORDS OF DEVIATIONS MUST BE
RETAINED FIVE YEARS FOR INSPECTION TO ASCERTAIN ANY POTENTIAL
HEALTH OR SAFETY PROBLEMS.
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.