00-16178. Agency Information Collection Activities: Submission for OMB Review; Comment Request; NESHAP, Pharmaceuticals Production

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 the following Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval: NESHAP, Subpart GGG, Pharmaceutical Production, OMB Control Number 2060-0358, expiration date 7/31/00. The ICR describes the nature of the information collection and its expected burden and cost; where appropriate, it includes the actual data collection instrument.

DATES:

Comments must be submitted on or before July 27, 2000.

FOR FURTHER INFORMATION CONTACT:

For a copy of the ICR contact Sandy Farmer at EPA by phone at [phone], by E-Mail at [e-mail] or download off the Internet at http://www.epa.gov/​icr and refer to EPA ICR No. 1781.02. For technical questions about the ICR contact Marcia Mia at 202-564-7042.

SUPPLEMENTARY INFORMATION:

Title: NESHAP, subpart GGG, Pharmaceuticals Production (OMB Control No. 2060-0358; EPA ICR No. 1781.02) expiring 07/31/00. This is a request for extension of a currently approved collection.

Abstract: In general all NESHAP require initial notifications, performance tests, and periodic reports. Owners or operators are also 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.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least 5 years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or Local authority and are entered into the AIRS database.

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pharmaceuticals Production 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 is all pharmaceutical manufacturing operations including process vents, storage tanks, equipment components, and wastewater systems commencing construction or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart GGG.

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 are listed in 40 CFR part 9 and 48 CFR Chapter 15. The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on 03/31/00 (65 FR 17258); no comments were received.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 409 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; 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 Plants.

Estimated Number of Respondents: 103.

Frequency of Response: Initial, quarterly, semiannually and on occasion.

Estimated Total Annual Hour Burden: 84,275 hours.

Estimated Total Annualized Capital, O&M Cost Burden: $0.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the following addresses. Please refer to EPA ICR No. 1781.02 and OMB Control No. 2060-0358 in any correspondence.

Ms. Sandy Farmer,

U.S. Environmental Protection Agency,

Office of Environmental Information,

Collection Strategies Division (2822),

1200 Pennsylvania Ave., NW,

Washington, DC 20460; and

Office of Information and Regulatory Affairs,

Office of Management and Budget,

Attention: Desk Officer for EPA,

725 17th Street, NW,

Washington, DC 20503.

Dated: June 19, 2000.

Oscar Morales,

Director, Collection Strategies Division.