2024-12277. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP-26)

ACTION:

Notice of availability; request for comments.

SUMMARY:

The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

DATES:

The OMB will consider all written comments that the agency receives on or before July 5, 2024.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

Michelle Neary by telephone at 202-693-6312, or by email at [e-mail].

SUPPLEMENTARY INFORMATION:

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. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 26, 2024 (89 FR 21015).

Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See5 CFR 1320.5(a) and 1320.6.

DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Agency: DOL-OWCP.

Title of Collection: Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP-26).

OMB Control Number: 1240-0NEW.

Affected Public: Private Sector—Businesses or other for-profits.

Total Estimated Number of Respondents: 78.

Total Estimated Number of Responses: 490.

Total Estimated Annual Time Burden: 245 hours.

Total Estimated Annual Other Costs Burden: $0.

(Authority: 44 U.S.C. 3507(a)(1)(D))

Michelle Neary,

Senior Paperwork Reduction Act Analyst.