[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48193-48194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12277]


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DEPARTMENT OF LABOR


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.

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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 [email protected].

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

[[Page 48194]]

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. See 5 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.
[FR Doc. 2024-12277 Filed 6-4-24; 8:45 am]
BILLING CODE 4510-CR-P