Notice2021-22097
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
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
October 12, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 194 (Tuesday, October 12, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56704-56705]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22097]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="http://www.regulations.gov">www.regulations.gov</a> (our
preferred method), by email to <a href="/cdn-cgi/l/email-protection#4b3928392a662f2428202e3f0b2e3b2a652c243d"><span class="__cf_email__" data-cfemail="a9dbcadbc884cdc6cac2ccdde9ccd9c887cec6df">[email protected]</span></a>, 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
<a href="/cdn-cgi/l/email-protection#4f20263d2e103c3a2d22263c3c2620210f20222d612a203f61282039"><span class="__cf_email__" data-cfemail="1877716a79476b6d7a75716b6b7177765877757a367d7768367f776e">[email protected]</span></a>. 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:
<a href="/cdn-cgi/l/email-protection#1e78776a64797b6c7f727a30756c776d6a77705e7b6e7f30797168"><span class="__cf_email__" data-cfemail="fe98978a84999b8c9f929ad0958c978d8a9790be9b8e9fd0999188">[email protected]</span></a>.
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
<a href="http://www.regulations.gov">www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>. 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 12, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.