Statement Supporting the Revision of the Information Collection Procedure for the Community Right to Know Regulation of the Emergency Planning and Community Right to Know Act 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection Request Community Right to Know Reporting Requirements under sections 311 and 312 of the Emergency Planning and Community Right to Know Act ( EPCRA)   EPA No. 1352.09.

1( b) Short Characterization This information collection request ( ICR) was previously approved as OMB No. 2050 0072 through August 31, 2001, for 2,041,500 hours. Section 311 of EPCRA allows the public access to Material Safety Data Sheets ( MSDSs) that facilities provide to their employees. The owner or operator of any facility that is required to prepare or have available an MSDS for a hazardous chemical under the Hazard Communication Standard ( HCS) of the Occupational Safety and Health Administration ( OSHA) must submit an MSDS to the state emergency response commission ( SERC), the local emergency planning committee ( LEPC), and the local fire department for each hazardous chemical stored on site in a quantity greater than the reporting threshold. Alternatively, a list of subject chemicals, grouped by hazard type, may be submitted instead. The current reporting threshold is 10,000 pounds unless the chemical is specifically listed as an extremely hazardous substance ( EHS) under EPCRA section 302, in which case the reporting threshold becomes 500 pounds or the threshold planning quantity ( TPQ), whichever is less. The reporting threshold for gasoline ( all grades combined) is 75,000 gallons and for diesel fuel ( all grades combined) is 100,000 gallons, when stored entirely underground at retail gas stations that are in compliance with UST regulations.

The submittal of a list of chemicals or MSDSs was a one time requirement, to be completed by October 17, 1987, for manufacturing facilities that were subject to OSHA HCS at that time. OSHA has revised its standard to include other sectors ( non manufacturers, construction etc.) in 1988 and 1989. So any new facility that become subject to OSHA HCS for a chemical at or above the reporting threshold under section 311, must submit a list of chemicals or MSDSs within three months to the appropriate SERC, LEPC, and local fire department. Also, facilities must submit updates to the list of MSDSs, within three months, when a new hazardous chemical comes on site above the reporting threshold. If significant new information arises concerning a previously submitted MSDS, a facility must submit a revised MSDS. Additionally, if the SERC or LEPC receives a request from the public, the facility must provide an MSDS, even if the hazardous chemical is stored below the reporting threshold.

Section 312 of EPCRA requires owners and operators of facilities subject to section 311 to annually report the inventories of those chemicals reported under section 311. The Environmental Protection Agency ( EPA) is required to publish two emergency and hazardous chemical inventory forms, known as " Tier I" and " Tier II," for use by these facilities. The Tier I Form provides the minimum amount of information necessary to comply with the section. Any facility that is required to submit an MSDS or list of chemicals under section 311 must submit a Tier I form annually on or before March 1, incorporating the chemicals reported under section 311. Tier I Forms are submitted to the SERC, LEPC, and local fire department. The Tier II Form, which provides chemical specific information, is submitted in lieu of the Tier I Form only if specifically requested by the SERC or LEPC. 2 EPA is proposing to limit the number of chemicals subject to routine reporting under section 312 by establishing an infinite threshold for chemicals that pose minimal hazards and minimal risks for the community and emergency responders.

EPA estimates that 504,000 manufacturing and non manufacturing facilities would be subject to reporting and recordkeeping requirements under EPCRA sections 311 and 312 with the proposed infinite threshold for low hazard chemicals. The total burden to facilities over the three year information collection period is estimated to be 4,515,400 hours, at a cost of $ 131 million. There are estimated to be 3,466 active SERCs and LEPCs, based on estimates taken from a recent EPA update of its LEPC database. The total burden associated with state and local activities is estimated to be 398,800 hours, at a cost of $ 7.8 million. MSDSs, chemical lists, and Tier I Forms are not submitted to EPA. Therefore, no Agency burden is estimated in association with this ICR.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection The authority for these requirements is EPCRA sections 311 and 312 ( 42 U. S. C. § 11011 and § 11012).

Section 311 requires the owner or operator of any facility that is required to prepare or have available an MSDS for a hazardous chemical under OSHA regulations to submit an MSDS for each such chemical, or a list of chemicals, to the SERC, LEPC, and local fire department. This submittal allows local emergency planners/ responders and the community to have the same information regarding the hazards of a chemical as the facility.

Section 312 requires the same owners or operators of facilities to annually report the inventories of the chemicals reported under section 311. Section 312( g) requires EPA to publish emergency and hazardous chemical inventory forms for use by facilities subject to this section. In final rules published in the Federal Register on October 15, 1987, and July 26, 1990, EPA published the two " formats" required under EPCRA, " Tier I" and " Tier II." Tier I is the minimum amount of information necessary to comply with the section. Using Tier I, facilities aggregate reportable chemicals by hazard type and provide the quantities and locations of the chemicals. The Tier II Form is chemical specific information and only needs to be submitted ( in lieu of the Tier I Form) if specifically requested by the SERC or LEPC.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non Duplication Many states have laws that require information similar to that called for by sections 311 and 312 of EPCRA. EPA allows the state program to suffice for reporting provided that the minimum reporting requirements are met. The burden estimate in this ICR also includes burden imposed on facilities that comply with state requirements. 3 3( b) Consultations To estimate the burden imposed by EPCRA Sections 311 and 312 regulations, EPA had contacted representatives of several industries, including small to large size facilities, and several local emergency planning committees ( LEPCs)( listed below). In certain cases where estimates were not available from other sources, professional judgement was used. EPA also contacted few states to collect estimates of the reduction in the number of facilities and reports with the proposal of infinite threshold for low hazard chemicals. EPA also used the Tier II data ( 1997) from Pennsylvania.

Tim Gablehouse Dow Freeport, TX ( 5000 FTE) Jefferson County LEPC, CO ( 409) 238 2981 ( 303) 572 0050 Elizabeth Gonzalez Paterson Frozen Foods, CA ( 750 FTE) Pasadena ( TX) LEPC ( 209) 892 2611 ( 713) 475 5588 Gary Brown Lyondell Chemical Worldwide, LA ( 514 FTE) Cass County LEPC ( Kansas City, MO) ( 318) 491 3107 ( 816) 474 4240 Stephen Whiteway Farmland Industries, IA ( 55 FTE) Richmond County ( VA) LEPC ( 515) 543 4365 ( 804) 333 3415 Rayna Leibowitz Joe Pulaski Maine Emergency Management Agency Connecticut SERC ( 207) 626 4505 ( 860) 424 3373 3( c) Effects of Less Frequent Collection The reporting deadlines for sections 311 and 312 are set by statute. EPA has no authority to allow less frequent collection.

3( d) General Guidelines The collection activities specified in this ICR adhere to the guidelines specified by OMB.

3( e) Confidentiality The respondent may claim specific chemical identities as trade secrets in reports submitted under section 312 and in the list of chemicals and material safety data sheets submitted under section 311. Such information must be submitted to EPA according to EPCRA sections 322 and 323 ( 40 CFR Part 350). 4 All trade secrecy claims submitted to EPA under Title III are handled and stored according to procedures set out in the Interim OSWER Procedures For Protecting Title III Trade Secret Documents. These procedures were developed expressly for Title III trade secrecy claims with the knowledge that these documents are sensitive. Handling and review of documents containing Title III trade secret information is permitted only by persons who have obtained formal clearance to access the information based on a workrelated need to engage in these activities. When not being processed or reviewed by authorized individuals, the claim submissions containing trade secret information are stored in restricted access areas. To ensure that appropriate handling procedures are activated and the confidentiality of Title III trade secret submissions is maintained, the Agency attaches a cover sheet to the top of each trade secret document and otherwise marks the document to clearly identify the document as Title III confidential.

3( f) Sensitive Questions The information gathering activities under this ICR do not involve any sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC Codes Sections 311 and 312 are applicable to all facilities that are required to prepare or have available an MSDS for a hazardous chemical as required under OSHA. This requirement includes all NAICS codes.

Section 1910.1200 of the OSHA regulations currently provides the following exemptions:

Hazardous wastes regulated under the Solid Waste Disposal Act;

Tobacco and tobacco products;

Wood and wood products;

Articles ( as defined by section 1910.1200);

Food, drugs, cosmetics, or alcoholic beverages in a retail establishment that are packaged for sale to consumers;

Foods, drugs, or cosmetics intended for personal consumption by employees while in the workplace;

Any consumer product or hazardous substance as defined by the Consumer Product Safety Act that the employer can demonstrate is used in the workplace in the same manner as normal consumer use and that results in a duration and frequency of exposure that is not greater than exposures experienced by consumers; and

Any drug, as defined by the Federal Food, Drug, and Cosmetic Act, when it is in solid, final form for direct administration to the patient. 5 In addition, section 311( e) of EPCRA excludes the following substances:

Any food, food additive, color additive, drug, or cosmetic regulated by the Food and Drug Administration;

Any substance present as a solid in any manufactured item to the extent exposure to the substance does not occur under normal conditions of use;

Any substance to the extent it is used for personal, family, or household purposes, or is present in the same form and concentration as a product packaged for distribution and use by the general public;

Any substance to the extent it is used in a research laboratory, hospital, or other medical facility under the direct supervision of a technically qualified individual; and

Any substance to the extent it is used in routine agricultural operations or is a fertilizer held for sale by a retailer to the ultimate customer.

Also, minimum reporting thresholds have been established under sections 311 and 312. A facility must report those hazardous chemicals that are present at the facility at any time at or above the following levels:

For hazardous chemicals other than EHSs, the reporting threshold is 10,000 pounds.

For EHSs, 500 pounds or the TPQ, whichever is less.

° For gasoline, 75,000 gallons ( all grades combined) and 100,000 gallons for diesel fuel ( all grades combined), when stored entirely underground at retail gas stations that are in compliance with UST regulations.

An infinite threshold is being proposed for chemicals that pose minimal hazard or minimal risks. Any facility must report chemicals that are not exempt and that meet the reporting criteria.

4( b) Information Requested 4( b)( i) Data Items Facilities having chemicals subject to section 311 are required to submit MSDSs for these chemicals. These MSDSs are the same as those required under OSHA regulations. A facility can also fulfill its section 311 reporting obligation by submitting a list of chemicals that are subject to the requirements, grouped by the following hazard types: fire, sudden release of pressure, reactivity, immediate health hazard, and acute health hazard.

On or before March 1 of each year, facilities having chemicals that need reporting must submit a Tier I Form. However, the Tier II Form may be submitted in lieu of the Tier I. The Tier I Form includes the following information as required by the statute: 6

An estimate in ranges of the maximum amount of hazardous chemicals in each hazardous category present at the facility at any time during the previous year; and

An estimate in ranges of the average daily amount of hazardous chemicals on site in each hazard category.

EPA has added the following information by regulation:

Primary SIC code and Dun and Bradstreet number ( added to facilitate entering and sorting the information on a computer);

Two emergency contacts ( added to give SERCs, LEPCs, and local fire departments a contact at the facility who could clarify information at any time, particularly in the event of an emergency);

Number of days on site ( added to produce a more accurate estimate of the average daily amount, particularly for those chemicals that are on site for only a short period of time each year); and

Certification and signature.

Even if Tier II information is not submitted in lieu of Tier I, it must be submitted upon request by the SERC, LEPC, or local fire department. The Tier II Form includes the following information as required by statute:

The chemical name;

An estimate in ranges of the maximum daily amount of the hazardous chemical present at the facility at any time;

An estimate in ranges of the average daily amount of hazardous chemicals present at the facility during the previous year;

A brief description of the manner of storage of the hazardous chemical; and

The location of the hazardous chemical within the facility.

EPA has added the following items in its regulations:

CAS number to identify more accurately each chemical as well as to simplify computer use;

The physical state to help identify the type of hazard a chemical represents in an emergency;

The physical and health hazards associated with the chemical; 7

Primary SIC code and Dun and Bradstreet number ( added to facilitate entering and sorting the information on a computer);

Two emergency contacts ( added to give SERCs, LEPCs, and local fire departments a contact at the facility who could clarify information at any time, particularly in the event of an emergency);

Number of days on site ( added to produce a more accurate estimate of the average daily amount, particularly for those chemicals that are on site for only a short period of time each year); and

Certification and signature.

4( b)( ii) Respondent Activities To determine if it is subject to section 311, a new facility must look at inventory records for all of its chemicals that are required to have MSDSs under OSHA Hazard Communication Standard. The facility would also have to review the EHS list to determine if any of its chemicals are subject to a lower reporting threshold.

If the facility determines that it has chemicals that must be reported, it must determine the address of the SERC, LEPC, and local fire department. Copies of the MSDSs for these chemicals may be submitted, or if preferred, the facility may provide a list of the subject chemicals grouped by hazard type. To use the list option, the facility would have to read the MSDS to determine into which of the five hazard types the chemical falls and to identify it on the list.

EPA is proposing to exempt some low hazard chemicals from routine 312 reporting. To complete the Tier I form, the facility would need to determine whether the chemical is on any of the lists subject to 312 reporting and monitor its inventory records for the chemical ( to determine the inventory information), add the quantities together for chemicals having the same hazards, and determine the correct code ( listed on the Tier I form to report maximum daily amount, average daily amount etc.).

EPA is also proposing that facilities that will be continued to be covered by these regulations, must submit a list of the chemicals, upon request by the SERC or the LEPC, that are no longer required to be routinely reported because of the infinite threshold. This additional information may only be required in the first year after the rule becomes final, to be submitted along with their inventory report.

A site map may be used to show locations of hazardous chemicals, or the facility may choose to provide the general location.

5. THE INFORMATION COLLECTED: AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities 8 1 To develop this estimate, 1997 U. S. Census data on the number of manufacturing establishments were reviewed. The summary data provided by the Census for changes in the number of manufacturers between 1992 and 1997 differed based on whether NAICS codes or SIC codes were used. The SIC code comparison indicated a growth of about 2 percent over the five years; the NAICS code comparison indicated a decline of almost 5 percent. To be conservative, EPA applied the 2 percent rate, adjusted to 0.4 percent annually. No information provided under sections 311 and 312 is sent to EPA except the trade secret claims, which is covered under a separate ICR. All of the information is kept at the state or local level.

5( b) Collection Methodology and Management EPA does not receive the data; therefore, EPA does not have any special data collection methodology and management. However, to assist SERCs and LEPCs, EPA has provided grants to several states to create an electronic reporting format. Some states have also created databases using their own resources. Facilities in states having the ability to receive section 311 and 312 information electronically are encouraged to use that option.

5( c) Small Entity Flexibility The burden hours for small businesses are considered to be smaller than those for large facilities because of the reduced number of chemicals present at smaller facilities.

5( d) Collection Schedule The frequency of collection for these sections of EPCRA is required by statute. Also, facilities are required to report any relevant changes when they occur. The submittal of a list of chemicals or MSDSs under section 311 is a one time requirement, unless significant new information arises concerning a previously submitted MSDS, in which case, a facility should submit a revised MSDS. Facilities must submit updates to the list or MSDSs, within three months, when a new hazardous chemical comes on site above the reporting threshold. The facilities subject to section 312 are required to submit either Tier I or Tier II on or before March 1 annually.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden EPA estimated the respondent burden hours and costs associated with all recordkeeping and reporting requirements of EPCRA sections 311 and 312.

The previous ICR estimated that approximately 560,000 facilities were subject to the requirements of EPCRA sections 311 and 312. EPA estimates that the exclusion of low hazard chemicals will lead to a ten percent reduction in the number of facilities reporting, resulting in a universe of 504,000 facilities. An additional ten percent of the facilities are expected to have at least one low hazard chemical and, therefore, need to familiarize themselves with the low hazard rule. An annual growth factor of 0.4 percent was applied to the 83,000 manufacturers in the universe to yield facilities that are subject to EPCRA section 311 and 312 requirements in the second and third years of the ICR approval period. 1 9 It is important to note that initial reporting burdens for these facilities under EPCRA sections 311 and 312 are assumed to have occurred and are not included in this ICR. This ICR accounts for reporting updates and other periodic reporting and recordkeeping activities that apply to all currently regulated facilities, as well as all initial reporting burdens for new facilities that are expected to become subject to the reporting requirements over the three year ICR approval period.

There are estimated to be 3,466 active SERCs and LEPCs, based on estimates taken from EPA's recent update of its LEPC database. These numbers are assumed to remain constant over the three year ICR approval period, although consolidations occurring in some states may reduce the total. The estimated burden to complete each reporting and recordkeeping activity is outlined below.

The unit burden estimates associated with this collection for facilities and state and local agencies are presented in Exhibit 1.

Read and Understand Regulations EPA estimates that 332 newly regulated facilities will need to read and understand the regulations ( 40 CFR Part 370) in the first year. This estimate is determined by applying the 0.4 percent annual growth rate to the number of manufacturing facilities subject to the regulation as of 2000. Second and third year estimates also assume a 0.4 annual growth rate in the size of the universe of regulated facilities. SERCs and LEPCs are assumed to have already completed the familiarization activities. EPA assumes that it takes an average of 11.0 hours per facility to read and understand regulations in 40 CFR Part 370.

EPA assumes that facilities currently subject to 40 CFR part 370 are already familiar with the regulations. This proposed rule is intended to provide burden relief to these facilities by proposing infinite threshold for chemicals that are not on specific lists. Most facilities are already familiar with these lists since they may be already complying with regulations associated with these lists. Therefore, EPA assumes facilities will have minimal burden to take advantage of the burden reductions in this proposed rule.

EPA estimates that 20 percent of the facilities will need to familiarize themselves with the low hazard rule; this 20 percent includes the ten percent who will no longer be required to report. Most facilities will not need to review the low hazard rule because they have very few chemicals, such as chlorine and sulfur dioxide at water treatment plants, ammonia at refrigeration plants, or fuel oil at industrial sites. These chemicals will not be excluded and, therefore, the facilities will not need to review the new rule.

Section 311: MSDS Reporting for Facilities ( 40 CFR 370.21)

The MSDS reporting burden only applies to the facility respondent universe. EPA estimates that 332 newly regulated facilities will need to determine which chemicals exceed the threshold limits and calculate quantities for mixtures for the MSDS reporting requirements in the first year. Of this universe, 34 percent ( 113 facilities in the first year) will submit MSDSs to LEPCs, SERCs, and local fire departments. Alternatively, facilities may submit a list of hazardous chemicals grouped by hazard category or a list of the chemical or common names of each hazardous chemical in lieu of submitting an MSDS. Sixty six percent ( 218 facilities in the first year) are expected to submit such lists. The percentages were determined from an analysis of the information collected for the 1991 State Title III Status Report. 10 Exhibit 1 Section 311 and 312 Reporting and Recordkeeping Requirements Estimated Unit Burden and Cost Annual Hours Burden Total Hours Information Collection Activity Legal Management Technical Clerical Burden Annual Cost RULE FAMILIARIZATION ( Facilities)

Read and understand regulations at 40 CFR Part 370 1.00 2.50 7.50 0.00 11.00 $ 423 MSDS REPORTING ( 370.21) ( Facilities)

Basic Reporting Determine which chemicals meet/ exceed MTLs 0.00 0.25 0.90 0.00 1.15 $ 37 Calculate quantity for mixtures 0.00 0.50 1.80 0.00 2.30 $ 73 Submit MSDSs to SERC, LEPC, and fire department 0.00 0.08 0.17 0.08 0.33 $ 10 Alternative Reporting Submit list of hazardous chemicals grouped by hazard category 0.00 0.00 1.00 0.08 1.08 $ 30 Submit revised MSDSs 0.00 0.08 0.17 0.08 0.33 $ 9 Submit new MSDSs 0.00 0.08 0.17 0.08 0.33 $ 9 Additional Reporting Submit MSDS upon request 0.00 0.08 0.17 0.08 0.33 $ 9 INVENTORY REPORTING ( 370.25) ( Facilities)

Rule familiarization with low hazard rule 1 1 $ 26 Basic Reporting Develop and submit Tier I inventory form annually 0.08 0.25 2.34 0.08 2.75 $ 81 Alternative Reporting Develop and submit Tier II inventory form, in lieu of Tier I form, annually 0.08 0.25 2.34 0.08 2.75 $ 81 Additional Reporting Submit Tier II form to LEPC, SERC, and fire department upon request 0.00 0.25 2.34 0.08 2.67 $ 73 Provide specific location to fire department upon request 0.00 0.00 0.50 0.08 0.58 $ 15 Provide list of low hazard chemicals on request 0.00 0.00 0.40 0.08 0.48 $ 12 INFORMATION REQUESTS ( 370.30) ( State and local governments)

File and maintain annual inventory forms and data 0.00 0.00 5 27.25 32.25 $ 628 Input data and maintain database of 312 data 0.00 0.00 40 280 320 $ 6,176 Provide MSDSs upon written request 0.00 0.00 0.50 0.17 0.67 $ 16 Provide Tier II information upon written request 0.00 0.00 0.50 0.17 0.67 $ 16 11 Of those facilities submitting lists in lieu of MSDSs, all facilities ( 218 facilities in the first year) are expected to elect the option of submitting a list of hazardous chemicals grouped by hazard category. Facilities may comply with this option by simply copying their Tier II form. As such, EPA estimates that no respondents will elect the second option of submitting a list of chemicals by name as provided in each MSDS.

In addition, EPA estimates that 25,200 facilities in the first year ( five percent of the universe, reporting Tier I or Tier II inventories in the first year) will need to submit a revised MSDS( s) and the same number will need to submit a new MSDS( s) in accordance with 40 CFR 370.21( c)( 1) and ( 2). This activity represents the incremental burden for a facility that has acquired a new chemical or has otherwise changed its inventory. Because little information is required from facilities after the initial submittal, EPA also estimates that only one percent of the total universe ( 5,040 facilities) may be specifically requested to submit an MSDS in accordance with 40 CFR 370.21( d). EPA assumes that to submit new MSDSs, submit revised MSDSs and submit MSDS upon request, it takes about 0.33 hours per facility.

Section 312: Inventory Reporting for Facilities ( proposed 40 CFR 370.25)

The inventory reporting burden only applies to the facility respondent universe. EPA estimates that 201,600 facilities ( about 40 percent) will develop and submit Tier I inventory forms in the first year, while 302,400 ( about 60 percent) facilities will submit Tier II forms in lieu of Tier I. Each of these estimates is derived from ratios applied to the total universe based on reporting information collected for the 1991 State Title III Status Report. Forty percent of facilities submitted Tier I forms, while 60 percent submitted Tier II, according to data from the 1991 report. The majority of facilities in the nonmanufacturing sector ( e. g., oil and gas extraction facilities) are assumed to store relatively few chemicals in amounts that exceed reporting thresholds in relation to the number stored at manufacturing facilities. The corresponding burden estimates for completing Tier I or II inventory forms are therefore assumed to be lower at non manufacturing facilities. The burden estimates in Exhibit 1 for technical personnel to perform inventory reporting are weighted averages of the burden for manufacturing facilities ( an estimated 8 hours) and of the burden for non manufacturing facilities ( an estimated 2 hours).

Since most facilities prefer to file Tier II forms, EPA estimates that only ten percent of those facilities submitting Tier I forms ( 20,160 facilities in the first year) may be required to submit Tier II forms to LEPCs, SERCs, and fire departments upon request. In addition, EPA estimates that only one percent of the total universe of facilities ( 5,040 facilities in the first year) reporting Tier I or Tier II inventories annually may be asked to provide specific chemical location information to local fire departments.

EPA contacted representatives of several industries ( including small to large size facilities) to reevaluate the burden that EPA estimated previously. The weighted average of all facilities ( small and large) showed that EPA's original estimate of 3.18 hours was higher than actually spent by facilities in part because for most facilities, the information submitted annually does not change. Also, there will be less time spent on Tier I/ II reports because of the proposed infinite threshold for minimal hazard and minimal risks chemicals. Consequently, EPA has reduced the estimated time per facility to file inventory reports to 2.75 hours and generally has reduced clerical time to five minutes ( 0.08 hours). Facilities that submit Tier I reports and are then asked to also submit a Tier II report are assumed to spend 2.67 hours developing a Tier II report. 12 Information Requests for SERCs and LEPCs ( proposed 40 CFR 370.62)

Information request burdens in proposed 40 CFR 370.62 are incurred by LEPCs and SERCs. EPA estimates that the LEPCs or SERCs will be requested to provide MSDSs for one percent of the total universe of facilities reporting Tier I or Tier II inventories annually ( 5,040 facilities in the first year). Also, EPA estimates that SERCs and LEPCs will request one percent of the universe ( 5,040) to submit a list of low hazard chemicals that are no longer required to be reported because of the proposed infinite threshold for these chemicals. This additional information may only be required in the first year of section 312 reporting after the rule becomes final. SERCs and LEPCs are also estimated to provide Tier II information to the public on one percent of the same universe of facilities ( 5,040 facilities in the first year) as a result of requests from the public for such information.

Electronic Submission An increasing number of states are encouraging facilities to file their inventory reports electronically. In some cases, states are allowing facilities to file on line. In an estimated 50 percent of the states, facilities may submit their reports in electronic format. Even MSDSs can be submitted electronically because most MSDSs are available from on line databases maintained by a number of universities. Electronic filing reduces the time needed to complete an inventory report because the file from the previous year can be edited. For most facilities, the information on an annual inventory report does not change appreciably from year to year. As a result of this movement to electronic filing, EPA has reduced its estimate of clerical time required to file all reports.

Also, EPA is in the process of developing personal computer software for use by facilities in submitting Tier II reports. The software will most likely be available in December 2001, so that facilities can use it to submit reports that are due on March 1, 2002.

Data Management for SERCs and LEPCs SERCs and LEPCs receive annual inventory forms from facilities, which they must make available to the public on request. The level of effort needed to manage these forms varies depending on both the number of forms received and the ways the LEPC or SERC uses the data. Smaller LEPCs receive few forms each year; LEPCs in industrialized areas or that cover several counties and SERCs may receive a large number of forms. The degree to which the information is used depends on whether the LEPC or SERC has the resources to actively handle the data. Based on discussions with LEPCs, EPA determined that small LEPCs spend on average five hours a year handling the forms; large LEPCs may spend as much as three months processing the forms. SERCs supported by fees ( 27 of 56) are also likely to spend considerable time on the data. EPA developed a weighted average of 32.5 hours a year, based on the assumption that 120 LEPCs and 27 SERCs would devote considerable effort to organizing and checking the data. In addition, a limited number of SERCs and LEPCs have developed databases and input the section 312 data into their CAMEO software systems. Based on discussions with LEPCs that have databases, EPA estimates that this effort would require two months or 320 hours. The number of SERCs and LEPCs with databases is estimated to be 45, a third of the SERCs and large LEPCs. 13 2 U. S. Bureau of Labor Statistics, Employer Cost for Employee Compensation, Table 12: Private Manufacturing and Non manufacturing Industries, March 2000.

3 U. S. Bureau of Labor Statistics, Employer Cost for Employee Compensation, Table 4: State and Local Government By Occupational and Industry Group, March 2000. 6( b) Estimating Respondent Costs The annual costs to respondents were estimated by multiplying the respondent burden estimates for each labor category by the corresponding labor rate for that category. The unit costs for each respondent or activity are then multiplied by the number of respondents or activities performed on an annual basis to yield a total cost for each information collection activity in Section 6( d). These costs are shown in Exhibit 1.

EPA estimates an hourly respondent labor cost for manufacturing facility respondents of $ 43.46 for managerial staff, $ 28.59 for technical staff, and $ 18.07 for clerical staff, including wages and benefits. Hourly respondent labor costs for non manufacturing facility respondents are estimated at $ 36.48 for managerial staff, $ 26.33 for technical staff, and $ 17.03 for clerical staff. Legal review is estimated at $ 100 per hour. 2 A weighted average was developed based on the percentage of manufacturing and nonmanufacturing facilities.

EPA estimates an hourly respondent labor cost ( including overhead) for LEPCs and SERCs of $ 36.20 for managerial staff, $ 24.76 for technical staff, and $ 18.52 for clerical staff. 3 Capital and O& M Costs Capital/ start up and operation and management ( O& M) costs were also estimated for facilities and state and local governments. Exhibit 5 presents the capital and O& M costs for complying with sections 311 and 312. Capital costs include the cost of space required to store information in filing cabinets. Given that the standard size, four drawer file cabinet is expected to hold approximately 12,500 pages of material, EPA estimates that the SERC and LEPC would need to purchase approximately 60 file cabinets in total within the time period of this ICR. ( EPA assumed that MSDSs are four pages and inventory forms one page and that the SERC and LEPC or fire department ( but not both) would maintain the records. Electronic filing reduces the need to store material on paper.) Facilities are assumed to need only 22 file cabinets in total to maintain copies of their annual inventory reports; the cost for storing MSDSs for facilities is covered by the OSHA's hazard communication standard ( 29 CFR 1910.1200). Using an estimated cost of $ 100 per filing cabinet, the cost of purchasing the 60 filing cabinets for SERCs and LEPCs is estimated to be $ 6,000. Annualizing the costs over 15 years, a single file cabinet has annual costs of $ 11.

State and local governments are assumed to incur capital costs in the form of filing cabinets for the storing new and revised MSDSs, lists of hazardous chemicals, and the annual inventory reports. 14 In addition, facilities were assumed to incur postage costs for mailing new and revised MSDSs, lists of hazardous chemicals, and the annual inventory reports. Total cost for facilities for purchasing 22 filing cabinets is $ 2200.

State and local governments are expected to incur postage costs to provide MSDSs to the public upon written request and to provide Tier II information upon written request.

Postage is estimated to cost $ 5 per certified package.

6( c) Estimating Agency Burden and Cost EPA estimates no annual Agency burden associated with this ICR. Only state and local government entities are required to comply with sections 311 and 312 of EPCRA. Burden associated with managing trade secret information is under a separate ICR.

6( d) Estimating Total Annual Respondent Burden Exhibits 2, 3, and 4 present the respondent burden for each information collection activity and for the sum of all information collection activities performed by each respondent type. Exhibit 5 shows the capital and O& M costs to facilities over the three year information collection period. The total average annual respondent burden for facilities for the three year period is 1,505,140 hours, for a total annualized cost of $ 44 million. The total average annual respondent burden for state and local governments for the three year period is 132,940 hours, for a total annualized cost of $ 2.6 million. These burden estimates are summarized in Exhibits 6 and 7.

6( e) Bottom Line Burden Hours and Cost The total burden to facility respondents over three years is 4,515,400 hours at a cost of $ 131 million. The total burden to LEPC and SERC respondents over three years is 398,800 hours at a cost of $ 7.8 million. Exhibits 6 and 7 present a summary of the bottom line burden and cost estimates for section 311 and 312 reporting for facilities and state and local governments, respectively. 15 Exhibit 2 Section 311 and 312 Reporting and Recordkeeping Requirements Estimated First Year Total Burden and Cost Number of Annual Hours Burden Total Hours Information Collection Activity Respondents Legal Management Technical Clerical Burden Annual Cost RULE FAMILIARIZATION ( Facilities)

Read and understand regulations at 40 CFR Part 370 332 332 831 2,493 0 3,657 $ 140,640 Subtotal 3,657 $ 140,640 MSDS REPORTING ( 370.21) ( Facilities)

Basic Reporting Determine which chemicals meet/ exceed MTLs 332 0 83 299 0 382 $ 12,165 Calculate quantity for mixtures 332 0 166 598 0 765 $ 24,331 Submit MSDSs to SERC, LEPC, and fire department 113 0 9 19 9 37 $ 1,101 Alternative Reporting Submit list of hazardous chemicals grouped by haz. type 218 0 0 218 17 235 $ 6,548 Supplemental Reporting Submit revised MSDSs 25,199 0 2,016 4,284 2,016 8,316 $ 223,333 Submit new MSDSs 25,199 0 2,016 4,284 2,016 8,316 $ 223,333 Additional Reporting Submit MSDS upon request 5,040 0 403 857 403 1,663 $ 44,667 Subtotal 19,714 $ 535,477 INVENTORY REPORTING ( 370.25) ( Facilities)

Rule familiarization for low hazard rule 111,920 0 0 111,920 0 111,920 $ 2,952,696 Basic Reporting Develop and submit Tier I inventory form annually 201,589 16,127 50,397 471,718 16,127 554,370 $ 16,231,055 Alternative Reporting Develop and submit Tier II form, in lieu of Tier I, annually 302,383 24,191 75,596 707,577 24,191 831,554 $ 24,346,582 Additional Reporting Submit Tier II to LEPC, SERC, and fire dept. upon request 20,159 0 5,040 47,172 1,613 53,824 $ 1,461,834 Provide specific location to fire department upon request 5,040 0 0 2,520 403 2,923 $ 73,357 Provide list of low hazard chemicals on request 5,040 0 0 2,016 403 2,419 $ 60,061 Subtotal 1,557,011 $ 45,125,585 Total ( Facilities) 1,580,381 $ 45,801,702 INFORMATION REQUESTS ( 370.30) ( State and local governments)

File and maintain annual inventory forms and data 3,466 0 0 17,330 94,449 111,779 $ 2,178,000 Input data and maintain database of 312 data 45 0 0 1,800 12,600 14,400 $ 278,000 Provide MSDS on written request 5,040 0 0 2,520 857 3,377 $ 78,300 Provide Tier II information upon written request 5,040 0 0 2,520 857 3,377 $ 78,300 Total ( State and local governments) 132,932 $ 2,612,715 16 Exhibit 3 Section 311 and 312 Reporting and Recordkeeping Requirements Estimated Second Year Total Burden and Cost Number of Annual Hours Burden Total Hours Information Collection Activity Respondents Legal Management Technical Clerical Burden Annual Cost RULE FAMILIARIZATION ( Facilities)

Read and understand regulations at 40 CFR Part 370 334 334 834 2,503 0 3,671 $ 141,203 Subtotal 3,671 $ 141,203 MSDS REPORTING ( 370.21) ( Facilities)

Basic Reporting Determine which chemicals meet/ exceed MTLs 334 0 83 300 0 384 $ 12,214 Calculate quantity for mixtures 334 0 167 601 0 768 $ 24,428 Submit MSDSs to SERC, LEPC, and fire department 113 0 9 19 9 37 $ 1,110 Alternative Reporting Submit list of hazardous chemicals grouped by haz. type 220 0 0 220 18 238 $ 6,616 Supplemental Reporting Submit revised MSDSs 25,215 0 2,017 4,287 2,017 8,321 $ 223,481 Submit new MSDSs 25,215 0 2,017 4,287 2,017 8,321 $ 223,481 Additional Reporting Submit MSDS upon request 5,043 0 403 857 403 1,664 $ 44,696 Subtotal 19,733 $ 536,026 INVENTORY REPORTING ( 370.25) ( Facilities)

Basic Reporting Develop and submit Tier I inventory form annually 201,722 16,138 50,431 472,031 16,138 554,737 $ 16,241,804 Alternative Reporting Develop and submit Tier II form, in lieu of Tier I, annually 302,584 24,207 75,646 708,046 24,207 832,105 $ 24,362,706 Additional Reporting Submit Tier II to LEPC, SERC, and fire dept. upon request 20,172 0 5,043 47,203 1,614 53,860 $ 1,462,802 Provide specific location to fire department upon request 5,043 0 0 2,522 403 2,925 $ 73,405 Subtotal 1,443,627 $ 42,140,717 Total ( Facilities) 1,467,031 $ 42,817,946 INFORMATION REQUESTS ( 370.30) ( State and local governments)

File and maintain annual inventory forms and data 3,466 0 0 17,330 94,449 111,779 $ 2,178,277 Input data and maintain database of 312 data 45 0 0 1,800 12,600 14,400 $ 277,920 Provide MSDS on written request 5,043 0 0 2,522 857 3,379 $ 78,311 Provide Tier II information upon written request 5,043 0 0 2,522 857 3,379 $ 78,311 Total ( State and local governments) 132,936 $ 2,612,818 17 Exhibit 4 Section 311 and 312 Reporting and Recordkeeping Requirements Estimated Third Year Total Burden and Cost Number of Annual Hours Burden Total Hours Information Collection Activity Respondents Legal Management Technical Clerical Burden Annual Cost RULE FAMILIARIZATION ( Facilities)

Read and understand regulations at 40 CFR Part 370 334 334 835 2,505 0 3,674 $ 141,307 Subtotal 3,674 $ 141,307 MSDS REPORTING ( 370.21) ( Facilities)

Basic Reporting Determine which chemicals meet/ exceed MTLs 334 0 84 301 0 384 $ 12,223 Calculate quantity for mixtures 334 0 167 601 0 768 $ 24,446 Submit MSDSs to SERC, LEPC, and fire department 114 0 9 19 9 37 $ 1,111 Alternative Reporting Submit list of hazardous chemicals grouped by haz. type 220 0 0 220 18 238 $ 6,608 Supplemental Reporting Submit revised MSDSs 25,232 0 2,019 4,289 2,019 8,327 $ 223,629 Submit new MSDSs 25,232 0 2,019 4,289 2,019 8,327 $ 223,629 Additional Reporting Submit MSDS upon request 5,046 0 404 858 404 1,665 $ 44,726 Subtotal 19,746 $ 536,372 INVENTORY REPORTING ( 370.25) ( Facilities)

Basic Reporting Develop and submit Tier I inventory form annually 201,857 16,149 50,464 472,344 16,149 555,105 $ 16,252,596 Alternative Reporting Develop and submit Tier II form, in lieu of Tier I, annually 302,785 24,223 75,696 708,516 24,223 832,658 $ 24,378,894 Additional Reporting Submit Tier II to LEPC, SERC, and fire dept. upon request 20,186 0 5,046 47,234 1,615 53,896 $ 1,463,774 Provide specific location to fire department upon request 5,046 0 0 2,523 404 2,927 $ 73,454 Subtotal 1,444,586 $ 42,168,718 Total ( Facilities) 1,468,006 $ 42,846,397 INFORMATION REQUESTS ( 370.30) ( State and local governments)

File and maintain annual inventory forms and data 3,466 0 0 17,330 94,449 111,779 $ 2,178,277 Input data and maintain database of 312 data 45 0 0 1,800 12,600 14,400 $ 277,920 Provide MSDS on written request 5,046 0 0 2,523 857 3,381 $ 78,363 Provide Tier II information upon written request 5,046 0 0 2,523 858 3,381 $ 78,352 Total ( State and local governments) 132,940 $ 2,612,912 18 Exhibit 5 Capital/ Start up and O& M Costs Capital/ Start up Costs O& M Costs Activity First Year Second Year Third Year First Year Second Year Third Year Maintain records $ 235 $ 233 $ 233 Submit MSDSs to SERC, LEPC, and fire department $ 1,100 $ 1,100 $ 1,100 Submit list of hazardous chemicals grouped by haz. type $ 2,200 $ 2,200 $ 2,200 Submit revised MSDSs $ 252,000 $ 252,000 $ 252,000 Submit new MSDSs $ 252,000 $ 252,000 $ 252,000 Submit MSDS upon request $ 25,200 $ 25,200 $ 25,200 Develop and submit Tier I inventory form annually $ 2,016,000 $ 2,017,000 $ 2,019,000 Develop and submit Tier II form, in lieu of Tier I, annually $ 3,024,000 $ 3,026,000 $ 3,028,000 Submit list of low hazard chemicals on request $ 50,400 Submit Tier II to LEPC, SERC, and fire dept. upon request $ 100,800 $ 100,900 $ 100,900 Provide specific location to fire department upon request $ 25,200 $ 25,200 $ 25,200 Total Facilities $ 235 $ 233 $ 233 $ 5,749,000 $ 5,702,000 $ 5,706,000 Maintain Files $ 666 $ 662 $ 662 Provide MSDSs upon written request $ 25,200 $ 25,200 $ 25,200 Provide Tier II information upon written request $ 25,200 $ 25,200 $ 25,200 Total SERCs/ LEPCs $ 666 $ 662 $ 662 $ 50,400 $ 50,400 $ 50,500 19 Exhibit 6 Summary of Total Burden and Cost Estimates for Facilities Total Hours Total Cost Year Burden( hrs) Labor Capital O& M Total First 1,580,381 $ 45,801,702 $ 235 $ 5,748,606 $ 51,550,542 Second 1,467,031 $ 42,817,946 $ 233 $ 5,701,980 $ 48,520,158 Third 1,468,006 $ 42,846,397 $ 233 $ 5,705,786 $ 48,552,416 Total 4,515,418 $ 131,466,044 $ 700 $ 17,156,372 $ 148,623,116 Annualized 1,505,139 $ 43,822,015 $ 233 $ 5,718,791 $ 49,541,039 Exhibit 7 Summary of Total Burden and Cost Estimates for SERCs and LEPCs Total Hours Total Cost Year Burden( hrs) Labor Capital O& M Total First 132,932 $ 2,612,715 $ 666 $ 50,397 $ 2,663,778 Second 132,936 $ 2,612,818 $ 662 $ 50,431 $ 2,663,911 Third 132,940 $ 2,612,912 $ 662 $ 50,464 $ 2,664,038 Total 398,808 $ 7,838,445 $ 1,990 $ 151,292 $ 7,991,727 Annualized 132,940 $ 2,612,815 $ 663 $ 50,430 $ 2,663,910 20 6( f) Reasons for Change in Burden The estimated average annual burden to facility respondents for reporting and recordkeeping activities under EPCRA sections 311 and 312 decreased from 1,895,207 hours per year in the previous ICR to 1,505,139 hours because of the reduction in the universe from the proposed infinite threshold for minimal hazard and minimal risk chemicals, the subsequent reduction of reports filed by facilities, and the increased number of electronic submission of Tier II reports.

The estimated average annual burden for SERCs, LEPCs, and fire departments decreased from 146,300 hours to 132,940 hours. The reason for this reduction is the revised estimate for the number of LEPCs.

6( g) Burden Statement The estimated burden for facilities to familiarize with this rule is 1.0 hour. The average burden for new facilities to read and understand the regulations in 40 CR Part 370 is 11.0 hours. The average burden for MSDS reporting under 40 CFR 370.21 is estimated at 1.15 hours for new and newly regulated facilities and approximately 0.33 hours for those existing facilities that obtain new or revised MSDSs or receive requests for MSDSs from local governments. For new and newly regulated facilities, this burden includes the time required to read and understand the regulations, to determine which chemicals meet or exceed reporting thresholds, and to submit MSDSs or lists of chemicals to SERCs, LEPCs, and local fire departments. For existing facilities, this burden includes the time required to submit revised MSDSs and new MSDSs to local officials. The average reporting burden for facilities to perform Tier I or Tier II inventory reporting under 40 CFR 370.25 is estimated to be approximately 2.75 hours per facility, including the time to develop and submit the information. There are no recordkeeping requirements for facilities under EPCRA sections 311 and 312 although it is assumed that they will maintain a copy of annual reports to use for future filings. EPA also estimated the cost for filing cabinets for facilities. The recordkeeping for MSDSs is mandated under OSHA rules.

The average burden for state and local governments to respond to requests for MSDSs or Tier II information under 40 CFR 370.30 is estimated to be 0.67 hours per request. The average burden for managing and maintaining the reports and MSDS files is estimated to be 32.25 hours. The average burden for maintaining and updating a section 312 database is estimated to be 320 hours.

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 currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

These reporting and recordkeeping burden estimates are based on the average burden for the threeyear period covered by this ICR. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Office of Environmental Information, Collection Strategies Division ( 2822), U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue 21 NW, Washington, DC 20460; and to Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, " Attention: Desk Officer for EPA." Include the EPA ICR number and OMB control number in any correspondence.


[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Rules and Regulations]
[Pages 37808-37810]
[FR Doc No: 2012-15511]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2012-0556]
RIN 1625-AA08

Special Local Regulation; East Tawas Offshore Gran Prix, Tawas
Bay; East Tawas, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a special local regulation on
Tawas Bay, Michigan. This action is necessary and intended to ensure
safety of life on the navigable waters immediately prior to, during,
and immediately after the East Tawas Offshore Gran Prix boat race. This
special local regulation will establish restrictions upon, and control
movement of, vessels in a portion of Tawas Bay. During the enforcement
period, no person or vessel may enter the regulated area without
permission of the Captain of the Port.

DATES: This rule is effective from 10:00 a.m. until 4:00 p.m. on June
24, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-0556]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box, and click ``Search.'' You may
visit the Docket Management Facility, 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 email LT Adrian Palomeque, Prevention
Department, Sector Detroit, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Thus, delaying the
effective date of this rule to wait for a comment period to run would
be both impracticable and contrary to the public interest because it
would inhibit the Coast Guard's ability to protect spectators,
participants and vessels from the hazards associated with power boat
races, which are discussed further below.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for 30 day notice period run would be
impracticable and contrary to the public interest.

B. Basis and Purpose

    Between 10:00 a.m. and 4:00 p.m. on June 24, 2012 the OPA Racing
LLC is holding an offshore powerboat race that will require the
immediate area to be clear of all vessel traffic. The Captain of the
Port Detroit has determined powerboat races in close proximity to
watercraft and infrastructure pose significant risk to public safety
and property. The likely combination of large numbers of recreation
vessels, powerboats traveling at high speeds, and large numbers of
spectators in close proximity to the water could easily result in
serious injuries or fatalities.

C. Discussion of Rule

    With the aforementioned hazards in mind, the Captain of the Port
Detroit has determined that a special local regulation is necessary to
ensure the safety of spectators, vessels, and participants. This
special local regulation will be effective and enforced from 10:00 a.m.
until 4:00 p.m. on June 24, 2012. This regulated area will encompass
all waters of Tawas Bay, beginning at a point on land at 44[deg]14'53''
N, 83[deg]27'34'' W; extending west to a point on land at position
44[deg]15'33'' N, 83[deg]31'30'' W. All geographic coordinates are
North American Datum of 1983 (NAD 83).
    Entry into, transiting, or anchoring within the regulated area is
prohibited unless authorized by the Captain of the Port Detroit or his
designated on scene representative. The Captain of the Port or his
designated on scene representative may be contacted via VHF Channel 16.

D. 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.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under that Orders. It is not ``significant''
under the regulatory policies and procedures of

the Department of Homeland Security (DHS). We conclude that this rule
is not a significant regulatory action because we anticipate that it
will have minimal impact on the economy, will not interfere with other
agencies, will not adversely alter the budget of any grant or loan
recipients, and will not raise any novel legal or policy issues. The
regulated navigation area created by this rule will be relatively small
and enforced for relatively short time. Also, the regulated navigation
area is designed to minimize its impact on navigable waters.
Furthermore, the regulated navigation area has been designed to allow
vessels to transit around it. Thus, restrictions on vessel movement
within that particular area are expected to be minimal. Under certain
conditions, moreover, vessels may still transit through the regulated
navigation area when permitted by the Captain of the Port.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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 rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of the Tawas Bay near East Tawas, MI on
June 24, 2012.
    This special local regulation will not have a significant economic
impact on a substantial number of small entities for the following
reasons: This regulated area would be activated, and thus subject to
enforcement, for only six hours in the day. Traffic may be allowed to
pass through the zone with the permission of the Captain of the Port.
The Captain of the Port can be reached via VHF channel 16. Before the
activation of the zone, we would issue local Broadcast Notice to
Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    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.

4. 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).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. 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 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

7. Taking of Private Property

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

8. 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.

9. 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.

10. 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.

11. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

12. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

13. 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 involves a special local regulation and, therefore it is
categorically excluded from further review under paragraph (34)(h) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Add Sec.  100.T09-0556 to read as follows:

Sec.  100.T09-0556  Special Local Regulation; East Tawas Offshore Gran
Prix, East Tawas, MI.

    (a) Location. The regulated area will encompass all waters of Tawas
Bay, East Tawas, Michigan, beginning at a point on land at
44[deg]14'53'' N, 83[deg]27'34'' W; extending west to a point on land
at position 44[deg]15'33'' N, 83[deg]31'30'' W. All geographic
coordinates are North American Datum of 1983 (NAD 83).
    (b) Enforcement Period. This regulation will be enforced on June
24, 2012 from 10:00 a.m. until 4:00 p.m.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  100.901 of
this part, entry into, transiting, or anchoring within this safety zone
is prohibited unless authorized by the Captain of the Port Detroit or
his designated on-scene representative.
    (2) This regulated navigation area is closed to all vessel traffic,
except as may be permitted by the Captain of the Detroit or his
designated on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Detroit is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Detroit or his on-scene
representative to obtain permission to do so. The Captain of the Port
Detroit or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Detroit, or his on-scene representative.

    Dated: June 12, 2012.
J.E. Ogden,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2012-15511 Filed 6-21-12; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Page 34376]
[FR Doc No: 2012-14083]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-787-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: HK 37731 to Sequent 39962 Cap Rel Neg Rate Agmt filing
to be effective 6/2/2012.
    Filed Date: 6/4/12.
    Accession Number: 20120604-5013.
    Comments Due: 5 p.m. ET 6/18/12.

    Docket Numbers: RP12-788-000.
    Applicants: El Paso Natural Gas Company.
    Description: Order on Rehearing Compliance for Docket No. RP08-426-
005 to be effective 5/1/2010.
    Filed Date: 6/4/12.
    Accession Number: 20120604-5095.
    Comments Due: 5 p.m. ET 6/18/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: June 5, 2012.
Nathaniel J. Davis, Sr.
Deputy Secretary
[FR Doc. 2012-14083 Filed 6-8-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 94 (Tuesday, May 18, 2021)]
[Rules and Regulations]
[Pages 26842-26843]
[FR Doc No: 2021-10269]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[EPA-HQ-OA-2020-0128, FRL-10024-07-OP]
RIN 2010-AA15

EPA Guidance; Administrative Procedures for Issuance and Public
Petitions; Rescission

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; rescission of regulations.

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SUMMARY: In accordance with the Presidential directive of January 20,
2021, ``Revocation of Certain Executive Orders Concerning Federal
Regulation,'' the Environmental Protection Agency (EPA) is rescinding
its October 19, 2020, final rule establishing administrative procedures
for issuing Agency guidance documents.

DATES: This final rule is effective on May 18, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OA-2020-0128. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., 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 https://www.regulations.gov. For information on the EPA Docket
Center services and the current status, please visit us online at
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sharon Cooperstein, Policy and
Regulatory Analysis Division, Office of Regulatory Policy and
Management (Mail Code 1803A), Environmental Protection Agency, 1200
Pennsylvania Avenue Northwest, Washington, DC 20460; telephone number:
202-564-7051; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What action is the Agency taking?

    In accordance with E.O. 13992, ``Revocation of Certain Executive
Orders Concerning Federal Regulation,'' issued by President Biden on
January 20, 2021 (86 FR 7049, January 25, 2021), the EPA is rescinding
the final rule (85 FR 66230, October 19, 2020) that established the
procedures and requirements regarding the issuance, revision, and
withdrawal of guidance documents. The prior final rule was promulgated
to implement E.O. 13891, ``Promoting the Rule of Law Through Improved
Agency Guidance Documents'' (84 FR 55235, October 15, 2019).

B. What is the Agency's authority for taking this action?

    The revisions to the EPA's policies and requirements surrounding
guidance are matters of agency organization, procedure, or practice
that lack the force and effect of law. Accordingly, the EPA is not
required to engage in a notice and comment process to issue or revise
internal procedures under the Administrative Procedure Act (APA). See 5
U.S.C. 553(b)(3)(A), which provides that an agency may issue
interpretive rules, general statements of policy, or rules of agency
organization, procedure, or practice without providing notice and an
opportunity for public comment. The EPA is providing an immediate
effective date for this rulemaking because it is procedural rather than
substantive. The APA's requirement, 5 U.S.C. 553(d), that substantive
rules not be effective until at least 30 days after publication in the
Federal Register is inapplicable because this rulemaking is procedural.

II. Background

    On October 9, 2019, President Trump issued E.O. 13891, ``Promoting
the Rule of Law Through Improved Agency Guidance Documents.'' The now
revoked E.O. 13891 provided a specific definition of guidance documents
and required Federal agencies to finalize regulations or amend existing
regulations to establish processes and procedures for issuing guidance
documents, among other actions. On October 19, 2020, the EPA published
a final rule consistent with E.O. 13891. The final rule, codified at 40
CFR part 2, subpart D, established the EPA's policy and internal
procedures for issuing, modifying, withdrawing, and using guidance
documents; making guidance documents available to the public; and
receiving and responding to petitions about guidance documents (85 FR
66230).
    On January 20, 2021, President Biden issued E.O. 13992,
``Revocation of Certain Executive Orders Concerning Federal
Regulation,'' which revoked E.O. 13891. E.O. 13992 states that it is
the policy of the Administration ``to use available tools to confront
the urgent challenges facing the Nation, including the coronavirus
disease 2019 (COVID-19) pandemic, economic recovery, racial justice,
and climate change. To tackle these challenges effectively, executive
departments and agencies (agencies) must be equipped with the
flexibility to use robust regulatory action to address national
priorities. This order revokes harmful policies and directives that
threaten to frustrate the Federal Government's ability to confront
these problems, and empowers agencies to use appropriate regulatory
tools to achieve these goals.'' Section 3 of E.O. 13992 directs
agencies to take steps to rescind any orders, rules, regulations,
guidelines or policies, or portions thereof, implementing or enforcing
the revoked Executive orders.

III. Discussion

    After consideration and review, the EPA has concluded that the
internal rule on guidance deprives the EPA of necessary flexibility in
determining when and how best to issue public guidance based on
particular facts and circumstances, and unduly restricts the EPA's
ability to provide timely guidance on which the public can confidently
rely. Therefore, in accordance with E.O. 13992, the EPA is issuing this
final rule to rescind the subpart D regulations.
    The EPA's stated purpose in issuing subpart D was to promote
transparency and public involvement in the development and amendment of
EPA guidance documents. The EPA notes, however, that the Agency has
historically employed procedures for public transparency and
involvement in the development of all Agency actions, including
guidance, and will continue these practices. The EPA will continue to
make Agency guidance available to the public on the Agency's website at
https://www.epa.gov. In addition, the EPA will comply with all
statutory obligations pertaining to posting documents for public
accessibility. The EPA will also continue its practice, as appropriate,
of soliciting stakeholder input on guidance of significant stakeholder
and public interest. Consistent with the APA, stakeholders may still
petition the EPA at any time regarding our regulatory programs,
including requests to issue, amend, or repeal EPA guidance, by
contacting the

EPA program office or regional office that is responsible for
administering the area of stakeholder interest. Finally, the EPA notes
that guidance is non-binding and does not have the force and effect of
law. Accordingly, the EPA will continue to include in all guidance a
disclaimer that the guidance is non-binding. Considering these
practices regarding guidance, the EPA believes that rescinding the
subpart D regulations will restore the flexibilities needed effectively
to address the challenges listed in E.O. 13992 and to otherwise meet
the Agency's statutory duties.
    Therefore, in accordance with E.O. 13992 and for the reasons stated
above, the EPA is rescinding its internal agency procedures for issuing
guidance documents codified at 40 CFR part 2, subpart D.

IV. Statutory and Executive Orders Reviews

    Additional information about these statues and Executive orders can
be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is exempt from review by the Office of Management and
Budget (OMB) because it is a rule of agency procedure and practice and
is limited to agency management.

B. Paperwork Reduction Act (PRA)

    This action does not contain any information collection activities
and therefore does not impose an information collection burden under
the PRA.

C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute.
This rule pertains to agency management or personnel, which the APA
expressly exempts from notice and comment rulemaking requirements under
5 U.S.C. 553(a)(2).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children. Per the definition of ``covered regulatory action'' in
section 2-202 of Executive Order 13891 and because this action does not
concern an environmental health risk or safety risk, it is not subject
to Executive Order 13045.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. This regulatory action is a
procedural rule and does not have any impact on human health or the
environment.

K. Congressional Review Act

    This rule is exempt from the CRA because it is a rule of agency
organization, procedure or practice that does not substantially affect
the rights or obligations of non-agency parties.

List of Subjects in 40 CFR Part 2

    Environmental protection, Administrative practice and procedure,
Organization and functions (Government agencies).

Michael S. Regan,
Administrator.

    For the reasons set forth in the preamble, the Environmental
Protection Agency amends 40 CFR part 2 as follows:

PART 2--PUBLIC INFORMATION

0
1. The authority citation for part 2 is revised to read as follows:

    Authority:  5 U.S.C. 552, 552a, 553; 28 U.S.C. 509, 510, 534; 31
U.S.C. 3717.

Subpart D [Removed]

0
2. Remove subpart D, consisting of Sec. Sec.  2.501 through 2.507.

[FR Doc. 2021-10269 Filed 5-17-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4083-4084]
[FR Doc No: 2021-00786]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FDA Drug Review Timeline Transparency; Statement of Policy

    The Department and its component agencies exist to serve the
American people. Consistent with and in follow up to the Department's
previous transparency efforts,\1\ and given the significant impact
FDA's approval of drugs has on Americans, the Secretary believes the
public would benefit from information regarding the timeline for FDA's
review of drug product applications as provided in this document.
---------------------------------------------------------------------------

    \1\ E.g., 85 FR 75893 (Nov. 27, 2020).
---------------------------------------------------------------------------

    In 1962, Congress amended the Food, Drug, and Cosmetic Act (FD&C
Act) to authorize the Food and Drug Administration (FDA) to review and
approve ``new drugs'' for safety and efficacy.\2\ When Congress made
this historic change to our nation's drug laws, it provided a timeframe
for FDA's review. In section 104 of the Drug Amendments of 1962,
codified at section 505(c) of the FD&C Act, 21 U.S.C. 355(c), Congress
required that, for New Drug Applications (NDAs), ``[w]ithin one hundred
eighty days after the filing of an application . . . , the Secretary
shall either approve the application . . . or give the applicant notice
of an opportunity for a hearing before the Secretary.'' As the Senate
Judiciary Committee explained at the time, ``this provision strikes a
balance between the need for governmental control to assure that new
drugs are not placed on the market until they have passed the relevant
tests and the need to insure that governmental control does not become
so rigid that the flow of new drugs to the market, and the incentive to
undergo the expense involved in preparing them for the market, become
stifled.'' \3\
---------------------------------------------------------------------------

    \2\ Drug Amendments of 1962, Pub. L. 87-781, 76 Stat. 780 (Oct.
10, 1962).
    \3\ 1962 U.S.C.C.A.N. 2884, 2891.
---------------------------------------------------------------------------

    At the time, the 180-day timeframe for review of ``new drugs'' was
uncontroversial. At a 1963 public hearing, the Acting Director for
FDA's Division of New Drugs stated that ``[a]pplications for drugs of
questionable safety or effectiveness will continue to take more of
every body's time.'' \4\ However, the Director ``pledge[d] action
greatly short of the 180-day limit on all applications and supplements
that present good scientific evidence of the safety and effectiveness
of the drugs and that are properly informative to the physician or
patient.'' \5\
---------------------------------------------------------------------------

    \4\ Proceedings, FDA Conference on the Kefauver-Harris Drug
Amendments and Proposed Regulations, at 7 (Feb. 15, 1963).
    \5\ Id. at 6.
---------------------------------------------------------------------------

    When Congress made additional amendments to the FD&C Act in 1984,
it borrowed from and applied the existing 180-day review framework to
the review of Abbreviated New Drug Applications (ANDAs), the approval
mechanism for generic drugs.\6\ Under section 505(j)(5)(A) of the FD&C
Act, 21 U.S.C. 355(j)(5)(A), the Secretary ``shall approve or
disapprove the [ANDA] application'' ``[w]ithin one hundred and eighty
days of the initial receipt of an application.'' FDA promulgated
regulations implementing the 180-day statutory provisions for review of
NDAs and ANDAs. See 21 CFR 314.100, 314.101. While the Prescription
Drug User Fee Act (PDUFA) and Generic Drug User Fee Act (GDUFA) in
their iterative forms have provided FDA with additional resources to
carry out its statutory mission, Congress did not do away with the 180-
day provisions in section 505 of the FD&C Act, 21 U.S.C. 355, in those
laws.
---------------------------------------------------------------------------

    \6\ Drug Price Competition and Patent Term Restoration Act of
1984, Public Law 98-417, 98 Stat. 1585, 1588 (Sept. 24, 1984).
---------------------------------------------------------------------------

    Though the agency has made strides over the years to expedite
review in the face of limited resources, the total time elapsed between
FDA's filing of an NDA or receipt of an ANDA to ultimate approval or
disapproval of the application often exceeds 180 days. Even so,
reporting on drug approvals, such as GAO's March 2020 report,\7\
focused primarily on agency compliance with PDUFA dates. The GAO report
did not mention the 180-day benchmark or discuss the agency's approval
timeframe in view of that requirement.
---------------------------------------------------------------------------

    \7\ GAO, FDA Drug Approval, Application Review Times Largely
Reflect Agency Goals (Mar. 2020), https://www.gao.gov/assets/710/705193.pdf.
---------------------------------------------------------------------------

    Given this gap in reporting, the Department reviewed FDA's New Drug
Therapy Approvals from 2019 \8\ in view of the 180-day timeframe. The
Department's review considered 48 products listed by the agency as
approved in 2019.\9\ The table below presents, among other things, the
date of submission, date of approval, total days from submission to
approval, and total days in excess of 180 days of submission for these
drugs.
---------------------------------------------------------------------------

    \8\ FDA, New Drug Therapy Approvals 2019, https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019.
    \9\ In its review, the Department obtained the ``submission
date'' (or, if available, ``filing date'') of the 48 drugs by
searching documents available to the public on FDA's [email protected]
website.

----------------------------------------------------------------------------------------------------------------
                                 Summary of FDA-                                       Days
        Drug brand name          approved use on    Submission     Approval date   submission to  Days in excess
                                  approval date        date                          approval       of 180 days
----------------------------------------------------------------------------------------------------------------
Accrufer......................  Iron deficiency        9/27/2018       7/25/2019             301             121
                                 anemia.
Adakveo.......................  Reduce                 5/16/2019      11/15/2019             183               3
                                 vasoocclusive
                                 crises in
                                 sickle cell
                                 disease.
Aklief........................  Acne vulgaris...       10/4/2018       10/4/2019             365             185
Balversa......................  Locally advanced       9/18/2018       4/12/2019             206              26
                                 or metastatic
                                 bladder cancer.
Beovu.........................  Wet age-related         2/7/2019       10/7/2019             242              62
                                 macular
                                 degeneration.
Brukinsa......................  Mantle cell            6/27/2019      11/14/2019             140             N/A
                                 lymphoma.
Cablivi.......................  Acquired                6/6/2018        2/6/2019             245              65
                                 thrombotic
                                 thrombocytopeni
                                 c purpura.
Caplyta.......................  Schizophrenia...       9/27/2018      12/20/2019             449             269
Dayvigo.......................  Insomnia........      12/27/2018      12/20/2019             358             178
Egaten........................  Fascioliasis....       6/14/2018       2/13/2019             244              64
Enhertu.......................  Metastatic             8/29/2019      12/20/2019             113             N/A
                                 breast cancer.
Evenity.......................  Osteoporosis....        7/9/2018        4/9/2019             274              94
ExEm Foam.....................  Diagnostic agent       10/9/2018       11/7/2019             394             214
                                 for fallopian
                                 tube assessment.
Fetroja.......................  Complicated           12/14/2018      11/14/2019             335             155
                                 urinary tract
                                 infection.
fluorodopa F 18...............  Diagnostic agent       4/10/2019      10/10/2019             183               3
                                 for
                                 Parkinsonian
                                 syndromes.

Ga 68 DOTATOC.................  Diagnostic agent       5/23/2018       8/21/2019             455             275
                                 for
                                 neuroendocrine
                                 tumors.
Givlaari......................  Acute hepatic           6/4/2019      11/20/2019             169             N/A
                                 porphyria.
Ibsrela.......................  Irritable bowel        9/12/2018       9/12/2019             365             185
                                 syndrome with
                                 constipation.
Inrebic.......................  Certain types of        1/4/2019       8/16/2019             224              44
                                 myelofibrosis.
Jeuveau.......................  Improve                5/15/2017        2/1/2019             627             447
                                 appearance of
                                 glabellar lines
                                 (lines between
                                 eyebrows).
Mayzent.......................  Relapsing forms        6/28/2018       3/26/2019             271              91
                                 of multiple
                                 sclerosis.
Nourianz......................  Parkinson's            7/27/2019       8/27/2019              31             N/A
                                 disease ``off''
                                 episodes.
Nubeqa........................  Non-metastatic         2/26/2019       7/30/2019             154             N/A
                                 prostate cancer.
Oxbryta.......................  Sickle cell            6/26/2019      11/25/2019             152             N/A
                                 disease.
Padcev........................  Refractory             7/15/2019      12/18/2019             146             N/A
                                 bladder cancer.
Piqray........................  Advanced or           12/18/2018       5/24/2019             157             N/A
                                 metastatic
                                 breast cancer.
Polivy........................  Relapsed or           12/19/2018       6/10/2019             173             N/A
                                 refractory
                                 diffuse large B-
                                 cell lymphoma.
pretomanid....................  Treatment-            12/14/2018       8/14/2019             243              63
                                 resistant forms
                                 of tuberculosis.
Reblozyl......................  Anemia                  4/4/2019       11/8/2019             218              38
                                 associated with
                                 beta
                                 thalassemia.
Recarbrio.....................  Complicated           11/16/2018       7/16/2019             242              62
                                 urinary tract
                                 infections and
                                 complicated
                                 intra-abdominal
                                 infections
Reyvow........................  Migraine with or      10/11/2018      10/11/2019             365             185
                                 without aura.
Rinvoq........................  Moderately to         12/18/2018       8/16/2019             241              61
                                 severely active
                                 rheumatoid
                                 arthritis.
Rozlytrek.....................  Metastatic non-       12/18/2018       8/15/2019             240              60
                                 small cell lung
                                 cancer and
                                 locally
                                 advanced or
                                 metastatic
                                 solid tumors
                                 with a specific
                                 genetic defect.
Scenesse......................  Increase pain-         11/8/2018       10/8/2019             334             154
                                 free light
                                 exposure in
                                 patients with
                                 erythropoietic
                                 protoporphyria.
Skyrizi.......................  Moderate-to-            4/3/2018       4/23/2019             385             205
                                 severe plaque
                                 psoriasis.
Sunosi........................  Excessive             12/20/2017       3/20/2019             455             275
                                 daytime
                                 sleepiness in
                                 patients with
                                 narcolepsy or
                                 obstructive
                                 sleep apnea.
TissueBlue....................  Dye used in eye        4/29/2019      12/20/2019             235              55
                                 surgery.
Trikafta......................  Cystic Fibrosis.       7/19/2019      10/21/2019              94             N/A
Turalio.......................  Symptomatic            12/3/2018        8/2/2019             242              62
                                 tenosynovial
                                 giant cell
                                 tumor.
Ubrelvy.......................  Migraine........      12/26/2018      12/23/2019             362             182
Vyleesi.......................  Hypoactive             3/23/2018       6/21/2019             455             275
                                 sexual desire
                                 disorder in
                                 premenopausal
                                 women.
Vyndaqel......................  Cardiomyopathy         11/2/2018        5/3/2019             182               2
                                 caused by
                                 transthyretin-
                                 mediated
                                 amyloidosis.
Vyondys 53....................  Duchenne              12/19/2018      12/12/2019             358             178
                                 muscular
                                 dystrophy.
Wakix.........................  Excessive             12/14/2018       8/14/2019             243              63
                                 daytime
                                 sleepiness in
                                 patients with
                                 narcolepsy.
Xcopri........................  Partial-onset         11/21/2018      11/21/2019             365             185
                                 seizures.
Xenleta.......................  Community-            12/19/2018       8/19/2019             243              63
                                 acquired
                                 bacterial
                                 pneumonia.
Xpovio........................  Relapsed or             8/6/2018        7/3/2019             331             151
                                 refractory
                                 multiple
                                 myeloma.
Zulresso......................  Postpartum              4/9/2018       3/19/2019             344             164
                                 depression.
----------------------------------------------------------------------------------------------------------------

    The Department found that 38 of the 48 drugs (79.1%) were approved
more than 180 days after submission of an application. The average time
from submission to approval for the 48 drugs in the table above was
273.8 days. It should be noted that in many instances the failure to
meet the 180-day statutory benchmark may have been justified and in
such cases, was frequently the result of questions by the agency and
responses by the applicant.
    Because FDA's approval of drugs affects the health and financial
well-being of all Americans, the Department believes the public is
entitled to information like the data provided in the table above
regarding the amount of the time required for FDA review and approval
of new and generic drugs. To that end, effective upon publication of
this Notice, for all NDA and ANDA approvals, FDA must take the
following action.
    FDA shall publish annually on its website, for each approved NDA
and ANDA approved after the date of this publication, (a) the date on
which FDA ``filed,'' in the case of an NDA, or ``received,'' in the
case of an ANDA, such application; (b) the date on which FDA approved
the NDA or ANDA; (c) the total days elapsed between the dates in (a)
and (b); and (d) the total days in excess of 180-days the date of (c).
For example, if an NDA was ``filed'' on January 25, 2021 and approved
on December 27, 2021, then the total days elapsed for review would be
336 days, and the days in excess of 180 days would be 156 days.
    Members of the public can use this information to further study the
health and economic impacts of FDA review timelines. This reporting is
also consistent with FDA's mission to ``promote the public health by
promptly and efficiently reviewing clinical research and taking
appropriate action on the marketing of regulated products in a timely
manner.'' 21 U.S.C. 393(b)(1). In addition to educating the public, the
Department believes this information will inform Congress as to whether
to provide FDA with additional resources to carry out the agency's
review obligations within the timeframe prescribed by Congress.

    Dated: January 8, 2021.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-00786 Filed 1-14-21; 8:45 am]
BILLING CODE 4150-26-P


[Federal Register Volume 75, Number 215 (Monday, November 8, 2010)]
[Notices]
[Page 68636]
[FR Doc No: 2010-28241]

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SECURITIES AND EXCHANGE COMMISSION

 [File No. 500-1]

8000, Inc.; Order of Suspension of Trading

November 4, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
8000, Inc. because of questions regarding the accuracy of statements
made by 8000, Inc. in press releases concerning, among other things, a
cash dividend the company announced it would pay stockholders and
Monk's Den, an investment program and online investor network the
company disclosed it acquired in September 2010.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of 8000, Inc.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EDT on
November 4, 2010, through 11:59 p.m. EST on November 17, 2010.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2010-28241 Filed 11-4-10; 4:15 pm]
BILLING CODE 8011-01-P