0053 RDRCs SSA 2020 EXT

0053 RDRCs SSA 2020 EXT.pdf

Radioactive Drug Research Committees

OMB: 0910-0053

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UNITED STATES FOOD AND DRUG ADMINISTRATION
Radioactive Drug Research Committees
OMB Control No. 0910-0053 – Extension
SUPPORTING STATEMENT:
Part A – Justification
1. Circumstances Making the Collection of Information Necessary
Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (FFDCA; 21
U.S.C. 321, 355, and 371), the Food and Drug Administration (FDA, the agency, us or we)
has authority to issue regulations governing the use of radioactive drugs for basic scientific
research. Accordingly we have issued regulations at 21 CFR 361.1. Section 361.1 (21 CFR
361.1) sets forth specific provisions governing the establishment and composition of
Radioactive Drug Research Committees (RDRCs) and their role in approving and
monitoring basic research studies using radiopharmaceuticals. No basic research study
involving any administration of a radioactive drug to research subjects is permitted without
the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that
may be undertaken with a radiopharmaceutical drug must be intended to obtain basic
information and not to carry out a clinical trial for safety or efficacy. The types of basic
research permitted are specified in the regulations and include studies of metabolism, human
physiology, pathophysiology, or biochemistry. This information collection supports
implementation of statutory and regulatory requirements applicable to RDRCs and
associated research.
To assist respondents with the applicable reporting requirements we developed Form FDA
2914 entitled, “REPORT ON RESEARCH USE OF RADIOACTIVE DRUGS: Membership
Summary,” and available at
www.fda.downloads/AboutFDA/Reports/ManualsForms/Forms/UCM094979.pdf; and Form FDA
2915, entitled, “REPORT ON RESEARCH USE OF RADIOACTIVE DRUGS: Study
Summary,” and available at
www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
Respondents to the information collection are also subject to the human subject protection
provisions of both the FFDCA and the Public Health Service Act, with implementing
regulations at 21 CFR parts 50 and 56 (information collection for 21 CFR parts 50 and 56 is
currently approved under OMB control no. 0910-0130). Under § 361.1(d)(5), each
investigator shall obtain the proper consent as required by all human subject protection
regulations. Also, under § 361.1(d)(8), an investigator shall immediately report to the
RDRC all adverse effects associated with use of the drug, and the committee shall then
report to FDA all adverse reactions probably attributed to the use of the radioactive drug.
Finally, the provisions set forth labeling requirements for radioactive drugs. Because the
labeling information is supplied by the Federal government to the recipient for the purposes
of disclosure to the public as defined under 5 CFR 1320.3(c)(2), we estimate no attendant
burden for such labeling.

Types of research studies not permitted under the regulations are also specified and include
those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the
safety or effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical
trial for safety or efficacy). These studies require filing of an investigational new drug
application under 21 CFR part 312 (information collection for INDs is approved under OMB
control no. 0910-0014).
We therefore request extension of OMB approval for the information collection associated
with RDRCs, along with Forms FDA 2914 and 2915, as discussed in this supporting
statement.
2. Purpose and Use of the Information Collection
We use the information collection to ensure compliance with applicable statutes and
regulations. The RDRC is responsible for the review of basic science research protocols
using radioactive drugs in humans that are subject to § 361.1. RDRC approval of a research
study is based on assurance that the following requirements of §§ 361.1(d)(1)-(9) are met:
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appropriate limit on the radiation dose
appropriate limit on the pharmacologic dose
qualified study investigators
medical facility properly licensed to possess and handle radioactive materials
appropriate selection and consent of research subjects
appropriate quality of radioactive drug administered
sound research protocol design
reporting of adverse events by the investigator to the RDRC
approval by an appropriate Institutional Review Board (IRB)

In addition we use the information to ensure adherence to applicable administrative
functions of the RDRC, as required under § 361.1.
3. Use of Improved Information Technology and Burden Reduction
We encourage the electronic submission of Forms FDA 2914 and 2915 when feasible, as
well as the other reporting submissions in these regulations. We have issued guidance
documents on regulatory submissions to FDA in electronic format:
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information. The Nuclear Regulatory Commission (NRC)
and some state and Federal Agencies, such as the Department of the Army, also regulate the
possession and use of radioactive materials and other radiation sources (x-ray) necessary to
conduct some of these RDRC studies. However, their responsibility is primarily related to

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occupational radiation safety and not the human use of the radiolabeled drug, and is
therefore not duplicative.
5. Impact on Small Businesses or Other Small Entities
Collection of this information does not involve small businesses. Most committees are
affiliated with large institutions. However, FDA and the Center for Drug Evaluation and
Research (CDER) provide general assistance to the research community.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements.
Composition of committee membership is reported to FDA on Form FDA 2914
(Membership Summary) yearly along with the annual report. Changes in membership may
occur at any time during the year and must be reported (also on Form FDA 2914) as soon as
or before vacancies occur on the Committee. Less frequent reporting could allow
unqualified members to serve on RDRCs for extended periods of time thereby placing the
safety of human research subjects at risk as these RDRCs continue to evaluate and approve
research protocols. Approved study protocols are reported to FDA on Form FDA 2915
(Study Summary) in the annual report. Less frequent reporting could result in safety risks to
human subjects due to a delay in the detection of studies that are inappropriate under 21
CFR 361.1.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
This information collection is consistent with the requirements of 5 CFR 1320.5.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in
the Federal Register of January 21, 2020 (85 FR 3390). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No remuneration is provided to respondents.
10. Assurance of Respondent Privacy and Confidentiality
In preparing this supporting statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected. We have determined that although PII is
collected, the Privacy Act of 1974 does not apply. The PII collected includes the names of
the chairperson(s) of each individual radioactive drug research committees (RDRCs),
investigators, and participants in the studies. PII is submitted via Forms FDA 2914 and
2915, however we do not use this data or any other personal identifier to routinely retrieve

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records from the information collected. We also have minimized the PII to be collected to
protect the privacy of the individuals.
The contents of submitted Forms FDA 2914 and 2915 are available for public disclosure
unless confidentiality is requested by the investigator and it is evident from the report(s) that
the material contains trade secret or confidential commercial information as defined in 21
CFR 20.61. When confidentiality is requested and justified, the forms will be marked as not
releasable and will be maintained in a manner similar to other confidential information.
Data is secured, with limited access to authorized FDA personnel only.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate:
21 CFR Section and Applicable
Form 

Table 1.--Estimated Annual Reporting Burden
No. of
No. of
Total
Responses per
Annual
Respondents
Respondent
Responses

§ 361.1(c)(3) reports and (c)(4)
approval (Form FDA 2914:
Membership Summary)

62

1

62

§ 361.1(c)(3) reports (Form
FDA 2915: Study Summary)

40

10

434

§ 361.1(d)(8) adverse events

10

1

10

Total

Average
Burden per
Response
1

3.5 hrs.

62

1,519

.5
(30 mins)

506

21 CFR Section 

Total
Hours

5
1,586

Table 2.--Estimated Annual Recordkeeping Burden
No. of
No. of Record
Total
Average
Recordkeepers
per
Annual
Burden per
Recordkeepers
Records
Recordkeeping

Total Hours

§ 361.1(c)(2) RDRC

62

4

248

10

2,480

§ 361.1(d)(5) human
research subjects

40

10

434

.75
(45 mins)

326

Total

682

2,806

12b. Annualized Cost Burden Estimate:
Using an average salary of $75 per hour (clerical and professional salaries combined), the
total estimated cost to the respondents is $329,400 ((1,586 hours + 2,806 hours) x $75).

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13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital expenditures or start-up, operating, or maintenance costs associated
with this information collection.
14. Annualized Cost to the Federal Government
The estimate of the cost to the Federal Government is $117,230 per year.
This figure is based on past experience, a current re-evaluation, and the cost of the following activities:
(1)
(2)
(3)
(4)

Preparing letters to RDRCs;
Printing Forms FDA 2914 and 2915;
Clerical time for processing and mailing documents at $30 per hour; and
Administrative and professional review time at $75 per hour.
Estimated Cost to the Federal Government

Item

Printing Clerical Time (hours)

Clerical Cost

Prof. Time (hours)

Prof. Cost

Total Cost

Letter

$0

20

$600

320

$ 24,000

$ 24,600

2914
2915

$30
$150

--

--

250
800

$ 18,750
$ 60,000

$ 18,780
$ 60,150

Total

$180

20 hrs

$600

1370 hrs

$102,750

$103,530

15. Explanation for Program Changes or Adjustments
We have adjusted our estimate to reflect a decrease of 525 hours and 147 responses to
correspond with a decrease in submissions that we have observed since last review of the
information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no publications or other schedules.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification statement.

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