                                                              RCRA REVISION CHECKLIST 207 and 207.1                      Uniform Hazardous Waste Manifest Rule                              70 FR 10776  -  10825                                  March 4, 2005                        (RCRA Cluster XV, HSWA/Non-HSWA)                                                           As amended on June 16, 2005 at 70 FR 35034                                            1)  A correction was made to this rule at 70 FR 35034 (June 16, 2005).  The sections affected are: 40 CFR 262.20(a)(2), 262.33, the Manifest form and continuation sheet, 264.72(e)(4) and 265.72(e)(4).  States are encouraged to adopt the correction at the same time that the March 4, 2005 provisions are adopted.  Those states that will incorporate the July 1, 2005 Code of Federal Regulations by reference, should include language that references or otherwise includes the correction published in the Federal Register on June 16, 2005 to ensure accuracy of regulations.

   2) As noted in a May 14, 2007 memorandum from Matt Hale, Director of the Office of Solid Waste, in 40 CFR 264.72(f)(2) and 265.72(f)(2), the March 4, 2005 final rule in advertently requires the designated facility to enter the generator's name and mailing address in Item 5 of the manifest.  Designated facilities should enter their own information in Item 5 of the manifest in cases of rejected shipments.  This checklist reflects the correction of this error.        3) States are encouraged to adopt these provisions and begin implementing them while seeking authorization.

Note that revisions to 262.27 were promulgated pursuant to HSWA.                                           Name of State:  Washington

State Statutory Authority:  70.105 RCW

Title of Regulations: Chapter 173-303 WAC             Effective Date:  July 31, 2009

Date Checklist Completed:  May 10, 2010

                             FEDERAL REQUIREMENTS                              FEDERAL RCRA CITATION                            ANALOGOUS STATE CITATION                                  WAC 173-303-                                STATE ANALOG IS:

                                  EQUIV-ALENT LESS STRIN-GENT                                 MORE STRIN-GENT                                BROADER IN SCOPE             PART 260  -  HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL                            SUBPART B -- DEFINITIONS DEFINITIONS amended by removing "Manifest document number," revising "Designated facility" and "Manifest," and adding "Manifest tracking number" to read as follows: 260.10 040 The state did not previously have a definition for "Manifest document number" so there was no definition to remove                                        X

Designated facility means: (1) A hazardous waste TSDF which: (i) Has received a permit (or interim status) in accordance with parts 270 and 124; (ii) Has received a permit (or interim status) from an authorized state; (iii) Is regulated under 261.6(c)(2) or 266 subpart F; and (iv) That has been designated on the manifest by the generator pursuant to 262.20.  (2) A generator site designated on the manifest to receive its waste as a return shipment (3)  If a waste is destined to a facility in an authorized State which has not obtained authorization to regulate that waste, then designated facility must be a facility allowed to accept the waste by the receiving State. 260.10    040 500 (2)(c)(ii) The state definition is equivalent; however it includes a reference to permit-by-rule facilities that the federal definition does not include.  This doesn't affect equivalency because the federal rule also considers permit-by-rule facilities to be designated facilities.

The state is broader in scope because the definition of designated facility includes recycling facilities operating in accordance with 500(2)(c)(ii). These facilities can only accept state-only waste.                                            X

                                       X Manifest means: Shipping document EPA Form 8700-22 (including 8700-22A), originated and signed by generator or offeror  260.10 040                                        X

Manifest tracking number means: The alphanumeric identification number which is pre-printed in Item 4 of the Manifest. 260.10 040                                        X

          PART 261  -  IDENTIFICATION AND LISTING OF HAZARDOUS WASTE                               SUBPART A -- GENERAL RESIDUES OF HAZARDOUS WASTE IN EMPTY CONTAINERS amended by revising (b)(1)(iii) to read as follows: 261.7 160(2)(a)

No more than 3% by weight of the total capacity remains in the container or inner liner if the container is less than or equal to 119 gallons; or 261.7(b)(1)(iii)(A) 160(2)(a)(ii)                                        X

No more than 0.3% by weight of the total capacity remains in the container or inner liner if the container is greater than 119 gallons.  261.7(b)(1)(iii)(B) 160(2)(a)(iii)                                        X

      PART 262  -  STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE                           SUBPART B  -  THE MANIFEST GENERAL REQUIREMENTS (a) is revised to read as follows: 262.20 180

A generator who transports, or offers for transport a hazardous waste for offsite treatment, storage, or disposal, or a TSDF who offers for transport a rejected hazardous waste load, must prepare a Manifest on EPA Form 8700-22, and if necessary, EPA Form 8700-22A 262.20(a)(1) 180 180(1)                                        X

The revised Manifest form and procedures, and the appendix to part 262 shall not apply until September 5, 2006.  The Manifest form and procedures, and the appendix to part 262 contained in 40 CFR 260  -  265 edition revised as of July 1, 2004 , shall be applicable until September 5, 2006. 262.20(a)(2) No analog. The state did not adopt this requirement until after the September 5, 2006 date had passed.                                        X

MANIFEST TRACKING NUMBERS, MANIFEST PRINTING, AND OBTAINING MANIFESTS revised to read as follows (including Section heading): 262.21 180(7)

Manifest tracking numbers, manifest printing, and obtaining manifests. 262.21/ Section heading 180(7)                                        X

A registrant may not print, or have printed, the  manifest for use or distribution unless it has received approval from the EPA Director of the Office of Solid Waste to do so under paragraphs (c) and (e) of this section. 262.21(a)(1) 180(7)(a) IBR 045(1)                                         X

The approved registrant is responsible for ensuring that the organizations identified in its application are in compliance with the procedures of its approved application and the requirements of this section.  The registrant is responsible for assigning manifest tracking numbers to its manifests. 262.21(a)(2) 180(7)(a) IBR 045(1)                                        X

A registrant must submit an initial application to the EPA Director of the Office of Solid Waste that contains the following information: 262.21(b) 180(7)(a) IBR 045(1)                                        X

Name and mailing address of registrant; 262.21(b)(1) 180(7)(a) IBR 045(1)                                        X

Name, telephone number and email address of contact person; 262.21(b)(2) 180(7)(a) IBR 045(1)                                        X

Brief description of registrant's government or business activity; 262.21(b)(3) 180(7)(a) IBR 045(1)                                        X

EPA identification number of the registrant if applicable; 262.21(b)(4) 180(7)(a) IBR 045(1)                                        X

Description of the scope of the operations that the registrant plans to undertake in printing, distributing, and using its manifests including: 262.21(b)(5) 180(7)(a) IBR 045(1)                                        X

A description of the printing operation.  The description should include an explanation of whether the registrant intends to print its manifests in-house or through a separate printing company.  If the registrant intends to use a separate printing company to print the manifest on its behalf, the application must identify this printing company and discuss how the registrant will oversee the company.  If this includes the use of intermediaries, the role of each must be discussed.  The application must provide the name and mailing address of each company, and the name and telephone number of the contact person 262.21(b)(5)(i) 180(7)(a) IBR 045(1)                                        X

A description of how the registrant will ensure that its organization and unaffiliated companies comply with the requirements.  The application must discuss how the registrant will ensure a unique manifest tracking number will be pre-printed on each manifest.  The application must describe the internal control procedures to be followed by the registrant and unaffiliated companies.  It must describe how the registrant will sassing manifest tracking numbers to manifests.  If computer or other infrastructure will be used to maintain numbers, these should be indicated.  The application must indicate how the printer will pre-print a unique number on each form. The application also must explain the other quality procedures to be followed. 262.21(b)(5)(ii) 180(7)(a) IBR 045(1)                                        X

An indication of whether the registrant intends to use the manifests for its own business operations or to distribute the manifests to a separate company or the general public. 262.21(b)(5)(iii) 180(7)(a) IBR 045(1)                                        X

A brief description of the qualifications of the company that will print the manifest.  The registrant may use readily available information. 262.21(b)(6) 180(7)(a) IBR 045(1)                                        X

Proposed unique three-letter manifest tracking number suffix.  If the registrant is approved to print the manifest, the registrant must use this suffix to pre-print a unique manifest tracking number on each manifest. 262.21(b)(7) 180(7)(a) IBR 045(1)                                        X

A signed certification by a duly authorized employee of the registrant that the organizations and companies in its application will comply with the procedures of its approved application and the requirements of this section and that it will notify the EPA Director of OSW of any duplicated manifest tracking numbers as soon as it becomes known. 262.21(b)(8) 180(7)(a) IBR 045(1)                                        X

EPA will review the application submitted under paragraph (b) of this section. 262.21(c) 180(7)(a) IBR 045(1)                                        X

Upon EPA approval of application, EPA will provide registrant an electronic file of manifest, continuation sheet, and manifest instructions and ask registrant to submit three manifests and continuation sheet samples, except as noted in paragraph (d)(3) of this section.  The registrant's samples must meet all of the specifications in paragraph (f) of this siection and be printed by the company that will print the manifest as identified in the application approved under paragraph (c). 262.21(d)(1) 180(7)(a) IBR 045(1)                                        X

Registrant must submit a description of the manifest samples as follows: 262.21(d)(2) 180(7)(a) IBR 045(1)                                        X

Paper type; 262.21(d)(2)(i) 180(7)(a) IBR 045(1)                                        X

Paper weight of each copy; 262.21(d)(2)(ii) 180(7)(a) IBR 045(1)                                        X

Ink color of the manifest's instructions.  If screening of the ink was used, the registrant must indicate the extent of the screening; and 262.21(d)(2)(iii) 180(7)(a) IBR 045(1)                                        X

Method of binding copies. 262.21(d)(2)(iv) 180(7)(a) IBR 045(1)                                        X

The registrant need not submit samples of the continuation sheet if it is printed on same paper and  uses same ink and binding as manifest samples. 262.21(d)(3) 180(7)(a) IBR 045(1)                                        X

EPA will evaluate the forms and either approve the registrant to print as proposed or request information or modification.  EPA will notify the registrant of decision by mail.  The registrant cannot use or distribute forms until EPA approves them.  An approved registrant must print the manifest and continuation sheet according to its application approved under paragraph (c) and the manifest specifications in paragraph (f).  It also must print using the approved paper type, ink color, and binding method. 262.21(e) 180(7)(a) IBR 045(1)                                        X

Paper manifests and continuation sheets must be printed according to the following specifications: 262.21(f) 180(7)(a) IBR 045(1)                                        X

The manifest and continuation sheet must be printed with the exact format and appearance as EPA Forms format.  However, information required to complete manifest may be pre-printed. 262.21(f)(1) 180(7)(a) IBR 045(1)                                        X

A unique tracking number assigned w/ EPA approved numbering system must be pre-printed in Item 4.  It must have a unique three-letter suffix following nine digits. 262.21(f)(2) 180(7)(a) IBR 045(1)                                        X

The manifest and continuation sheet must be printed on durable 8.5x11 in. white paper.   262.21(f)(3) 180(7)(a) IBR 045(1)                                        X

The manifest and continuation sheet must be printed in black ink except marginal words indicating copy distribution in red ink. 262.21(f)(4) 180(7)(a) IBR 045(1)                                        X

The manifest and continuation sheet must be printed as six copy forms.  Copy-to-copy registration must be w/in 1/32[nd] of an in.  Handwritten and typed impressions must be legible on all copies.  Copies must be bound together by one or more common stubs. 262.21(f)(5) 180(7)(a) IBR 045(1)                                        X

Each copy of the manifest and continuation sheet must indicate how the copy must be distributed as follows: 262.21(f)(6) 180(7)(a) IBR 045(1)                                        X

Page 1: "Designated facility to destination State (if required)". 262.21(f)(6)(i) 180(7)(a) IBR 045(1)                                        X

Page 2: "Designated facility to generator state (if required)". 262.21(f)(6)(ii) 180(7)(a) IBR 045(1)                                        X

Page 3: "Designated facility to generator". 262.21(f)(6)(iii) 180(7)(a) IBR 045(1)                                        X

Page 4: "Designated facility's copy". 262.21(f)(6)(iv) 180(7)(a) IBR 045(1)                                        X

Page 5: "Transporter's copy". 262.21(f)(6)(v) 180(7)(a) IBR 045(1)                                        X

Page 6: "Generator's initial copy" 262.21(f)(6)(vi) 180(7)(a) IBR 045(1)                                        X

The instructions in the appendix to part 262 must appear legibly on the back of the copies of the manifest and continuation sheet as provided in this paragraph (f).  The instructions must not be visible through the front of the copies when photocopied or faxed. 262.21(f)(7) 180(7)(a) IBR 045(1)                                        X

Manifest Form 8700-22 262.21(f)(7)(i) 180(7)(a) IBR 045(1)                                        X

The "Instructions for Generators" on Copy 6; 262.21(f)(7)(i)(A) 180(7)(a) IBR 045(1)                                        X

The "Instructions for International Shipment Block" and "Instructions for Transporters" on Copy 5; and 262.21(f)(7)(i)(B) 180(7)(a) IBR 045(1)                                        X

The "Instructions for Treatment, Storage, and Disposal Facilities" on Copy 4. 262.21(f)(7)(i)(C) 180(7)(a) IBR 045(1)                                        X

Manifest Form 8700-22A 262.21(f)(7)(ii) 180(7)(a) IBR 045(1)                                        X

The "Instructions for Generators" on Copy 6; 262.21(f)(7)(ii)(A) 180(7)(a) IBR 045(1)                                        X

The "Instructions for Transporters" on Copy 5; and  262.21(f)(7)(ii)(B) 180(7)(a) IBR 045(1)                                        X

The "Instructions for Treatment, Storage, and Disposal Facilities" on Copy 4. 262.21(f)(7)(ii)(C) 180(7)(a) IBR 045(1)                                        X

A generator may use manifests printed by any source so long as the source of the printed form has received approval from EPA to print the manifest.  A registered source may be a: 262.21(g)(1) 180(7)(b)

                                       X

State agency; 262.21(g)(1)(i) 180(7)(b)(i)                                        X

Commercial printer; 262.21(g)(1)(ii) 180(7)(b)(ii)                                        X

Hazardous waste generator, transporter or TSDF; or 262.21(g)(1)(iii) 180(7)(b)(iii)                                        X

Hazardous waste broker or other preparer. 262.21(g)(1)(iv) 180(7)(b)(iv)                                        X

A generator must determine whether the generator state or consignment state regulates any additional wastes. They must also determine whether the consignment or generator state requires the generator to submit any copies of the manifest to these states.  In these cases the generator is responsible for supplying photocopies. 262.21(g)(2) 180(7)(c)                                        X

If an approved registrant would like to update information provided in application, the registrant must revise the application and submit to the EPA Director of OSW along with an indication or explanation of update ASAP.  If the Agency denies revision, it will explain the reasons and contact registrant for modification. 262.21(h)(1) 180(7)(a) IBR 045(1)                                        X

If registrant would like a new tracking number suffix, he must submit a proposed suffix to the EPA Director of OSW and a reason for requesting it.  The Agency will approve or deny and provide an explanation. 262.21(h)(2) 180(7)(a) IBR 045(1)                                        X

If a registrant would like to change paper type or weight, or ink color, or binding method of manifest or continuation sheet, then he must submit three samples of the revised form for EPA review.  If the approved registrant would like to use a new printer, he must submit three manifest samples printed by the new printer and a brief description of the printer's qualifications.  EPA will either approve or request additional information or modification.  EPA will notify the registrant of decisions by mail.  The registrant can not distribute revised forms until EPA approves. 262.21(h)(3) 180(7)(a) IBR 045(1)                                        X

If, subsequent to approval, a registrant typesets its manifest or continuation sheet instead of using the electronic file of the forms provided by EPA, it must submit three samples of the manifest or continuation sheet to the registry for approval. EPA will either approve or request additional information or modification.  EPA will notify the registrant of its decision by mail.  The registrant can not distribute forms until EPA approves them. 262.21(i) 180(7)(a) IBR 045(1)                                        X

EPA may exempt a registrant from the requirement to submit form samples if the Agency is persuaded that a separate review of the registrant's forms would serve little purpose in informing an approval decision.  A registrant may request an exemption from EPA by indicating why it is warranted. 262.21(j) 180(7)(a) IBR 045(1)                                        X

An approved registrant must notify EPA by phone or email as soon as it becomes aware that it has duplicated tracking numbers on any manifests that have been used or distributed. 262.21(k) 180(7)(a) IBR 045(1)                                        X

If, subsequent to approval of a registrant, EPA becomes aware that the approved paper type, weight, ink color or binding method of registrant's forms is unsatisfactory, EPA will contact the registrant and require modifications. 262.21(l) 180(7)(a) IBR 045(1)                                        X

EPA may suspend and revoke printing privileges if we find that the registrant: 262.21(m)(1) 180(7)(a) IBR 045(1)                                        X

Has used or distributed forms that deviate from approved form samples; or 262.21(m)(1)(i) 180(7)(a) IBR 045(1)                                        X

Exhibits a continuing pattern of behavior in using or distributing manifests that contain duplicate tracking numbers. 262.21(m)(1)(ii) 180(7)(a) IBR 045(1)                                        X

EPA will send a warning letter to the registrant that specifies the date by which it must come into compliance with the requirements.  If the registrant does not come into compliance by the specified date, EPA will send a second letter notifying the registrant that EPA has suspended or revoked its printing privileges.  An approved registrant must provide information on its printing activities to EPA if requested. 262.21(m)(2) 180(7)(a) IBR 045(1)                                        X

                     ♦ WASTE MINIMIZATION CERTIFICATION add a new 262.27 to read as follows: 262.27 180(8)

Waste minimization certification. 262.27/ Section heading 180(8)                                        X

A generator who initiates a shipment of hazardous waste must certify to one of the following statements in Item 15 of the uniform hazardous waste manifest: 262.27 180(8)                                        X

"I am a large quantity generator.  I have a program in place to reduce the volume and toxicity of waste generated to the degree I have determined to be economically practicable and I have selected the practicable method of treatment, storage, or disposal currently available to me which minimizes the present and future threat to human health and the environment;" or 262.27(a) 180(8)(a)                                        X

"I am a small quantity generator.  I have made a good faith effort to minimize my waste generation and select the best waste management method that is available to me and that I can afford." 262.27(b) 180(8)(b) The state rule uses the word "medium" in place of "small" because of the difference in the name for this category of generators.  The state rule includes a note explaining this difference.                                        X

                    SUBPART C  -  PRE-TRANSPORT REQUIRMENTS                                     MARKING revise paragraph (b) to read as follows: 262.32 190(3)

Before transporting hazardous waste or offering hazardous waste for transportation off-site, a generator must mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of 49 CFR 172.304.: HAZARDOUS WASTE  -  Federal Law Prohibits Improper Disposal.  If found, contact the nearest police or public safety authority or the US EPA. Generator's Name and Address. Generator's EPA ID Number.  Manifest Tracking Number. 262.32(b) 190(3)(b)

                                       X

                                  PLACARDING revised to read as follows: 262.33 190(4)

Before transporting hazardous waste or offering hazardous waste for transportation off-site, a generator must placard or offer the initial transporter the appropriate placards according to the DOT regulations for hazardous materials under 49 CFR 172, subpart F.  If placards are not required, a generator must mark each motor vehicle according to 49 CFR 171.3(b)(1). 262.33 190(4)                                        X

                               ACCUMULATION TIME add new paragraph (m) to read as follows: 262.34 200

A generator who sends a shipment of hazardous waste to a designated facility with the understanding that the designated facility can accept and manage the waste and later receives that shipment back as a rejected load or residue may accumulate the returned waste on-site depending on the amount of hazardous waste on-site in that calendar month.  Upon receipt of the returned shipment, the generator must: 262.34(m) 200(6) .                                        X

Sign Item 18c of the manifest, if the transporter returned the shipment using the original manifest; or 262.34(m)(1) 200(6)(a)                                        X

Sign Item 20 of the manifest if the transporter returned the shipment using a new manifest. 262.34(m)(2) 200(6)(b)                                        X

                   SUBPART E  -  EXPORTS OF HAZARDOUS WASTE                          SPECIAL MANIFEST REQUIREMENTS revise paragraphs (c) and (e) to read as follows: 262.54 230 IBR 045(1)                                        X

In the International Shipments block, the primary exporter must check the export box and enter the point of exit (city and State) from the U.S. 262.54(c) 230 IBR 045(1)                                        X

The primary exporter may obtain the manifest from any source that is registered with the US EPA as a supplier of manifests. 262.54(e) 230 IBR 045(1)                                        X

                   SUBPART F  -  IMPORTS OF HAZARDOUS WASTE                           IMPORTS OF HAZARDOUS WASTE revise paragraph (c) and add paragraphs (d) and (e) to read as follows: 262.60 230(2)                                        X

A person who imports hazardous waste may obtain the manifest form from any source that is registered with the US EPA as a supplier of manifests. 262.60(c) 230(2)(c)                                        X

In the International Shipments block, the importer must check the import box and enter the point of entry into the U.S. 262.60(d) 230(2)(d)                                        X

The importer must provide the transporter with an additional copy of the manifest to be submitted by the receiving facility to US EPA.  262.60(e) 230(2)(e)                                        X

revised to read as follows: 262/ Appendix 180(1) IBR

Appendix to Part 262  -  Uniform Hazardous Waste Manifest and Instructions (EPA Form 8700-22 and 8700-22A and Their Instructions) Read all instructions before completing this form. 262/ Appendix

045(1) IBR                                        X

1.  This form has been designed for use on a 12-pitch typewriter which is also compatible with standard computer printers; a firm point pen may also be used  -  press down hard. 262/ Appendix  180(1) IBR 045(1)                                        X

2. Federal regulations require generators and transporters of hazardous waste and owners and operators of hazardous waste TSDFs to complete this form and, if necessary,  continuation sheet for both inter- and intrastate transportation of hazardous waste. 262/ Appendix 180(1) IBR 045(1)                                        X

Manifest 8700-22 262/ Appendix/ 8700-22 180(1) IBR 045(1)                                        X

The following statement must be included with each Uniform Hazardous Waste Manifest, either on the form, in the instructions, or accompanying the form: 262/ Appendix/ 8700-22 180(1) IBR 045(1)                                        X

Public reporting burden for this collection of information is estimated to average: 30 minutes for generators, 10 minutes for transporters, and 25 minutes for owners or operators of TSDFs.  This includes time for reviewing instructions, gathering data, completing, reviewing and transmitting the form.  Send comments regarding burden estimate to: Director, Collection Strategies Division, at the US EPA, main address, mailcode (2822T) 262/ Appendix/ 8700-22 180(1) IBR 045(1)                                        X

I. Instructions for Generators 262/ Appendix/ 8700-22/ I. Instructions for Generators 180(1) IBR 045(1)                                        X

Enter the generator's U.S. EPA twelve digit identification number, or the State generator identification number if the generator site does not have an EPA ID. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 1. Generator's U.S. EPA Identification Number

180(1) IBR 045(1)                                        X

Enter the total number of pages used to complete this Manifest plust the number of Continuation Sheets. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 2. Page 1 of ___ 180(1) IBR 045(1)                                        X

Enter a phone number for which emergency response information can be obtained in the event of an incident.  The emergency phone number must: 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 3.  Emergency Response Phone Number

180(1) IBR 045(1)                                        X

1.  Be the number of the generator or number of an agency or organization who is capable of and accepts responsibility providing detailed information about shipment; 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 3.  Emergency Response Phone Number

180(1) IBR 045(1)                                        X

2.  Reach a phone that is monitored 24 hours a day at all times waste is in transportation; and  262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 3.  Emergency Response Phone Number

180(1) IBR 045(1)                                        X

3.  Reach someone who is either knowledgeable of the hazardous waste being shipped and has emergency response and spill cleanup/ incident mitigation information or has immediate access to a person who has that knowledge. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 3.  Emergency Response Phone Number

180(1) IBR 045(1)                                        X

Note: Emergency Response phone number information should only be entered in Item 3 when there is one phone number that applies to all the waste materials in Item 9b.  If more than one Emergency Response phone number applies, the phone numbers associated with each material should be entered after the description in 9b. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 3.  Emergency Response Phone Number

180(1) IBR 045(1)                                        X

This unique tracking number must be pre-printed on the manifest by forms printer. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 4.  Manifest Tracking Number 180(1) IBR 045(1)                                        X

Enter the name of the generator, the mailing address and the phone number.  Note, the phone number should be the number where the generator or his authorized agent may be reached to provide instructions in event of an emergency or if the designated facility rejects some of the shipment.  Also enter the physical site address from which the shipment originates if different from mailing address. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 5.  Generator's Mailing Address, Phone Number and Site Address

180(1) IBR 045(1)                                        X

Enter the company name and EPA ID number of the first transporter who will transport waste.  Vehicle or driver information may not be entered here. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 6.  Transporter 1 Company Name, and U.S. EPA ID Number 180(1) IBR 045(1)                                        X

If applicable, enter the company name and EPA ID number of the second transporter who will transport the waste.  Vehicle or driver information may not be entered here.  If more than two transporters are needed, use a Continuation Sheet. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 7.  Transporter 2 Company Name, and U.S. EPA ID Number 180(1) IBR 045(1)                                        X

Enter company name and site address of facility that will receive the waste.  Enter the facility's phone number and EPA ID. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 8. Designated Facility Name, Site Address, and U.S. EPA ID Number 180(1) IBR 045(1)                                        X

Item 9a. If the waste identified in 9b consists of hazardous and nonhazardous materials, then identify the hazardous materials by entering an "x" in this Item.

262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 9. U.S.DOT Description (Including Proper Shipping Name, Hazard Class or Division, Identification Number, and Packing Group) 180(1) IBR 045(1)                                        X

Item 9b.  Enter the DOT Proper Shipping Name, Hazard Class or Division, Identification Number and Packing Group for each waste as identified in 49 CFR 172.  Include reportable quantity references if applicable.

262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 9. U.S.DOT Description (Including Proper Shipping Name, Hazard Class or Division, Identification Number, and Packing Group) 180(1) IBR 045(1)                                        X

Note: If additional space is needed, enter descriptions on Item 27 on Continuation Sheet.  If more than one Emergency Response phone number applies, enter them immediately following shipping descriptions. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 9. U.S.DOT Description (Including Proper Shipping Name, Hazard Class or Division, Identification Number, and Packing Group) 180(1) IBR 045(1)                                        X

Enter number of containers for each waste and abbreviation for container type from Table I. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 10. Containers (Number and Type) 180(1) IBR 045(1)                                        X

                       Table I.  -  Types of Containers                   BA = Burlap, cloth, paper, or plastic bags.                  CF = Fiber or plastic boxes, cartons, cases.             CM = Metal boxes, cartons, cases (including roll-offs).                       CW = Wooden boxes, cartons, cases.                                 CY = Cylinders.                DF = Fiberboard or plastic drums, barrels, kegs.                        DM = Metal drums, barrels, kegs.                                DT = Dump truck.                        DW = Wooden drums, barrels, kegs.                          HG = Hopper or gondola cars.                                 TC = Tank cars.                              TP = Portable tanks.                         TT = Cargo tanks (tank trucks). Enter total quantity of waste.  Round to nearest whole unit.  Report quantities using appropriate units of measure.  Quantities should be based on actual measurements or reasonable estimates.  Container capacities are not acceptable estimates. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 11. Total Quantity

180(1) IBR 045(1)                                        X

Enter abbreviation from Table II for unit of measure. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 12. Units of Measure (Weight/ Volume) 180(1) IBR 045(1)                                        X

                        Table II.  -  Units of Measure G = Gallons (liquids only). K = Kilograms. L = Liters (liquids only). M = Metric Tons (1000 kilograms). N = Cubic Meters. P = Pounds. T = Tons (2000 pounds). Y = Cubic Yards. Note: Tons, Metric Tons, Cubic Meters, and Cubic Yards should only be reported in connection with very large bulk shipments, such as rail cars, tank trucks, or barges. Enter up to six federal and state waste codes to describe each waste stream. State waste codes that are not redundant must be entered here in addition to the federal codes. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 13. Waste Codes

 180(1) IBR 045(1)                                        X

1. Generators may enter any special handling information necessary.  Generators may also enter descriptive information about shipped materials.

262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 14. Special Handling Instructions and Additional Information. 180(1) IBR 045(1)                                        X

2. This space may be used to record federally required information for which there is no specific space.  Generators cannot be required to enter information in this space to meet state requirements. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 14. Special Handling Instructions and Additional Information. 180(1) IBR 045(1)                                        X

1. The generator must read, sign, and date the waste minimization certification statement.  Also contains the shipper's certification.

262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 15. Generator's/ Offeror's Certifications 180(1) IBR 045(1)                                        X

2. Generator or Offeror personnel may preprint the words, "On behalf of" in the signature block to indicate that the individual signs as the employee or agent of the named principal. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 15. Generator's/ Offeror's Certifications 180(1) IBR 045(1)                                        X

Note: All of the above information except the handwritten signature may be pre-printed. 262/ Appendix/ 8700-22/ I. Instructions for Generators/ Item 15. Generator's/ Offeror's Certifications 180(1) IBR 045(1)                                        X

Instructions for International Shipment Block 262/ Appendix/ 8700-22/ II. Instructions for International Shipment Block 180(1) IBR 045(1)                                        X

For export shipments, the primary exporter must check the export box, and enter the point of exit from US.  For import shipments, the importer must check the import box and enter point of entry into US. For exports, transporter must sign and date manifest to indicate the day the shipment left the US.  Transporters of hazardous waste shipments must deliver a copy of manifest to US Customs when exporting waste across US border. 262/ Appendix/ 8700-22/ II. Instructions for International Shipment Block/ Item 16. International Shipments

180(1) IBR 045(1)                                        X

Instructions for Transporters 262/ Appendix/ 8700-22/ III. Instructions for Transporters 180(1) IBR 045(1)                                        X

Enter the name of the person accepting waste on behalf of first transporter.  Acknowledge acceptance of waste by signing manifest and entering date of receipt.  Only one signature required.  Signatures are not required to track waste in and out of transfer facilities unless there is a change of custody.  If applicable, enter name of person accepting waste on behalf of the second transporter.  Acknowledge acceptance of waste by signing manifest and entering date of receipt.   262/ Appendix/ 8700-22/ III. Instructions for Transporters/ Item 17. Transporters' Acknowledgements of Receipt

180(1) IBR 045(1)                                        X

Note: Transporters carrying imports, who are acting as importers, may have responsibilities to enter information in the International Shipments Block.  Transporters carrying exports may have these responsibilities. 262/ Appendix/ 8700-22/ III. Instructions for Transporters/ Item 17. Transporters' Acknowledgements of Receipt

180(1) IBR 045(1)                                        X

IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities 262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities 180(1) IBR 045(1)                                        X

1. The authorized representative of the facility's owner or operator must note any discrepancy between the waste described and the waste received.  Manifest discrepancies are: significant differences between the quantity or type of hazardous waste designated on manifest and that actually received.   262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 18. Discrepancy/ Item 18a. Discrepancy Indication Space

180(1) IBR 045(1)                                        X

2. For rejected loads and residues, check appropriate box if shipment is a rejected load or a regulated residue that cannot be removed from container.  Enter reason for rejection or inability to remove residue and description of waste.  Reference the manifest tracking number for any additional manifests being used to track the rejected waste or residue shipment on original manifest.  Indicate original manifest number in Item 14 of the additional manifests.  262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 18. Discrepancy/ Item 18a. Discrepancy Indication Space

180(1) IBR 045(1)                                        X

3. Owners or operators of facilities located in unauthorized States who cannot resolve significant differences in quantity or type within 15 days of receiving waste must submit to the Regional Administrator a letter w/ a copy of the Manifest describing the discrepancy and attempts to reconcile it. 262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 18. Discrepancy/ Item 18a. Discrepancy Indication Space

180(1) IBR 045(1)                                        X

4. Owners and operators of facilities in authorized States should contact their state agency for information on where to report discrepancies to state officials. 262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 18. Discrepancy/ Item 18a. Discrepancy Indication Space 180(1) IBR 045(1)                                        X

Enter name, address, phone number and EPA ID of Alternate Facility which the rejecting TSDF has designated to receive a fully rejected waste shipment.  In the event that a fully rejected shipment is being returned to the generator, the rejecting TSDF may enter the generator's site information in this space.  This field is not to be used to forward partially rejected loads or residue shipments. 262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 18. Discrepancy/ Item 18b. Alternate Facility (or Generator) for Receipt of Full Load Rejections

180(1) IBR 045(1)                                        X

The authorized representative of the alternate facility must sign and date this field to acknowledge receipt of the fully rejected waste or residue. 262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 18. Discrepancy/ Item 18c. Alternate Facility (or Generator) Signature 180(1) IBR 045(1)                                        X

Enter appropriate Hazardous Waste Report Management Method code for each waste listed in Item 9.  The code is to be entered by first TSDF that receives waste and is the code that describes way in which waste is to be managed when received by TSDF. 262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 19. Hazardous Waste Report Management Method Codes 180(1) IBR 045(1)                                        X

Enter name of the person receiving waste on behalf of owner or operator.  That person must acknowledge receipt or rejection by signing and entering the date of receipt or rejection.  The rejection should be noted and described in 18a.  Fully rejected wastes may be forwarded or returned using Item 18b.  Enter the name of the person accepting the waste on behalf of the owner/ operator of alternate facility or original generator. That person must acknowledge receipt or rejection by signing and entering date in Item 18c. Partially rejected wastes and residues must be re-shipped under a new manifest, to be initiated and signed by the rejecting TSDF.   262/ Appendix/ 8700-22/ IV. Instructions for Owners and Operators of Treatment, Storage, and Disposal Facilities/ Item 20. Designated Facility Owner or Operator Certification of Receipt (Except As Noted in Item 18a) 180(1) IBR 045(1)                                        X

Manifest Continuation Sheet

262/ Appendix/ 8700-22A 180(1) IBR 045(1)                                        X

Instructions  -  Continuation Sheet, U.S. EPA Form 8700-22A 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet 180(1) IBR 045(1)                                        X

Read all instructions before completing this form.  This form has been designed for use on a 12-pitch typewriter; a firm point pen may also be used. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet 180(1) IBR 045(1)                                        X

This form must be used as a continuation sheet to form 8700-22 if: More than two transporters are to be used; or  More space is required for the U.S. DOT descriptions and related information in Item 9. Federal regulations require generators and transporters and owner/ operators of TSDFs to use the uniform hazardous waste manifest and this continuation sheet for inter-and intrastate transportation. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet 180(1) IBR 045(1)                                        X

Enter the generator's EPA ID or State generator ID if the generator does not have an EPA ID. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 21. Generator's ID Number 180(1) IBR 045(1)                                        X

Enter the page number of this Continuation Sheet. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 22. Page __ 180(1) IBR 045(1)                                        X

Enter the Manifest Tracking number from Item 4 of the Manifest to which this continuation sheet is attached. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 23. Manifest Tracking Number 180(1) IBR 045(1)                                        X

Enter the generator's name as it appears in Item 5 in the Manifest 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 24. Generator's Name 180(1) IBR 045(1)                                        X

If additional transporters are used, enter the company name of each additional transporter in the order in which they will transport the waste.  Enter after the word "Transporter" the order of the transporter.  Also enter in the EPA ID of the transporter named in Item 25. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 25. Transporter- Company Name 180(1) IBR 045(1)                                        X

If additional transporters are used, enter the company name of each additional transporter in the order in which they will transport the waste. Enter after the word "Transporter" the order of the transporter.  Each Continuation Sheet can record the names of two additional transporters.  Also enter the EPA ID number of the transporter named in Item 26. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 26. Transporter- Company Name 180(1) IBR 045(1)                                        X

For each row enter a sequential number under Item 27b that corresponds to the order of waste codes from one continuation sheet to the next, to reflect total number of wastes being shipped.  Refer to instructions for Item 9 of the manifest for information to be entered. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 27. U.S. DOT Description Including Proper Shipping Name, Hazardous Class, and ID Number (UN/NA) 180(1) IBR 045(1)                                        X

Refer to instructions for Item 10  262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 28. Containers (No. And Type) 180(1) IBR 045(1)                                        X

Refer to instructions for Item 11. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 29. Total Quantity 180(1) IBR 045(1)                                        X

Refer to the instructions for Item 12.   262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 30. Units of Measure (Weight/ Volume) 180(1) IBR 045(1)                                        X

Refer to the instructions for Item 13. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 31. Waste Codes 180(1) IBR 045(1)                                        X

Refer to the instructions for Item 14. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Item 32. Special Handling Instructions and Additional Information 180(1) IBR 045(1)                                        X

Transporters 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Transporter 180(1) IBR 045(1)                                        X

Enter the same number of the Transporter as identified in Item 25.  Enter also the name of the person accepting the waste on behalf of the Transporter identified in Item 25.  That person must acknowledge acceptance of the waste  by signing and entering date of receipt. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Transporter/ Item 33. Transporter  -  Acknowledgement of Receipt of Materials 180(1) IBR 045(1)                                        X

Enter the same number of the Transporter as identified in Item 26.  Enter also the name of the person accepting the waste on behalf of the Transporter identified in Item 26.  That person must acknowledge receipt of the waste by signing and entering date of receipt. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/Transporter/  Item 34. Transporter  -  Acknowledgement of Receipt of Materials 180(1) IBR 045(1)                                        X

Owner and Operators of Treatment, Storage, or Disposal Facilities 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Owner and Operators of Treatment, Storage, or Disposal Facilities  180(1) IBR 045(1)                                        X

Refer to Item 18.  This space may be used to more fully describe information on discrepancies identified in Item 18a. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Owner and Operators of Treatment, Storage, or Disposal Facilities/ Item 35. Discrepancy Indication Space 180(1) IBR 045(1)                                        X

For each field, enter the sequential number that corresponds to the waste materials described under Item 27, and enter the appropriate process code.  If additional continuation sheets are attached, continue numbering the waste materials and process code fields sequentially, and enter on each sheet the process codes corresponding to the wastes identified. 262/ Appendix/ 8700-22A/ Instructions  -  Continuation Sheet/ Owner and Operators of Treatment, Storage, or Disposal Facilities/ Item 36. Hazardous Waste Report Management Method Codes 180(1) IBR 045(1)                                        X

     PART 263  -  STANDARDS APPLICABLE TO TRANSPORTERS OF HAZARDOUS WASTE       SUBPART B -- COMPLIANCE WITH THE MANIFEST SYSTEM AND RECORDKEEPING THE MANIFEST SYSTEM amended by revising paragraphs (a) and (g) to read as follows: 263.20 250

Manifest requirement.  A transporter may not accept hazardous waste from a generator unless the transporter is also provided with a manifest signed in accordance with requirements of 262.23. 263.20(a)(1) 250(1)(a)                                        X

Exports.  In the case of exports other than those subject to subpart H of part 262, a transporter may not accept such waste from a primary exporter or other person if he knows the shipment does not conform to EPA Acknowledgement of Consent; and unless, in addition to a manifest signed by the generator, the transporter shall also be provided with an EPA Acknowledgement of Consent which, is attached to the manifest.  For exports of hazardous waste subject to the requirements of subpart H of part 262, a transporter may not accept hazardous waste w/o a tracking document that includes information required in 262.84. 263.20(a)(2) 250(1)(b)                                        X

Compliance Date for Form Revisions.  The revised Manifest form and procedures in 260.10, 261.7, 263.20, and 263.21 shall not apply until September 5, 2006.  The Manifest form and procedures contained in the 40 CFR edition revised as of July 1, 2004 shall be applicable until September 5, 2006.  263.20(a)(3) No analog The state rule does not include this language regarding the date the new provisions went into effect because it did not adopt its rule until after the requirements were in effect.                                        X

Transporters who transport hazardous waste out of the United States must: 263.20(g) 250(9)                                        X

Sign and date the manifest in the International Shipments block to indicate the date that the shipment left the United States; 263.20(g)(1) 250(9)(a)                                        X

Retain one copy; 263.20(g)(2) 250(9)(b)                                        X

Return a signed copy of the manifest to generator; and 263.20(g)(3) 250(9)(c)                                        X

Give a copy of manifest to a US Customs official at the point of departure from US. 263.20(g)(4) 250(9)(d)                                        X

COMPLIANCE WITH THE MANIFEST revise paragraph (b) to read as follows: 263.21 250(5) & (6)                                        X

If the hazardous waste cannot be delivered in accordance w/ paragraph (a) because of an emergency condition, then the transporter must contact the generator for further directions and revise the manifest according to generator instructions. 263.21(b)(1) 250(6)(a)                                        X

If hazardous waste is rejected by the designated facility while the transporter is on the facility's premises, then the transporter must obtain the following: 263.21(b)(2) 250(6)(b)                                        X

For a partial load rejection or for regulated quantities of container residues, a copy of the original manifest that includes the facility's date and signature, and the Manifest Tracking Number of the new manifest that will accompany shipment and a description of the partial rejection or container residue in the discrepancy block of the original manifest.  The transporter must retain a copy of this manifest and give remaining copies of original to the rejecting facility.  If the transporter is forwarding the rejected part of the shipment or a regulated container residue to a alternate facility or returning it to generator, the transporter must obtain a new manifest to accompany the shipment, and the new manifest must include all of the required information. 263.21(b)(2)(i) 250(6)(b)(i)                                        X

For a full load rejection that will be taken back by transporter, a copy of the original manifest that includes the rejecting facility's signature and date attesting to rejection, the description of rejection in the discrepancy block, and the name, address, phone number, and ID number for alternate facility to whom the shipment must be delivered.  The transporter must retain a copy of the manifest and give a copy to the rejecting facility.  If original manifest is not used, then transporter must obtain a new manifest for shipment. 263.21(b)(2)(ii) 250(6)(b)(ii)                                        X

PART 264  -  STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES           SUBPART E  -  MANIFEST SYSTEM, RECORDKEEPING, AND REPORTING APPLICABILITY section revised to read as follows: 264.70 370

The regulations in this subpart apply to owners/ operators of both on-site and off-site facilities except as 264.1 provides. Sections 264.71, 264.72, and 264.76, do not apply to owners/ operators that do not receive hazardous waste from off-site, or to off-site facilities w/ respect to military munitions exempt from requirements.  264.73(b) only applies to permittees who treat, store, or dispose of hazardous waste on-site where wastes are generated. 264.70(a)

370(1)   The state is more stringent because 370(1) does not give a manifest exemption for military munitions, whereas the federal version does.  Also, 578(1)(b) infers  that a manifest is required for transporting waste munitions between military installations.   The state applicability subsection in 370(1) Manifest system does not apply to on-site facilities. The federal rule excludes on-site facilities (who do not accept off-site hazardous waste) from manifest requirements. The state rule is equivalent in this matter. X

                                       X

The revised Manifest form and procedures in 40 CFR 260.10, 261.7, 264.70, 264.71, 264.72, and 264.76 shall not apply until September 5, 2006.  The Manifest form and procedures in 40 CFR revised as of July 1, 2004 shall be applicable until September 5, 2006. 264.70(b) No analog. The state did not adopt this requirement until after the September 5, 2006 date had passed.

USE OF MANIFEST SYSTEM revise paragraphs (a) and (b)(4) and add paragraph (e) to read as follows: 264.71 370

If a facility receives hazardous waste w/ a manifest, the owner/ operator must sign and date manifest to certify waste was received, waste was received except as noted in discrepancy, or waste was rejected. 264.71(a)(1) 370(1)                                        X

If a facility receives a hazardous waste shipment w/ a manifest, the owner/ operator must: 264.71(a)(2) 370(2) "his" is changed to "their" to be gender neutral                                        X

Sign and date each copy 264.71(a)(2)(i) 370(2)(a)                                        X

Note any discrepancies   264.71(a)(2)(ii) 370(2)(b)                                        X

Give transporter one copy 264.71(a)(2)(iii) 370(2)(c)                                        X

W/ in 30 days send copy to generator; and 264.71(a)(2)(iv) 370(2)(d)                                        X

Retain at facility a copy for at least three years. 264.71(a)(2)(v) 370(2)(e)                                        X

If a facility receives hazardous waste from a foreign source, the facility must mail a copy of the manifest to the following address w/in 30 days of delivery: International Compliance Assurance Division [insert EPA address] 264.71(a)(3) 370(3)                                        X

W/in 30 days send a copy of signed and dated manifest or shipping paper to generator; and 264.71(b)(4) 370(4)(d)                                        X

Facility must determine whether consignment state regulates any additional wastes.  Facilities must determine whether consignment state or generator state requires submission of any copies of manifest to these states. 264.71(e) 370(8)                                        X

MANIFEST DISCREPANCIES amended as follows: 264.72 370(5)                                        X

Manifest discrepancies are: 264.72(a) 370(5)(a)                                        X

  Significant differences between quantity or type of waste on manifest and waste a facility receives; 264.72(a)(1) 370(5)(a)(i)                                        X

Rejected wastes, full or partial shipment, the TSDF cannot accept; or 264.72(a)(2) 370(5)(a)(ii)                                        X

Container residues exceeding quantity for "empty containers" 264.72(a)(3) 370(5)(a)(iii)                                        X

Significant differences in quantity are: For bulk waste, >10% weight; for batch waste, variation in piece count.  Differences in type are those discovered through inspection/ waste analysis, or toxic constituents not reported on manifest. 264.72(b) 370(5)(b)                                        X

Upon discovering a significant difference, the owner/ operator must attempt to reconcile discrepancy w/ generator or transporter. If discrepancy is not resolved w/in 15 days, the owner/operator must submit to Regional Administrator letter describing discrepancy and attempts to reconcile it, and copy of manifest. 264.72(c) 370(5)(c) The state rule does not include the example, but it does not affect equivalency.                                        X

Upon rejecting waste or identifying container residue exceeding "empty" limits, the facility must consult w/ generator prior to forwarding waste to a facility that can manage it.  If it is impossible to locate alternate facility, the facility may return rejected waste to generator.  Waste must be sent to alternate facility or generator w/in 60 days of rejection. 264.72(d)(1) 370(5)(d)(i)                                        X

While facility is making arrangements for forwarding rejected wastes or residues, it must ensure that either the delivering transporter retains custody of waste, or, the facility must provide custody of waste, pending delivery of waste to first transporter designated on manifest prepared under paragraph (e) or (f). 264.72(d)(2) 370(5)(d)(ii)                                        X

Except as provided in paragraph (e)(7), for rejections/ residues to be sent to an alternate facility, the facility is required to prepare a new manifest in accordance w/ 262.20(a) and the following instructions: 264.72(e) 370(5)(e)                                        X

Write generator's EPA ID number in Item 1 of new manifest.  Write generator's name and mailing address in Item 5. If generator's site address is different, write site address in Item 5. 264.72(e)(1) 370(5)(e)(i)                                        X

Write name of alternate facility and EPA ID number in Item 8 of new manifest. 264.72(e)(2) 370(5)(e)(ii)                                        X

Copy manifest tracking number in Item 4 of old manifest to Special Handling and Additional Information block, and indicate shipment is residue/ rejection from previous shipment. 264.72(e)(3) 370(5)(e)(iii)                                        X

Copy manifest tracking number in Item 4 of new manifest to manifest reference number line in Discrepancy Block of old manifest. 264.72(e)(4) 370(5)(e)(iv)                                        X

Write the DOT description for rejected load or residue in Item 9 of new manifest and write container types, quantity, and waste volume. 264.72(e)(5) 370(5)(e)(v)                                        X

Sign the Generator's/ Offeror's Certification to certify that waste has been properly packaged, marked and labeled and is in condition for transportation. 264.72(e)(6) 370(5)(e)(vi)                                        X

For full load rejections made while transporter remains at facility, the facility may forward rejected shipment to alternate facility by completing Item 18b of the original manifest and supplying information in the Alternate Facility space.  The facility must retain copy of this manifest for records, and give remaining copies to transporter.  If original manifest is not used, then the facility must use a new manifest and comply w/ (e)(1)  -  (6). 264.72(e)(7) 370(5)(e)(vii)                                        X

Except as provided in paragraph (f)(7), for rejected/ residue wastes that must be sent back to generator, the facility is required to prepare a new manifest in accordance w/ 262.20(a) and the following instructions: 264.72(f) 370(5)(f)                                        X

Write facility's EPA ID number in Item 1 of new manifest. Write generator's name and mailing address in Item 5.  If generator's site address is different, then write site address in space in Item 5. 264.72(f)(1) 370(5)(f)(i)                                        X

Write name of initial generator and EPA ID in block 8  of new manifest. 264.72(f)(2) 370(5)(f)(ii)                                        X

Copy manifest tracking number from Item 4 in old manifest to Special Handling and Additional Information block of new manifest, and indicate shipment is residue/ rejection from previous shipment. 264.72(f)(3) 370(5)(f)(iii)                                        X

Copy manifest tracking number in Item 4 of new manifest to manifest reference number line in Discrepancy Block of old manifest (Item 18a). 264.72(f)(4) 370(5)(f)(iv)                                        X

Write DOT description for rejection/ residue in Item 9 of new manifest and write container types, quantity, and volumes of waste. 264.72(f)(5) 370(5)(f)(v)                                        X

Sign the Generator's/ Offeror's Certification to certify that waste has been properly packaged, marked and labeled and is in condition for transportation. 264.72(f)(6) 370(5)(f)(vi)                                        X

For full load rejection made while transporter remains at facility, the facility may return shipment to generator w/ the original manifest by completing Item 18a and 18b of manifest and supplying generator's information in Alternate Facility space. The facility must retain copy for its records and give remaining copies of manifest to transporter.  If original manifest is not used, then facility must use a new manifest and comply w/ paragraphs f(1) - (6). 264.72(f)(7) 370(5)(f)(vii)                                        X

If a facility rejects a waste or identifies residue that exceeds limits for "empty" containers after it has signed, dated, and returned a copy of manifest to the delivering transporter or generator, the facility must amend its copy of the manifest to indicate the rejected waste/ residue in the discrepancy space of amended manifest.  The facility must also copy the manifest tracking number from Item 4 of the new manifest to Discrepancy space of amended manifest, and must re-sign and date manifest to certify to the information as amended.  The facility must retain the amended manifest for at least three years and must w/in 30 days send a copy of amended manifest to the transporter and generator that received copies prior to amendment. 264.72(g) 370(5)(g)                                        X

UNMANIFESTED WASTE REPORT revised to read as follows: 264.76 390(1)

If a facility accepts hazardous waste from an off-site source w/o a manifest or shipping papers, and the waste is not excluded by a requirement of this chapter, then the owner/ operator must submit a letter to Regional Administrator w/in 15 days after receiving waste.  The unmanifested waste report must contain the following: 264.76(a) 390(1) The state's rule specifies that the un-manifested waste report letter is to be sent to one of Ecology's regional offices.

                                         X

EPA ID number, name and address of facility; 264.76(a)(1) 390(1)(a)                                        X

Date facility received waste; 264.76(a)(2) 390(1)(b)                                        X

EPA ID number, name, and address of generator and transporter; 264.76(a)(3) 390(1)(c)                                        X

Description of quantity of each unmanifested hazardous waste facility received; 264.76(a)(4) 390(1)(d)                                        X

Method of treatment, storage or disposal for each hazardous waste; 264.76(a)(5) 390(1)(e) The state rule has always differed slightly in that it refers to method of management, and does not specifically list treatment, storage or disposal.  The meaning is the same.  The state rule on the whole infers that recycling is a method of management.                                        X

The certification signed by the owner/ operator of facility or his authorized representative; and  264.76(a)(6) 390(1)(f) Included "or her" to be gender neutral                                          X

A brief explanation of why the waste was un-manifested, if known. 264.76(a)(7) 390(1)(g)                                        X

[Reserved] 264.76(b) No analog- not necessary as this was due to a renumbering in the federal regulations                                        X

PART 265  -  INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE, TREATMENT, STORAGE, AND DISPOSAL FACILITIES           SUBPART E  -  MANIFEST SYSTEM, RECORDKEEPING, AND REPORTING                                  APPLICABILITY revised to read as follows: 265.70 370

The regulations in this subpart apply to owners/ operators of both on- and off-site facilities except as 265.1 provides.  Sections 265.71, 265.72, and 265.76 do not apply to owners/ operators of on-site facilities that do not receive hazardous waste from off-site sources, nor to owners/ operators of off-site facilities w/ respect to military munitions waste.   265.70(a)

370(1)  The state is more stringent because 370(1) does not give a manifest exemption for military munitions, whereas the federal version does.  Also, 578(1)(b) infers  that a manifest is required for transporting waste munitions between military installations.   The state applicability subsection in 370(1) Manifest system does not apply to on-site facilities. The federal rule excludes on-site facilities (who do not accept off-site hazardous waste) from manifest requirements. The state rule is equivalent in this matter.

                                       X   X

The revised Manifest form and procedures in 40 CFR 260.10, 261.7, 265.70, 265.71, 265.72, and 265.76 shall not apply until September 5, 2006.  The Manifest form and procedures in the July 1, 2004 CFR shall be applicable until September 5, 2006. 265.70(b) No analog. The state did not adopt this requirement until after the September 5, 2006 date had passed.                                        X

                            USE OF MANIFEST SYSTEM amended by revising paragraph (a) and  (b)(4) and adding paragraph (e) to read as follows: 265.71 370                                        X

If a facility receives hazardous waste and a manifest, the owner/ operator must sign and date manifest to certify that the hazardous waste covered by manifest was received, received w/ discrepancies, or rejected. 265.71(a)(1) 370(1)

                                       X

If a facility receives a hazardous waste shipment w/ a manifest, the owner/ operator must:  265.71(a)(2) 370(2)                                        X

Sign and date each copy; 265.71(a)(2)(i) 370(2)(a)                                        X

Note any discrepancies;  265.71(a)(2)(ii) 370(2)(b)                                        X

Give transporter at least one copy; 265.71(a)(2)(iii) 370(2)(c)                                        X

W/in 30 days of delivery, send copy of manifest to generator; 265.71(a)(2)(iv) 370(2)(d)                                        X

Retain at facility a copy of each manifest for at least three years. 265.71(a)(2)(v) 370(2)(e)                                        X

If a facility receives hazardous waste imported from a foreign source, the facility must mail a copy of the manifest to the following address w/in 30 days: International Compliance Assurance Division [insert EPA Address]. 265.71(a)(3) 370(3)                                        X

W/in 30 days, send a copy of signed and dated manifest to generator; and 265.71(b)(4) 370(4)(d)                                        X

A facility must determine whether the consignment state for a shipment regulates any additional wastes under its state hazardous waste program.  Facilities must also determine whether the consignment state or generator state requires the facility to submit any copies of the manifest to these states. 265.71(e) 370(8)                                        X

                            MANIFEST DISCREPANCIES revised as follows: 265.72 370(5)                                        X

Manifest discrepancies are: 265.72(a) 370(5)(a)                                        X

Significant differences b/t the quantity or type of hazardous waste on the manifest, and hazardous waste actually received. 265.72(a)(1) 370(5)(a)(i)                                        X

Rejected wastes, which may be a full or partial shipment of hazardous waste the TSDF cannot accept; or 265.72(a)(2) 370(5)(a)(ii)                                        X

Container residues, which are residues that exceed the quantity limits for "empty" in 261.7(b). 265.72(a)(3) 370(5)(a)(iii)                                        X

Significant differences in quantity are: For bulk waste, >10% weight; for batch waste, variation in piece count.  Differences in type are those discovered through inspection/ waste analysis, or toxic constituents not reported on manifest. 265.72(b) 370(5)(b)                                        X

Upon discovering a significant difference, the owner/ operator must attempt to reconcile discrepancy w/ generator or transporter. If discrepancy is not resolved w/in 15 days, the owner/operator must submit to Regional Administrator a letter describing discrepancy and attempts to reconcile it, and copy of manifest. 265.72(c) 370(5)(c)                                        X

Upon rejecting waste or identifying container residue exceeding "empty" limits, the facility must consult w/ generator prior to forwarding waste to a facility that can manage it.  If it is impossible to locate alternate facility, the facility may return rejected waste to generator.  Waste must be sent to alternate facility or generator w/in 60 days of rejection. 265.72(d)(1) 370(5)(d)(i) X

While facility is making arrangements for forwarding rejected wastes or residues, it must ensure that either the delivering transporter retains custody of waste, or, the facility must provide custody of waste, pending delivery of waste to first transporter designated on manifest prepared under paragraph (e) or (f). 265.72(d)(2) 370(5)(d)(ii)                                        X

Except as provided in paragraph (e)(7), for rejections/ residues to be sent to an alternate facility, the facility is required to prepare a new manifest in accordance w/ 262.20(a) and the following instructions: 265.72(e) 370(5)(e)                                        X

Write generator's EPA ID number in Item 1 of new manifest.  Write generator's name and mailing address in Item 5. If generator's site address is different, write site address in Item 5. 265.72(e)(1) 370(5)(e)(i)                                        X

Write name of alternate facility and EPA ID number in Item 8 of new manifest. 265.72(e)(2) 370(5)(e)(ii)                                        X

Copy manifest tracking number in Item 4 of old manifest to Special Handling and Additional Information block of new manifest, and indicate shipment is residue/ rejection from previous shipment. 265.72(e)(3) 370(5)(e)(iii)                                        X

Copy manifest tracking number in Item 4 of new manifest to manifest reference number line in Discrepancy Block of old manifest (Item 18a). 265.72(e)(4) 370(5)(e)(iv)                                        X

Write the DOT description for rejected load or residue in Item 9 of new manifest and write container types, quantity, and waste volume. 265.72(e)(5) 370(5)(e)(v)                                        X

Sign the Generator's/ Offeror's Certification to certify that waste has been properly packaged, marked and labeled and is in condition for transportation. 265.72(e)(6) 370(5)(e)(vi)                                        X

For full load rejections made while transporter remains at facility, the facility may forward rejected shipment to alternate facility by completing Item 18b of the original manifest and supplying information in the Alternate Facility space.  The facility must retain copy of this manifest for records, and give remaining copies to transporter.  If original manifest is not used, then the facility must use a new manifest and comply w/ (e)(1)  -  (6). 265.72(e)(7) 370(5)(e)(vii)                                        X

Except as provided in paragraph (f)(7), for rejections/ residues that must be sent back to generator, the facility must prepare a new manifest in accordance w/ 262.20(a) and the following instructions: 265.72(f) 370(5)(f)                                        X

Write facility's EPA ID number in Item 1 of new manifest.  Write generator's name and mailing address in Item 5. If generator's site address is different, write site address in Item 5. 265.72(f)(1) 370(5)(f)(i)                                        X

Write name of initial generator and generator's EPA ID number in Item 8. 265.72(f)(2) 370(5)(f)(ii)                                        X

Copy manifest tracking number found in Item 4 of old manifest to Special Handling and Additional Information block of new manifest, and indicate that shipment is residue/ rejection from previous shipment, 265.72(f)(3) 370(5)(f)(iii)                                        X

Copy manifest tracking number found in Item 4 of new manifest to manifest reference number line in Item 18a of old manifest. 265.72(f)(4) 370(5)(f)(iv)                                        X

Write DOT description for rejected load or residue in Item 9 of new manifest and write container types, quantity, and waste volumes. 265.72(f)(5) 370(5)(f)(v)                                        X

Sign the Generator's/ Offeror's Certification to certify, that waste has been properly packaged, marked and labeled and is in condition for transportation 265.72(f)(6) 370(5)(f)(vi)                                        X

For full load rejections that are made while transporter remains at facility, the facility may return shipment to generator w/ original manifest by completing Item 18b of manifest and supplying generator's information in Alternate Facility space.  The facility must retain a copy for its records and then give the remaining copies to transporter.  If original manifest is not used, then facility must use a new manifest and comply w/ f(1)  -  (6). 265.72(f)(7) 370(5)(f)(vii)                                        X

If a facility rejects a waste or identifies a container residue that exceeds the quantity limits for "empty" containers after it has signed, dated, and returned a copy of the manifest to the delivering transporter or to the generator, the facility must amend its copy of manifest to indicate the rejection/ residue in discrepancy space of amended manifest.  The facility must also copy the manifest tracking number from Item 4 of new manifest to discrepancy space of amended manifest, and must re-sign and date the manifest to certify to the information amended.  The facility must retain amended manifest for at least three years, and must w/in 30 days send a copy of amended manifest to transporter and generator that received copies prior to being amended. 265.72(g) 370(5)(g)                                        X

UNMANIFESTED WASTE REPORT revised to read as follows: 265.76 390(1)

If a facility accepts any hazardous waste from an off-site source w/o a manifest, and if the waste is not excluded from the manifest requirement, then owner/ operator must submit a letter to the Regional Administrator w/in 15 days. The unmanifested waste report must contain the following information: 265.76(a) 390(1) The state rule says to submit the letter to the appropriate Ecology regional office and clarifies that the letter is the same as the unmanifested waste report.                                        X

EPA ID number, name and address of facility; 265.76(a)(1) 390(1)(a) The state rule clarifies that the EPA ID number is the same as the state ID number.                                        X

Date facility received waste; 265.76(a)(2) 390(1)(b)                                        X

EPA ID number, name and address of generator and transporter; 265.76(a)(3) 390(1)(c)                                        X

Description and quantity of each unmanifested hazardous waste received; 265.76(a)(4) 390(1)(d)                                        X

Method of treatment, storage, or disposal for each hazardous waste; 265.76(a)(5) 390(1)(e)   The state rule has always differed slightly in that it refers to method of management, and does not specifically list treatment, storage or disposal.  The meaning is the same. The state rule on the whole infers that recycling is a method of management.                                        X

Certification signed by owner/ operator of facility or his authorized representative; and 265.76(a)(6) 390(1)(f)                                        X

Brief explanation of why waste was unmanifested, if known. 265.76(a)(7) 390(1)(g)                                        X

[Reserved] 265.76(b) No analog Not necessary as this was due to a renumbering in the federal regulations                                        X


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33434]
[DOCID:fr13jy09-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. OR09-14-000]

Tesoro Refining and Marketing Company, Complainant v. Calnev Pipe
Line, LLC, Respondent; Notice of Complaint

July 2, 2009.
    Take notice that on June 30, 2009, Tesoro Refining and Marketing
Company (Tesoro) filed a formal complaint against Calnev Pipe Line, LLC
(Calnev) pursuant to Rule 206 of the Rules of Practice and Procedure of
the Federal Energy Regulatory Commission, 18 CFR 385.206; the
Procedural Rules Applicable to Oil Pipeline Proceedings, 18 CFR 343.2,
sections 1(5), 8, 9, 13, 15, and 16 of the Interstate Commerce Act
(ICA), 49 U.S.C. App. Sec. Sec.  1(5), 8, 9, 13, 15 and 16 (1984); and
section 1803 of the Energy Policy Act of 1992 (EPAct).
    Tesoro alleges that Calnev has overstated its cost of service in
the 2007 and 2008 Form 6 filed with the Commission. Tesoro requests
that the Commission determine that the cost of service methodology
employed by Calnev in the 2007 and 2008 Form 6s improperly
characterized Calnev's cost of service, resulting in unjust and
unreasonable rates, thereby violating sections 1(4) and 1(5) of the ICA
and section 343.2(c)(1) of the Commission's regulations.
    Tesoro certifies that copies of the complaint were served on the
contacts for Calnev as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link, and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 20, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16432 Filed 7-10-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 6, 2008 (Volume 73, Number 88)]
[Notices]
[Page 25016-25018]
[DOCID:fr06my08-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0259]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry: Fast Track Drug Development
Programs: Designation, Development, and Application Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information concerning requests by sponsors of investigational new
drugs and applicants for new drug approvals or biologics licenses for
fast track designation as provided in the guidance for industry on fast
track drug development programs.

DATES: Submit written or electronic comments on the collection of
information by July 7, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comment on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Guidance for Industry: Fast Track Drug Development Programs:
Designation, Development, and Application Review (OMB Control Number
0910-0389)--Extension

    Section 112(a) of the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Pub. L. 105-115) amended the Federal Food, Drug,
and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356). The
section authorizes FDA to take appropriate action to facilitate the
development and expedite the review of new drugs, including biological
products, intended to treat a serious or life-threatening condition and
that demonstrate a potential to address an unmet medical need. Under
FDAMA section 112(b), FDA issued guidance to industry on fast track
policies and procedures outlined in section 506 of the act. The
guidance discusses collections of information that are specified under
section 506 of the act, other sections of the Public Health Service Act
(the PHS Act), or implementing regulations. The guidance describes
three general areas involving collection of information: (1) Fast track
designation requests, (2) premeeting packages, and (3) requests to
submit portions of an application. Of these, fast track designation
requests and premeeting packages, in support of receiving a fast track
program benefit, provide for additional collections of information not
covered elsewhere in statute or regulation. Information in support of
fast track designation or fast track program benefits that has
previously been submitted to the agency, may, in some cases, be
incorporated into the request by referring to the information rather
than resubmitting it.
    Under section 506(a)(1) of the act, an applicant who seeks fast
track designation is required to submit a request to the agency showing
that the product: (1) Is intended for a serious or life-threatening
condition; and (2) the product has the potential to address an unmet
medical need. Mostly, the agency expects that information to support a
designation request will have been gathered under existing provisions
of the act, the PHS Act, or the implementing regulations. If such
information has already been submitted to the agency, the information
may be summarized in the fast track designation request. The guidance
recommends that a designation request include, where applicable,
additional information not specified elsewhere by statute or
regulation. For example, additional information may be needed to show
that a product has the potential to address an unmet medical need where
an approved therapy exists for the serious or life-threatening
condition to be treated. Such information may include clinical data,
published reports, summaries of data and reports, and a list of
references. The amount of information and discussion in a designation
request need not be voluminous, but it should be sufficient to permit a
reviewer to assess whether the criteria for fast track designation have
been met.
    After the agency makes a fast track designation, a sponsor or
applicant may submit a premeeting package which may include additional
information supporting a request to participate in certain fast track
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for fast track designation, the agency expects that
most sponsors or applicants will have gathered such information to meet
existing requirements under the act, the PHS Act, or implementing
regulations. These may include descriptions of clinical safety and
efficacy trials not conducted under an investigational new drug
application (i.e., foreign studies), and information to support a
request for accelerated approval. If such information has already been
submitted to FDA, the information may be summarized in the premeeting
package. Consequently, FDA anticipates that the additional collection
of information attributed solely to the guidance will be minimal.
    Under section 506(c) of the act, a sponsor must submit sufficient
clinical data for the agency to determine, after preliminary
evaluation, that a fast track product may be effective. Section 506(c)
also requires that an applicant provide a schedule for the submission
of information necessary to make the application complete before FDA
can commence its review. The guidance does not provide for any new
collection of information regarding the submission of portions of an
application that is not required under section 506(c) of the act or any
other provision of the act. All forms referred to in the guidance have
a current OMB approval: FDA Forms 1571 (OMB Control No. 0910-0014);
356h (OMB Control No. 0910-0338); and 3397 (OMB Control No. 0910-0297).
    Respondents to this information collection are sponsors and
applicants who seek fast track designation under section 506 of the
act. The agency estimates the total annual number of respondents
submitting requests for fast track designation to the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research is approximately 64, and the number of requests received
is approximately 77 annually. FDA estimates that the number of hours
needed to prepare a request for fast track designation is approximately
60 hours per request.
    Not all requests for fast track designation may meet the statutory
standard. Of the requests for fast track designation made per year, the
agency granted 60 from 54 respondents, and for each of these granted
requests a premeeting package was submitted to the agency. FDA
estimates that the preparation hours are approximately 100 hours per
premeeting package.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
    Reporting            No. of        Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Designation                       64               1.28                 77                 60              4,620
 Request
----------------------------------------------------------------------------------------------------------------
Premeeting                        54               1.11                 60                100              6,000
 Packages
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................             10,620
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: April 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9882 Filed 5-5-08; 8:45 am]

BILLING CODE 4160-01-S