Document ID: EPA-HQ-RCRA-2007-0932-0469
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Management Standards for Hazardous Waste Pharmaceuticals (Renewal)
Posted Date: 2022-03-18T04:00Z

[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15421-15422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05769]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2007-0932, FRL-9675-01-OMS]

Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; Management Standards for Hazardous Waste 
Pharmaceuticals (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an 
information collection request (ICR), Management Standards for 
Hazardous Waste Pharmaceuticals (EPA ICR Number 2486.03, OMB Control 
Number 2050-0212) to the Office of Management and Budget (OMB) for 
review and approval in accordance with the Paperwork Reduction Act. 
This is a proposed extension of the ICR, which is currently approved 
through May 31, 2022. Public comments were previously requested via the 
Federal Register on October 12, 2021 during a 60-day comment period. 
This notice allows for an additional 30 days for public comments. A 
fuller description of the ICR is given below, including its estimated 
burden and cost to the public. An Agency may not conduct or sponsor and 
a person is not required to respond to a collection of information 
unless it displays a currently valid OMB control number.

[[Page 15422]]

DATES: Additional comments may be submitted on or before April 18, 
2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-RCRA-
2007-0932, online using www.regulations.gov (our preferred method) or 
by mail to: EPA Docket Center, Environmental Protection Agency, Mail 
Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's 
policy is that all comments received will be included in the public 
docket without change including any personal information provided, 
unless the comment includes profanity, threats, information claimed to 
be Confidential Business Information (CBI), or other information whose 
disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed 
information collection 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: Kristin Fitzgerald, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; 
telephone number: 202-566-0512; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in 
detail the information that the EPA will be collecting, are available 
in the public docket for this ICR. The docket can be viewed online at 
www.regulations.gov. For further information and updates on EPA Docket 
Center services, please visit us online at https://www.epa.gov/dockets. 
The telephone number for the Docket Center is 202-566-1744.
    Abstract: Some pharmaceuticals are regulated as hazardous waste 
under the Resource Conservation and Recovery Act (RCRA) when discarded. 
In 2019 EPA promulgated regulations for the management of hazardous 
waste pharmaceuticals by healthcare facilities and reverse distributors 
(84 FR 5816, February 22, 2019). Healthcare facilities (for both humans 
and animals) and reverse distributors now manage their hazardous waste 
pharmaceuticals under a new set of sector-specific standards in lieu of 
the existing hazardous waste generator regulations. These regulations 
are found in 40 CFR 266, subpart P, and are mandatory. The new 
requirements include labeling containers holding non-creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals with the words ``Hazardous Waste Pharmaceuticals''. 
Healthcare facilities and reverse distributors must also track or 
manage rejected shipments by sending a copy of the manifest to the 
designated facility that returned or rejected the shipment. 
Additionally, healthcare facilities and reverse distributors must 
submit exception reports for a missing copy of a manifest. Reverse 
distributors are required to amend their contingency plan under 40 CFR 
262 subpart M. A reverse distributor must submit an unauthorized 
hazardous waste report if it receives waste it is not authorized to 
receive.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by 
this action are the private sector.
    Respondent's obligation to respond: Mandatory (RCRA Section 3001).
    Estimated number of respondents: 8,163.
    Frequency of response: Annual.
    Total estimated burden: 40,045 hours per year. Burden is defined at 
5 CFR 1320.03(b).
    Total estimated cost: $3,580,140 (per year), includes $0 annualized 
capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 3,532 hours 
compared to the currently approved ICR due to a decrease in the 
universe. The universe estimates are based on real data for this 
renewal.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-05769 Filed 3-17-22; 8:45 am]
BILLING CODE 6560-50-P