10 CFR 26, Fitness for Duty Programs

Forms and Documents

Document Name	Status
Form NRC Form 890 10 CFR 26, Fitness for Duty Program Form and Instruction	Modified
Draft Regulatory Guide 5-89, Urine Specimen Collection and Test Results.pdf Supplementary Document	2019-09-16
Supporting statement for Part 26 Fitness for Duty Drug Testing Requirements Proposed Rule.docx Supporting Statement A	2019-08-20
Regulatory Analysis for Fitness for Duty Drug Testing Requirements Proposed Rule.pdf Supplementary Document	2019-08-20

IC Document Collections

IC ID	Document Title	Status
33422	10 CFR 26, Fitness for Duty Program Form and Instruction	Modified

ICR Details

OMB Control No: 3150-0146	ICR Reference No: 201908-3150-004
Status: Historical Inactive	Previous ICR Reference No: 201709-3150-004
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 26, Fitness for Duty Programs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 10/31/2019
	Date Received in OIRA: 09/16/2019
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is withholding approval at this time. Prior to publication of the final rule, the agency must submit to OMB a summary of all comments related to the information collection contained in the proposed rule and the agency response. The agency should clearly indicate any changes made to the information collection as a result of these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved	04/30/2021
Responses	441,843	0	441,843
Time Burden (Hours)	719,196	0	719,196
Cost Burden (Dollars)	75,581	0	75,581

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Abstract: FITNESS FOR DUTY DRUG TESTING REQUIREMENTS PROPOSED RULE - 10 CFR part 26 contains the NRC’s requirements for licensee and other entity FFD programs, which focus on preventing and detecting the impairment of personnel from the misuse of legal drugs and alcohol, use of illegal drugs, fatigue, and any other causes such as mental or psychological distress. The NRC is seeking to update the drug testing panel and to lower the testing cutoff levels for some drugs tested, which would impact the information collections contained in 10 CFR part 26, because additional individuals would likely test positive for drugs. The expected additional positive test results would increase the recordkeeping and reporting burdens on licensees and other entities. The NRC is proposing to include new information collection requirements in §§ 26.107(d), 26.157(a), 26.165(b)(2) and (b)(3), 26.165(f)(1) and 26.185(f)(3). This information is needed to uniformly address subversion attempts identified at the collection site (§ 26.107(d)), clarify that HHS-certified laboratories are to maintain testing procedures specific to 10 CFR part 26 (§ 26.157(a)), permit the MRO to initiate retesting of a donor specimen upon receiving an oral request from the donor and maintaining a record of receiving that request (§ 26.165(b)(2) and (b)(3)), document the existing process that the MRO is to report a cancelled test result to the licensee or other entity if the results of specimen retesting fail to confirm the test results from the initial laboratory (§ 26.165(f)(1)), and establish procedures to review invalid specimen test results due to high pH values (§ 26.165(f)(3)).

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Authorizing Statute(s): PL: Pub.L. 83 - 703 68 STAT 919 Name of Law: Atomic Energy Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3150-AI67	Proposed rulemaking	84 FR 48750	09/16/2019

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Federal Register Notices & Comments

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
10 CFR 26, Fitness for Duty Program	NRC Form 890, NRC Form 891, NRC Form 892	Single Positive Test Form ,   Annual Reporting Form for Drug and Alcohol Tests ,   Annual Fatigue Reporting Form

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The estimated burden of the information collections contained in the proposed rule is 1,382 hours. This estimate is comprised of one-time and annual requirements of the proposed rule. As a result of the changes associated with the proposed rule, the total estimated annual burden for all information collections in 10 CFR Part 26 would increase by 1,382 hours from 719,196 hours to 720,578 hours and from 441,843 responses to 449,656 responses (an increase of 7,813 responses). The factors that account for the increased burden include the following: The proposed rule requires licensees and other entities to: (1) update FFD program policies and procedures; (2) inform existing employees on the FFD program testing policy changes; (3) revise contracts with HHS-certified laboratories and BPTS suppliers; and (4) document additional positive test results and subversion attempts, as well as the actions taken in response to these testing events. The proposed rule also contains new provisions that include recordkeeping and reporting burdens that were not part of previous estimates.

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Annual Cost to Federal Government: $496,080

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? 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: 09/16/2019

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