Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Pharmaceuticals Production (Renewal), 24472-24473 [2018-11449]

Download as PDF 24472 Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OECA–2013–0356; FRL–9978– 68–OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Group I Polymers and Resins (Renewal) Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) has submitted an information collection request (ICR)— NESHAP for Group I Polymers and Resins (Renewal), EPA ICR Number 2410.04, OMB Control Number 2060– 0665—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 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 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: Additional comments may be submitted on or before June 28, 2018. ADDRESSES: Submit your comments, referencing Docket ID Number EPA– HQ–OECA–2013–0356, to (1) EPA online using www.regulations.gov (our preferred method), by email to docket.oeca@epa.gov, 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 oira_submission@omb.eop.gov. 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 daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:39 May 25, 2018 Jkt 244001 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564– 2970; fax number: (202) 564–0050; email address: yellin.patrick@epa.gov. 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, EPA 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 the regulations published at 40 CFR part 63, subpart U were proposed on June 12, 1995, promulgated on September 5, 1996, and amended on June 19, 2000, July 16, 2001, December 16, 2008, and April 21, 2011. These regulations apply to existing and new elastomer product process units (EPPU) and associated equipment including waste management units, maintenance wastewater, heat exchange systems, and equipment required by or utilized to comply with this Subpart located at facilities that are major sources of hazardous air pollutants (HAPs) and are classified in the Group I Polymers and Resins source category. The Group I Polymers and Resins source category includes the following categories: Butyl Rubber Production, Epichlorohydrin Elastomers Production, Ethylene Propylene Rubber Production, Hypalon Production, Neoprene Production, Nitrile Butadiene Rubber (NBR) Production, Polybutadiene Rubber Production, Polysulfide Rubber Production, and Styrene Butadiene Rubber and Latex Production. New facilities include those that commenced construction, or reconstruction after the date of proposal. This ICR combines burden from the 2011 amendment with the burden associated with the existing provisions of the rule. 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/ PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 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 United States Environmental Protection Agency (EPA) regional office. Form Numbers: None. Respondents/affected entities: Facilities with elastomer product process units and associated equipment. Respondent’s obligation to respond: Mandatory (40 CFR part 63, subpart U). Estimated number of respondents: 19 (total). Frequency of response: Initially, occasionally, and semiannually. Total estimated burden: 56,400 hours (per year). Burden is defined at 5 CFR 1320.3(b). Total estimated cost: $11,200,000 (per year), includes $5,230,000 annualized capital or operation & maintenance costs. Changes in the Estimates: There is an adjustment increase in the total estimated burden, labor costs, and capital and O&M costs 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 because the previously approved ICR only covered the burden and costs associated with the 2011 amendment. This ICR combines the burden from both the 2011 amendment and the pre-2011 provisions of the rule. Courtney Kerwin, Director, Collection Strategies Division. [FR Doc. 2018–11450 Filed 5–25–18; 8:45 am] BILLING CODE 6560–50–P 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) Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency has submitted an information collection request (ICR)—NESHAP for Pharmaceuticals Production (40 CFR E:\FR\FM\29MYN1.SGM 29MYN1 daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices 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 60day 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 docket.oeca@epa.gov, 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 oira_submission@omb.eop.gov. 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: yellin.patrick@epa.gov. 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. VerDate Sep<11>2014 16:39 May 25, 2018 Jkt 244001 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 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 24473 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 previouslyapproved 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 FEDERAL ELECTION COMMISSION Sunshine Act Meetings FEDERAL REGISTER CITATION NOTICE OF PREVIOUS ANNOUNCEMENT: 83 FR 23682. PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING: Thursday, May 24, 2018 at 10:00 a.m. The Following Item Was Also Discussed: Adoption of Forty Year Report. CONTACT PERSON FOR MORE INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. CHANGES IN THE MEETING: Dayna C. Brown, Secretary and Clerk of the Commission. [FR Doc. 2018–11552 Filed 5–24–18; 4:15 pm] BILLING CODE 6715–01–P FEDERAL ELECTION COMMISSION [Notice 2018–10] Filing Dates for the Pennsylvania Special Election in the 7th Congressional District Federal Election Commission. Notice of filing dates for special election. AGENCY: ACTION: E:\FR\FM\29MYN1.SGM 29MYN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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