Proposed of Information Collection; Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP-26), 21015-21016 [2024-06359]

Agencies

• DEPARTMENT OF LABOR
• Office of the Worker's Compensation Programs

[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 21015-21016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06359]


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DEPARTMENT OF LABOR

Office of the Worker's Compensation Programs

[OMB Control No. 1240-0NEW]


Proposed of Information Collection; Authorization Request Form 
and Certification/Letter of Medical Necessity for Compounded Drugs 
(OWCP-26)

AGENCY: Office of Workers' Compensation (OWCP), Labor.

ACTION: Request for public comments.

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SUMMARY: The Department of Labor, as part of its continuing effort to 
reduce paperwork and respondent burden, conducts a pre-clearance 
request for comment to provide the general public and Federal agencies 
with an opportunity to comment on proposed collections of information 
in accordance with the Paperwork Reduction Act of 1995. This request 
helps to ensure that: requested data can be provided in the desired 
format; reporting burden (time and financial resources) is minimized; 
collection instruments are clearly understood; and the impact of 
collection requirements on respondents can be properly assessed. 
Currently, OWCP is soliciting comments on the information collection 
for Authorization Request Form and Certification/Letter of Medical 
Necessity for Compounded Drugs (OWCP-26).

DATES: All comments must be received on or before May 28, 2024.

ADDRESSES: You may submit comment as follows. Please note that late, 
untimely filed comments will not be considered.
    Written/Paper Submissions: Submit written/paper submissions in the 
following way:
     Mail/Hand Delivery: Mail or visit DOL-OWCP/, Office of 
Workers' Compensation Programs, U.S. Department of Labor, 200 
Constitution Ave. NW, Room S-3524, Washington, DC 20210.
     OWCP will post your comment as well as any attachments, 
except for information submitted and marked as confidential, in the 
docket at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Anjanette Suggs, Office of Workers' 
Compensation Programs, OWCP, at [email protected] (email); (202) 
354-9660 (phone).

SUPPLEMENTARY INFORMATION:

I. Background

    In 2013, the President of the United States, Barack Obama, signed a 
law, which provides greater federal oversight over compounding 
pharmacies that custom mix medication in bulk for patients who may 
benefit from prescriptions that are specific to their individual 
medical needs. See Compounding Quality Act, Public Law 113-54, 127 
Stat. 587 (2013).
    Compounded drugs have two or more ingredients and are offered as an 
alternative to Food and Drug Administration (FDA)-approved medications 
that do not meet an individual patient's health needs, such as when a 
patient has an allergy that requires a medication to be made without a 
certain dye. See Compounding and the FDA: Questions and Answers, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm.
    Compounded drugs are not FDA-approved. This means that the FDA does 
not verify the safety or effectiveness of compounded drugs. Consumers 
and health professionals rely on the drug approval process to ensure 
that drugs are safe and effective, and made in accordance with Federal 
quality standards. Compounded drugs also lack an FDA finding of 
manufacturing quality before they are marketed.
    Health risks associated with compounded drugs include the use of 
ingredients that may be sub- or super-potent, contaminated, or 
otherwise adulterated. Additionally, patients may use ineffective 
compounded drugs instead of FDA-approved drugs, which have been shown 
to be safe and effective.

[[Page 21016]]

Impacts on the Office of Workers' Compensation Programs (OWCP)

    Due to the safety concerns surrounding compounded drugs, the 
Department of Labor has deemed it necessary to scrutinize the medical 
necessity of these medications in OWCP claims more closely by 
instituting a pre-authorization process. The OWCP believes that using a 
form to monitor compounded medications will improve the quality of 
medical management, increase patient safety, assist our stakeholders in 
controlling costs due to medically unnecessary treatments, and lessen 
the potential for fraud, waste, and abuse in the compensation programs 
administered by the OWCP. Requiring justification before payment will 
assist the OWCP in determining whether the prescribed medication will 
assist in curing, giving relief, and lessening the degree of 
disability.
    OWCP's authority to require use of the OWCP-26 is derived from the 
following sources:

 FECA: 5 U.S.C. 8103; 20 CFR 10.310, 10.800 and 10.809.
 EEOICPA: 42 U.S.C. 7384t; 20 CFR 30.700(b).
 BLBA: 33 U.S.C. 907, as incorporate by 30 U.S.C. 932(a); 20 
CFR part 725, subpart J.
 LHWCA: 33 U.S.C. 907, 939; 20 CFR part 702, subpart D.

II. Desired Focus of Comments

    OWCP is soliciting comments concerning the proposed information 
collection (ICR) titled, ``Authorization Request Form and 
Certification/Letter of Medical Necessity for Compounded Drugs'', OWCP-
26.
    OWCP is particularly interested in comments that:
     Evaluate whether the collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information has practical utility;
     Evaluate the accuracy of OWCP's estimate of the burden 
related to the information collection, including the validity of the 
methodology and assumptions used in the estimate;
     Suggest methods to enhance the quality, utility, and 
clarity of the information to be collected; and
     Minimize the burden of the information collection on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.
    Background documents related to this information collection request 
are available at https://regulations.gov and at DOL-OWCP located at 200 
Constitution Avenue NW, Room S-3524, Washington, DC 20210. Questions 
about the information collection requirements may be directed to the 
person listed in the FOR FURTHER INFORMATION section of this notice.

III. Current Actions

    This information collection request concerns the Authorization 
Request Form and Certification/Letter of Medical Necessity for 
Compounded Drugs (OWCP-26).
    OWCP has updated the data with respect to the number of 
respondents, responses, burden hours, and burden costs supporting this 
information collection request from the previous information collection 
request.
    Type of Review: Extension, without change, of a currently approved 
collection.
    Agency: Office of Workers' Compensation Programs OWCP.
    OMB Number: 1240-0NEW.
    Affected Public: Individuals or Households; Business or other for-
profit.
    Number of Respondents: 78.
    Frequency: On occasion.
    Number of Responses: 490.
    Annual Burden Hours: 245 hours.
    Annual Respondent or Recordkeeper Cost: $28,116.20.

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

    Comments submitted in response to this notice will be summarized in 
the request for Office of Management and Budget approval of the 
proposed information collection request; they will become a matter of 
public record and will be available at https://www.reginfo.gov.

Anjanette Suggs,
Certifying Officer.
[FR Doc. 2024-06359 Filed 3-25-24; 8:45 am]
BILLING CODE 4510-CR-P