[Federal Register Volume 75, Number 98 (Friday, May 21, 2010)]
[Notices]
[Pages 28605-28606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12273]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0381; FRL-9143-9]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request; NESHAP for Pharmaceutical 
Production (Renewal), EPA ICR Number 1781.05, OMB Control Number 2060-
0358

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this document announces that an Information Collection 
Request (ICR) has been forwarded to the Office of Management and Budget 
(OMB) for review and approval. This is a request to renew an existing 
approved collection. The ICR which is abstracted below describes the 
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before June 21, 2010.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2009-0381 to (1) EPA online using http://www.regulations.gov (our 
preferred method), or by e-mail to [email protected], or by mail to: 
EPA Docket Center (EPA/DC), Environmental Protection Agency, 
Enforcement and Compliance Docket and Information Center, mail code 
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) 
OMB at: Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th 
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment 
and Media Programs Division, Office of Compliance, Mail Code 2223A, 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone number: (202) 564-4113; fax number: 
(202) 564-0050; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB 
for review and approval according to the procedures prescribed in 5 CFR 
1320.12. On July 8, 2009 (74 FR 32580), EPA sought comments on this ICR 
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional 
comments on this ICR should be submitted to EPA and OMB within 30 days 
of this notice.
    EPA has established a public docket for this ICR under docket ID 
number EPA-HQ-OECA-2009-0381, which is available for public viewing 
online at http://www.regulations.gov, in person viewing at the 
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC), 
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The 
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Reading Room is (202) 566-1744, and the telephone number 
for the Enforcement and Compliance Docket is (202) 566-1752.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, to access the 
index listing of the contents of the docket, and to access those 
documents in the docket that are available electronically. Once in the 
system, select ``docket search,'' then key in the docket ID number 
identified above. Please note that EPA's policy is that public 
comments, whether submitted electronically or on paper, will be made 
available for public viewing at http://www.regulations.gov, as EPA 
receives them and without change, unless the comment contains 
copyrighted material, Confidential Business Information (CBI), or other 
information whose public disclosure is restricted by statute. For 
further information about the electronic docket, go to http://www.regulations.gov.
    Title: NESHAP for Pharmaceutical Production (Renewal).
    ICR Numbers: EPA ICR Number 1781.05, OMB Control Number 2060-0358.
    ICR Status: This ICR is scheduled to expire on July 31, 2010. Under 
OMB regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB. 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. The OMB control numbers for EPA's regulations 
in title 40 of the CFR, after appearing in the Federal Register when 
approved, are listed in 40 CFR part 9, and displayed either by 
publication in the Federal Register or by other appropriate means, such 
as on the related collection instrument or form, if applicable. The 
display of OMB control numbers in certain EPA regulations is 
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air 
Pollutants (NESHAP) for Pharmaceutical Production (40 CFR part 63, 
subpart GGG) were proposed on April 2, 1997, and promulgated on 
September 21, 1998. These standards apply to the facilities in 
pharmaceutical production that are major sources of hazardous air 
pollutants (HAP). The affected facility is all pharmaceutical 
manufacturing operation, which includes process vents, storage tanks, 
equipment components, and wastewater systems commencing construction or 
reconstruction after the date of the proposal. In general, all NESHAP 
require initial notifications, performance tests, and periodic reports.
    Owners/operators of affected pharmaceutical production are 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, in general, are required of all sources subject to 
NESHAP. Semiannual reports are also required.
    Any owner or operator subject to the provisions of this part shall 
maintain a file of these measurements, and retain the records for at 
least five years following the date of such measurements, maintenance 
reports, and records. Performance tests reports are required as this is 
the Agency's record of a source's initial capability to comply with the 
emission standard, and serve as a record of the operating conditions 
under which compliance was achieved.
    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 EPA regional office. This information is being 
collected to assure compliance with 40 CFR part 63, subpart GGG, as

[[Page 28606]]

authorized in sections 112 and 114(a) of the Clean Air Act. The 
required information consists of emissions data and other information 
that have been determined to be private.
    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. The OMB Control Number for EPA 
regulations listed in 40 CFR part 9 and 48 CFR chapter 15, are 
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information estimated to average 178 
hours per response. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, or 
disclose, and provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information. All 
existing ways will have to adjust to comply with any previously 
applicable instructions and requirements that have subsequently 
changed; train personnel to be able to respond to a collection of 
information; search data sources; complete and review the collection of 
information; and transmit or otherwise disclose the information.
    Respondents/Affected Entities: Pharmaceutical production 
facilities.
    Estimated Number of Respondents: 27.
    Frequency of Response: Initially, quarterly, semiannually, and 
occasionally.
    Estimated Total Annual Hour Burden: 44,246.
    Estimated Total Annual Cost: $4,297,480 which includes $4,185,214 
in labor costs, no capital/startup costs, and $112,266 in operation and 
maintenance (O&M) costs.
    Changes in the Estimates: There is an adjustment in the labor hours 
in this ICR, compared to the previous ICR. The labor burden is 
decreased compared to the most recently approved ICR due to a reduction 
in the number of sources. The reduction was caused by a number of 
sources becoming synthetic area minor sources before the compliance 
date. All of the sources subject to the standard are major sources.
    There is a decrease in the capital/startup and operations and 
maintenance (O&M) costs from the previous ICR due to the decrease in 
the number of sources.

    Dated: May 17, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-12273 Filed 5-20-10; 8:45 am]
BILLING CODE 6560-50-P