[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)]
[Notices]
[Pages 24472-24473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11449]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0349; FRL-9978-60-OEI]


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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    The Environmental Protection Agency has submitted an information 
collection request (ICR)--NESHAP for Pharmaceuticals Production (40 CFR

[[Page 24473]]

part 63, subpart GGG) (Renewal), EPA ICR Number 1781.08, OMB Control 
Number 2060-0358--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, 2018. Public comments were previously requested via the 
Federal Register (82 FR 29552) on June 29, 2017 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, 2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0349, to: (1) EPA online using www.regulations.gov (our 
preferred method), or 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: 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 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 National Emission Standards for Hazardous Air 
Pollutants (NESHAP) for Pharmaceuticals Production (40 CFR part 63, 
subpart GGG) were proposed on April 2, 1997; promulgated on September 
21, 1998; and amended on both April 21, 2011 and February 27, 2014. The 
2014 amendment promulgated technical correction was made to allow for 
EPA Method 320 as an alternative to EPA Method 18 for demonstrating 
that a `vent' is not a process vent. These regulations apply to 
existing and new pharmaceuticals manufacturing operations that are 
major sources of hazardous air pollutants (HAP). The affected 
facilities encompass all pharmaceuticals manufacturing operations that 
include process vents, storage tanks, equipment components, and 
wastewater systems. New facilities include those that commenced 
construction or reconstruction after the date of proposal. This 
information is being collected to assure compliance with 40 CFR part 
63, subpart GGG. In general, all NESHAP standards require initial 
notifications, performance tests, and periodic reports by the owners/
operators of the affected facilities. They are also required to 
maintain records of the occurrence and duration of any startup, 
shutdown, or malfunction 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 are required of all affected facilities subject to 
NESHAP. Any owner/operator subject to the provisions of this part shall 
maintain a file containing these documents, and retain the file for at 
least five years following the generation date of such maintenance 
reports and records. All reports are sent to the delegated state or 
local authority. In the event that there is no such delegated 
authority, the reports are sent directly to the U.S. Environmental 
Protection Agency (EPA) regional office.
    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: $4,760,000 (per year), which includes 
$112,000 in either annualized capital and/or operation & maintenance 
costs.
    Changes in the Estimates: There is a reduction in the estimated 
number of responses, by one. The previous ICR included one response for 
affirmative defense. However, that item has subsequently been removed 
from this ICR as those provisions are outdated. There is an adjustment 
increase in the respondent labor hours as currently identified in the 
OMB Inventory of Approved Burdens. This increase is not due to any 
program changes. The change in the burden and cost estimates occurred 
due to a change in assumption. In accordance with the Terms of 
Clearance, this ICR assumes all existing respondents will have to 
familiarize with the regulatory requirements each year. There is also a 
small adjustment decrease in the total capital and O&M costs as 
compared the previously-approved ICR. This decrease is not due to any 
program changes, but occurred because, in accordance with the terms of 
clearance, this ICR rounds totals to three significant figures.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-11449 Filed 5-25-18; 8:45 am]
BILLING CODE 6560-50-P


