1 1 INFORMATION COLLECTION REQUEST ( ICR) SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STRATOSPHERIC OZONE PROTECTION 1. Identification of Information Collection a) Title: Significant New Alternatives Policy ( SNAP) ( 40 CFR part 82, subpart G) ( Renewal). ICR Number 1596.06, OMB Number 2060 0226.

b) Short Characterization Title VI of the Clean Air Act Amendments of 1990 ( the Act) implements the obligation of the United States under the Montreal Protocol to phase out the use of ozone depleting substances. Section 612 of Title VI establishes as U. S. policy the requirement that Class I and Class II ozone depleting substances shall be replaced, to the maximum extent practicable, by chemicals, product substitutes, or alternative manufacturing processes that reduce overall risks to human health and the environment.

EPA developed its Significant New Alternatives Policy ( SNAP) program to fulfill the requirements of Section 612. The five major provisions of Section 612 are:

Rulemaking: Section 612( c) requires EPA to enact rules making it unlawful to replace any Class I or II substance with any substitute that the Administrator determines may present adverse effects to human health or the environment where an alternative has been identified that ( 1) reduces the overall risk to human health and the environment, and ( 2) is currently or potentially available.

Listing of Unacceptable/ Acceptable Substitutes: Section 612( c) also requires EPA to publish a list of the substitutes prohibited for specific uses. EPA must publish a corresponding list of acceptable alternatives for specific uses as well.

Petition Process: Section 612( d) grants the right for any person to petition EPA to add or delete a substance from the lists published in accordance with Section 612( c). EPA has 90 days to grant or deny a petition.

90 Day Notification: Section 612( e) authorizes EPA to require any person who produces a chemical substitute for a Class I substance to notify EPA not less than 90 days before the new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a Class I substance. The producer must also provide EPA with all unpublished health and safety studies on such substitutes.

Clearinghouse: Section 612( b)( 4) requires EPA to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use Class I and II substances. 2 2 EPA issued regulations on March 18, 1994, in 59 FR 13043, which are codified at 40 CFR part 82, subpart G ( Section 82.170 et seq.), establishing the SNAP program. EPA's major activities in the SNAP program are to review proposed substitutes based on the risk assessment criteria and the procedures set forth in the regulations, and to publish ( and update) a list of acceptable and unacceptable substitutes by end use categories.

The information required for collection under the SNAP regulations is described below in Section 4 of this statement, and is currently approved by OMB for use through October 31, 2004. EPA is in the process of publishing a notice of intention to renew this information collection request. This notice of intention will be published in the Federal Register.

The previous ICR of 2001 had the following Terms of Clearance:

This collection is approved. OMB questions the need for respondents to retain information for five years. EPA should reconsider this requirement and amend it as appropriate. OMB notes further that the cost estimate associated with this collection and reported in block 14 of the 83 I appears to be erroneous. In particular, OMB notes that the cost estimates contained in the supporting statement do not appear to be properly discounted. EPA should revise its cost estimate, also explaining how the costs have changed since the previously approved collection.

EPA has addressed each of the items. Section 3e contains a justification for retaining records. Cost estimates have been discounted per OMB guidance ( 7% discount rate). Section 6 contains additional clarification.

2. Need for and Use of the Collection a) Authority for the Collection Information required to be collected under the SNAP program is intended to fulfill the general mandate in Section 612( c) of identifying acceptable substitutes that can serve as replacements for ozone depleting substances being phased out under the Act, as well as unacceptable substances which may not be used as replacements for ozone depleting substances being phased out under the Act. Section 612 ( 42 U. S. C. 7671k) is attached as Appendix B, and EPA's implementing regulations ( 40 CFR part 82, subpart G, Sect. 82.170 et seq.) are attached as Appendix C.

b) Use/ Users of the Data EPA's Global Programs Protection Division ( GPD) will use the information submitted to evaluate the acceptability or unacceptability of the proposed alternatives for Class I and Class II ozone depleting substances.

3. Non duplication, Consultations, and Other Collection Criteria a) Non duplication 3 3 The specific information requested by this notice is not currently collected by EPA or any other government agency. Use of the TSCA/ SNAP Addendum form ( described in section 4( b) of this statement) will insure that companies participating in the Toxic Substances Control Act ( TSCA) Pre Manufacture Notice ( PMN) program will not have to duplicate their data for the SNAP program.

b) Public Notice Required Prior to ICR Submission to OMB An announcement for a public comment period for the renewal of this ICR was published in the Federal Register ( 69 FR 33383) on June 15, 2004. No comments were received on the burden published in the Federal Register.

c) Consultations In developing the regulations under the Act, EPA established an advisory committee for issues relating to stratospheric ozone. The Stratospheric Ozone Protection Advisory Committee ( STOPAC) membership included representatives from affected industries, environmental interest groups, and academics in related fields. Within the STOPAC, subcommittees were formed to look at more detailed issues. The subcommittee on the SNAP program met several times to discuss possible substitutes for ozone depleting substances, guiding principles for SNAP evaluations, and strategies to obtain information about substitutes from industry. This consultation was invaluable in developing the SNAP Information Notice form ( described below in section 4( b)). EPA also received comments on its proposed SNAP regulations, which identified the information to be collected through the SNAP program, and these comments were helpful in developing the SNAP Information Notice form.

In preparing to renew this information collection request, EPA consulted with fewer than nine actual or potential respondents to discuss estimated burden hours and costs associated with this information collection request. The respondents with whom EPA consulted are from various industries, companies, and organizations. They include: Tony Vogelsberg of Dupont Fluoroproducts ( 302) 774 1000; Bob Pfahl of Motorola/ American Electronics Association ( 847) 576 5102, Alan Miller of Uni of Maryland Center for Global Climate Change   currently with International Finance Corporation ( 202) 473 8324; Kevin Fay of Alliance for Responsible CFC Policy ( 703) 243 0344.

d) Effects of Less Frequent Collection The SNAP program has minimized the number of reporting and record keeping requirements as much as possible by requiring only a one time application, in the case of reporting requirements, or a one time record keeping.

e) General Guidelines This rule does not exceed any of the guidelines set forth in 5 CFR 1320.5( d)( 2), except for records retention for more than 3 years. Retention periods for the two SNAP record keeping requirements ( described below in section 4( b) of this statement) are not specified in Title VI of 4 4 the Act or in the SNAP regulations, but EPA requires retention of these records for five years for enforcement purposes, pursuant to statutory authority under 28 U. S. C. Section 2462, the applicable statute of limitations. Sec. 2462 states,

Except as otherwise provided by Act of Congress, an action, suit or proceeding for the enforcement of any civil fine, penalty, or forfeiture, pecuniary or otherwise, shall not be entertained unless commenced within five years from the date when the claim first accrued if, within the same period, the offender or the property is found within the United States in order that proper service may be made thereon.

f) Confidentiality and Sensitive Questions i) Confidentiality Measures to protect confidentiality of information collected under the SNAP program are based on EPA's confidentiality regulations ( 40 CFR 2.201 et seq., or Subpart B.) SNAP regulations ( at 40 CFR 82.182) describe these measures, which are also mentioned on the front page of each of the SNAP forms. Each form mentions basic information about asserting confidentiality claims, and also instructs the submitter to read the Guidance Document, which contains more detailed discussion of the procedures for confidentiality claims. ( See pages 2 4 of the Guidance Document, which, as described in section 4( b), is attached as Appendix F). These procedures are described briefly below.

Submitters may designate all or portions of their forms or petitions as confidential. EPA requires the submitters to substantiate their claim of confidentiality. The submitter is advised that, under Section 114( c) of the Act, emissions data may not be claimed as confidential. The submitter is also advised that there are further instances, described in the provisions of 40 CFR part 2, subpart B, in which confidential assertions may be reopened or denied even when confidentiality claims are initially received. The submitter will be contacted as part of such an evaluation process.

If required substantiation is not provided along with the submission of information claimed as confidential, EPA may make the information available to the public without further notice. The submitter must provide three copies of all submissions under the SNAP program, one of which contains no information claimed as confidential. The non confidential submission will be put in the public docket.

If toxicity or health and safety studies are listed as confidential, this information cannot be maintained as confidential where such data are also submitted under TSCA or FIFRA, to the extent that confidential treatment is prohibited under those statutes. However, information in a toxicity study that is not health and safety data and is not relevant to the effects of a substance on human health and the environment, e. g., discussion of process information, or proprietary blends, can be maintained as confidential subject to 40 CFR part 2, subpart B.

Information submitted as part of a joint submission to either SNAP/ TSCA or SNAP/ FIFRA must adhere to the security provisions of the program offices implementing these statutes. For such submissions, the SNAP handling of such notices will follow the security provisions under 5 5 these statutes.

ii) Sensitive Questions This section does not apply because the SNAP regulations and the associated information collection request do not seek information of a sensitive nature.

4. The Respondents and the Information Requested a) Respondents Respondents for reporting requirements, as well as for the recordkeeping requirement for the exemption for small volume use, include manufacturers, importers, formulators and processors of substitutes for ozone depleting substances. Principally, these respondents are in the following major categories of industry groups, by Standard Industry Code ( SIC) and North American Industry Classification System ( NAICS):

Manufacturers, Chemicals and Allied Products Industry SIC NAICS Plastics materials and synthetics 282 325211 Soap, cleaners, and toilet goods 284 325611 Paints and allied products 285 32551 Industrial organic chemicals 286 325191 Agricultural chemicals 287 32532 Miscellaneous chemical products 289 325998 Manufacturers, Rubber and Misc. Plastics Products Industry SIC NAICS Plastics foam products 3086 32615 6 6 Wholesale Trade Nondurable Goods Industry SIC NAICS Chemicals and allied products 516 42261 Miscellaneous nondurable products 519 42299 Respondents for the narrowed use limit recordkeeping requirement include end users of the substitutes in the following industrial sectors:

Construction Special Trade Contractors Industry SIC NAICS Plumbing, heating, and airconditioning 171 23511 Manufacturing Industrial Machinery & Equipment Industry SIC NAICS Computer and office equipment 357 334111 , 333313 Refrigeration and service machinery 358 333415 Manufacturing Electronic & Other Electric Equipment Industry SIC NAICS Electric distribution equipment 361 335311 Electric industrial apparatus 362 335312 Communications equipment 366 33421 Electronic components and accessories 367 334411 Manufacturing Transportation Equipment Industry SIC NAICS Aircraft and parts 372 336412 Ship and boat building and repairing 373 336611 Manufacturing Instruments & Related Products Industry SIC NAICS Search and navigation equipment 381 334511 7 7 Medical instruments and supplies 384 339112 Ophthalmic goods 385 339115 Services Industry SIC NAICS Services to buildings 734 56179 Computer and data processing services 737 541511 Refrigeration service and repair 7623 811412, 81131 8 8 b) Information Requested i) Data Items ( for reporting and recordkeeping requirements):

To simplify and expedite the submission and review of SNAP notices, EPA has developed the following forms and a guidance document:

 SNAP Information Notice ( Appendix D)  TSCA/ SNAP Addendum ( Appendix E)  Guidance Document for the SNAP Program Information Notice ( Appendix F)

The SNAP Information Notice is the form used in most submissions to give notice of a respondent's plans to introduce a proposed substitute into the marketplace. The TSCA/ SNAP Addendum is an abbreviated SNAP form for submissions in situations where there is joint statutory review between the TSCA PMN program and the SNAP program. The full SNAP Information Notice should be used in the case of a joint review with the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). A petition should include the same information that is requested in the SNAP Information Notice. No additional information is required for a petition. The guidance document provides further information for a respondent preparing any of these submissions.

The forms were developed to minimize the reporting burden for the submitter; however, their use is optional. Respondents with more efficient means of submitting the information are encouraged to use them. EPA has based the estimated respondent burden and cost on the use of the recommended forms; to the extent a respondent uses more efficient means to submit the data, the estimates contained in this analysis may overestimate the respondent burden and cost.

1. SNAP Information Notice/ Petition Data Items: Reference: Sections 82.176( a), 82.178, 82.180( a)( 5), 82.184( c)

The information requested on the SNAP Information Notice includes the following data items:

Name and description of the substitute. To the extent possible, the substitute should be identified by its ( 1) commercial name, ( 2) chemical name, ( 3) trade name( s), ( 4) generic name, ( 5) identification numbers ( e. g., CAS registry, NIOSH RTECS, EPA hazardous waste, OHMTADS DOT/ UN/ NA/ IMCO shipping, HSDB, NCI), ( 6) chemical formula, and ( 7) chemical structure.

Physical and chemical information. Key properties that should be included to characterize the substitute are: molecular weight; physical state; melting point; boiling point; density; odor threshold; solubility; partition coefficients ( Log Kow, Log Koc); and vapor pressure. 9 9 Substitute applications. Identification of the applications in which the substitutes are likely to be used is required. It is essential to provide a complete list of potential uses as the substitute listing required by section 612( c) is specific to application.

Process description. For each application identified, EPA is requesting available descriptive data on processing, including in place pollution controls. Such information will be helpful in characterizing workplace and environmental releases and exposures.

Ozone depletion potential. The predicted ozone depletion potential ( ODP) of substitute chemicals is requested. The submitter should also provide sufficient supporting documentation either a citation or the background information used to develop the ODP. For purposes of calculating ODP, EPA recommends the methodology used in the most recent Scientific Assessment of Ozone Depletion: 1991, which was prepared for the United Nations Environment Programme. [ 1] If a submitter is uncertain about a compound's ODP, he or she should contact EPA to receive a list of Class I and II compounds. In those few cases where a compound is believed to have an ODP but is not on this list, EPA will work directly with the submitter to determine the appropriate course of action.

Global warming potential. EPA is requesting readily available data on the total global warming potential ( GWP) of the substitute in its particular application ( e. g., as a refrigerant, foam blowing agent, etc.) The total GWP considers both direct and indirect effects. Direct effects comprise the direct global warming impacts of using a substitute. EPA is requesting that all GWPs be referenced to CO2 using the methodology recommended by the Intergovernmental Panel for Climate Change ( IPCC). [ 2] Indirect effects explicitly consider the impact on global warming arising from changes in energy consumption associated with the use of a substitute ( e. g., an alternative refrigerant). This latter measure can be identified as changes in energy efficiency or demand relative to the substitute being replaced.

Toxicity data. Information on toxicity from acute and chronic exposure by inhalation of a substitute chemical, its impurities, and its degradation products on any organism ( e. g., humans, mammals, fish, wildlife, and plants) is required. For mammals, EPA is requesting a minimum submission of the following tests to characterize substitute risks: a range finding 10 10 study, and a 90 day subchronic repeated dose study in an appropriate rodent species. For substitutes that are being evaluated as fire suppressants, a cardiotoxicity study, usually performed on a dog, is also required. Additional mammalian toxicity tests will be identified based on the substitute and application being evaluated. To sufficiently characterize aquatic toxicity concerns, both acute and chronic toxicity test results for a variety of species is required. EPA requires a minimum data set as described in " Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and their Uses," which is available through the National Technical Information Service (# PB 85 227049). Other relevant information and data summaries, such as the Material Safety Data Sheets, should also be submitted. Submission of the actual toxicity studies is most beneficial; however, it is not necessary to submit these reports if they have been supplied to EPA as part of other regulatory submissions. To assist in locating these studies, the submitter must provide a sufficiently clear citation to ensure that these studies can be located by EPA in a timely fashion. EPA requires that submitters providing information on new chemicals for joint review under TSCA and SNAP adhere to the TSCA minimum testing requirements described in TSCA section 5.

Environmental Fate and Transport. Where available, information must be submitted on the environmental fate and transport of substitutes. Such data shall include information on bioaccumulation, biodegradation, adsorption, volatility, transformation, and other data necessary to characterize movement and reaction of substitutes in the environment.

Flammability. Data on the flammability of a substitute chemical or mixture are required. Specifically, data on flash point and flammability limits are needed, as well as information on the procedures used for determining the flammability limits. For substitutes that will be used in consumer applications, documentation of testing results conducted by independent laboratories ( e. g., Underwriters Laboratories) should be submitted where appropriate. Detail on any suggested abatement techniques to minimize the risks associated with the use of flammable substances or blends should also be provided. EPA recognizes that many promising alternatives may be considered marginally flammable, but can be used safely and effectively. The information requested on this topic will help EPA make a balanced decision regarding the use of a flammable alternative, which one commenter supported.

Exposure data. The submitter should provide extant modeling or monitoring data on exposures associated with the manufacture, formulation, transport, and use of a substitute. Descriptive process information for each substitute application, as requested above, will be used to develop exposure estimates where exposure data are not readily available. Depending on the application, exposure profiles will be needed for workers, consumers, and the general population. 11 11 Environmental release data. Available data on emissions from the substitute application and equipment, as well as pollutant releases or discharge to all environmental media ( ambient air, surface water, hazardous/ solid waste), are needed to complete the risk characterization. Submitters should provide information on release locations, if known. Any information on any pollution controls used or that could be used in association with the substitute ( e. g., emissions reduction technologies, wastewater treatment, treatment of hazardous waste) and the costs of such technology are also requested.

Replacement ratio for a chemical substitute. EPA is requesting information on the replacement ratio for a chemical substitute versus the Class I or II substances being replaced. For example, in the case of a degreasing agent, how much more or less of the substitute chemical is needed? This will have an impact on the estimated incremental cost and environmental effects associated with use of the substitute.

Required changes in technoloqy. Detail on the changes in technology needed to use the alternative is requested. Such information should include a description of whether the substitute can be used in existing equipment with or without some retrofit or in new equipment. Data on the cost ( capital and operating) and estimated life of the technology modifications should also be submitted. These economic data are essential to understanding the near term potential of using an alternative.

Cost of substitute. EPA is requesting data on the expected average cost of the alternative. The cost of the substitute can be expressed, for example, in terms of $/ pound ( for a chemical substitute) or as incremental capital and operating costs associated with a retrofit or new equipment. In addition, information is needed on the expected equipment lifetime for an alternative technology. Other critical cost considerations should be identified, as appropriate. For example, it is important to understand the incremental costs associated with losses or gains in energy efficiency associated with use of a substitute relative to current experience.

Availability of substitute. EPA needs to understand the extent to which a substitute is already commercially available or the expected date at which it may become available. The timing of availability is an important factor in assessing the overall health and environmental impacts of the substitute.

Anticipated market share. Data on the anticipated near term and long term ( over the next five years) nationwide substitute sales ( not just those of the submitter) is requested. This information can be presented in several ways, for example: a percentage of existing nationwide use of Class I or Class II chemicals in a particular application; number of units/ products to be produced; or pounds of substitute sold. This information is required to assess the potential impacts related to total consumption and environmental releases.

Applicable regulations under other environmental statutes. The submitter is requested to provide information on whether the substitute( s) are regulated under other statutory authorities, in particular the Clean Water Act, Safe Drinking Water Act, the Resource Conservation and Recovery Act, the Federal Insecticide, Fungicide, and Rodenticide Act, the Toxic Substances Control Act, and other titles under the CAA. EPA will evaluate substitutes under the SNAP program subject to these existing regulatory constraints. 12 12 Information already submitted to EPA. Individuals may have already submitted information being requested in the SNAP program notice to EPA as part of past regulatory and information gathering activities. If such a situation exists, and to minimize reporting burden, the submitter should provide the following information to help locate the data already maintained at EPA: type of information submitted; the date of submission; the name of the EPA office to which the data were sent; description of the regulatory program; and a document control number, if assigned ( e. g., a PMN number). If the submitter cannot provide references to data sent previously to EPA, he or she should include all requested information in the SNAP notice.

Information already available in the literature. If any of the data needed to complete the SNAP program notice are available in the literature, the submitter should provide EPA with references for such information. Failure to provide EPA with sufficient citation, however, will delay review of the notice. Additionally, submitters are encouraged to provide copies of any literature to expedite review, particularly if the citation is from a source not readily available to EPA researchers. Any references from sources in foreign languages should be translated.

Additional information. If critical new information becomes available during the review period that may influence EPA's evaluation of a substitute, the submitter must notify EPA of the existence of such information within 10 days of learning of such data. The submitter must also inform EPA of new studies underway, even if the results will not be available within the review period.

2. TSCA/ SNAP Addendum Form Data Items: Reference: Sections 82.176( a), 82.178, 82.180( a)( 5)

EPA has identified only a few additional data elements, beyond those already required by the Premanufacture Notice ( PMN) program, that would need to be included for review under the SNAP program. For this reason, the added burden to respondent from the SNAP program, above that already required by the PMN program, is very small.

The additional data elements in the TSCA/ SNAP Addendum include:

 The ozone depletion potential,  The global warming potential,  Explicit quantification of the cost of using the substitute ( including the chemical replacement data, chemical cost data, incremental equipment expenditures needed to use the substitute, and information on the cost implications resulting from changes in energy consumption), and  Documentation of testing results regarding the flammability of substitutes that will be used in consumer applications.

If critical new information becomes available during the review period that may influence EPA's evaluation of a substitute, the submitter must notify EPA of the existence of such information within 10 days of learning of such data. The submitter must also inform EPA of new studies underway, even if the results will not be available within the review period.

3. Notification for Test Marketing Activity Data Items Reference: Section 82.176( b)( 5) 13 13 Uses of substitutes for the sole purpose of test marketing is exempt from SNAP notification requirements until 90 days prior to the introduction of such substitutes for full scale commercial sale in interstate commerce. Persons taking advantage of this exemption are, however, required to notify EPA in writing that they are conducting test marketing 30 days prior to the commencement of such marketing. Notification shall include the following data items:

 Name of the substitute  Volume used in the test marketing  Intended sector end uses  Expected duration of the test marketing period 4. Recordkeeping for Substitutes Acceptable Subject to Narrowed Use Limits Data Items Reference: Section 82.180( b)( 3)

If a substitute is listed by EPA, in a decision on a SNAP information notice, TSCA/ SNAP addendum, or petition, as acceptable subject to narrowed use limits, end users intending to use the substitute must determine that other alternatives are not technically feasible. Such end users must document the results of their evaluation and retain the results on file for the purpose of demonstrating compliance. This documentation shall include the following data items:

 Descriptions of substitutes examined and rejected  Processes or products in which the substitute is needed  Reason for rejection of other alternatives, e. g., performance, technical or safety standards  The anticipated date other substitutes will be available and projected time for switching to other available substitutes.

Respondents are required to maintain these records five years. See section 3( d) of this statement for the justification for this length of time.

5. Recordkeeping for Small Volume Use Exemption Data Items Reference: Section 82.176( b)( 3)

Within the eight principal SNAP sectors, persons introducing a substitute whose expected volume of use amounts to less than 10,000 pounds per year within a SNAP sector are exempt from notification requirements. Persons taking advantage of this exemption for small uses must maintain documentation for each substitute describing how the substitute meets this small use definition. This documentation must include the following data item:

 Annual production and sales information by sector Respondents are required to maintain these records five years. See section 3( d) of this statement for the justification for this length of time.

ii) Respondent Activities 14 14 There are five types of respondent reporting and recordkeeping activities required pursuant to Section 612 of the Act and the SNAP regulations promulgated thereunder, 40 CFR Sections 82.170 82.184:

Reporting: SNAP Information Notice/ Petition This includes the following types of activities:

 Pre submittal contact with EPA.  Prepare and submit notice or petition to EPA.  Respond to EPA requests for additional information and/ or notify EPA of additional information as it becomes available.

Reporting: TSCA/ SNAP Addendum This includes the following types of activities:

 Pre submittal contact with EPA.  Prepare and submit form to EPA.  Respond to EPA requests for additional information and/ or notify EPA of additional information as it becomes available.

Reporting: Notification for Test Marketing Activity  Compile information, and prepare and submit letter to EPA with the information.

Recordkeeping: Substitutes Acceptable Subject to Narrowed Use Limits  Assess other acceptable alternative substitutes.  Compile and prepare record of assessment.

Recordkeeping: Small Volume Uses  Assess sector sales.  Compile and prepare record of sector sales.

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

a) Agency Activities EPA activities associated with reviewing SNAP submissions consist of the following:

Pre submittal contact with respondent  Send forms and guidance document to potential respondents.  Answer questions regarding the completion of SNAP program forms and the need to submit 15 15 a SNAP notice.

Review and Communication regarding submission  Assign tracking number to SNAP notice or petition.  Review SNAP notice or petition for sufficiency of information provided, send letter of receipt, and notify submitter if additional information is required.  Review requests for confidentiality and provide appropriate protection.  Review SNAP notice or petition, and notify submitter of decision.  Review TSCA/ SNAP Addendum in detail, coordinate with TSCA office, and notify submitter of decision.  Prepare and evaluate EPA initiated changes to the SNAP determinations.

Administrative operations  Maintain administrative tracking system for all submissions.  Maintain technical clearinghouse to help users identify acceptable substitutes that are listed under the SNAP.  Prepare and publish in the Federal Register periodic notices and rulemakings to inform the public of any changes to the SNAP lists and of all pending determinations.

b) Collection Methodology and Management ( including discussion of the items mentioned in OMB's remarks in the 1994 approval of the original ICR)

EPA collects information through submission by respondents of a SNAP Information Notice, a TSCA/ SNAP Addendum, or a petition. In each case, the collection methodology is the same. EPA has 90 days from receipt of a complete submission to respond to the filing, and EPA must publish its decisions in these submissions in its periodic Federal Register notices and rulemakings.

Initially, EPA reviews each submission for completeness within 15 days of receipt of the submission. If information is incomplete, the submitter will be contacted for this information. Thus, the 15 day completeness review period begins on the date EPA receives a submission, and it ends 15 days after the date of receipt.

The 90 day review period will not commence until EPA judges the submission complete, although manufacturers of a new substitute may introduce the substitute into interstate commerce 90 days after EPA receives a submission if EPA has not already rendered an unacceptability determination. Once the 90 day review period has begun, EPA may determine that additional data are necessary, or the submitter may notify EPA of additional information, which has become available and may influence EPA's evaluation of the proposed substitute. In either case, EPA may contact the submitter to explore extending or suspending the review period, depending on the type of data and the stage of review. Thus, the 90 day review period begins on the date a complete submission is received by EPA, and it ends 90 days thereafter, unless EPA and the submitter have agreed to another date. 16 16 EPA will check data quality of each submission by its review of the data in each submission. EPA will use its existing systems for telephones and computers to process each submission. Each submission is assigned a tracking number, which will identify the submission in the public docket where non confidential versions of each submission are filed, as well as the filing system at EPA for the confidential versions of each submission. The public can get access to non confidential data in each submission by visiting the public docket maintained in Washington, DC.

There is a means for filing electronic SNAP submissions with EPA. EPA has established both a telephone " hotline" clearinghouse and an electronic clearinghouse of useful information about the SNAP program, including updated lists of acceptable and unacceptable substitutes, which helps some respondents reduce the burden of gathering information to prepare a SNAP submission.

c) Small Entity Flexibility Submission of a notice to EPA 90 days before introducing a new substitute into commerce is required by statute, regardless of the size of the submitter. The information requested in the SNAP program is necessary for EPA to evaluate the proposed substitute chemicals which will be listed as acceptable or unacceptable, depending on the evaluations. The SNAP program has directed the burden on manufacturers and formulators, rather than the end user, which greatly reduces the potential burden on small entities.

Additionally, SNAP reporting requirements provide an exemption for persons introducing a substitute whose expected volume of use amounts to less than 10,000 pounds per year within a SNAP industrial sector. This exemption reduces the potential burden on small entities, although such persons are subject to a recordkeeping requirement documenting their qualification for this exemption.

d) Collection Schedule The SNAP regulations were promulgated March 18, 1994, and collection of information as required therein commenced on that date. EPA accepts and reviews SNAP submissions as they are provided to EPA by respondents. Information in the public docket on these submissions has been available since submissions have been received.

6. Estimating the Burden and Cost of Collection a) Estimating Respondent Burden b) Estimating Respondent Costs The following tables ( 6A/ B 1 through 6A/ B 5) present estimates of annual respondent burden hours and costs for each of the respondent activities described in section 4( b)( ii), with explanations of the assumptions made in each table. All cost values are in 2004 $ and reflect inflation since the previous ICR. Labor costs are from the Bureau of Labor Statistics.

Exhibit 6A/ B 1: SNAP Information Notice/ Petition: Annual Respondent Burden and Cost 17 17 ( 1)

The following table shows estimates of respondent burden hours and costs for the first set of activities listed above in section 4( b)( ii). In making these estimates, EPA relied on its experience in ten years of implementing the SNAP program and its consultations with respondents, and made the following assumptions:

 The number of inquiries about filing a SNAP Information Notice or petition is 15 per year, of which 90% ( rounded to 14) submit the filing. The number of CBI requests is 50% of the 14 submittals. The number of filings for which additional information is required is 50% of the 14 submittals.

 Labor cost of $ 56.00 represents an average hourly rate of pay, including overhead and benefits, for a private company for labor that would be classified as " technical" time for the bulk of the effort and " clerical" time for a small part of the effort.

 Estimated start up cost is based on the cost of required toxicological data which, in 25% of SNAP filings, is a one time event incurred for the sole purpose of fulfilling SNAP requirements. EPA estimates the cost of such data ranges from $ 30,000 to $ 350,000, with more than half of respondents incurring such costs in an amount equal to or less than $ 75,000. EPA multiplied a weighted average of these costs ($ 133,610) by .25 to get an estimated average start up cost of $ 33,402 which represents the cost distributed among all respondents. This total start up cost was discounted to present value using 20 years as the useful life of the chemical for which data was collected and 7% as the discount value.

 There is no annual operating and maintenance cost associated with this reporting requirement.

Table 6A/ B 1: SNAP INFORMATION NOTICE / PETITION ( A)

Hours/

Year Resp. ( B) Labor Cost (@

$ 56/

hr) per Resp.

per Year ( C)

Annualized Startup Cost per Resp. ( D) No. of Resp. ( E) Total Hrs/ Year ( All Resp.)

( A* D) ( F)

Total Annualized Cost per Year ( All Resp.)

( C* D) ( G) Total Labor Cost per Year ( All Resp.)

( B* D) ( H) Total Cost per Yea ( All Resp.)

( F+ G)

a) Pre submittal contact with EPA Obtain form and guidance document from EPA 0.5 $ 28 $ 0 15 7.5 $ 0 $ 420 $ 420 Review form and guidance document from EPA 3 $ 168 0 $ 0 $ 0 Identify chemical and applications 0.5 $ 28 $ 0 15 7.5 $ 0 $ 420 $ 420 b) Prepare and submit form to EPA $ 0 Collect data for form 122 $ 6,832 $ 3,153 14 1708 $ 44,142 $ 95,648 $ 139,790 Prepare notification form 10 $ 560 $ 0 14 140 $ 0 $ 7,840 $ 7,840 Prepare non confidential version of form if CBI is declared 4 $ 224 $ 0 7 28 $ 0 $ 1,568 $ 1,568 c) Respond to EPA requests for add'l information and/ or notify EPA of add'l. info. $ 0 Communicate with EPA 2 $ 112 $ 0 7 14 $ 0 $ 784 $ 784 18 18 Collect data 6 $ 336 $ 0 7 42 $ 0 $ 2,352 $ 2,352 Prepare data to send to EPA 2 $ 112 $ 0 7 14 $ 0 $ 784 $ 784 Subtotals 150 $ 8,400 $ 3,153 varies but 15 is most 1,961.0 $ 44,142 $ 109,816 $ 153,958 Exhibit 6A/ B 2: TSCA/ SNAP ADDENDUM: Annual Respondent Burden and Cost ( 2)

The following table shows estimates of respondent burden hours and costs for the second set of activities listed above in section 4( b)( ii). In making these estimates, EPA relied on its experience in ten years of implementing the SNAP program and its consultations with respondents, and made the following assumptions:

 Three inquires per year come in regarding a TSCA/ SNAP Addendum. Half actually submit the filing ( rounded to 2). One CBI request comes from the 2 submittals. The number of filings for which additional information is required is 1 of the 2 submittals.

 Labor cost of $ 56.00 represents an average hourly rate of pay, including overhead and benefits, for a private company for labor that would be classified as " technical" time for the bulk of the effort and " clerical" time for a small part of the effort.

 There is no start up or operating and maintenance cost associated with the TSCA/ SNAP Addendum.

Table 6A/ B 2: TSCA/ SNAP Addendum ( A)

Hours/

Year Resp. ( B) Labor Cost (@

$ 56/

hr) per Resp.

per Year ( C) No. of Resp. ( D) Total Hrs/ Year ( All Resp.)

( A* C) ( E) Total Labor Cost per Year ( All Resp.)

( B* C)

a) Pre submittal contact with EPA Obtain form and guidance document from EPA 0.5 $ 28 3 1.5 $ 84 Review form and guidance document from EPA 3 $ 168 3 9 $ 504 Identify chemical and applications 0.5 $ 28 3 1.5 $ 84 b) Prepare and submit form to EPA Collect data for form 30 $ 1,680 2 60 $ 3,360 Prepare notification form 5 $ 280 2 10 $ 560 Prepare non confidential version of form if CBI is declared 2 $ 112 1 2 $ 112 c) Respond to EPA requests for add'l information and/ or notify EPA of add'l. info.

Communicate with EPA 1 $ 56 2 2 $ 112 Collect data 3 $ 168 2 6 $ 336 Prepare data to send to EPA 1 $ 56 2 2 $ 112 19 19 Subtotals 46 $ 2,576 varies but 3 is most 94.0 $ 5,264 Exhibit 6A/ B 3: Notification for Test Marketing Activity: Annual Respondent Burden and Cost ( 3)

The following table shows estimates of respondent burden hours and costs for the third set of activities listed above in section 4( b)( ii). In making these estimates, EPA relied on its experience in ten years of implementing the SNAP program and its consultations with respondents, and made the following assumptions:

 The number of notifications for test marketing activity is one per year, and the number of hours per notification is two.

 Labor cost of $ 56.00 represents an average hourly rate of pay, including overhead and benefits, for a private company for labor that would be classified as " technical" time for the bulk of the effort and " clerical" time for a small part of the effort.

 There is no start up or operating and maintenance cost associated with the notification.

Table 6A/ B 3: Notification for Test Marketing Activity ( A)

Hours/

year Resp. ( B) Labor Cost (@

$ 56/

hr) per resp.

per year ( C) No. of Resp. ( D) Total Hrs/ Year ( A* C) ( E) Total Labor Cost per resp.

per year ( B* C)

a) Compile information and prepare letter 2 $ 112 1 2 $ 112 Subtotal 2 $ 112 1 2 $ 112 Exhibit 6A/ B 4: Record Keeping For Substitutes Acceptable to Narrowed Used Limits: Annual Respondent Burden and Cost ( 4)

The following table shows estimates of respondent burden hours and costs for the fourth set of activities listed above in section 4( b)( ii). In making these estimates, EPA relied on its experience in ten years of implementing the SNAP program and its consultations with respondents, and made the following assumptions:

 The number of record keeping collections is 250 per year. Each collection is a one time occurrence. Users of restricted alternatives may periodically reevaluate alternatives available.

 Labor cost of $ 56.00 represents an average hourly rate of pay, including overhead and benefits, for a private company for labor that would be classified as " technical" time for the bulk of the effort and " clerical" time for a small part of the effort.

 There is no start up cost associated with the record keeping collection. 20 20 Annual operating and maintenance cost represents an estimate of cost of storage space for keeping the records.

Table 6A/ B 4: Record Keeping For Substitutes Acceptable to Narrowed Used Limits ( A) Hours/

Year Resp. ( B) Labor Cost (@

$ 56/

hr) per Resp.

per Year ( C)

Annualized Startup Cost per Resp. ( D) No. of Resp. ( E) Total Hrs/ Year ( All Resp.)

( A* D) ( F)

Total Annualized Cost per Year ( All Resp.)

( C* D) ( G) Total Labor Cost per Year ( All Resp.)

( B* D) ( H) Total Cost per Year ( All Resp.)

( F+ G)

a) Assessment of other acceptable alternatives 25 $ 1,400 $ 0 250 6,250 $ 0 $ 350,000 $ 350,000 b) Compile information and prepare recordkeeping 2 $ 112 $ 1 250 500 $ 250 $ 28,000 $ 28,250 Subtotal 27 $ 1,512 $ 1 250 6,750 $ 250 $ 378,000 $ 378,250 Exhibit 6A/ B 5: Record Keeping for Small Volume Uses: Annual Respondent Burden and Cost ( 5)

The following table shows estimates of respondent burden hours and costs for the fifth set of activities listed above in section 4( b)( ii). In making these estimates, EPA relied on its experience in ten years of implementing the SNAP program and its consultations with respondents, and made the following assumptions:

 The number of record keeping collections is 10 per year, and each collection is a one time occurrence.

 Labor cost of $ 56.00 represents an average hourly rate of pay, including overhead and benefits, for a private company for labor that would be classified as " technical" time for the bulk of the effort and " clerical" time for a small part of the effort.

 There is no start up cost associated with the record keeping collection.

 Annual operating and maintenance cost represents an estimate of cost of storage space for keeping the records.

Table 6A/ B 5: Record Keeping for Small Volume Uses: Annual Respondent Burden and Cost 21 21 ( A)

Hours/

Year Resp. ( B) Labor Cost (@

$ 56/

hr) per Resp.

per Year ( C)

Annualized Startup Cost per Resp. ( D) No. of Resp. ( E) Total Hrs/ Year ( All Resp.)

( A* D) ( F)

Total Annualized Cost per Year ( All Resp.)

( C* D) ( G) Total Labor Cost per Year ( All Resp.)

( B* D) ( H) Total Cost per Year ( All Resp.)

( F+ G)

a) Assessment of sector sales 10 $ 560 $ 0 10 100 $ 0 $ 5,600 $ 5,600 b) Compile information and prepare recordkeeping 2 $ 112 $ 1 10 20 $ 10 $ 1,120 $ 1,130 Subtotal 12 $ 672 $ 1 10 120 $ 10 $ 6,720 $ 6,730 c) Estimating Agency Burden and Costs Exhibit 6C 1: Annual Agency Burden and Costs The following table shows estimates of EPA burden hours and costs ( including the cost of contractor services) for the activities listed in section 5 above. In making these estimates, EPA made the following assumptions:

 The number of occurrences is based on the number of inquiries and submittals by respondents estimated above in tables 6A 1 and 6A 2.

 The number of EPA initiated changes in SNAP determinations is estimated to be two per year.

 The number of hours per detailed review of a TSCA/ SNAP Addendum assumes 60 hours per form.

 Labor cost is based on the annual 2004 salary for a GS 12/ Step 2 employee ($ 62,659), which is divided by 2,080 hours, the number of hours in a federal work year ( resulting in an hourly rate of $ 22.44), then multiplied by 1.6, the standard government benefits multiplication factor ( resulting in a final hourly rate of $ 48.20.)

 The cost of contractor services in the two circumstances noted in the chart is based on a percentage of the total annual cost to SPD of the contractor's charges under the respective contracts. The percentage in each case represents an estimate of the time spent by the contractor on SNAP issues as distinguished from other SPD issues not related to SNAP. The hourly rate noted in each case represents the average rate charged per hour under these contracts.

Table 6C1: EPA burden hours and costs 22 22 No. of Occurrences No. of Hours per Occurrence Total no. of Hours per Year Labor Cost (@

$ 48.20/ hr) per Year Cost of Contract Services per Year Total Cost per Year 1) Pre submittal contact w/ respondent Send forms/ guidance to potential submitters 19 0.5 9.5 $ 457.90 n/ a $ 458 Answer questions re potential submissions 19 3 57 $ 2,747.40 n/ a $ 2,747 2) Review & communication re submission Assign tracking number to submission 15 0.5 7.5 $ 361.50 n/ a $ 362 Review submission, send receipt, notify if add'l info required 15 2 30 $ 1,446.00 n/ a $ 1,446 Review CBI requests and protect as appropriate 9 4 36 $ 1,735.20 n/ a $ 1,735 Review submission in detail and notify submitter of decision 14 120 1680 $ 80,976.00 n/ a $ 80,976 Contractor assistance in reviewing submissions (@

$ 78.25/ per hr) n/ a n/ a 1422 n/ a $ 111,272 $ 111,272 Review TSCA/ SNAP Addendum in detail and notify submitter of decision 3 60 180 $ 8,676.00 n/ a $ 8,676 Prepare and evaluate EPAinitiated changes to determinations 2 40 80 $ 3,856.00 n/ a $ 3,856 3) Administrative operations Maintain system of tracking submissions on going 75 75 $ 3,615.00 n/ a $ 3,615 Maintain clearinghouse to help users on going 80 80 $ 3,856.00 n/ a $ 3,856 Contractor assistance for clearinghouse(@ $ 55/ per hr) n/ a n/ a 3701 n/ a $ 203,555 $ 203,555 Prepare FR notices and rulemakings re changes to SNAP lists 4 40 160 $ 7,712.00 n/ a $ 7,712 Totals varies varies 7518 $ 115,439.00 $ 314,827 $ 430,266 d) Estimating the Respondent Universe and Total Burden and Costs. See the tables in section 6( a) and ( b) for these estimates.

Bottom Line Burden Hours and Cost Tables 23 23 Exhibit 6E 1: Information Collection Activity: Total Estimated Respondent Burden and Cost Summary Table 6E1: Total Estimated Respondent Burden and Cost Summary No. of Respondents per year No. of Activities per year Total Hours per year Total Labor Cost per year Total Annualized Start up Costs Total Annualized O& M Costs Total Annualized Costs Total Costs SNAP Information Notice/

Petition 15 15 2,006 $ 112,336 $ 44,142 $ 0 $ 44,142 $ 156,478 TSCA/ SNAP Addendum 3 3 94 $ 5,264 $ 0 $ 0 $ 0 $ 5,264 Notification for test marketing activity 1 1 2 $ 112 $ 0 $ 0 $ 0 $ 112 Recordkeeping for Substitutes Acceptable Subject to Use Limits 250 250 6,750 $ 378,000 $ 0 $ 250 $ 250 $ 378,250 Recordkeeping for Small Volume Uses 10 10 120 $ 6,720 $ 0 $ 10 $ 10 $ 6,730 Totals 280 280 8972 $ 502,432 $ 44,142 $ 260 $ 44,402 $ 546,834 These numbers are from the subtotals of tables in 6( a) and 6( b), and are used to complete items 13 and 14 in Form 83 1.

Exhibit 6E 2: Total Estimated Agency Burden and Cost Summary Table 6E2: Total Estimated Agency Burden and Cost Summary No. of Respond ents No. of Activities Total Hours per Year Total Govt Labor Hours per Year Total Annual Govt Labor Cost (@$ 48.20/ Hr) Cost of Contract Services per Year Total Cost per Year Pre submittal contact with respondents 19 19 66.5 66.5 $ 3,205 $  $ 3,205 Review and communicate re submission 15 15 3,436 2,014 $ 97,051 $ 111,272 $ 208,322 Administrative operations varies varies 4,016 315 $ 15,183 $ 203,555 $ 218,738 Totals varies varies 7,518 2,395 $ 115,439 $ 314,827 $ 430,266 f) Reasons for Change in Burden The total number of burden hours requested for this information collection has decreased from 10,363 in 2000 to 8,972. The reason for this change in burden is the smaller number of respondents keeping records for alternatives that are subject to narrowed use limits than three years ago because of the development of new substitutes. For example, users of some restricted fire suppressants now have other options available with no restriction, and thus, no paperwork requirement. In addition, we have noticed a reduction in the number of TSCA/ SNAP addendums being filed over the past three years. EPA has taken steps to reduce paperwork burden by converting the forms for the Internet and to allow electronic filing. The 24 24 recordkeeping estimates also have been reduced.

g) Burden Statement Exhibits 6A/ B 1 through 6A/ B 5 present the average annual respondent burden for each person subject to SNAP reporting and record keeping requirements. For persons filing a SNAP Information Notice or petition, the reporting burden is estimated to average 150 hours per year. For persons filing a TSCA/ SNAP Addendum, the reporting burden is estimated to average 46 hours per year. For persons filing a notification of test marketing activity, the reporting burden is estimated to average 2 hours per year. For persons keeping records of use of a substitute subject to narrowed use limits, the recordkeeping burden is estimated to average 27 hours per year. For persons keeping records of a small volume use, the recordkeeping burden is estimated to average 12 hours per year.

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; 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.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number OAR 2004 0077, which is available for public viewing at the Air and Radiation Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, 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 Air and Radiation Docket and Information Center is ( 202) 566 1742. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number OAR 2004 0077 and OMB Control Number 2060 0226 in any correspondence.

Part B of the Supporting Statement 25 25 This part is not applicable because no statistical methods were used in collecting this information.

APPENDICES Appendix A Draft FR notice announcing request for ICR renewal Please see this draft notice as a separate document submitted with this ICR package.

Appendix B Text of Section 612 of the Clean Air Act as amended in1990 Please visit: http:// www. epa. gov/ oar/ caa/ caa612. txt Appendix C Text of SNAP Regulations, 40 CFR part 82, subpart G Please visit: http:// www. epa. gov/ ozone/ snap/ regs/ 59fr13044. html ( Subpart G is close to the bottom)

Appendix D SNAP Information Notice ( EPA Form 1265 93) ( Please see attached form)

Appendix E TSCA/ SNAP Addendum ( EPA Form 1265 94) ( Please see attached form)

Appendix F Guidance Document for the SNAP Program Information Notice ( EPA Form 1265 93( 1) ( Please see attached form)

Please note the OMB Control Number expiration date listed on the first page of the forms in Appendices D and E is incorrect. The OMB Control Number expiration date is listed as October 31, 2007. EPA plans to re print the forms with the correct OMB Control Number and expiration date pending approval of this request for extension of the ICR.


[Federal Register: January 16, 2007 (Volume 72, Number 9)]
[
Notices]
[Page 1713]
[DOCID:fr16ja07-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP98-18-027]

Iroquois Gas Transmission System, L.P.; Notice of Compliance
Filing

January 8, 2007.
    Take notice that on January 5, 2007, Iroquois Gas Transmission
System, L.P. (Iroquois) tendered for filing as part of its FERC Gas
Tariff, First Revised Volume No. 1, Substitute Original Sheet No. 6K,
to be effective on December 1, 2006.
    Iroquois states that the filing is being made in compliance with
the Commission's order issued on December 18, 2006 in the above-
referenced proceeding.
    Iroquois states that copies of its filing were served on all
jurisdictional customers and interested state regulatory agencies.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail

<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-430 Filed 1-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Rules and Regulations]
[Pages 17405-17408]
[FR Doc No: 2014-06776]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0701; Directorate Identifier 2013-NM-073-AD;
Amendment 39-17768; AD 2014-04-09]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 727 airplanes. This AD will complete certain
mandated programs intended to support the airplane reaching its limit
of validity

(LOV) of the engineering data that support the established structural
maintenance program. This AD requires repetitive inspections for
cracking of small repairs done on the vertical flange of the rib chord,
repetitive inspections for cracking along the upper fillet radius of
the rib chord, and a large repair or preventive modification if
necessary. Accomplishment of a large repair or preventive modification
terminates the actions of this AD. We are issuing this AD to prevent
cracks in the rib upper chord, which could result in the inability of
the wing structure to support the limit load condition, and consequent
loss of structural integrity of the wing.

DATES: This AD is effective May 2, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 2, 2014.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2013-
0701; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Chandraduth Ramdoss, Aerospace
Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft
Certification Office (ACO), 3960 Paramount Blvd., Suite 100, Lakewood,
CA 90712-4137, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model 727 airplanes. The NPRM published in the Federal Register on
August 27, 2013 (78 FR 52875). The NPRM proposed to require repetitive
inspections for cracking of small repairs done on the vertical flange
of the rib chord, repetitive inspections for cracking along the upper
fillet radius of the rib chord, and a large repair or preventive
modification if necessary. Accomplishment of a large repair or
preventive modification would terminate the actions of the NPRM. We are
issuing this AD to prevent cracks in the rib upper chord, which could
result in the inability of the wing structure to support the limit load
condition, and consequent loss of structural integrity of the wing.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(78 FR 52875, August 27, 2013) and the FAA's response to each comment.

Request To Remove Statement of Difference Between NPRM (78 FR 52875,
August 27, 2013) and Service Information

    Boeing requested that we revise ``Differences Between the Proposed
AD and the Service Information'' in the NPRM (78 FR 52875, August 27,
2013) to instead state that there are no differences. Boeing stated
that the NPRM specified the same type, location, and interval of the
inspections specified in Boeing Service Bulletin 727-57-0112, Revision
5, dated July 31, 1997, for a small repair.
    We find that clarification of the requirements of this final rule
is necessary in light of the information provided in Boeing Service
Bulletin 727-57-0112, Revision 5, dated July 31, 1997. The post-small-
repair inspection is described in Part III of the service information;
some of this information is provided in notes, and the description of
the area to be inspected needed slight clarification. To ensure that
operators understand that all actions specified in Part III are
required for compliance, and to give more specific direction to the
area of inspection, paragraph (g) in this final rule specifies these
actions, including the information in the notes, with slightly
different wording to describe the inspection area. Since the inspection
is a direct requirement of this final rule, there is a difference
between this AD and the service information. We have not changed this
final rule regarding this issue.

Request To Refer to a Single Service Information Source

    Paragraph (g) of the NPRM (78 FR 52875, August 27, 2013) referred
to actions specified in ``Boeing 727 Service Bulletin 57-112; or Part
III of the Accomplishment Instructions of Boeing Service Bulletin 727-
57-0112.'' Boeing stated that only one of these references is required.
Boeing added that one of the references did not follow the standard
format. Boeing therefore requested that we revise the NPRM to refer to
only ``Part III of the Accomplishment Instructions of Boeing Service
Bulletin 727-57-0112.''
    We disagree to revise the source of service information as cited in
this final rule. We are required by OFR regulations to precisely
specify all possible revisions of this service bulletin by their unique
identities. Boeing Service Bulletin 727-57-0112 has actually been
revised five times; some versions are old and were published in
Boeing's older service bulletin format. The earlier version (``Boeing
727 Service Bulletin 57-112'') does not have a separate
``Accomplishment Instructions'' section. Two citations are therefore
necessary to refer to the description of the small repair actions in
the service information. However, we have added Note 1 to paragraph (g)
of this final rule to clarify the use of the different document
citations.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the change described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 52875, August 27, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 52875, August 27, 2013).

Costs of Compliance

    We estimate that this AD affects 106 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
             Action                    Labor cost       Parts cost    Cost per product    Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Inspections (per wing)..........  6 work-hours x $85            $0  $510 per inspection  Up to $108,120 per
                                   per hour = $510                   cycle.               inspection cycle per
                                   per inspection                                         airplane.
                                   cycle.
----------------------------------------------------------------------------------------------------------------

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Large repair \1\ \2\.......................  300 work-hours x $85 per hour =             $12,139         $37,639
                                              $25,500.
Preventive modification \1\ \3\............  57 work-hours x $85 per hour =               10,614          15,459
                                              $4,845.
----------------------------------------------------------------------------------------------------------------
\1\ Cost for on-condition actions (either \2\ or \3\), per wing.
\2\ Cost for large repair, per wing.
\3\ Cost for preventive modification, per wing.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-04-09 The Boeing Company: Amendment 39-17768; Docket No. FAA-
2013-0701; Directorate Identifier 2013-NM-073-AD.

(a) Effective Date

    This AD is effective May 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 727, 727C, 727-
100, 727-100C, 727-200, and 727-200F series airplanes, certificated
in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD will complete certain mandated programs intended to
support the airplane reaching its limit of validity (LOV) of the
engineering data that support the established structural maintenance
program. We are issuing this AD to prevent cracks in the rib upper
chord, which could result in the inability of the wing structure to
support the limit load condition, and consequent loss of structural
integrity of the wing.

(f) Compliance

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

(g) Post-Repair Inspection

    For any small repair that has been done as specified in Boeing
727 Service Bulletin 57-112; or Part III of the Accomplishment
Instructions of Boeing Service Bulletin 727-57-0112: Within 3,500
flight cycles after the small repair was installed or inspected as
specified in Boeing Service Bulletin 727-57-0112, or within 18
months after the effective date of this AD, whichever occurs latest,
do a high frequency eddy current inspection for cracking of the
vertical flange of the rib chord from the inboard side, and do a
detailed (close visual) inspection for cracking along the upper
fillet radius of the rib chord, in accordance with Part III of the
Accomplishment Instructions of Boeing Service Bulletin 727-57-0112,
Revision 5, dated July 31, 1997. Repeat the inspections thereafter
at intervals not to exceed 3,500 flight cycles until accomplishment
of the repair or modification specified in paragraph (i) or (j) of
this AD.
    Note 1 to paragraph (g) of this AD: Boeing 727 Service Bulletin
57-112 and Boeing Service Bulletin 727-57-0112 are both versions of
the same document. The formatting of service bulletins was revised
by Boeing following publication of Boeing 727 Service Bulletin 57-
112, Revision 1, dated April 23, 1976. Boeing Service Bulletin 727-
57-0112, Revision 2, dated May 19, 1988, was published using
Boeing's revised formatting.

(h) Inspection Definition

    For the purposes of this AD, a detailed inspection is an
intensive examination of a specific item, installation, or assembly
to detect damage, failure, or irregularity. Available lighting is
normally supplemented with a direct source of good lighting at an

intensity deemed appropriate. Inspection aids such as mirror,
magnifying lenses, etc., may be necessary. Surface cleaning and
elaborate procedures may be required.

(i) Corrective Action for Cracks

    If any crack is found during any inspection required by
paragraph (g) of this AD, before further flight, do either action
specified in paragraph (i)(1) or (i)(2) of this AD. Accomplishment
of either action terminates the requirements of paragraph (g) of
this AD.
    (1) Do a large repair, in accordance with Part IV of the
Accomplishment Instructions of Boeing Service Bulletin 727-57-0112,
Revision 5, dated July 31, 1997.
    (2) Do a preventive modification, in accordance with Part V of
the Accomplishment Instructions of Boeing Service Bulletin 727-57-
0112, Revision 5, dated July 31, 1997.

(j) Optional Terminating Action

    Accomplishment of the actions specified in either paragraph
(j)(1) or (j)(2) of this AD terminates the requirements of
paragraphs (g) and (i) of this AD.
    (1) A large repair, in accordance with Part IV of the
Accomplishment Instructions of Boeing Service Bulletin 727-57-0112,
Revision 5, dated July 31, 1997. Any crack found must be repaired
before further flight using a method approved in accordance with the
procedures specified in paragraph (l) of this AD.
    (2) A preventive modification, in accordance with Part V of the
Accomplishment Instructions of Boeing Service Bulletin 727-57-0112,
Revision 5, dated July 31, 1997. Any crack found must be repaired
before further flight using a method approved in accordance with the
procedures specified in paragraph (l) of this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for the inspections, large
repair, and modification specified in this AD, if those actions were
performed before the effective date of this AD using Boeing Service
Bulletin 727-57-0112, Revision 4, dated October 29, 1992.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (m) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.

(m) Related Information

    For more information about this AD, contact Chandraduth Ramdoss,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office (ACO), 3960 Paramount Blvd., Suite
100, Lakewood, CA 90712-4137, phone:<PHONE_NUMBER>; fax: 562-627-
5210; email<EMAIL_ADDRESS>
(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.

(i) Boeing Service Bulletin 727-57-0112, Revision 5, dated July 31,
1997.
(ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on February 14, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-06776 Filed 3-27-14; 8:45 am]
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[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11716-11717]
[FR Doc No: 2022-04155]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0836]

Pre-Launch Activities Importation Requests; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Pre-Launch
Activities Importation Requests (PLAIR).'' This guidance finalizes and
updates the draft guidance of the same title issued on July 24, 2013.
This guidance finalizes FDA's approach for overseeing requests
regarding the importation of unapproved finished dosage form drug
products by applicants preparing products for market launch based on
anticipated approval of a pending new drug application (NDA) or an
abbreviated new drug application (ANDA). This guidance also applies to
biologics licensing applications (BLAs) regulated by the Center for
Drug Evaluation and Research. This guidance further describes the
procedures for making these requests and FDA's actions on such
requests. Finalizing this policy will help increase efficiencies in
ensuring timely access to drug products upon approval.

DATES: The announcement of the guidance is published in the Federal
Register on March 2, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-0836 for ``Pre-Launch Activities Importation Requests
(PLAIR).'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as

``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Kathleen Joyce, Center for Drug
Evaluation and Research, Bldg. 51, Rm. 4236, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130, [email protected], or PLAIR Program, Office of
Drug Security, Integrity and Recalls (ODSIR), [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Pre-Launch Activities Importation Requests (PLAIR).''
Historically, when applicants with a pending NDA, ANDA, or CDER-
regulated BLA sought to import unapproved finished dosage form drug
products into the United States in preparation for market launch, we
considered such requests, informally referred to as ``PLAIRs,'' on a
case-by-case basis. In July 2013, FDA issued a draft guidance
announcing the Agency's approach for overseeing the import of some
unapproved finished dosage form drug products regulated by CDER prior
to their approval to facilitate the availability of those products to
patients upon approval. This guidance largely tracks the July 2013
draft guidance.
    An applicant with a pending NDA, ANDA, or BLA that is nearing an
FDA decision may submit a PLAIR to FDA seeking permission to import the
unapproved finished dosage form drug product that is the subject of the
application to prepare the product for market launch. If FDA grants the
PLAIR, FDA intends to detain the unapproved finished dosage form drug
product when the product covered by the PLAIR is offered for import.
FDA will, however, consider the PLAIR submission to mean that the owner
or consignee has requested to recondition the drug, as specified in the
PLAIR request. FDA will thus detain the drug for up to 6 months pending
a decision on the underlying application. The Agency will release the
drug product if, and when, FDA approves the underlying NDA, BLA, or
ANDA within 6 months and the conditions of the PLAIR are otherwise met.
If FDA refuses to approve the application or 6 months otherwise elapse
without FDA approval, FDA may determine that the product is subject to
refusal.
    FDA's granting of a PLAIR does not represent an implicit or
explicit statement of the approvability of the application. Rather,
PLAIR facilitates the process of importing unapproved finished dosage
form products to prepare for market launch based on the anticipated
approval by FDA of the pending application. The PLAIR guidance outlines
which products the PLAIR program covers, what information should be
submitted to FDA in a PLAIR, when and how we recommend submitting a
PLAIR, and the process for FDA's action on a PLAIR.
    FDA considered comments received on the draft guidance as the
guidance was finalized. One change we made in response to comments was
to include recommended timeframes for earlier submission of certain
PLAIR-eligible products subject to priority review.
    This guidance finalizes the draft guidance entitled ``Pre-Launch
Activities Importation Requests (PLAIR)'' issued on July 24, 2013 (78
FR 44572) and is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Pre-Launch Activities Importation Requests
(PLAIR).'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The time
required to complete this information collection is estimated to
average 16 hours for the first submission, including the time to review
instructions. We expect any additional PLAIRs submitted by the same
firm to take less time. The collections of information pertaining to
FDA's Pre-Launch Activities Importation Requests have been approved
under OMB control number 0910-0046. The guidance also refers to other
previously approved FDA collections of information. The collections of
information in 21 CFR part 314 relating to new drug applications and
abbreviated new drug applications have been approved under OMB control
number 0910-0001; the collections of information in part 601 relating
to biologics license applications have been approved under OMB control
number 0910-0338; the collections of information in 21 CFR part 207
relating to domestic and foreign facility registration, including
assignment of a national drug code, have been approved under OMB
control number 0910-0045; and the collections of information in parts
210 and 211 pertaining to current good manufacturing practice
requirements have been have been approved under OMB control number
0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04155 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P