INFORMATION COLLECTION REQUEST:

NOTICE OF INTENT FOR STORM WATER DISCHARGES ASSOCIATED WITH CONSTRUCTION ACTIVITY UNDER A NPDES GENERAL PERMIT February, 20, 2003 Prepared for U. S. Environmental Protection Agency Office of Wastewater Management 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Prepared by Tetra Tech, Inc. 10306 Eaton Place, Suite 340 Fairfax, VA 22030 EPA Contract Number 68 C 99 253 EPA Work Assignment Number 3 15 Tetra Tech Project Number 12695 15 01 TABLE OF CONTENTS 1. IDENTIFICATION OF THE INFORMATION COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . Page 1 1( a) TITLE OF THE INFORMATION COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1 1( b) SHORT CHARACTERIZATION/ ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1 2. NEED FOR AND USE OF THE COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3 2( a) NEED/ AUTHORITY OF THE COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3 2( b) PRACTICAL UTILITY/ USERS OF THE DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4 3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA . . . . Page 5 3( a) NONDUPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 3( b) PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB . . . . . . . . . . Page 5 3( c) CONSULTATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 3( d) EFFECTS OF LESS FREQUENT COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5 3( e) GENERAL GUIDELINES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 3( f) CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 3( g) SENSITIVE QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 4. THE RESPONDENTS AND THE INFORMATION REQUESTED . . . . . . . . . . . . . . . . . . . . . Page 7 4( a) RESPONDENTS/ SIC CODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 7 4( b) INFORMATION REQUESTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 7 Data Items, Including Recordkeeping Requirements . . . . . . . . . . . . . . . . . . . . . . . . . Page 7 Respondent Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 9 5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11 5( a) AGENCY ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11 5( b) COLLECTION METHODOLOGY AND MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . Page 11 5( c) SMALL ENTITY FLEXIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12 5( d) COLLECTION SCHEDULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION . . . . . . . . . . . . . . . . . . Page 13 6( a) ESTIMATING RESPONDENT BURDEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13 Burden on Construction Respondents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 14 Burden on NPDES Authorized States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 14 6( b) ESTIMATING RESPONDENT COSTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 15 Costs to Construction Respondents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 15 Costs to NPDES Authorized States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 16 6( c) ESTIMATING AGENCY BURDEN AND COST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 17 Burden Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 17 Cost Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 17 6( d) ESTIMATING THE RESPONDENT UNIVERSE AND TOTAL BURDEN AND COSTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 17 Estimating the Universe of Construction Respondents . . . . . . . . . . . . . . . . . . . . . . . Page 17 Estimating the NPDES Authorized State Universe . . . . . . . . . . . . . . . . . . . . . . . . . . Page 18 Total Burden and Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 18 6( e) BOTTOM LINE BURDEN HOURS AND COST TABLES . . . . . . . . . . . . . . . . . . . . . . . Page 19 Respondent Tally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 19 Agency Tally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 20 Total Tally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 20 Variations in the Annual Bottom Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 20 6( f) REASONS FOR CHANGE IN BURDEN AND COST . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 20 6( g) BURDEN STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 21 Storm Water Construction General Permit ICR February 20, 2003 Page 1 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) TITLE OF THE INFORMATION COLLECTION Title: Notice of Intent for Stormwater Discharges Associated with Construction Activity Under a NPDES General Permit EPA ICR Number: 1842.04 OMB Control Number: 2040 0188 1( b) SHORT CHARACTERIZATION/ ABSTRACT This Information Collection Request ( ICR) renews OMB Number 2040 0188 ( Notice of Intent for Storm Water Discharges Associated with Construction Activity).

EPA's National Pollutant Discharge Elimination System ( NPDES) Permitting Program, as authorized by the Clean Water Act ( CWA), establishes regulations for the discharge of pollutants or combinations of pollutants to waters of the United States, including discharges of storm water. Phase I of the storm water program, promulgated on November 16, 1990 ( 55 FR 47990), applied to eleven categories of storm water discharges associated with industrial activity ( including construction activities disturbing five acres or more) and to discharges from large and medium municipal separate storm sewer systems. Phase II of the regulatory development effort, promulgated on December 8, 1999 ( 64 FR 68722), regulates storm water discharges from small municipal separate storm sewer systems and construction sites with activities disturbing one to five acres of land. Together, Phase I and Phase II of the NPDES Storm Water Program now regulate all construction activities of one acre or more. However, this ICR only covers the burden on construction sites of five or more acres, as small construction activities are addressed in the Storm Water Phase II ICR ( OMB Control Number 2040 0211, EPA ICR Number 1820.03).

The primary permitting mechanism for construction site owner/ operators is the Construction General Permit ( CGP), issued by EPA or a state authorized to administer the NPDES Program. To obtain coverage under the CGP, a construction site owner/ operator must submit a Notice of Intent ( NOI) to the permitting authority. Once received, CGP NOIs are checked for completeness and, if complete, an acceptance letter is sent to the applicant notifying them of their permit number.

One of the main components of the CGP is the requirement for permittees to develop a Storm Water Pollution Prevention Plan ( SWPPP). The SWPPP serves as the primary condition of the permit of which facilities must comply. Although the SWPPP is not typically submitted to the permitting authority, burden and costs associated with its preparation is included in this ICR because it must be prepared at the time of permit application ( i. e., when the NOI is submitted). The permitting authority is not required to review and approve these plans; rather, these are to be implemented by the permitted facility, and must be available for review as requested by the permitting authority. Facilities retain the SWPPP on site unless the permitting authority specifically requests that it be submitted.

The information collection and reporting activities covered in this ICR include only those Storm Water Construction General Permit ICR February 20, 2003 Page 2 activities related to completing and submitting an NOI form and those resulting from the development of a SWPPP. The CGP also requires submittal of a Notice of Termination ( NOT) upon the cessation of the storm water discharge associated with construction activity, but the burden associated with completing the NOT is not included in this ICR because it is provided in the NPDES Applications ICR ( OMB Control Number 2040 0086, EPA ICR Number 0226.15).

It is expected that respondents will submit information in hard copy form. The information from them will be entered into a computer database and the original document will be filed. The information will be submitted by the respondents directly to each NPDES authorized state or Territory, or to EPA in areas where EPA is the NPDES permitting authority. Plans are underway to allow electronic submission of much of the required information but these options are not included in the ICR. At the time those options become available, EPA will update this information collection to reflect a revised burden estimate.

The calculations performed for this ICR cover the burden and costs for the Agency ( EPA), NPDES authorized states, and owner/ operators of construction sites of five acres or more. This ICR estimates a burden of 7,729,696 hours annually for 201,213 respondents, excluding state respondents. Burden for the state respondents is 190,549 hours annually. Agency burden is 21,499 hours. Storm Water Construction General Permit ICR February 20, 2003 Page 3 2. NEED FOR AND USE OF THE COLLECTION 2( a) NEED/ AUTHORITY OF THE COLLECTION The purpose of the CWA is to restore and maintain the chemical, physical and biological integrity of the nation's waters. To meet that end, the CWA establishes the NPDES program to regulate the discharge of any pollutant or combination of pollutants from point sources into waters of the United States.

EPA and NPDES permitting authorities issue permits to discharge storm water from construction sites under the NPDES storm water program and need the information collection in order to:

° Ensure coverage of construction sites under an NPDES general permit for construction activity,

° Identify the location of the construction activity,

° Identify the responsible party or parties on site,

° Identify the need to issue an individual permit in cases where a general permit will not adequately meet the objectives of the CWA,

° Provide a data source with which future NPDES storm water general permits will be developed with appropriate requirements and permit conditions that meet the objectives of the CWA,

° Determine compliance with general permits and no exposure requirements,

° Compile statistics on national permit issuance, backlog, and compliance rates,

° Evaluate nationwide or area wide water quality,

° Ensure consistency in storm water permitting,

° Prioritize permit issuance activities,

° Develop appropriate policy and budgets,

° Perform cost benefit analyses,

° Respond to complaints from the public of possible non compliance with permit conditions, and ° Respond to Congressional and public inquiries.

CWA Section 402( a), as amended, authorizes the EPA Administrator to issue permits for the discharge of pollutants if those discharges meet all applicable requirements of CWA Sections 301, 302, 306, 307, 308, and 403, or any conditions the Administrator determines are necessary to carry out the provisions and objectives of the CWA. The authorization to issue permits for storm water discharges in particular is provided at Section 402( p). NPDES storm water regulations are found in 40 CFR § 122.26. Storm Water Construction General Permit ICR February 20, 2003 Page 4 2( b) PRACTICAL UTILITY/ USERS OF THE DATA Generally, construction general permit applicants submit similar basic information: the NOI for construction activities. The data contained in the NOI can be split into two types: locational information details ( e. g., name, location, description of the construction activity), and site characteristics ( e. g., site size, estimated construction start and end dates).

Permitting authorities use locational information to uniquely identify the construction activities requesting coverage under the CGP.

Permitting authorities gather site characteristics from the CGP NOI to use in estimating environmental impacts. Permitting authorities can also use the data from the CGP NOI, as well as from the SWPPP, as part of a compliance evaluation to ensure that the permittee adheres to conditions as stated in the CGP NOI and SWPPP.

EPA stores all information submitted on the NOI in a database housed at the NOI Processing Center. The NOI database provides an inventory of construction sites permitted by EPA. EPA uses the information contained in the NOI database to develop reports on permit issuance, backlog, and compliance rates. EPA also uses the information to respond to public and Congressional inquiries, develop and guide its policies, formulate its budgets, and manage its programs to ensure national consistency in permitting. The database serves as a source of general information and a mailing list. This provides EPA with a comprehensive record keeping system on permit issuance and the overall assimilation of the NPDES permitting program. For the most part, States and territories authorized to implement the NPDES permitting program manage and use the data in a similar fashion to that of EPA and as such incur similar types of burden.

Facilities must reapply for coverage under the CGP at least every five years. The reapplication process is the only mechanism for obtaining up to date information on discharges.

To meet its obligations under the Clean Water Act, National Historic Preservation Act ( NHPA), and Endangered Species Act ( ESA), and to promote those Acts' goals, EPA is seeking to ensure that discharges covered under the CGP are protective of historic properties, endangered and threatened species, and critical habitat. Applicants for coverage under the CGP are required to assess the impacts of their storm water discharges on historic properties, Federally listed endangered and threatened species, and designated critical habitat. Information from this assessment is provided in the NOI and therefore entered into the NOI database. NPDESauthorized states are not required by EPA to meet the ESA and NHPA obligations and as such, no ESA or NHPA burden is associated with State ( or Territory) issued permits. Storm Water Construction General Permit ICR February 20, 2003 Page 5 3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) NONDUPLICATION EPA has examined all other reporting requirements contained in the Clean Water Act and 40 CFR Parts 122, 123, 124, 125, 403, 501, and 503. The Agency also has consulted the following sources of information to determine if similar or duplicate information is available elsewhere:

° the EPA Information Systems Inventory;

° the EPA Inventory of Information Collection Requests; and ° the Federal Information Locator System.

Examination of these databases revealed no duplicate requirements. EPA has concluded that it has no other way to obtain the information addressed in this ICR.

3( b) PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB This ICR was published in the Federal Register on December 6, 2002. The notice included a request for comments on the content and impact of the proposed rule on the regulated community. No comment were received.

3( c) CONSULTATIONS EPA finalized the requirements addressed in this ICR after receiving comments from the public and the regulated community. In addition, the Agency actively solicits comments when it develops its regulations. EPA holds public meetings, assembles workgroups of experts and potential respondents, and consults government agencies, such as OMB, before finalizing requirements.

In developing regulations for storm water dischargers, EPA met with potential respondents, industry and trade organizations, environmental groups, and municipal, state, and public works associations. EPA made several changes to its regulations based on comments presented at meetings. For example, at a meeting in 1987, the National Homebuilders Association pointed out that sampling data for construction sites would be extremely variable because construction activities are continually changing. Based on this comment, EPA now requires general information on construction activities rather than quantitative sampling data, since general information will adequately indicate any potential problems from storm water runoff at construction sites. Additionally, several data fields on the CGP NOI were included per comments from the Urban Wet Weather Flows Federal Advisory Committee.

3( d) EFFECTS OF LESS FREQUENT COLLECTION The CWA prohibits NPDES permits to have terms longer than five years. It is a statutory requirement that permitted entities reapply for coverage under NPDES storm water permits before their existing permits expire, generally once every five years. Therefore, less frequent collection Storm Water Construction General Permit ICR February 20, 2003 Page 6 of information could be a violation of the CWA.

3( e) GENERAL GUIDELINES This information collection complies with PRA guidelines [ 5 CFR 1320.5( d)( 2)]. Requests for supplemental information for the purposes of emergency response or enforcement activities are exempt from the PRA requirements.

3( f) CONFIDENTIALITY Permit applications may contain confidential business information. If this is the case, the respondent may request that such information be treated as confidential. All confidential data will be handled in accordance with 40 CFR § 122.7, 40 CFR Part 2, and EPA's Security Manual Part III, Chapter 9, dated August 9, 1976. However, CWA § 308( b) specifically states that effluent data may not be treated as confidential.

3( g) SENSITIVE QUESTIONS Reporting requirements addressed in this ICR do not include sensitive questions. Storm Water Construction General Permit ICR February 20, 2003 Page 7 4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) RESPONDENTS/ SIC CODES Entities that wish to apply for coverage of storm water discharges related to construction activity under the NPDES CGP must complete and submit an NOI and develop and maintain a SWPPP. For the purposes of this ICR, operations that may include any clearing, grading, or excavation activities that disturb five or more acres of land must apply for coverage under the CGP. Construction activities that result in a disturbance of less than 5 acres of total land area are also required to submit an NOI and develop a SWPPP, but the burden on those respondents is already accounted for in the Storm Water Phase II ICR ( OMB Control Number 2040 0211, EPA ICR Number 1820.03).

The largest portion of construction activities will be carried out by builders, local developers, and contractors. Relevant SIC codes include the following: 1531, 1541, 1542, 1611, 1622, 1623, 1629, and 1764.

At present, 45 states and one Territory have received authorization from EPA to act as the NPDES permitting authority in those respective areas. Because they incur burden in administering the program, permitting authorities are considered respondents for the purposes of this ICR.

4( b) INFORMATION REQUESTED This section presents the data items, including record keeping requirements, and required respondent activities involved in preparing and submitting those data items.

Data Items, Including Recordkeeping Requirements Notice of Intent Construction site operators are required to complete an NOI or an individual application and develop and implement a storm water pollution prevention plan that includes proper erosion and sediment controls.

Storm water discharges associated with construction activity exist in vast numbers. EPA has recognized that the burden to issue individual permits to each discharger would be prohibitive. EPA currently uses, and expects to continue and encourage the use of, a general permit option and standardized application forms for construction activities. EPA expects that all operators of construction sites of five or more acres will submit a Notice of Intent ( NOI) for coverage under a general permit consistent with the requirements of 40 CFR § 122.28( b)( 2).

Although the NPDES regulations allow the option of submitting individual applications instead of an NOI, EPA does not anticipate any operator will choose this option. Because EPA expects no respondents for this activity, the burden and costs associated with the preparation and submittal of an individual application are not necessary for this ICR. However, the information required for an individual application, Forms 1 and 2F, was estimated in the ICR that was developed to assess the information collection burden of the storm water regulations as promulgated in 1990. Storm Water Construction General Permit ICR February 20, 2003 Page 8 Federal regulations require, at a minimum, that applicants provide the following information in their NOI:

° the legal name and address of the owner or operator,

° the facility name and address,

° the type of facility or discharges, and ° the name of the receiving water( s).

When NPDES permitting authorities issue general permits, they may require additional information to be submitted with the NOI that is deemed necessary to ensure that facilities covered under the permits comply with the objectives and provisions of the CWA. However, NPDES permitting authorities typically use general permits to minimize the burden associated with reviewing application information. Consequently, applicants are usually required to provide simple, easily obtainable data in their NOIs.

EPA has issued an NOI that applies to both Phase I and Phase II of the construction storm water program. Entities within the construction industry and their industry organizations are familiar with the idea of an NOI as a means of seeking coverage under Phase I of the storm water program.

The following information is requested from both Phase I and Phase II construction operators:

° Name, address, and phone number of the construction site operator,

° County in which the construction site is located,

° Ownership class of the construction site ( i. e., Federal, state, public, or private),

° Name and location of the construction site,

° Whether the facility is located on Indian Lands,

° Latitude and longitude of the construction site,

° Whether a SWPPP has been developed,

° Address of the location of the SWPPP,

° Estimated construction start date and completion date,

° Estimated land area to be disturbed,

° An estimate of the likelihood of a discharge, and ° Whether any endangered or threatened species are in proximity to storm water discharges or best management practices ( BMPs) to be constructed for the discharges.

Storm Water Pollution Prevention Plan ( SWPPP)

As an NPDES construction permit condition, EPA requires operators of construction sites to develop a SWPPP. A SWPPP is typically kept on site and not submitted. The development of a SWPPP is unique to each construction site even though they are based on common required elements. The SWPPP typically includes: Storm Water Construction General Permit ICR February 20, 2003 Page 9 ° a site plan, including proper erosion and sediment controls and storm water management,

° a pollution prevention site map, and ° an inspection and maintenance plan.

EPA requires SWPPPs consistent with the best management practices requirements specified in 40 CFR § 122.44( k)( 2).

Record Maintenance The CGP requires that the SWPPP and copies of the NOI ( or other permit application) are kept on site. The SWPPP also requires the construction site owner or operator to keep records of bi weekly inspections of their BMPs used for erosion and sediment control. These requirements are consistent with the requirements of § § 122.41( h)( j) & ( l).

Respondent Activities Respondent activities can vary depending on the characteristics of the applicant and of the particular authorized state or Territory. This ICR explains these activities for each set of application requirements ( see Section 6 of this ICR, " Estimating Respondent Burden"). Respondent activities are summarized below for both permittees and NPDES authorized states and territories.

Construction Permittees Any particular construction respondent preparing and submitting an NOI may engage in the following types of activities:

Preparing basic information for the NOI. This includes reading and reviewing instructions and regulations for the current CGP NOI, reviewing guidance materials, gathering general information, typing/ completing the CGP NOI form, submitting the form, and maintaining a record of the NOI.

Preparing basic information for the SWPPP. This includes reading and reviewing instructions and regulations for SWPPP requirements, gathering general information, and developing a plan for SWPPP preparation.

Generating detailed information for the SWPPP. Detailed information may include topographic maps, data on effluent characteristics, management programs, financial estimates, engineering data, or other information required to be included in SWPPPs.

Maintaining records. The CGP requires that the permittee keep records for at least three years from the date that the site is finally stabilized. Also, SWPPPs must be maintained on site from the date of project initiation to the date of final stabilization. Applicants may need to develop a recordkeeping system, enter data, train personnel, and file information.

NPDES Authorized States and Territories Respondent activities can vary depending on the characteristics of the particular authorized state or Territory and the methodology they chose in administering the program. However, any NPDES permitting authority may be expected to engage in the following types of activities: Storm Water Construction General Permit ICR February 20, 2003 Page 10 Maintaining records. states and territories need to develop a recordkeeping system, develop a master database, train personnel, enter data, and distribute the information to interested parties, such as reviewers and enforcement personnel.

Reviewing submitted data. states and territories may need to answer respondent questions and provide a review of CGP NOIs for completeness and technical accuracy. In addition, states and territories need to notify applicants of receipt/ approval of CGP NOI submissions. Because the NPDES regulations do not require SWPPPs to be submitted to the permitting authority, there are no SWPPP related respondent activities for any NPDES authorized state or Territory. Storm Water Construction General Permit ICR February 20, 2003 Page 11 5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) AGENCY ACTIVITIES The Agency's activities as the NPDES permitting authority for five states, the District of Columbia, and all U. S. territories except the Virgin Islands are the same as the activities performed by the 45 NPDES authorized states and the Virgin Islands. The sole activity is the processing and review of CGP NOIs.

The development of information collection forms by the NPDES authorized states has not been included in this ICR. EPA expects all necessary forms to be developed as part of EPA Headquarters' ongoing rule implementation efforts. Furthermore, because the NPDES permitting authorities may simply adopt the EPA forms or use their pre existing NOI forms, EPA estimates that the NPDES permitting authorities will not incur any additional burden for the development of forms.

As EPA receives NOIs, they must be reviewed for completeness. If an NOI is incomplete, applicants are notified and instructed to submit the missing information. If the NOI is complete, an acceptance letter is sent to the permittee, along with a unique permit number. The NOI data are entered and maintained in the NOI database at the NOI Processing Center.

The Fish and Wildlife Service ( FWS) and National Marine Fisheries Service ( NMFS) must assist some applicants with obtaining information relating to endangered species and critical habitat and participate in formal and informal Endangered Species Act ( ESA) consultations when endangered species or critical habitat are present or will be impacted by construction activity. NPDES authorized states are not required to include these requirements in their general permits, and therefore neither the NPDES authorized states nor the construction sites within those states incur any burden for ESA consultations.

As mentioned previously, permittees are not required to submit SWPPPs to EPA for review. These plans are to be maintained on site where the construction activities are taking place and must be available for EPA review as requested. Therefore, for the purposes of this ICR, the pollution prevention plans are integral to the day to day operational control of each construction site, but are not included as a component of Agency activities.

5( b) COLLECTION METHODOLOGY AND MANAGEMENT In collecting and analyzing the information associated with this ICR, EPA will use paperbased forms, personal computers, and a database to ultimately store the information. EPA will ensure accuracy and completeness of the information by reviewing each submittal. Any form that is considered inaccurate or incomplete will not be accepted and will be returned to the sender with a letter requesting the missing and/ or inaccurate information.

In the future, EPA plans to analyze the use of Internet based forms to facilitate the transfer of information such as that contained in NOIs between the regulated community and EPA to see Storm Water Construction General Permit ICR February 20, 2003 Page 12 if there are any potential reductions in burden or costs. This ICR will be revised at that time to address the likely reduction in burden.

5( c) SMALL ENTITY FLEXIBILITY For many reasons, EPA believes the reporting requirements discussed in this ICR do not place an unreasonable burden on small business. Over the last decade, EPA has reduced reporting burdens on businesses of all sizes. The Agency developed the general permit procedures to reduce burdens associated with the application process, especially the burden associated with storm water discharges.

The NOI requests minimal information required to characterize the site and construction activity. Most site related information is contained in the SWPPP, which is not required to be submitted to the Agency. Furthermore, sites submit NOIs once every five years and the burden represented by these NOIs cannot easily be reduced for small businesses because EPA needs certain basic information to make permitting decisions. This basic information is not dependent on an organization's size. One of the measures taken by EPA to reduce burden and costs is that facilities submitting NOIs for coverage under EPA's CGP, for instance, do not need to submit any sampling data.

The CGP NOI ( EPA form 3510 9) was developed specifically to reduce the burden for construction activities. The pre existing NOI form ( EPA form 3510 6) that was replaced in 1998 required more detailed information since the form was also used for industrial activities requesting coverage under a general permit. The current NOI is simplified and only relevant information for construction activities is requested.

5( d) COLLECTION SCHEDULE Federal regulations require permittees to reapply for permits at least every five years, although the regulations also grant permit writers the authority to impose more frequent reissuance. General permits are issued only for a five year term. All facilities that wish to be covered under the general permit must reapply or notify EPA once every five years using the CGP NOI. When calculating burden, this ICR assumes that all permit applicants follow this schedule. Storm Water Construction General Permit ICR February 20, 2003 Page 13 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) ESTIMATING RESPONDENT BURDEN In this section, EPA presents estimated burden for each information request on construction sites disturbing five or more acres. Per EPA ICR guidance, the 45 NPDES authorized states and the Virgin Islands are also included as respondents in this section.

Burden on Construction Respondents The respondent activities for construction sources are preparation and submittal of an NOI, the development of a SWPPP, and record keeping. Burden associated with the preparation and submittal of an NOT is included in the NPDES Applications ICR ( OMB Control Number 2040 0086, EPA ICR Number 0226.15).

EPA estimates that all construction sources required to seek coverage will use the NOI rather than seek coverage using an application for an individual permit. To determine the average burden for the NOI, EPA developed an estimate of the time increment necessary to complete the form. A poll of contractor and EPA staff familiar with the NOI requests indicated that the current form would take a typical applicant a total of 1.5 hours to complete if there were no endangered species or critical habitat listed for the project area. Should the permittee need to informally consult with the Fish and Wildlife Service ( FWS) or National Marine Fisheries Service ( NMFS) to determine if species or critical habitat may be present and if an adverse impact is likely to occur, then an average of 6 hours would be needed to complete the form. EPA estimates that 37.3% of applicants would need to perform informal consultations. Based on information provided by FWS, PA estimates that 2.7 percent of applicants would need formal consultation for actions that are likely to adversely affect species or critical habitat, and thus incur 20 hours of burden preparing biological evaluations and related correspondence. EPA assumes that 60 percent would not have listed endangered species or critical habitat in the project area. A discussion with FWS staff confirmed this assumption was a good estimate given the areas that the permit covered. However, in NPDES authorized states, the ESA requirement of the CGP does not necessarily apply, unless specifically provided for by the state. Therefore, for the purposes of this ICR, only construction sites in non NPDES authorized states might incur burden in consultations with FWS and/ or NMFS. In other words, in NPDES authorized states, the burden is 1.5 hours for completion of the NOI, while in areas where EPA is the permitting authority, the burden is dependent on the required level of consultation with FWS and NMFS.

The burden to develop a SWPPP was estimated using best professional judgement of contractor staff familiar with the storm water CGP process and the design of SWPPPs. Despite the fact that the components of a SWPPP are similar, each site's design and size and function, as well as the level of effort involved, will vary for each site. To calculate the burden to prepare a SWPPP, EPA and EPA contractor staff identified a " typical" respondent and then estimated the burden for that respondent to prepare a SWPPP. The various activities carried out in the preparation of a SWPPP are presented in Section 4( b). EPA estimates that the average time for a respondent to develop a SWPPP is 36.4 hours. This is a one time development activity. The breakdown of cost and burden by labor category is provided in Section 6( b). Storm Water Construction General Permit ICR February 20, 2003 Page 14 The estimated recordkeeping burden for the CGP NOI and SWPPP is expected to be 0.4 hours per construction start, based on a poll of contractor and EPA staff familiar with the recordkeeping activities associated with the construction storm water program. The burden is estimated at 0.2 hours each for the CGP NOI and SWPPP, respectively.

A summary of estimated respondent burden is presented below in Table 1.

Table 1. Burden on Each Respondent Information Collection Activity Annual Burden on Each Respondent ( hours) In NPDES Authorized States NOI preparation & submittal 1.5 Development of SWPPP 36.4 Recordkeeping 0.4 Annual Total 38.3 In States where EPA is the Permitting Authority For sites where no ESA consultation is necessary NOI preparation & submittal 1.5 Development of SWPPP 36.4 Recordkeeping 0.4 Annual Total 38.3 For sites where an informal ESA consultation is necessary NOI preparation & submittal 6.0 Development of SWPPP 36.4 Recordkeeping 0.4 Annual Total 42.8 For sites where a formal ESA consultation is necessary NOI preparation & submittal 20.0 Development of SWPPP 36.4 Recordkeeping 0.4 Annual Total 56.8 Burden on NPDES Authorized States The Office of Management and Budget requires the state administrative burden and cost to be included in the respondent burden section of the ICR. The burden incurred by the NPDESauthorized states in managing and implementing the construction storm water program is consistent with that incurred by the Agency. Burden and costs will impact the Agency where it is the NPDES permitting authority, and NPDES authorized states will incur burden and costs where EPA is not the permitting authority.

The sole activity required for administration of the construction program in NPDESauthorized states is the processing and review of NOIs. This includes data entry of the NOI information into a database and for responding to any inquiries. Most NPDES authorized states and territories use a CGP NOI process similar to that implemented by EPA. This greatly reduces the burden upon governments to develop new forms and new databases to record information and track applicants. The burden estimate for administration of the construction program is based on a poll of contractor and EPA staff familiar with the conditions of the waivers and the level of review necessary. It is presented below in Table 2. Storm Water Construction General Permit ICR February 20, 2003 Page 15 Table 2. Burden on NPDES authorized States Information Collection Activity Burden Per Respondent ( hours) NOI processing & review 1.0 6( b) ESTIMATING RESPONDENT COSTS Because EPA has determined that there are no capital or operation and maintenance costs associated with any of the respondent activities, this ICR only includes labor costs in its estimates. The CGP does not require construction site operators expend funds for capital assets. Respondents are not required to pay for capital equipment or operations and maintenance to respond to the additional information requests.

Hourly wage rates are fully loaded ( i. e., including fringe benefits and overhead and profit, if applicable) in June, 2002 dollars and are derived from statistics provided by the U. S. Department of Labor.

Costs to Construction Respondents EPA used the following labor categories and hourly rates to estimate labor costs for activities by construction sources:

° Project manager: $ 47.20,

° Engineering assistant, $ 38.50,

° Drafter, $ 30.03, and ° Clerical support, $ 20.95.

For purposes of this analysis, EPA used data provided by the U. S. Department of Labor, Bureau of Labor Statistics in a table entitled Employer Costs for Employee Compensation, Table 11: Employer costs per hour worked for employee compensation and costs as a percent of total compensation: Private industry goods producing and service producing workers, by occupational group, June 2002. EPA assumes that the a project manager's compensation equates to the " Executive, administrative, and managerial" level of White Collar Occupations shown in Table 11. Similarly, an Engineering Assistant's compensation is assumed to be the same as the " Professional Specialty and Technical" level, a Drafter's compensation equates to the " Technical" level, and Clerical Support personnel's compensation is equal to the " Administrative support, including clerical" level.

EPA used an hourly labor cost of $ 38.50 for an engineering assistant to prepare and submit the NOI, and a combination of all four staff labor categories for the development of a SWPPP. Specifically, EPA assumed the following hourly distribution for SWPPP development: project manager ( 1.0 hours), engineering assistant ( 13.0 hours), drafter ( 22.0 hours), and clerical support ( 0.4 hours). That labor mix equates to an effective hourly rate of $ 33.42. Recordkeeping activities for both the CGP NOI and SWPPP are based on hourly rates for clerical staff.

EPA calculated the administrative costs for each of the information collection activities by multiplying the estimated burden by the appropriate hourly labor rate. The results are presented below in Table 3.

Table 3. Costs to Each Respondent Storm Water Construction General Permit ICR February 20, 2003 1U. S. Department of Labor, Bureau of Labor Statistics. Employer Costs for Employee Compensation, Table 3 Employer costs per hour worked for employee compensation and costs as a percent of total compensation: State and local government, by selected characteristics, June 2002 Page 16 Information Collection Activity Annual Burden for Each Respondent ( hours) Labor Rate ($ per hour) Annual Cost to Each Respondent In NPDES Authorized States NOI preparation & submittal 1.5 $ 38.50 $ 57.75 Development of SWPPP 36.4 $ 33.42 $ 1,216.49 Recordkeeping 0.4 $ 20.95 $ 8.38 Annual Total 38.3  $ 1,282.62 In States where EPA is the Permitting Authority For sites where no ESA consultation is necessary NOI preparation & submittal 1.5 $ 38.50 $ 57.75 Development of SWPPP 36.4 $ 33.42 $ 1,216.49 Recordkeeping 0.4 $ 20.95 $ 8.38 Annual Total 38.3  $ 1,282.62 For sites where an informal ESA consultation is necessary NOI preparation & submittal 6.0 $ 38.50 $ 231.00 Development of SWPPP 36.4 $ 33.42 $ 1,216.49 Recordkeeping 0.4 $ 20.95 $ 8.38 Annual Total 42.8  $ 1,455.87 For sites where a formal ESA consultation is necessary NOI preparation & submittal 20.0 $ 38.50 $ 770.00 Development of SWPPP 36.4 $ 33.42 $ 1,216.49 Recordkeeping 0.4 $ 20.95 $ 8.38 Annual Total 56.8  $ 1,994.87 Costs to NPDES Authorized States The hourly labor rate for NPDES authorized states was based on the average hourly wage for state employees as determined by the U. S. Department of Labor1. The mean hourly cost of employment for all occupations is $ 31.20, including benefits. This hourly rate was used for all activities performed by NPDES authorized states in this ICR.

EPA calculated the administrative costs of the information collection activities by multiplying the estimated burden by the hourly labor rate. The results are presented below in Table 4.

Table 4. Costs to NPDES Authorized States Information Collection Activity Annual Burden Per Respondent ( hours) State Labor Cost ($/ hr) Annual Cost Per Respondent ($) NOI processing & review 1.0 $ 31.20 $ 31.20 6( c) ESTIMATING AGENCY BURDEN AND COST Storm Water Construction General Permit ICR February 20, 2003 Page 17 The Agency burden and costs are included where EPA is the NPDES permitting authority in the non NPDES authorized states and territories. An estimate of the burden and costs for the Agency result from activities as described in Section 5( a). These burden and costs are identical to those for NPDES authorized states and territories, with the exception of the need to provide FWS and NMFS consultations in areas where threatened or endangered species may be in the project area.

Burden Estimates For NOIs, Agency burden is expected to be 1.0 hours per respondent for data entry of the NOI information into a database and to respond to any inquiries. The FWS and NMFS will incur a burden due to ESA related questions and consultations. EPA estimates that the FWS and NMFS will incur 10 hours of burden for formal consultations and 2 hours for informal consultations.

No burden is included for SWPPPs as described in Section 5( a).

Cost Estimates All cost calculations in this ICR account for labor costs only. The hourly labor rate for the Federal government is based on the following:

The hourly employment cost of Federal employees was determined using methodology established in previous ICRs. According to the U. S. Office of Personnel Management, 2002 General Schedule ( Table 2002 GS), the average annual salary of a government employee at the GS 9, Step 10 level is $ 44,783. At 2,080 hours per year, the hourly wage is $ 21.53. Assuming overhead costs of 50 percent, or $ 10.76 per hour, the fully loaded cost of employment for a federal employee is $ 32.39. Costs incurred by the Agency are presented in Table 5.

Table 5. Agency Costs Information Collection Activity Annual Burden Per Respondent ( hours) Agency Labor Cost ($/ hr) Annual Cost Per Respondent ($)

NOI processing & review 1.0 $ 32.39 $ 32.39 FWS/ NMFS informal consultation 2.0 $ 32.39 $ 64.78 FWS/ NMFS formal consultation 10.0 $ 32.39 $ 323.90 6( d) ESTIMATING THE RESPONDENT UNIVERSE AND TOTAL BURDEN AND COSTS The total burden and cost on the all respondents as a group can be calculated by multiplying the burden and cost per respondent by the number of respondents in the regulated universe.

Estimating the Universe of Construction Respondents EPA estimates that nationwide, there will be an annual average of 201,213 construction starts of five acres or more in 2003, 2004, and 2005. This number was calculated based on information contained in the Economic Analysis ( EA) for the Final Phase II Storm Water Rule. As indicated in Exhibit 3 3 of the EA, EPA estimates that there were 186,198 construction starts in 1998 that were five acres or more in size. The EPA further estimates that the number of annual construction starts increases by 1.3% per year. Using these estimates to projecting out the number of construction starts in 2003, 2004, and 2005 and averaging the number over three years, one is able to estimate that there will be an average of 201,213 construction starts per year during the course of this ICR. Storm Water Construction General Permit ICR February 20, 2003 Page 18 Estimating the NPDES Authorized State Universe To determine what percentage of the 201,213 annual construction starts take place in NPDES authorized states, where the burden of administering the program falls on the state, EPA assembled data from the U. S. Census Bureau, Table ST 2001EST 01 website at the following address: ( http:// eire. census. gov/ popest/ data/ states/ populartables/ table01. php). According to the 2000 Census, approximately 5.3 percent of the population lives in the five non NPDESauthorized states, Washington, DC, and all non NPDES authorized territories. Applying this percentage to the total universe of construction sites yields approximately 10,664 sites in non NPDES authorized states and territories, and 190,549 sites ( 94.7 percent) in NPDES authorized states and the Virgin Islands. These estimates are summarized in Table 6.

Table 6. Relative Number of Respondents Information Collection Activity Number of Annual Respondents In NPDES Authorized States NOI preparation & submittal 190,549 Development of SWPPP 190,549 Recordkeeping 190,549 In States where EPA is the Permitting Authority For sites where no ESA consultation is necessary ( 60% of starts in non NPDES authorized states) NOI preparation & submittal 6,399 Development of SWPPP 6,399 Recordkeeping 6,399 For sites where an informal ESA consultation is necessary ( 37.3% of starts in non NPDES authorized states) NOI preparation & submittal 3,978 Development of SWPPP 3,978 Recordkeeping 3,978 For sites where a formal ESA consultation is necessary ( 2.7% of starts in non NPDES authorized states) NOI preparation & submittal 288 Development of SWPPP 288 Recordkeeping 288 Total Burden and Costs Table 7 presents the estimated annual average burden and costs for construction activities. Table 8 presents the estimated annual average burden and costs for NPDES authorized states. Total burden and costs are calculated by multiplying the cost associated with each activity by the number of estimated respondents. Storm Water Construction General Permit ICR February 20, 2003 Page 19 Table 7. Total Respondent Burden and Cost Estimates Information Collection Activity Annual Number of Respondents Annual Burden Hours Per Respondent Annual Burden ( hours) Respondent Labor Cost ($/ hr) Annual Cost ($)

In NPDES Authorized States NOI preparation & submittal 190,549 1.5 285,823.5 $ 38.50 $ 11,004,205 Development of SWPPP 190,549 36.4 6,935,983.6 $ 33.42 $ 231,800,572 Recordkeeping 190,549 0.4 76,219.6 $ 20.95 $ 1,596,801 Annual Subtotal  38.3 7,298,026.7  $ 244,401,577 In States where EPA is the Permitting Authority For sites where no ESA consultation is necessary NOI preparation & submittal 6,399 1.5 9,597.9 $ 38.50 $ 369,518 Development of SWPPP 6,399 36.4 232,908.1 $ 33.42 $ 7,783,788 Recordkeeping 6,399 0.4 2,559.4 $ 20.95 $ 53,620 Annual Subtotal  38.3 245,065.4  $ 8,206,925 For sites where an informal ESA consultation is necessary NOI preparation & submittal 3,978 6.0 23,866.7 $ 38.50 $ 918,867 Development of SWPPP 3,978 36.4 144,791.2 $ 33.42 $ 4,838,921 Recordkeeping 3,978 0.4 1,591.1 $ 20.95 $ 33,334 Annual Subtotal  42.8 170,249.0  $ 5,791,122 For sites where a formal ESA consultation is necessary NOI preparation & submittal 288 20.0 5,758.7 $ 38.50 $ 221,711 Development of SWPPP 288 36.4 10,480.9 $ 33.42 $ 350,270 Recordkeeping 288 0.4 115.2 $ 20.95 $ 2,413 Annual Subtotal  56.8 16,354.8  $ 574,394 ANNUAL TOTAL   7,729,695.8  $ 258,974,019 Table 8. Total NPDES Authorized State Burden and Costs Information Collection Activity Annual Number of Respondents Burden Per Respondent ( hours) Annual Burden ( hours) Labor Cost ($/ hr) Annual Cost ($)

NOI processing & review 190,549 1.0 190,549 $ 31.20 $ 5,945,129 TOTAL 190,549  190,549  $ 5,945,129 6( e) BOTTOM LINE BURDEN HOURS AND COST TABLES The bottom line burden hours and cost are the sum of all the hours and costs incurred for all activities by construction operators, NPDES authorized states, and the Agency.

Respondent Tally This ICR calculated burden and cost for two types of respondents: 1) construction sites disturbing five acres or more, and 2) NPDES authorized states. The combined bottom line totals for the two respondent types are 201,259 respondents performing 4 information collection activities Storm Water Construction General Permit ICR February 20, 2003 Page 20 resulting in an average of 7,920,245 annual burden hours at an annual cost of $ 264,919,148. The respondent tally is presented in Table 9.

Table 9. Annual Respondent Burden and Cost Summary Respondent Type Total Number of Respondents Number of Activities Annual Burden ( hours) Average Annual Cost ($) Construction sources 201,213 3 7,729,696 $ 258,974,019 NPDES authorized states 46 1 190,549 $ 5,945,129 TOTAL 201,259 4 7,920,245 $ 264,919,148 Agency Tally Agency activities associated with information collection burden and costs are similar to those for the NPDES authorized states. The difference between the two is that the Agency has authorized 45 states and the Virgin Islands to implement the NPDES storm water program and as such, Agency burden is only included for the remaining states and territories ( as described in 6( d)).

The Agency's total burden and costs is presented in Table 10. Bottom line annual burden is 21,499 hours at an annual cost of $ 696,359.

Table 10. Total Agency Burden and Costs Information Collection Activity Annual Number of Respondents Number of Activities Annual Burden ( hours) Annual Cost ($)

NOI processing & review 10,664 1 10,664 $ 345,416 FWS/ NMFS informal consultation 3,978 1 7,956 $ 257,681 FWS/ NMFS formal consultation 288 1 2,879 $ 93,262 TOTAL 14,930 3 21,499 $ 696,359 Total Tally The sum of respondent, NPDES authorized state, and Agency bottom line totals are 7,941,744 burden hours per year at an annual cost of $ 265,615,507.

Variations in the Annual Bottom Line There will not be a significant variation in the annual respondent reporting/ recordkeeping burden or cost over the course of the clearance period.

6( f) REASONS FOR CHANGE IN BURDEN AND COST Table 11 presents the change in the respondent burden from the previous ICR for each information item covered by this ICR. The increase in applicant respondent and NPDESauthorized state burden is due to a technical correction to the methodology used to estimate the number of construction sites covered by a permit. The small decrease in Agency burden because of the use of population data to more accurately determine the ratio of construction starts in NPDES and non NPDES authorized states. Table 11 also includes data from the second Federal Register Notice for the previous ICR that was published on July 30, 1999 ( 64 FR 41416). That column Storm Water Construction General Permit ICR February 20, 2003 Page 21 presents data based on the number of construction starts using a methodology that is consistent with the methodology used in this current ICR. The burden that was approved in the previous ICR was based on an inaccurate estimation of construction starts that has since been corrected.

Table 11. Change in Annual Burden and Costs Information Collection Activity Reported Annual Burden ( hours) Change Current ICR Previous ICR Federal Register Notice from July 30, 1999 Change between Previous ICR and Current ICR Change between July 30, 1999 Federal Register Notice and Current ICR Construction Sources: NOI preparation & submittal 325,047 416,853 N/ A  91,806 N/ A Development of SWPPP 7,324,164 4,100,933 N/ A 3,223,231 N/ A Recordkeeping 80,485 45,066 N/ A 35,419 N/ A Subtotal 7,729,696 4,562,852 7,697,707 3,166,844 31,989 NPDES Authorized States NOI processing & review 190,549 190,600 N/ A  51 N/ A Subtotal 190,549 190,600 N/ A  51 N/ A Respondent Total 7,920,245 4,753,452 N/ A 3,166,793 N/ A Agency NOI processing & review 10,664 18,121 N/ A  7,457 N/ A FWS/ NMFS informal consultation 7,956 13,518 N/ A  5,562 N/ A FWS/ NMFS formal consultation 2,879 4,890 N/ A  2,011 N/ A Agency Total 21,499 36,529 N/ A  15,030 N/ A No capital operations and maintenance costs are associated with this ICR. As such the estimated capital cost of $ 2,045,000 from the previous ICR was adjusted to $ 0.

6( g) BURDEN STATEMENT Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 38.3 hours per response in NPDES authorized states and 40.5 hours per response in states and territories where EPA is the permitting authority. 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. Storm Water Construction General Permit ICR February 20, 2003 Page 22 To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OW 2003 0010, which is available for public viewing at the Water Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Water Docket is ( 202) 566 2426. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ( OW 2003 0010) and OMB control number ( 2040 0188) in any correspondence.

Table 12. Burden Statement Respondent Average Annual Burden ( hours) Construction Sources Each Construction Source in an NPDES Authorized State 38.30 Each Construction Source in a non NPDES Authorized State 40.50 Each NPDES Authorized State 4,142.37 Agency ( EPA) 21,499.21


[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Page 76997]
[FR Doc No: 2016-26631]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Cancellation of Environmental Impact Statement for the
Norfolk International Airport, Norfolk, Virginia

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of cancellation of preparation of environmental impact
statement.

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SUMMARY: The Federal Aviation Administration (FAA) announces that it
has discontinued preparation of an Environmental Impact Statement (EIS)
for the proposed construction of new Runway 5R/23L and associated
development at Norfolk International Airport, Norfolk, Virginia. The
FAA's discontinued preparation of the EIS is based upon the completion
of the first phase of the EIS. Based on the results of the first phase
(Scoping and Purpose & Need development), the FAA has determined that
the fundamental purpose and need is not supported by the current or
anticipated development needs of the Airport at this time.

FOR FURTHER INFORMATION CONTACT: Marcus Brundage, Environmental
Protection Specialist, Federal Aviation Administration, Washington
Airports District Office, 23723 Air Freight Lane, Suite 210, Dulles,
Virginia 20166; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On June 12, 2015, the FAA, published in the
Federal Register a Notice of Intent (NOI) to prepare an Environmental
Impact Statement (EIS) and hold two public scoping meetings in Norfolk
and Virginia Beach, Virginia (Volume 80, Number 113, FR 33582-33583).
The public meetings were held at the Bayside High School and at the
Holiday Inn Norfolk Airport on July 22 and 23, 2015, respectively.
    The stated purpose of the project was to ``meet relevant FAA
airfield safety standards and enhance airfield safety without reducing
runway availability.'' The proposed project included the
decommissioning and demolition of Runway 14/32, the construction of new
Runway 5R/23L and associated development at the airport, and
improvement of roadway access to the airport by realigning Robin Hood
Road. Other associated infrastructure was proposed for construction or
demolition or relocation including taxiways, lighting, hangers,
maintenance facilities, runway safety areas and runway protection
zones.
    In 2001, the FAA began preparing an EIS for similar projects based
on the need to accommodate additional operations at the airport. During
the first EIS process, the needs of the airport changed and it was
determined that the projects were no longer justified based on the
stated need and the preparation of the first EIS was cancelled. In
2013, the FAA agreed to proceed with a phased second EIS preparation to
review a similar project proposed by the Norfolk Airport Authority. The
first phase of the project consisted of consultant selection, EIS
scoping, and an analysis of the proposed project's purpose and need to
determine if the FAA should continue to the second phase, which would
be completion of the EIS and determination.
    At the conclusion of the first phase of the second EIS, the FAA
determined that the fundamental purpose and need of the projects were
not supported by the current or anticipated needs of the airport. The
FAA is now terminating the second EIS process. However, the FAA
recognizes the importance of ORF to the greater Norfolk/Hampton Roads
region and to the Commonwealth of Virginia. Moreover, the FAA agrees
that a parallel runway may still be a viable long-term plan for the
future, if and when operational demand warrants. Therefore, the FAA
continues to support the proposed runway remaining on the approved
Airport Layout Plan, as conditionally approved pending environmental
review on October 5, 2011, and protecting the associated airspace.

    Issued in Dulles, Virginia on October 28, 2016.
Matthew J. Thys,
Manager, Washington Airports District Office, Eastern Region.
[FR Doc. 2016-26631 Filed 11-3-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36862-36865]
[FR Doc No: 2015-15690]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75257; File No. SR-NASDAQ-2015-055]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Approving a Proposed Rule Change Regarding NASDAQ Last Sale Plus

June 22, 2015.

I. Introduction

    On May 11, 2015, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission''), pursuant to section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to establish a market data
product called NASDAQ Last Sale Plus (``NLS Plus''). The proposed rule
change was published for comment in the Federal Register on May 21,
2015.\3\ No comments on the proposed rule change have been received.
The Commission is publishing this Order to approve the proposed rule
change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 74972 (May 15,
2015), 80 FR 29370 (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to amend Rule 7039 (NASDAQ Last Sale Data
Feed) to include the NLS Plus data feed,

which is offered by NASDAQ OMX Information LLC.\4\ Currently, Rule 7039
contains the NASDAQ Last Sale data feed (``NLS''). NLS consists of
``NLS for NASDAQ,'' which is a real-time data channel that provides
real-time last sale information including execution price, volume, and
time for executions occurring within the NASDAQ system as well as those
reported to the FINRA/NASDAQ Trade Reporting Facility (``FINRA/NASDAQ
TRF''). NLS also consists of ``NLS for NYSE/NYSE MKT,'' which provides
real-time last sale information over a second data channel including
execution price, volume, and time for NYSE- and NYSE MKT-securities
executions occurring within the NASDAQ system as well as those reported
to the FINRA/NASDAQ TRF.\5\
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    \4\ NASDAQ OMX Information LLC is a subsidiary of The NASDAQ OMX
Group, Inc. (``NASDAQ OMX'').
    \5\ These products are available via two separate data channels.
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Content of NLS Plus

    NLS Plus contains the three last sale products offered by each of
NASDAQ OMX's three U.S. equity markets.\6\ Thus, NLS Plus includes all
transactions from all of NASDAQ OMX's equity markets, as well as the
FINRA/NASDAQ TRF data that is included in the current NLS product.
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    \6\ The NASDAQ OMX U.S. equity markets include The NASDAQ Stock
Market (``NASDAQ''),\,\ NASDAQ OMX BX (``BX''), and NASDAQ OMX PSX
(``PSX'') (together known as the ``NASDAQ OMX equity markets''). The
Exchange represents that PSX and BX will shortly file companion
proposals regarding NLS Plus. NLS includes last sale information
from the FINRA/NASDAQ TRF, which is jointly operated by NASDAQ and
FINRA. Accordingly, NASDAQ expects that FINRA will submit a proposed
change to FINRA Rule 7640A with respect to NLS Plus.
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    NLS Plus also contains cumulative consolidated volume
(``consolidated volume'') of real-time trading activity across all U.S.
exchanges for Tape C securities \7\ and 15-minute delayed information
for Tape A and Tape B securities.\8\ NLS Plus features total cross-
market volume information at the issue level, thereby providing
redistribution of consolidated volume information from the securities
information processors (``SIPs'') for Tape A, B, and C securities.
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    \7\ Tape C securities are disseminated pursuant to the NASDAQ
Unlisted Trading Privileges (``UTP'') Plan.
    \8\ Tape A and Tape B securities are disseminated pursuant to
the Security Industry Automation Corporation's (``SIAC'')
Consolidated Tape Association Plan/Consolidated Quotation System, or
CTA/CQS (``CTA'').
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    Similar to NLS, NLS Plus offers data for all U.S. equities via two
separate data channels: The first data channel reflects NASDAQ, BX, and
PSX trades with real-time consolidated volume for NASDAQ-listed
securities; and the second data channel reflects NASDAQ, BX, and PSX
trades with delayed consolidated volume for NYSE, NYSE MKT, NYSE Arca
and BATS-listed securities.\9\
---------------------------------------------------------------------------

    \9\ These NLS Plus channels are each made up of a series of
sequenced messages so that each message is variable in length based
on the message type and is typically delivered using a higher level
protocol. NLS Plus Channel 1 contains NASDAQ trades with real time
consolidated volume for NASDAQ listed (Tape C) securities. NLS Plus
Channel 2 contains NASDAQ trades with delayed (15 minutes)
consolidated volume for NYSE, NYSE Market, NYSE Arca, and BATS
listed (Tape A and Tape B) securities.
---------------------------------------------------------------------------

    In addition to last sale information, NLS Plus also disseminates
the following data elements: Trade Price, Trade Size, Sale Condition
Modifiers, Cumulative Consolidated Market Volume, End of Day Trade
Summary, Adjusted Closing Price, IPO Information, and Bloomberg ID
(together the ``data elements''). NLS Plus also features and
disseminates the following messages: Market Wide Circuit Breaker, Reg
SHO Short Sale Price Test Restricted Indicator, Trading Action, Symbol
Directory, Adjusted Closing Price, and End of Day Trade Summary
(together the ``messages'').\10\ NASDAQ states that these data elements
and messages are the same as in and are sourced from NLS, BX Last Sale,
and PSX Last Sale, except consolidated volume and Bloomberg ID, which
are sourced from other publicly accessible or obtainable resources.
---------------------------------------------------------------------------

    \10\ The Reg SHO Short Sale Price Test Restricted Indicator
message is disseminated intra-day when a security has a price drop
of 10% or more from the adjusted prior day's NASDAQ Official Closing
Price. Trading Action indicates the current trading status of a
security to the trading community, and indicates when a security is
halted, paused, released for quotation, and released for trading.
Symbol Directory is disseminated at the start of each trading day
for all active NASDAQ and non-NASDAQ-listed security symbols.
Adjusted Closing Price is disseminated at the start of each trading
day for all active symbols in the NASDAQ system, and reflects the
previous trading day's official closing price adjusted for any
applicable corporate actions; if there were no corporate actions,
however, the previous day's official closing price is used. End of
Day Trade Summary is disseminated at the close of each trading day,
as a summary for all active NASDAQ- and non-NASDAQ-listed
securities. IPO Information reflects IPO general administrative
messages from the UTP and CTA Level 1 feeds for Initial Public
Offerings for all NASDAQ- and non-NASDAQ-listed securities.
---------------------------------------------------------------------------

    Consolidated volume reflects the consolidated volume at the time
that the NLS Plus trade message is generated, and includes the volume
for the issue symbol as reported on the consolidated market data feed.
The consolidated volume is based on the real-time trades reported via
the UTP Trade Data Feed (``UTDF'') and delayed trades reported via CTA.
NASDAQ OMX calculates the real-time trading volume for its trading
venues, and then adds the real-time trading volume for the other (non-
NASDAQ OMX) trading venues as reported via the UTDF data feed. For non-
NASDAQ-listed issues, the consolidated volume is based on trades
reported via SIAC's Consolidated Tape System (``CTS'') for the issue
symbol. The Exchange calculates the real-time trading volume for its
trading venues, and then adds the 15-minute delayed trading volume for
the other (non-NASDAQ OMX) trading venues as reported via the CTS data
feed.
    The second data point that is not sourced from NLS, BX Last Sale,
and PSX Last Sale is Bloomberg ID. NASDAQ states that this composite ID
is a component of Bloomberg's Open Symbology and acts as a global
security identifier that Bloomberg assigns to securities, and is
available free of charge.\11\
---------------------------------------------------------------------------

    \11\ See http://bsym.bloomberg.com/sym/pages/bbgid-fact-sheet.pdf. http://bsym.bloomberg.com/sym/pages/NASDAQ_Adopts_BSYM.pdf.
---------------------------------------------------------------------------

    NASDAQ states that NLS Plus may be received by itself or in
combination with NASDAQ Basic.\12\ If a subscriber choses to receive
NLS Plus in combination with NASDAQ Basic, the subscriber receives all
of the elements contained in NLS Plus as well as the best bid and best
offer information provided by NASDAQ Basic.
---------------------------------------------------------------------------

    \12\ NASDAQ Basic provides the information contained in NLS,
together with NASDAQ's best bid and best offer. See NASDAQ Rule
7047.
---------------------------------------------------------------------------

    The Exchange believes that market data distributors may use the NLS
Plus data feed to feed stock tickers, portfolio trackers, trade alert
programs, time and sale graphs, and other display systems. NASDAQ notes
that NLS Plus provides investors with options for receiving market data
that parallel products currently offered by BATS and BATS Y, EDGA, and
EDGX and NYSE equity exchanges.\13\
---------------------------------------------------------------------------

    \13\ See Securities Exchange Act Release No. 73918 (December 23,
2014), 79 FR 78920 (December 31, 2014) (SR-BATS-2014-055; SR-BYX-
2014-030; SR-EDGA-2014-25; SR-EDGX-2014-25) (approving BATS One Data
Feed). See also Securities Exchange Act Release No. 73553 (November
6, 2014), 79 FR 67491 (November 13, 2014) (SR-NYSE-2014-40)
(approving NYSE Best Quote & Trades Data Feed).
---------------------------------------------------------------------------

Distribution of NLS Plus

    The Exchange states that NASDAQ OMX Information LLC distributes no
data that is not equally available to all market data vendors. NASDAQ
further states that NASDAQ OMX Information LLC has no competitive
advantage over other market data vendors as it receives

data from the exchange that is equally available to other market data
vendors, with the same information distributed to NASDAQ OMX
Information LLC at the same time it is distributed to other vendors.
    The Exchange represents that the path for distribution by the
Exchange of NLS Plus is not faster than the path for distribution that
would be used by a market data vendor to distribute an independently
created NLS Plus-like product. As such, NASDAQ states that the proposed
NLS Plus data feed is a data product that a competing market data
vendor could create and sell without being in a disadvantaged position
relative to the Exchange. In recognition that the Exchange is the
source of its own market data and with BX and PSX being equity markets
owned by NASDAQ OMX, the Exchange represents that the source of the
market data it would use to create proposed NLS Plus is available to
other vendors. The Exchange further represents that NASDAQ, BX, and PSX
will continue to make available these individual underlying data
elements, and thus, that the source of the market data that the
Exchange would use to create the proposed NLS Plus is the same as what
is available to other market data vendors.
    The Exchange states that the system creating and supporting NLS
Plus receives the individual data feeds from each of the NASDAQ OMX
equity markets and, in turn, aggregates and summarizes that data to
create NLS Plus and then distribute it to end users. The Exchange notes
that this is the same process that a competing market data vendor would
undergo should it want to create a market data product similar to NLS
Plus to distribute to its end users. The Exchange believes that a
competing market data vendor could receive the individual data feeds
from each of the NASDAQ OMX equity markets at the same time the system
creating and supporting NLS Plus would for it to create NLS Plus.
Therefore, NASDAQ believes that a competing market data vendor could
obtain the underlying data elements from the NASDAQ OMX equity markets
on the same latency basis as the system that would be performing the
aggregation and consolidation of proposed NLS Plus, and provide a
similar product to its customers with the same latency they could
achieve by purchasing NLS Plus from the Exchange. As such, the Exchange
believes it would not have any unfair advantage over competing market
data vendors with respect to NLS Plus. The Exchange notes that it would
access the underlying NLS feed from the same point as would a market
data vendor and the Exchange would not have a speed advantage. The
Exchange also represents that NLS Plus would not have any speed
advantage vis-[agrave]-vis competing market data vendors with respect
to access to end user customers.

Fees for NLS Plus

    The Exchange represents that it will file a separate proposal
regarding the NLS Plus fee structure. The Exchange also represents that
these fees will be designed to ensure that vendors could compete with
the Exchange by creating a similar product as NLS Plus. The Exchange
expects that the pricing will reflect the incremental cost of the
aggregation and consolidation function for NLS Plus, and would not be
lower than the cost to a vendor creating a competing product, including
the cost of receiving the underlying data feeds. The Exchange
represents that the pricing the Exchange would charge clients for NLS
Plus would enable a vendor to receive the underlying data feeds and
offer a similar product on a competitive basis and with no greater cost
than the Exchange. For these reasons, the Exchange believes that
vendors could readily offer a product similar to NLS Plus on a
competitive basis at a similar cost.

Miscellaneous Changes

    The Exchange also proposes two housekeeping changes. In the Rule
7039 title, the Exchange adds the phrase ``and NASDAQ Last Sale Plus''
to make it clear that the rule contains both NLS and NLS Plus. In
section (a), the Exchange adds the phrase ``NASDAQ Last Sale'' to make
it clear that section (a), (b), and (c) refers only to NLS.

III. Discussion and Commission Findings

    After carefully considering the proposal the Commission finds that
the proposed rule change is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to national
securities exchanges.\14\ In particular, the Commission finds that the
proposed rule change is consistent with the requirements of section
11A(c)(1)(C) of the Act \15\ and with Rule 603(a)(2) of Regulation NMS
thereunder,\16\ which requires that any national securities exchange,
national securities association, broker, or dealer that distributes
information with respect to quotations for or transactions in an NMS
stock to a securities information processor, broker, dealer, or other
persons shall do so on terms that are not unreasonably discriminatory.
The Commission also finds that the proposed rule change is consistent
with section 6(b)(5) of the Act, which requires that the rules of an
exchange be designed to promote just and equitable principles of trade,
remove impediments to and perfect the mechanisms of a free and open
market and a national market system and, in general, to protect
investors and the public interest, and section 6(b)(8) of the Act,
which requires that the rules of an exchange not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.\17\
---------------------------------------------------------------------------

    \14\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
    \15\ Section 11A(c)(1)(C) of the Act requires, among other
things, that no self-regulatory organization, member thereof,
securities information processor, broker or dealer make use of the
mails or any means or instrumentality of interstate commerce to
collect, process, distribute, publish or prepare for distribution or
publication any information with respect to quotations for or
transactions in any security other than an exempted security in
contravention of such rules and regulations as the Commission shall
prescribe as necessary or appropriate in the public interest, for
the protection of investors, or otherwise in furtherance of the
purposes of the Act to assure that all securities information
processors may, for purposes of distribution and publication, obtain
on fair and reasonable terms such information with respect to
quotations for and transactions in such securities as is collected,
processed, or prepared for distribution or publication by an
exclusive processor of such information acting in such capacity. 15
U.S.C. 78k-1(c)(1)(C).
    \16\ 17 CFR 242.603(a)(2).
    \17\ 15 U.S.C. 78f(b)(5) and (b)(8).
---------------------------------------------------------------------------

    The Commission notes that, to create NLS Plus, the Exchange would
use underlying data feeds that belong to the NASDAQ OMX Equity Markets:
NLS, BX Last Sale and PSX Last Sale. Accordingly, the Commission's
review of the Exchanges' proposals has focused, in particular, on
whether the proposals would result in affiliated exchanges--which are
separate self-regulatory organizations under the Act--making their data
products or services available to one another at terms (e.g., content,
pricing, or latency) that are more favorable than those available to
unaffiliated market participants.
    The Exchange represents that NLS Plus would be created using
underlying data feeds that are available for subscription by vendors.
In recognition that the Exchange is the source of its own market data
and that it is affiliated with the other NASDAQ OMX equity markets, the
Exchange also represents that it will continue to make available all of
the individual underlying feeds and that the source of the market data

they would use to create the proposed NLS Plus feed is the same as the
source available to competing vendors.
    With respect to latency, the Exchange represents that a competing
vendor could obtain the underlying data feeds on the same latency basis
as the system that would be performing the aggregation and
consolidation of the proposed NLS Plus feed and could provide the same
kind of product to its customers with the same latency they could
achieve by purchasing the NLS Plus feed from NASDAQ.\18\ The Exchange
also represents that it has designed the NLS Plus feed so that it will
have no advantages over a competing vendor with respect to the speed of
access to the underlying feeds.
---------------------------------------------------------------------------

    \18\ The Exchange represents that, in order to create NLS Plus,
the system creating and supporting NLS Plus receives the individual
data feeds from each of the NASDAQ OMX equity markets and, in turn,
aggregates and summarizes that data to create NLS Plus and then
distribute it to end users. The Exchange further represents that
this is the same process that a competing market data vendor would
undergo should it want to create a market data product similar to
NLS Plus to distribute to its end users. The Exchange also
represents that a competing market data vendor could receive the
individual data feeds from each of the NASDAQ OMX equity markets at
the same time the system creating and supporting NLS Plus would for
it to create NLS Plus. Therefore, a competing market data vendor
could obtain the underlying data elements from the NASDAQ OMX equity
markets on the same latency basis as the system that would be
performing the aggregation and consolidation of proposed NLS Plus,
and provide a similar product to its customers with the same latency
they could achieve by purchasing NLS Plus from the Exchange. The
Exchange further represents that it would access the underlying NLS
feed from the same point as would a market data vendor.
---------------------------------------------------------------------------

    With respect to pricing, although specific fees to be charged for
NLS Plus are not part of the proposed rule change, the Exchange
represents that the pricing will reflect the incremental cost of the
aggregation and consolidation function for NLS Plus, and would not be
lower than the cost to a vendor creating a competing product, including
the cost of receiving the underlying data feeds. The Exchange further
represents that the pricing it would charge clients for NLS Plus would
enable a vendor to receive the underlying data feeds and offer a
similar product on a competitive basis and with no greater cost than
the Exchange.
    Based on the Exchange's representations with respect to the
content, latency, and pricing of NLS Plus--which are central to the
Commission's analysis of the proposal--the Commission finds that the
proposal is consistent with the Act and the rules and regulations
thereunder applicable to national securities exchanges. The Commission
believes that these representations are designed to ensure that the
NASDAQ OMX equity markets, which are separate self-regulatory
organizations, do not, because of their relationship as affiliates,
offer one another products or services on a more favorable basis than
that available to other competing market participants.
    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with section 11A(c)(1)(C) of the Act and Rule
603(a)(2) of Regulation NMS thereunder,\19\ and sections 6(b)(5) and
(b)(8) of the Act.\20\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78k-1(c)(1)(C) and 17 CFR 242.603(a)(2).
    \20\ 15 U.S.C. 78f(b)(5) and (b)(8).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\21\ that the proposed rule change (SR-NASDAQ-2015-055) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
Robert W. Errett,
Deputy Secretary.
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2015-15690 Filed 6-25-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Pages 12852-12853]
[FR Doc No: 2012-5069]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0108]

Draft Guidance for Industry on Limiting the Use of Certain
Phthalates as Excipients in Center for Drug Evaluation and Research-
Regulated Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Limiting the
Use of Certain Phthalates as Excipients in CDER-Regulated Products.''
This draft guidance provides the pharmaceutical industry with the
Center for Drug Evaluation and Research's (CDER's) current thinking on
the potential human health risks associated with exposure to dibutyl
phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular,
the draft guidance recommends that the pharmaceutical industry avoid
the use of these two specific phthalates as excipients in CDER-
regulated drug and biologic products, including prescription and
nonprescription products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 31, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Laurie Muldowney, Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, Bldg.
51, Rm. 4154, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1571.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Limiting the Use of Certain Phthalates as Excipients in
CDER-Regulated Products.'' This draft guidance provides the
pharmaceutical industry with CDER's current thinking on the potential
human health risks associated with exposure to DBP and DEHP. In
particular, the draft guidance recommends that the pharmaceutical
industry avoid the use of these two specific phthalates as excipients
in CDER-regulated drug and biologic products, including prescription
and nonprescription products. The recommendations in this guidance do
not address the use of DBP or DEHP in other types of FDA-regulated
products or exposure to DBP or DEHP due to the presence of any of these
compounds as an impurity--including as a result of leaching from
packaging materials.
    Phthalate esters (phthalates) are synthetic chemicals with a broad
spectrum of uses. Phthalates are found in certain pharmaceutical
formulations, primarily as a plasticizer in enteric-coatings of solid
oral drug products to maintain flexibility, but they also may be used
for different functions in other dosage forms. Phthalates also are
found in other products for uses such as softeners of plastics,
solvents in perfumes, and additives to nail polish, as well as in
lubricants and insect repellents.
    Phthalates have been studied extensively in animals, and DBP and
DEHP have been shown to be developmental and reproductive toxicants in
laboratory animals. While the data in humans are less clear,
epidemiological studies suggest that certain phthalates may affect
reproductive and developmental outcomes. Other studies have confirmed
the presence of DBP and DEHP in amniotic fluid, breast milk, urine, and
serum.
    Data from the National Health and Nutrition Examination Survey
(NHANES) indicate widespread exposure of the general population to
phthalates. Humans are exposed to phthalates by multiple routes,
including inhalation, ingestion, and to a lesser degree absorption
through the skin. Several observational human studies have reported an
association between exposure to certain phthalates and adverse
developmental and reproductive effects. The ubiquitous presence of
phthalates in the environment and the potential consequences of human
exposure to phthalates have raised concerns, particularly in vulnerable
populations such as pregnant women and infants.
    Although the currently available human data are limited, the Agency
has determined that there is evidence that exposure to DBP and DEHP
from pharmaceuticals presents a potential risk of developmental and
reproductive toxicity. While it is recognized that drug products may
carry inherent risks, DBP and DEHP are used as excipients, and safer
alternatives are available. Therefore, the Agency recommends avoiding
the use of DBP and DEHP as excipients in CDER-regulated drug and
biologic products.
    These recommendations apply to CDER-regulated drug and biologic
products that are under development (i.e., investigational new drugs),
nonapplication products (e.g., over the counter monograph products),
and both marketed approved products and those currently under review
for marketing consideration (i.e., new drug applications, abbreviated
new drug applications, and biologics license applications).
    There are alternatives to DBP and DEHP for use as excipients in
CDER-regulated products. Manufacturers with products that contain DBP
or DEHP should consider alternative excipients and determine if the
alternative excipient they plan to use has been used in similar CDER-
approved products and at what level.
    The Inactive Ingredients Database provides information on
excipients present in FDA-approved drug products, and this information
can be helpful in developing drug products. As manufacturers
reformulate their products, the listings for DBP and DEHP will be
removed from the Inactive Ingredients Database.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on limiting the
use of certain phthalates as excipients in CDER-regulated products. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is

only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and
have been approved under OMB Control Numbers 0910-0014 and 0910-0001.

IV. Electronic Access

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

    Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5069 Filed 3-1-12; 8:45 am]
BILLING CODE 4160-01-P