Document ID: EPA-HQ-OECA-2006-0713-0002
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request EPA; NESHAP for Pharmaceuticals Production (Renewal); ICR Number 1781.04; OMB Control Number 2060-0358
Posted Date: 2007-04-30T04:00Z

[Federal Register: April 30, 2007 (Volume 72, Number 82)]
[Notices]               
[Page 21255-21257]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap07-62]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2006-0713; FRL-8307-2]

 
Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request EPA; NESHAP for Pharmaceuticals 
Production (Renewal); ICR Number 1781.04; OMB Control Number 2060-0358

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this document announces that an Information Collection 
Request

[[Page 21256]]

(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 May 30, 2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2006-0713, to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to docket.oeca@epa.gov, or by mail to: 

EPA Docket Center (EPA/DC), Environmental Protection Agency, 
Enforcement and Compliance Docket and Information Center, Mail Code 
2201T, 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: Marcia B. Mia, Office of Compliance, 
Mail Code 2223A, Environmental Protection Agency, 1200 Pennsylvania 
Avenue, NW., Washington, DC 20460; telephone number: 202-564-7042; fax 
number: 202-564-0038; e-mail address: mia.marcia@epa.gov.

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 October 5, 2006 (71 FR 58853), 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-2006-0713, which is available for public viewing 
online at http://www.regulations.gov, or in person viewing at the 

Enforcement and Compliance Docket and Information Center 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 and 
Information Center is (202) 566-1927.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit, or view public comments, 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 in 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, 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 Pharmaceuticals Production (Renewal).
    ICR Numbers: EPA ICR Number 1781.04; OMB Control Number 2060-0358.
    ICR Status: This ICR is scheduled to expire on June 30, 2007. 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 Pharmaceuticals Production was proposed on 
April 2, 1997, and promulgated on September 21, 1998. These standards 
apply to facilities in pharmaceuticals facilities 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 commencing construction, or reconstruction after the date of 
that proposal. This information is being collected to assure compliance 
with 40 CFR part 63, subpart GGG. HAP emissions are the pollutants 
regulated under this subpart.
    In general, all NESHAP standards require initial notifications, 
performance tests, and periodic reports. Owners, or operators also 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. 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.
    Any owner, or operator subject to the provisions of this part will 
maintain a file of these measurements, and retain the file for at least 
five years following the date of such measurements, 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.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 177 
hours per response. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, or 
disclose or 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; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements which 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: Pharmaceuticals facilities that are 
major sources of hazardous air pollutants (HAP).
    Estimated Number of Respondents: 100.
    Frequency of Response: Initially, Semi-annually and on occasion.
    Estimated Total Annual Hour Burden: 163,371.
    Estimated Total Annual Cost: $14,901,733, which consists of no 
Capital/Startup costs, $415,800 in Operations and Maintenance Costs, 
and $14,485,933 in Labor Costs associated with this ICR.
    Changes in the Estimates: There is an increase of 5,192 hours in 
the total estimated burden currently identified in the OMB Inventory of 
Approved ICR Burdens. The increase in burden is due

[[Page 21257]]

to adjustments. Burden items were added to the ICR which were 
previously omitted, and the burden associated with some items was 
increased to be consistent with more recently approved ICRs for similar 
source categories.

    Dated: April 19, 2007.
Sara Hisel-McCoy,
Acting Director, Collection Strategies Division.
 [FR Doc. E7-8166 Filed 4-27-07; 8:45 am]

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