Document ID: EPA-HQ-OECA-2013-0349-0002
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: NESHAP for Pharmaceuticals Production (Renewal)
Posted Date: 2014-06-04T04:00Z

[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32280-32281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12911]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0349; FRL-9910-93-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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SUMMARY: The Environmental Protection Agency (EPA) has submitted an 
information collection request (ICR), ``NESHAP for Pharmaceuticals 
Production (Renewal)'' (EPA ICR No. 1781.07, OMB Control No. 2060-
0358), to the Office of Management and Budget (OMB) for review and 
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.) This is a proposed extension of the ICR, which is currently 
approved through June 30, 2014. Public comments were previously 
requested via the Federal Register 78 FR 35023 on June 11, 2013 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 July 7, 2014.

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.
    Abstract: The NESHAP for Pharmaceuticals Production were proposed 
on April 2, 1997, and promulgated on September 21, 1998. 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 the standards to insure that 
the maximum achievable control technologies are being applied.

[[Page 32281]]

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: 44,266 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $4,442,518 (per year), includes $112,266 
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the labor hours in 
this ICR compared to the previous ICR. This is due to two 
considerations: 1) The regulations have not changed since the 
publication of the 2011 final rule, which was covered in the last ICR 
renewal; and 2) the growth rate for the industry is very low, negative 
or non-existent. However, there is an increase in industry cost as the 
burden calculations in this ICR, including affirmative defense, have 
been updated to use more recent labor rates.

    Dated: May 27, 2014.
Erin Collard,
Acting Director, Collection Strategies Division.
[FR Doc. 2014-12911 Filed 6-3-14; 8:45 am]
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