            Supporting Statement for a Request for OMB Review under
                          the Paperwork Reduction Act

 1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title and Number of the Information Collection

            Title:	TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals

            EPA ICR No.:  1188.13	OMB Control No.:  2070-0038

      1(b)	Short Characterization

      Section 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2604 (see Attachment 1), authorizes EPA to determine that a use of a chemical substance is a "significant new use."  EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2).  Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a notice to EPA at least 90 days before they manufacture, import or process the substance for that use.  Regulations implementing significant new uses appear at 40 CFR part 721 (see Attachment 2).

      Once EPA receives a significant new use rule (SNUR) notice, EPA may take regulatory action under TSCA sections 5(e), 5(f), 6 or 7 to control the activities for which it has received a SNUR notice.  If EPA does not take action, TSCA section 5(g) requires EPA to explain in the Federal Register its reasons for not taking action.

      Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b).  The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707.

 2.	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection

      TSCA section 5(a)(2) provides the Office of Pollution Prevention and Toxics (OPPT) with the authority to monitor and control significant new uses of existing chemical substances.  The factors considered by the Administrator in determining a significant new use are:

      1)	The projected volume of manufacturing and processing of a chemical substance;
      2)	The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance;
      3)	The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance; and
      4)	The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

      Once the Administrator makes such a designation, the Agency proposes a Significant New Use Rule (SNUR).  If a final rule is promulgated, a person who intends to engage in a significant new use of a chemical covered by a SNUR must notify EPA of his/her intentions.  This notification, made via the Significant New Use Notice (SNUN), must occur at least 90 days prior to commencing the new use of the identified substance.  The required notice must be submitted electronically, via the Central Data Exchange (CDX), using the Agency's e-PMN software. The PMN form, which is generated by the e-PMN software, provides data on the identity of, use of, and possible exposures to the chemical substance.  In addition, the PMN form provides test data plus descriptions of health and environmental effects data based on the manufacture, processing, use, distribution in commerce, and disposal of the chemical.

      The Agency has 90 days to evaluate a SNUN once it has been received.  This evaluation focuses on the health and environmental effects of the substance's significant new use.  Should EPA find cause for concern, the Agency can take regulatory action as per TSCA sections 5(e) and 5(f).  Likewise, the Agency may extend the evaluation period by up to 90 days with good cause.  If EPA takes no action at the end of the review period, the submitter can engage in the intended new use without any restrictions.

      2(b)	Practical Utility/Users of the Data

      EPA uses this information to evaluate the health and environmental effects of the significant new use.  During the evaluation period, EPA can take further regulatory action pursuant to TSCA sections 5(e) and 5(f).  Under TSCA section 5(e), the Administrator may issue an order to prohibit or limit the manufacture, import, processing, distribution in commerce, use, or disposal of such substance.  TSCA section 5(f) allows the Administrator to, among other things, prohibit or limit the manufacture of the chemical substance, if the substance presents or will present an unreasonable risk of injury to health or the environment.

      To date, EPA has promulgated SNURs on 413 existing chemicals.

3.	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION
	CRITERIA

      3(a)	Non-Duplication

      EPA is the only federal agency that collects information on significant new uses of chemical substances.  A notification of an intent to engage in a significant new use serves two functions: as a notice, and as a document that contains information about a chemical substance and potential exposures to that substance.  The notification element is unique to SNURs and therefore not obtainable elsewhere.  The chemical information aspect will also contain unique information.  Only the person who intends to commence a significant new use of a chemical substance will know the potential for human and environmental exposures to that substance, the quantity intended to be produced, imported, or processed, and the manner in which the person will engage in the significant new use.

      A person submitting a significant new use notice is not required to develop test data.  However, the person must submit data that are known to or reasonably ascertainable by that person.  For published data the submitter need only provide a literature citation (40 CFR 720.50(d)(3)(ii)).  For existing chemicals that are related to the chemical substance that is the subject of the SNUR (e.g., impurities, byproducts), neither the published data nor a literature citation need be submitted.  Also, notices need not include information previously submitted to EPA (unless the previously submitted information was claimed confidential, in which case it must be resubmitted).

      3(b)	Public Notice Required Prior to ICR Submission to OMB

      In proposing to renew this ICR, EPA provided a 60-day public notice and comment period that ended on November 2, 2015 (80 FR 53151, September 2, 2015). EPA received two comments, from the American Chemistry Council and the Society of Chemical Manufacturers and Affiliates (SOCMA), during the comment period. Copies of the comments are included as Attachment 4, and EPA's response to the comments is found at Attachment 5.

      3(c)	Consultations

      Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB for review and approval. In accordance with this regulation, EPA submitted questions to nine parties via e-mail. The individuals contacted were:

      Mike Walls
      American Chemistry Council, Inc.
<EMAIL_ADDRESS>
      Jim Ford
      American Petroleum Institute
<EMAIL_ADDRESS>
      Brigid Klein
      Consumer Specialty Products Association
<EMAIL_ADDRESS>
      John Carroll
      Novozymes North America, Inc.
<EMAIL_ADDRESS>      Lee O. Fuller
      Independent Petroleum Association of America
<EMAIL_ADDRESS>
      Stephen R. Sides
      National Paint and Coatings Association
<EMAIL_ADDRESS>
      Jim Cooper
      National Petrochemical & Refiners Association
<EMAIL_ADDRESS>
      William Carteaux
      Society of the Plastics Industry, Inc.
<EMAIL_ADDRESS>
      Bill Allmond
      Synthetic Organic Chemical Manufacturers Association
<EMAIL_ADDRESS>
      EPA received no responses to its solicitation for consultations. A copy of EPA's consultation e-mail to the above nine potential respondents is included in Attachment 6.

      3(d)	Effects of Less Frequent Collection

      Whenever a person intends to engage in a significant new use, they must notify EPA.  This is an explicit requirement of TSCA.  TSCA section 5(a)(1)(B) states, "... no person may ... manufacture or process any chemical substance for a use which the Administrator has determined ... is a significant new use ... unless such person submits to the Administrator ...  a notice ..."  The consequence of  less frequent collection of information (i.e., requiring only the first person who intends to engage in a significant new use to submit notice) is a violation of TSCA and would allow manufacturers, importers and processors to use a substance in a manner that EPA has determined may cause significant adverse exposures to the substance without prior notification to EPA.

      3(e)	General Guidelines

      This information collection activity is necessary to implement the statutory requirements of TSCA section 5(a)(2) and is consistent with the requirements of 5 CFR 1320.6.

      EPA has developed e-PMN software for use in preparing and submitting PMNs and other TSCA section 5 notices such as SNUNs and support documents electronically to the Agency via CDX.  Note also that EPA is in the process of updating its e-PMN software so that it will more efficiently operate as a "cloud" software system rather than as a downloadable software system.  EPA's CDX is the point of entry on the Environmental Information Exchange Network (Exchange Network) for environmental data submissions to the Agency. CDX provides the capability for submitters to access their data through the use of web services.  CDX enables EPA and participating program offices to work with stakeholders - including State, tribal, and local governments and regulated industries - to enable streamlined electronic submission of data via the Internet. For more information about CDX, go to http://www.epa.gov/cdx.  The use of CDX for submission of TSCA section 5 notices and support documents is consistent with the Government Paperwork Elimination and Reduction Act (GPERA) that requires Federal agencies to provide electronic submission, maintenance, or disclosure of information, when practicable as a substitute for paper.

      3(f)	Confidentiality

      Information provided in a significant new use notice may receive confidential treatment.  TSCA section 14 allows a manufacturer, importer or processor to designate submitted information as confidential business information (CBI).  The Agency has developed a comprehensive system to prevent the unauthorized disclosure of CBI.  This system includes procedures for logging CBI in and out of designated locked file cabinets, for photocopying and transmitting CBI, and for restricting confidential information only to personnel with CBI security clearance.  No one is allowed access to CBI until they have received instructions for handling CBI.

      EPA will ensure secure transmission of SNUN data submitted through CDX via the Transport Layer Security (TLS) protocol. TLS is a widely used approach for securing Internet transactions, and is endorsed by the National Institute of Standards and Technology (NIST) for protecting data sent over the Internet. See NIST Special Publication 800 - 52 Revision 1, "Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations, (dated April 2014)" http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-52r1.pdf.  In addition, e-PMN software enables the SNUN submitter to electronically sign, encrypt, and submit reports which EPA subsequently provides back to the submitter as an unaltered copy of record. This assures the submitter that the Agency has received exactly what the submitter sent to EPA.

      Additionally, special procedures also restrict access to computerized CBI.  These security measures apply to CBI submitted by manufacturers as well as CBI generated by EPA staff in the course of their review.

      3(g)	Sensitive Questions

      This section is not applicable.  The information requested is not sensitive in nature.

4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondent NAICS Codes

      Respondents affected by this collection activity are mainly NAICS categories 325 - Chemicals and Allied Products Manufacturers and 32411- Petroleum Refining.

      4(b)	Information Requested

       (i) Data items, including record keeping requirements

      Information submitted under this collection must include, insofar as it is known to or reasonably ascertainable by the submitter, information described in TSCA section 8(a)(2) (i.e., chemical identity, use, and exposure data), as well as test data, and descriptions of other data related to the effects on health and the environment of the manufacture, processing, use, distribution in commerce, and disposal of the chemical substance (TSCA section 5(d)).  After  receipt of a notice, EPA has 90 days (extendable to 180 days) to evaluate the notice's content.

       (ii) Respondent Activities

           Only those persons who intend to engage in a significant new use of a chemical substance must submit notice of their intentions to EPA.  According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 720.50. SNUNs must be on EPA Form No. 7710 - 25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

5. 	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION
	METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities

      A significant new use rule (SNUR) on an existing chemical substance is the product of a process that is designed to develop the appropriate information-gathering collection for a substance.  This process has three major steps: Chemical Referral, Regulatory Selection, and Regulation Development.

      Step 1.  Chemical Referral:  EPA offices that have identified information-gathering or follow-up monitoring needs for a particular chemical may refer the substance to OPPT.  A systematic process has been developed for receiving and handling chemical referrals.  Offices referring substances are asked to prepare concise summaries of relevant data.  This information is used to select a regulatory approach and for rulemaking activities.
      Step 2.  The Regulatory Selection Process - Referral and Review:  Once an office has detailed its need for information, an information collection approach is determined that best satisfies that office's needs.  The rulemaking options are: a TSCA section 8(a) reporting rule, a TSCA section 8(c) call-in, a TSCA section 8(d) health and safety data reporting rule, a TSCA section 5(a)(2) SNUR, or any combination of the above.  It may also be determined that an alternative approach is more appropriate (e.g., use of existing data sources, no data-gathering at the present time, TSCA section 4 or 6 action, or referral to another office for information-gathering under a different statutory authority).

      Step 3.  Regulatory Development:  Prior to the development of a rule, the recommended rulemaking approach must be reviewed by the referring office and approved by the Office Director of OPPT.  If the recommendation is approved, then the rulemaking process begins.

      A SNUR is drafted only if it is appropriate for a particular substance that has received approval prior to the development of the rule.  The proposal then undergoes intra-agency review, OMB review and public comment.  Once a decision has been made to promulgate an information collection rule, the next decision is to determine whether a TSCA section 8(a) rule or a TSCA section 5 SNUR is most appropriate.  See Attachment 3 for selection criteria.

      5(b)	Collection Methodology and Management

      Submitters are able to generate TSCA section 5 notices, including SNUNs, using the e-PMN software available at the EPA New Chemicals Program website (https://cdx.epa.gov/ssl/pmn/download.asp).  The e-PMN software is available as a free internet download. The data being transmitted electronically via CDX is encrypted to protect CBI.  CDX is the mechanism for submission of section 5 notices to the Agency. An electronic signature will be required for TSCA section 5 notices submitted to the Agency via CDX.  Electronic signatures are granted as part of the CDX user-registration process.

      Because companies will be registered with EPA to submit their data electronically to the Agency via CDX, the Agency in turn is able to communicate electronically with submitters via CDX.  Some examples of routine communications from EPA that could go through CDX include the Acknowledgment Letter (acknowledging receipt of a submission) and the Incomplete Letter (stating why a submission has been declared incomplete).

      SNUN submitters are required to use the e-PMN software to generate section 5 notices and support documents. The e-PMN software includes many useful features for section 5 notice preparers.  One feature is a built-in validation mechanism which will alert users that information, required by regulation, is missing or potentially incorrect.  This should help reduce the number of incomplete section 5 notices, saving submitter and EPA processing resources and time.  Also, the new e-PMN software allows for the creation of a sanitized non-CBI version from the complete section 5 notices submission containing CBI.  It also allows submitters to share a draft notice within their company during the creation of a section 5 notice and to save a copy of the final file for future reference.  The software allows the submitter to create a profile with his/her contact information, which saves the submitter time in reentering that information on subsequent notices.
      In addition to support provided with the e-PMN software, OPPT has set up a TSCA Hotline that provides information regarding TSCA section 5(a)(2) reporting as well as other regulatory information.  When Hotline staff are unable to answer questions regarding TSCA section 5(a)(2), the questions are referred to the OPPT Chemical Control Division (CCD) staff for resolution.

      5(c)	Small Entity Flexibility

      All business, regardless of size, must comply with the requirements of TSCA section 5.  However, OPPT has taken a number of steps intended to minimize the burden placed on small business.  For instance, TSCA section 26(d) established an Assistance Office to provide technical and other nonfinancial assistance to manufacturers, importers and processors of chemical substances and mixtures.  This office has established a toll-free hotline, performs on-site field visits and consultations, and has hired a contractor to assist small businesses, free of charge, in complying with TSCA requirements.  Small businesses also pay a lower fee for SNUN submissions.

      5(d)	Collection Schedule

      Whenever any person intends to engage in a significant new use of a chemical substance, they are required to submit a notice of their intentions to EPA not less than 90 days before beginning to manufacture, import or process the substance for the intended use.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      This section presents estimates of the cost and burden associated with the recordkeeping and reporting requirements for significant new use rules for existing chemicals under TSCA section 5(a)(2). The methodology used to estimate the recordkeeping costs, reporting costs, and burden for this ICR renewal is largely based on previous experience with SNURs, and is consistent with the analysis presented in the supporting statement prepared for the previous ICR. This ICR is updated from the previous ICR to account for the changes in burden resulting from updated assumptions and corrections to prior analyses.

      To comply with the regulation, manufacturers (including importers) must complete the activities listed in Table 1. Table 1 also provides a cross-walk of the related Information Collection that corresponds to each activity.

Table 1: Cross-walk between Industry Activities and Related Information Collections (ICs)
Activity
Description
Related IC(s)
Chemical verification
When a SNUR is published, companies must review the rule to verify whether a chemical they manufacture or import is subject to the rule.
Chemical Verification

Rule familiarization
Site staff must familiarize themselves with the requirements of the rule. This entails reading the rule, understanding the various reporting and administrative requirements, and determining the manner in which the reporting requirements will be met.
Rule Familiarization
CDX registration, electronic signature agreement, and Pay.gov account set up
Before submitting a SNUN, all respondents must register with CDX. In addition, respondents must complete an Electronic Signature Agreement form, which is signed, dated, and either submitted electronically or mailed back to EPA, and register for a Pay.gov account.
CDX Registration Activities
Preparation of reports (form completion and form submission)
Site staff must collect all information required for a SNUN and submit an electronic SNUN form. Firms must also keep records supporting their submissions.
Prepare and Submit Report, and Maintain Records

    6(a) 	Estimating Respondent Burden

    Number of Significant New Use Notices Projected

    During the years 2012 through May 2015, EPA proposed five and finalized five existing chemical SNURs under TSCA section 5(a)(2).  EPA cannot estimate future SNUR activity with certainty.  Therefore, based on past ICRs and the best professional judgment of Agency staff, EPA is estimating it will promulgate an average of five existing chemical SNURs per year under TSCA section 5(a)(2) during the time period covered by this ICR.

      EPA may receive SNUNs as a result of SNURs.  EPA's experience is that, in response to promulgation of well over 1,000 SNURs under both its new and existing chemicals programs, the Agency receives an average of only 10 SNUNs per year, based on January 2012  -  June 2015 data. Of those SNUNs, only a small fraction result from existing chemical SNURs promulgated under section 5(a)(2).

Table 2: Anticipated Number of SNURs and SNUNs
                                     Year
                          Anticipated Number of SNURs
                          Anticipated Number of SNUNS
                                  First Year
                                       5
                                      10
                                  Second Year
                                       5
                                      10
                                  Third Year
                                       5
                                      10
                               Three Year Totals
                                      15
                                      30

      Using SNUN submission data from the three and a half year period of January 2012 through June 2015, EPA estimates that the average firm submits 1.65 SNUNs. This may be an overestimate because it was not determined whether the SNUN submissions were in response to new or existing chemical SNURs. Given the uncertainty in projecting possible new uses for existing chemicals, it is not possible to determine whether a large or small number of firms would be affected by any given SNUR. However, EPA has looked at historical data to determine the number of SNUNs submitted as well as the number of firms submitting SNUNs in the past and has estimated that a total of 6.06 firms will be impacted annually (10 SNUNs/1.65 SNUNs per firm).

 Alternative Responses

      The burden associated with a SNUR could involve a number of possible industry responses. That is, when a SNUR is promulgated, a firm seeking to engage in a new use for a subject chemical has five options regarding possible courses of action that may generate burden:

         1)	The company could submit a SNUN. This option would be chosen by any company not intending to abide by the provisions of the SNUR.

         2)	In the event that a significant new use is described as the failure to establish and implement programs for providing for the use of specific measures to control worker exposure to or release of substances, a company can request an equivalency determination. This option would be chosen if a manufacturer/importer had reason to believe that there may be alternative methods not considered by EPA that provide equivalent or superior protection from worker exposure or environmental release of the subject chemical.

         3)	The company can comply with the SNUR, ensuring that all provisions of the SNUR are implemented in connection with the planned use of the subject chemical.

         4)	The company can request review of the SNUR for possible modification or revocation.

         5)	The company may simply decide to forgo the new use, avoiding regulatory compliance activities altogether.

      Additionally, under current regulations at 40 CFR 721.5(a)(2), all manufacturers, processors, and importers of chemicals subject to SNURs are subject to certain requirements regardless of whether they engage in a significant new use unless certain information can be demonstrated.  However, without prior knowledge of chemicals which would be the subject of future SNURs, estimating the number of potentially affected entities subject to 40 CFR 721.5(a)(2) is not possible.

      The following section estimates the cost of submitting a SNUN (option 1) and then discusses the other options.

 Burden Estimates

      TSCA section 5(a)(2) imposes two requirements on industry. First, manufacturers, processors, and importers of chemicals must choose among the options mentioned above. This section presents estimates of submitting SNUNs (i.e., the first option) and then briefly discusses the other four options. Second, manufacturers, processors, and importers of chemicals covered by SNURs will incur burden and costs associated with notifying customers of the hazards posed by the covered chemical. Therefore, they must first determine if their chemical is subject to the SNUR and then must determine how to notify their customers.

      Chemical Verification

      When a SNUR is published, companies must review the rule to verify whether their chemical is subject to the rule. From 2012 to 2015, the majority of SNURs promulgated by the Agency under TSCA section 5(a) applied to new chemicals submitted to the Agency under the Premanufacture Notice Program. A total of ten SNURs applying to existing chemicals were issued during the same time period, including 5 SNURS that were finalized and an additional five SNURs that were proposed but were not finalized. These SNURs proposed to regulate an average of eight chemicals. The Agency typically notifies the manufacturer(s) of chemicals subject to a SNUR prior to its issuance. Therefore, it is estimated that no more than 0.167 hours (10 minutes) of technical labor time per chemical is used to verify that a chemical is subject to the rule. This is equivalent to 1.34 hours (0.167 hours/chemical x 8 chemicals/SNUR) per SNUR.

      Rule Familiarization

      Staff at firms who are subject to the SNUR must become familiar with the SNUR and its various requirements. In EPA's best professional judgment, rule familiarization is estimated to be equivalent to the burden for companies to become familiar with the Premanufacture Notification Electronic Reporting Rule, which requires the mandatory electronic reporting of SNUNs and other TSCA section 5 notices: 0.55 hours of technical labor and 0.27 hours of managerial labor, as described in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a).

Table 3: Rule Familiarization Burden for SNUR Submitters
                                   Activity
                                Clerical Hours
                                Technical Hours
                               Managerial Hours
                                  Total Hours

                             Rule familiarization
                                     0.00
                                     0.55
                                     0.27
                                     0.82
Note: Some burden estimate totals may not calculate due to rounding of unit burden estimates

 	CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup

      First-time submitters of any section 5 notice (including Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Test Market Exemption (TME) applications, Low Volume Exemption (LVE) notices, Low Exposure/Low Release (LoREX) exemption notices, Biotechnology Notices for genetically modified microorganisms, Notices of Commencement of Manufacture or Import (NOCs), and support documents to section 5 notices) are required to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account.  These activities are only required of first-time submitters of any section 5 notice. It is not known how many submitters of SNUNs from existing chemical SNURs will be first-time submitters of any section 5 notices; therefore, EPA assumes that all submitters will incur these costs. These activities are estimated to require the following burden, based on the estimates presented in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a):

       CDX registration: EPA estimates that companies will spend approximately 0.1833 hours per employee to register with CDX, and that an average of four technical staff members and one manager will need to register for each company, totaling approximately 0.917 hours of burden per company.
       CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee. This burden will apply to four technical staff members and one manager per company, totaling 1.25 hours of burden per company. In addition, EPA estimates that a manager will spend an additional 0.50 hours accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by companies submitting and then verifying electronic signature agreements is 1.75 hours. Note that this burden does not include any additional time required to contact EPA's CDX help desk to notify a change of submitter status, should one occur.
       Payment via Pay.gov account: EPA estimates that one manager per company will spend approximately 0.13 hours setting up a Pay.gov ID account, logging into the system, finding the appropriate form, and filling it out. This burden does not include the time required to click `submit' on the form and wait for payment processing.

Table 4: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden for First-Time Submitters
Activity
                                Clerical Hours
                                Technical Hours
                               Managerial Hours
                                  Total Hours

CDX registration
                                     0.00
                                     0.73
                                     0.18
                                     0.92
CDX electronic signature
                                     0.00
                                     1.00
                                     0.75
                                     1.75
E-payment (Pay.gov ID)
                                     0.00
                                     0.00
                                     0.13
                                     0.13
Total
                                     0.00
                                     1.73
                                     1.07
                                     2.80
Note: Some burden estimate totals may not calculate due to rounding of unit burden estimates

      Submitting a SNUN

      When submitting a SNUN, individuals at different occupational levels must spend time on the required recordkeeping and reporting activities. SNUN submitters are required to gather and submit information regarding the data elements identified in the applicable SNUN reporting form. The methodology and calculations assume that the employee responsible for collecting, filling out, and submitting the requested information has a reasonable level of familiarity with the company and knowledge of operations at the site. It is assumed that, for most entities, these tasks are similar to other employee duties that require familiarity with EPA, state, and other federal agency requests for chemical information and do not require additional familiarization or training beyond the basic rule familiarization described above.

Estimates of the burden of completing a SNUN form are based on the burden of completing a PMN submission, since the data requirements are the same and the same form is used for both. EPA has harmonized estimates of the reporting and recordkeeping burden related to the submission of both new and existing chemical SNUNs. The reporting and recordkeeping burden for Existing Chemical SNUNs is estimated to be 91.68 hours and is based on the1994 Regulatory Impact Analysis of Amendments (RIA) to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994) and has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms is expected to remove all clerical burden and reduce the recordkeeping burden associated with preparing and submitting a SNUN (EPA, 2009a). In addition, electronic submission is expected to generate an additional 0.18 hours of technical burden associated with the completion of the User Fee Payment Identification Number and email address data elements on the electronic SNUN form.

      Alternative Options

      Should a company choose to request an equivalency determination (i.e., the second option), or review for modification/revocation (i.e., the fourth option), EPA estimates that a data collection and preparation effort similar to that of a SNUN would be required, and thus the burden is estimated to range up to 91.68 hours for these alternatives, the same as for submitting a SNUN.

      In complying with a SNUR, a company would incur costs to ensure all provisions of the SNUR were implemented at the subject facility (i.e., the third option). Since the nature of such provisions will vary depending on the significant new uses identified in each respective SNUR, estimating burden at this time is not possible. In addition to costs of implementation, firms choosing this option will have minor costs associated with keeping records that document compliance with SNUR conditions for avoiding a Significant New Use. Such recordkeeping requirements may involve copying and filing relevant records, including those related to: category of use and marketing, and production volume. Records would typically be required to be maintained for five years from the date of their creation. Previous existing chemical SNUR ICRs have estimated recordkeeping requirements to be five percent of the reporting burden for a certain activity (EPA, 2009b). Per-activity burden is taken from the midpoint estimated burden of each section of the SNUN form (EPA, 1994). The recordkeeping burden per significant new use is estimated to range from 0.01 hours (0.25 * 0.05) for keeping records of trade names and chemical synonyms to 0.76 hours (15.25 * 0.05) for keeping records of sites controlled by others. The total recordkeeping burden per firm will depend on the significant new use(s) identified.

      The final alternative for a company considering a significant new use of a chemical which is the subject of a SNUR is to forgo the new use (i.e., the fifth option). In carrying out such a response, the company would incur no direct regulatory burden or costs.

      Customer Notification

      Manufacturers, processors, and importers of chemicals subject to SNURs must notify recipients of such chemicals of the SNUR or verify that knowledge of the SNUR has been otherwise acquired by recipients, or that the recipients are unable to engage in significant new uses. Since it is not expected that all such entities will have complete knowledge of all uses of any products subject to a SNUR, and because filing a SNUN could require significantly more burden, it is assumed that manufacturers, processors, and importers will most often choose to notify their customers of SNUR regulatory activities. As this notification may be accomplished by simply annotating an MSDS, EPA estimates the associated burden to be about one hour of a technical employee's time per manufacturer, processor, or importer per chemical. EPA estimates that each SNUR will cover approximately eight chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers per chemical. Therefore, the burden per SNUR is estimated to be 16 hours per SNUR.

      Summary of Unit Burdens

      The following table summarizes the burden associated with the activities required under a SNUR, under compliance option 1.
                  Table 5: Summary of Unit Burdens
Collection Activity
                            Estimated Burden Hours
Chemical verification (per SNUR)
                                     1.34
Rule Familiarization (per company)
                                     0.82
CDX registration, electronic signature, and Pay.gov account set-up (per company)
                                     2.80
SNUN preparation (per report)
                       91.68
Notifying customers (per SNUR)
                                      16

6(b)	Estimating Respondent Costs

The unit costs of filing a SNUN are estimated by monetizing the labor time spent preparing the SNUN and then adding any fixed costs associated with filing a SNUN. This section derives these unit costs.

(i) 	Wages

      EPA multiplied burden estimates by standard wage rates for managerial, technical, and clerical levels developed from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b). Wage data for the three occupational categories were gathered for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006  -  March 2015 (BLS, 2015).

      The cost of fringe benefits, such as health insurance and vacation, is taken for each labor category from the same ECEC series. Following the methodology outlined in EPA 2002b, fringe benefits are calculated as a percentage of total wages for each category. EPA added 17 percent to the wages in each category to account for overhead, based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). The wages for each of the three categories were then multiplied by benefits and overhead factors to estimate loaded, annual salaries in year 2014 dollars. Table 6 contains the loaded wage rates for the managerial, technical and clerical occupational categories.

Table 6: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in 2014$

                                    Wage[1]
                              Fringe Benefits[1]
                             Fringes as % of Wage
                             Overhead % of Wage[2]
                           Fringe + Overhead Factor
                                 Loaded Wages

                                      (a)
                                      (b)
                                 (c) = (b)/(a)
                                      (d)
                                (e)=(1)+(c)+(d)
                                (f) = (a) x (e)
Clerical
                                    $18.68
                                    $9.40
                                     50.3%
                                      17%
                                     1.67
                                    $31.26
Technical
                                    $42.19
                                    $22.86
                                     54.2%
                                      17%
                                     1.71
                                    $72.22
Managerial
                                    $47.90
                                    $24.18
                                     50.5%
                                      17%
                                     1.67
                                    $80.22
[1] Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006  -  March 2015, US Bureau of Labor Statistics, June 2015 (BLS, 2015).
[2] An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).

      (ii) 	Summary of Unit Costs

	Costs for Chemical Verification

      The Agency estimates that chemical verification will require 1.17 technical hours per SNUR. The total estimated cost per SNUR is estimated to be $96.78 (1.34 hours per SNUR x $72.22).

      Costs for Rule Familiarization

      EPA estimates rule familiarization costs will require 0.82 hours per firm and total costs are expected to be $63.62.

      Costs for CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup

      First-time submitters of any section 5 notice are required to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account. EPA estimates that companies will spend approximately $67.67 on CDX registration, $132 on completing the Electronic Signature Agreements, $2.79 mailing electronic signature agreements, and $10.69 setting up a Pay.gov account. Therefore the total expected costs associated with CDX registration, completing and mailing an electronic signature agreement and setting up a Pay.gov account is approximately $214.

Table 7: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Cost for First-Time Submitters
Activity
                         Clerical Labor ($31.26/hour)
                         Technical Labor ($72.22/hour)
                        Managerial Labor ($80.22/hour)
                               Total Labor Cost
                                    (2014$)

CDX registration
                                    $0.00
                                    $52.96
                                    $14.70
                                    $67.67
CDX electronic signature
                                    $0.00
                                    $72.22
                                    $60.17
                                     $132
Mailing cost

                                     $2.79
E-payment (Pay.gov ID)
                                    $0.00
                                    $0.00
                                    $10.69
                                    $10.69
Total
                                    $0.00
                                     $125
                                    $85.57
                                     $214

      Costs for Submitting a SNUN

      Using these labor wage rates and midpoint burden estimates presented above, EPA estimates that the labor cost associated with filing a SNUN is $6,765. In addition, SNUN filers must pay a $2,500 user fee to EPA. Thus, the total cost of filing a SNUN is approximately $9,265.

Table 8: Unit Reporting Cost Estimates, Associated with Filing a SNUN by Labor Category
                                   Activity
                         Clerical Labor ($31.26/hour)
                         Technical Labor ($72.22/hour)
                        Managerial Labor ($80.22/hour)
                               Total Labor Cost
                                    (2014$)

SNUN preparation
                                    $0.00
                                    $5,321
                                    $1,444
                                    $6,765
User fee

                                    $2,500
Total
                                    $0.00
                                    $5,321
                                    $1,444
                                    $9,265

	Alternative Responses

      As noted in section 4, five alternative responses to any particular SNUR could be chosen by firms planning to engage in significant new uses of subject chemicals. Although EPA has not projected or quantified how frequently these alternatives might be selected, the unit costs associated with each option are discussed briefly below.

      The estimated burden of requesting an equivalency determination (the second option) or review for modification/revocation (the fourth option) was judged to be similar to filing the SNUN; thus, total costs including the EPA user fee were estimated to be $9,265. However, the firm may incur additional costs in developing the data necessary to justify the alternative.  This option will be preferable to compliance with the SNUR if the total cost of obtaining EPA approval of a request is less than the costs of SNUR compliance.

      Firms choosing to comply with a SNUR (the third option), will incur costs to ensure all provisions of the SNUR were implemented at the subject facility and to implement recordkeeping. The costs of implementing provisions at a facility were not quantified for this ICR. Recordkeeping is expected to range from 0.01 hours to 0.76 hours for each significant new use. All recordkeeping activities are expected to be conducted by clerical staff; therefore, recordkeeping costs range from $0.31 to $23.75 per significant new use. The total recordkeeping burden per firm will depend on the significant new use(s) identified.

	Customer Notification

      EPA assumes that the customer notification requirement will be handled by technical labor. Section 5 of this analysis assumed that one hour of labor per chemical would be required to perform the notification, thus the unit cost of notification is estimated to be $72.22 (i.e., the hourly wage for technical labor). EPA estimates that each SNUR will cover approximately eight chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers per chemical. Therefore, the burden per SNUR is estimated to be 16 hours per SNUR ([8 chemicals per SNUR]*[1 hour per manufacturer, processor, or importer]*[2 manufacturers, processors, or importers per chemical]), and the cost per SNUR is equal to $1,156 [($72.22 per hour)*(16 hours per SNUR)].

	Summary

      Table 9 summarizes the unit costs estimated in this section. Reviewing a SNUR to verify that a chemical is included is estimated to cost $96.87 per SNUR and notifying customers is $1,156 per SNUR. The cost of completing and submitting a SNUN is approximately $9,265. EPA estimates the costs associated with rule familiarization to be $63.62 per company, and CDX registration activities to be $214 per company.

                  Table 9: Summary of Unit Costs
                              Collection Activity
                                Estimated Cost
Chemical verification (per SNUR)
                                    $96.78

Rule familiarization (per company)
                                    $63.62
CDX registration, electronic signature, and Pay.gov account set-up (per company)
                                     $214
SNUN preparation*
                                    $9,265
Notifying customers (per SNUR)
                                    $1,156

		* Includes $2,500 user fee per SNUN.

 Total Burden and Costs to Industry

      This section provides estimates of the total burden and costs imposed by the TSCA section 5(a) requirements. These estimates can be divided into five categories: chemical verification, rule familiarization, completing and submitting SNUNs, CDX registration activities, and notifying customers.

      The total cost and burden imposed on industry by TSCA section 5(a)(2) requirements can be calculated by multiplying the unit burden and cost estimates by the expected number of SNURs, SNUNs, and firms. As noted above, this analysis assumes that EPA will promulgate five SNURs and receive 10 SNUNs per year. Table 10 presents the annual burden and cost to industry. EPA estimates the total annual industry burden of existing chemical SNUR action is 1,025 hours and $99,811.

Table 10: Estimated Annual Respondent Burden and Cost
                        Information Collection Activity
                       Total Burden per Activity (hours)
                            Total Cost per Activity
                                    (2014$)
                        Total Number of Units Annually
                          Total Annual Burden (hours)
                           Total Annual Cost (2014$)
Rule familiarization (per firm)
                                     0.82
                                     $64
                                  6.06 Firms
                                      5.0
                                     $386
Preparation, submission, and recordkeeping for SNUN (per report)
                                     91.68
                                    $9,265
                                   10 SNUNs
                                      917
                                    $92,654
CDX registration, electronic signature, Pay.gov set-up  (per firm)
                                      2.8
                                     $214
                                  6.06 Firms
                                      17
                                    $1,294
Chemical verification (per SNUR)
                                     1.34
                                     $97
                                    5 SNURs
                                      6.7
                                     $484
Notifying customers (per SNUR)
                                      16
                                    $1,156
                                    5 SNURs
                                     80.0
                                    $5,778
Total Industry Burden and Cost
                                     1,025
                                   $100,595
Some burden estimate totals may not calculate due to rounding of unit burden estimates

      Table 11 presents the total burden and cost to industry over the three-year ICR period. EPA estimates the total annual industry burden of existing chemical SNUR action to be 3,076 hours and $301,784.

Table 11: Estimated Total Respondent Burden and Cost, Three Year Totals
                        Information Collection Activity
                       Total Burden per Activity (hours)
                            Total Cost per Activity
                                    (2014$)
                            Total Number of Units
                          Total Annual Burden (hours)
                           Total Annual Cost (2014$)
Rule familiarization (per firm)
                                     0.82
                                     $64
                                  18.18 Firms
                                     14.9
                                    $1,157
Preparation, submission, and recordkeeping for SNUN (per report)
                                     91.68
                                    $9,265
                                   30 SNUNs
                                     2,750
                                   $277,961
CDX registration. electronic signature, Pay.gov set-up (per firm)
                                      2.8
                                     $214
                                  18.18 Firms
                                     50.9
                                    $3,882
Chemical verification (per SNUR)
                                     1.34
                                     $97
                                   15 SNURs
                                      20
                                    $1,452
Notifying customers (per SNUR)
                                      16
                                    $1,156
                                   15 SNURs
                                      240
                                    $17,333
Total Industry Burden and Cost
                                     3,076
                                   $301,784
Some burden estimate totals may not calculate due to rounding of unit burden estimates

      Table 12 presents the annual burden by collection activity. Chemical verification is expected to have a total burden of 6.70 hours annually. Notifying consumers is expected to have a total burden of 80 hours annually. Companies are expected to incur a total burden of 4.97 hours for rule familiarization, 16.97 hours for CDX registration activities and a total of 917 hours for SNUN completion, each year.
Table 12: Annual Information Collection Tally for ICR Reporting Period (2016-2019)
                            Information Collection
                                    No. of
                                  Respondents
                         No. of Responses / Respondent
                              Responses Subtotal
                       Annual Burden Hours per Response
                       Annual Burden Hours per Activity
                              Per Firm Activities
Rule familiarization
                                     6.06
                                       1
                                     6.06
                                     0.82
                                     4.97
CDX registration activities
                                     6.06
                                       1
                                     6.06
                                     2.80
                                     16.97
    CDX registration
                                     6.06
                                       1
                                     6.06
                                     0.92
                                     5.56
    ESA
                                     6.06
                                       1
                                     6.06
                                     1.75
                                     10.61
    Pay.gov account
                                     6.06
                                       1
                                     6.06
                                     0.13
                                     0.81
Preparation, submission, and recordkeeping for SNUN
                                     6.06
                                     1.65
                                      10
                                     91.68
                                      917
                              Per SNUR Activities
Chemical verification
                                       5
                                       1
                                       5
                                     1.34
                                     6.70
Notifying customers (per SNUR)
                                      40
                                       2
                                      80
                                       1
                                     80.00
                                     Total
                                     1,025
 Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

      Table 13 presents the total burden hours for the ICR period (2016 - 2019), organized by information collection. Chemical verification is expected to result in a total burden of 20.1 hours over the three-year ICR period. Notifying consumers is expected to result in a total burden of 240 hours over the three-year ICR period. Companies are expected to incur at total of 14.91 hours in burden for rule familiarization, 50.91 hours for CDX registration activities and a total of 2,750 hours for SNUN completion, submission and recordkeeping over the three-year ICR period.

Table 13: Total Information Collection Tally for ICR Reporting Period (2016- 2019)
                            Information Collection
                                    No. of
                                  Respondents
                         No. of Responses / Respondent
                              Responses Subtotal
                        Total Burden Hours per Response
                          Total Burden Hours Subtotal
                              Per Firm Activities
Rule familiarization
                                     18.18
                                       1
                                     18.18
                                     0.83
                                     14.91
CDX registration activities
                                     18.18
                                       1
                                     18.18
                                     2.80
                                     50.91
    CDX registration
                                     18.18
                                       1
                                     18.18
                                     0.92
                                     16.67
    ESA
                                     18.18
                                       1
                                     18.18
                                     1.75
                                     31.82
    Pay.gov account
                                     18.18
                                       1
                                     18.18
                                     0.13
                                     2.42
Preparation, submission, and recordkeeping for SNUN
                                     18.18
                                     1.65
                                     30.00
                                     91.68
                                     2,750
                              Per SNUR Activities
Chemical verification
                                      15
                                       1
                                      15
                                     1.34
                                     20.1
Notifying customers (per SNUR)
                                      120
                                       2
                                      240
                                       1
                                      240
                                     Total
                                     3,076
 Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

	6(c)	Estimating Agency Burden and Cost

 SNUN Processing

      EPA's costs to review and process SNUNs are assumed to be the same as EPA costs to review PMNs. The list of review steps, estimates of extramural costs, and the percent of chemicals requiring a particular review step are derived from the costs for processing PMN submissions in Table VII-1 of EPA's Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency burden associated with processing a PMN has been adjusted to reflect burden reductions resulting from the ePMN rule that requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28). The Extramural Cost column shows costs for contractor support and other outside purchases for chemicals requiring the selected review step, and is inflated from 1993 prices using the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) data (BLS, 2011b). The not seasonally adjusted ECI for total compensation of private industry professional and related workers (Series ID CIU2010000120000I) is used because it is the only series with continuous data since 1985, and that includes professional and technical labor, which perform the majority of Agency extramural activities. Table 14 contains the derivation of inflation factors for Agency extramural costs.
  Table 14: Derivation of Inflation Factors for Agency Extramural Costs
                                     Item
                           Inflation index source[1]
                                 Starting year
                          Index for starting year (a)
                              Index for 2014
(b)
                         Inflation factor
(b)/(a)[2]
Agency extramural costs
White collar labor; equipment; supplies
BLS ECI, NSA, Total comp, Private industry, Professional and related, 4[th] Q [BLS 2015b]
                                     1993
                                     67.0
                                     122.9
                                     1.834

[1] In 2006, the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series "were rebased to December 2005 = 100 from June 1989 = 100." The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (BLS, 2006).

The "Starting year" ECI index is SIC-OCS based: ECS11102I for private industry White Collar Workers.  The index is Seasonally Adjusted (SA).

The year 2014 ECI index is NAICS-SOC based: CIU2010000120000I (B) for private industry White Collar Workers.  The index is Seasonally Adjusted (SA).

[2] Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values.  BLS CPI values were published with one decimal place through 2006 and with three decimal places after that.

      Agency labor costs are calculated based on annual federal salaries for the Washington-Baltimore area published by the Office of Personnel Management effective January 2014 (OPM, 2010). EPA assumes that, on average, a federal GS-13, Step 5 full-time equivalent (FTE) will conduct its collection and administrative activities[6]. The average salary for a GS-13 Step 5 employee was $101,914 in 2014, without fringe benefits and overhead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary of $163,062.40. Dividing the fully loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an hourly FTE wage rate of $78.40.

      Total Agency costs are expected to be $5,166, per SNUN, for submission review and processing, as shown in Table 15.

_____________________________________________________________________________________________
[6] The GS-13, Step 5 is consistent with ICR OMB Control Number 2070-0012, EPA Tracking Number 0574.13, EPA 2007.

Table 15: Agency Costs for SNUN and Other Submission Review and Processing
Review Steps
EPA staff (FTE) Cost
Extramural Cost [2]
Unweighted Cost
Pct. of Cases
Weighted Cost[3]
ePMN Burden Reduction[4]
Weighted Cost with ePMN Burden Reduction
Weighted FTE with ePMN Burden Reduction

FTE fraction
Cost per FTE [1]
FTE Total (2014$)
1993 dollars
2014 dollars

(a)
(b)
(c)=(a)*(b)
(d)
(e)
(f)=(c)+(e)
(g)
(h)=(f)*(g)
(i)
(j)=(h)*(1-(i))
(k)=(a)*(g)*(1-(i))
Pre-notice consultation
                                    0.0024
                                   $163,062
                                   $391.35
                                    $4.00
                                    $7.34
                                     $399
                                      41%
                                   $163.46
                                     0.165
                                     $136
                                     0.001
Administrative prescreen/ notice receipt/user fee
                                    0.0024
                                   $163,062
                                   $391.35
                                    $92.00
                                   $168.76
                                     $560
                                     100%
                                   $560.11
                                     0.165
                                     $468
                                     0.002
CRSS (Chemical Review and Search Strategy)
                                    0.0025
                                   $163,062
                                   $407.66
                                   $268.00
                                   $491.60
                                     $899
                                     100%
                                   $899.26
                                     0.165
                                     $751
                                     0.002
SAT (Structure Activity Team)
                                    0.0006
                                   $163,062
                                    $97.84
                                    $14.00
                                    $25.68
                                     $124
                                     100%
                                   $123.52
                                     0.165
                                     $103
                                     0.001
Engineering/Exposure
                                    0.0015
                                   $163,062
                                   $244.59
                                    $56.00
                                   $102.72
                                     $347
                                     100%
                                   $347.32
                                     0.165
                                     $290
                                     0.001
Exposure/Fate
                                    0.0008
                                   $163,062
                                   $130.45
                                    $0.00
                                    $0.00
                                     $130
                                     100%
                                   $130.45
                                     0.165
                                     $109
                                     0.001
Focus
                                    0.0009
                                   $163,062
                                   $146.76
                                    $23.00
                                    $42.19
                                     $189
                                     100%
                                   $188.95
                                     0.165
                                     $158
                                     0.001
Standard Review Functions
                                    0.0219
                                   $163,062
                                  $3,571.07
                                   $511.00
                                   $937.34
                                    $4,508
                                      29%
                                  $1,307.44
                                     0.165
                                    $1,092
                                     0.005
Division Directors Meeting
                                    0.0129
                                   $163,062
                                  $2,103.50
                                   $113.00
                                   $207.28
                                    $2,311
                                      15%
                                   $346.62
                                     0.165
                                     $289
                                     0.002
Order Development/Negotiation Review
                                    0.0171
                                   $163,062
                                  $2,788.37
                                    $22.00
                                    $40.36
                                    $2,829
                                      3%
                                    $84.86
                                     0.165
                                     $71
                                     0.000
Post Order Data Review
                                    0.0886
                                   $163,062
                                  $14,447.33
                                    $0.00
                                    $0.00
                                   $14,447
                                      3%
                                   $433.42
                                     0.165
                                     $362
                                     0.002
Order Modification
                                    0.2167
                                   $163,062
                                  $35,335.62
                                    $0.00
                                    $0.00
                                   $35,336
                                      3%
                                  $1,060.07
                                     0.165
                                     $885
                                     0.005
New Chemical SNUR Development
                                    0.0277
                                   $163,062
                                  $4,516.83
                                    $85.00
                                   $155.92
                                    $4,673
                                      7%
                                   $327.09
                                     0.165
                                     $273
                                     0.002
Notices of Commencement
                                    0.0012
                                   $163,062
                                   $195.67
                                    $40.00
                                    $73.37
                                     $269
                                      31%
                                    $83.40
                                     0.165
                                     $70
                                     0.000
FOIA (Freedom of Information Act) Requests
                                    0.0333
                                   $163,062
                                  $5,429.98
                                   $287.00
                                   $526.45
                                    $5,956
                                      1%
                                    $59.56
                                     0.165
                                     $50
                                     0.000
CBI (Confidential Business Information) Substantiation
                                    0.0004
                                   $163,062
                                    $65.22
                                    $3.00
                                    $5.50
                                     $71
                                     100%
                                    $70.73
                                     0.165
                                     $59
                                     0.000
TOTAL
                                    $6,186
                                     0.165
                                    $5,166
                                     0.026
Notes:
[1] GS-13 Step 5 salaries loaded with benefits and overhead. [2] Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993.
3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table.
[4] Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28).
Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM, 2014.

      Using the estimates of annual SNUR promulgation and SNUR notice submissions presented above, EPA's estimated costs are presented in Table 16. Processing SNUNs is estimated to cost the Agency $51,655 annually. The Agency may also incur a cost for modifying a SNUR if submitted data indicate a need for such an action. Costs to perform such a modification have not been estimated.

Table 16: Annual Agency Costs
                                   Activity
                        Total Burden per Activity (FTE)
                       Total Burden per Activity (Hours)
                        Total Cost per Activity (2014$)
                            Total Number of Units
                          Total Annual Burden (hours)
                           Total Annual Cost (2014$)
SNUN processing
                                     0.026
                                    53.30
                                    $5,166
                                   10 SNUNs
                                      533
                                    $51,655
Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

	Table 17 presents the total Agency cost for SNUN processing over the three-year ICR period, which is $154,966.

Table 17: Total Agency Costs
                                   Activity
                        Total Burden per Activity (FTE)
                       Total Burden per Activity (Hours)
                        Total Cost per Activity (2014$)
                            Total Number of Units
                          Total Annual Burden (hours)
                           Total Annual Cost (2014$)
SNUN processing
                                     0.026
                                     53.30
                                    $5,166
                                   30 SNUNs
                                     1,599
                                   $154,966
 Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

       6(d)	Reasons for Change in Burden

      There is an increase of 289 hours (from 736 hours to 1,025 hours) in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB (Request for a Non-Substantive Change to an Existing Approved Information Collection submitted September 2012). This change results from adjustment changes that updated the number of affected sites (from 4.24 to 6.06 per year), average number of SNUNs submitted annually (from 7 SNUNs to 10 SNUNS per year), from recalculating the average number of chemicals per SNUR (7 chemicals to 8 chemicals), and correcting rounding errors in the burden estimate for completing a SNUN, (92.2 hours to 91.68 hours), and rule familiarization (0.83 hours to 0.82 hours).

Table 18: Estimate of Changes in Annual Burden Hours from Previous ICR by Activity

                              Annual Burden Hours
Current OMB Inventory
                                       736
Change in Burden due to Adjustments
                                       289
    Due to correction of rounding error
                                         -4
    Updating number of sites and SNUN submissions
                                       282
    Updating average number of chemicals per SNUR
                                        11
Change in Burden due to Program Changes
                                         0
Total Change in Burden
                                      289
Total Burden
                                     1,025

	6(e)	Burden Statement

      The annual public burden for this collection of information, which is approved under OMB Control No. 2070-0038, is estimated to average approximately 16.3 hours per response. Burden is defined in 5 CFR 1320.3(b).  An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a current and valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

	The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2015-0273, which is available for online viewing at www.regulations.gov, or in person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC.  The EPA/DC 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 EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone number for the Pollution Prevention and Toxics Docket is<PHONE_NUMBER>.

	You may submit comments regarding 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. Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2015-0273 and OMB Control No. 2070-0038, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
                                  REFERENCES
     BLS, 2006. U.S. Bureau of Labor Statistics, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (April 28, 2006), at http://www.bls.gov.
BLS, 2015a. U.S. Bureau of Labor Statistics. "Employer Costs for Employee Compensation Supplementary Tables: Historic Data December 2006  -  March 2015" Accessed July 1, 2015. http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf

BLS, 2015b. Bureau of Labor Statistics. Employment Cost Index  -  Total Compensation: Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted July 1, 2015. http://data.bls.gov/cgi-bin/srgate.
EPA, 1994. U.S. EPA, Office of Pollution Prevention and Toxics,Regulatory Impacts Branch. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications.  Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9, 1994.
EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC. August 2002.
EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch, Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC: June 10, 2002.
EPA, 2007. U.S. EPA Office of Pollution Prevention and Toxics, Supporting Statement for Information Collection Request: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. OMB Control Number 2070-0012, EPA Tracking Number 0574.13, December 11, 2007.
EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule. (EPA-HQ-OPPT-2008-0296). July 13, 2009
EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics ICR No. 118.09. [Information Collection Request for] TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act, February 6, 2009.
Office of Personnel Management (OPM), 2014.  Salary Tables 2014-DCB for the Locality Pay Area of Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2014/DCB.pdf

                    ATTACHMENTS TO THE SUPPORTING STATEMENT

	Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2015-0273. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.

Attachment 1:		Toxic Substances Control Act Section 5 - 15 U.S.C. 2604

Attachment 2:	40 CFR Part 721 (Subpart A through Subpart D) - Significant New Uses of Chemical Substances

Attachment 3:	Selection Criteria -- TSCA section 8(a) Rule vs.  SNUR

Attachment 4:	Public Comments Received and EPA's Response to Public Comments

Attachment 5: 	EPA's Response to Public Comments

Attachment 6:	Copy of Consultations Message Sent by EPA to Potential Respondents


[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Page 36310]
[FR Doc No: 2016-13182]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3432]

Organon USA et al.; Withdrawal of Approval of 67 New Drug
Applications and 128 Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of October 13, 2015 (80 FR
61426). The document announced the withdrawal of approval of 67 new
drug applications (NDAs) and 128 abbreviated new drug applications from
multiple applicants, effective November 12, 2015. The document
indicated that FDA was withdrawing approval of the following two NDAs
after receiving a request from the NDA holder, Merck Sharp & Dohme
Corp. (Merck), 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889:
NDA 016096, MINTEZOL (thiabendazole) Tablets, and NDA 016097, MINTEZOL
(thiabendazole) Oral Suspension. Before withdrawal of these NDAs became
effective, Merck informed FDA that it did not want approval of the NDAs
withdrawn. Because Merck timely requested that approval of these NDAs
not be withdrawn, the approval of NDAs 016096 and 016097 is still in
effect.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, October
13, 2015, appearing on page 61426 in FR Doc. 2015-25922, the following
correction is made:
    On page 61426, in table 1, the entries for NDAs 016096 and 016097
are removed.

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13182 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P