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View ICR - OIRA Conclusion

OMB Control No: 1240-0062	ICR Reference No: 202405-1240-007
Status: Active	Previous ICR Reference No:
Agency/Subagency: DOL/OWCP	Agency Tracking No:
Title: Authorization Request Form and Certification /Letter of Medical Necessity for Compounded Drugs (OWCP-26)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/08/2024
	Date Received in OIRA: 06/05/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved
Responses	490	0	0
Time Burden (Hours)	245	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	490	490
Annual Time Burden (Hours)	245	245
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: OWCP will require the claimant’s treating physician to complete a Form OWCP-26 online before payment will be made for a compounded drug. The physician will be required to specify the ingredients in the compounded drug, indicate whether the compounded drug and each of its ingredients are medically necessary, and explain why the claimant cannot use an FDA-approved drug instead of the compounded drug being prescribed. The form will permit the OWCP to more easily track the volume, type, and characteristics of compounded drugs prescribed for claimants. It will allow additional oversight of the pharmacy benefit—improving patient safety, decreasing cost for stakeholders, and decreasing the risk for fraud, waste, and abuse. Completed forms will be reviewed by a clinical pharmacist or physician before being reviewed for decision by the individual program staff.

Annual Cost to Federal Government: $28,783

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. Yes

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

Agency Contact: Anjanette Suggs 202 354-9660 suggs.anjanette@dol.gov

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