From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Tuesday, January 17, 2023 4:25 PM
To:
Brenna M Harden<EMAIL_ADDRESS>Cc:
Rob Sanch<EMAIL_ADDRESS>David W Fanning Jr<EMAIL_ADDRESS>Laura J Harris<EMAIL_ADDRESS>Tim Rodak<EMAIL_ADDRESS>Mcginn, Kevin<EMAIL_ADDRESS>Shappley, Ned<EMAIL_ADDRESS>French, Chuck<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
RE: ICR Enclosure 2 Fugitive Monitoring - DTE Vantage EES Coke

Ms. Harden  -  Thanks for letting me know in detail about the issues impacting the deadline for DTE's EES Coke's fugitive emissions data. We would prefer you send any data as soon as you are ready to send.

To summarize, please send "preliminary report on January 24 deadline with an amended report by February 10."

Please also provide in cover email for each set of data, what exactly is included, i.e., locations, methods, and dates of data.

Thank you for your work on this section 114 request.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Brenna M Harden<EMAIL_ADDRESS>Sent: Tuesday, January 17, 2023 3:35 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Rob Sanch<EMAIL_ADDRESS>David W Fanning Jr<EMAIL_ADDRESS>Laura J Harris<EMAIL_ADDRESS>Tim Rodak<EMAIL_ADDRESS>Subject: ICR Enclosure 2 Fugitive Monitoring - DTE Vantage EES Coke

Dr. Jones, I hope the new year finds you well. EES Coke has been diligently completing fugitive monitoring at the Island. As we prepare for the upcoming deadline, laboratory results have been taking longer than standard turn around times. I am sure some of it may have to do with the holidays but I believe that the majority of the delay revolves around labor shortage and delays in laboratory reports that the industry is observing since COVID. According to my notes the ICR would require the first three months of monitoring results for Fugitive Monitoring to be submitted by January 24, 2023. As of today, we have only received results from October 12, 2022 up to November 22, 2023 for Method BTEX (Method 324A/B) (three data sets). Additionally we have only received one data set for TO-13A (PAHs) and TO-15 (VOCs) from October 2022. Typically DTE likes to have a minimum of two weeks to review / correct any agency submission for good QA/QC protocols. After discussion with the subcontractor, we may receive one more set of data prior to January 24, 2023.

EES would love to meet the January 24, 2023 deadline but any report submitted by then would cover sampling results much less than the requested three months.  As EES is quite sure that EPA is eager to receive results, we can submit what we have for the January 24, 2023 deadline but it will be short several values. Subsequently, EES could send an amended 3-month report by February 10[th] based on current anticipated delivery of data, review and report generation.

Dr. Jones, would EPA be OK with this approach (preliminary report on January 24 deadline with an amended report by February 10) or would you prefer all data at one report for the monitoring period on February 10[th]?

Regards,
Brenna Harden
DTE Vantage | EES Coke Battery, L.L.C., Senior Environmental Engineer
PO Box 18309, River Rouge, MI 48218
o<PHONE_NUMBER> | m<PHONE_NUMBER>
dtevantage.com


ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [ EPA R01 OAR 2005 ME 0006 ; A 1 FRL ]

Approval and Promulgation of Air Quality Implementation Plans; Maine; 15% and 5% Emission Reduction Plans, Inventories, and Transportation Conformity Budgets for the Portland One and Eight Hour Ozone Nonattainment Areas AGENCY: Environmental Protection Agency ( EPA).

ACTION: Proposed rule.

SUMMARY: The EPA is proposing to approve State Implementation Plan ( SIP) revisions submitted by the state of Maine. These revisions establish a 15% VOC emission reduction plan,

and revised 1990 base year emissions inventory, for the Portland Maine one hour ozone nonattainment area. Additionally, these revisions establish a 5% increment of progress emission reduction plan, 2002 base year inventory, and transportation conformity budget for the Portland Maine eight hour ozone nonattainment area. The intended effect of this action is to propose approval of these plans as revisions to the Maine SIP. This action is being taken under the Clean Air Act.

DATES: Written comments must be received on or before [ Insert date 30 days from date of publication].

ADDRESSES: Submit your comments, identified by Regional Material in EDocket ( RME) ID Number EPA R01 OAR 2005 ME 0006 by one of the following methods:

1. Federal eRulemaking Portal: http:// www. regulations. gov. Follow the on line instructions 2 for submitting comments.

2. Agency Website: http:// docket. epa. gov/ rmepub/ Regional Material in EDocket ( RME),

EPA's electronic public docket and comment system, will be replaced by an enhanced federal wide electronic docket management and comment system located at www. regulations. gov. On November 28, 2005, when that occurs, you will be redirected to that site to access the docket EPA R01 OAR 2005 ME 0006 and submit comments.

Follow the on line instructions for submitting comments.

3. E mail: conroy. dave@ epa. gov 4. Fax: 617 918 0661 5. Mail: " RME ID Number EPA R01 OAR 2005 ME 0006" David Conroy, U. S.

Environmental Protection Agency, EPA New England Regional Office, One Congress Street, Suite 1100 ( mail code CAQ), Boston, MA 02114 2023.

6. Hand Delivery or Courier. Deliver your comments to: David Conroy, Manager, Air Programs Branch, Office of Ecosystem Protection, U. S. Environmental Protection Agency, EPA New England Regional Office, One Congress Street, 11th floor, ( CAQ),

Boston, MA 02114 2023. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8: 30 to 4: 30 excluding federal holidays.

Instructions: Direct your comments to Regional Material in EDocket ( RME) ID Number EPAR01 OAR 2005 ME 0006. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http:// docket. epa. gov/ rmepub/

including any personal information provided, unless the comment includes information claimed to 3 be Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. Do not submit through Regional Material in EDocket ( RME), regulations. gov, or e mail,

information that you consider to be CBI or otherwise protected. The EPA RME website and the federal regulations. gov website are " anonymous access" systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e mail comment directly to EPA without going through RME or regulations. gov,

your e mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the electronic docket are listed in the Regional Material in EDocket ( RME) index at http:// docket. epa. gov/ rmepub/. Although listed in the index, some information is not publicly available, i. e., CBI or other information whose disclosure is restricted by statute.

Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in RME or in hard copy at Office of Ecosystem Protection, U. S. Environmental Protection Agency, EPA New England Regional Office, One Congress Street, Suite 1100,

Boston, MA. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional 4 Office's official hours of business are Monday through Friday, 8: 30 to 4: 30 excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Air Quality Planning Unit,

U. S. EPA Region 1, One Congress Street, Suite 1100 CAQ, Boston, MA, 02114 2023, telephone number 617 918 1046, fax number 617 918 0046, e mail mcconnell. robert@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. How Can I Get Copies Of This Document and Other Related Information ?

In addition to the publicly available docket materials available for inspection electronically in Regional Material in EDocket, and the hard copy available at the Regional Office, which are identified in the ADDRESS section above, copies of the state submittal and EPA's technical support document are also available for public inspection during normal business hours, by appointment at the Bureau of Air Quality Control, Department of Environmental Protection,

Tyson Building, First Floor, Augusta Mental Health Institute Complex, Augusta, ME 04333

0017.

B. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/ or data you used that support your views. 5 4. If you estimate potential burden or costs, explain how you arrived at your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

7. Make sure to submit your comments by the comment period deadline identified.

8. To ensure proper receipt by EPA, identify the appropriate regional file/ rulemaking identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

II. Rulemaking Information Organization of this document. The following outline is provided to aid in locating information in this preamble.

A. Background B. 15% VOC Emission Reduction Plan 1. Background 2. Calculation of required reductions a. Step 1: 1990 Base Year Inventory b. Step 2: 1990 rate of progress inventory c. Step 3: Adjusted base year inventory d. Step 4: Calculation of required reductions e. Step 5: Determination of total expected reductions f. Step 6: Target level of emissions g. Step 7: Project emissions to target year 3. Evaluation of control measures 6 a. Point source controls b. Area source controls c. On road mobile source controls d. Nonroad mobile source controls 4. Contingency measures C. 5% Increment of Progress Plan 1. Background 2. 5% increment of progress plan requirements a. Step 1: Establish 2002 emissions baseline b. Step 2: Calculate 5% reduction c. Step 3: Project emissions to 2007 d. Step 4: Determine emissions target e. Step 5: Compare 2007 to 2002 inventory 3. Evaluation of control measures a. Chapter 130 solvent cleaning rule b. Chapter 151 AIM coatings rule c. Chapter 152 consumer products rule d. Chapter 153 auto repair & refinishing rule D. Transportation Conformity Budgets A. Background On June 9, 13, and 14, 2005, the Maine Department of Environmental Protection ( DEP)

submitted revisions to its State Implementation Plan ( SIP) for ozone. These revisions consist of a 7 15% rate of progress ( ROP) plan, a 5% increment of progress emission reduction plan, the associated base year emission inventories developed in support of these plans, and transportation conformity budgets for 2007 established by the 5% increment of progress plan. A public hearing on these SIP revisions was conducted by the state on April 21, 2005. This action proposes approval of these SIP revisions, and provides EPA's rationale for doing so.

B. 15% VOC Emission Reduction Plan 1. Background Section 182( b)( 1) of the Clean Air Act ( CAA) as amended in 1990 requires that moderate and above one hour ozone nonattainment areas develop plans to reduce area wide Volatile Organic Compound ( VOC) emissions from a 1990 baseline by 15%. The plans were required to be submitted by November 15, 1993 and the reductions were required to be achieved within 6 years after enactment, meaning by November 15, 1996. The CAA also set limitations on the creditability of certain types of reductions. For example, states cannot take credit for reductions achieved by Federal Motor Vehicle Control Program ( FMVCP) measures ( new car emissions standards) that were already in place prior to the 1990 amendments to the CAA, or for reductions due to controls on gasoline Reid Vapor Pressure ( RVP) that were promulgated prior to 1990.

In 1991, EPA designated the Portland area, which includes all of Cumberland, Sagadahoc and York counties, as a nonattainment area for the one hour ozone standard, and classified the area as moderate. Maine is, therefore, subject to the 15% rate of progress ( ROP) requirement. Maine submitted a final 15% ROP plan to EPA on July 25, 1995. However, air quality in the Portland area fluctuated above and below the one hour ozone national ambient air quality standard 8 1 May 10, 1995, guidance memorandum signed by John S. Seitz, Director of the Office of Air Quality Planning and Standards, which stated in part that ozone nonattainment areas subject to 15% ROP requirements that were meeting the ozone standard did not need to submit 15% ROP plans as long as the area continued to meet the standard. ( NAAQS) after 1995. Pursuant to EPA policy1, the Agency interpreted the Act not to require a 15% plan during times that the Portland area's air quality was better than EPA's one hour ozone NAAQS, and so EPA never approved the state's June 1995 plan into the SIP.

Beginning in 2002, the Portland area has again been in violation of the one hour ozone standard,

and so the 15% plan requirement is again pertinent for this area. In consultation with Maine DEP,

it was determined that the state would revise the 15% plan submitted in 1995 to reflect up to date emission estimation methodologies and control strategies. On June 9, 2005, the state submitted a revised, adopted 15% rate of progress plan for the Portland one hour nonattainment area.

2. Calculation of required reductions a. Step 1: 1990 base year inventory.

The first step in calculating the emission reductions needed to comply with the 15% VOC emission reduction requirement is to prepare a 1990 base year emission inventory for VOCs. The EPA approved Maine's 1990 base year inventory of ozone precursors on February 28, 1997 ( 62 FR 9081). Some of the emission estimates contained within Maine's revised 15% plan submitted in June of 2005 were updated using improved methodologies that have arisen since the earlier inventory was prepared. The most significant revisions made occurred in the estimates for mobile sources. For the nonroad sector ( excluding commercial marine, rail, and emissions from aircraft),

Maine DEP's prior emission estimates were based on outdated studies conducted for EPA's then 9 Office of Mobile Sources in 1991. Since that time, EPA has made numerous refinements to its emission estimation techniques for the diverse types of nonroad engines, and compiled them in a software program referred to as the Nonroad Model. Maine DEP used this tool to generate a revised 1990 emission estimate for this sector. Additionally, Maine DEP's originally approved 1990 emission estimate for on road vehicles was based on EPA's Mobile 5a model. The state recalculated its 1990 emission estimate using the Mobile 6.2 version of the model, as that is the most current version. Maine also made changes to some of its emission estimates for stationary sources, as outlined in the support material submitted by the state with this SIP revision.

Table 1 below compares the previously approved emission estimates to those in the state's revised 1990 inventory.

Table 1: Comparison of 1990 Emission Estimates ( tpsd)

SOURCE CATEGORY Originally approved emissions June, 2005 emissions Point Source 9.65 9.65 Area Source 31.8 33.43 Non road Mobile 7.4 18.08 On Road Mobile 49.87 63.31 Biogenic 197.6 197.6 Total 296.32 322.07 10 During development of the revised 15% plan, Maine DEP and EPA ensured that the 1990 emission estimation methodologies matched the methods used to prepare its projected 2005 inventory to ensure that the same methods were used for both inventories. This was done to ensure that emission reduction credit was not taken due simply to changes in emission estimation technique.

b. Step 2: 1990 rate of progress inventory The second step involves excluding biogenic emissions and emissions included within the base year inventory which do not emanate from within the boundaries of the nonattainment area.

Maine's base year inventory for the Portland nonattainment area did not include any emissions from sources outside of the area. Therefore, step 2 consists of simply subtracting the biogenic VOC component, producing a " rate of progress" inventory of 124.47 tpsd.

c. Step 3: Adjusted base year inventory The third step in calculating the required emission reductions is to subtract the emission reductions that are not creditable toward the 15% VOC emission reduction goal. The reductions which are not creditable include those which would have occurred even without passage of the 1990 CAA Amendments due to control programs already in place. The FMVCP and gasoline RVP standards are examples of such non creditable programs. Maine had no RVP reductions to account for since the state has been using gasoline that meets the required RVP maximum of 9.0 psi or lower since 1989, but did have to account for the non creditable FMVCP reductions.

Maine included within the 15% plan the input and output MOBILE6.2 files documenting its determination of these reductions, which turned out to be 35.93 tpsd. Subtracting this amount 11 from the rate of progress inventory calculated in step 2 of 124.47 tpsd yields 88.54 tpsd.

d. Step 4: Calculation of required reductions In this step, the adjusted base year inventory is multiplied by 15% to calculate the amount of the required 15% emission reduction: 88.54 * 0.15 = 13.28 tpsd.

e. Step 5: Determination of total expected reductions The total expected reductions from the 1990 rate of progress inventory ( calculated in step 2)

include the 15% emission reduction calculated in step 4, and the emission reductions anticipated from the noncreditable programs as outlined in step 3. Additionally, emission reductions that occur between 1990 and 1996 due to corrections to pre existing ( pre 1990) but deficient I& M programs and/ or deficient RACT rules, though not eligible to count towards the 15% emission reduction requirement, still represent emission reductions that are expected to occur between 1990 and 1996. Maine did not have a pre 1990 I& M requirement, nor any " RACT Fix up"

obligations, and so the total expected emission reductions for the Portland nonattainment area are the sum of reductions from steps 3 and 4: 35.93 + 13.28 = 49.21 tpsd.

f. Step 6: Target level of emissions The target level of emissions for 1996 is obtained by subtracting the total required reductions ( step 5) from the 1990 rate of progress inventory ( step 2). For the Portland area this yields:

124.47  49.21 = 75.26 tpsd.

g. Step 7: Project emission to target year 12 The original 15% plans required by the CAA were required to be submitted to EPA in 1993.

These plans were to include emission projections to 1996, the year by which the 15% emission reductions were to be achieved. Due to the circumstances described above, Maine DEP's revised 15% plan could not conceivably demonstrate that a 15% emission reduction occurred from 1990 levels by 1996, as that year has passed. Once a statutory deadline has passed and has not been replaced by a later one, it is reasonable to require the plan to comply with the act " as soon as possible." See Delaney v. EPA, 898 F. 2d 687, 691 ( 9th Circuit, 1990). EPA has interpreted this requirement to be " as soon as practicable." Upon consultation between EPA and Maine DEP,

EPA determined that 2005 is the most suitable year by which Maine's revised 15% analysis must demonstrate the 15% reduction. Accordingly, an estimate of emissions in 2005 was needed.

Although an estimate of 2005 emission was needed, the most current inventory available to Maine DEP was its 2002 inventory, and so an estimate of growth in emissions from 2002 to 2005 was used to complete the 15% VOC emission reduction demonstration. This was accomplished by taking the 2002 inventory and multiplying it by growth factors which estimate growth from 2002 to 2005. Growth factors specific to each source category were used since the sources typically grow at different rates. For example, Maine used growth factors obtained from the Bureau of Economic Analysis ( BEA) via a tool they developed called the Economic Growth Analysis System ( EGAS) to project most of the point and area source emissions growth from 2002 to 2005.

Once emissions were projected to 2005, a review was made to see if any controls not in existence in 2002 became effective by 2005. If so, the state reduced emissions to account for the controls, 13 as will be described in section II. B. of this document. Maine DEP did not use the emission reductions generated pursuant to its adoption of area source VOC rules developed by the Ozone Transport Commission ( OTC) in its 15% plan, i. e., Maine's projected 2005 emission estimates do not reflect emission reductions from these measures. Maine DEP did use reductions from these measures to meet its 5% plan emission reductions requirements as is explained in Section C. of this document.

Table 2 below compares Maine's projected, controlled 2005 emissions for the Portland nonattainment area with its 1990 emission estimates:

Table 2: Comparison of 1990 and 2005 VOC Emissions Emission Source Category 1990 Base Year Emissions 2005 projected, controlled Emissions Point 9.65 4.32 *

Area 33.43 24.7 Off road Mobile 18.08 15.75 On road Mobile 63.31 23.48 Total 124.47 68.25 * includes 0.82 tpsd in VOC offsets awarded to Spinnaker Coating The CAA Section 182( b)( 1)( A) language regarding the 15% VOC emission reduction requirement states that this reduction must occur, " accounting for any growth in emissions after 14 the year in which the CAAA of 1990 were enacted." EPA interprets this passage to mean any growth in emission levels between 1990 and 1996 must also be offset so that by 1996, emission levels will be truly 15% lower than they were in 1990. In actuality, emission levels will be reduced by more than 15% in the evaluation year because other required reductions, such as those from pre enactment FMVCP, will also be occurring as described above.

Maine's projected, controlled 2005 inventory for the Portland area totals 68.25 tpsd. This is considerably lower than the target level of emissions of 75.26 calculated in step 6. Maine DEP has therefore shown that emissions have been reduced by 15% from 1990 levels, after accounting for growth, and not counting the non creditable reductions from the FMVCP program.

3. Evaluation of control measures.

a. Point source controls.

Maine DEP's revised 15% plan analysis shows that VOC emissions from point sources fell 5.33 tpsd ( 55%) between 1990 and 2005. Table 3 below summarizes the control programs that affected this decrease in emissions.

Table 3: Point Source Controls for VOC Sources Point Source Category Rule Implementation Date Federal Approval Chapter 129 ( Surface Coating) May 31, 1995 June 17, 1994 ( 59 FR 31154) 15 Chapter 130 ( Solvent Degreasers) May 31, 1995 June 17, 1994 ( 59 FR 31154)

Chapter 134 ( Non CTG Sources) May 31, 1995 April 18, 2000 ( 65 FR 20749)

Bulk Terminal Emission Limit May 31, 1996 October 15, 1996 ( 61 FR 53636)

Additional information on each of these regulations is available in the Federal Register notice that contains EPA's approval of them.

VOC offsets: Maine DEP's revised 15% plan indicates that one source in the Portland area,

Spinnaker Coatings in Westbrook, applied for and obtained VOC offset credits in the amount of 213 tons which could be used ( emitted) in the future. To account for this, Maine DEP translated these emissions into what could be emitted during a typical summer day, ( 0.82 tons), and added that value to its projected 2005 ( and 2007 for its 5% plan) emission estimate from point sources.

b. Area source controls Maine DEP's revised 15% plan analysis shows that VOC emissions from area sources fell 8.73 tpsd ( 26%) between 1990 and 2005, despite the growth that occurred in population and other activity indicators. The discussion below summarizes the area source control programs that caused this change in emissions.

Stage I: Maine has adopted and submitted to EPA a Stage I vapor recovery regulation that limits 16 VOC emissions from the filling of underground storage tanks at gasoline stations. The rule applies to facilities with through puts that exceed 10,000 gallons per month. Chapter 118 of the state's VOC control regulations entitled " Gasoline Dispensing Facilities Vapor Control" was submitted to EPA on July 11, 1994, and approved as a revision to the Maine SIP within a Federal Register notice published on June 29, 1995 ( 60 FR 33730). The state projects that VOC emissions will be reduced by 1.35 ( 52%) tpsd by this program between 1990 and 2005.

Stage II: Maine has adopted and submitted to EPA a Stage II vapor recovery regulation that limits VOC emissions from vehicle refueling activity in the Portland nonattainment area. Chapter 118 of the state's VOC control regulations entitled " Gasoline Dispensing Facilities Vapor Control" was submitted to EPA on July 26, 1995, and approved as a revision to the Maine SIP within a Federal Register notice published on October 15, 1996 ( 61 FR 53636). The rule is applicable to gasoline stations with throughputs greater than 1,000,000 gallons per year. Maine used EPA's Mobile 6.2 program to calculate emission reductions from all of the state's on road mobile source control programs simultaneously, and therefore a separate amount of emission reduction credit from the Stage II program is not reported in the state's 15% SIP.

Cutback asphalt: Maine has adopted and submitted to EPA a cutback asphalt regulation ( Chapter 131) that prohibits the use of cutback asphalt for most applications during the ozone season.

Maine adopted this rule on January 6, 1993, and submitted it to EPA as a revision to the state's SIP. EPA approved the rule as part of the state's SIP within a Federal Register notice dated June 17, 1994 ( 59 FR 31154). The state determined that emissions were reduced by 7.33 tpsd 17 ( 95%) between 1990 and 2005 due to this control program.

Architectural and industrial maintenance ( AIM) coatings: Emission reductions were taken from the Architectural and Industrial Maintenance ( AIM) surface coating emission source category due to a federal rule that required such coatings be reformulated to emit less VOCs. In a memo dated March 22, 1995, EPA provided guidance on the expected reductions from the national rulemaking on AIM coatings, stating that emissions would be reduced by 20%. The state determined that despite growth in this sector between 1990 and 2005, emissions were reduced by 0.46 tpsd ( 9%)

in the Portland nonattainment area due to this federal rule.

Automobile refinishing: A November 29, 1994, EPA guidance memorandum specifies that states can assume a 37% control level for this source category due to a National rule. The state projects that between 1990 and 2005, the net effect of activity growth and implementation of the federal rule reduced emissions by 0.12 tpsd ( 20%) in the Portland nonattainment area.

Consumer products: On June 22, 1995, EPA issued a guidance memorandum regarding the regulatory schedule for consumer and commercial products which indicated that states that have not adopted their own consumer and commercial products rule could take emission reduction credit from a pending national consumer and commercial products rulemaking. After recalculating its base year emission estimate to account for updated guidance as mentioned earlier in this document, the state applied the recommended control level of 12.5% and determined that between 1990 and 2005, emissions from this sector actually rose by 0.19 tpsd ( 4%) as population growth overwhelmed the reductions from the federal rule. 18 c. On road mobile source controls Maine DEP identified and modeled within its Mobile 6.2 runs a number of state and federal motor vehicle emission and fuel control programs that reduce emissions in the state. These control programs are discussed below. Region 1 has confirmed that Maine correctly modeled these programs together to calculate the overall emission reduction benefit from them.

Low RVP gasoline program: On June 26, 1991 the state submitted a letter from the Governor requesting that Maine participate in the reformulated fuels program. This request was published in the Federal Register on September 10, 1991, 56 FR 46119. However, Maine subsequently rescinded its participation in this program and replaced it with its Chapter 119 rule, a low RVP program which limits the RVP of gasoline sold in the 7 southern most Maine counties, including all of the Portland 1 hour area, to a level no greater than 7.8 from May 1 to September 15 of each year. This regulation was submitted to EPA and approved into the state's SIP on March 6, 2002 ( 67 FR 10099).

Motor vehicle inspection and maintenance ( I& M) program: Maine state regulations include an I& M program which has minimal requirements. In Cumberland county, the program requires a check of gas cap fitting adequacy. Additionally, an anti tampering program checks for any modification to exhaust catalysts exists in Portland, Sagadahoc, and York counties. Maine adopted its automobile inspection and maintenance program on July 9, 1998, and submitted it to EPA as a revision to the state's SIP. EPA approved the program into the state's SIP in a Federal Register notice published on January 10, 2001 ( 66 FR 1875). 19 Tier I federal motor vehicle control program: The EPA promulgated standards for 1994 and later model year light duty vehicles and light duty trucks ( 56 FR 25724, June 5, 1991). Since the standards were adopted after the Clean Air Act amendments of 1990, the resulting emission reductions are creditable toward the 15 percent reduction goal.

California low emission vehicle program: Chapter 127 of the Maine DEP Air rules is entitled " New Motor Vehicle Emission Standards," began phasing in during 2001, and requires the sale of motor vehicles meeting California certification standards contained within Title 13 of the California Code of Regulations pertaining to emission standards for motor vehicles. Maine submitted this rule to EPA as a revision to the state's SIP on February 25, 2004. EPA approved the program into the Maine SIP in a final rule published in the Federal Register on April 28,

2005 ( 70 FR 21959).

Onboard vapor recovery systems: This is a federal program required by section 202( a)( 6) of the 1990 CAAA. For passenger cars, the onboard control requirements will be phased in over three model years with 40 percent, 80 percent, and 100 percent of new car production being required to meet the standard in model years 1998, 1999, and 2000, respectively. The phase in of onboard controls for light trucks will follow the phase in period for cars. Onboard controls for the lighter class of light trucks ( those under 6000 pounds GVWR) will be phased in during models years 2001 through 2003, while onboard controls for the heavier light trucks ( those from 6001 through 8500 pounds GVWR) will be phased in during models years 2004 through 2006. When fully phased in, the new controls will capture 95 percent of refueling emissions. 20 d. Nonroad mobile source controls EPA has established emission standards for a variety of non road engine categories that will reduce ozone precursor emissions over the time period covered by the Maine 15% plan. These standards affect heavy duty compression ignition ( diesel) engines, small non road spark ignition ( gasoline) engines, large non road gasoline engines, gasoline powered outboard and personal water craft engines, commercial diesel marine engines, recreational stern drive and inboard engines, and locomotives. Detailed information regarding each of these emission control programs is available on EPA's web site at: www. epa. gov/ otaq.

EPA has also created a draft nonroad air emissions estimation model that can be used to calculate emissions from all nonroad engines except those used to power aircraft, locomotives, and large commercial marine vessels, for the present year, and for past or future years. Maine DEP used the Nonroad Model to calculate air emissions from this sector in the Portland area. Region 1 has reviewed and confirmed the emission estimates for nonroad engines Maine has used in its revised inventories and ROP plans.

4. Contingency measures On April 30th, 2004, EPA published a final rule ( the " Phase 1" rule), which included provisions for revoking the one hour ozone standard one year from the effective date of the designations for the 8 hour ozone standard. This requirement is codified in the Code of Federal Regulations at 40 CFR Part 50.9( b). Prior to revocation, ozone nonattainment areas classified as moderate or above were required to include in their submittals under section 172( b) of the CAA, contingency 21 measures to be implemented if ROP was not achieved or if the standard is not attained by the applicable date. However, on May 26, 2005, EPA published a final rule ( 70 FR 30592) that, in light of the revocation of the one hour ozone standard, removed the requirement that contingency plans be adopted for ROP plans submitted to make progress toward achievement of the one hour ozone standard. Accordingly, Maine DEP's revised 15% ROP plan does not contain contingency measures.

C. 5% Increment of Progress Plan 1. Background On July 18, 1997, EPA promulgated a new NAAQS for ozone based on an 8 hour averaging period. Court challenges to the 8 hour ozone standard delayed implementation of it, but were eventually resolved and on April 30, 2004, EPA promulgated designations for the 8 hour ozone standard in the Federal Register ( 69 FR 23858). The effective date for the designations was June 15, 2004. Portions of Maine were designated nonattainment for this standard, including the Portland 8 hour area which was classified as a marginal nonattainment area. The Portland 8 hour marginal nonattainment area consists of Sagadahoc county, most portions of Cumberland and York counties, and one town in Androscoggin county. As such, it differs geographically from the Portland 1 hour nonattainment area, as that area consists of Cumberland, Sagadahoc, and York counties in their entirety.

On April 30, 2004, EPA also published the first part of its rule governing implementation of the 8

hour ozone standard ( 69 FR 23951). Although this rule dealt primarily with issues pertaining to the new 8 hour ozone standard, it included some provisions relevant to the one hour ozone 22 NAAQS. Of particular interest to Maine was a provision allowing one hour areas with unmet attainment demonstration obligations to submit, in lieu of a full one hour ozone attainment demonstration, an early 5% increment of progress plan toward achievement of the 8 hour standard. Such plans would need to be submitted no later than one year from the effective date of the 8 hour ozone standard, meaning by no later than June 15, 2005. Maine's Portland one hour nonattainment area has an unmet attainment demonstration obligation, and so Maine DEP decided to prepare a 5% increment of progress plan to meet its unmet one hour attainment demonstration obligation. Accordingly, Maine's June 9, 2005 SIP revision request to EPA included a 5%

increment of progress plan.

The geographic area covered by the Portland 8 hour area is smaller than the area covered by the Portland 1 hour area in that it only includes portions of Cumberland and York counties, whereas the 1 hour area covers these two counties entirely ( plus all of Sagadahoc county). Given the difficulties of SIP planning activities at a sub county level, in particular preparation of emission inventories at a sub county level, Maine DEP developed its 5% increment of progress plan such that it covers all of the old one hour nonattainment area. As such it covers a larger area and plans for more emission reductions than is required, even though one town, the town of Durham in Androscoggin county, is not covered by the plan. EPA worked closely with the Maine DEP in development of this plan, and we believe that the geographic area Maine DEP chose to cover in its 5% increment of progress plan is appropriate and reasonable. We believe this to be so because the mix of stationary and mobile emission sources is fairly uniform across the area, and so the net result of expansion of the geographic area is primarily an increase in the amount of emission reductions that must be planned for. 23 2 " Guidance on 5% Increment of Progress" ( 40 CFR 51.905( a)( 1)( ii)); dated August 18, 2004; from Lydia Wegman, Director, OAQPS, to EPA Regional Air Directors. Given the difficulty and additional uncertainty introduced by developing emission inventories at the sub county level, it is not likely that doing so would produce data that would improve our decision making ability. Accordingly, as mentioned above we believe that Maine DEP's use of full county emission inventories is appropriate. However, transportation conformity budgets need to match the exact geographic borders of the nonattainment area they are associated with. Since development of on road mobile source emission estimates at the sub county level is not unduly burdensome, and critical for transportation conformity purposes, Maine DEP's 5% increment of progress plan contains on road mobile source inventories for 2007 that exactly match the geographic area of its 8 hour nonattainment area.

2. 5% increment of progress plan requirements EPA issued a guidance memorandum2 on August 18, 2004 which outlines the criteria for 5%

increment of progress plans. In brief summary, the guidance requires the emission reduction be based on a 2002 inventory, does not allow credit from federal measures or measures already in the SIP as of 2002, requires that the reduction occur by 2007, and allows use of VOC, NOx, or some combination of both pollutants. The steps involved in determining the magnitude of the emission reductions needed to meet the 5% plan obligation are outlined below.

Step 1: Establish 2002 emissions baseline The first step in this calculation is the establishment of a 2002 emissions baseline. Although 24 EPA's August 18, 2004 guidance allows states to use EPA's draft 2002 National Emissions Inventory ( NEI) for the 2002 baseline, Maine DEP provided a better 2002 emissions baseline by developing their own 2002 inventory. This inventory includes better activity data in many instances than what is available in EPA's NEI. Maine's 2002 inventory of ozone precursors for the full 3 county area is shown below in Table 4 by major source category.

Table 4: 2002 Anthropogenic Emissions for the Portland Area Major Source Category 2002 VOC Emissions ( tpsd) 2002 NOx Emissions ( tpsd)

Point 3.29 13.08 Area 23.65 1.89 On road 30.94 61.20 Off road 16.59 13.23 Com. marine, rail, and aircraft 0.45 2.33 Total 74.90 91.70 Step 2: Calculate 5% reduction EPA's August 18, 2004 5% plan guidance allows the 5% reduction to be made from only VOC emission reductions, only NOx reductions, or from a combination of VOC and NOx reductions which in total equal 5%. Maine DEP chose to demonstrate it could meet the 5% emission reduction requirement by relying exclusively on VOC emission reductions. Therefore, its emission reduction obligation is calculated as follows: 0.05 * 74.90 = 3.75 tpsd of VOC emissions. 25 Step 3: Project emissions to 2007 The third step in the 5% calculation is to develop a 2007 inventory that reflects growth and controls from measures already in the SIP or expected to occur due to federal measures. Maine DEP prepared its projected 2007 inventory for the three county Portland area in a manner similar to the way it prepared its 2005 projected inventory as described in section 2. g of this document.

Table 5 below shows Maine's 2002 baseline and projected 2007 emissions inventory for VOCs.

Table 5: 2002 and 2007 VOC Emissions by Major Source Category Major Source Category 2002 VOC Emissions ( tpsd) 2007 VOC Emissions ( tpsd)

Point 3.29 4.0 Area 23.65 25.52 On road 30.94 20.48 Off road 16.59 14.21 Commercial Marine, Rail, and Aircraft 0.45 0.5 Total 74.90 64.73 Step 4: Determine emissions target In Step 4, the required 5% emission reduction of 3.75 tpsd is subtracted from the projected 2007 emission inventory of 64.73 tpsd, establishing an emissions target level of 60.98 tpsd for 2007.

Maine's 5% plan demonstrates that it will meet this target by reducing the area source inventory by 4.47 tpsd, taking it from 25.52 tpsd down to 21.05. This will reduce the overall inventory similarly, taking it from 64.73 tpsd to 60.26 tpsd, which is 0.72 tpsd below the target level of 26 emissions.

Step 5: Compare 2007 to 2002 inventory The final step in the 5% calculation is to ensure that the 2007 projected, controlled inventory is 5% lower than the 2002 emissions baseline. This step is required because in a rapidly growing area, a large increment of growth could conceivably overwhelm the 5% emission reduction, and the reductions from already scheduled SIP and federal control programs. This is not the case in Maine, however, as the projected, controlled 2007 emission level of 60.26 tpsd is almost 20%

lower than 2002 emissions.

3. Evaluation of control measures Maine DEP's 5% plan demonstrates that it will achieve the required level of emission reductions via adoption of four VOC emission control measures that are based on model rules developed by the Ozone Transport Commission ( OTC). The four rules apply to small source solvent cleaners ( degreasers), architectural and industrial maintenance ( AIM) coatings, consumer and commercial products, and mobile equipment repair and refinishing. Several of these rules require control measures beyond those already required by the corresponding federal measures relied on in Maine's 15% plan. Each of these rules, and the emission reductions anticipated from them, are discussed below.

a. Chapter 130 solvent cleaning rule: This regulation establishes requirements for testing,

evaluating, and limiting VOCs from solvent cleaning machines and sets minimum requirements for equipment and operation standards in order to reduce VOC emissions. Maine used a control 27 3 E. H. Pechan and Associates, " Control Measures Development Support Analysis of Ozone Transport Commission Model Rules," March 31, 2001. factor of 66% as recommended in a report by E. H. Pechan and associates3 in work done for the OTC. Facilities were required to comply with the rule by January 1, 2005, and Maine DEP expects it to produce 2.57 tpsd in emission reductions. EPA approved this rule into the state's SIP in a final rule published in the Federal Register on May 26, 2005 ( 70 FR 30367).

b. Chapter 151 AIM coatings rule: Chapter 151 establishes limits for emissions of VOCs from 51 AIM coating categories. Compliance with the rule will be required as of January 1, 2006, and Maine DEP expects it to produce 0.99 tpsd in emission reductions beyond the reductions already achieved by the federal program. However, Maine DEP will need to adjust the credit claimed for AIM reductions downward to reflect recent revisions to its Chapter 151 rule. Specifically, the proposal contains a new, less stringent, emission limit for interior wood clear and semitransparent stains. The proposal also includes a less stringent 2006 emission limit for varnishes ( although by 2011 varnishes are required to meet the same limit as in the existing rule). These revisions will impact the emission reductions Maine achieves from the implementation of Chapter 151 by 2007.

However, given that Maine's 5% plan currently includes 0.72 tpsd of surplus credits, it appears that even with these adjustments, Maine will be able to meet its 5% plan target.

Additionally, in the August 31, 2005 Federal Register ( 70 FR 51694) EPA published a notice soliciting comments, data and information with regard to calculation of emission reductions from AIM coating rules. Therefore, future adjustments may also need to be made to Maine's credit claim from this rule. However, EPA has analyzed the emission credit claims made by states that 28 have adopted AIM rules based on the OTC's model rule, and determined a 35% post federal AIM rule reduction factor is currently the most appropriate reduction factor to use. Maine DEP used the 35% post federal rule reduction factor in its AIM credit calculation. EPA has not yet approved this rule into the state's SIP. Therefore, emission reduction credit will only be granted to Maine for reductions from this rule if EPA approves it into the state's SIP on or before the date final action is taken on Maine's 5% increment of progress plan. On December 15, 2005, EPA publised a notice of proposed rulemaking ( 70 FR 74259) that proposes approval of Maine's AIM coatings rule. The comment period for that proposed rule ends January 17, 2006.

c. Chapter 152 consumer and commercial products rule: This regulation limits emissions of VOC from consumer products by establishing emission limits for consumer product source categories.

Compliance with the rule was required by May 1, 2005, and Maine DEP expects it to produce 0.72 tpsd in emission reductions in the three county area beyond the reductions already achieved by the federal program. EPA approved this rule into the state's SIP in a final rule published in the Federal Register on October 24, 2005 ( 70 FR 61382).

d. Chapter 153 mobile equipment repair and refinishing rule: This regulation limits emissions of VOCs from mobile equipment refinishing and repair facilities by limiting the VOC content of coatings, by requiring the use of high efficiency coating application systems, and through work practice standards. Maine used a control factor of 38% as recommended in the previously mentioned report by E. H. Pechan. This 38% emission reduction is above and beyond the emission reductions achieved from this sector by an earlier federal rule. Facilities were required to comply with the rule by January 1, 2005, and Maine DEP expects it to produce 0.19 tpsd in 29 emission reductions in the three county area. EPA approved this rule into the state's SIP in a final rule published in the Federal Register on May 26, 2005 ( 70 FR 30367).

D. Transportation conformity budgets Maine's 5% increment of progress plan contains projected, controlled emission levels for on road mobile sources for 2007. Although the 15% plan also contains projected, controlled emission levels, they are for 2005, and are geographically matched to the full county Portland one hour nonattainment area. EPA revoked the one hour ozone standard on June 15, 2005. Therefore, the on road mobile source VOC and NOx emissions estimates for 2007 contained in Maine's 5%

increment of progress plan will establish a transportation conformity budget, and the 2005 onroad mobile estimates in the 15% plan will not.

Although Maine DEP prepared its base year and future year inventories at the full county level,

the state included in its 5% plan a 2007 emission estimate for on road mobile sources for the exact geographic area that comprises the Portland 8 hour nonattainment area. These 2007 emission estimates establish transportation conformity budgets, and they are as follows: for VOCs, 20.115 tpsd, and for NOx, 39.893 tpsd.

In the August 30, 2005 Federal Register ( 70 FR 51353) EPA published a notice of adequacy determination for the above transportation conformity budgets. These budgets were calculated in accordance with standard EPA methods, and should be approved into the state's SIP along with the 5% increment of progress plan. 30 III. PROPOSED ACTION: EPA's review of this material indicates that Maine has prepared these emission inventories, emission reduction plans, and transportation conformity budgets in accordance with EPA methods and guidance. EPA is proposing to approve Maine's 15% rate of progress plan and associated revised 1990 inventory, and also proposing approval of the state's 5% increment of progress plan, 2002 base year inventory, and transportation conformity budgets for 2007 for VOC and NOx for the Portland 8 hour ozone nonattainment area as a revision to the state's SIP. These SIP revisions were submitted to EPA on June 9, 13, and 14, 2005. EPA is soliciting public comments on the issues discussed in this notice or on other relevant matters.

These comments will be considered before EPA takes final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA New England Regional Office listed in the ADDRESSES section of this action, or by submitting comments electronically, by mail, or through hand delivery/ courier following the directions in the SUPPLEMENTARY INFORMATION, I. General Information section of this action .

IV. Statutory and Executive Order Reviews Under Executive Order 12866 ( 58 FR 51735, October 4, 1993), this action is not a " significant regulatory action" and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, " Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" ( 66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act ( 5 U. S. C. 601 et seq.). Because this 31 rule approves pre existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 ( Public Law 104 4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175 ( 65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 ( 64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 " Protection of Children from Environmental Health Risks and Safety Risks"( 62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards ( VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, 32 15%, 5% Reduction Plans; Maine pg. 32 of 32 when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( 15 U. S. C. 272 note) do not apply.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 ( 44 U. S. C. 3501 et seq.)

List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Nitrogen dioxide, Ozone, Volatile organic compounds.

AUTHORITY: 42 U. S. C. 7401 et seq.

_______________________ ___________________________

Dated: Robert W. Varney,

Regional Administrator,

EPA New England.


[Federal Register Volume 84, Number 203 (Monday, October 21, 2019)]
[Notices]
[Pages 56194-56195]
[FR Doc No: 2019-22821]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3989]

Drug Master Files; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Drug
Master Files.'' Once finalized, this guidance will provide FDA's
current thinking on drug master files (DMFs), which are submissions to
FDA that may be used to provide confidential, detailed information
about facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of human drug products. DMFs are
submitted solely at the discretion of their holders and are not
required by statute or regulation. This draft guidance, when finalized,
will revise the guidance for industry ``Drug Master Files: Guidelines''
that published in September 1989.

DATES: Submit either electronic or written comments on the draft
guidance by December 20, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3989 for ``Drug Master Files.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20

and other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Rick Ensor, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Drug Master Files.'' Once finalized, this guidance will
provide FDA's current thinking on DMFs, which are submissions to FDA
that may be used to provide confidential, detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of human drug products. DMFs are
submitted solely at the discretion of their holders and are not
required by statute or regulation. After submission, information in
DMFs can be incorporated by reference into applications \1\ or other
DMFs submitted to FDA.
---------------------------------------------------------------------------

    \1\ This guidance focuses on DMFs under 21 CFR 314.420 that are
used to support new drug applications, abbreviated new drug
applications, and investigational new drug applications under the
FD&C Act and DMFs and other master files under 21 CFR 601.51(a) that
are used to support biologics license applications under the Public
Health Service Act. Additionally, information contained in DMFs can
generally be referenced in premarket submissions for devices (e.g.,
premarket approvals) and animal drugs (e.g., new animal drug
applications).
---------------------------------------------------------------------------

    This draft guidance, when finalized, will revise the guidance for
industry ``Drug Master Files: Guidelines'' that published in September
1989. This update includes a change in FDA's contact person for the
guidance, new procedures for DMFs referenced in abbreviated new drug
applications that reflect commitments under the Generic Drug User Fee
Amendments of 2012 (Pub. L. No. 112-144, Title III; reauthorized in
2017, Pub. L. 115-52), more detailed instructions regarding the
submission of original DMFs versus amendments, reference to the
electronic submission requirements under section 745A of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1) that apply
to certain DMFs, removal of Type I as a DMF category, and clarification
and reorganization of material associated with Type III and Type IV
DMFs.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Drug Master
Files.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR part 314 has been
approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: October 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22821 Filed 10-18-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4305-4310]
[FR Doc No: 2016-01474]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0117]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Acetylfentanyl; MT-45; para-
Methoxymethylamphetamine (PMMA); [alpha]-Pyrrolidinovalerophenone
([alpha]-PVP); para-Methyl-4-methylaminorex (4,4'-DMAR); Methoxetamine
(MXE); Phenazepam; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments, and to request
an informal public meeting concerning recommendations by the World
Health Organization (WHO) to impose international manufacturing and
distributing restrictions, under international treaties, on certain
drug substances. The comments received in response to this notice and/
or public meeting will be considered in preparing the United States'
position on these proposals for a meeting of the United Nations
Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2016.
This notice is issued under the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by February 25,
2016. Submit requests for a public meeting on or before February 5,
2016. The short time period for the submission of comments and requests
for a public meeting is needed to ensure that HHS may, in a timely
fashion, carry out the required action and be responsive to the United
Nations. For additional information, see section IV of this document.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-0117 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; Acetylfentanyl; MT-45;
para-Methoxymethylamphetamine (PMMA); [alpha]-Pyrrolidinovalerophenone
([alpha]-PVP); para-Methyl-4-methylaminorex (4,4'-DMAR); Methoxetamine
(MXE); Phenazepam; Request for Comments.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Section 201(d)(2)(B) of the CSA
(21 U.S.C. 811(d)(2)(B)) provides that when the United States is
notified under Article 2 of the Psychotropic Convention that the CND
proposes to decide whether to add a drug or other

substance to one of the schedules of the Psychotropic Convention,
transfer a drug or substance from one schedule to another, or delete it
from the schedules, the Secretary of State must transmit notice of such
information to the Secretary of Health and Human Services (Secretary of
HHS). The Secretary of HHS must then publish a summary of such
information in the Federal Register and provide opportunity for
interested persons to submit comments. The Secretary of HHS must then
evaluate the proposal and furnish a recommendation to the Secretary of
State that shall be binding on the representative of the United States
in discussions and negotiations relating to the proposal.
    As detailed in the following paragraphs, the Secretary of State has
received notification from the Secretary-General of the United Nations
(the Secretary-General) regarding 5 substances to be considered for
control under the Psychotropic Convention. This notification reflects
the recommendation from the 36th WHO Expert Committee for Drug
Dependence (ECDD), which met in June 2014. In the Federal Register of
December 30, 2013 (78 FR 79465), FDA announced the WHO ECDD review and
invited interested persons to submit information for WHO's
consideration.
    The full text of the notification from the Secretary-General is
provided in section II of this document. Section 201(d)(2)(B) of the
CSA requires the Secretary of HHS, after receiving a notification
proposing scheduling, to publish a notice in the Federal Register to
provide the opportunity for interested persons to submit information
and comments on the proposed scheduling action.
    The United States is also a party to the 1961 Single Convention on
Narcotic Drugs (1961 Single Convention). The Secretary of State has
received a notification from the Secretary-General regarding 2
substances to be considered for control under this convention. The CSA
does not require HHS to publish a summary of such information in the
Federal Register. Nevertheless, in an effort to provide interested and
affected persons an opportunity to submit comments regarding the WHO
recommendations for narcotic drugs, the notification regarding these
substances is also included in this Federal Register notice. The
comments will be shared with other relevant Agencies to assist the
Secretary of State in formulating the position of the United States on
the control of these substances. The HHS recommendations are not
binding on the representative of the United States in discussions and
negotiations relating to the proposal regarding control of substances
under the 1961 Single Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the
drug substances and explains the basis for the recommendations is
reproduced as follows:

Reference:
NAR/CL.5/2015
WHO/ECDD37; 1961C-Art.3; 1971C-Art.2
CU 2014/288/DTA/SGB

    The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of America
and has the honour to inform the Government that the Director-General
of the World Health Organization (WHO), pursuant to article 3,
paragraphs 1 and 3 of the Single Convention on Narcotic Drugs of 1961
as amended by the 1972 Protocol (1961 Convention) and article 2,
paragraphs 1 and 4 of the Convention on Psychotropic Substances of 1971
(1971 Convention) notified the Secretary-General of the following
recommendations:
    Acetylfentanyl be placed in Schedule I and in Schedule IV of the
1961 Convention
    and
    MT-45 be placed in Schedule I of the 1961 Convention
    and
    para-Methoxymethylamphetamine (PMMA) be placed in Schedule I of the
1971 Convention
    and
    [alpha]-Pyrrolidinovalerophenone ([alpha]-PVP); para-Methyl-4-
methylaminorex (4,4'-DMAR) and methoxetamine (MXE) be placed in
Schedule II of the 1971 Convention
    and
    Phenazepam be placed in Schedule IV of the 1971 Convention.
    In the letter from the Director-General of the World Health
Organization to the Secretary-General reference is also made to
Commission on Narcotic Drugs decision 58/2 of 13 March 2015, by which
the Commission decided to postpone the consideration of the proposal
concerning the recommendation to place ketamine in Schedule IV of the
Convention on Psychotropic Substances of 1971 and to request additional
information from the World Health Organization and other relevant
sources.

His Excellency
Mr. John Kerry
Secretary of State of the United States of America

    In accordance with the provisions of article 3, paragraph 2 of the
1961 Convention and article 2, paragraph 2 of the 1971 Convention, the
Secretary-General hereby transmits the notification as annex I to the
present note.
    In accordance with the provisions of article 3, paragraph 2 of the
1961 Convention and article 2, paragraph 2 of the 1971 Convention, the
notification from WHO will be brought to the attention of the fifty-
ninth session of the Commission on Narcotic Drugs, 14-22 March 2016.
    In connection with the notification, WHO has also submitted the
relevant extract from the report of the thirty-seventh session of the
WHO Expert Committee on Drug Dependence which is hereby transmitted as
annex II.
    In order to assist the Commission in reaching a decision, it would
be appreciated if the Government could communicate any economic,
social, legal, administrative or other factors that it considers
relevant to the possible scheduling of the afore-mentioned substances
under the 1961 Convention and the 1971 Convention, at the latest by 1
February 2016 to the Executive Director of the United Nations Office on
Drugs and Crime, c/o Secretary, Commission on Narcotic Drugs, P.O. Box
500, 1400 Vienna, Austria, fax: +43-1-26060-5885, email<EMAIL_ADDRESS>
30 December 2015
NAR/CL.5/2015
Annex I

Annex I

Letter addressed to the Secretary-General of the United Nations from
the Director-General of the World Health Organization

    ``The Thirty-seventh meeting of the WHO Expert Committee on Drug
Dependence was convened from 16 to 20 November 2015, at WHO
headquarters in Geneva.
    With reference to Article 2, paragraphs 1, 4 and 6 of the
Convention on Psychotropic Substances (1971) and Article 3, paragraphs
1, 3 and 5 of the Single Convention on Narcotic Drugs (1961), as
amended by the 1972 Protocol, I am pleased to submit recommendations of
the World Health Organization as follows:

--Acetylfentanyl be placed in Schedule I and in Schedule IV of the
Single Convention on Narcotic Drugs (1961), and that:
--MT-45 be placed in Schedule I of the Single Convention on Narcotic
Drugs (1961), and that:

--para-Methoxymethylamphetamine (PMMA) be placed in Schedule I of the
Convention on Psychotropic Substances (1971), and that:
--[alpha]-Pyrrolidinovalerophenone ([alpha]-PVP); para-Methyl-4-
methylaminorex (4,4'- DMAR) and methoxetamine (MXE) be placed in
Schedule II of the Convention on Psychotropic Substances (1971), and
that:
--Phenazepam be placed in Schedule IV of the Convention on Psychotropic
Substances (1971).

    The recommendations and the assessments and findings on which they
are based are set out in detail in the Report of the 37th Expert
Committee on Drug Dependence, which is the Committee that advises me on
these issues. An extract of the Committee's Report is attached in Annex
1 to this letter.
    In decision 58/2 of 13 March 2015, the Commission on Narcotic Drugs
decided to postpone the consideration of the proposal concerning the
recommendation to place ketamine in Schedule IV of the Convention on
Psychotropic Substances of 1971 and to request additional information
from the World Health Organization and other relevant sources.
Consequentially, an update review paper on ketamine was commissioned
and provided to the Expert Committee. Following its deliberations the
Committee unanimously agreed that it found nothing in the updates, nor
in what was disclosed during its deliberations, that would give it
reason to recommend a new pre-review or critical review of ketamine
with a view to potentially change its standing recommendation of 2014
that ketamine should not be placed under international control. The
current standing recommendation is consistent with the earlier
recommendation made in 2012.
    I am very pleased with the ongoing collaboration between UNODC,
INCB and WHO, in particular, the support to the work of the WHO Expert
Committee on Drug Dependence and preparations for the Special Session
of the United Nations General Assembly on the World Drug Problem in
2016.''

NAR/CL.5/2015
Annex II

Annex II

Extract from the Report of the 37th Expert Committee on Drug Dependence
    Substance recommended to be scheduled in Schedule I and Schedule IV
of the Single Convention on Narcotic Drugs (1961), as amended by the
1972 Protocol:
Acetylfentanyl
    Chemically, acetylfentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-
piperidinyl]acetamide. It is in the phenylpiperidine class of synthetic
opioids that includes fentanyl, a Schedule I drug under the UN 1961
Single Convention on Narcotic Drugs. Acetylfentanyl has also been
referred to as ``desmethyl fentanyl''.
    Acetylfentanyl has not been previously reviewed by the Committee. A
critical review was proposed based on information brought to WHO's
attention that acetylfentanyl is clandestinely manufactured, poses a
risk to public health and society, and has no recognized therapeutic
use by any Party.
    Acetylfentanyl has effects similar to those of morphine and
fentanyl that are included in Schedule I of the 1961 Single Convention
on Narcotic Drugs. It has no recorded therapeutic use and its use has
resulted in fatalities. Thus, because it meets the required condition
of similarity, it is recommended that acetylfentanyl be placed in
Schedule I of the Single Convention on Narcotic Drugs, 1961, as
consistent with Article 3, paragraph 3 (iii) of that Convention in that
the substance is liable to similar abuse and productive of similar ill
effects as drugs in Schedule I. In addition, in accordance with Article
3, paragraph 5 of that Convention, considering acetylfentanyl is
particularly liable to abuse and to produce ill-effects, and its
liability is not offset by substantial therapeutic advantages, it is
recommended it be included in Schedule IV of the Single Convention on
Narcotic Drugs, 1961.
    Substance recommended to be scheduled in Schedule I of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972 Protocol:
MT-45
    Chemically, MT-45 is 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine.
MT-45 has two enantiomers and is commonly available as the racemic
mixture.
    MT-45 has not been previously reviewed by the Committee. A critical
review was proposed based on information brought to WHO's attention
that MT-45 is clandestinely manufactured, poses a risk to public health
and society, and has no recognized therapeutic use by any Party.
    MT-45 is a compound with morphine-like effects. The Committee
considered that the degree of risk to public health and society
associated with the abuse liability and accompanying evidence warranted
its placement under international control. Therapeutic use in humans
has not been recorded. The Committee recommended that MT-45 be placed
in Schedule I of the 1961 Single Convention, as amended by the 1972
Protocol.
    Substance recommended to be scheduled in Schedule I of the
Convention on Psychotropic Substances (1971):

para-Methoxymethylamphetamine (PMMA)

    Chemically, PMMA (para-methoxymethylamphetamine) is 1-(4-
methoxyphenyl)-N-methylpropan-2-amine. PMMA has two enantiomers and is
commonly available as the racemic mixture.
    PMMA has not been previously reviewed by the Committee. A critical
review was proposed based on information brought to WHO's attention
that PMMA is clandestinely manufactured, poses a risk to public health
and society, and has no recognized therapeutic use by any Party.
    The Committee considered that the effects of PMMA are similar to
PMA, a drug listed in Schedule I of the Convention on Psychotropic
Substances of 1971, and the degree of risk to public health and society
associated with its abuse is especially serious. The Committee also
noted it has no recorded therapeutic use. The Committee considered that
the evidence of its abuse warranted its placement under international
control and recommended that PMMA be placed in Schedule I of the 1971
Convention.
    Substances recommended to be scheduled in Schedule II of the
Convention on Psychotropic Substances (1971):
[alpha]-Pyrrolidinovalerophenone ([alpha]-PVP)
    Chemically, [alpha]-PVP ([alpha]-pyrrolidinovalerophenone) is 1-
phenyl-2-(pyrrolidin-1-yl)pentan-1-one. This synthetic cathinone is the
desmethyl analogue of pyrovalerone that is listed in Schedule IV of the
1971 United Nations Convention on Psychotropic Substances. [alpha]-PVP
has two enantiomers and is commonly available as the racemic mixture.
[alpha]-PVP is closely related to 3',4'-methylenedioxypyrovalerone
(MDPV) that has recently been placed in Schedule II of the UN
Convention on Psychotropic Substances (1971).
    [alpha]-PVP has not been previously reviewed by the Committee. A
direct critical review was proposed based on information brought to
WHO's attention that [alpha]-PVP is clandestinely manufactured, poses a
risk to public health and society, and has no recognized therapeutic
use by any Party.
    The Committee considered that the degree of risk to public health
and

society associated with the abuse of [alpha]-PVP is substantial.
Therapeutic usefulness has not been recorded. Its pharmacological
effects are similar to methamphetamine and MDPV, psychostimulants
listed in Schedule II of the 1971 Convention. The Committee considered
that the evidence of its abuse warranted its placement under
international control. As per the Guidance on the WHO review of
psychoactive substances for international control, higher regard was
accorded to the substantial public health risk than to the lack of
therapeutic usefulness. The Committee recommended that [alpha]-PVP be
placed in Schedule II of the 1971 Convention.
para-Methyl-4-methylaminorex (4,4'-DMAR)
    Chemically, 4,4'-DMAR (para-methyl-4-methylaminorex) is 4-methyl-5-
(4-methylphenyl)-4,5-dihydro-1,3- oxazol-2-amine. 4,4'-DMAR has four
enantiomers and exists as racemic cis- or trans- forms. It is a
synthetic substituted oxazoline derivative interpretable as an analogue
of 4-methylaminorex (4-MAR) and aminorex, which are psychostimulants
listed as Schedule I and Schedule IV substances, respectively, under
the 1971 United Nations Convention on Psychotropic Substances.
    4,4'-DMAR has not been previously reviewed by WHO. A critical
review was proposed based on information brought to WHO's attention
that 4,4'-DMAR is clandestinely manufactured, poses a risk to public
health and society, and has no recognized therapeutic use by any Party.
    As per the Guidance on the WHO review of psychoactive substances
for international control, higher regard was accorded to the
substantial public health risk than to the lack of therapeutic
usefulness. The Committee considered that the degree of risk to public
health and society associated with the abuse of 4,4'-DMAR is
substantial. The Committee recommended that 4,4'-DMAR be placed in
Schedule II of the 1971 Convention.
Methoxetamine (MXE)
    Chemically, methoxetamine (MXE) is 2-(ethylamino)-2-(3-
methoxyphenyl)cyclohexanone. It is a synthetic drug and belongs to the
arylcyclohexylamine class like phencyclidine. Methoxetamine has two
enantiomers and is commonly available as the racemic mixture.
    During its 36th meeting, the WHO Expert Committee on Drug
Dependence discussed the critical review report on methoxetamine and
concluded that owing to the insufficiency of data regarding dependence,
abuse and risks to public health, methoxetamine should not be placed
under international control at that time, but be kept under
surveillance. In 2014 the European Union decided to bring methoxetamine
under control after a risk assessment by the EMCDDA. Furthermore new
information on its abuse potential and more reports of fatal and non-
fatal intoxications warranted a critical review for the 37th ECDD.
    Methoxetamine has been shown to have effects similar to
phencyclidine, a compound listed in Schedule II of the Convention on
Psychotropic Substances of 1971. The Committee considered that the
degree of risk to public health and society associated with the abuse
liability of methoxetamine is substantial. The Committee also noted it
has no recorded therapeutic use. The Committee considered that the
evidence of its abuse warranted its placement under international
control. The Committee recommended that methoxetamine be placed in
Schedule II of the 1971 Convention.
    Substance recommended to be scheduled in Schedule IV of the
Convention on Psychotropic Substances (1971):
Phenazepam
    Chemically, phenazepam is 7-bromo-5-(2-chlorophenyl)-1,3-dihydro-
2H-1,4-benzodiazepin-2-one.
    Phenazepam has not been previously reviewed by the Committee. The
Committee undertook a pre-review of the substance and considered that
the information provided in the pre-review report was sufficient and
indicated that dependence and harm caused by phenazepam was of such
magnitude that proceeding directly into critical review within the
meeting was warranted. All procedural requirements for a critical
review, including two peer reviews, were fulfilled. Phenazepam has been
shown to have effects similar to diazepam that is in Schedule IV of the
Convention on Psychotropic Substances of 1971. The Committee considered
that the degree of risk to public health and society associated with
the abuse of phenazepam has a smaller but still significant risk to
public health compared to substances in Schedules I-III and has a
therapeutic usefulness from little to great. The Committee considered
that the evidence of its abuse warranted its placement under
international control. The Committee further recommended that
phenazepam be placed in Schedule IV of the 1971 Convention.
    Substance recommended for critical review:
Etizolam (INN)
    Chemically, etizolam is 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine.
    The Expert Committee on Drug Dependence (ECDD) reviewed etizolam
for the first time at its 26th meeting in 1989. At that time, the
Committee rated the abuse liability of etizolam as moderate and the
therapeutic usefulness as moderate to high. In view of the lack of
clear-cut abuse, and of public health and social problems associated
with its use, the Committee was unable to come to a decision concerning
the scheduling of etizolam and recommended that a decision be deferred
to the 27th meeting of the Committee.
    At its 27th meeting in 1990, the Committee again rated the abuse
liability of etizolam as low to moderate and the therapeutic usefulness
as moderate to high. The Committee noted few public health and social
problems associated with its use at that time and considered that the
degree of seriousness of these problems was not great enough to warrant
international control. Consequently, the Committee did not recommend
scheduling of etizolam in 1990.
    At the 37 ECDD, on the basis of the evidence available regarding
dependence, abuse and risks to public health, the Committee recommended
that a critical review of etizolam is warranted for a future meeting.
    Substance recommended for surveillance:
4-Fluoroamphetamine (4-FA)
    Chemically, 4-FA (4-fluoroamphetamine) is 1-(4-fluorophenyl)propan-
2-amine. 4-FA has two enantiomers and is commonly available as the
racemic mixture.
    4-FA has not been previously reviewed by the Committee. A critical
review was proposed based on information brought to WHO's attention
that 4-FA is clandestinely manufactured, poses a risk to public health
and society, and has no recognized therapeutic use by any Party.
    Owing to the current insufficiency of data regarding dependence,
abuse and risks to public health (including risks to the individual),
the Committee recommended that 4-FA not be placed under international
control at this time, but be kept under surveillance.
    Update on cannabis:
    The Commission on Narcotic Drugs, in Resolution 52/5, expressed
that it ``. . . looks forward to an updated

report on cannabis by the Expert Committee, subject to the availability
of extra budgetary resources'', and the Report of the International
Narcotics Control Board for 2014 reiterated, ``. . . its invitation to
WHO to evaluate the potential medical utility of cannabis and the
extent to which cannabis poses a risk to human health.'' WHO therefore
commissioned an update report paper on cannabis and cannabis resin.
    An update on the scientific literature of cannabis was presented
and reviewed during the session including the pharmacology, toxicology
and the claimed therapeutic applications. The Committee then
deliberated about the content of the material presented. The Committee
requested the Secretariat to begin collecting data towards a pre-review
of cannabis, cannabis resin, extracts and tinctures of cannabis at a
future meeting. Furthermore it specifically requested the Secretariat
to place emphasis on any therapeutic advantages that they may have
relative to other existing therapeutics.
    Update on ketamine:
    Updates on ketamine were presented in which the levels and
consequences of its abuse, and new potential medical applications were
identified. Levels of ketamine abuse appeared to be declining in many
countries world-wide. Potential new therapeutic uses were identified
including depression and refractory status epilepticus. Evaluation of
ketamine for treating depression is in Phase III studies. Ketamine is
widely used as an anaesthetic agent for human and veterinary use
globally. Ketamine is the anaesthetic agent of choice in low income
countries and emergency situations where there are limitations in
trained medical personnel, anesthesia machines, and consistent sources
of electricity.
    Following its deliberations, the Committee unanimously agreed that
it found nothing in the updates, nor that which was disclosed during
its deliberations, that would give it reason to recommend a new pre-
review or critical review of ketamine with a view to potentially change
its standing recommendation of 2014 that ketamine should not be placed
under international control.

III. Discussion

    Although WHO has made specific scheduling recommendations for each
of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered
for control under the Psychotropic Convention include the following:
(1) Accept the WHO recommendations; (2) accept the recommendations to
control, but control the drug substance in a schedule other than that
recommended; or (3) reject the recommendations entirely.
    Acetylfentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) is
a potent opioid analgesic in the phenylpiperidine class of synthetic
opioids. On July 17, 2015, acetylfentanyl was temporarily placed into
Schedule I of the CSA for 2 years upon finding that it posed an
imminent hazard to the public safety. The U.S. Attorney General (the
Attorney General), though, may extend this temporary scheduling for up
to 1 year. The WHO ECDD met in November 2015 and recommended that
acetylfentanyl be placed in Schedule I and in Schedule IV of the 1961
Single Convention. On July 17, 2015, acetylfentanyl was temporarily
placed in Schedule I of the CSA under the temporary scheduling
provision of section 201(h) of the CSA. These provisions provide the
Attorney General with the authority to temporarily place a substance
into Schedule I of the CSA for 2 years, without regard to the
requirements of 21 U.S.C. 811(b), if he finds that such action is
necessary to avoid an imminent hazard to the public safety. In
addition, if proceedings to control a substance are initiated under 21
U.S.C. 811(a)(1), the Attorney General may extend the temporary
scheduling for up to 1 year (21 U.S.C. 811(h)(2)). Therefore,
considering the previously mentioned time limitations of temporary
scheduling under section 201(h) of the CSA, it will be necessary to
adopt non-temporary controls to fulfill U.S. obligations if
acetylfentanyl is controlled under Schedule I and Schedule IV of the
1961 Single Convention.
    1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine (MT-45) is a
synthetic opioid with potent analgesic activity comparable to morphine
despite being structurally unrelated to most other opioids. MT-45 use
has been associated with deaths in the United States and in other
countries. The WHO ECDD met in November 2015 and recommended that MT-45
be placed in Schedule I of the 1961 Single Convention. MT-45 is not
currently controlled in the United States under the CSA. As such,
additional controls will be necessary to fulfill U.S. obligations if
MT-45 is controlled under Schedule I of the 1961 Single Convention.
    Phenazepam belongs to a class of substances known as
benzodiazepines. Benzodiazepines produce central nervous system
depression and are commonly used to treat insomnia, anxiety, and
seizure disorders. The WHO ECDD at its 37th meeting recommended that
Phenazepam be placed in Schedule IV of the Psychotropic Convention.
While Phenazepam is currently prescribed in some countries, it is not
approved for medical use or controlled in the United States under the
CSA. Additional controls will be necessary to fulfill U.S. obligations
if Phenazepam is controlled under Schedule IV of the Psychotropic
Convention.
    Para-Methoxymethylamphetamine (PMMA) is a substituted amphetamine
of the phenethylamine class, as well as a structural analog of para-
methoxyamphetamine (PMA) which produces effects similar but not
identical to that of MDMA. The WHO ECDD at its 37th meeting recommended
PMMA be placed in Schedule I of the Psychotropic Convention. PMMA is
not currently controlled in the United States under the CSA. Additional
controls will be necessary if PMMA is placed in Schedule I of the
Psychotropic Convention.
    Para-Methyl-4-methylaminorex (4,4'-DMAR) is a derivative of the
stimulant drug 4-methylaminorex and has been involved in several deaths
in the United States. The WHO ECDD at its 37th meeting recommended
4,4'-DMAR be placed in Schedule II of the Psychotropic Convention.
4,4'-DMAR is not currently controlled in the United States under the
CSA. Additional controls will be necessary to fulfill U.S. obligations
if 4,4'-DMAR is controlled under Schedule II of the Psychotropic
Convention.
    [alpha]-Pyrrolidinovalerophenone ([alpha]-PVP or alpha-PVP) is a
synthetic cathinone structurally and pharmacologically similar to
amphetamine; 3,4-methylenedioxymethamphetamine (MDMA); cathinone; and
other related substances. On March 7, 2014, [alpha]-PVP was temporarily
placed into Schedule I of the CSA for 2 years upon finding that it
posed an imminent hazard to the public safety. The Attorney General,
though, may extend this temporary scheduling for up to 1 year. The WHO
ECDD at its 37th meeting recommended that [alpha]-PVP be placed in
Schedule II of the Psychotropic Convention. Therefore, considering the
previously mentioned time limitations of temporary scheduling under
section 201(h) of the CSA, additional controls will be necessary to
fulfill U.S. obligations if [alpha]-PVP is controlled under Schedule II
of the Psychotropic Convention.
    Methoxetamine (MXE) is a synthetic drug substance and belongs in
the arylcyclohexamine class. The WHO

ECDD at its 37th meeting recommended that MXE be placed in Schedule II
of the Psychotropic Convention. MXE is not currently controlled under
the CSA in the United States. Additional controls will be necessary to
fulfill U.S. obligations if MXE is controlled under Schedule II of the
Psychotropic Convention.
    FDA, on behalf of the Secretary of HHS, invites interested persons
to submit comments on the notifications from the United Nations
concerning these drug substances. FDA, in cooperation with the National
Institute on Drug Abuse, will consider the comments on behalf of HHS in
evaluating the WHO scheduling recommendations. Then, under section
201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State
what position the United States should take when voting on the
recommendations for control of substances under the Psychotropic
Convention at the CND meeting in March 2015.
    Comments regarding the WHO recommendations for control of
acetylfentanyl and MT-45 under the 1961 Single Convention will also be
forwarded to the relevant Agencies for consideration in developing the
U.S. position regarding narcotic substances at the CND meeting.

IV. Opportunity for Public Meeting

    FDA does not presently plan to hold a public meeting. If any person
believes that, in addition to written comments, a public meeting would
contribute to the development of the U.S. position on the substances to
be considered for control under the Psychotropic Convention, a request
for a public meeting and the reasons for such a request should be sent
to James R. Hunter (see FOR FURTHER INFORMATION CONTACT) on or before
February 5, 2016.

    Dated: January 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01474 Filed 1-25-16; 8:45 am]
BILLING CODE 4164-01-P