	SUPPORTING STATEMENT

	ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Portland Cement (40 CFR Part 63, Subpart LLL) (Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Portland Cement (40 CFR Part 63, Subpart LLL) (Renewal),

EPA ICR Number 1801.08, OMB Control Number 2060-0416

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for the regulations published at 40 CFR part 63, subpart LLL, were proposed on March 24, 1998, promulgated on June 14, 1999, and subsequently revised on December 20, 2006.  These regulations apply to the following facilities: each new, existing or reconstructed kiln, in-line kiln/raw mill and greenfield raw material dryer at these facilities, except for kilns and in-line kiln/raw mills that burn hazardous waste and are subject to 40 CFR 63, subpart EEE or that burn municipal solid waste and are subject to 40 CFR part 60, subpart Cb or Ea.  In addition, the rule applies to each new, existing or reconstructed clinker cooler; raw mill; finish mill; raw material, clinker or finished product storage bin; conveying system transfer point; bagging system and bulk loading and unloading system at facilities that are major sources; and to each existing, reconstructed or new brownfield raw material dryer at facilities that are major sources.  This information is being collected to assure compliance with 40 CFR part 63, subpart LLL.

Emission limits for mercury from new cement kilns were established under the December 2006 final amendments. A mercury performance test is required to demonstrate compliance with the emission limits for mercury. The final amendments also established emission limits for total hydrocarbons (THC) for new kilns and revise the emission limits for new greenfield kilns.  To demonstrate compliance with the THC limits, owners or operators of new kilns would be required to continuously monitor THC emissions. To ensure proper combustion of organic HAP from existing kilns, owners or operators of portland cement manufacturing plants must implement good combustion practices (GCP) designed to minimize THC from fuel combustion. Respondents are required to maintain additional records to demonstrate compliance with THC limits. The 2006 final amendments also required that records be kept of the amount of cement kiln dust (CKD) that is removed from existing and new kiln systems and either disposed of as solid waste or otherwise recycled for a beneficial use outside of the kiln system.

In addition to the new requirements established from the 2006 amendments, in general, all NESHAP standards 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.  These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to the NESHAP.

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 five years following the date of such measurements, maintenance reports, and records.  All reports are sent to the delegated state or local authority.  In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency (EPA) regional office.

Approximately 94 portland cement plants with 158 non-hazardous waste cement kilns are currently subject to the regulation.  It is estimated that 20 new kilns will be built over the next five years or 12 additional sources will become subject to the regulation over the next three year ICR period.  All new kilns are estimated to be constructed at existing portland cement plants, and it is estimated that two new kilns will be installed at two existing plants, for a total of 4 new kilns per year.  Since the records and reports are maintained at the plant-level, the estimate for the number of respondents to this ICR is tracked at the plant-level.  Although there are new kilns estimated at existing plants, there are no new respondents estimated during this ICR.

The Office of Management and Budget (OMB) approved the currently active Information Collection Request (ICR) without any ”Terms of Clearance.”

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants.  These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction.  In addition, section 114(a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations,    at such intervals, during such periods, and in such manner as the Administrator shall prescribe); (E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; (F) submit compliance certifications in accordance with section 114(a)(3);  and (G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, hazardous air pollutant (HAP) emissions from portland cement manufacturing facilities cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare.  Therefore, the NESHAP were promulgated for this source category at 40 CFR part 63, subpart LLL.

2(b)  Practical Utility/Users of the Data

The control of emissions of HAPs from portland cement manufacturing facilities requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment.  Emissions of HAPs from portland cement manufacturing facilities are the result of operation of the affected facilities.  The subject standards are achieved by the capture of particulate HAP emissions using fabric filters or electrostatic precipitators control, temperature control for the reduction of dioxins and furans (D/F), and feed selection for reduction of other organic HAP.

The recordkeeping and reporting requirements in the standard(s) ensure compliance with the applicable regulations that were promulgated in accordance with the Clean Air Act.  The collected information is also used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected facility’s initial capability to comply with the emission standards.  Continuous emission monitors are used to ensure compliance with the standards at all times.  During the performance test a record of the operating parameters under which compliance was achieved may be recorded and used to determine compliance in place of a continuous emission monitor.

The notifications required in the standards are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations.  The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and leaks are being detected and repaired and the standards are being met.  The performance test may also be observed.

The required semiannual reports are used to determine periods of excess emissions, identify problems at the facility, verify operation/maintenance procedures and for compliance determinations.

3.  Non-duplication, Consultations, and Other Collection Criteria

The recordkeeping and reporting requested is required under 40 CFR part 63, subpart LLL.

3(a)  Non-duplication

If the 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 its own similar regulation 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 on July 8, 2009 (74 FR 32580).  No comments were received on the burden published in the Federal Register.

3(c)  Consultations

 The agency is basing the burden estimates of this ICR on estimates prepared for the December 20, 2006 amendments. During those amendments, the Agency consulted with industry experts and internal data sources to project the number of affected facilities and industry growth over the next three years.  Those included in those consultations included State and local agencies, individual portland cement manufacturing plants, industry trade associations, and environmental groups. We specifically consulted with stakeholders on some of the ICR requirements of these final amendments.  Participants in the development process for those amendments included STAPPA/ALAPCO, the Portland Cement Association (PCA), the American Portland Cement Alliance (APCA), the Small Company MACT Coalition, the Sierra Club, and Earth Justice.  Several meetings with industry representatives were held in the period leading to proposal and the final amendments, and public comments received from trade associations, cement companies, State and local regulatory agencies, and environmental groups were considered in the development of the current rule. Public comments received following proposal were considered in developing the final amendments regarding monitoring, recordkeeping, or reporting procedures.

It is our policy to respond after a thorough review of comments received since the last ICR renewal as well as those submitted in response to the first Federal Register notice.  In this case, no comments were received.

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 collected less frequently, the proper operation and maintenance of control equipment and the possibility of detecting violations would be less likely.

3(e)  General Guidelines

These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR Part 1320, section 1320.5. However, most NESHAP standards and a few NSPS standards require records to be kept more than three years.  In general, these standards require the respondents to maintain all records, including reports and notifications, for five years.  The five-year record retention requirement is consistent with the permit program at 40 CFR part 70, and the five-year statute of limitations on which the permit program is based.

The retention of records for five years allows EPA to establish the compliance history of the respondent for purposes of determining the appropriate level of enforcement action.  Historically, EPA notes that the most flagrant violations have extended beyond a five-year period.  If records are retained for less than five years, EPA would be deterred from pursuing the most flagrant violations due to the destruction of records documenting noncompliance.

3(f)  Confidentiality

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 (CBI) (see 40 CFR 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

The reporting or recordkeeping requirements in the standard do not include sensitive questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/NAICS Codes

The respondents to the recordkeeping and reporting requirements are portland cement manufacturing facilities.  The United States Standard Industrial Classification (SIC) code for the respondents affected by the standards is 3241 which corresponds to the North American Industry Classification System (NAICS) 32731 for portland cement manufacturing facilities.

4(b)  Information Requested

(i)  Data Items

All data in this ICR that is recorded and/or reported is required by NESHAP for the Portland Cement Manufacturing Industry (40 CFR part 63, subpart LLL).

A source must make the following reports:

Notification Reports

Notification of anticipated startup	63.9(b)(3)

Notification of applicability

63.9(b)(1&2)

Notification of actual startup

63.9(b)(4)

Notification of construction/reconstruction

63.9(b)(5)

Request for extension of compliance

63.9(c)

Notification of special compliance requirements

63.9(d)

Notification of initial performance test

63.9(e), 63.7(b)

Notification of opacity and visible emission observations

63.9(f)

Notification of the continuous emission monitoring performance evaluation

63.8(e), 63.9(g)

Notification of compliance status

63.9(h)

Adjustments to time periods or postmark deadlines for submittal and review of required communications

63.9(i)

Change in information already provided

63.9(j)

Reports

Operations and maintenance plan

63.1350(a)

Report of performance test

63.10(d)(2)

Opacity and visual emission observation

63.10(d)(3)

Progress reports

63.10(d)(4)

Periodic startup, shutdown, malfunction reports

63.10(d)(5)(i)

Immediate startup, shutdown, malfunction reports

63.10(d)(5)(ii)

Reporting results of continuous monitoring system performance evaluations

63.10(e)(2)

Excess emissions and continuous monitoring system performance report and summary report

63.10(e)(3)

Reporting continuous opacity monitoring system data produced during a performance test

63.10(e)(4)

Waiver of recordkeeping and reporting requirements

63.10(f)

A source must maintain the following records:

Recordkeeping

All reports and notifications

63.10(b)

Startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative

63.10(b)(2)

Record of applicability

63.10(b)(3)

Records for sources with continuous monitoring systems

63.10(c)

Records for cement dust kilns (CDK)	63.1355(d)

Records are required to be retained for five (5) years.  The first two (2) years of records must be retained at the facility	63.1355(a), 63.10(b)(1)

(ii)  Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate CMS for: 1) opacity; 2) to record the temperature of the exhaust gases to monitor D/F; 3) to record the rate of carbon injection and the carrier gas parameter, if using activated carbon injection to control D/F; and 4) to measure Total Hydrocarbons (THC), if applicable.

Perform initial performance test, Reference Method 5 test for Particulates, Method 9 test for Opacity, Method 23 test for dioxin/furans (D/F), and Performance Specification 8A of Appendix B to part 60 for THC, if applicable.  Repeat performance tests, if necessary.

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.

Electronic Reporting

At the present, many respondents to CAA standards use monitoring equipment that automatically records parameter data.  Although personnel at the affected facility must evaluate the data, this internal automation has significantly reduced the burden associated with monitoring and recordkeeping at the plant site.

Also regulatory agencies, in cooperation with the respondents, continue to create reporting systems to transmit data electronically.  However, electronic reporting systems are still not widely used.  At this time, it is estimated that approximately 10 percent of the respondents use electronic reporting.

5.  The Information Collected: Agency Activities, Collection Methodology, and Information Management

5(a)  Agency Activities

EPA conducts one or more of the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests, if 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

The required data and reports can be evaluated on-site by conducting a partial compliance evaluation, full compliance evaluation or inspection, or through an off-site review of compliance monitoring records and reports.  Evaluation reports and inspection results are maintained by the Agency or delegated authority.

The results of these evaluations are entered into the Air Facility Subsystem (AFS) which is operated and maintained by EPA's Office of Compliance.  AFS is EPA’s database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government-owned facilities.  EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters.  EPA and delegated authorities can retrieve and analyze the data.

The records required by this regulation must be retained by the owner/operator for five years.

5(c)  Small Entity Flexibility

A majority of the respondents are large entities (i.e., large businesses).  However, the impact on small entities (i.e., small businesses) was taken into consideration during the development of the regulation.  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 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.  The PCA study “U.S. and Canadian Portland Cement Industry:  Plant Information Summary,” indicates there are 35 companies with affected Portland cement facilities.  Of these, six companies (or 17 percent) are considered small entities.  The Agency assumes that 17 percent of the 94 facilities affected by this ICR, or 16 facilities, are small entities.

5(d)  Collection Schedule

The specific frequency for each information collection activity within this request is shown below in Table 1.

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry.  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 28,242 hours (Total Labor Hours from Table 1).  The recordkeeping hours shown below in Table 1 are 25,545 hours.  The reporting requirement hours shown below in Table 1 are 2,697.  These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

This ICR uses the following labor rates:

Managerial	$114.77 ($54.65 + 110%)

Technical	$97.59 ($46.47 + 110%)

Clerical	$48.26 ($22.98 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2009, “Table 2. Civilian Workers, by occupational and industry group.”  The rates are from column 1, “Total compensation.”  The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

The types of industry costs associated with the information collection activity in the regulations are for labor and continuous emission monitoring (CEM).  Since the 2006 amendments required all new kilns constructed on or after December 2, 2005, to install THC monitors, it is also assumed that a THC CEM will be installed on each new kiln. The capital cost and the O&M cost of the THC monitor were estimated using an updated Version 3 of EPA’s Continuous Emission Monitoring System Cost Model.  The capital/startup costs are one-time costs when a facility becomes subject to the regulation.  The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs such as photocopying and postage.

(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring Device

(B)

Capital/Startup Cost for One Respondent

(C)

Number of New Respondents

(D)

Total Capital/Startup Costs,

(B X C)

(E)

Annual O&M Cost for One Respondent

(F)

Number of Respondents with O&M

(G)

Total O&M Costs,

(E X F)

Continuous Emission Monitors

$220,000

4

$880,000

$7,400

94

$791,800

THC Continuous Emission Monitors

$139,800

4

$559,200

$22,073

4

$88,292

The total capital/startup costs for this ICR are $1,439,200.  This is the total of column D in the above table.

The total operation and maintenance (O&M) costs for this ICR are $880,092.  This is the total of column G.

The average annual cost for capital/startup and O&M costs to the industry over the next three years of the ICR is estimated to be $2,319,292.  This is the average annual cost for the 3-year ICR period from column G above which includes annual O&M costs and annualized capital costs as discussed below.  These are recordkeeping costs.

(iv) Annualizing Capital Costs

The capital cost associated for a THC monitor and CEM was annualized assuming a 7 percent interest rate and 10-year life (i.e., capital recovery factor [CRF] of 0.1424).  The total annualized capital costs total $204,910.

6(c)  Estimating Agency Burden and Costs

The only costs to the Agency are those associated with analysis of the reported information.  EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $243,774 and is shown below in Table 2.

This cost is based on the average hourly labor rate as follows:

	Managerial	$61.36 (GS-13, Step 5, $38.35 + 60%)

           Technical	$45.52 (GS-12, Step 1, $28.45 + 60%)

           Clerical		$24.64 (GS-6, Step 3, $15.40 + 60%)

These rates are from the Office of Personnel Management (OPM) 2009 General Schedule, which excludes locality rates of pay.  The rates have been increased by 60% to account for the benefit packages available to government employees.  Details upon which this estimate is based appear below in Table 2: Average Annual EPA Burden – NESHAP for Portland Cement (40 CFR Part 63, Subpart LLL) (Renewal).

6(d)  Estimating the Respondent Universe and Total Burden and Costs

Number of respondents is calculated using the following table that addresses the three years covered by this ICR.

Number of Respondents

Respondents That Submit Reports

Respondents That Do Not Submit Any Reports

Year

(A)

Number of New Respondents 1

(B)

Number of Existing Respondents

(C)

Number of Existing Respondents That Keep Records but Do Not Submit Reports

(D)

Number of Existing Respondents That Are Also New Respondents

(E)

Number of Respondents

(E=A+B+C-D)

1

2

94

0

2

94

2

2

94

0

2

94

3

2

94

0

2

94

Average

2

94

0

2

94

1 New respondents include sources with constructed, reconstructed and modified affected facilities.

Because all of the new kilns expected to be constructed are located at plants that also have existing sources, two of the 94 plants (respondents) can be classified as both a new and existing source. To avoid double-counting respondents, column D is subtracted.  The average Number of Respondents over the three-year period of this ICR is shown in column E.

The total number of annual responses per year is calculated using the following table:

Total Annual Responses

(A)

Information Collection Activity

(B)

Number of Respondents

(C)

Number of Responses

(D)

Number of Existing Respondents That Keep Records But Do Not Submit Reports

(E)

Total Annual Responses

E=(BxC)+D

Notification of Applicability

2

2

0

4

Notification of Construction/Reconstruction

2

2

0

4

Notification of Actual Startup

2

2

0

4

Notification of THC Performance Tests

2

2

0

4

Notification of Hg Performance Tests

2

2

0

4

Notification of Performance Test

56.4

1.1

0

62

Notification of Opacity and Visible Emissions Observation

56.4

1

0

56.4

Notification of the Continuous Emission Monitor Performance Evaluation

2

2

0

4

Notification of Compliance Status

2

2

0

4

Report of Initial Performance Tests

2

2

0

4

Report of Periodic Performance Tests

56.4

1.1

0

62

Excess Emissions and Continuous Monitoring System Performance Report and Summary Report

94

2

0

188

Immediate Startup, Shutdown, Malfunction Reports

5

1

0

5

Total

405.5

The number of Total Annual Responses is shown in column E.

The total annual labor cost may be found in Table 1.

The average annual Agency burden and cost over next three years is shown in Table 2.

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively, and summarized below.

(i) Respondent Tally

The total annual labor hours are 28,242.  Details regarding these estimates may be found below in Table 1:  Annual Respondent Burden and Cost - NESHAP for Portland Cement (40 CFR Part 63, Subpart LLL) (Renewal).  Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 69.56 hours per response.

The average annualized capital/startup and annual O&M costs to the regulated entity are $2,319,292.  The cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs.

(ii) The Agency Tally

	The average annual Agency burden and cost over next three years is estimated to be 5,437 labor hours at a cost of $243,774.  See below Table 2:  Annual Agency Burden and Cost - NESHAP for Portland Cement (40 CFR Part 63, Subpart LLL) (Renewal).

	6(f)  Reasons for Change in Burden

The increase in burden hours and dollars from the most recently approved ICR renewal (EPA ICR number 1801.07) is due to a 2006 program change in the regulation requiring additional performance testing, monitoring, recordkeeping, and reporting requirements. These amendments would affect any new, modified, or reconstructed sources after December 2, 2005.

There was a decrease in number of responses currently identified in the OMB Inventory of Approved Burdens.  This decrease is due to the correction of transpose error in the currently approved burden estimates in ICRAS. Further, the number of responses also decreased due to a decrease in the number of estimated portland cement plants affected by ICR since the last renewal.

The increase in capital/start-up and O&M costs is also due to a 2006 program change in the regulation requiring new monitoring equipment. The THC monitors are a new requirement for new sources since the last ICR renewal.  Further, the change in labor costs for industry and EPA is due to the use of more current labor rates.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 69.56 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency.  This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to adjust the existing ways to comply with any previously applicable instructions and requirements; to train personnel to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number.  The OMB Control Numbers for EPA’s regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2009-0425. An electronic version of the public docket is available at http://www.regulations.gov/ which may be used to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically.  When in the system, select “search,” then key in the docket ID number identified in this document.  The documents are also available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is (202) 566-1752.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID Number EPA-HQ-OECA-2009-0425 and OMB Control Number 2060-0416 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this information.

 PAGE  3


Draft, 4/ 12/ 05; subject to change Page 1 of 10 Independent and Standalone Laboratories Introduction This section discusses independent standalone laboratories separately from medical and dental laboratories which have their own profile.

Industry Profile Independent and Standalone Laboratories include facilities in SIC codes 8731: Commercial Physical and Biological Research, and 8734: Testing Laboratories. The 1987 SIC Code Manual defines these SIC codes as follows:

8731: Establishments primarily engaged in commercial physical and biological research and development on a contract or fee basis, such as chemical laboratories and commercial research facilities. Noncommercial research establishments funded by endowments, grants, or contributions are classified in Industry 8733. Separate establishments of aircraft, guided missile, or spacecraft manufacturers primarily engaged in research and development on these products are classified in Manufacturing, Major Group 37.

8734: Establishments primarily engaged in providing testing services, such as forensic laboratories, pollution testing, hydrostatic testing, and radiation dosimetry laboratories. Establishments primarily engaged in performing clinical laboratory testing for the medical profession are classified in Industry 8071.

Table 6 1. Census Data SIC Code NAICS Code Number of Facilities in 1997 Number of Facilities in 2002 8731: Commercial physical & biological research 541710: Research & Development in the Physical, Engineering, and Life Sciences 9,173 13,033 8734: Testing laboratories 541380: Testing laboratories 5,488 None Draft, 4/ 12/ 05; subject to change Table 6 4 ( Continued)

Page 2 of 10 Table 6 2. TRI Facility Counts SIC Code Number of Facilities Reporting to 2000 TRI Direct Only Indirect Only Both No Reported Discharge 8731 1 0 1 1 8734 0 1 0 0 Table 6 3. PCS Facility Counts SIC Code Minors Majors 8731 31 4 8734 6 3 Lab operations differ from other industries in that labs typically use low quantities of a wide variety of substances. Operations are also highly variable. As a result, labs typically generate a small quantity of a large variety of pollutants.

Table 6 4. Wastewater Flow Data SIC Code NPID Flow ( MGY)

8731 AR0044415 4.31 8731 AR0048003 1.79 8731 DE0000566 41.31 8731 FL0044377 189.67 8731 IL0001473 156.96 8731 IL0048119 140.13 8731 MA0003638 1.50 8731 MD0000850 0.15 8731 MD0020842 77.50 8731 MD0020851 45.95 8731 MD0057452 0.16 8731 MD0057991 0.00 8731 NJ0000272 38.56 Draft, 4/ 12/ 05; subject to change Table 6 4 ( Continued)

SIC Code NPID Flow ( MGY)

Page 3 of 10 8731 NJ0000809 13.32 8731 NJ0004243 3.67 8731 NJ0027731 134.80 8731 NJ0031305 68.40 8731 NJ0032913 19.98 8731 NY0001201 111.06 8731 NY0003972 131.65 8731 NY0005754 320.57 8731 NY0005835 936.15 8731 NY0005843 273.00 8731 NY0005851 1,822.72 8731 NY0007030 104.10 8731 NY0007170 19.21 8731 OH0000949 13.09 8731 TN0002941 6,388.33 8731 TX0052761 404.34 8731 TX0106526 0.22 Max 6,388.33 Min 0.00 Median 57.18 8734 IL0045241 36.10 8734 IN0000493 439.95 8734 MI0001911 73.25 8734 MI0003425 6.69 8734 MI0046540 74.85 8734 NH0022055 0.91 8734 NH0022985 2.24 8734 NJ0005053 5.82 8734 WA0025917 290.70 Max 439.95 Min 0.91 Draft, 4/ 12/ 05; subject to change Table 6 4 ( Continued)

SIC Code NPID Flow ( MGY)

Page 4 of 10 Median 36.10 Table 6 5. TRIReleases2000 Data for Wastewater to POTW SIC Code # of Facilities Reporting Pounds TWPE 8731 1 14 14 8734 1 25 0.42 Table 6 6. Discharges Reported to TRIReleases2000 SIC Code Discharge Status Pounds TWPE 8731 Direct 50,919 240 8731 Indirect 3.6 5.0 8734 Indirect 1.04 0.016 Table 6 7. Discharges Reported to PCSLoads2000 SIC Code Pounds TWPE 8731 604,051 1,187 8734 1,112,662 6.91 Draft, 4/ 12/ 05; subject to change Page 5 of 10 Table 6 8. Top Discharges in TRIReleases2000 Data SIC Code Top Pollutants by TWPE Top Pollutants by Pounds Chemical TWPE % of Total SIC TWPE Chemical Pounds % of Total SIC Pounds 8731 Copper 149 61% Nitrate compounds 50,000 98%

8731 Lead 91 37%

8731 Total 245 Total 50,923 8734 1,2,4 Trimethylbenzene 0.0081 51% Benzene 0.30 28%

8734 Benzene 0.0054 34% 1,2,4 Trimethylbenzene 0.29 28%

8734 Toluene 0.0014 9% Toluene 0.25 24%

8734 Xylene ( mixed isomers) 0.20 19%

8734 Total 0.016 Total 1.04 Table 6 9. Top Pollutants from PCSLoads2000 SIC Code Top Pollutants by TWPE Top Pollutants by Pounds Parameter TWPE % of Total SIC TWPE Parameter Pounds % of Total SIC Pounds 8731 Iron, Total ( As Fe) 805 68% Sulfate, Total ( As SO4) 351,671 58%

8731 Chlorine, Total Residual 133 11% Iron, Total ( As Fe) 143,834 24%

8731 Silver, Total ( As Ag) 121 10% Solids, Total Dissolved 60,422 10%

8731 Copper, Total ( As Cu) 67 6%

8731 Total 1,187 Total 604,051 8734 Silver Total Recoverable 1.68 24% Solids, Total Dissolved 1,100,407 99%

8734 Zinc, Total ( As Zn) 1.33 19%

8734 Copper Total Recoverable 1.25 18% Draft, 4/ 12/ 05; subject to change Table 6 9 ( Continued)

SIC Code Top Pollutants by TWPE Top Pollutants by Pounds Parameter TWPE % of Total SIC TWPE Parameter Pounds % of Total SIC Pounds Page 6 of 10 8734 Aluminum, Total Recoverable 1.17 17%

8734 Lead Total Recoverable 0.39 6%

8734 Nitrogen, Ammonia Total ( As N) 0.37 5%

8734 Arsenic, Total Recoverable 0.22 3%

8734 Total 6.91 Total 1,112,662 Typical operations at Independent and Stand Alone Laboratories include the following:

° Contract research in the healthcare, chemical, natural resources, energy, or manufacturing industries; or ° Commercial testing labs in the environmental, material science, healthcare, industrial hygiene, food, and engineering sectors.

Facilities in SIC codes 8731 and 8734 who do not meet the TRI reporting thresholds are not required to report to TRI. If a lab operates as part of a larger facility that is subject to TRI reporting, then its releases are included in the facility's TRI report. Table 6 10 lists the facilities that reported to TRI under SIC codes 8731 and 8734 for reporting year 2000.

Table 6 10. List of Facilities in TRIReleases2000 SIC Facility Name City State Discharge Type TWPE 8731 Alcoa Tech. Center New Kensington PA Direct 5.9 8731 Penta Biotech Union City CA No Reported Discharge 8731 U. S. DOE Oak Ridge Natl. Laboratory Oak Ridge TN Direct 234.6475 8731 U. S. DOE Oak Ridge Natl. Laboratory Oak Ridge TN Indirect 4.953196 8731 W. R. Grace & Co. Conn Columbia MD No Reported Discharge 8734 BP Naperville Complex F 3ehs Naperville IL Indirect 0.0159 Draft, 4/ 12/ 05; subject to change Table 6 11 ( Continued)

Page 7 of 10 Table 6 11 lists the facilities that reported to PCS for reporting year 2000.

Table 6 11. List of Facilities in PCSLoads2000 SIC Facility Name City TWPE Major/ Minor NPDES 8731 Brookhaven National Laboratory Upton 1,015 Major NY0005835 8731 Hopewell Business Center Hopewell Twp 1.27 Major NJ0000809 8731 Occidental  Technology Ctr Grand Island 140 Major NY0001201 8731 USDOE ORNL Anderson County 30.72 Major TN0002941 8731 Chazy Drug Safety Eval Fac Chazy 0.35 Minor NY0007170 8731 Corning Inc  Sullivan Park Painted Post  Minor NY0003972 8731 Dupont chestnut Run Wilmington 4.15 Minor DE0000566 8731 Edi Test Facility ... Albany  Minor NY0000001 8731 Elementis Specialties_ inc E Windsor Minor NJ0004243 8731 Exxonmobil Research & Eng Co Annandale 0.90 Minor NJ0035084 8731 Factory Mutual Engineering Cor Norwood  Minor MA0003638 8731 FMC Corp Plainsboro 1.77 Minor NJ0027731 8731 General Electric Res & Dev Ctr Niskayuna 147 Minor NY0007030 8731 Heat Transfer Research Inc and College Station Minor TX0106526 8731 Hercules Incorporated Wilmington Minor DE0000230 8731 Honeywell International Inc Morristown 0.07 Minor NJ0031305 8731 Huntsman Polyurethanes W Deptford Minor NJ0033588 8731 Hydrocarbon Technologies Inc Lawrenceville Minor NJ0032913 8731 International Steel Group Inc Independence Minor OH0000949 8731 Knolls Atomic Power Lab Schenectady 216 Minor NY0005851 8731 Knolls Atomic Power Lab Kessel West Milton 13 Minor NY0005843 8731 Northrop Grumman Systems Corp Linthicum 0.18 Minor MD0000850 8731 Pepco Hallowing Point Prince Frederick Minor MD0057452 8731 Pulaski Technical College Bauxite 0.04 Minor AR0048003 8731 Quaker Oats Company Barrington  Minor IL0001473 8731 Sarnoff Corp Princeton 17 Minor NJ0000272 8731 Shell Devel houston Houston  Minor TX0052761 Draft, 4/ 12/ 05; subject to change Table 6 11 ( Continued)

SIC Facility Name City TWPE Major/ Minor NPDES 1Water and Wastewater Products, 2003. Safety and pollution prevention strategies for wastewater laboratories, Stevens Publishing Corporation, Dallas, Texas.

2Anastas, P. T.; Warner, J. C. Green Chemistry: Theory and Practice, Oxford University Press: New York, 1998, Cited at: www. chemistry. org/ portal/ a/ c/ s/ 1/ acsdisplay. html? DOC= greenchemistryinstitute\ gc_ principles. html.

Page 8 of 10 8731 Texaco at Beacon Glenham 21 Minor NY0005754 8731 U of A Rice Research & Extensi Stuttgart 0.05 Minor AR0044415 8731 UMBC Technology Center Baltimore  Minor MD0057991 8731 University of Nebr Ard Center Ithaca Minor NE0112291 8731 UOP LLC Desplaines Des Plaines Minor IL0048119 8731 USDA East Side_ WWTP Beltsville 0.69 Minor MD0020842 8731 USDA West Side WWTP Beltsville  Minor MD0020851 8731 USEPA Gulf Breeze Research Lab Pensacola Beach Minor FL0044377 8734 Envirosystems Incorporated Hampton 0.30 Major NH0022055 8734 Fluor Daniel Hanford Inc Richland 4.95 Major WA0025917 8734 Gm proving Grounds Milford Milford 1.67 Major MI0001911 8734 Aquatic Research Organisms Inc Hampton 0.61 Minor NH0022985 8734 Bechtel Plant Machinery Inc. Mishawaka Minor IN0000493 8734 Bp Naperville Complex Naperville Minor IL0045241 8734 Campbell Soup Co Camden Minor NJ0005053 8734 Chrys chelsea Proving Grounds Chelsea 2.30 Minor MI0046540 8734 Ford Michigan Proving Ground Romeo Minor MI0003425 On Site Wastewater Treatment/ Pretreatment According to data in TRIReleases2000, about 50% of independent and standalone laboratories discharge their wastewater indirectly. Common techniques at reducing or eliminating pollutant discharges from laboratory wastewaters include the following: 1,2

Substitute chemicals with less toxic alternatives.

Use the minimum amount of chemical required. Draft, 4/ 12/ 05; subject to change Page 9 of 10

Label all chemical containers properly.

Store glassware and breakable containers on textured rubber mats.

Order chemicals in plastic coated bottles.

Transport solvent bottles in protective holders.

Keep doors of chemical storage cabinet latched.

Equip chemical storage shelves with barriers one fifth the height of the tallest container.

Keep all counter top chemicals in a tray or within bermed areas.

Never store chemical bottles and containers in sinks.

Surround sinks and counter tops with a protective lip.

Plug all floor drains.

Protect safety shower drain from chemical spills with temporary plugs or sumps.

Maintain adequate and readily available supply of spill cleanup materials.

Check chemical disposal guidelines and POTW acceptance criteria prior to discharging to a drain.

Keep work areas clean and well organized to help prevent accidents.

Use drip pans and splash guards where spills frequently occur.

Table 8 15 lists comments on the proposed 2004 Biennial Plan, regarding stand alone laboratories. Table 8 15: Summary of 2004 Biennial Plan Comments Commenter Summary of Comment The Metropolitan Council Environmental Services ( MCES) Inspected several independent and stand alone labs based on the following pollutant concerns:

 Wastewater discharges from labs may be highly acidic or basic, and may be flammable; and  Depending on the lab's operations, wastewater may contain mercury or other heavy metals, which could increase loadings at POTWs.

MCES determined that none of the facilities inspected warranted a permit because:

 The facilities make a conscious effort to minimize the volume and strength of discharges to POTWs;  Heavy metal concentrations in lab wastewater were low enough to ensure compliance with MCES Local Limits;  Infectious waste and blood waste are sent offsite for incineration;  Facilities follow federal, state, and local regulations for disposing of hazardous wastes;  Pollutant loading contributions to POTWs from labs were relatively insignificant compared to other industries.

National EPA should develop an effluent limitation guideline ( ELG) for stand alone laboratories. Draft, 4/ 12/ 05; subject to change Page 10 of 10 References US EPA. 2000. Environmental Management Guide for Small Laboratories, 233 B 00 001.


Ohio NPDES OH0001473 OH0001589 OH0001708 OH0001953 OH0002704 OH0003123 OH0005843 OH0005908 OH0007749 OH0009598 OH0009741 OH0012165 OH0020001 OH0020010 OH0020028 OH0020036 OH0020044 OH0020052 OH0020079 OH0020087 OH0020109 OH0020117 OH0020125 OH0020133 OH0020141 OH0020168 OH0020192 OH0020206 OH0020214 OH0020222 OH0020249 OH0020257 OH0020265 OH0020273 OH0020281 OH0020303 OH0020311 OH0020320 OH0020338 OH0020346 OH0020354 OH0020362 OH0020371 OH0020389 OH0020397 OH0020401 OH0020419 OH0020427 OH0020443 OH0020451 OH0020478 OH0020486 OH0020494 OH0020508 OH0020516 OH0020524 OH0020532 OH0020541 OH0020559 OH0020567 OH0020575 OH0020583 OH0020591 OH0020605 OH0020613 OH0020621 OH0020630 OH0020648 OH0020656 OH0020664 OH0020672 OH0020681 OH0020729 OH0020737 OH0020753 OH0020761 OH0020770 OH0020796 OH0020800 OH0020818 OH0020826 OH0020834 OH0020842 OH0020851 OH0020869 OH0020877 OH0020885 OH0020893 OH0020907 OH0020915 OH0020923 OH0020931 OH0020940 OH0020966 OH0020974 OH0020991 OH0021008 OH0021016 OH0021024 OH0021041 OH0021059 OH0021067 OH0021075 OH0021083 OH0021105 OH0021113 OH0021121 OH0021130 OH0021148 OH0021156 OH0021164 OH0021172 OH0021181 OH0021199 OH0021202 OH0021229 OH0021245 OH0021270 OH0021300 OH0021318 OH0021326 OH0021334 OH0021342 OH0021351 OH0021377 OH0021393 OH0021415 OH0021423 OH0021431 OH0021440 OH0021466 OH0021482 OH0021491 OH0021504 OH0021539 OH0021547 OH0021563 OH0021571 OH0021580 OH0021598 OH0021610 OH0021628 OH0021644 OH0021652 OH0021679 OH0021687 OH0021709 OH0021725 OH0021733 OH0021741 OH0021750 OH0021768 OH0021776 OH0021784 OH0021806 OH0021814 OH0021822 OH0021831 OH0021849 OH0021857 OH0021865 OH0021873 OH0021881 OH0021903 OH0021938 OH0021962 OH0021971 OH0021989 OH0022047 OH0022055 OH0022063 OH0022071 OH0022098 OH0022101 OH0022110 OH0022128 OH0022144 OH0022195 OH0022209 OH0022217 OH0022225 OH0022276 OH0022284 OH0022322 OH0022331 OH0022446 OH0022454 OH0022471 OH0022489 OH0022497 OH0022519 OH0022527 OH0022535 OH0022543 OH0022586 OH0022616 OH0022624 OH0022641 OH0022659 OH0022667 OH0023221 OH0023337 OH0023345 OH0023353 OH0023361 OH0023370 OH0023388 OH0023396 OH0023400 OH0023493 OH0023507 OH0023515 OH0023531 OH0023540 OH0023566 OH0023582 OH0023604 OH0023612 OH0023779 OH0023825 OH0023833 OH0023841 OH0023850 OH0023868 OH0023876 OH0023884 OH0023892 OH0023906 OH0023914 OH0023931 OH0023957 OH0023981 OH0023990 OH0024007 OH0024015 OH0024023 OH0024040 OH0024058 OH0024066 OH0024091 OH0024104 OH0024139 OH0024244 OH0024261 OH0024279 OH0024287 OH0024295 OH0024309 OH0024317 OH0024325 OH0024333 OH0024350 OH0024368 OH0024406 OH0024465 OH0024597 OH0024627 OH0024643 OH0024651 OH0024660 OH0024678 OH0024686 OH0024694 OH0024732 OH0024741 OH0024759 OH0024767 OH0024775 OH0024864 OH0024872 OH0024881 OH0024899 OH0024911 OH0024929 OH0024945 OH0024953 OH0024970 OH0024996 OH0025003 OH0025011 OH0025062 OH0025071 OH0025127 OH0025135 OH0025143 OH0025151 OH0025160 OH0025275 OH0025283 OH0025291 OH0025313 OH0025321 OH0025330 OH0025356 OH0025364 OH0025372 OH0025381 OH0025429 OH0025445 OH0025453 OH0025461 OH0025470 OH0025488 OH0025577 OH0025674 OH0025704 OH0025763 OH0025771 OH0025801 OH0025810 OH0025852 OH0025861 OH0025879 OH0025887 OH0025895 OH0025917 OH0025925 OH0025933 OH0025941 OH0026018 OH0026026 OH0026051 OH0026069 OH0026093 OH0026131 OH0026140 OH0026158 OH0026166 OH0026182 OH0026204 OH0026263 OH0026271 OH0026328 OH0026344 OH0026352 OH0026395 OH0026492 OH0026514 OH0026522 OH0026531 OH0026565 OH0026573 OH0026590 OH0026638 OH0026646 OH0026654 OH0026662 OH0026671 OH0026689 OH0026697 OH0026719 OH0026727 OH0026735 OH0026743 OH0026778 OH0026794 OH0026808 OH0026824 OH0026841 OH0026859 OH0026913 OH0026921 OH0026930 OH0026948 OH0026964 OH0026972 OH0027031 OH0027049 OH0027057 OH0027065 OH0027090 OH0027197 OH0027201 OH0027219 OH0027260 OH0027278 OH0027294 OH0027324 OH0027332 OH0027341 OH0027375 OH0027383 OH0027421 OH0027430 OH0027472 OH0027481 OH0027511 OH0027545 OH0027553 OH0027570 OH0027600 OH0027618 OH0027651 OH0027677 OH0027723 OH0027740 OH0027758 OH0027855 OH0027863 OH0027880 OH0027898 OH0027910 OH0027936 OH0027952 OH0027987 OH0028002 OH0028011 OH0028029 OH0028037 OH0028045 OH0028088 OH0028118 OH0028126 OH0028134 OH0028142 OH0028177 OH0028185 OH0028193 OH0028207 OH0028215 OH0028223 OH0028240 OH0028801 OH0028827 OH0028835 OH0028843 OH0028851 OH0028860 OH0028878 OH0028886 OH0028894 OH0028916 OH0028924 OH0028932 OH0029122 OH0029220 OH0029289 OH0029386 OH0029394 OH0029408 OH0029432 OH0029441 OH0029459 OH0029475 OH0029483 OH0029491 OH0029700 OH0029858 OH0030503 OH0030996 OH0031003 OH0031062 OH0031097 OH0031101 OH0031119 OH0031763 OH0033693 OH0033707 OH0033782 OH0033839 OH0033847 OH0033871 OH0033880 OH0033910 OH0033952 OH0033961 OH0033987 OH0034223 OH0034509 OH0035831 OH0035882 OH0035891 OH0036013 OH0036021 OH0036056 OH0036188 OH0036196 OH0036234 OH0036242 OH0036251 OH0036285 OH0036471 OH0036501 OH0036595 OH0036641 OH0036692 OH0036722 OH0036757 OH0036765 OH0036790 OH0036803 OH0036838 OH0036854 OH0036978 OH0037117 OH0037249 OH0037273 OH0037290 OH0037311 OH0037320 OH0037338 OH0037346 OH0037389 OH0037427 OH0037664 OH0037681 OH0037788 OH0037796 OH0037800 OH0037818 OH0037826 OH0037834 OH0037842 OH0037851 OH0037869 OH0038539 OH0038563 OH0038580 OH0038601 OH0038661 OH0038768 OH0038792 OH0039004 OH0039080 OH0039098 OH0039209 OH0039217 OH0039225 OH0039233 OH0039268 OH0039276 OH0039284 OH0039292 OH0039403 OH0039411 OH0040592 OH0040690 OH0041114 OH0041131 OH0041149 OH0041157 OH0041165 OH0041173 OH0041220 OH0041238 OH0041254 OH0041262 OH0041327 OH0041360 OH0041408 OH0041416 OH0041424 OH0041441 OH0041467 OH0041505 OH0041629 OH0041688 OH0043401 OH0043478 OH0043486 OH0043494 OH0043541 OH0043559 OH0043567 OH0043851 OH0043940 OH0043966 OH0043982 OH0043991 OH0044113 OH0044148 OH0044156 OH0044164 OH0044172 OH0044202 OH0044211 OH0044300 OH0044458 OH0044466 OH0044512 OH0044555 OH0045195 OH0045233 OH0045314 OH0045373 OH0045390 OH0045462 OH0045489 OH0045705 OH0045721 OH0045748 OH0045829 OH0045896 OH0045993 OH0046728 OH0046752 OH0047198 OH0047384 OH0047392 OH0047554 OH0047571 OH0047775 OH0047902 OH0048020 OH0048097 OH0048241 OH0048267 OH0048321 OH0048381 OH0048615 OH0049026 OH0049051 OH0049310 OH0049328 OH0049361 OH0049379 OH0049387 OH0049417 OH0049476 OH0049484 OH0049492 OH0049611 OH0049646 OH0049794 OH0049999 OH0050016 OH0050032 OH0050059 OH0050130 OH0050148 OH0050172 OH0050181 OH0050253 OH0050351 OH0050385 OH0050393 OH0050407 OH0050423 OH0050440 OH0050466 OH0050474 OH0050482 OH0050491 OH0050539 OH0050555 OH0050563 OH0050571 OH0050580 OH0050628 OH0050636 OH0050661 OH0050725 OH0050750 OH0050776 OH0050784 OH0050792 OH0050865 OH0050873 OH0050881 OH0050903 OH0050954 OH0051021 OH0051039 OH0051047 OH0051055 OH0051110 OH0051136 OH0051144 OH0051969 OH0052604 OH0052698 OH0052744 OH0052817 OH0052876 OH0052906 OH0052914 OH0052922 OH0052949 OH0053007 OH0053082 OH0053155 OH0053171 OH0053180 OH0053198 OH0053279 OH0053317 OH0053325 OH0053341 OH0053350 OH0053368 OH0053384 OH0053431 OH0053465 OH0053473 OH0053481 OH0053490 OH0053503 OH0053597 OH0053601 OH0053635 OH0053660 OH0053678 OH0053686 OH0053694 OH0053732 OH0053759 OH0053848 OH0053881 OH0053902 OH0053961 OH0054038 OH0054046 OH0054178 OH0054305 OH0054321 OH0054364 OH0054399 OH0054445 OH0054461 OH0054488 OH0054500 OH0054518 OH0054542 OH0054631 OH0054836 OH0054844 OH0054852 OH0054879 OH0054887 OH0054909 OH0054917 OH0058009 OH0058157 OH0058319 OH0058327 OH0058483 OH0058815 OH0058823 OH0058831 OH0058971 OH0059307 OH0059714 OH0059731 OH0063223 OH0063746 OH0063771 OH0064009 OH0064360 OH0070637 OH0071692 OH0072087 OH0078204 OH0078441 OH0078760 OH0079031 OH0079197 OH0089672 OH0089826 OH0092045 OH0094528 OH0094684 OH0095176 OH0095257 OH0098043


[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 713-714]
[FR Doc No: 2020-00039]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3885]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Center for Tobacco
Products, Food and Drug Administration Funded Trainee/Scholar Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 6, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Center for Tobacco Products, Food and Drug Administration
Funded Trainee/Scholar Survey.'' Also include the FDA docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Center for Tobacco Products, Food and Drug Administration Funded
Trainee/Scholar Survey

OMB Control Number 0910-NEW

    The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food,
Drug, and Cosmetic Act (FD&C Act) to grant FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect the public health and to reduce tobacco use by minors.
    FDA's Center for Tobacco Products (CTP) and the National Institutes
of Health maintain an interagency partnership to foster the development
of the emerging field of tobacco regulatory science (TRS). This study
will use the CTP, FDA Funded Trainee/Scholar Survey to gather data on
the characteristics, activities, and impact of training programs funded
by the CTP and other partners. This evaluation will also determine how
CTP-funded research and associated training programs and activities
increase knowledge and skills related to TRS and interest to pursue
careers in a TRS-related field. This survey provides support to
determine the extent to which programs and activities generate positive
impacts to increase the number of researchers who focus on TRS and TRS-
related topics, specifically within CTP's priority domains. The survey
builds upon previous evaluations of trainees and training activities
and provides necessary evidence to inform FDA decision making. The web
survey will gather responses from Tobacco Centers of Regulatory Science
(TCORS) trainees and other CTP-funded trainees and scholars. Results
will provide insights and directions to support future training and
funding investments.
    FDA CTP will use findings from this study to determine whether its
TRS training support investments lead to meaningful change that
supports CTP aims, and to inform decisions about potential future
investments. CTP's training support intends to build additional
capacity for TRS that establishes an evidence base related to CTP's
research priorities so that FDA regulations, communications, and
application review are founded on rigorous, relevant scientific study.
    Respondents include current and former TCORS or other CTP-funded
trainees and trainee principal investigators (PIs) or training
directors. PIs and training directors will be asked to provide trainee
names and email addresses and encourage trainees to participate in the
survey. Current and former trainees will be asked to read an informed
consent and take a brief web-based survey.
    In the Federal Register of September 12, 2019 (84 FR 48148), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
         Type of respondent/activity             Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Current or Former Trainee/Scholar
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lead Letter.................................             350               1             350  0.025 (2 minutes).........................               9
Email invitation............................             350               1             350  0.016 (1 minute)..........................               6
Informed consent............................             298               1             298  0.033 (2 minutes).........................              10
Survey......................................             298               1             298  0.16 (10 minutes).........................              48
Followup email..............................             176               3             528  0.016 (1 minute)..........................               8
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 PI or Training Director
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trainee list email..........................             350               1             350  0.16 (10 minutes).........................              56
Notification email..........................             350               1             350  0.016 (1 minute)..........................               6
                                             -----------------------------------------------------------------------------------------------------------

    Total...................................  ..............  ..............  ..............  ..........................................             143
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 summarizes the total annual burden hours estimated for this
information collection. There is no cost to participants other than
their time. The total estimated annualized burden hours are 143. A
total of approximately 350 trainees will be invited to participate in
the web survey. Burden hours were estimated based on experience with
prior similar survey activities and information obtained from informal
testing by contractor staff.

    Dated: December 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00039 Filed 1-6-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 27, 2009 (Volume 74, Number 165)]
[Notices]
[Page 43742]
[DOCID:fr27au09-108]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Joint Open Meeting with the
Commodity Futures Trading Commission to seek input from the public on
harmonization of market regulation on September 2, 2009 from 9 a.m.
until 5 p.m. at the CFTC and on September 3, 2009 from 9 a.m. until
12:30 p.m. at the SEC.
    The Joint Open Meeting will take place on September 2, 2009 at the
CFTC's headquarters at Three Lafayette Centre, 1155 21st Street, NW.,
Lobby Level Hearing Room (Room 1000), Washington, DC 20581 and on
September 3, 2009 at the SEC's headquarters at 100 F Street, NE.,
Auditorium (Room L-002), Washington, DC 20549. The Joint Open Meeting
will be open to the public with seating on a first-come, first-served
basis. Visitors will be subject to security checks.
    Discussion topics at the Joint Open Meeting will include the
regulation of exchanges and markets; the regulation of intermediaries;
the regulation of clearance and settlement; enforcement; and the
regulation of investment funds. For further information, please
contact: The Office of the Secretary at<PHONE_NUMBER>.

    Dated: August 25, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-20843 Filed 8-25-09; 4:15 pm]

BILLING CODE 8010-01-P


	SIP SUBMITTAL COMPLETENESS CRITERIA CHECKLIST

	(in accordance with 40 CFR Part 51 - App. V)

SIP Submitted by:  Pennsylvania Department of Environmental Protection (PADEP)

Date Submitted:  June 15, 2007

Subject:  Redesignation of the York (York and Adams Counties) 8-hour Ozone Nonattainment Area to Attainment and Approval of the Area’s Maintenance Plan and 2002 Base Year Inventory

Completeness Review

Completed by:  LaKeshia Robertson /s/

Date Completed:  July 11, 2007

Administrative Materials

	ACCEPTABLE

	EPA REQUIREMENT

	STATE SUBMITTAL

(X)

1. A formal letter of submittal from the Governor or his designee, requesting EPA approval of the plan or revision thereof.

1.  Letter was submitted June 14, 2007 on behalf of Commonwealth of Pennsylvania from Kathleen A. McGinty, Secretary, PADEP to Donald S. Welsh, Regional Administrator, US EPA Region III. 	X

2. Evidence that the State has adopted the plan in the State code or body of regulations; or issued the permit, order, consent agreement in final form.  That evidence shall include the date of adoption or final issuance as well as the effective date of the plan, if different from the adoption/issuance date.

2.  N/A.  Not a regulatory change.  The submittal is a request for redesignation and a maintenance plan and a 2002 base-year inventory that is effective June 2007.

 X

3. Evidence that the State has the necessary legal authority under State law to adopt and implement the plan.

3.  State has legal authority to adopt this maintenance plan under Section 5 of the Air Pollution Control Act.	X

4. A copy of actual regulation, or document submitted for approval and incorporation by reference into the plan, including indication of the changes made to the existing approved plan, where applicable.  The submittal shall be a copy of the official State regulation/document signed, stamped, dated by the appropriate State official indicating that it is fully enforceable by the State.  The effective date of the regulation/document shall, whenever possible, be indicated in the document itself.

4.  N/A.  See number 2 above.	X

5. Evidence that the State followed all of the procedural requirements of the State's laws and constitution in conducting and completing the adoption/issuance of the plan.

5.  N/A.	X

6. Evidence that public notice was given of the proposed change consistent with procedures approved by EPA, including the date of publication of such notice.

6.  PADEP provided proof that the notice of public hearing was published in the Pennsylvania Bulletin on May 5, 2007

 X

7. Certification that public hearings were held in accordance with the information provided in the public notice and the State's laws and constitution, if applicable.

7. Notice of public hearing was given to the public in The Gettysburg Times and York Newspaper Company on May 5, 2007.

 X

8. Compilation of public comments and the State's response thereto.

8.  EPA received a copy of PADEP’s response to comments along with its redesignation package on June 14, 2007.

 X

 Technical Materials

1. Identification of all regulated pollutants affected by the plan.

1.8-Hour Ozone	X

2. Identification of the locations of affected sources including the EPA attainment/nonattainment designation of the locations and the status of the attainment plan for the affected area(s).

2.  Applies to York (York and Adams Counties), Pennsylvania.	X

3. Quantification of the changes in plan allowable emissions from the affected sources; estimates of changes in current actual emissions from affected sources or, where appropriate, quantification of changes in actual emissions from affected sources through calculations of the differences between certain baseline levels and allowable emissions anticipated as a result of the revision.

3.  An updated allowable emissions inventory was provided along with submittal.	X

4. The State's demonstration that the national ambient air quality standards, prevention of significant deterioration increments, reasonable further progress demonstration, and visibility, as applicable, are protected if the plan is approved and implemented.

4.   The state has developed a current and projected (2002, 2004, 2009, and 2018) emissions inventory showing attainment o the national ambient air quality standard (NAAQS).  This portion of maintenance plan shows how the NAAQS will be protected since emission levels are expected to remain at or below the levels needed for attainment.

X

5. Modeling information required to support the proposed revision, including input data, output data, models used,  ambient monitoring data used, meteorological data used, justification for use of offsite data (where used), modes of models used, assumptions, and other information relevant to the determination of adequacy of the modeling analysis.

5.  All data and evidence is present for this action.

X

6. Evidence, where necessary, that emission limitations are based on continuous emission reduction technology.

6.  N/A

X

7. Evidence that the plan contains emission limitations, work practice standards and recordkeeping/reporting requirements, where necessary, to ensure emission levels.

7.  Evidence is shown that PADEP will do period emission inventory updates and analysis.

X

8. Compliance/enforcement strategies, including how compliance will be determined in practice.

8.  Pennsylvania will continue to monitor ambient air in the area and to review the emissions inventory.  If an exceedance or growth in the emissions inventory occurs, contingency measures will be triggered.

X

9. Special economic and technological justifications required by any applicable EPA policies. (If a policy is not appropriate, explain why.)

9.  N/A

X

10. A Section 107 request must be accompanied by a maintenance plan demonstrating maintenance to the relevant NAAQS for at least 10 years after redesignation.

10.  The Maintenance Plan was submitted to EPA Region III on June 14, 2007.  The plan demonstrates maintenance for 2007-2018.

X


United States Environmental Protection Agency Office of Ground Water and Drinking Water Query Tool Production Release 2.0 Contract No. 68 W 99 002 Task Order No. 007 Product Control No. SDC 0002 007 HB 2008B April 21, 2000 SDC 0002 007 HB 2008B April 21, 2000 QUERY TOOL PRODUCTION RELEASE 2.0 CONTRACT NO. 68 W 99 002 TASK ORDER NO. 007 Prepared for:

United States Environmental Protection Agency Office of Ground Water and Drinking Water 401 M Street, SW. Washington, DC 20460 Task Order Project Officer:

Edward A. Cottrill Prepared by:

Systems Development Center Science Applications International Corporation 6565 Arlington Boulevard Falls Church, VA 22042 SDC 0002 007 HB 2008B April 21, 2000 iii CONTENTS 1.0 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1.3 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2.0 SUMMARY OF FUNCTIONALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3.0 INSTALLATION INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 SDC 0002 007 HB 2008B April 21, 2000 1 1.0 INTRODUCTION 1.1 Purpose The United States Environmental Protection Agency ( EPA) Office of Ground Water and Drinking Water ( OGWDW) is responsible for implementing the Public Water System Supervision ( PWSS) Program established under the auspices of the Safe Drinking Water Act ( SDWA) of 1974 ( Public Law 93 523) and the 1996 reauthorization of the Act. Two of OGWDW's major responsibilities under the Act are to set national standards for drinking water quality and to ensure that the states that have assumed primary enforcement responsibility are enforcing these standards.

In February 1994, OGWDW proposed an Information Collection Rule ( ICR), requiring certain Public Water Systems ( PWS) to generate and provide the Agency with specific microbiological contaminant and Disinfection By Product ( DBP) monitoring data, general water quality data, and treatment plant design and operating information characterizing their water systems. OGWDW began developing a Data Management System ( DMS) to support the PWSS Program Information Systems Modernization ( ISM) effort. The purpose was to provide contractor support to complete the development of and provide support for the following automated systems:

The ICR Water Utility Database System.

The ICR Laboratory Quality Control ( QC) Database System.

The ICR Federal Database System.

ICR Data Analysis Database 1 ( i. e., Auxiliary 1 Database) and accompanying Query Tool.

These systems are described collectively as the ICR DMS. The ICR Water Utility Database System allows water utilities to report required data via software directly to EPA. The Laboratory QC Database System enables the analytical laboratories that are approved to perform sample analyses under the ICR to report data directly to the Agency. Capabilities of the ICR Federal Database System include data population, or the capability to upload data from utilities and laboratories to the central database; validation of Sample Analytical Result ( SAR) data, according to standards established by EPA; and support for tracking the approval status of analytical laboratories. SDC 0002 007 HB 2008B April 21, 2000 2 After data are loaded into the ICR Federal Database System and validated, the data must be analyzed by a number of researchers and analysts. The analysts use the ICR data to develop regulations to assure public health protection from disease causing microbes ( pathogens), including cryptosporidium, virus, giardia, and DBPs. The ICR DMS Team was tasked with developing the Auxiliary 1 Database, which stores a subset of data extracted from the ICR Federal Database System. The Auxiliary 1 Database provides researchers and analysts with a smaller, yet still comprehensive, version of the ICR Federal Database System.

The Auxiliary 1 Database is designed such that it is simple to examine a single variable across all plants ( e. g., Total Trihalomethane [ TTHM] concentration at the finished water sample point in chlorination plants). It is more difficult, although not impossible, to examine a single variable through a single plant ( e. g., change in Total Organic Carbon [ TOC] concentration through a specific plant practicing enhanced coagulation). The Query Tool is designed to facilitate throughplant analyses for the ICR data analysts. Its primary function is to allow ICR data analysts to aggregate plant data in a horizontal fashion. The Query Tool enables analysts to perform analyses without having an in depth knowledge of database execution, such as making complex joins in Microsoft ® AccessJ.

1.2 Scope The Task Order Project Officer ( TOPO) tasked the ICR DMS Team with delivering the Query Tool Production Release 2.0 and the Query Tool User Documentation Release 2.0 on April 19, 2000. This document presents the release notes for the Query Tool and the Query Tool User Documentation.

The Query Tool User Documentation is the on line help for the Query Tool. The on line help was developed in RoboHelp ® and is designed to work with the Query Tool software. The online help for the Query Tool ( aux1help. hlp) is included in the Query Tool deliverable. Installation instructions for the Query Tool are listed in Section 3.0 of this document. The Query Tool User Documentation will be automatically be installed along with the Query Tool.

1.3 References The following documents are applicable to the release of the Query Tool and the Query Tool User Documentation. They include government, industry, and ICR project documents, standards, specifications, plans, regulations, manuals, and other materials used to develop the software for the release.

Note: The documents are listed in reverse chronological order.

Query Tool Production Release 1.0. SDC 0002 007 HB 2008B April 21, 2000 3 SDC; SDC 0002 007 MS 2008A; January 19, 2000.

Auxiliary 1 Database and Documentation, Production Release 5.0. Systems Development Center ( SDC); SDC 0002 007 HB 2011B; April 19, 2000

Auxiliary 1 User Documentation, Version 4.0. SDC; SDC 0002 007 EB 1026A; January 7, 2000.

Year 2000 Calendar Date Standard Waiver, ICR, Contract: 68 W 99 002, Task Order 007, Mod: 09, August 12, 1999.

Project Plan for Information Systems Development and User Support for the Public Water System Supervision ( PWSS) Program's Information Collection Rule ( ICR). EPA SDC; SDC 0002 007 HB 1001A; December 22, 1998.

Revised Information Collection Rule ( ICR) Data Management System ( DMS) System Manual. EPA SDC; SDC 0002 007 SS 1021; July 2, 1999.

Chapters 3 through 9 of the Information Collection Rule ( ICR) Data Analysis Requirements Specification. EPA SDC; SDC 0055 083 EB 7031; September 29, 1998.

Technical Summary for the Information Collection Rule ( ICR) Data Extraction Joint Application Design ( JAD) Meeting, August 17 19, 1998. EPA SDC; SDC 0055 083 BN 7027; September 23, 1998.

Primary Auxiliary Database Chapter of the Information Collection Rule ( ICR) Data Extraction Design Specification, EPA SDC; SDC 0055 083 FH 7026; August 21, 1998.

Primary Auxiliary Database Chapter of the Information Collection Rule ( ICR) Data Extraction Requirements Specification. EPA SDC; SDC 0055 083 EB 7022A; July 24, 1998.

Technical Summary for the Information Collection Rule ( ICR) Data Extraction Joint Application Design ( JAD) Meeting, June 15 17, 1998. EPA SDC; SDC 0055 083 MH 7023; July 6, 1998.

Technical Summary for the Information Collection Rule ( ICR) Data Extraction Joint Requirements Planning ( JRP) Meeting, May 19 20, 1998. EPA SDC; SDC 0055 083 MH 7021; June 1, 1998. SDC 0002 007 HB 2008B April 21, 2000 4

Revised Technical Summary for the Information Collection Rule ( ICR) Data Extraction Joint Requirements Planning ( JRP) Meeting, April 14 16, 1998. EPA SDC; SDC 0055 083 EB 7019A; May 22, 1998.

Information Collection Rule ( ICR) Data Extraction Joint Requirements Planning ( JRP) Meeting, February 20, 1998. EPA SDC; SDC 0055 083 MH 7015; March 6, 1998.

2.0 SUMMARY OF FUNCTIONALITY The release of the Query Tool incorporates all functions listed as requirements in the document, Auxiliary 1 Database and Documentation, Production Release 5.0. Systems Development Center ( SDC); SDC 0002 007 HB 2011B; April 19, 2000.

The Query Tool User Documentation provides on line help to Query Tool users. The following functions are included in the Query Tool help:

Instructions regarding the use of the Query Tool.

On line data dictionary.

Data mapping of the Auxiliary 1 Database Field Attribute Name to the Field Name in the Auxiliary 1 Database to the Query Output Field Caption ( i. e., Microsoft ® AccessJ Alias).

3.0 INSTALLATION INSTRUCTIONS This software is designed to be run under Microsoft ® AccessJ 97 on a Windows 95J Personal Computer ( PC) platform. Please note that Microsoft ® AccessJ 97 must be installed on your computer before you install the Query Tool. To install the Query Tool:

Ensure that you do not have a sub directory called QTOOL on your hard drive.

Copy TACRUN. EXE, Install. bat and Qtool. mdb files to a temporary sub directory on the C:\ drive.

Double click on the Install. bat file from the temporary sub directory on the C:\ drive. The install is complete when " finished" displays in the title bar of the DOS window. SDC 0002 007 HB 2008B April 21, 2000 5 Note: The Query Tool help file, aux1help. hlp, is included in the install. This help file must reside in the same directory as the qtool. mdb in order to function properly.

Use Windows Explorer to find the C:\ QTOOL sub directory and find the QTOOL. MDB.

Double click on the QTOOL. MDB to open the Query Tool.

If a message displays stating that the links to the Auxiliary 1 Database are invalid or do not exist, click OK to display a dialog box where you can search for the Auxiliary 1 Database. Click on Open to establish the links to the database.

The Intro screen of the Query Tool contains the Query Tool Help button. Click the Query Tool Help button to list the table of contents. SDC 0002 007 HB 2008B April 21, 2000 6 This page intentionally left blank.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

RE:  Meetings with Henkel on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)
List of Contents
Meeting Summary
Attendees
Meeting Summaries

On February 15, 2023, representatives from EPA met with Henkel to discuss their use of PIP (3:1) as an intermediate in a closed system to produce cyanoacrylate adhesives. EPA inquired about their use of Personal Protective Equipment (PPE) and other worker protection measures (e.g., engineering controls and closed loop systems); Henkel indicated that they would be submitting Confidential Business Information (CBI) in this regard. Henkel asked about the timing of the pending PIP (3:1) rule and EPA confirmed that we are aiming for a final rule in the fall of 2024.
Attendees:
EPA:
Damaris Christensen
Sofia Sonner
Scott Drewes

Henkel:
Martina Werner
Senthil Pichandi
Gary Pierson
Rebecca Coons
Kevin McKenney
Christine Poulsen


[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Page 38726]
[FR Doc No: 2013-15350]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0007; OMB No. 1660-0076]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use. This notice reflects changes to the
collection since the publishing of the 60 day notice on March 12, 2013.
Since the 60 day notice, FEMA has decided to use a different, more
effective quarterly reporting collection tool to monitor Hazard
Mitigation Grant Program (HMGP) grantee project activities and
expenditure of funds, FEMA Form No. 009-0-111A. This will allow FEMA to
more effectively better meet regulatory mandates. Previous quarterly
reporting was covered by a different OMB ICR. FEMA estimates that use
of this tool will change the total burden hours for this collection.

DATES: Comments must be submitted on or before July 29, 2013.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Hazard Mitigation Grant Program Application and Reporting.
    Type of Information Collection: Revision of a currently approved
information collection.
    Form Titles and Numbers: Narratives and FEMA Form No. 009-0-111A.
    Abstract: Grantees administer the Hazard Mitigation Grant Program,
which is a post-disaster program that contributes funds toward the cost
of hazard mitigation activities in order to reduce the risk of future
damage, hardship, loss or suffering in any area affected by a major
disaster. FEMA uses applications to collect information for determining
whether to provide financial assistance in the form of grant awards and
monitors grantee project activities and expenditure of funds through a
new grantee quarterly reporting tool, FEMA Form No. 009-0-111A. This
new instrument will enable FEMA to meet requirements set out in 44 CFR
206.438(c).
    Affected Public: State, Local or Tribal Government.
    Estimated Number of Respondents: 56.
    Estimated Total Annual Burden Hours: 37,576.
    Estimated Cost: There is no annual operation or maintenance cost
associated with this collection.

    Dated: June 18, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-15350 Filed 6-26-13; 8:45 am]
BILLING CODE 9110-13-P


[Federal Register: March 15, 2011 (Volume 76, Number 50)]
[Notices]
[Page 14023-14024]
[DOCID:fr15mr11-80]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0177]

Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250
Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial,
Approved Under New Drug Application 050585, Were Not Withdrawn From
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined ROCEPHIN
(ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g),
2g, and 10g base/vial, approved under new drug application (NDA)
050585, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for any of these products if all other
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of an NDA. The only clinical data required in an ANDA
are data to show that the drug that is the subject of the ANDA is
bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
    ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and
10g base/vial, are the subject of NDA 050585 held by F. Hoffman-La
Roche Ltd. (La Roche). ROCEPHIN (ceftriaxone sodium) is a semisynthetic
cephalosporin antibiotic for intravenous or intramuscular
administration and is indicated for the treatment of certain infections
as described in the labeling. The drug products approved under NDA
050585 are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
    Steven H. Sklar of Leydig, Voit & Mayer, Ltd., submitted a citizen
petition dated April 3, 2009 (Docket No. FDA-2009-P-0177), under 21 CFR
10.30, requesting that FDA determine that ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved under NDA
050585, were withdrawn from sale for reasons other than safety or
effectiveness.
    After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec.  314.161 that ROCEPHIN
(ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/
vial, approved under NDA 050585, were not withdrawn from sale for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that these products were withdrawn
from sale for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of these
products from sale. We have also independently evaluated the relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that any of these products
were

withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ROCEPHIN (ceftriaxone
sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved
under NDA 050585, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been withdrawn from sale for
reasons other than safety or effectiveness. ANDAs that refer to any of
the products described in this notice may be approved by FDA as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. If FDA determines that labeling for any of these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5947 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P