Notice2024-06359
Proposed of Information Collection; Authorization Request Form and Certification/Letter of Medical Necessity for Compounded Drugs (OWCP-26)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 26, 2024
Issuing agencies
Labor DepartmentWorkers' Compensation Programs Office
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 59 (Tuesday, March 26, 2024)</title>
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[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 21015-21016]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> 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.
<bullet> OWCP will post your comment as well as any attachments,
except for information submitted and marked as confidential, in the
docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Anjanette Suggs, Office of Workers'
Compensation Programs, OWCP, at <a href="/cdn-cgi/l/email-protection#0d7e786a6a7e236c63676c63687979684d696261236a627b"><span class="__cf_email__" data-cfemail="93e0e6f4f4e0bdf2fdf9f2fdf6e7e7f6d3f7fcffbdf4fce5">[email protected]</span></a> (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, <a href="http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm">http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm</a>.
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:
<bullet> FECA: 5 U.S.C. 8103; 20 CFR 10.310, 10.800 and 10.809.
<bullet> EEOICPA: 42 U.S.C. 7384t; 20 CFR 30.700(b).
<bullet> BLBA: 33 U.S.C. 907, as incorporate by 30 U.S.C. 932(a); 20
CFR part 725, subpart J.
<bullet> 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:
<bullet> 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;
<bullet> 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;
<bullet> Suggest methods to enhance the quality, utility, and
clarity of the information to be collected; and
<bullet> 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 <a href="https://regulations.gov">https://regulations.gov</a> 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 <a href="https://www.reginfo.gov">https://www.reginfo.gov</a>.
Anjanette Suggs,
Certifying Officer.
[FR Doc. 2024-06359 Filed 3-25-24; 8:45 am]
BILLING CODE 4510-CR-P
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