        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 665
        [I.D. 052506A]
        RIN 0648-AT95
        Fisheries in the Western Pacific; Omnibus Amendment for the Bottomfish and Seamount Groundfish Fisheries, Crustacean Fisheries, and Precious Coral Fisheries of the Western Pacific Region

          AGENCY:
           National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
           Notice of availability of FMP amendments; request for comments.

          SUMMARY:
           NMFS announces that the Western Pacific Fishery Management Council (WPFMC) proposes to amend three fishery management plans (western Pacific omnibus amendment) to include fisheries in waters around the Commonwealth of the Northern Mariana Islands (CNMI) and Pacific Remote Island Areas (PRIA). These amendments would establish new permitting and reporting requirements for vessel operators targeting bottomfish species around the PRIA to improve understanding of the ecology of these species and the activities and harvests of the vessel operators that target them. It would also establish new permitting and reporting requirements for vessel operators targeting crustacean species and precious coral around the CNMI and PRIA.

          DATES:
           Comments on the amendment must be received by August 7, 2006.

          ADDRESSES:
           Comments on the western Pacific omnibus amendment, identified by 0648-AT95, should be sent to any of the following addresses:
          • E-mail: AT95Omnibus@noaa.gov. Include in the subject line of the e-mail comment the following document identifier “AT95 Omnibus.” Comments sent via e-mail, including all attachments, must not exceed a 5 megabyte file size.
          • Federal e-Rulemaking portal: www.regulations.gov. Follow the instructions for submitting comments.
          • Mail: William L. Robinson, Regional Administrator, NMFS, Pacific Islands Region (PIR), 1601 Kapiolani Boulevard, Suite 1110, Honolulu, HI 96814-4700.

          Copies of the western Pacific omnibus amendment, the Environmental Assessment, and related analyses may be obtained from Kitty M. Simonds, Executive Director, WPFMC, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813, or on the internet at www.wpcouncil.org.

          FOR FURTHER INFORMATION CONTACT:
           Robert Harman, NMFS PIR, 808-944-2271.

        SUPPLEMENTARY INFORMATION:

        The western Pacific omnibus amendment, developed by the WPFMC, has been submitted to NMFS for review under the Magnuson-Stevens Fishery Conservation and Management Act. This document announces that the amendment is available for public review and comment for 60 days. NMFS will consider public comments received during the comment period described above in determining whether to approve, partially approve, or disapprove the western Pacific omnibus amendment.

        The Pacific Islands region encompasses Federal waters, i.e., the U.S. Exclusive Economic Zone (EEZ), around the Territories of Guam and American Samoa, the State of Hawaii, the CNMI, and the PRIA. The inner boundary of the EEZ is the seaward limit of each coastal state, commonwealth, territory and possession. The EEZ extends from this inner boundary to 200 nautical miles (nm) offshore.
        The WPFMC has developed, and NMFS has approved and implemented, five fishery management plans covering pelagic species, crustaceans, bottomfish and seamount groundfish, precious corals, and coral reef ecosystems fisheries. Federal waters around the CNMI are currently not included in the Fishery Management Plans for the Bottomfish, Crustaceans, or Precious Corals Fisheries of the Western Pacific Region (Bottomfish FMP), Crustaceans FMP), and (Precious Corals FMP). Federal waters around the PRIAs are not included in the Bottomfish or Crustaceans FMP, except for Midway Atoll. Therefore, Federal fisheries management, including data collection, is limited for these areas. New fishery developments suggest to the WPFMC that the preliminary step of including these waters under the FMPs is necessary to facilitate further steps to monitor fish catches, and to implement other management measures if needed in the future. Amendment 8 to the Bottomfish FMP, Amendment 12 to the Crustaceans FMP, and Amendment 6 to the Precious Corals FMP would include the fisheries operating in these areas under the FMPs.
        The omnibus amendment has the following objectives:
        1. To improve the database for future bottomfish management decisions through data reporting requirements (Bottomfish FMP);
        2. To collect and analyze biological and economic information about lobster fisheries and improve the statistical base for conservation and management in the future (Crustaceans FMP); and
        3. To encourage the acquisition and analysis of new information concerning the distribution, abundance and ecology of precious corals (Precious Corals FMP).
        After considering a wide range of management options, including many options suggested by the public during a public scoping process, the WPFMC recommended the following management measures.
        CNMI Management Measures
        1. Include the CNMI EEZ as a management area in the Bottomfish FMP, with regulations applied only to the offshore area (3 to 200 nm, again the EEZ around the CNMI extends from the shoreline to 200 nm, but the WPFMC recommends deferring regulatory control for fishing by CMNI citizens in waters 0 to 3 nm of the EEZ around CNMI; however, the FMP amendments do not confer authority to CNMI over EEZ resources), and with no new Federal permitting or reporting requirements;
        2. Include the CNMI EEZ under the Crustaceans FMP, with regulations applied to the offshore area (3 to 200 nm), and include existing permit and reporting requirements; and
        3. Include the CNMI EEZ in the Precious Corals FMP, with regulations applied to the offshore area (3 to 200 nm), and include existing exploratory area permit and reporting and quota requirements.
        PRIA Management Measures
        1. Include the PRIA EEZ (0-200 nm) in the Bottomfish FMP, and implement new Federal permitting and reporting requirements for all vessels targeting bottomfish management unit species; and
        2. Include the PRIA EEZ under the Crustaceans FMP, and include existing Federal permitting and reporting requirements.
        This action is designed to establish mechanisms to implement specific regulatory controls should the need arise; specific management measures (such as time and area closures, or effort and landing limits) are not included.
        Public comments on the western Pacific omnibus amendment must be received by August 7, 2006, to be considered by NMFS in the decision to approve, partially approve, or disapprove the amendment. A proposed rule to implement the amendment has been submitted for Secretarial review and approval.
        NMFS expects to publish and request public comment on the proposed regulation in the near future.

          Authority:
          16 U.S.C. 1801 et seq.

          Dated: June 1, 2006.
          Alan D. Risenhoover,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. E6-8860 Filed 6-6-06; 8:45 am]
      BILLING CODE 3510-22-S


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 622
        [Docket No. 0612242911-7380-01]
        RIN 0648-AU28
        Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery off the Southern Atlantic States; Amendment 14

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments.

          SUMMARY:
          NMFS issues this proposed rule to implement the applicable provisions of Amendment 14 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council). Amendment 14 proposes, and this rule would implement, establishment of eight marine protected areas (MPAs) in which fishing for or possession of South Atlantic snapper-grouper would be prohibited. The prohibition on possession would not apply to a person aboard a vessel that was in transit with fishing gear appropriately stowed. Amendment 14 also proposes to prohibit the use of shark bottom longlines within the MPAs, however, NMFS is proposing to implement the prohibition of shark bottom longlines through separate rulemaking. The intended effects of this proposed rule are to protect a portion of the population and habitat of long-lived, slow growing, deepwater snapper-grouper from fishing pressure to achieve a more natural sex ratio, age, and size structure within the proposed MPAs, while minimizing adverse social and economic effects.

          DATES:
          Written comments on this proposed rule must be received no later than 5 p.m., eastern time, on August 15, 2008.

          ADDRESSES:
          You may submit comments, identified by “0648-AU28”, by any of the following methods:

          • Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal http://www.regulations.gov.
          • Fax: 727-824-5308; Attention: Kate Michie.
          • Mail: Kate Michie, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701.

          Instructions: All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.
          NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.

          Copies of Amendment 14 may be obtained from the South Atlantic Fishery Management Council, 4055 Faber Place, Suite 201, North Charleston, SC 29405; phone: 843-571-4366 or 866-SAFMC-10 (toll free); fax: 843-769-4520; e-mail: safmc@safmc.net. Amendment 14 includes a Final Environmental Impact Statement (FEIS), a Biological Assessment, an Initial Regulatory Flexibility Analysis (IRFA), a Regulatory Impact Review, and a Social Impact Assessment/Fishery Impact Statement.

          FOR FURTHER INFORMATION CONTACT:

          Kate Michie, telephone: 727-824-5305, fax: 727-824-5308, e-mail: Kate.Michie@noaa.gov.

        SUPPLEMENTARY INFORMATION:

        The snapper-grouper fishery off the southern Atlantic states is managed under the FMP. The FMP was prepared by the Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. NMFS issues this proposed rule to implement the applicable provisions of Amendment 14 to the FMP. The Atlantic shark fishery is managed under the Consolidated Highly Migratory Species Fishery Management Plan (HMS FMP). The HMS FMP is implemented under the authority of the Magnuson-Stevens Act by regulations at 50 CFR part 635.

        Background
        Many snapper-grouper species are vulnerable to overfishing because they are long-lived (e.g., snowy grouper, golden tilefish, red snapper, gag, scamp, red grouper, and red porgy); they are protogynous, i.e., they may change sex from females to males as they grow older/larger (e.g., snowy grouper, speckled hind, Warsaw grouper, yellowedge grouper, gag, scamp, red porgy, and black sea bass); they form spawning aggregations (e.g., snowy grouper, gag, scamp, and red snapper); and they suffer high release mortality when taken from deep water. Deepwater snapper-grouper species (speckled hind, snowy grouper, Warsaw grouper, yellowedge grouper, misty grouper, golden tilefish, and blueline tilefish) are most vulnerable to overfishing because they live longer than 50 years, do not survive the trauma of capture, and are protogynous (groupers) or exhibit sexual dimorphism, i.e., males and females grow at different rates (tilefishes).
        Stock assessments indicate that black sea bass, red porgy, and snowy grouper are overfished, i.e., spawning stock biomass is not sufficient to reproduce and support continued productivity. In addition, black sea bass, golden tilefish, snowy grouper, and vermilion snapper are experiencing overfishing, i.e., the current rate of fishing mortality jeopardizes the capacity of the fishery to produce its maximum sustainable yield on a continuing basis. Reductions in catch and protection of habitat are needed.
        Proposed Measures
        This rule would establish eight MPAs in which a portion of the population and habitat of long-lived, slow growing, deepwater snapper-grouper species would be protected from directed fishing pressure. Fishing for or possession of South Atlantic snapper-grouper would be prohibited in the MPAs. However, the prohibition on possession would not apply to a person aboard a vessel that was in transit with fishing gear appropriately stowed, as specified in § 622.35(i)(2) of this proposed rule. MPAs are considered to be the most effective fishery management tool that would allow deepwater snapper-grouper to reach a more natural sex ratio, age, and size structure, protect spawning locations, and provide a refuge for early developmental stages of fish species.
        Using a collaborative process, the Council selected specific sites for MPAs on the basis of maximizing the biological benefits and enhancing enforceability and monitoring while minimizing the adverse social and economic effects. Sizes of the MPAs would range from approximately 5 by 10 nautical miles (nm) to approximately 22 by 23 nm. One would be off North Carolina, three off South Carolina, one off Georgia, and three off the east coast of Florida. An artificial reef may be established at one of the South Carolina sites. The two most southern MPAs would be approximately 9 and 13 nm offshore, respectively, and the others at least 38 nm offshore. The eight proposed MPAs and their relative locations are shown in Figure 1.
        The prohibition of use of shark bottom longlines in the MPAs is considered necessary for habitat protection and to prevent the mortality of incidentally caught snapper-grouper. The Council voted to include this prohibition in Amendment 14 because of concerns regarding the enforcement of fishing activities by vessels that hold permits in both the snapper-grouper and shark bottom longline fisheries, both of which deploy similar gear. However, because the Atlantic shark fishery is managed under the HMS FMP, NMFS requested the HMS Division promulgate the prohibition of use of shark bottom longlines within the proposed MPAs. The HMS Division published a final rule on June 24, 2008 (72 FR 35778), prohibiting shark bottom longlining in the proposed MPAs through Amendment 2 to the consolidated HMS FMP.
        Availability of Amendment 14

        Additional background and rationale for the measures discussed above are contained in Amendment 14. The availability of Amendment 14 was announced in the Federal Register on June 6, 2008, (73 FR 32281). Written comments on Amendment 14 will be accepted through August 5, 2008. All comments received on Amendment 14 or on this proposed rule during their respective comment periods will be addressed in the preamble to the final rule.
        Classification
        Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with Amendment 14, the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
        This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
        The Council prepared an FEIS for Amendment 14; a notice of availability was published on June 13, 2008 (73 FR 33813).

        NMFS prepared an IRFA, as required by section 603 of the Regulatory Flexibility Act, for this proposed rule. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the objectives of, and legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A copy of the full analysis is available from the Council (see ADDRESSES). A summary of the IRFA follows.
        This proposed rule would establish eight MPAs in the Federal waters of the South Atlantic and prohibit fishing for or possession of South Atlantic snapper-grouper within any of the MPAs. The purpose of this proposed rule is to assist in the recovery of overfished stocks and persistence of healthy fish stocks, fisheries, and habitats. The Magnuson-Stevens Act provides the statutory basis for the proposed rule.
        No duplicative, overlapping, or conflicting Federal rules have been identified.
        Two general classes of small business entities would be directly affected by the proposed rule, commercial fishing vessels and for-hire fishing vessels. The Small Business Administration defines a small entity in the commercial fishing sector as a firm that is independently owned and operated, is not dominant in its field of operation, and has average annual gross receipts not in excess of $4 million (2002 NAICS 11411). For a for-hire business, the appropriate revenue benchmark is $6.5 million (2002 NAICS 487210).

        Average net incomes estimated from boats operating in the South Atlantic snapper-grouper fishery were sampled in a 1994 study that separated the fishery into northern and southern zones. The northern zone includes the area north of 28° N. latitude to the North Carolina/Virginia border. The southern zone includes the area south of 25° N. latitude to the border between the South Atlantic and Gulf of Mexico Fishery Management Councils. The estimated average net incomes, in 1994 (and 2006) dollars, were $83,224 ($113,212) for boats that primarily used bottom longlines in the northern zone, $23,075 ($31,389) for boats that primarily used black sea bass pots in the northern zone, $15,563 ($21,171) for boats that primarily used bottom longlines in the southern zone, $11,649 ($15,842) for boats that primarily used vertical lines in the southern zone, and $8,307 ($11,300) for boats that primarily used vertical lines in the northern zone. Overall, boats in the northern zone averaged $14,143 ($19,239) in net income based on average revenues of $48,702 ($66,250), while boats in the southern zone averaged $12,388 ($16,852) net income based on average revenues of $39,745 ($54,066). More recent data from the Southeast logbook program show the average annual ex-vessel revenue from landings of snapper-grouper species per vessel from 1999 to 2003 to range from $14,408 to $16,376 (2006 dollars).
        Although some fleet activity may exist in this fishery, the extent of such has not been determined. Thus, all vessels are assumed to be unique business entities. Given historic income data and the gross revenue profile captured by the Southeast logbook program, it is determined that all vessels that would be affected by the proposed rule are small entities.
        Charterboats are defined as boats for hire carrying six or fewer passengers that charge a fee to rent the entire boat. Headboats tend to be larger, generally can carry a maximum of around 60 passengers, and the fee is paid on an individual angler basis. This analysis, which estimates the range of the average gross revenues in 2006 dollars for this sector, is as follows: $61,714 to $83,820 for charterboats on the Atlantic coast of Florida; $72,768 to $88,778 for charterboats in North Carolina, $31,830 to $38,833 for charterboats in South Carolina; $68,629 to $83,486 for charterboats in Georgia; $170,276 to $362,482 for headboats in Florida; and $148,840 to $317,030 for headboats in the other South Atlantic states. Similar to the situation with the commercial harvest sector, some fleet activity may exist within the for-hire sector. The magnitude and identity of such is unknown, however, and all vessels are assumed to represent unique business entities. Given the gross revenue profiles provided, vessels in the for-hire recreational sector are determined to be small business entities.
        There were 1,066 commercial snapper-grouper permitted vessels in the South Atlantic during 2004. A number of these permitted vessels were not active in the snapper-grouper fishery. It is not possible to estimate the total number of true latent permits (i.e., those permits which are not expected to be fished in any given year and may exist only for speculative purposes) since permits with no associated landings could become active in a subsequent year. The number of permitted vessels, however, is an upper bound on the universe of vessels in this fishery. The assumed lower bound of the universe of vessels is the number of active vessels in the latest year for which data are available. This lower bound estimate is 906 vessels, which is the number of vessels/permits with recorded landings of snapper-grouper species in the South Atlantic in 2003. The upper bound is the 1,066 commercial snapper-grouper permitted vessels in the South Atlantic during 2004. Thus, the range of vessels assumed to potentially operate in the commercial snapper-grouper fishery is 906 to 1,066. Currently, there is insufficient information to determine the number of commercial fishing vessels that fish for or possess any snapper-grouper species in the proposed MPAs.
        In the for-hire sector, 1,594 snapper-grouper for-hire permits were issued to vessels in the South Atlantic states in 2004. The for-hire fishery operates as an open access fishery, and not all of the permitted snapper-grouper for-hire vessels are necessarily active in this fishery. Some vessel owners have been known to purchase open access permits as insurance for uncertainties in the fisheries in which they currently operate. Currently, there is insufficient information to assess the number of for-hire vessels that fish for or possess any snapper-grouper species in the proposed MPAs.
        There is insufficient information to assess the numbers or percentages of commercial and for-hire vessels that fish for or possess snapper-grouper species in the proposed MPAs and would be directly affected by the proposed rule. Consequently, it cannot be determined if the proposed rule would affect a substantial number of small entities. A direct cost of the proposed rule would be the lost revenues and profits derived from fishing for or possessing snapper-grouper species in those areas. It is expected that any vessel that historically fished in these areas would mitigate some of these losses by relocating to other areas. There is insufficient information to quantify any potential losses of revenues and profits from the creation of the MPAs. However, the relatively small sizes of the MPAs suggest there would not be significant adverse economic impact.
        Three alternatives, including the status quo, were considered for the first of the eight actions. Both the proposed action (Alternative 1) and Alternative 2 would establish an MPA at the area of the Snowy (Grouper) Wreck off the coast of North Carolina. The proposed MPA is 55 nm southeast of Southport, North Carolina, and Alternative 2 is located approximately 57 nm southeast of Southport. Each MPA is about 15 by 10 nm. Fishermen from Little River, Carolina Beach, and Southport ports would most likely be affected by either alternative. The proposed MPA and the MPA specified by Alternative 2 include an area ranging from 150 meters (m) to 300 m deep. The proposed MPA includes a shallow area ranging from 60 to 100 m, while the MPA specified by Alternative 2 includes a deeper area exceeding 300 m in depth. Alternative 2 could result in the displacement of fewer fishermen than the proposed action, but would not be expected to protect as many mid-shelf species as the proposed action. The status quo alternative (Alternative 3) would not create an MPA in the Snowy (Grouper) Wreck area off the coast of North Carolina, would not increase the protection of mid-shelf and deepwater snapper-grouper species, and would not, therefore, meet the Council's objective.
        Four alternatives, including the status quo, were considered for the second action. The proposed action (Alternative 2) and two of the other alternatives (Alternatives 1 and 3) would establish an MPA off the northern South Carolina coast. The proposed MPA is located approximately 54 nm from Murrells Inlet, while Alternative 1 is located approximately 61 nm from Murrells Inlet, and the MPA specified by Alternative 3 is about 65 nm from Murrells Inlet. The proposed MPA and the MPAs specified by Alternatives 1 and 3 are 10 by 5 nm in size. Both the proposed MPA and the MPA specified by Alternative 1 run east to west, while the MPA specified by Alternative 3 runs parallel to shore. Waters in the proposed MPA area range from 50 to 180 m deep. The MPAs specified by Alternatives 1 and 3 share an area ranging in depth from 70 to 140 m, but the MPA specified by Alternative 1 includes more shallow waters, while the MPA specified by Alternative 3 includes a greater area of deep water. The proposed MPA is expected to protect more deepwater and mid-shelf snapper-grouper species than the MPAs specified by Alternatives 1 and 3. The status quo alternative (Alternative 4) would not create an MPA off the coast of northern South Carolina, would not increase the protection of mid-shelf and deepwater snapper-grouper species, and would not, therefore, meet the Council's objective.

        Three alternatives, including the status quo, were considered for the third action. Both the proposed action (Alternative 1) and Alternative 2 would establish an MPA off the coast of central South Carolina. The proposed MPA is oriented perpendicular to the coast and is located about 45 nm southeast of Charleston Harbor. The MPA specified by Alternative 2 is oriented parallel to the shoreline and is located approximately 50 nm southeast of Charleston Harbor. Both MPAs are 10 by 5 nm in size. The proposed MPA is expected to protect more mid-shelf and rare deepwater snapper-grouper species than Alternative 2. The status quo alternative (Alternative 3) would not create an MPA off the coast of central South Carolina, would not increase the protection of mid-shelf and deepwater snapper-grouper species, and would not, therefore, meet the Council's objective.
        Three alternatives, including the status quo, were considered for the fourth action. Both the proposed action (Alternative 1) and Alternative 2 would establish an MPA off the coast of Georgia. The proposed MPA is located approximately 69 nm southeast of the mouth of Wassaw Sound, while the MPA specified by Alternative 2 is located about 65 nm southeast of the mouth of Wassaw Sound. Both the proposed MPA and the MPA specified by Alternative 2 are 10 by 10 nm in size, and both share a common area with waters 90 to 210 m deep. However, the proposed MPA also includes waters ranging from 90 to 300 m deep and runs parallel to the shore, while the MPA specified by Alternative 2 includes an area with a wider depth range, from 65 to 380 m and does not run parallel to the coast. The proposed MPA is expected to be easier for industry to maneuver around and may result in greater protection of the mid-shelf habitat that serves as a nursery for deepwater species, notably tilefish, than the MPA specified by Alternative 2. The status quo alternative (Alternative 3) would not create an MPA off the coast of Georgia, would not increase the protection of tilefish, snowy grouper, and mid-shelf snapper-grouper species, and would not, therefore, meet the Council's objective.
        Seven alternatives, including the status quo, were considered for the fifth action. The proposed action (Alternative 4) and five of the other alternatives would establish an MPA off the coast of north Florida. The proposed MPA is approximately 60 nm off the mouth of St. John's River near Jacksonville. The MPA specified by Alternative 1 is approximately 57 nm off the mouth of the St. John's River; the MPA specified by Alternative 2 is about 47 nm east of St. Augustine; the MPA specified by Alternative 3 is approximately 43 nm off New Smyrna Beach; the MPA specified by Alternative 5 is about 55 nm east of St. Augustine; and the MPA specified by Alternative 6 is approximately 45 nm off New Smyrna Beach. The proposed MPA and the MPAs specified by Alternatives 1, 2, and 5 are 10 by 10 nm in size, while the MPAs specified by Alternatives 3 and 6 are 22 by 23 nm in size. The proposed MPA shares an area with the MPA specified by Alternative 1 that ranges from 60 to 200 m in depth. The proposed MPA also includes deeper waters, ranging from 200 to 380 m in depth, while the MPA specified by Alternative 1 includes an area of shallower water, ranging from 50 to 80 m in depth. The MPAs specified by Alternatives 2 and 5 share an area with depths ranging from 90 to 150 m. The MPA specified by Alternative 5 also includes a deeper area that ranges from 150 to 390 m, while the MPA specified by Alternative 2 includes a shallower area of 55 to 80 m. Most of the area included by the MPAs specified by Alternatives 3 and 6 overlap in an area ranging from 200 to 690 m deep. The MPA specified by Alternative 3 also includes a deeper area that exceeds 700 m, while the MPA specified by Alternative 6 includes a shallower area of 80 to 150 m. Although the MPAs specified by Alternatives 1 and 2 would protect more mid-shelf snapper-grouper species than the proposed MPA, while the MPAs specified by Alternatives 3, 5 and 6 would protect more deepwater species, these alternatives would also be expected to result in greater adverse economic impacts than the proposed MPA. The status quo alternative (Alternative 7), would not create an MPA off the coast of north Florida, would not increase the protection of mid-shelf and deepwater snapper-grouper species, and would not, therefore, meet the Council's objective.
        Two alternatives, including the status quo, were considered for the sixth action. The proposed action would establish an MPA in the area known as Sea Bass Rocks off the coast of Florida. The status quo alternative would not create an MPA in this area, would not increase the protection of deepwater snapper-grouper species in this area, and would not, therefore, meet the Council's objective.
        Two alternatives, including the status quo, were considered for the seventh action. The proposed action would establish an MPA in the vicinity of the area known as East Hump and Unnamed Hump off the coast of the Florida Keys. The status quo alternative, would not create an MPA in this area, would not increase the protection of deepwater snapper-grouper and protected species in this area, and would not, therefore, meet the Council's objectives.
        Two alternatives, including the status quo, were considered for the eighth action. The proposed action would establish an artificial reef MPA off the coast of South Carolina. The status quo alternative would not create this MPA, would not increase the opportunity to improve snapper-grouper populations in this area, and would not, therefore, meet the Council's objective.

          List of Subjects in 50 CFR Part 622

        Fisheries, Fishing, Puerto Rico, Reporting and recordkeeping requirements, Virgin Islands.

          Dated: July 10, 2008.
          Samuel D. Rauch III,
          Deputy Assistant Administrator For Regulatory Programs, National Marine Fisheries Service.

        For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

          PART 622—FISHERIES OF THE CARIBBEAN, GULF, AND SOUTH ATLANTIC

        1. The authority citation for part 622 continues to read as follows:

          Authority:
          16 U.S.C. 1801 et seq.

          2. In § 622.2, the definition of “MPA” is added in alphabetical order to read as follows:

          § 622.2
          Definitions and acronyms.

            MPA means marine protected area.

        3. In § 622.35, paragraph (i) is added to read as follows:

          § 622.35
          Atlantic EEZ seasonal and/or area closures.

          (i) MPAs. (1) No person may fish for a South Atlantic snapper-grouper in an MPA, and no person may possess a South Atlantic snapper-grouper in an MPA. However, the prohibition on possession does not apply to a person aboard a vessel that is in transit with fishing gear appropriately stowed as specified in paragraph (i)(2) of this section. In addition to these restrictions, see § 635.21(d)(1)(iii) of this chapter regarding restrictions applicable within these MPAs for any vessel issued a permit under part 635 of this chapter that has longline gear on board. MPAs consist of deepwater areas as follows:
          (i) Snowy Grouper Wreck MPA is bounded by rhumb lines connecting, in order, the following points:

              Point
              North lat.
              West long.

              A
              33°25′
              77°04.75′

              B
              33°34.75′
              76°51.3′

              C
              33°25.5′
              76°46.5′

              D
              33°15.75′
              77°00.0′

              A
              33°25′
              77°04.75′

          (ii) Northern South Carolina MPA is bounded on the north by 32°53.5′ N. lat.; on the south by 32°48.5′ N. lat.; on the east by 78°04.75′ W. long.; and on the west by 78°16.75′ W. long.
          (iii) Edisto MPA is bounded on the north by 32°24′ N. lat.; on the south by 32°18.5′ N. lat.; on the east by 78°54.0′ W. long.; and on the west by 79°06.0′ W. long.
          (iv) Charleston Deep Artificial Reef MPA is bounded by rhumb lines connecting, in order, the following points:

              Point
              North lat.
              West long.

              A
              32°04′
              79°12′

              B
              32°08.5′
              79°07.5′

              C
              32°06′
              79°05′

              D
              32°01.5′
              79°09.3′

              A
              32°04′
              79°12′

          (v) Georgia MPA is bounded by rhumb lines connecting, in order, the following points:

              Point
              North lat.
              West long.

              A
              31°43′
              79°31′

              B
              31°43′
              79°21′

              C
              31°34′
              79°29′

              D
              31°34′
              79°39′

              A
              31°43′
              79°31′

          (vi) North Florida MPA is bounded on the north by 30°29′ N. lat.; on the south by 30°19′ N. lat.; on the east by 80°02′ W. long.; and on the west by 80°14′ W. long.
          (vii) St. Lucie Hump MPA is bounded on the north by 27°08′ N. lat.; on the south by 27°04′ N. lat.; on the east by 79°58′ W. long.; and on the west by 80°00′ W. long.
          (viii) East Hump MPA is bounded by rhumb lines connecting, in order, the following points:

              Point
              North lat.
              West long.

              A
              24°36.5′
              80°45.5′

              B
              24°32′
              80°36′

              C
              24°27.5′
              80°38.5′

              D
              24°32.5′
              80°48′

              A
              24°36.5′
              80°45.5′

          (2) For the purpose of paragraph (i)(1) of this section, transit means direct, non-stop progression through the MPA. Fishing gear appropriately stowed means—
          (i) A longline may be left on the drum if all gangions and hooks are disconnected and stowed below deck. Hooks cannot be baited. All buoys must be disconnected from the gear; however, buoys may remain on deck.
          (ii) A trawl or try net may remain on deck, but trawl doors must be disconnected from such net and must be secured.
          (iii) A gillnet, stab net, or trammel net must be left on the drum. Any additional such nets not attached to the drum must be stowed below deck.
          (iv) Terminal gear (i.e., hook, leader, sinker, flasher, or bait) used with an automatic reel, bandit gear, buoy gear, handline, or rod and reel must be disconnected and stowed separately from such fishing gear. A rod and reel must be removed from the rod holder and stowed securely on or below deck.
          (v) A crustacean trap, golden crab trap, or sea bass pot cannot be baited. All buoys must be disconnected from the gear; however, buoys may remain on deck.
          4. Add Figure 1 to Part 622 to read as follows:

            EP16JY08.009

      [FR Doc. E8-16252 Filed 7-15-08; 8:45 am]
      BILLING CODE 3510-22-S


        DEPARTMENT OF JUSTICE
        Drug Enforcement Administration
        21 CFR Part 1308
        [Docket No. DEA-402]
        Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 Into Schedule I

          AGENCY:
          Drug Enforcement Administration, Department of Justice.

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:
          The Drug Enforcement Administration proposes placing N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This proposed scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would continue to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle AB-CHMINACA, AB-PINACA and THJ-2201.

          DATES:
          Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Comments must be submitted electronically or postmarked on or before February 27, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
          Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),” may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before February 27, 2017.

          ADDRESSES:
          To ensure proper handling of comments, please reference “Docket No. DEA-402” on all electronic and written correspondence, including any attachments.
          • Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.
          • Paper comments: Paper comments that duplicate the electronic submission are not necessary. Should you wish to mail a paper comment, in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
          • Hearing requests: All requests for a hearing and waivers of participation must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing and waivers of participation should be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

          FOR FURTHER INFORMATION CONTACT:
          Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

        SUPPLEMENTARY INFORMATION:

        Posting of Public Comments

        Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.
        If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

        Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

        An electronic copy of this document and supplemental information to this proposed rule are available at http://www.regulations.gov for easy reference.
        Request for Hearing, or Waiver of Participation in Hearing
        Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. In accordance with 21 CFR 1308.44(a)-(c), requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).” 21 CFR 1300.01. Such requests or notices must conform to the requirements of 21 CFR 1308.44(a) or (b), and 1316.47 or 1316.48, as applicable, and include a statement of interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) and may include a written statement regarding the interested person's position on the matters of fact and law involved in any hearing.
        Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of a hearing held in relation to this rulemaking is restricted to: “(A) find[ing] that such drug or other substance has a potential for abuse, and (B) mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *.” All requests for hearing and waivers of participation must be sent to the DEA using the address information provided above.
        Legal Authority
        The DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.
        Under the CSA, controlled substances are classified into one of five schedules based upon their potential for abuse, their currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of scheduled substances is published at 21 CFR part 1308.
        Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
        The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS); 1
           or (3) on the petition of any interested party. 21 U.S.C. 811(a). This proposed action is supported by a recommendation from the Assistant Secretary of the HHS and an evaluation of all other relevant data by the DEA. If finalized, this action would continue to impose the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle AB-CHMINACA, AB-PINACA and THJ-2201.

            1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993.

        Background

        On January 30, 2015, the DEA published a final order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place the three synthetic cannabinoids [1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201); N-1-Amino-3-methyl-1-oxo-2-butanyl]-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA); and N-[1-Amino-3-methyl-1-oxo-2-butanyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 80 FR 5042. That final order, which became effective on the date of publication, was based on findings by the Administrator of the DEA that the temporary scheduling of these three synthetic cannabinoids was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). At the time the final order took effect, section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), required that the temporary scheduling of a substance expire at the end of two years from the date of the scheduling order, and it provided that, during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, temporary scheduling of that substance could be extended for up to 1 year. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling of THJ-2201, AB-PINACA, and AB-CHMINACA expires on January 29, 2017, unless extended. An extension of the temporary order is being ordered by the DEA Administrator in a separate action.

        The Administrator of the DEA, on his own motion pursuant to 21 U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to permanently schedule THJ-2201, AB-PINACA and AB-CHMINACA. The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these three synthetic cannabinoids. In accordance with 21 U.S.C. 811(b) and (c), on August 26, 2015, the DEA submitted a request to the HHS to provide the DEA with a scientific and medical evaluation of available information and a scheduling recommendation for THJ-2201, AB-PINACA and AB-CHMINACA. Upon evaluating the scientific and medical evidence, on November 14, 2016, the HHS submitted to the Administrator of the DEA its three scientific and medical evaluations for these substances. Upon receipt of the scientific and medical evaluations and scheduling recommendations from the HHS, the DEA reviewed the documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of THJ-2201, AB-PINACA and AB-CHMINACA in accordance with 21 U.S.C. 811(c). The DEA has published a temporary order for the extension of the placement of THJ-2201, AB-PINACA and AB-CHMINACA into schedule I elsewhere in this issue of the Federal Register.
        Proposed Determination To Schedule THJ-2201, AB-PINACA and AB-CHMINACA

        Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or substance to those controlled under the CSA may be initiated by the Attorney General, or her delegate, the DEA Administrator. On August 26, 2015, the DEA requested scientific and medical evaluations and scheduling recommendations from the Assistant Secretary of Health for the U.S. Department of Health and Human Services (HHS) for THJ-2201, AB-PINACA and AB-CHMINACA pursuant to 21 U.S.C. 811(b). Upon receipt of the scientific and medical evaluations and scheduling recommendations from the HHS dated November 14, 2016, the DEA reviewed the documents and all other relevant data and conducted its own eight-factor analysis of the abuse potential of THJ-2201, AB-PINACA and AB-CHMINACA pursuant to 21 U.S.C. 811(c). Included below is a brief summary of each factor as analyzed by the HHS and the DEA, and as considered by the DEA in its proposed scheduling action. Please note that both the DEA 8-Factor and HHS 8-Factor analyses and the Assistant Secretary's November 14, 2016, letter, are available in their entirety under the tab “Supporting Documents” of the public docket of this action at http://www.regulations.gov, under Docket Number “DEA-402.”
        1. The Drug's Actual or Relative Potential for Abuse: The term “abuse” is not defined in the CSA. However, the legislative history of the CSA suggests that the DEA consider the following criteria in determining whether a particular drug or substance has a potential for abuse: 2

            2 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970 U.S.C.C.A.N. 4566, 4603.

          (a) There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or of the community; or

          (b) There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; or

          (c) Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or

          (d) The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

        Through epidemiological and case report data, HHS has demonstrated that the ingestion of AB-CHMINACA, AB-PINACA and/or THJ-2201 in sufficient amounts is creating a hazard to the health and safety of both the individual users and others within the community. Adverse effects observed following the ingestion of synthetic cannabinoids (SCs), including AB-CHMINACA, AB-PINACA and THJ-2201, include nausea and vomiting, shortness of breath or depressed breathing, hypertension, tachycardia, chest pain, muscle twitching, acute renal failure, anxiety, agitation, psychosis, suicidal ideation, and cognitive impairment. The HHS also stated that SCs like AB-CHMINACA, AB-PINACA and THJ-2201 are easily accessible and difficult to detect in standard urine drug screens, which contributes to their popularity and high rates of abuse.
        The American Association of Poison Control Centers (AAPCC) reported 7,779 calls to poison centers about exposures to SCs from January 1, 2015 through December 31, 2015. This number is significantly higher than the number of calls in all of 2014 (3,682), or all of 2013 (2,668). In 2015, there was a notable increase in calls during April (1,512) and May (1,205), falling to a stable, but higher baseline for the rest of the year: A seasonal pattern not seen in previous years. In 2016, the numbers of exposure calls (2,695) have dropped again, mirroring those of 2013 (2,668). Although the AAPCC does not identify specific cannabinoid substances, their data do support the high prevalence of toxic exposures to SCs in general. In 2015, at least 15 calls to Poison Centers regarding SCs exposures were associated with deaths, which is triple the 5 deaths associated with such calls for all of 2014.

        The HHS stated that there are no FDA-approved drug products containing AB-CHMINACA, AB-PINACA and THJ-2201 in the United States and there appear to be no legitimate sources for these substances as marketed drugs. Therefore, this criterion for assessing the abuse potential of these SCs is not applicable. According to the HHS, because AB-CHMINACA, AB-PINACA and THJ-2201 are not approved for medical use and are not formulated or available for clinical use, the human use of these substances is assumed to be on an individual's own initiative, rather than on the basis of medical advice from a practitioner licensed by law to administer drugs. Further, published scientific and medical literature, and reports from AAPCC and law enforcement, indicate that individuals are taking these SCs on their own initiative, rather than on the basis of medical advice of a licensed practitioner. As noted by the HHS, pharmacological studies sponsored by the National Institute on Drug Abuse (NIDA) have demonstrated that AB-CHMINACA, AB-PINACA and THJ-2201 are similar to other schedule I SCs. All three of these substances, similar to schedule I SCs, display high affinity binding and potent agonist functional activity at the cannabinoid (CB1) receptor, while drug discrimination studies have demonstrated the ability of all three substances to substitute for Δ9-tetrahydrocannabinol (Δ9-THC) (see factor 2). The HHS stated in their review that AB-CHMINACA, AB-PINACA and THJ-2201 are markedly more potent at CB1 receptors than the natural phytocannabinoids (cannabinoids that occur naturally in the cannabis plant, i.e. Δ9-THC).
        2. Scientific Evidence of the Drug's Pharmacological Effects, if Known: In vitro receptor binding and functional assays were conducted with AB-CHMINACA, AB-PINACA and THJ-2201. In addition, drug discrimination assays using Sprague Dawley rats were performed to identify drugs with similar subjective effects to Δ9-THC. The tetrad assay was also conducted for AB-CHMINACA and AB-PINACA. These results indicate that AB-CHMINACA, AB-PINACA and THJ-2201, similar to other schedule I SCs, bind to CB1 receptors with high affinity and act as agonists at CB1 receptors.
        Based on results from the receptor binding (Ki), CB1 functional assay, and drug discrimination studies, the HHS concluded that AB-CHMINACA, AB-PINACA and THJ-2201 act as full psychoactive cannabinoid agonists with no antagonist activity, and that these three substances are more potent than Δ9-THC (schedule I), and are similar in activity to JWH-018, AM2201, ADB-PINACA, and AB-FUBINACA (schedule I). As stated by the HHS, these data indicate that AB-CHMINACA, AB-PINACA and THJ-2201 are more potent at producing behavioral pharmacological effects that are recognizable as those produced by the schedule I cannabinoid Δ9-THC.
        3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: The DEA is not aware of any currently accepted medical uses for AB-CHMINACA, AB-PINACA and THJ-2201. A letter dated September 17, 2014 was sent from the DEA Deputy Administrator to the Acting Assistant Secretary for Health, of the Department for Health and Human Services as notification of intent to temporarily place these three substances in schedule I and solicited comments, including whether an exemption or approval was in effect for the substances in question under the Federal Food, Drug and Cosmetic Act. The Acting Assistant Secretary of Health responded that there were no current INDs or NDAs for these synthetic cannabinoids in a letter to the DEA Deputy Administrator dated September 30, 2014. The HHS in its scientific and medical evaluation and scheduling recommendation dated November 14, 2016 reiterated that these three SCs are not the subjects of any approved new drug applications (NDAs) or investigational new drug applications (INDs); are not currently marketed as approved drug products; and have no accepted medical uses in the United States.
        4. Its History and Current Pattern of Abuse: Synthetic cannabinoids intended for illicit use were first encountered in the United States in November 2008 during seizure and analysis by the United States Customs and Border Protection (CBP) of a shipment of “Spice” in Dayton, Ohio. The popularity of these cannabinoids and their associated products has increased since January 2010 in the United States as evidenced by the increasing number of seizures and public health and media reports. The HHS noted that SC abuse has been repeatedly noted in athletes, military personnel, employees who undergo frequent drug testing, and other individuals seeking intoxication while hoping to evade detection. AB-CHMINACA, AB-PINACA and THJ-2201 are another generation of SCs encountered by law enforcement. These substances and their products are commonly marketed as “legal highs” with a disclaimer of “not for human consumption.” As detailed in reports, law enforcement and public health officials are encountering the abuse of these substances.
        Most users of SCs abuse these substances by smoking the product following application to plant material. Recently, law enforcement has also been encountering new variations of SCs in liquid form. The liquids contain one or more SC(s), including AB-CHMINACA and AB-PINACA, as well as previously controlled substances including AB-FUBINACA and XLR11. Users have been identified as applying the liquid to hookahs (an instrument for vaporizing and smoking a given material whereby the smoke or vapor passes through a water basin prior to inhalation), vaporizers (also known as “vaping” or an “e-cigarette,” which allows the user to administer a liquid to be aerosolized and then inhaled), and hookah pens (a type of vaporizer, often much smaller and intended for increased discretion while smoking). As reported by users, specifically adolescents, this method of vaporizing and inhaling SCs is viewed as being safer than traditional smoking (blunt, pipe, cigarette, etc.). In a recent study, 91% of SC users reported inhalation of the product via a cigarette or blunt, 27% of the respondents also reported using methods that included vaporization, water pipe, bong, or hookah as a delivery method.
        5. The Scope, Duration, and Significance of Abuse: AB-CHMINACA, AB-PINACA and THJ-2201 are SCs that have pharmacological effects similar to the schedule I hallucinogen Δ9-THC. Poison control centers continue to report toxic exposures to SCs and their associated products. These substances remain a threat to both the short- and long-term public health and safety. THJ-2201 was first reported in September 2013 while AB-CHMINACA was first reported in February of 2014. AB-PINACA was encountered on the illicit drug market as early as March 2013. From December 2013 through May 2015, CBP reported select encounters of these substances with most shipments originating in China and intended for destinations within the United States: AB-CHMINACA-50 seizures involving 56.29 kg; AB-PINACA-11 seizures involving 15 kg; THJ-2201-6 seizures involving 5.5 kg. The DEA has reported multiple encounters of large quantities of AB-CHMINACA, AB-PINACA and THJ-2201 that have been confirmed by forensic laboratories.
        6. What, if Any, Risk There is to the Public Health: Clinical symptoms as reported from overdoses with AB-CHMINACA and AB-PINACA in particular have included excited delirium, seizure, coma, agitation, myocardial infarction, convulsions, difficulty breathing, and an altered state of consciousness. The HHS reported that despite the increasing public recognition of the harms of SCs, multiple groups, including athletes, military personnel, employees who undergo frequent drug testing, and individuals seeking intoxication, continue to abuse these substances while hoping to evade detection.
        Since abusers obtain these drugs through unknown sources, the purity of these drugs is uncertain, thus posing significant adverse health risks to these users. From October 2013 through the present, multiple deaths and severe overdoses have occurred involving AB-CHMINACA, AB-PINACA and/or THJ-2201.
        7. Its Psychic or Physiological Dependence Liability: As stated by the HHS, AB-CHMINACA, AB-PINACA and THJ-2201 have pharmacological profiles that are similar to other schedule I SCs. Although there are no clinical studies evaluating dependence liabilities specific for AB-CHMINACA, AB-PINACA and THJ-2201, the pharmacological profiles of these substances strongly suggest that they possess dependence liabilities that are qualitatively similar to, and potentially stronger than Δ9-THC (schedule I) or marijuana (schedule I) and likely to be similar to other schedule I synthetic cannabinoids such as, JWH-018.
        8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA: AB-CHMINACA, AB-PINACA and THJ-2201 are not immediate precursors of any controlled substance of the CSA.

          Conclusion: After considering the scientific and medical evaluation conducted by the HHS, the HHS's recommendation, and the DEA's own eight-factor analysis, the DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of AB-CHMINACA, AB-PINACA and THJ-2201. As such, the DEA hereby proposes to schedule AB-CHMINACA, AB-PINACA and THJ-2201 as controlled substances under the CSA.
        Proposed Determination of Appropriate Schedule

        The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for HHS and review of all other available data, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
        1. AB-CHMINACA, AB-PINACA and THJ-2201 have a high potential for abuse that is comparable to other schedule I substances such as delta 9-tetrahydrocannabinol (Δ9-THC) and JWH-018;
        2. AB-CHMINACA, AB-PINACA and THJ-2201 have no currently accepted medical use in treatment in the United States; and
        3. There is a lack of accepted safety for use of AB-CHMINACA, AB-PINACA and THJ-2201 under medical supervision.
        Based on these findings, the Administrator of the DEA concludes that N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), including their salts, isomers and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrant continued control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
        Requirements for Handling AB-CHMINACA, AB-PINACA and THJ-2201
        If this rule is finalized as proposed, AB-CHMINACA, AB-PINACA and THJ-2201 would continue 3
           to be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, of schedule I substances including the following:

            3 AB-CHMINACA, AB-PINACA and THJ-2201 are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 80 FR 5042, Jan. 30, 2015.

        1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) AB-CHMINACA, AB-PINACA or THJ-2201, or who desires to handle AB-CHMINACA, AB-PINACA or THJ-2201, would continue to be required to be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.
        2. Security. AB-CHMINACA, AB-PINACA or THJ-2201 would continue to be subject to schedule I security requirements and would need to be handled and stored pursuant to 21 U.S.C. 821, 823 and in accordance with 21 CFR 1301.71-1301.93.
        3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of AB-CHMINACA, AB-PINACA or THJ-2201would continue to need to be in compliance with 21 U.S.C. 825 and 958(e), and continue to be in accordance with 21 CFR part 1302.
        4. Quota. Only registered manufacturers would continue to be permitted to manufacture AB-CHMINACA, AB-PINACA or THJ-2201 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
        5. Inventory. Any person who becomes registered with the DEA on or after the effective date of the final rule must take an initial inventory of all stocks of controlled substances (including AB-CHMINACA, AB-PINACA and THJ-2201) on hand on the date the registrant first engages in the handling of controlled substances pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
        After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including AB-CHMINACA, AB-PINACA and THJ-2201) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
        6. Records and Reports. Every DEA registrant would continue to be required to maintain records and submit reports with respect to AB-CHMINACA, AB-PINACA and/or THJ-2201 pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312.
        7. Order Forms. Every DEA registrant who distributes AB-CHMINACA, AB-PINACA or THJ-2201 would continue to be required to comply with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305.
        8. Importation and Exportation. All importation and exportation of AB-CHMINACA, AB-PINACA or THJ-2201 would continue to need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
        9. Liability. Any activity involving AB-CHMINACA, AB-PINACA or THJ-2201 not authorized by, or in violation of, the CSA or its implementing regulations would continue to be unlawful, and could subject the person to administrative, civil, and/or criminal sanctions.
        Regulatory Analyses
        Executive Orders 12866 and 13563
        In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.
        Executive Order 12988
        This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
        Executive Order 13132
        This proposed rulemaking does not have federalism implications warranting the application of Executive Order 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
        Executive Order 13175
        This proposed rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects 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.
        Regulatory Flexibility Act

        The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On January 30, 2015, the DEA published a final order to temporarily place these three SCs into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The DEA estimates that all entities handling or planning to handle AB-CHMINACA, AB-PINACA or THJ-2201 have already established and implemented the systems and processes required to handle AB-CHMINACA, AB-PINACA or THJ-2201. There are currently 25 registrations authorized to handle AB-CHMINACA, AB-PINACA and/or THJ-2201 specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. These 25 registrations represent 18 entities, of which 8 are small entities. Therefore, the DEA estimates eight small entities are affected by this proposed rule.
        A review of the 25 registrations indicates that all entities that currently handle AB-CHMINACA, AB-PINACA or THJ-2201 also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle AB-CHMINACA, AB-PINACA or THJ-2201. Therefore, the DEA anticipates that this proposed rule will impose minimal or no economic impact on any affected entities; and thus, will not have a significant economic impact on any of the eight affected small entities. Therefore, the DEA has concluded that this proposed rule will not have a significant effect on a substantial number of small entities.
        Unfunded Mandates Reform Act of 1995

        In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.
        Paperwork Reduction Act of 1995
        This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

          List of Subjects in 21 CFR Part 1308
          Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.

        For the reasons set out above, the DEA proposes to amend 21 CFR part 1308:

          PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

        1. The authority citation for 21 CFR part 1308 continues to read as follows:

          Authority:
           21 U.S.C. 811, 812, 871(b), unless otherwise noted.

        2. In § 1308.11,
        a. Add new paragraphs (d)(59) through (61); and
        b. Remove paragraphs (h)(11) through (13); and
        c. Redesignate paragraphs (h)(14) through (19) as (h)(11) through (16);
        The additions to read as follows:

          § 1308.11
           Schedule I.

          (d) * * *

              (59) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)
              (7031)

              (60) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA)
              (7023)

              (61) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)
              (7024)

          Dated: January 17, 2017.
          Chuck Rosenberg,
          Acting Administrator.

      [FR Doc. 2017-01514 Filed 1-26-17; 8:45 am]
       BILLING CODE 4410-09-P