Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

Forms and Documents

Document Name	Status
0409 In Vivo Radiopharms SSA 2021 EXT.docx Supporting Statement A	2021-04-13

IC Document Collections

IC ID	Document Title	Status
6072	In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring	Modified

ICR Details

OMB Control No: 0910-0409	ICR Reference No: 202103-0910-004
Status: Received in OIRA	Previous ICR Reference No: 201804-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/14/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2021
Responses	15	2
Time Burden (Hours)	18,750	4,000
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports agency regulations at 21 CFR 315.4, 315.5, and 315.6. The regulations require manufacturers of diagnostic radiopharmaceuticals to submit certain information demonstrating safety and effectiveness of these products.

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Authorizing Statute(s): PL: Pub.L. 105 - 115 122 Name of Law: FDA Modernization Act of 1997
   US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 71923	11/12/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 19622	04/14/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	15	2	0	0	13	0
Annual Time Burden (Hours)	18,750	4,000	0	0	14,750	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall increase of 14,750 hours and a corresponding increase of 13 responses, including submissions involving NDAs, which we mentioned in our last information collection and supplement to approved NDAs, which we are now mentioning in this information collection. We attribute this adjustment to an increase in the number of submissions for NDAs for diagnostic radiopharmaceuticals we received over the past few years and because we are now capturing supplements to approved NDA for diagnostic radiopharmaceuticals.

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Annual Cost to Federal Government: $5,500,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/14/2021

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