U.S. Nuclear Medicine Technologists Study (NCI)

Forms and Documents

Document Name	Status
Form 1 U.S. Nuclear Medicine Technologists Nuclear Medicine Questionnaire Form and Instruction	New
Form 1C Fourth Survey FG Module (Attachment 1C) Form and Instruction	Removed
Form 1B Fourth Survey NM Module (Attachment 1B) Form and Instruction	Removed
Form 1A Fourth Survey CORE Module (Attachment 1A) Form and Instruction	Removed
Supplementary Document S2-USRT General Questionnaire-Work History Section.pdf Supplementary Document	2016-06-02
Supplementary Document S1-USRT Radioisotope Procedures Questionnaire.pdf Supplementary Document	2016-06-02
Attachment 8-Bibliography.docx Supplementary Document	2016-06-01
Attachment 7-Privacy Impact Assessment.pdf Supplementary Document	2016-06-01
Attachment 6-Privacy Act Memo.docx Supplementary Document	2016-06-01
Attachment 5B-UMN IRB approval.pdf Supplementary Document	2016-06-01
Attachment 5A-NCI IRB approval with stipulations.pdf Supplementary Document	2016-06-01
Attachment 4-Consent information sheet.docx Supplementary Document	2016-06-01
Attachment 3B-Follow-up Email.docx Supplementary Document	2016-06-01
Attachment 3A-Recruitment Email.docx Supplementary Document	2016-06-01
Attachment 2-Revisions and Additions to Previously-Approved Questions.docx Supplementary Document	2016-06-01
Revised Supporting Statement B_0925-0656_2016-11-14.docx Supporting Statement B	2016-11-21
Revised Supporting Statement A_0925-0656_2016-11-14.docx Supporting Statement A	2016-11-21

IC Document Collections

IC ID	Document Title	Status
221765	U.S. Nuclear Medicine Technologists Nuclear Medicine Questionnaire Form and Instruction	New
200491	Medical Validation (Attachment 3) Instruction	Removed
200490	Fourth Survey FG Module (Attachment 1C) Form and Instruction	Removed
200489	Fourth Survey NM Module (Attachment 1B) Form and Instruction	Removed
200488	Fourth Survey CORE Module (Attachment 1A) Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0656	ICR Reference No: 201605-0925-012
Status: Historical Active	Previous ICR Reference No: 201112-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: U.S. Nuclear Medicine Technologists Study (NCI)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/22/2016
	Date Received in OIRA: 06/07/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved	04/30/2015
Responses	250	0	37,053
Time Burden (Hours)	125	0	14,746
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for a Reinstatement with Change for approval for 3 years. The reinstatement is requested to administer a slightly revised version of a previously-approved and administered questionnaire to a sample of nuclear medicine technologists certified after 1980. The reason for the proposed collection is to assess the feasibility of conducting a large-scale study of radiation-related cancers and other diseases in nuclear medicine technologists.

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Authorizing Statute(s): US Code: 42 USC 411 Name of Law: Public Health Service 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:
	81 FR 17192	03/28/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 36553	06/07/2016
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
Fourth Survey CORE Module (Attachment 1A)	1A	CORE module
Fourth Survey NM Module (Attachment 1B)	1B	Nuclear Medicine Module
Fourth Survey FG Module (Attachment 1C)	1C	Fluoroscopically-guided (FG) Interventional Module
Medical Validation (Attachment 3)
U.S. Nuclear Medicine Technologists Nuclear Medicine Questionnaire	1	Nuclear Medicine Procedures Questionnaire

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ICR Summary of Burden

	Total Approved	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	250	37,053	0	-36,803	0	0
Annual Time Burden (Hours)	125	14,746	0	-14,621	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This submission requests a reinstatement with changes that will reinstatement the burden of this information collection. The proposed changes have resulted in a decrease in the estimated annual number of respondents from 37,053 general radiologic technologists in the USRT cohort (21,700 to the fourth survey general questionnaire, 7,000 to the radioisotope (nuclear medicine) procedures questionnaire, 6,300 to the fluoroscopically-guided procedures questionnaire, and 2,053 medical records clerks) to an estimated 250 annual respondents (to the revised nuclear medicine procedures questionnaire only) among a sample of 1,500 nuclear medicine technologists targeted.

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Annual Cost to Federal Government: $94,903

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 06/07/2016

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