[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Proposed Rules]
[Page 21198]
[FR Doc No: 2015-08889]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2014-0188; FRL-9926-30-Region 5]

Approval and Promulgation of Air Quality Implementation Plans;
Michigan; SO2 Rules

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a request by the Michigan Department of Environmental Quality
(MDEQ) submitted on February 14, 2014, and supplemented on October 27,
2014, to revise the Michigan state implementation plan (SIP) to
incorporate sulfur dioxide (SO2) limits found in ``Part 4:
Emissions Limitations and Prohibitions--Sulfur Bearing Compounds'' of
Michigan's Air Pollution Control Rules. EPA is proposing to take no
action on the provisions pertaining to the Federal Clean Air Interstate
Rule (CAIR) SO2 trading program because CAIR is no longer in
effect.

DATES: Comments must be received on or before May 18, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2014-0188 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section (AR-
18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard,
Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies Section
(AR-18J), U.S. Environmental Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted
during the Regional Office normal hours of operation, and special
arrangements should be made for deliveries of boxed information. The
Regional Office official hours of business are Monday through Friday,
8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving a portion of the State's SIP submittal as a
direct final rule without prior proposal because the Agency views this
as a noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If EPA does not receive adverse comments in response to this
rule, no further activity is contemplated. If EPA receives adverse
comments, EPA will withdraw the direct final rule and will address all
public comments received in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rulemaking, and if that provision can be
severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
For additional information, see the direct final rule which is located
in the Rules section of this Federal Register.

    Dated: April 2, 2015.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2015-08889 Filed 4-16-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Page 45514]
[FR Doc No: 2019-18693]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1742]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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

SUMMARY: On August 8, 2019, FEMA published in the Federal Register a
final flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table. The table
provided here represents the final flood hazard determinations and
communities affected for San Diego County, California and Incorporated
Areas.

DATES: The date of December 20, 2019 has been established for the FIRM
and, where applicable, the supporting FIS report showing the new or
modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

Correction

    In the final flood hazard determination notice published at 84 FR
39008 in the August 8, 2019, issue of the Federal Register, FEMA
published a table titled San Diego County, California and Incorporated
Areas Docket No.: FEMA-B-1742. This table contained inaccurate
information as to the community map repository for the City of Del Mar,
City of San Diego and Unincorporated Areas of San Diego County featured
in the table.
    In this document, FEMA is publishing a table containing the
accurate information. The information provided below should be used in
lieu of that previously published.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           San Diego County, California and Incorporated Areas
                         Docket No.: FEMA-B-1742
------------------------------------------------------------------------
City of Carlsbad.......................  Building and Development
                                          Department, 1635 Faraday
                                          Avenue, Carlsbad, CA 92008.
City of Chula Vista....................  City Hall, 276 4th Avenue,
                                          Chula Vista, CA 91910.
City of Coronado.......................  City Hall, 1825 Strand Way,
                                          Coronado, CA 92118.
City of Del Mar........................  City Hall, 1050 Camino Del Mar,
                                          Del Mar, CA 92014.
City of Encinitas......................  City Hall, 505 South Vulcan
                                          Avenue, Encinitas, CA 92024.
City of Imperial Beach.................  City Hall, 825 Imperial Beach
                                          Boulevard, Imperial Beach, CA
                                          91932.
City of National City..................  City Hall, 1243 National City
                                          Boulevard, National City, CA
                                          91950.
City of Oceanside......................  City Hall, 300 North Coast
                                          Highway, Oceanside, CA 92054.
City of San Diego......................  Development Services
                                          Department, 1222 First Avenue,
                                          MS 301, San Diego, CA 92101.
City of Solana Beach...................  City Hall, 635 South Highway
                                          101, Solana Beach, CA 92075.
Unincorporated Areas of San Diego        Department of Public Works,
 County.                                  Flood Control, 5510 Overland
                                          Avenue, Suite 410, MS 0326,
                                          San Diego, CA 92123.
------------------------------------------------------------------------

[FR Doc. 2019-18693 Filed 8-28-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Page 33175]
[FR Doc No: 2020-11728]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0002; Internal Agency Docket No. FEMA-B-2017]

Proposed Flood Hazard Determinations for Hays County, Texas and
Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its proposed notice concerning proposed flood hazard determinations,
which may include the addition or modification of any Base Flood
Elevation, base flood depth, Special Flood Hazard Area boundary or zone
designation, or regulatory floodway (herein after referred to as
proposed flood hazard determinations) on the Flood Insurance Rate Maps
and, where applicable, in the supporting Flood Insurance Study reports
for Hays County, Texas and Incorporated Areas.

DATES: This withdrawal is effective June 1, 2020.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
2017, to Rick Sacbibit, Chief, Engineering Services Branch, Federal
Insurance and Mitigation Administration, FEMA, 400 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 3, 2020, FEMA published a proposed
notice at 85 FR 19010, proposing flood hazard determinations for Hays
County, Texas and Incorporated Areas. FEMA is withdrawing the proposed
notice.

    Authority:  42 U.S.C. 4104; 44 CFR 67.4.

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2020-11728 Filed 5-29-20; 8:45 am]
 BILLING CODE 9110-12-P


1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NSPS SUBPART J: PETROLEUM REFINERIES 1. Identification of the Information Collection 1( a) Title of the Information collection ICR for Standards of Performance for Petroleum Refineries ( 40 CFR Part 60, Subpart J)

1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS) for Petroleum Refineries for the standards published at 40 CFR Part 60, Subpart J were proposed on June 11, 1973, and promulgated on March 8, 1974. These standards apply to the following affected facilities in petroleum refineries: fluid catalytic cracking unit catalyst regenerators, fuel gas combustion devices, and Claus sulfur recovery plants of more than 20 long tons per day commencing construction, modification or reconstruction after the date of proposal. The pollutants regulated under this Subpart are particulate matter, carbon monoxide, and sulfur oxides. This information is being collected to assure compliance with 40 CFR Part 60, Subpart J.

In general, all NSPS require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any start up, 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 are required of all sources subject to NSPS.

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 two 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 EPA Regional Office.

Approximately 130 affected facilities are currently subject to the standard. It is estimated that on average, no additional affected units per year will become subject to the standard in the next three years. This information is being collected to assure compliance with 40 CFR Part 60, Subpart J. The average annual respondent cost for this ICR will be $ 960,646.01.

There are no terms of clearance for this ICR. This submission properly accounts for the amortization of capital costs beyond the three year period for which this ICR is approved. 2 2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act ( CAA), as amended, to establish standards of performance for new stationary sources that reflect:

". . . application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any non air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated." Section 111( a)( l).

The Agency refers to this charge as selecting the best demonstrated technology. Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years. In the Administrator's judgment, particulate matter, carbon monoxide and sulfur oxides emissions from petroleum refineries cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NSPS were promulgated for this source category at 40 CFR Part 60, Subpart J.

2( b) Practical Utility/ Users of the Data The control of emissions of particulate matter, carbon monoxide, and sulfur oxides from petroleum refineries requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of particulate matter, carbon monoxide, and sulfur oxides from petroleum refineries are the result of operation of fluid catalytic cracking unit catalyst regenerators, fuel gas combustion devices and Claus sulfur recovery plants. For sulfur oxides emissions the standards rely on the capture of sulfur oxides emissions vented to a control device or by allowing a maximum sulfur content in the feed stream. The owners or operators of affected facilities are required to install a continuous emission monitor and record the emission levels of opacity, carbon monoxide, and sulfur dioxide or hydrogen sulfide. Owners or operators are required to report all periods of emissions in excess of the standard.

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. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and/ or note the operating conditions ( maximum hydrogen sulfide levels in the fuel gas) under which compliance was achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. 3 Except for excess emission data for SO 2, EPA reduced the reporting frequency for this information from quarterly to semiannually in a December 1990 Federal Register Notice. The reduction in reporting frequency was in response to OMB's previous questions regarding the need for quarterly versus semiannual reporting. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment and achieve compliance with the standards. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 60, Subpart J.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or local agency. If a State or local agency has adopted their own similar standards to implement the Federal standards, a copy of the report submitted to the State or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register ( 67 FR 4421), on January 30, 2002. No comments were received on the burden published in the Federal Register.

3( c) Consultations Because petroleum refineries are one of the national priority industry sectors EPA data bases ( such as AFS) have accurate and up to date information on this industry so no consultation beyond the request for comments was undertaken. No comments were received on the burden published in the Federal Register.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was 4 collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR Part 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping and reporting requirements are petroleum refineries which commenced construction, modification, or reconstruction after June 11, 1973, for fluid catalytic cracking unit catalyst regenerators or fuel gas combustion devices, or after October 4, 1976, for any Claus sulfur recovery plants. The SIC code for the respondents affected by the standards is SIC ( U. S. Standard Industrial Classification) 2911 which corresponds to the NAICS ( The North American Industry Classification System) 324110 for petroleum refineries.

4( b) INFORMATION REQUESTED ( i) Data Items All data in this ICR that are recorded and/ or reported are required by the New Source Performance Standards for Petroleum Refineries ( 40 CFR Part 60, Subpart J). 5 A source must make the following reports:

Reports for 40 CFR Part 60, Subpart J Construction/ reconstruction 60.7( a)( 1)

Initial notifications 60.7 Actual Start up 60.7( a)( 3)

Opacity or Visible Emissions 60.7 ( a)( 6), ( a)( 7)

Monitor Downtime 60.107( c)( 2)( 4)

Excess emissions SO 2 60.7( c), 60.107 ( c)( 1)  ( 2)

Initial performance test results 60.8 ( a)

Notification of initial performance test 60.8( d)

Rescheduled initial performance test 60.108 Demonstration of continuous monitoring system ( CMS) 60.7( a)( 5)

Notification of Compliance status 60.11( a),( b),( c)

Physical or Operational Change 60.7( a)( 4)

Periodic start up, shutdown, malfunction reports 60.8( c)

Semiannual Reports 60.107( e)

A Signed Statement 60.107( d),( f)

A source must keep the following records:

Recordkeeping for 40 CFR Part 60, Subpart J Start ups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative 60.7( b)

All reports and notifications 60.7 Emission test methods and other data needed to determine emissions 60.106 Excess emissions and monitor downtime data 60.107( b)( 1)( 4)

( ii) Respondent Activities 6 Respondent Activities Read instructions.

Gather relevant information.

Install, calibrate, maintain, and operate CMS for opacity, or for pressure drop and liquid supply pressure for wet scrubber Perform initial performance test, Reference Method 1 6, 8 11, 15.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of 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.

Transmit, or otherwise disclose the information.

Continuous Monitoring System ( CMS) information collection is automated and may be submitted electronically. In any event, hard copy reports from the CMS information may easily be generated from a computer. It is estimated that 70% of the responses to this ICR can be collected electronically.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information. 7 Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Conduct on site inspections as necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS ( Aerometric Information Retrieval System) Facility Subsystem ( AFS) database.

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to check if the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard. Data obtained during periodic visits by Agency personnel from records maintained by the respondents are tabulated and published for internal Agency use in compliance and enforcement programs. The quarterly reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into AFS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by State and local regulatory agencies, EPA Regional Offices and EPA Headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this NSPS must be retained by the owner or operator for two years.

5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses). However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. The recordkeeping and reporting requirements were selected within the context of Subpart J and the specific process equipment and pollutants. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance 8 and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown on Table 2: Industry Burden from Recordkeeping and Reporting  NSPS Subpart J.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the Subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The 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.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 11,375 ( Total Labor Hours from Table 2). These hours are based on Agency studies and background documents from the development of the standards, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses a Technical Labor Rate of $ 55.34 ($ 26.35 + 110% overhead) per hour. This rate is from the United States Department of Commerce, Bureau of Labor Statistics, March 2000, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The wage rate has been increased by 110% to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital and Operations and Maintenance Costs The type of industry costs associated with the information collection activity in the regulations are labor and Continuous Emissions Monitoring. The capital/ startup costs are one time costs when a facility becomes subject to the standards. The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs such as 9 photocopying and postage. Since there are no new sources on average anticipated over the next 3 years there are no capital costs associated with this information collection.

( iii) Capital/ Start up vs. Operating and Maintenance ( O& M) Costs Since there are no new sources on average anticipated over the next 3 years there are no capital costs associated with this information collection. Capital/ startup costs are shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. It should be noted that the numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

The total operation and maintenance ( O& M) costs for this ICR are $ 91,000. This is based on 130 existing sources multiplied by $ 700 dollars ( increasing from the last ICR to reflect the current Consumer Price Index) for upkeep of the monitoring device. These costs are shown in block 14( b), Total annual costs ( O& M), on the OMB 83 I form.

The total respondent non labor costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup, and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 91,000 . This cost is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. Publication and distribution of the information are part of the AFS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Agency cost during the 3 years of the ICR is estimated to be $ 14,630 ( see Table 1: Average Annual EPA Resource Requirements Resulting From NSPS Subpart J). This cost is based on the average hourly labor rate at a GS 12, Step 1 ($ 23.94), times a 1.6 benefits multiplication factor to account for government overhead expenses for a total of $ 38.30. These rates are from OPM's " 2002 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 1.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondent Universe Regulation Citation ( A) No. of New Sources/ Year ( B) No. of Initial Reports for New Sources ( C) No. of Existing Sources ( D) No. of Reports for Existing Sources ( E) Total Annual Responses ( AxB)+( CxD) Respondent Universe 10 40 CFR Part 60, Subpart J 0 4 130 2 260 The number of total respondents is 130. This number is the sum of Column A and Column C of the Respondent Universe table above. This represents the number of existing sources plus the number of anticipated new sources over the three year period of this ICR. It is shown in block 13( a), Number of respondents, on the OMB 83 I form.

The number of Total Annual Responses is 260. This is the number in Column E of the Respondent Universe table above. It is shown in block 13 ( b), Total annual responses, on the OMB 83 I form. The total annual labor costs are $ 767,178.37. This number is not shown on the OMB 83 I form in block 13( c), Total hours requested. Only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Table 2: Industry Burden From Recordkeeping and Reporting  NSPS Subpart J.

The total annual capital and O& M costs to the regulated entity are $ 91,000. This number is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. These costs are detailed in section 6( b)( iii), Capital/ Start up vs. Operating and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours And Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents are attached.

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to an adjustment in labor rates and a correction in calculation errors from the prior ICR.. The previous ICR counted 1.5 affected units per refinery for the respondents, and this ICR counts each refinery as a respondent. Also the previous ICR did not properly account for quarterly reporting.

6( g) Burden Statement 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 11 collection of information; and transmit or otherwise disclose the information. 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.

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 Susan Auby, Collection Strategies Division ( Mail Code 2822T), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, N. W., Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N. W., Washington, DC 2050, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 12 TABLE 1: AVERAGE ANNUAL EPA RESOURCE REQUIREMENTS RESULTING FROM NSPS SUBPART J ( A) ( B) ( C) a ( D) ( E) c EPA hours/ Occurrences/ EPA hours/ Plants/ EPA hours/

Activity Occurrence plant/ year plant year yearb year New Plants: d _________________________________ Not Applicable __________________________________________________

Existing Plants:

Quarterly Emission Reports 1 4 4 84 336 Semiannual Emission Reports 0.5 2 1 46 46 TOTAL ANNUAL HOURS 382 Salary: e ( 382 hours/ year * $ 38.30/ hour) = $ 14,630/ year TOTAL ANNUAL COST = $ 14,630 ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

a A * B = C b Assume that 65% of the 130 plants will have at least one quarter with excess emissions, and 35% will report semiannually.

c C * D = E d Assume that on average, no new sources will be subject to Subpart J e Estimate an hourly wage of $ 23.94 plus 60% overhead expense which equals $ 38.30. 13 TABLE 2: INDUSTRY BURDEN FROM RECORDKEEPING AND REPORTING  NSPS SUBPART J a Occurrences/ Hours/ Total Labor Cost Hours per respondent/ respondent/ Responses Hours per Occurrence year year per year per year yearc ( A) ( B) ( C = A * B) ( D) ( E = C * D) ( F)

1. APPLICATIONS ____________________________________ Not Applicable _____________________________________________

2. SURVEY AND STUDIES ____________________________________ Not Applicable _____________________________________________

3. REPORTING REQUIREMENTS A. Read Instructionsb 1 1 1 7 7 $ 387.38 B. Required Activities Performance testb Relative Accuracy Testb 146 1 146 7 51d $ 2,822.34 CEMS Audits ( RAA or CGA) b 160 2 320 7 112d $ 6,198.03 C. Create Information Included in 3B D. Gather Existing Information Included in 3E E. Write Report Notification Requirementsa ______________________________________ Not Applicable ___________________________________________

Report of performance testb 2 1 2 7 14 $ 774.76 Quarterly Emission Reports 4 4 16 340f 5,440 $ 301,049.60 Semiannual Emission Reports 2 2 4 90f 360 $ 19,922.40 4. RECORDKEEPING REQUIREMENTS A. Read Instructions Included in 3A B. Plan Activities Included in 3B C. Implement Activities Included in 3B D. Develop Record System ____________________________________ Not Applicable ______________________________________________

E. Time to Enter Information 0.25 350e 87.5 130 11,375 $ 629,492.50 Records of operating parameters F. Train Personnel ____________________________________ Not Applicable _____________________________________________

G. Audits ____________________________________ Not Applicable _____________________________________________

))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

5. TOTAL ANNUAL BURDEN 17,359 $ 960,646.01 ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

a Assume that on average, no new sources will be subject to Subpart J. Therefore, estimate is for existing sources only.

b Assume the 5% of the existing sources are requested by the regulatory agency to conduct a performance test.

c Assume an hourly wage of $ 26.35 plus 110 percent overhead costs which equals $ 55.34. This amount was multiplied by the hours per year in Column E.

d Person hours and annual cost are estimated to be 5% of the time that a CEMS is in operation. ( E=. 05CxD)

e Assume operation 350 days per year as specified in the NSPS review document f Assume that 65% ( 85/ 130) of respondents will have quarterly reports and 35% ( 45/ 130) will report semiannually.


June 19, 2000 Page 1 Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection TITLE: Voluntary Cover Sheet for TSCA Submissions EPA ICR No.: 1780.02 OMB Control No.: 2070 0156 1( b) Short Characterization This Information Collection Request ( ICR) pertains to the voluntary use of a cover sheet that has been developed by industry and EPA to facilitate the processing of information that is submitted to the Agency under sections 4 and 8 of the Toxic Substances Control Act ( TSCA). The cost and burdens related to the submissions under TSCA sections 4 and 8 have already been approved the Office of Management and Budget ( OMB) and are contained in the following ICRs:

( 1) The ICR for TSCA section 4 submissions are found in " Section 4 Test Rules and Consent Orders," OMB No. 2070 0033, EPA ICR No. 1139. ( 2) The ICR for TSCA section 8( d) submissions are found in " TSCA Section 8( d) Health and Safety Data Reporting Rule," OMB No. 2070 0004, EPA ICR No. 0575. ( 3) The ICR for TSCA section 8( e) reporting requirements are found in " Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e)," OMB No. 2070 0046, EPA ICR No. 0794.

This ICR, therefore, only applies to the burden and costs associated with the use of the voluntary cover sheet for those submissions.

Under TSCA sections 4 and 8, industry is required to submit certain information and studies for existing chemical substances. Under normal TSCA reporting conditions, EPA receives approximately 1,700 submissions each year; with each submission consisting of three studies, on average. In addition, specific data ( study) call ins may also be imposed on industry.

The submissions that EPA receives can be numerous, lengthy and complex. For example, EPA received 10,000 submissions in FY 1992 in response to the TSCA Section 8( e) Compliance Audit Program. Processing of these submissions was completed in FY 1995. In June 1994, OPPT received 900 submissions, representing approximately 3,500 studies, under a TSCA section 8( d) data call in for siloxanes in support of the TSCARECEIVED OPPT NCIC 2003 July 25 9: 56AM OPPT 2003 0048 0002 June 19, 2000 Page 2 mandated Interagency Testing Committee ( ITC).

Submissions/ studies are received, logged, internally tracked, duplicated, distributed to government scientists for review and analysis, indexed, microfiched and made publicly available through the TSCA Test Submissions ( TSCATS) database. However, TSCATS is only an online index of, and pointer system to, the large volume of unpublished studies; the full texts are available only in paper or on microfiche.

Under the auspices and funding of the Silicone Environmental Health and Safety Council ( SEHSC), industry, EPA, and the ITC developed a model software application for submitting summary data for the section 8( d) siloxane data call in. This model was designed around the TSCATS data structure but expanded to include additional data elements deemed valuable by industry. The objective was to capture comprehensively all submissions and studies from the ten SEHSC member companies for EPA's more efficient and effective receipt, tracking, processing, identification, internal and external search and retrieval, and upload to TSCATS for public availability. In addition, discussions were initiated and are ongoing for the electronic transfer by electronic medium or EDI of full submissions.

OPPT has initiated a voluntary pilot program to accept certain Health and Safety Data submissions in an electronic format. Participating companies submit TSCA Health and Safety Study Cover Sheet( s) with attached electronic copies of the studies over the Internet. The attached studies are submitted in Portable Document Format ( PDF) and digitally signed using the Public Key Infrastructure ( PKI) standard. Allowing industry to submit TSCA Health and Safety Studies over the Web will reduce burden on Industry as well as the Agency by incorporating standardization and indexing of data, on line help and automatic processing. This will also assist EPA in meeting goals established in the Paperwork Reduction Act ( PRA) and the Government Paperwork Elimination Act ( GPEA).

As a follow up to the experience with the TSCA section 8( d) siloxane data call in, the Chemical Manufacturers Association ( CMA), the Specialty Organics Chemical Manufacturers Association ( SOCMA), and the Chemical Industry Data Exchange ( CIDX), are actively and cooperatively pursuing summary data transfer by software application and EDI. In particular, CMA lead the effort to develop the standardized cover sheet for voluntary use by industry as a first step to an electronic future and to begin familiarizing companies with standard requirements and concepts of electronic commerce. This form, entitled " TSCA Health and Safety Study Cover Sheet," is designed by CMA for voluntary use as a cover sheet for submissions of information under TSCA sections 4, 8( d) and 8( e).

The voluntary use of a cover sheet facilitates the submission of information by displaying certain basic data elements, permitting EPA more easily to identify, log, track, distribute, review and index submissions, and makes information publicly available more rapidly and at reduced cost via TSCATS, to the mutual benefit of both industry and EPA. It is this form/ cover sheet that is addressed in this information collection request. June 19, 2000 Page 3 June 19, 2000 Page 4 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection The standardized cover sheet discussed in this ICR is used in conjunction with submissions of information as required under TSCA sections 4, 8( d) and 8( e). The need and authority for these reporting requirements are discussed in detail in the information collection requests associated with these requirements and are not themselves relevant to the discussion of the use of the standardized cover sheet form that follows.

CMA and member companies actively utilize electronic commerce in their daily business operations. They recognize the future importance of electronic commerce for all their operations. This TSCA Cover Sheet is a first step in standardizing data and terms to promote the acceptance and implementation of electronic TSCA submissions to and communications with the Agency. CMA has determined that this TSCA Cover Sheet, as a paper and near term electronic version, will achieve efficiencies through industry industry and industry EPA cooperation, will engender more efficient systems, and will result in significant money and time savings.

2( b) Use/ Users of the Data EPA staff in the Office of Pollution Prevention and Toxics ( OPPT) are the primary users of the data found on the standardized cover sheet. OPPT employees use the information displayed on the cover sheet to identify the submission when it reaches EPA without having to examine portions of a submission that may be very lengthy and complex. OPPT staff subsequently use information from the cover sheet to distribute, locate and track the submission as the submission moves through Agency reviews and decision points, to index the data, and to identify the data within the TSCATS database in making the data publicly available.

OPPT and CMA expect the use of the TSCA Cover Sheet by industry will provide EPA the following benefits: expedited processing; reduced errors; improved data quality; more timely EPA access and scientific review; improved communication between EPA and industry submitters; quicker public availability; and overall time and money savings.

In addition, CMA and OPPT expect the use of the TSCA Cover Sheet by industry will provide industry the following benefits: improved internal company storage; more efficient preparation and submission; standardized keywords; improved data quality; quicker decisions; improved understanding of EPA's needs; quicker access through TSCATS to relevant studies by industry toxicologists; and significant potential cost savings from non initiation/ non duplication of studies through rapid TSCATS availability. June 19, 2000 Page 5 3. THE RESPONDENTS AND THE INFORMATION REQUESTED 3( a) Respondents/ SIC Codes Respondents affected by this activity are mainly in SIC categories 28  Chemicals and Allied Products Manufacturers, and 29  Petroleum Refining and related industries.

3( b) Information Requested ( i) Data Items The Voluntary Cover Sheet simply captures certain information that is being submitted under another approved ICR. The data items included on the Cover Sheet are already contained in the attached submission, and include the following:

Data Element Description 1. Submission Type identifies the submission, including the type of submission, and whether it is the initial submission, a follow up or a final report 2. Summary of Attachment allows the respondent to provide a summary or abstract of the attached study or report, any internal company tracking number, an EPA tracking number, and indication of the number of studies submitted.

3. Chemical Identification identifies the chemical( s) addressed in the submission 4. Title of attachment identifies the title of the attached study( s) or report.

5. Indexing Terms allows the respondent to identify the proper terms to use for indexing purposes, which facilitates the search and retrieval of the information.

6. Study/ Report Information provides specific information regarding the the attached study or report, including the source, date of the study or report, sponsor( s), and the length of the document.

7. Submitter Information identifies the submitter and/ or technical contact, including name, title, company, mailing address, phone, e mail address.

8. Comments this section on the form allows the submitter to provide any additional comments, so as to avoid the need or use of a separate cover letter.

9. Signature Signature is required for submissions under section 8( e), so the cover forms provides the opportunity for the submitter to sign the form, so as to avoid the need or use of a separate cover letter. June 19, 2000 Page 6 10. Continuation this simply allows the submitter to expand the response to any of the previous items, if needed, without the need to use a separate cover letter or additional forms.

A copy of the sample Voluntary Cover Sheet for TSCA Submissions is attached, along with the instructions provided to users. CMA designed the form to capture all data and information required under " Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e)," and determined there was significant value for standardized data presentation under TSCA sections 4, 8( d) and 8( e). Additionally, TSCATS index codes to identify study type, subject organism ( if appropriate), and route of exposure ( if appropriate) are included.

( ii) Respondent Activities After making the determination to submit information to EPA under TSCA sections 4 or 8, or to otherwise submit TSCA related chemical information to EPA, the submission of which is covered under separate ICRs, the respondent will decide whether or not to use the TSCA Cover Sheet for that submission. The use of the TSCA Cover Sheet for submissions under TSCA is completely voluntary. However, CMA and SOCMA explicitly solicit and encourage their members to use it for all such submissions.

Once the respondent has decided to use the Voluntary TSCA Cover Sheet, the respondent simply completes the form by transferring or summarizing the information that the respondent has already assembled as part of its submission. In many cases the use of this cover sheet takes the place of a cover or transmittal letter to EPA that the respondent might otherwise routinely prepare, containing much of the same information as is found on the cover sheet. Respondents are not be obliged to prepare or develop additional data or information in order to use the cover sheet.

The completed cover sheet is then included as part of its submission to EPA. Please note, this ICR does not include any burden or costs associated with the actual transmittal of the information to EPA, or that associated with maintaining a copy of the submission in their records. The existing ICRs that address the underlying submission already include the burden and costs associated with copying and mailing the submission to the Agency, and with keeping a copy of the submission in their records.

4. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 4( a) Agency Activities OPPT staff uses the information found on the cover sheet to identify the type of submission or the type of information contained in a submission, to route a submission to other EPA staff for review, evaluation or action, to file or retrieve a submission, and to conduct other routine information management tasks associated with the receipt and June 19, 2000 Page 7 processing of a submission. Since the information appears in a consistent, standardized format, OPPT staff is able to complete these tasks in a highly efficient manner.

OPPT staff review and take action upon the submissions themselves in accordance with procedures that are described in greater detail in the information collection requests associated with the specific reporting requirements previously referenced.

4( b) Collection Methodology and Management Since this is a standardized cover sheet attached to a more detailed and lengthy submission, the collection methodology and management of this cover sheet necessarily follows the collection methodology and management associated with the specific information collections for which this cover sheet will be utilized. These collections are described in greater detail in the information collection requests associated with the specific reporting requirements previously referenced.

In general EPA staff enters the information found on the cover sheet into Agency information management systems so as to identify, locate and track the submission as the submission moves through appropriate Agency reviews and actions. EPA anticipates that the use of the cover sheet by respondents will result in cost and time savings, greater data accuracy and quality, and more timely public availability to data.

4( c) Small Entity Flexibility The use of this voluntary cover sheet does not directly affect any existing small entity flexibility applicable to respondents to the reporting requirements under TSCA sections 4, 8( d) or 8( e). Any small entity flexibility associated with these collections is described in greater detail in the information collection requests associated with these reporting requirements. ( In general, reporting requirements under TSCA sections 8( d) and 8( e) apply to all respondents, regardless of size. Small entities required to report under TSCA section 4 have certain options available to them in responding to those requirements). For those respondents, whether large or small, that are required to respond to these information collections, the use of this cover sheet should provide a more efficient means of submitting required information. However, since the use of this cover sheet is strictly voluntary, a respondent may choose not to use the form at all.

4( d) Collection Schedule Since this is a standardized cover sheet attached to a more detailed and lengthy submission, the collection schedule associated with this cover sheet necessarily follows the collection schedules associated with the specific information collections for which this cover sheet will be utilized. In general, responses to reporting requirements under TSCA sections 4, 8( d), 8( e) and FYI are " on occasion" responses for which a strict collection schedule does not apply. June 19, 2000 Page 8 5. NON DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA 5( a) Non Duplication The use of the voluntary TSCA Cover Sheet is not a separate collection activity, it simply offers a cover form that may be used in conjunction with other submissions. These submissions still occur only once. As such, there is no duplicative collection.

5( b) Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA provided a 60 day public notice and comment period that ended on November 30, 1999 ( 64 FR 53377, October 1, 1999). EPA received no comments during the comment period.

5( c) Consultations This effort developed from the cooperative effort among the Silicone Environmental Health and Safety Council ( SEHSC), the Interagency Testing Committee ( ITC), and EPA for the SEHSC developed data base effort in response to the 30th ITC list/ TSCA section 8( d) reporting. Out of this effort, CMA and SOCMA initiated subsequent discussions with EPA for their design and pilot of the Voluntary TSCA Cover Sheet. CMA and SOCMA are committed to encouraging member companies to use the cover sheet when submitting TSCA studies under sections 4, 8( d) and 8( e) to EPA.

CMA, in consultation and in cooperation with EPA, is pursuing development of an electronic version of this cover sheet for availability through the Internet. This electronic form could be interactively completed and immediately transmitted for even more efficient, timely and complete data. EPA intends actively to continue this effort in cooperation with CMA and any other interested parties.

5( d) Effects of Less Frequent Collection Since the use of this cover sheet is strictly voluntary on the part of respondents, this is not applicable.

5( e) General Guidelines To the best of EPA's knowledge, the use of this cover sheet does not exceed any of the PRA guidelines at 5 CFR 1320.6.

5( f) Confidentiality Any information included on the cover sheet may be claimed as confidential by the respondent. Claims of confidentiality are handled according to EPA procedures described in 40 CFR Part 2 and in the TSCA Confidential Business Information Security June 19, 2000 1 Based on an estimated labor cost of $ 75/ hour, as discussed in section 6( b).

2 Section 4 Test Rules and Consent Orders; OMB No. 2070 0033; EPA ICR No. 1139; April 1996.

3 TSCA Section 8( d) Health and Safety Data Reporting Rule; OMB No. 2070 0004; EPA ICR No. 0575; April, 1996.

Page 9 Manual, which call for careful protection of confidential, trade secret or proprietary information.

5( g) Sensitive Questions This information collection does not include questions of a sensitive nature.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION In using this voluntary TSCA Cover Sheet effort, respondents are not required to generate any new data, they simply need to transfer information from the underlying submission to the cover sheet. Although the information included in the cover sheet is often included in a cover letter, the Agency has not attempted to estimate any burden adjustment to the underlying ICRs to reflect the use of the voluntary TSCA Cover Sheet, rather than a cover letter to the Agency. This ICR only estimates the burden and costs associated with the use of the voluntary TSCA Cover Sheet. As such, it estimates the burden and costs related to the respondent's review of the instructions, completion of the form, and the identification of the appropriate TSCATS study index terms.

6( a) Estimating Respondent Burden Based on the industry estimates provided during the CMA initiated twelve month pilot of the cover sheet in the spring of 1996, which ranged from 15 minutes to an hour, the Agency estimates that the average burden associated with using of the cover sheet is approximately 30 minutes ( 0.5 hour).

Using the most recent estimates of the yearly average number of potential submissions expected under the other ICRs for submissions related to TSCA sections 4, 8( d) and 8( e), and assuming that the voluntary TSCA Cover Sheet was used for each and every submission, Table 1 illustrates the total potential burden related to this ICR.

Table 1   Total Maximum Potential Burden Submission Type Total # of Annual Submissions Cover Sheet Burden Costs1 Totals Burden Costs TSCA § 42 168 0.5 $ 37.50 84 $ 3,150.00 TSCA § 8( d) 3 852 0.5 $ 37.50 426 $ 15,975.00 June 19, 2000 4 Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794; June 1997.

5 Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794; June 1997.

6 Since FYI submissions are only submitted when the respondent wishes to do so, the annual potential submissions varies greatly and is highly unpredictable. The Agency believes that it is therefore reasonable to use 10 in this estimate.

Page 10 TSCA § 8( e)  initial4 250 0.5 $ 37.50 125 $ 46,875.00 TSCA § 8( e)  follow up5 550 0.5 $ 37.50 275 $ 13,312.50 FYI Submissions6 10 0.5 $ 37.50 5 $ 187.50 Total Potential Burden 1,830 0.5 $ 37.50 915 $ 79,500.00 Since the Voluntary TSCA Cover Sheet is expected to be used in lieu of the letter that has been used in the past to transmit submission to the Agency, this burden should not be considered additive to the existing burden estimates provided in the underlying ICRs. Accounting for this separately in this ICR may also result in the double counting of this particular burden. However, the Agency wishes to continue the voluntary use of this cover sheet and will account for its minimal burden separately until the form is more widely used.

6( b) Estimating Respondent Cost Based on the information provided by CMA, a technical level person is expected to complete the voluntary TSCA Cover Sheet. For purposes of estimated the cost associated with completing this cover sheet, the Agency used the most current average industry labor costs of $ 75 per hour ( Source: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794; June 1997). As illustrated in Table 1, the total potential cost associated with completing the cover form is $ 79,500.

6( c) Estimating Agency Burden and Cost Industry use of the cover sheet does not increase Agency burden and cost over that currently associated with these information collections. It is anticipated, in fact, that the Agency's costs for data processing, system support and storage and distribution may decrease. Currently EPA staff must extract cover sheet information from the submission itself and any accompanying cover letter; this task will be eased by EPA staff being able to obtain necessary information directly from the standardized form.

Current Agency burden and costs are:

Section 4: 606 hours/$ 99,034 June 19, 2000 Page 11 ( Source: Section 4 Test Rules and Consent Orders; OMB No. 2070 0033; EPA ICR No. 1139.05; April 1996)

Section 8( d): 7,280 hours/$ 164,751 ( Source: TSCA Section 8( d) Health and Safety Data Reporting Rule; OMB No. 2070 0004; EPA ICR No. 0575.07; April, 1996)

Section 8( e): $ 100,000 ( Source: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794.08; June1997)

In addition, it should be noted that the time and costs for making publicly available TSCA data and information in TSCATS is estimated to be reduced by approximately 25 33% for studies/ submissions utilizing the voluntary cover sheet.

6( d) Bottom Line Burden Hours and Costs ( i) Respondent Tally Each use of the cover sheet is estimated to result in a burden of 0.5 hours, at a cost of $ 37.50. The Agency estimates a maximum total of 1,830 submissions each year, so the total potential burden associated with this ICR is estimated to be 915 hours, at an estimated cost of $ 79,500.

( ii) Agency Tally Industry use of the cover sheet does not increase Agency burden and cost over that currently associated with the underlying information collections with which the cover sheet is used, which are covered by other ICRs.

6( e) Reasons for Change in Burden The burden hours included in this request represents a decrease of 433 hours in the annual burden, from 1,348 hours to 915 hours, from the request most recently approved by OMB. This decrease reflects a net decrease in the estimated number of submissions under TSCA sections 4, 8( d) and 8( e). Since the use of the Voluntary TSCA Cover Sheet is a direct reflection of the number of submissions received under TSCA sections 4, 8( d) and 8( e), any change in the estimated numbers of submissions under those requirements may be viewed as a potential parallel change in the burden hours associated with this information collection. The potential number of annual submissions may change from year to year, but the Agency believes that the estimated number of submissions used in this ICR is reasonable. This represents an adjustment.

6( f) Burden Statement June 19, 2000 Page 12 The annual public burden for this collection of information, which is approved under OMB Control No. 2070 0156 ( EPA ICR # 1780.02), is estimated to average 0.5 hours per response. According to the Paperwork Reduction Act, " 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. For this collection it includes the time needed to review instructions; train personnel to be able to respond to the collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. 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 this information collection appears above and on the form. In addition, the OMB control number for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

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 Director, Collection Strategies Division ( Mail Code 2822), U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D. C. 20460. Include the OMB control number in any correspondence but do not submit the requested information to this address. The completed forms should be submitted in accordance with the instructions accompanying the form, or as specified in the corresponding regulation.

Attachments to this Supporting Statement:

TSCA Health & Safety Study Cover Sheet and Instructions June 19, 2000 ATTACHMENT TSCA Health & Safety Study Cover Sheet and Instructions Approved Under OMB Control # 2070 0156 TSCA HEALTH & SAFETY STUDY COVER SHEET Use of this form is voluntary, but recommended by EPA as a cover sheet for TSCA section 4, 8( d), and 8( e) submssions to expedite and improve the management, processing, quality, review, and public availability of data in TSCATS TSCA CBI STATUS: 9 CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION ( CBI) Clearly mark the confidential information with bracketing and check the box in the appropriate section ( 9 Contains CBI). Submit a sanitized cover sheet with CBI deleted. Mark the sanitized copy, " Public Display Copy" in the heading.

1.0 SUBMISSION TYPE 9 Contains CBI 9 8( d) 9 8( e) 9 FYI 9 4 9 OTHER: Specify____________________ 9 Initial Submission 9 Follow up Submission 9 Final Report Submission Previous EPA Submission Number or Title if update or follow up: Docket Number, if any: # ITC Submission 9 Yes 9 No 9 continuation sheet attached 2.1 SUMMARY/ ABSTRACT ATTACHED ( may be required for 8( e): optional for § 4, 8( d) & FYI) 9 YES 9 NO 2.2 SUBMITTER TRACKING NUMBER OR INTERNAL ID 2.3 FOR EPA USE ONLY 2.4 Study ___ of ____

3.0 CHEMICAL/ TEST SUBSTANCE IDENTITY 9 Contains CBI Reported Chemical Name ( specify nomenclature if other than CAS name): CAS#__________________ Purity _______% 9 Single Ingredient 9 Commercial/ Tech Grade 9 Mixture Trade Name: ________________________ Common Name: __________________________ CAS Number NAME % WEIGHT Other chemical( s) present in tested mixture 9 continuation sheet attached 4.0 REPORT/ STUDY TITLE 9 Contains CBI 9 continuation sheet attached 5.1 STUDY/ TSCATS INDEXING TERMS [ CHECK ONE] HEALTH EFFECTS ( HE): ENVIRONMENTAL EFFECTS ( EE): ENVIRONMENTAL FATE ( EF):_____ 5.2 STUDY/ TSCATS INDEXING TERMS ( see instructions for 4 digit codes) STUDY SUBJECT ROUTE OF VEHICLE OF TYPE: ___________ ORGANISM ( HE, EE only): EXPOSURE ( HE only): EXPOSURE ( HE only)_____ Other:____________ Other:_________________________ Other: ____________________ Other:__________________ 6.0 REPORT/ STUDY INFORMATION 9 Contains CBI 9 Study is GLP Laboratory Report/ Study Date_______ Source of Data/ Study Sponsor ( if different than submitter) Number of pages _________ 9 continuation sheet attached 7.0 SUBMITTER INFORMATION 9 Contains CBI Submitter: _____________________________________ Title: ________________________ Phone: ( )______________ Company Name: _________________________________ Company Address:_____________________________________ _____________________________________________ ________________________________________ _______________________________________________ Submitter Address ( if different): _____________________________________ Technical Contact: ________________ ______________ Phone: ( )______________ 9 continuation sheet attached e mail address__________________________________________________________ June 19, 2000 8.0 ADDITIONAL COMMENTS 9 Contains CBI 9 continuation sheet attached Submitter Signature: Date:

EPA Form No. ( Revised 6/ 25/ 96) Page____ of____ Approved Under OMB Control # 2070 0156 TSCA HEALTH & SAFETY STUDY COVER SHEET 9.0 CONTINUATION SHEET TSCA CBI STATUS: 9 CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION ( CBI) Clearly mark the confidential information with bracketing and check the box in the appropriate section ( 9 Contains CBI). Submit a sanitized cover sheet with CBI deleted. Mark the sanitized copy, " Public Display Copy" in the heading.

Submitter Tracking Number/ Internal ID CONTINUED FROM COVER SHEET SECTION # _______________ June 19, 2000 9 Contains CBI EPA Form No.  C ( Revised 6/ 25/ 96) Page____ of____ Approved under OMB Control # 2070 0156 TSCA HEALTH & SAFETY STUDY COVER SHEET  INSTRUCTIONS ( Note: Do not mail these instructions with your submission)

Paperwork Reduction Act Notice The annual public burden for this collection of information is estimated to average 30 minutes per response, including the time needed for reading the instructions and completing the necessary information contained in this form . Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, Collection Strategies Division, Office of Environmental Information, U. S. Environmental Protection Agency ( Mail Code 2822), 1200 Pennsylvania Avenue, N. W., Washington, D. C. 20460. Include OMB number 2070 0156 in any correspondence. Do not send the completed form to this address. The actual information or form should be submitted in accordance with the instructions specified in the corresponding regulations General Instructions ° This voluntary cover sheet was designed to serve as a tool for industry and EPA in the preparation, processing, review, and availability of TSCA information, and as an alternative for cover letters to TSCA submissions.

° As with all EPA submissions, follow applicable EPA regulations and guidance in submitting the information.

° A check box at the top has been provided to indicate if there is confidential business information ( CBI). Check this box if the page contains information that is confidential. For information what can be claimed confidential under TSCA refer to TSCA section 14, 40 CFR Part 2 Sub Part B and other applicable EPA and TSCA guidance. If the page contains CBI, clearly mark the information with bracketing. Check the box " Contains CBI" in the appropriate section. Submit another cover sheet with the CBI deleted and mark " Public Display Copy" in the heading.

° Under TSCA reporting requirements, a submission may contain multiple studies. A cover sheet should be completed for each study in the submission and go to box 2.4 and add Study 1 of 1 for a submission having a single study, Study 1 of x, Study 2 of x, etc. ( for a submission having multiple or x number of studies).

° A cover sheet is unnecessary for submissions containing no health and safety data. Examples of submissions with no health and safety data include: section 4 related correspondence on issues of different test protocols; section 8( e) or FYI voluntary actions of submitters to reduce exposures; information on chemical use or commercial status; substantiation for submitting FYI vs 8( e). If a submission is related to a previous submission, please reference the EPA assigned Document ID for PMN, 8( e) and FYI submissions ( PMN, 8EHQ and FYI numbers). For other submissions, please reference the EPA Document Control Number ( DCN) or Study title with submission date. The EPA will provide the Document ID as well as the DCN when acknowledging PMNs, 8( e) s and FYIs.

If additional space is needed in any of the sections of the Cover Sheet, please check the " continuation sheet attached" box in the appropriate section and attach a Continuation Sheet ( a standardized continuation sheet has been provided; it is titled 9.0 Continuation Sheet). INSTRUCTIONS  continued page 2 ° It is important to indicate if a study/ submission is initial, follow up or final. An initial submission is for a given chemical/ case identified or initiated by a company. A follow up or a supplement is a submission which contains information specifically requested by EPA ( Follow up) or information related to a previous submission but not specifically requested by EPA ( Supplement).

° Please attach to the cover sheet package an abstract or summary for each study prepared by or for the submitter, if available, and check the box " YES" under section 2.1. Otherwise check the box " NO". [ Note: a summary/ abstract is required under 8( e).]

° Space is provided in section 8.0 for the submitter to provide any additional study interpretation, comments, etc which could immediately assist in EPA's screening and review of the study/ submission. A continuation sheet may be attached.

° If any information in the cover sheet is unknown, write " unknown." If it is not applicable write " N. A." Provide written explanation if appropriate.

Detailed Instructions For Completing Cover Sheet TSCA CBI ( Confidential Business Information) Status  Check this box if the page contains information that is confidential. For information what can be claimed confidential under TSCA refer to TSCA section 14, 40 CFR Part 2 Sub Part B and other applicable EPA and TSCA guidance. If the page contains CBI, clearly mark the information with bracketing. Check the box " Contains CBI" in the appropriate section. Submit another cover sheet with the CBI deleted and mark " Public Display Copy" in the heading.

1.0 Submission Type  Check one of the boxes for the TSCA section that the submission is being made under 8( d), 8( e), FYI, 4 or OTHER. Check the appropriate box to indicate if a study/ submission is initial, follow up or final. An initial submission is for a given chemical/ case identified or initiated by a company. A follow up or a supplement is a submission which contains information specifically requested by EPA ( Follow up) or information related to a previous submission but not specifically requested by EPA ( Supplement).

2.1 Summary/ Abstract Attached  Please attach to the cover sheet package an abstract or summary for each study prepared by or for the submitter, if available, and check the box " YES" under section 2.1. Otherwise check the box " NO". [ Note: a summary/ abstract may be required under 8( e).]

2.2 Submitter Tracking Number or Internal ID  Enter an internal company id number; also, write this ID on the complete submission for easy linkage to and retrieval of the entire study/ submission for EPA processing, review, and public availability.

2.3 For EPA Use Only  Please leave this section blank. This is for EPA purposes such as assignment of submission tracking numbers.

2.4 Study of  INSTRUCTIONS  continued page 3 3.0 Chemical/ Test Substance Identity  If additional space is required for any chemical identity data element, check the continuation box and attach a continuation sheet appropriately identifying the relevant specific data element and referencing the study/ submission. Enter the CAS# of the chemical for the specific study of the cover sheet. Enter the chemical name; specify nomenclature if other than CAS name. Enter the % purity if impurities are present, leave blank if unknown. Check one of three boxes indicating if the chemical is a single ingredient ( e. g., 100% NaCl), technical grade product ( e. g., 50% NaOH solution), or mixture ( e. g., perfume formula with many ingredients). Enter the trade names and common names for the material if applicable. If the test substance contains more than one chemical, list the components by CAS number, name, and % weight in the mixture. Submitters are requested to provide informative generic chemical names for substances whose chemical identity has been claimed TSCA confidential business information.

4.0 Report/ Study Title  Provide the title of the entire submission, not the title of any specific study subsection; if insufficient space, check the continuation box and attach a continuation sheet with the complete title.

5.1 Study/ TSCATS Indexing Terms  Check either Health Effects, Environmental Effects, or Environmental Fate  check only one.

5.2 Study/ TSCATS Indexing Terms  See the attached Study Indexing Terms Sheet. Find appropriate ( checked) Study Type and select relevant, detailed Study Type ( for HE, EE, EF), Subject Organism ( HE, EE only), Route of Exposure ( HE only), and Vehicle ( HE only, if applicable); transfer the 4 letter TSCATS code to the cover sheet. If an appropriate indexing term is not available, check other box and clearly print description.

6.0 Report/ Study Information  If additional space is required for any study information data, check the continuation box and attach a continuation sheet identifying the relevant specific data element and referencing the study/ submission. Enter the complete name of the contractor or laboratory which conducted the study. Include the source of data or study sponsor, if different than the submitter. Enter the actual completion date of the study/ submission as dd/ mm/ yy. Check GLP box if existing Good Laboratory Practices were used in the conduct of the study.

7.0 Submitter Information  If additional space is required for any submitter information, check the continuation box and attach a continuation sheet identifying this data element and referencing the study/ submission ( e. g. submitter tracking number). Enter submitter name, title, and phone. Enter company name and address. Enter the address of the submitter if the submitters address is different than the company address. Please provide a key technical contact name and telephone number of an individual who can discuss the content/ substance of the study/ submission during the EPA scientific review process.

8.0 Additional Comments  This space is provided for the submitter to provide any additional study interpretation, comments, etc., which could immediately assist in EPA's screening and review of the study/ submission. A continuation sheet may be attached. For TSCA section 8( e) and FYI submissions state rationale for submitting information as 8( e) versus FYI and voluntary actions taken by the submitter in response to the new information.

Submitter Signature/ Date  TSCA section 8( e) submissions must be signed by the submitter and dated. All submissions should be submitted by certified mail with return receipt to demonstrate submission receipt by the EPA.

9.0 Continuation Sheet  If additional space is needed in any of the sections of the cover sheet, please check the " continuation sheet attached" box in the appropriate section and attach a Continuation Sheet, Section 9.0. INSTRUCTIONS  continued page 4 STUDY INDEXING TERMS FOR HEALTH EFFECT ( HE) STUDIES ONLY Study Type ___ Acute Toxicity ( ATOX) ___ Subchronic Toxicity ( STOX) ___ Chronic Toxicity ( CTOX) ___ Carcinogenicity ( CARC) ___ Combined Chronic Toxicity/ Carcinogenicity ( CTCA) ___ Cell Transformation ( TRFM) ___ Biochemical Interactions and/ or Mechanism of Toxic Effects ( BCHM) ___ Absorption, Distribution, Metabolism Excretion ( ADME) ___ Primary Dermal Sensitization ( DSEN) ___ Primary Dermal irritation ( DIRR) ___ Primary Eye irritation ( EIRR) ___ Reproduction/ Fertility Effects ( RTOX) Teratology ( TERA) ___ Combined Teratology/ Reproductive Effects ( TERE) ___ Epidemiology Study ( EPID) ___ Case Report ( CASE) ___ Genotoxicity ( GTOX) ___ Gene Mutation ( MUTA) ___ Chromosomal Effects ( CHRM) ___ DNA Effects ( DNAF) ___ Tissue Determination Concentration ( TCON) ___ Industrial Hygiene ( HYGN) ___ Neurotoxicity ( NEUR) ___ Immunotoxicity ( ITOX) ___ Target Organ Toxicity: specify____ ___ Other: specify_________________ Subject Organism/ Test System ___ Mammals ( MAMM) ___ Rats ( RATS) ___ Mice ( MICE) ___ Hamsters ( HAMS) ___ Guinea Pigs ( GUIN) ___ Rabbits ( RABB) ___ Dogs ( DOGS) ___ Cats ( CATS) ___ Monkeys ( MNKY) ___ Pigs ( PIGS) ___ Cattle ( COWS) ___ Sheep ( SHEP) ___ Goats ( GOAT) ___ Humans ( HUMN) ___ Other Mammals ( OTMA) ___ Bacteria ( BACT) ___ Algae ( ALGA) ___ Fungi ( FUNG) ___ Yeast ( YEST) ___ Plant ( PLNT) ___ Insect ( INSE) ___ Bird ( BIRD) Route of Exposure ___ Oral ( ORAL) ___ Gavage ( GAVG) ___ Dermal ( DERM) ___ Inhalation ( INHL) ___ Intratracheal Instillation ( INTR) ___ Parenteral ( PARN) ___ Intravenous ( INTV) ___ Intraperitoneal ( INTP) ___ Intramuscular ( INTM) ___ Subcutaneous ( SUBC) ___ Implant ( IMPL) ___ Transplacental ( TRPL) ___ In Vitro ( INVR)

Vehicle of Exposure ( check only if applicable)

___ Water ___ Corn Oil ___ Food ___ Other: specify________________

FOR ENVIRONMENTAL EFFECT ( EE) STUDIES ONLY FOR ENVIRONMENTAL FATE ( EF) STUDIES ONLY Study Type ___ Acute Toxicity ( ATOX) ___ Subchronic Toxicity ( STOX) ___ Chronic Toxicity ( CTOX) ___ Critical Life Stage Test ( CLIF) ___ Seed Germination Test ( SEED) ___ Plant Growth or Damage Test ( PGRD) ___ Microbiological Function Test ( MICR) ___ Ecosystem Modeling ( ECOS) ___ Reproduction/ Fertilization Test ( RTOX) ___ Absorption, Distribution, Metabolism Excretion ( ADME) ___ Tissue Concentration ( TCON) ___ Other Environmental Effects ( OTEE) specify __________________________ Subject Organism ___ Bacteria ( BACT) ___ Algae ( ALGA) ___ Fungi ( FUNG) ___ Yeast ( YEST) ___ Plant ( PLNT) ___ Amphibians ( AMPH) ___ Mollusks ( MOLL) ___ Fish  Freshwater ( FFRE) ___ Fish  Marine ( FMAR) ___ Reptiles ( REPT) ___ Bird ( BIRD) ___ Insect ( INSE) ___ Invertebrates ( INVE) ___ Other Wildlife ( WILD) specify ________________________ Study Type ___ Physical / Chemical Properties ( PCHE) ___ Water Solubility ( WSOL) ___ Vapor Pressure ( VPRE) ___ Partition Coefficient ( PART) ___ Dissociation Constant ( DISS) ___ Henry's Law Constant ( HLAW) ___ Transport Processes ( TSPT) ___ Biodegradation ( BDEG) ___ Bioconcentration / Bioaccumulation ( BIOC) ___ Photolysis ( PHOT) ___ Hydrolysis ( HYDR) ___ Monitoring Information ( MONT) ___ Production and Process Info ( PROD) ___ Other Studies ( OTHR) specify ____________________________


[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8081-8082]
[FR Doc No: 2010-3552]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0585]

Patrick J. Lais: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) permanently
debarring Patrick J. Lais from providing services in any capacity to a
person that has an approved or pending drug product application. We
base this order on a finding that Mr. Lais was convicted of a felony
under Federal law for conduct relating to the regulation of a drug
product under the act. Mr. Lais has notified FDA that he acquiesces to
debarment, and therefore has waived his opportunity for a hearing
concerning this action.

DATES: This order is effective February 23, 2010.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On April 25, 2005, Mr. Patrick J. Lais, formerly president of York
Pharmaceutical, pleaded guilty to introducing and delivering, and
causing to be introduced and delivered into interstate commerce, a drug
that was adulterated within the meaning of 21 U.S.C. 351(a)(2)(B) of
the act, a felony under Federal law in violation of 21 U.S.C. 331(a)
and 333(a)(2). Judgment was entered against him for this felony on
August 15, 2005. The basis for this conviction was as follows:
    Beginning in 1997 and lasting until September 2001, Mr. Lais was
the president of York Pharmaceutical (York). Mr. Lais had
responsibility for and authority over drug manufacturing at York. York
manufactured generic over-the-counter drugs during the period January
1999 through July 2001.
    York distributed in interstate commerce human drug products that
were adulterated within the meaning of 21 U.S.C. 351(a)(2)(B) of the
act, in that York manufactured and distributed, among other things,
subpotent burn spray, aspirin that had failed dissolution testing, and
antacid products contaminated with bacteria.
    Mr. Lais knew that York's manufacturing facility lacked basic
validation processes and controls and that York's drug products were
adulterated within the meaning of the act. Mr. Lais also knew that
York: (1) Did not use procedures that ensured that its drugs had the
identity, strength, quality, and purity characteristics that they were
represented to possess; (2) did not test raw materials before using
them; (3) did not perform appropriate laboratory determinations of
conformance with final specifications for each of its drug products;
(4) shipped drug product known not to meet established quality control
criteria; (5) frequently failed to assess the stability characteristics
of the drugs it produced; (6) did not maintain the buildings used in
the manufacture, processing, packing, and holding of its drug products
in a clean and sanitary condition; and (7) did not clean, maintain, and
sanitize its manufacturing equipment and utensils in such a way as to
prevent contamination of final drug products.
    In January 2000, York manufactured and compressed a drug product
identified as ``Uncoated Aspirin.'' This drug failed its final
dissolution testing. Neither Mr. Lais nor the employees under his
authority and control determined the cause of the dissolution failure.
Rather, York coated the failed aspirin and renumbered the lot. Part of
this lot then was packaged as ``Coated Aspirin.'' On or about February
21, 2000, Mr. Lais caused the shipment of 625 cases of adulterated drug
products, identified as ``Coated Aspirin,'' to customers in Kansas
City, MO. In May 2000, this ``Coated Aspirin'' failed 3-month stability
testing. Mr. Lais and the employees under his authority and control did
not determine the cause of the failure and did not inform York's
customers that the aspirin was adulterated.

    Mr. Lais is subject to debarment based on a finding, under section
306(a)(2)(B) of the act (21 U.S.C. 355a(a)(2)(B)), that he was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product.
    In the plea agreement entered on April 25, 2005, Mr. Lais expressly
waived his right, if any, to contest any debarment that may be
initiated by the Secretary of Health and Human Services under 21
U.S.C.335a. In accordance with section 306(c)(2)(B) of the act, Mr.
Lais notified FDA of his acquiescence to debarment in a letter signed
on October 3, 2006. A person subject to debarment is entitled to an
opportunity for an agency hearing on disputed issues of material fact
under section 306(i) of the act, but by acquiescing to debarment Mr.
Lais waived his opportunity for a hearing and to raise any contentions
concerning his debarment.

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the act, under
authority delegated to the Acting Director (Staff Manual Guide
1410.35), finds that Patrick J. Lais has been convicted of a felony
under Federal law for conduct relating to the regulation of a drug
product under the act.
    As a result of the foregoing finding and based on his notification
of acquiescence, Mr. Lais is permanently debarred from providing
services in any capacity to a person with an approved or pending drug
product application under sections 505, 512, or 802 of the act (21
U.S.C. 355, 360b, or 382), or under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective October 3, 2006, the date of
notification of acquiescence (see sections 306(c)(1)(B), (c)(2)(A)(ii),
and 201(dd) of the act (21 U.S.C. 321(dd))). Any person with an
approved or pending drug product application who knowingly employs or
retains as a consultant or contractor, or otherwise uses the services
of Patrick J. Lais, in any capacity during Mr. Lais's debarment, will
be subject to civil money penalties (section 307(a)(6) of the act (21
U.S.C. 335b(a)(6))). If Mr. Lais provides services in any capacity to a
person with an approved or pending drug product application during his
period of debarment he will be subject to civil money penalties
(section 307(a)(7) of the act). In addition, FDA will not accept or
review any abbreviated new drug applications submitted by or with the
assistance of Mr. Lais during his period of debarment (section
306(c)(1)(B) of the act).
    Any application by Mr. Lais for special termination of debarment
under section 306(d)(4) of the act should be identified with Docket No.
FDA-2009-N-0585 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 26, 2010.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-3552 Filed 2-22-10; 8:45 am]
BILLING CODE 4160-01-S