[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28595-28596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11184]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0349; FRL-10024-52-OMS]


Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; NESHAP for Pharmaceuticals Production 
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an 
information collection request (ICR), NESHAP for Pharmaceuticals 
Production, 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 July 
31, 2021. Public comments were previously requested, via the Federal 
Register, on May 12, 2020 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 neither conduct nor sponsor, and 
a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before June 28, 2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID Number 
EPA-HQ-OECA-2013-0349, online using www.regulations.gov (our preferred 
method), or by mail to: EPA Docket Center, Environmental Protection 
Agency, Mail Code 28221T, 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: Patrick Yellin, Monitoring, 
Assistance, and Media Programs Division, Office of Compliance, Mail 
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460; telephone number: (202) 564-2970; fax number: 
(202) 564-0050; 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

[[Page 28596]]

can be viewed online at www.regulations.gov, or in person, at the EPA 
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, 
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit: 
http://www.epa.gov/dockets.
    Abstract: The NESHAP for Pharmaceuticals Production were proposed 
on April 2, 1997, and promulgated on September 21, 1998, and amended on 
both April 21, 2011 and February 27, 2014. In general, all NESHAP 
standards require initial notifications, performance tests, and 
periodic reports. Owners or operators are also required to maintain 
records of the occurrence and duration of any malfunctions in the 
operation of an affected facility, or any period during which the 
monitoring system is inoperative. These notifications, reports, and 
records are essential in determining compliance and, in general, are 
required of all sources subject to NESHAP. This information is used by 
the Agency to identify sources subject to these standards to ensure 
that the maximum achievable control technologies are being applied. 
Semiannual summary reports are also required.
    Form Numbers: None.
    Respondents/affected entities: Pharmaceutical manufacturing 
operations.
    Respondent's obligation to respond: Mandatory (40 CFR part 63, 
subpart GGG).
    Estimated number of respondents: 27 (total).
    Frequency of response: Initially, occasionally, quarterly and 
semiannually.
    Total estimated burden: 44,300 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $5,300,000 (per year), which includes 
$112,000 in annualized capital/startup and/or operation & maintenance 
costs.
    Changes in the Estimates: There is no change in burden from the 
most-recently approved ICR as currently identified in the OMB Inventory 
of Approved Burdens. This is due to two considerations: (1) The 
regulations have not changed over the past three years and are not 
anticipated to change over the next three years; and (2) the growth 
rate for this industry is very low or non-existent, so there is no 
significant change in the overall burden. Since there are no changes in 
the regulatory requirements and there is no significant industry 
growth, there are also no changes in the capital/startup or operation 
and maintenance (O&M) costs.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-11184 Filed 5-26-21; 8:45 am]
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