[Federal Register Volume 69, Number 40 (Monday, March 1, 2004)]
[Notices]
[Pages 9612-9613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4466]


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

ENVIRONMENTAL PROTECTION AGENCY

[OECA-2003-0035; FRL-7628-1]


Agency Information Collection Activities; Submission for OMB 
Review and Approval; Comment Request; NESHAP for Pharmaceuticals 
Production, EPA ICR Number 1781.03, OMB Control Number 2060-0358

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act, 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. 
This ICR is scheduled to expire on February 29, 2004. Under OMB 
regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB. This 
ICR describes the nature of the information collection and its 
estimated burden and cost.

DATES: Additional comments may be submitted on or before March 31, 
2004.

ADDRESSES: Submit your comments, referencing docket ID number OECA-
2003-0035, to (1) EPA online using EDOCKET (our preferred method), by 
e-mail to [email protected], or by mail to: EPA Docket Center, 
Environmental Protection Agency, Enforcement and Compliance Docket and 
Information Center (ECDIC), Mail Code 2201T, 1200 Pennsylvania Ave., 
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 Ave., 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 May 19, 2003 (68 FR 27059), EPA sought comments on this ICR 
pursuant to 5 CFR 1320.8(d). EPA received no comments.
    EPA has established a public docket for this ICR under Docket ID 
Number OECA-2003-0035, which is available for public viewing at the 
Enforcement and Compliance Docket and Information Center in the EPA 
Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., 
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) 566-1752. An electronic version of the

[[Page 9613]]

public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket. Use EDOCKET to submit or view public comments, 
access the index listing of the contents of the public docket, and to 
access those documents in the public docket that are available 
electronically. When in the system, select ``search,'' then key in the 
docket ID number identified above.
    Any comments related to this ICR should be submitted to EPA and OMB 
within 30 days of this notice. EPA's policy is that public comments, 
whether submitted electronically or in paper, will be made available 
for public viewing in EDOCKET 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. When EPA identifies a comment containing 
copyrighted material, EPA will provide a reference to that material in 
the version of the comment that is placed in EDOCKET. The entire 
printed comment, including the copyrighted material, will be available 
in the public docket. Although identified as an item in the official 
docket, information claimed as CBI, or whose disclosure is otherwise 
restricted by statute, is not included in the official public docket, 
and will not be available for public viewing in EDOCKET. For further 
information about the electronic docket, see EPA's Federal Register 
notice describing the electronic docket at 67 FR 38102 (May 31, 2002), 
or go to http://www.epa.gov/edocket.
    Title: NESHAP for Pharmaceuticals Production (40 CFR part 63, 
subpart GGG), OMB Control Number 2060-0358, EPA ICR Number 1781.03.
    Abstract: The National Emission Standards for Hazardous Air 
Pollutants (NESHAP), were proposed on April 2, 1997 and promulgated on 
September 21, 1998. These standards apply to the facilities in 
Pharmaceuticals Production that are major sources of hazardous air 
pollutants (HAP). The affected facility includes all pharmaceutical 
manufacturing operations, 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 
requires initial notifications, performance tests, and periodic 
reports.
    Owners or operators 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. The required notifications 
are used to inform the Agency or delegated authority when a source 
becomes subject to the standard. The reviewing authority may then 
inspect the source to check if the pollution control devices are 
properly installed and operated, and that the standard is being met.
    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. Performance tests reports are needed as they are 
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.
    Any 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 are listed in 40 CFR part 9 and 48 CFR chapter 15, and are 
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information are estimated to average 250 
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; to 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; to 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; to train personnel to be able to respond 
to a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information.
    Respondents/Affected Entities: Pharmaceuticals Production Plants.
    Estimated Number of Respondents: 101.
    Frequency of Response: Quarterly, semiannually and on occasion.
    Estimated Total Annual Hour Burden: 158,179 hours.
    Estimated Total Annual Costs: $10,015,020 which includes $4,400 
annualized capital/startup costs, $4,158 annual O&M costs and 
$10,006,462 Labor costs for Respondents.
    Changes in the Estimates: There is a decrease of 3,147 hours in the 
total estimated hour burden currently identified in the OMB Inventory 
of Approved ICR Burdens. The decrease in hour burden from the most 
recently approved ICR is due to a decrease in the number of sources. 
Our data indicates that there are approximately 101 sources, including 
one new source due to reconstruction.

    Dated: February 19, 2004.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. 04-4466 Filed 2-27-04; 8:45 am]
BILLING CODE 6560-50-P