SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for Mineral Wool Production ( 40 CFR part 63, subpart DDD)

1. Identification of the Information Collection 1( a) Title of the Information Collection NESHAP for Mineral Wool Production ( 40 CFR part 63, subpart DDD)

1( b) Short Characterization/ Abstract The NESHAP regulations published at 40 CFR part 63, subpart DDD were proposed on May 8, 1997, and promulgated on June 1, 1999. These regulations apply to each cupola and/ or curing oven located at a mineral wool production facility commencing construction or reconstruction after the date of proposal. This information is being collected to assure compliance with part 63, subpart DDD.

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 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 12 sources are currently subject to the regulation, and it is estimated that there will be no additional sources subject to the regulation in the next three years. It is further assumed that there is a total of approximately 18 cupolas operating at these 12 sources. This information was provided by the North American Insulation Manufacturing Association ( NAIMA). All but two of the 12 sources are members of NAIMA.

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 2 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, particulates and formaldehyde emissions from the production of mineral wool 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 DDD.

2( b) Practical Utility/ Users of the Data The control of particulates and formaldehyde emissions from mineral wool production facilities requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of particulates and formaldehyde from Mineral Wool Production are the result of operation of the cupola and curing ovens. This standard relies on a fabric filter for particulate emission control for cupolas and a thermal incinerator for formaldehyde control for curing ovens. The notifications required in the applicable regulations 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 regulations are 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 standards, and serve as a record of the operating conditions under which compliance was achieved. This standard requires respondents to install fabric filter bag leak detection systems and initiate corrective action procedures in the event of an operating problem. Failure to initiate corrective actions within 1 hour of the alarm would constitute a violation of the emissions limit. 3 The standards also require respondents to continuously monitor and record the operating temperature of each thermal incinerator. An average temperature in any 3 hour period that falls below the average established during the initial performance test is considered a violation of the applicable emission standard. Additionally, all respondents are required to continuously monitor and record the cupola production ( melt) rate, and respondents with affected curing ovens are required to monitor and record the formaldehyde content of each binder formulation used to manufacture bonded products. These requirements pose no additional burden upon the industry because cupola melt rate and binder formulation are currently monitored and recorded as customary business practices. Monitoring of the melt rate ( i. e., amount of rock and slag charged into the cupola) is necessary to maintain the proper raw materials ratio. Monitoring of binder formaldehyde content is necessary to ensure product specifications, which include binder formulation, are being achieved. Respondents would be required to maintain records of this specific information to ensure that the standards are being achieved and maintained.

The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. 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 NESHAP continue to operate the control equipment in compliance with the regulation. Adequate monitoring, recordkeeping, and reporting are 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 requested recordkeeping and reporting are required under 40 CFR part 63, subpart DDD.

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 its 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 ( 68 FR 27059) on May 19, 2003. No comments were received on the 4 1 This standard applies to cupolas and curing ovens located at mineral wool production facilities. However, for this ICR it is assumed that no additional equipment is needed to meet the monitoring requirements for the curing ovens. Therefore, capital costs and operation and maintenance ( O& M) costs for this ICR are associated only with the cupolas, specifically the capital cost and O& M costs associated with the installation and operation of a baghouse leak detection system. burden published in the Federal Register.

3( c) Consultations In estimating the affected number of sources and the growth rate of mineral wool production facilities subject to this standard, EPA contacted Angus Crane of the North American Insulation Manufacturers Association ( NAIMA) at ( 703) 684 0084. All but two of the 12 mineral production facilities subject to this standard are members of NAIMA. Therefore, NAIMA was able to provide us with accurate estimates regarding the number of existing facilities, the number of affected units located at these facilities and the predicted growth rate of the industry over the next three years. NAIMA indicated that there are currently 12 mineral wool production plants located in the United States. There is a total of approximately 18 affected units ( e. g., cupolas) 1 located at these plants. Due to increased competition from the cellulose insulation manufacturing industry, particularly in the mobile home production sector, NAIMA estimates that there will be no growth in the mineral wool production industry over the next three years.

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 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 part 1320, Section 1320.5.

These standards require affected facilities to maintain all records, including reports and notifications for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five year records retention requirement is consistent the Part 70 permit program and the five year statute of limitations on which the permit program is based. Also, the retention of records for five years would allow EPA to establish the compliance history 5 of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years. EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

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 ( 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 None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are mineral wool production facilities. The SIC ( United States Standard Industrial Classification) code for the respondents affected by the standards is SIC 3296 which corresponds to the NAICS ( The North American Industry Classification System) code 327993 for mineral wool production facilities.

4( b) Information Requested ( i) Data Items All data in this ICR that are recorded and/ or reported are required by NESHAP for Mineral Wool Production ( 40 CFR part 63, subpart DDD)

A source must make the following reports: 6 NESHAP subpart DDD  Notification Reports Applicability 63.9( a), 63.1191( a)

Construction/ reconstruction 63.9( b)( 3) and ( 4), 63.1191( b)

Actual startup 63.9( b)( 2) and ( 4)

Special compliance requirements 63.9( d), 63.1191( c)

Initial performance test 63.9( e), 63.1191( d)

Compliance status 63.9( h), 63.1191( e)

Request for extension of compliance, adjustments to time periods, and changes in information 63.9( c),( i) and ( j)

NESHAP subpart DDD  Monitoring Reports Report of performance test results 63.10( d)( 2), 63.1193( a)

Startup, shutdown, and malfunctions plan 63.6( c)( 3), 63.1193( b)

Startups, shutdowns, and malfunctions plan and reports 63.6( e)( 3), 63.10( d)( 5), 63.1193( c)

Operations, maintenance, and monitoring plan 63.6( e)( 1)( e)( 2), 63.1193( d)

Semiannual excess emissions report 63.10( e)( 3), 63.1193( e)

Semiannual no excess emissions report 63.10( e)( 3), 63.1193( f)

A source must keep the following records: 7 NESHAP subpart DDD  Recordkeeping General recordkeeping requirements ( e. g., startups, shutdowns, and malfunctions including process equipment, air pollution control equipment, maintenance performed, and actions taken outside the scope of the existing plans) 63.10( b), 63.1192( a)

Maintain records of the following information:  Cupola production ( melt) rate ( Mg/ hr ( tons/ hr) of melt)  All bag leak detection system alarms  Free formaldehyde content of each resin lot and binder formulation  Incinerator operating temperature and results of incinerator inspections 63.1192( b)

Retain records for five years following the date of each occurrence, measurement, corrective action, maintenance record, or report. The most recent two years of records must be retained at the facility. 63.1192( c)

Retain records on microfilm, on a computer, on computer disks, on magnetic tape disks, or on microfiche. 63.1192( d)

Report the required information on paper or on a labeled computer disk using commonly available and compatible computer software. 63.1192( e)

Presently, sources are using monitoring equipment that provides parameter data in an automated way, e. g., leaks and spills of mercury. Although personnel at the source still need to evaluate the data, this type of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping. In addition, some regulatory agencies are setting up electronic reporting systems to allow sources to report electronically, which is reducing the reporting burden. However, electronic reporting systems are still not widely used by the regulatory agencies. It is estimated that approximately 10% of the respondents use electronic reporting.

( ii) Respondent Activities 8 Respondent Activities for NESHAP subpart DDD Read instructions.

All monitoring systems and equipment must be installed, operational, and properly calibrated before the performance test.

Perform initial performance test. Use the following methods found in Appendix A of part 60: Method 1 for the selection of the sampling port locations and the number of sampling ports, Method 2 for stack gas velocity and volumetric flow rate, Method 3 or 3A for oxygen and carbon dioxide for diluent measurement needs to correct the concentration measurements to a standard basis, Method 4 for moisture content of the stack gas, Method 5 for the concentration of PM, Method 10 for the concentration of CO ( using the continuous sampling option described in section 7.1.1 of the method). Also, use Method 318 in Appendix A to part 63 for the concentration of formaldehyde or CO and the method described to determine the free formaldehyde content of each resin lot. All tests are repeated 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. 9 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.

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 Air Facility System ( AFS).

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether 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 and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual 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 the 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 and annual emission inventory data for more than 100,000 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 its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five years. 10 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. 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.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 1: Annual Burden of Reporting and Recordkeeping Requirements, National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Mineral Wool Production ( 40 CFR part 63, subpart DDD).

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 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 3,018. 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. 11 2 For this table, the number of respondents is the number of cupolas that are required to have leak detection systems installed on their baghouses. It is estimated that there are 18 cupolas located at 12 facilities. 6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates: $ 93.09 per hour for Executive, Administrative, and Managerial labor; $ 64.13 per hour for Technical labor, and $ 39.65 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, June 2003, " Table 10. Private industry, by occupational and industry group." The following 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.

Managerial $ 93.04 ($ 44.33 + 110%) Technical $ 64.13 ($ 30.54 + 110%) Clerical $ 39.65 ($ 18.88 + 110%)

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The types of industry costs associated with the information collection activities in the subject standard( s) are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring. 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( s) 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/ Startu p Cost for One Respondent ( C) Number of New Respondents ( D) Total Capital/ Startu p Cost, ( B X C) ( E) Annual O& M Costs for One Respondent ( F) Number of Respondents with O& M2 ( G) Total O& M, ( E X F)

Baghouse Leak Detection $ 14,900 0 $ 0 $ 500 18 $ 9,000 12 The compliance date for this standard was June 2, 2002. Therefore, all existing facilities incurred capital costs during the previous ICR time period. Since we estimate that no new facilities will startup over the next three years, capital costs associated with this standard for this ICR period will be zero. This is the total of column D in the above table. These costs are shown on the OMB 83 I form in block 14( a), Total annualized capital/ startup costs.

The total operation and maintenance ( O& M) costs for this ICR are estimated to be $ 9,000. This is the total of column G. These costs are shown on the OMB 83 I form in block 14( b), Total annual costs ( O& M).

The total respondent 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 $ 9,000. This cost is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars. The continuous monitoring costs that are included in this section consist only of those capital/ startup and O& M costs that a source incurs as a result of the standard. Some continuous monitoring costs may not be included in this section. For instance, if a particular industry typically utilizes a control device that must have a continuous monitor ( e. g., temperature, pressure drop, etc.) to function properly, and the recordkeeping of additional measurements beyond the minimum is required by the standard, then there is no capital/ startup or O & M cost, but there is a labor cost to record the additional readings. Such a cost would not appear in this section, but in the industry burden Section 6( d) below.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs 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, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $ 27,211. This ICR uses the following labor rates:

Managerial $ 53.22 ( GS 13, Step 5, $ 33.26 x 1.6) Technical $ 39.49 ( GS 12, Step 1, $ 24.68 x 1.6) Clerical $ 21.38 ( GS 6, Step 3, $ 13.36 x 1.6)

These rates are from the Office of Personnel Management ( OPM) " 2003 General Schedule" which excludes locality rates of pay. These rates can be obtained from the OPM web site, 13 3 New respondents include sources with constructed, reconstructed and modified affected facilities. http:// www. opm. gov/ oca/ payrates/ index/ htm. Details upon which this estimate is based appear in Table 2: ( Average Annual EPA Resource Requirement).

6( d) Estimating the Respondent Universe and Total Burden and Costs Based on our research for this ICR, approximately 12 existing sources are subject to the standard. It is estimated that no new sources will become subject to the regulation in the next three years.

Number of respondents is calculated using the following table which 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 Respondents3 ( 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 0 12 0 0 12 2 0 12 0 0 12 3 0 12 0 0 12 Average 0 12 0 0 12 . To avoid double counting respondents, column D is subtracted. As shown above, the average Number of Respondents over the three year period of this ICR is 12. This number appears on the OMB 83 I form in block 13( a), Number of respondents.

The total number of annual responses per year is calculated using the following table: 14 Total Annual Responses ( A) Number of New Respondents ( B) Number of Reports for New Respondents ( C) Number of Existing Respondent s ( D) Number of Reports for Existing Respondents ( F) Number of Existing Respondents That Keep Records But Do Not Submit Reports ( E) Total Annual Responses E=( AxB)+( CxD)+ F 0 9 12 2 0 24 The number of Total Annual Responses is 24. This number is shown on the OMB 83 I form in block 13( b), Total annual responses.

The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are estimated to be $ 190,906. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1: Annual Burden of Reporting and Recordkeeping Requirements, National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Mineral Wool Production ( 40 CFR part 63, subpart DDD)

Note that the total annual capital and O& M costs to the regulated entity are $ 9,000. 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/ Startup vs. Operation and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents appear in Tables 1 and 2.

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to an adjustment in burden hours. The primary reason for the adjustment in burden hours is due to the fact that the compliance date of June 2, 2002, has passed and all existing facilities have already submitted all required notifications and completed all required performance testing. Therefore the remaining burden on the industry is primarily the operation and maintenance of the control equipment ( e. g., baghouse leak detection systems) and the semiannual reporting.

The decrease in burden hours can also be attributed to the fact that there is one less existing facility subject to the standard and 10 fewer cupolas at these facilities. As mention in Section 3( c) this is attributed primarily to the fact that the mineral wool production industry is encountering increased competition from the cellulose insulation manufacturing industry, particularly in the mobile home insulation market. 15 The increase in labor costs associated with this ICR is due to the increase in wage rates provided by the United States Department of Labor, Bureau of Statistics.

6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 126 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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 OECA 2003 0029, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the OECA Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. 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 No. ( OECA 2003 0029) and OMB control number ( 2060 0362) in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3370-3371]
[FR Doc No: 2020-00877]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10004-35-ORD]

Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA), Office of the
Science Advisor, Policy, and Engagement announces two separate public
meetings of the Human Studies Review Board (HSRB) to advise the Agency
on the ethical and scientific review of research involving human
subjects.

DATES: A virtual public meeting will be held on Thursday, January 30,
2020 from 1 p.m. to approximately 5:30 p.m. Eastern Time. A separate,
subsequent teleconference meeting is planned for Tuesday, March 17,
2020, from 2 p.m. to approximately 3:30 p.m. Eastern Time for the HSRB
to finalize its Report of the January 30, 2020 meeting and review other
possible topics.

ADDRESSES: All of these meetings will be conducted entirely by
telephone and on the internet. For detailed access information visit
the HSRB website: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact the HSRB Designated Federal
Official (DFO), Thomas O'Farrell on telephone number<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>or
mailing address: Environmental Protection Agency, Office of the Science
Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW, Washington, DC
20460.

SUPPLEMENTARY INFORMATION:
    Meeting access: These meetings will be open to the public. The full
agenda with access information and meeting materials will be available
at the HSRB website: http://www2.epa.gov/osa/human-studies-review-board. For questions on document availability, or if you do not have
access to the internet, consult with the DFO, Thomas O'Farrell, listed
under FOR FURTHER INFORMATION CONTACT.
    Special accommodations. For information on access or services for
individuals with disabilities, or to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in
these meetings by following the instructions in this section.
    1. Oral comments. To pre-register to make oral comments, please
contact the DFO, Thomas O'Farrell, listed under FOR FURTHER INFORMATION
CONTACT. Requests to present oral comments during the meeting will be
accepted up to Noon Eastern Time on Thursday, January 23, 2020, for the
January 30, 2020 meeting and up to Noon Eastern Time on Tuesday, March
10, 2020 for the March 17, 2020 meeting. To the extent that time
permits, interested persons who have not pre-registered may be
permitted by the HSRB Chair to present oral comments during either
meeting at the designated time on the

agenda. Oral comments before the HSRB are generally limited to five
minutes per individual or organization. If additional time is
available, further public comments may be possible.
    2. Written comments. Submit your written comments prior to the
meetings. For the Board to have the best opportunity to review and
consider your comments as it deliberates, you should submit your
comments via email or fax by Noon Eastern Time on Thursday, January 23,
2020, for the January 30, 2020 meeting and by Noon Eastern Time on
Tuesday, March 10, 2020 for the March 17, 2020 meeting. If you submit
comments after these dates, those comments will be provided to the HSRB
members, but you should recognize that the HSRB members may not have
adequate time to consider your comments prior to their discussion. You
should submit your comments to the DFO, Thomas O'Farrell listed under
FOR FURTHER INFORMATION CONTACT. There is no limit on the length of
written comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 5 U.S.C. App.2 Sec.  9. The
HSRB provides advice, information, and recommendations on issues
related to scientific and ethical aspects of third-party human subjects
research that are submitted to the Office of Pesticide Programs (OPP)
to be used for regulatory purposes.
    Topic for discussion. On January 30, 2020, the HSRB will consider a
study titled ``Determination of Dermal and Inhalation Exposure to
Workers during Closed System Loading of Liquids in Returnable and Non-
Returnable Containers'' and a report titled ``Agricultural Handler
Scenario Monograph: Mechanical Transfer of Liquids'', both submitted by
the Agricultural Handlers Exposure Task Force.
    The agenda and meeting materials for this topic will be available
in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On March 17, 2020, the HSRB will review and finalize their draft
Final Report from the January 30, 2020 meeting, in addition to other
topics that may come before the Board. The HSRB may also discuss
planning for future HSRB meetings. The agenda and the draft report will
be available prior to the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings,
summarizing the matters discussed and recommendations made by the HSRB,
will be released within 90 calendar days of the meeting. These minutes
will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will
be found at http://www2.epa.gov/osa/human-studies-review-board or from
Thomas O'Farrell listed under FOR FURTHER INFORMATION CONTACT.

    Dated: January 9, 2020.
Jennifer Orme-Zavaleta,
EPA Science Advisor.
[FR Doc. 2020-00877 Filed 1-17-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Page 29836]
[FR Doc No: 2014-11982]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice before Waiver With Respect to Land at Richmond
International Airport, Richmond, Virginia

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent of waiver with respect to land.

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

SUMMARY: The FAA is publishing notice of proposed release of 1.318
acres of land at the Richmond International Airport, Richmond, Virginia
to the Henrico County for construction of the widening of Charles City
Road. An additional 0.622 Acres will be permanently utilized by Henrico
County within utility, and drainage easements. There are no adverse
impacts to the Airport and the land is not needed for airport
development as shown on the Airport Layout Plan. Fair Market Value of
the land has been established. The Airport will benefit from the
improvements to Charles City Road with the more efficient intersection
at Airport Drive. The east and west bound through lanes and dedicated
right and left turn lanes will provide a more efficient entry to the
Airport. These intangible benefits will offset the value of the
released property.

DATES: Comments must be received on or before June 23, 2014.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Terry J. Page, Manager, FAA
Washington Airports District Office, 23723 Air Freight Lane, Suite 210,
Dulles, VA 20166.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Jon E. Mathiasen, President & CEO, Capital
Region Airport Commission, at the following address: Jon E. Mathiasen,
President & CEO, Capital Region Airport Commission, 1 Richard E. Byrd
Terminal Drive, Richmond International Airport, VA 23250.

FOR FURTHER INFORMATION CONTACT: Mr. Terry Page, Manager, Washington
Airports District Office, 23723 Air Freight Lane, Suite 210, Dulles, VA
20166; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Wendell H. Ford Aviation investment and
Reform Act for the 21st Century, public Law 10-181 (Apr. 5, 2000; 114
Stat. 61) (AIR 21), as amended, requires that a 30 day public notice
must be provided before the Secretary may waive any condition imposed
on an interest in surplus property.

    Issued in Dulles, Virginia on May 16, 2014.
Terry J. Page,
Manager, Washington Airports District Office, Eastern Region.
[FR Doc. 2014-11982 Filed 5-22-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 28, 2008 (Volume 73, Number 168)]
[Notices]
[Page 50808-50809]
[DOCID:fr28au08-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR08-15-000]

ExxonMobil Oil Corporation and BP West Coast Products LLC,
Complainants, v. SFPP, L.P., Respondent; Notice of Complaint

August 21, 2008.
    Take notice that on August 20, 2008, pursuant to sections 206 and
212 of the Rules of Practice and Procedure, 18 CFR 385.206 and 385.212
and sections 205 and 306 of the Federal Power Act, 16 U.S.C. 824(e) and
825(e), ExxonMobil Oil Corporation and BP West Coast Products LLC
(Complainants) filed a complaint against SFPP, L.P. (Respondent)
challenging Respondent's 2008 index rate increases as unjust and
unreasonable under section 1(5) of the Interstate Commerce Act.
Complainants request that the Commission review and investigate SFPP's
index rate increases; resolve the legal issues, and, if necessary, set
the proceeding for an evidentiary hearing; require the payment of
refunds and reparations for the index rate increase; and award such
other relief as is necessary and appropriate under the Interstate
Commerce Act.
    The Complainant states that a copy of the complaint has been served
on the Respondent.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to

become a party must file a notice of intervention or motion to
intervene, as appropriate. The Respondent's answer and all
interventions, or protests must be filed on or before the comment date.
The Respondent's answer, motions to intervene, and protests must be
served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 9, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-19931 Filed 8-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Rules and Regulations]
[Page 46014-46016]
[DOCID:fr08se09-16]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0383]
RIN 1625-AA00

Safety Zone; Paddle for Clean Water; San Diego; CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone upon the
navigable waters of the Pacific Ocean, San Diego, CA, in support of a
paddling regatta near the Ocean Beach Pier. This safety zone is
necessary to provide for the safety of the participants, crew,
spectators, participating vessels, and other vessels and users of the
waterway. Persons and vessels are prohibited from entering into,
transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

DATES: This rule is effective on September 13, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2009-0383 and are available online by going to
http://www.regulations.gov, inserting USCG-2009-0383 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Petty Officer Shane Jackson, Waterways
Management, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 29, 2009 we published a notice of proposed rulemaking
(NPRM) entitled Safety zone; Paddle for Clean Water; San Diego;
California in the Federal Register (74 FR 30991). We received 0
comments on the proposed rule. No public meeting was requested, and
none was held.

Background and Purpose

    The Surfrider Foundation San Diego Chapter is sponsoring the Paddle
for Clean Water. The event will consist of 900 to 1000 participants
paddling around the Ocean Beach Pier. The sponsor will provide rescue
vessels, as well as perimeter safety boats for the duration of this
event. This safety zone is necessary to provide for the safety of the
participants, crew, spectators, participating vessels, and other
vessels and users of the waterway.

Discussion of Rule

    The Coast Guard is establishing a safety zone that will be enforced
on September 13, 2009 from 9 a.m. to 4 p.m. The limits of the safety
zone will be as follows:

    32[deg]45.00' N, 117[deg]15.12' W;
    32[deg]45.10' N, 117[deg]15.30' W;
    32[deg]44.55' N, 117[deg]15.38' W;
    32[deg]44.43' N, 117[deg]15.19' W; along the shoreline to
    32[deg]45.00' N, 117[deg]15.12' W.

    This safety zone is necessary to provide for the safety of the
participants, crew, spectators, participating vessels, and other
vessels and users of the waterway. Persons and vessels will be
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port or his
designated representative.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. We expect the economic impact of this
temporary final rule to be so minimal that a full Regulatory Evaluation
is unnecessary. This determination is based on the size and location of
the safety zone. Commercial vessels will not be hindered by the safety
zone. Recreational vessels will not be allowed to transit through the
designated safety zone during the specified times unless authorized to
do so by the Captain of the Port or his designated representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This determination is based on the size and location of the
safety zone. Commercial vessels will not be hindered by the safety
zone. Recreational vessels will not be allowed to transit through the
designated safety zone during the specified times.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have Tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian Tribes, on the relationship between the Federal Government and
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g) of the Instruction. This rule involves establishment of a
safety zone. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a new temporary zone Sec.  165.T11-201 to read as follows:

Sec.  165.T11-201  Safety zone; Paddle for Clean Water; San Diego;
California

    (a) Location. The limits of the safety zone will be as follows:

    32[deg]45.00' N, 117[deg]15.12' W;
    32[deg]45.10' N, 117[deg]15.30' W;
    32[deg]44.55' N, 117[deg]15.38' W;
    32[deg]44.43' N, 117[deg]15.19' W; along the shoreline to
    32[deg]45.00' N, 117[deg]15.12' W.

    (b) Enforcement Period. This section will be enforced on September
13, 2009 from 9 a.m. to 4 p.m. If the event concludes prior to the
scheduled termination time, the Captain of the Port will cease
enforcement of this safety zone and will announce that fact via
Broadcast Notice to Mariners.

    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State, and Federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Command Center
(COMCEN). The COMCEN may be contacted on VHF-FM Channel 16 or (619)
278-7033.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other Federal, State, or
local agencies.

    Dated: August 18, 2009.
D.L. Leblanc,
Commander, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-21439 Filed 9-4-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Rules and Regulations]
[Pages 4774-4776]
[FR Doc No: 2015-00999]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0624; Directorate Identifier 2014-NM-005-AD;
Amendment 39-18072; AD 2015-02-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 717-200 airplanes; Model DC-10-10, DC-10-10F, DC-
10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40 and DC-10-40F
airplanes; Model MD-10-10F and MD-10-30F airplanes; Model DC-9-81 (MD-
81), DC-9-82 (MD-82), DC-9-83 (MD-83), and DC-9-87 (MD-87) airplanes;
Model MD-88 airplanes; and Model MD-90-30 airplanes. This AD was
prompted by reports of latent air data transducer degradation. This AD
requires revising the maintenance or inspection program, as applicable,
to incorporate special compliance items (SCIs). We are issuing this AD
to prevent erroneous air data information, which could lead to a mid-
air collision within reduced vertical separation minimum (RVSM)
airspace.

DATES: This AD is effective March 5, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 5,
2015.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0624; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jeffrey W. Palmer, Aerospace Engineer,
Systems and Equipment Branch, ANM-130L, Los Angeles Aircraft
Certification Office (ACO), FAA, 3960 Paramount Boulevard, Lakewood, CA
90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model 717-200 airplanes; Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30,
DC-10-30F (KC-10A and KDC-10), DC-10-40 and DC-10-40F airplanes; Model
MD-10-10F and MD-10-30F airplanes; Model DC-9-81 (MD-81), DC-9-82 (MD-
82), DC-9-83 (MD-83), and DC-9-87 (MD-87) airplanes; Model MD-88
airplanes; and Model MD-90-30 airplanes. The NPRM published in the
Federal Register on September 12, 2014 (79 FR 54672). The NPRM was
prompted by reports of latent air data transducer degradation. The NPRM
proposed to require revising the maintenance or inspection program, as
applicable, to incorporate SCIs. We are issuing this AD to correct the
unsafe condition on these products.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. Boeing stated that it
concurred with the NPRM (79 FR 54672, September 12, 2014).

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed, except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 54672, September 12, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 54672, September 12, 2014).

Related Service Information

    We reviewed Boeing Report No. MDC-02K1003, Trijet Special
Compliance Item (SCI) Report 34-4, ``Functional Test of the Captain and
First Officer's Altimeter,'' Revision K, dated February 1, 2013; and
Boeing Report No. MDC-92K9145, Twinjet SCI Report 34-1--``Functional
Test of the Captain and First Officer's Altimeter,'' Revision M, dated
February 5, 2013. The service information describes procedures for a
functional test of the captain and first officer's altimeters. You can
find this information at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-0624.

Costs of Compliance

    We estimate that this AD affects 716 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Maintenance or inspection program     1 work-hour x $85 per                $0              $85          $60,860
 revision.                             hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):
2015-02-05 The Boeing Company: Amendment 39-18072; Docket No. FAA-
2014-0624; Directorate Identifier 2014-NM-005-AD.

(a) Effective Date

    This AD is effective March 5, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company airplanes identified
in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in
any category.
    (1) The Boeing Company Model 717-200 airplanes.
    (2) The Boeing Company Model DC-10-10, DC-10-10F, DC-10-15, DC-
10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40, and DC-10-40F
airplanes; and Model MD-10-10F and MD-10-30F airplanes.
    (3) The Boeing Company Model DC-9-81 (MD-81), DC-9-82 (MD-82),
DC-9-83 (MD-83), and DC-9-87 (MD-87) airplanes; Model MD-88
airplanes; and Model MD-90-30 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by reports of latent air data transducer
degradation. We are issuing this AD to prevent erroneous air data
information, which could lead to a mid-air collision within reduced
vertical separation minimum (RVSM) airspace.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance or Operations Program Revision

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, by incorporating
the information specified in paragraphs (g)(1), (g)(2), or (g)(3) of
this AD, as applicable. The initial compliance time for the tasks is
within 18 months after the effective date of this AD.
    (1) For Model 717-200 airplanes; Model DC-9-81 (MD-81), DC-9-82
(MD-82), DC-9-83 (MD-83), and DC-9-87 (MD-87) airplanes; Model MD-88
airplanes; and Model MD-90-30 airplanes: Incorporate Special
Compliance Item (SCI) 34-1, ``Functional Test of the Captain and
First Officer's Altimeter, of Appendix A--``SCIs'' to Boeing Report
No. MDC-92K9145, ``Twinjet Special Compliance Items Report,''
Revision M, dated February 5, 2013.
    (2) For Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F
(KC-10A and KDC-10), DC-10-40 and DC-10-40F airplanes: Incorporate
SCI 34-4, ``Functional Test of the Captain and First Officer's
Altimeter,'' of Appendix A--``SCIs'' to Boeing Report No. MDC-
02K1003, ``Trijet Special Compliance Item Report,'' Revision K,
dated February 1, 2013.
    (3) For Model MD-10-10F and MD-10-30F airplanes: Incorporate SCI
34-4, ``Functional Test of the Captain and First Officer's
Altimeter, of Appendix A--``SCIs'' to Boeing Report No. MDC-02K1003,
``Trijet Special Compliance Item Report,'' Revision K, dated
February 1, 2013.

(h) No Alternative Actions and Intervals

    After accomplishment of the revision required by paragraph (g)
of this AD, no alternative actions (e.g., inspections) or intervals
may be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j) of this AD.
Information may be emailed to<EMAIL_ADDRESS>

    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.

(j) Related Information

    For more information about this AD, contact Jeffrey W. Palmer,
Aerospace Engineer, Systems and Equipment Branch, ANM-130L, Los
Angeles ACO, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Special Compliance Item (SCI) 34-4, ``Functional Test of the
Captain and First Officer's Altimeter,'' of Appendix A--``SCIs,'' to
Boeing Report No. MDC-02K1003, ``Trijet Special Compliance Item
Report,'' Revision K, dated February 1, 2013. There is no page ``i''
identified in this document.
    (ii) Special Compliance Item (SCI) 34-1--``Functional Test of
the Captain and First Officer's Altimeter,'' of Appendix A ``SCIs,''
to Boeing Report No. MDC-92K9145, Twinjet Special Compliance Item
Report, Revision M, dated February 5, 2013.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA
90846-0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>;
Internet https://www.myboeingfleet.com.
    (4) You may view this referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on January 11, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-00999 Filed 1-28-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8504-8505]
[FR Doc No: 2016-03393]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0545]

Recommendations for Donor Screening, Deferral, and Product
Management To Reduce the Risk of Transfusion-Transmission of Zika
Virus; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a document entitled ``Recommendations for Donor
Screening, Deferral, and Product Management to Reduce the Risk of
Transfusion-Transmission of Zika Virus: Guidance for Industry.'' The
guidance document provides blood establishments that collect blood and
blood components with recommendations for donor screening, donor
deferral, and product management to reduce the risk of transfusion-
transmitted Zika virus (ZIKV). The guidance applies to the collection
of Whole Blood and blood components intended for transfusion. The
guidance does not apply to the collection of Source Plasma.

DATES: The Agency is soliciting public comment, but is implementing
this guidance immediately because the Agency has determined that prior
public participation is not feasible or appropriate. Submit either
electronic or written comments on Agency guidances at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0545 for ``Recommendations for Donor Screening, Deferral,
and Product Management to Reduce the Risk of Transfusion-Transmission
of Zika Virus; Guidance for Industry.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Valerie Butler, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled
``Recommendations for Donor Screening, Deferral, and Product Management
to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance
for Industry.'' The guidance document provides blood establishments
that collect blood and blood components with recommendations for donor
screening, donor deferral, and product management to reduce the risk of
transfusion-transmitted ZIKV. The guidance applies to the collection of
Whole Blood and blood components intended for transfusion. The guidance
does not apply to the collection of Source Plasma, which is used for
further manufacture of plasma-derived products. Viral inactivation and
removal methods are currently used to clear

viruses in the manufacturing process for such plasma-derived products.
    ZIKV is an arbovirus from the Flaviviridae family, genus
Flavivirus. It is transmitted to humans primarily by the Aedes aegypti
mosquito, but it may also be transmitted by the Aedes albopictus
mosquito. In addition, intrauterine, perinatal, and sexual transmission
of ZIKV has been reported. Two instances of possible transfusion-
transmission of ZIKV in Brazil have been described in media
announcements.
    The most common ZIKV disease symptoms include fever, arthralgia,
maculopapular rash, and conjunctivitis. Neurological manifestations and
congenital anomalies have been associated with ZIKV disease outbreaks.
Association of ZIKV infection with Guillain-Barr[eacute] syndrome cases
has been reported during outbreaks in Polynesia and in Brazil. In
Brazil there has also been a marked increase in the incidence of
microcephaly in regions most affected by the ZIKV epidemic.
    ZIKV reached the Americas in early 2015 with local transmission
first reported in Brazil and as of February 10, 2016, there are 30
countries and territories worldwide with active local transmission of
the virus. As of February 10, 2016, local mosquito-borne transmission
of ZIKV has not been reported in the continental United States, but
cases have been reported in travelers returning to the United States
from areas with local transmission.
    Consistent with existing regulations and applicable guidance,
donors must be in good health at the time of donation Sec.  640.3(b)
(21 CFR 640.3(b)) as indicated by, among other things, freedom from any
disease transmissible by blood transfusion, as can be determined by
history and examination (Sec.  640.3(b)(6)). Standard operating
procedures that are already in place should result in the deferral of
individuals who have symptoms consistent with ZIKV infection at the
time of donation. The recommendations in the guidance are intended to
reduce the risk of collecting blood and blood components from at-risk
donors who could be potentially infected with ZIKV and do not display
clinical symptoms during the incubation period or have an asymptomatic
infection.
    The guidance recommends that blood collection establishments in
areas without active transmission of ZIKV defer donors at risk for ZIKV
infection as follows: Defer for 4 weeks after the resolution of
symptoms a donor with a history of ZIKV infection or a donor who
reports symptoms suggestive of ZIKV within 2 weeks of departure from an
area with active transmission of ZIKV; defer for 4 weeks after the last
sexual contact a donor who has had sexual contact with a man who has
been diagnosed with ZIKV or who traveled to or resided in an area with
active transmission of ZIKV in the 3 months prior to that instance of
sexual contact; and defer for 4 weeks from the date of his or her
departure, a donor who has been a resident of or has travelled to an
area with active transmission of ZIKV.
    For areas with active transmission of ZIKV, the guidance recommends
that blood collection establishments obtain blood and blood components
from areas of the United States without active transmission of ZIKV to
fulfill orders. However, a blood establishment may collect platelets
and plasma locally if the blood establishment implements FDA-approved
pathogen reduction technology for platelets and plasma. Further, blood
establishments in areas of active transmission may collect blood
components locally provided the establishment tests blood donations
with an FDA-licensed blood donor screening test for ZIKV, when such a
test becomes available.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). FDA is issuing this guidance for
immediate implementation in accordance with 21 CFR 10.115(g)(2) without
initially seeking prior comment because the Agency has determined that
prior public participation is not feasible or appropriate. The guidance
represents the current thinking of FDA on ``Recommendations for Donor
Screening, Deferral, and Product Management to Reduce the Risk of
Transfusion-Transmission of Zika Virus.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 601.12 have been approved under
OMB control number 0910-0338; and the collections of information in 21
CFR 606.100(b), 606.160(b)(1), and 640.3(a) have been approved under
OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03393 Filed 2-18-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Page 12610]
[FR Doc No: 2012-4901]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2012-0011]

Pre-Disaster Emergency Declaration Requests, FD 010-4

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of availability; request for comments.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is accepting
comments on Pre-Disaster Emergency Declaration Requests.

DATES: Comments must be received by April 2, 2012.

ADDRESSES: Comments must be identified by docket ID FEMA-2012-0011 and
may be submitted by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments. Please note that this proposed
policy is not a rulemaking and the Federal Rulemaking Portal is being
utilized only as a mechanism for receiving comments.
    Mail: Regulatory Affairs Division, Office of Chief Counsel, Federal
Emergency Management Agency, Room 835, 500 C Street SW., Washington, DC
20472-3100.

FOR FURTHER INFORMATION CONTACT: Ryan Buras, Federal Emergency
Management Agency, 500 C Street SW., Washington, DC 20472, 202-212-
1677.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    Instructions: All submissions received must include the agency name
and docket ID. Regardless of the method used for submitting comments or
material, all submissions will be posted, without change, to the
Federal eRulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Therefore, submitting
this information makes it public. You may wish to read the Privacy Act
notice, which can be viewed by clicking on the ``Privacy Notice'' link
in the footer of www.regulations.gov.
    You may submit your comments and material by the methods specified
in the ADDRESSES section above. Please submit your comments and any
supporting material by only one means to avoid the receipt and review
of duplicate submissions.
    Docket: The proposed policy is available in docket ID FEMA-2012-
0011. For access to the docket to read background documents or comments
received, go to the Federal eRulemaking Portal at http://www.regulations.gov and search for the docket ID. Submitted comments
may also be inspected at FEMA, Office of Chief Counsel, Room 835, 500 C
Street SW., Washington, DC 20472.

II. Background

    This policy applies to any gubernatorial requests to the President
for an emergency declaration in advance or anticipation of the impact
of an incident that threatens such destruction as could result in a
major disaster, and is effective upon the date of issuance. This policy
applies to pre-disaster emergency declaration requests from all States,
Territories, and the District of Columbia.
    The proposed policy does not have the force or effect of law.
    FEMA seeks comment on the proposed policy, which is available
online at http://www.regulations.gov in docket ID FEMA-2012-0011. Based
on the comments received, FEMA may make appropriate revisions to the
proposed policy. Although FEMA will consider any comments received in
the drafting of the final policy, FEMA will not provide a response to
comments document. When or if FEMA issues a final policy, FEMA will
publish a notice of availability in the Federal Register and make the
final policy available at http://www.regulations.gov. The final policy
will not have the force or effect of law.

    Authority:  42 U.S.C. 5191-5193; 44 CFR part 206.

David J. Kaufman,
Director, Office of Policy and Program Analysis, Federal Emergency
Management Agency.
[FR Doc. 2012-4901 Filed 2-29-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22669-22670]
[FR Doc No: 2017-09960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2364]

Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/
Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

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 a new drug application (NDA).
    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 generally known 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) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug product listed in the table in
this document is no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
    Application No.            Drug name           Active ingredient         Strength(s)                Dosage form/route                Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 018874............  CALCIJEX..............  Calcitriol............  1 microgram (mcg)/     Injectable; Injection.............  AbbVie, Inc.
                                                                         milliliter (mL); 2
                                                                         mcg/mL.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness.\1\
Accordingly, the Agency will continue to list the drug product listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
---------------------------------------------------------------------------

    \1\ We have also determined that the previous CALCIJEX
formulation originally approved on September 25, 1986, and
superseded by the currently approved formulation was not withdrawn
for reasons of safety or effectiveness.
---------------------------------------------------------------------------

    Approved ANDAs that refer to the NDA listed in this document are
unaffected by the discontinued marketing of the products subject to
that NDA. Additional ANDAs that refer to this product may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
    This is not a significant regulatory action subject to Executive
Order 12866 and does not impose any additional burden on regulated
entities.

    Dated: May 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09960 Filed 5-16-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Rules and Regulations]
[Pages 74265-74266]
[FR Doc No: 2020-24950]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R04-RCRA-2020-0402; FRL-10016-11-Region 4]

South Carolina: Final Authorization of State Hazardous Waste
Management Program Revisions

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency is granting South Carolina
final authorization for changes to its hazardous waste program under
the Resource Conservation and Recovery Act (RCRA). The Agency published
a Proposed Rule on September 11, 2020 and provided for public comment.
The Agency received one comment in support of authorizing the South
Carolina program changes. This comment can be reviewed in the docket
for this action under Docket ID No. EPA-R04-RCRA-2020-0402. No further
opportunity for comment will be provided.

DATES: This final authorization is effective November 20, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R04-RCRA-2020-0402. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leah Davis, RCRA Programs and Cleanup
Branch, LCR Division, U.S. Environmental Protection Agency, Atlanta
Federal Center, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. What changes to South Carolina's hazardous waste program is EPA
authorizing with this action?

    South Carolina submitted a complete program revision application,
dated April 8, 2020, seeking authorization of changes to its hazardous
waste program in accordance with 40 CFR 271.21. The EPA now makes a
final decision that South Carolina's hazardous waste program revisions
that are being authorized are equivalent to, consistent with, and no
less stringent than the Federal program, and therefore satisfy all the
requirements necessary to qualify for final authorization. For a list
of State rules being authorized with this final authorization, please
see the Proposed Rule published in the September 11, 2020 Federal
Register at 85 FR 56200.

B. What is codification and is the EPA codifying South Carolina's
hazardous waste program as authorized in this rule?

    Codification is the process of placing citations and references to
the State's statutes and regulations that comprise the State's
authorized hazardous waste program into the Code of Federal
Regulations. The EPA does this by adding those citations and references
to the authorized State rules in 40 CFR part 272. The EPA is not
codifying the authorization of South Carolina's revisions at this time.
However, the EPA reserves the ability to amend 40 CFR part 272, subpart
PP, for the authorization of South Carolina's program changes at a
later date.

C. Statutory and Executive Order Reviews

    This final authorization revises South Carolina's authorized
hazardous waste management program pursuant to Section 3006 of RCRA and
imposes no requirements other than those currently imposed by State
law. For further information on how this authorization complies with
applicable executive orders and statutory provisions, please see the
Proposed Rule published in the September 11, 2020 Federal Register at
85 FR 56200. The Congressional Review Act, 5 U.S.C. 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. The EPA will submit a report containing
this document and other required information to the U.S. Senate, the
U.S. House of Representatives, and the Comptroller General of the
United States prior to publication in the Federal Register. A major
rule cannot take effect until 60 days after it is published in the
Federal Register. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2). This final action will be effective November 20, 2020.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Indian lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

    Dated: November 2, 2020.
Mary Walker,
Regional Administrator, Region 4.
[FR Doc. 2020-24950 Filed 11-19-20; 8:45 am]
BILLING CODE 6560-50-P