0409 In Vivo Pharmaceutical Regs SSA 2018 Ext

U.S. Food and Drug Administration
Regulations for In Vivo Radiopharmaceuticals
Used for Diagnosis
OMB Control No. 0910-0409
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations regarding diagnostic radiopharmaceuticals intended for in vivo administration for
diagnostic and monitoring use. Under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act, or the act), as amended, FDA is responsible for ensuring the safety and efficacy of drug
products including radiopharmaceuticals. Applicable regulations have been promulgated and
codified under 21 CFR Part 315 setting forth criteria used to evaluate the safety and
effectiveness of diagnostic radiopharmaceuticals. The regulations supplement other CFR
provisions regarding information that must be submitted to FDA for the evaluation and
approval of drug and biological product applications. When these products are intended for use
as described under 21 CFR Part 315, additional information is needed. While information
submitted as part of a new drug application (NDA) or biologics license application (BLA), or
as a supplement to an approved application, typically includes nonclinical and clinical data on
the pharmacology, toxicology, adverse events, radiation safety assessments, chemistry, and
manufacturing controls; Part 315 discusses additional factors relevant to safety and the
evaluation of effectiveness unique to these products.
We therefore request extension of OMB approval for the information collection requirements
found under 21 CFR Part 315: Diagnostic Radiopharmaceuticals.
2. Purpose and Use of the Information Collection
The information collection is used by FDA to evaluate the safety and efficacy of
radiopharmaceuticals intended for a specific use. Respondents to the information collection are
applicants or sponsors of these products who must demonstrate compliance with the applicable
regulations. In addition, establishment and enforcement of the underlying regulatory
provisions serves to implement FDA’s public health protection responsibilities under the act.
3. Use of Improved Information Technology and Burden Reduction
The regulation does not specifically prescribe the use of automated, electronic, mechanical or
other technological techniques or other forms of information technology to fulfill the
information collection requirements. Respondents may utilize information technology as
desired and we estimate nearly all (95%) will use electronic means to fulfill the information
collection.

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Other information collections have been
established to support regulatory requirements associated with new drug or biologic
applications (e.g., OMB Control Nos. 0910-0001 and 0910-0338). However, this information
collection covers only those requirements described in 21 CFR Part 315 regarding
radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring use.
5. Impact on Small Businesses or Other Small Entities
We believe the information collection poses no undue burden on small entities. At the same
time, we assist small businesses in complying with our requirements through our Regional
Small Business Representatives and through the scientific and administrative staffs within the
agency. We also provide a Small Business Guide on our website at:
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory requirements and applicable
regulations.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
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 in the Federal Register of
November 2, 2017 (82 FR 50885) inviting public comment on the information collection.
None were received.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of the information received by FDA is consistent with the Freedom of
Information Act and regulations under 21 CFR Part 20. Manufacturers seeking to market a
diagnostic radiopharmaceutical or a new indication for use for an approved diagnostic
radiopharmaceutical may be required to reveal proprietary information or trade secrets to gain
FDA approval of the product or new indication. However, such information is deleted from the
application before it is released under the Freedom of Information Act and FDA regulations.

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11. Justification for Sensitive Questions
This information collection does not involve questions that are of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
We estimate the burden of this collection of information as follows:
12 a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section
Part 915
Diagnostic
Radiopharmaceuticals
315.4, 315.5, and 315.6

No. of
No. of
Responses per
Respondents
Respondent

2

1

Total
Annual
Responses

Avg.
Burden per
Response

Total
Hours

2

2,000

4,000

1

 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 1 contains estimates of the annual reporting burden for preparation of the safety
and effectiveness information covered by the applicable regulations. This estimate does not
include time needed to conduct studies and clinical trials or other research from which the
reported information is obtained. Based on past submissions (human drug applications and/or
new indication supplements for diagnostic radiopharmaceuticals), we estimate two submissions
will be received annually. We assume the time needed to prepare a complete application for a
diagnostic radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth of which,
or 2,000 hours, is estimated to be spent preparing the portions of the application that would be
affected by these regulations. The regulations do not impose any additional reporting burden
for safety and effectiveness information on diagnostic radiopharmaceuticals beyond the
estimated burden of 2,000 hours because safety and effectiveness information is already
required by § 314.50 (collection of information approved under OMB control number 09100001). In fact, clarification in these regulations of FDA’s criteria for evaluation of diagnostic
radiopharmaceuticals is intended to streamline overall information collection burdens,
particularly for diagnostic radiopharmaceuticals that may have well-established, low-risk safety
profiles, by enabling manufacturers to tailor information submissions and avoid unnecessary
clinical studies.
12 b. Annualized Cost Burden Estimate
Using the total annual reporting burden of 4,000 hours, and assuming a fully-loaded
wage rate of $85.00/hour for compiling the information, we calculate a respondent cost of
$340,000.

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13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
FDA allocates 22 FTEs to the review of NDAs and supplements received under §§ 315.4,
315.5, and 315.6. Based on an average FTE cost of $250,000, the total cost to the Federal
government is $5,500,000.
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden estimate for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no plans to tabulate and publish information from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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