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JAMES G PONTO, MS, RPh, BCNPChief Nuclear Pharmacist, Dept. of Radiology,and Professor (Clinical), College of Pharmacy

Nuclear Medicine, Room 38University of Iowa Hospita200 Hawkins Dr.

lhagi4s “07 phone: 319356-2741319-384-6389

Iowa City, Iowa 522421077

Dockets Management Branch (HFA-3 05)

Food and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20857

RE: Docket No. OON-1682

Dear Sir or Madam,

I would like to take this opportunity to comment on “Agency Information Collection Activities;Proposed Collection; Comment Request; Radioactive Drug ResearchCommittee” pocket No.OON-16821 ublished in the Federal Register Jan. 5,2001, Vol66, No. 4, pp 1137-l 138.

I wish to focus my comments on one particular item: the reporting requirements on Form 2915as required by 361.1(c)(3). Specifically, item # 6.b. on Form 2915 states If this is a studysummary submitted within the annual report, provide the radiation dose commitment to the

whole body, the critical organ, and each organ specified in 21 CFR 361.1(b)(3)(i) received byeach subject.. . ..”

Comment # 1. The term “radiation dose commitment to the whole body” is not clear.

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Comment #3. I believe that the reporting of sex and age of each patient over 18 years isunnecessary. Note that Item 6.f. of the form requests he “number of researchsubjects studiedthis reporting year under 18 years of age.” For those subjects over 18 years, age is irrelevant forFDA review. Similarly, sex s irrelevant for FDA review. Therefore, I recommend thatreporting requirements for sex of each subject and for age of each subject over 18 years of age bedeleted.

Comment #4. For most RDRC protocols, each subject will be administered the same amount ofradioactivity and will receive the same nominal radiation absorbeddoses; i.e, each subject isequivalently a representative subject. In this situation, re-stating, in the annual report, theidentical numerical values for a representativesubject again for each ndividual subject iswasteful of resourcesand is of no additional value. Furthermore, for subjectswho are notrepresentative,absorbeddose values are of relevance only if the absorbeddose o the body or toa specified organ is greater than that estimated for a representativesubject. Therefore, Irecommend that absorbeddoses or individual subjects who are also representativesubjects orabsorbeddoses or individual subjects which are less than those estimated for a representativesubject be eliminated from the annual reporting requirements; i.e., listing absorbed doseswouldonly be required for individual subjectswho are not representativeof the intended researchsubject population and who receive an absorbeddose to the body or a specified organ thatexceeds hat estimated for a representativesubject.

Comment #5. I believe that the Estimated Annual Reporting Burden stated n Table 1 of theFederal Register notice for Form 1915 under-estimates he time required for completion of theform as currently exists. I estimate that the time expended o complete an annual summary onForm 2915 is approximately 10 hours (nearly 3 times longer than the 3.5 hours cited), largelydue to irrelevant, duplicative listing of absorbeddoses or each ndividual subject as describedabove. Elimination of this unnecessary eporting would reduce the time expended o completethe summary report back down to the original estimate of 3.5 hours.

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iv* of Nuclear Medicine, 3832 ppniversitY of Iowa Hospitals &Clinicswit city, IA 52242

THE UNIVERSITY OF IOWA

FIRST CLASS MAIL

Do&&s ManagementBranch (mAw305)Food and Drug Administration

5630 Fishers Lane, &II lo61Rockville, m 208s7