10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Final 10CFR35 SS 110510.docx	Supporting Statement A	Uploaded 2010-11-15	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
42721	10 CFR 35, Medical Use of Byproduct Material		Modified

ICR Details

OMB Control No: 3150-0010	ICR Reference No: 201011-3150-006
Status: Historical Active	Previous ICR Reference No: 200902-3150-003
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 35, Medical Use of Byproduct Material
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/17/2011
	Date Received in OIRA: 11/19/2010
Terms of Clearance: In accordance with 5 CFR 1320, the collection is approved for 3 years.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2014	36 Months From Approved	02/28/2011
Responses	246,581	0	261,394
Time Burden (Hours)	1,173,785	0	1,025,958
Cost Burden (Dollars)	74,597	0	79,079

---

Abstract: 10 CFR Part 35 contains NRC's requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. 10 CFR Part 35 contains mandatory requirements that apply to NRC licensees authorized to adminster byproduct material or radiation there from to humans for medical use. The information in the required reports and records is used by the NRC to ensure that public health and safety is protected, and that the possession and use of byproduct material is in compliance with the license and regulatory requirements.

---

Authorizing Statute(s): PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 48996	08/12/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 69706	11/15/2010
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

IC Title	Form No.	Form Name
10 CFR 35, Medical Use of Byproduct Material

---

ICR Summary of Burden

table that charts list 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	246,581	261,394	0	0	-14,813	0
Annual Time Burden (Hours)	1,173,785	1,025,958	0	0	147,827	0
Annual Cost Burden (Dollars)	74,597	79,079	0	0	-4,482	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: Although the overall burden has increased by 147,827 hours from 1,025,958 (259,513 NRC Licensees + 766,445 Agreement States) to 1,173,785 hours (NRC Licensees 156,536 hrs + Agreement States 1,017,245 hrs), the number of responses decreased by 14,813 responses from 261,394 responses (55,629 NRC Licensees + 205,765 Agreement States) to 246,581 responses (32,880 NRC Licensees + 213,701 Agreement States). The burden calculations were affected by (1) a correction for medical event reporting based on the actual number of medical events reported per year, (2) an increase in the number of Agreement States, and (3) a shift in the distribution of medical uses by the remaining NRC licensees. Approximately 38 medical events are reported each year by both NRC and Agreement State licensees instead of the previously estimated 164. This correction resulted in a burden reduction of 995 hours (327 hours for NRC licensees and 668 hours for the Agreement State licensees). Three states (Pennsylvania, Virginia and New Jersey) entered into agreements with NRC since 2007. NRC now has fewer licensees then in 2007 and the Agreement States have more. This accounts for a marked decrease in burden for NRC licensees and a marked increased shift in burden to the Agreement States. NRC calculates the burden for Agreement State medical use licensees based on the ratio of NRC licensees to Agreement State licensees, ratio of remaining medical use licensees to NRC licensees, and distribution of the types of medical uses retained by NRC medical licensees. The result is an estimated decrease in the total number of NRC and Agreement State medical use licensees from 8,751 to 8,610 and a shift in the types of medical uses retained by NRC licensees to those medical uses with larger calculated record keeping burdens. For example, NRC lost approximately one third of its medical use licensees but approximately one half of its brachytherapy, gamma sterotactic radiosurgery and remote afterloader use licensees which because of lower patient loads have fewer record keeping burdens. At this time, NRC cannot determine whether the resulting calculations for the Agreement State licensee are less or more accurate.

---

Annual Cost to Federal Government: $77,100

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

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

---

Common Form ICR:  No

---

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: 11/19/2010

---