E7-8166. 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.

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 May 30, 2007.

ADDRESSES:

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

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 [phone], and the telephone number for the Enforcement and Compliance Docket and Information Center is [phone].

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 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 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.