[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56704-56705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22097]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2007-0932, FRL-8936-01-OLEM]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Management Standards for Hazardous Waste 
Pharmaceuticals Title of ICR, EPA ICR No. 2486.03, OMB Control No. 
2050-0212

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to 
submit the information collection request (ICR), Management Standards 
for Hazardous Waste Pharmaceuticals (EPA ICR No. 2486.03, OMB Control 
No. 2050-0212) to the Office of Management and Budget (OMB) for review 
and approval in accordance with the Paperwork Reduction Act (PRA). 
Before doing so, the EPA is soliciting public comments on specific 
aspects of the proposed information collection as described in 
SUPPLEMENTARY INFORMATION. This is a proposed extension of the ICR, 
which is currently approved through May 31, 2022. 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.

DATES: Comments must be submitted on or before December 13, 2021.

ADDRESSES: Submit your comments, referencing by Docket ID No. EPA-HQ-

[[Page 56705]]

RCRA-2007-0932, to: (1) EPA online using www.regulations.gov (our 
preferred method), by email to [email protected], or by mail to: EPA 
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to 
[email protected]. Address comments to OMB Desk Officer for 
EPA.
    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.

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. Out of an abundance of caution for members of the 
public and our staff, the EPA Docket Center and Reading Room is closed 
to the public, with limited exceptions, to reduce the risk of 
transmitting COVID-19. Our Docket Center staff will continue to provide 
remote customer service via email, phone and webform. For further 
information about the EPA's public docket, Docket Center services and 
the current status, please visit us online at https://www.epa.gov/dockets. The telephone number for the Docket Center is 202-566-1744.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting 
comments and information to enable it to: (i) Evaluate whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the Agency, including whether the 
information will have practical utility; (ii) evaluate the accuracy of 
the Agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (iii) enhance the quality, utility, and clarity of the 
information to be collected; and (iv) minimize the burden of the 
collection of information 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. The 
EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval. At that time, the EPA will issue another Federal 
Register notice to announce the submission of the ICR to OMB and the 
opportunity to submit additional comments to OMB.
    Abstract: Some pharmaceuticals are regulated as hazardous waste 
under the Resource Conservation and Recovery Act (RCRA) when discarded. 
This final rule added regulations for the management of hazardous waste 
pharmaceuticals by healthcare facilities and reverse distributors. 
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: 13,373.
    Frequency of response: Annual.
    Total estimated burden: 43,577 hours. Burden is defined at 5 CFR 
1320.03(b).
    Total estimated cost: $2,543,409, which includes $2,543,409 
annualized labor costs and $0 annualized capital or O&M costs.
    Changes in Estimates: The burden hours are expected to decrease as 
some of the burden associated with the rule have been incorporated into 
other existing ICRs.

    Dated: October 5, 2021.
Carolyn Hoskinson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2021-22097 Filed 10-8-21; 8:45 am]
BILLING CODE 6560-50-P