82 FR 20544 - Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 84 (May 3, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 84 (May 3, 2017)
| Page Range | 20544-20548 | |
| FR Document | 2017-08943 |
[Federal Register Volume 82, Number 84 (Wednesday, May 3, 2017)] [Rules and Regulations] [Pages 20544-20548] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08943] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-452] Schedules of Controlled Substances: Temporary Placement of 4- Fluoroisobutyryl Fentanyl into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Temporary scheduling order. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide (4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl fentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of 4-fluoroisobutyryl fentanyl into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, 4- fluoroisobutyryl fentanyl. DATES: This temporary scheduling order is effective May 3, 2017, until May 3, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence. 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: Legal Authority Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two 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. 21 U.S.C. 811(h)(1). 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 \1\ for up to one year. 21 U.S.C. 811(h)(2). --------------------------------------------------------------------------- \1\ Though DEA has used the term ``final order'' with respect to temporary scheduling orders in the past, this notice adheres to the statutory language of 21 U.S.C. 811(h), which refers to a ``temporary scheduling order.'' No substantive change is intended. --------------------------------------------------------------------------- Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. [[Page 20545]] Background Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into schedule I of the CSA.\2\ The Administrator transmitted the notice of intent to place 4-fluoroisobutyryl fentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated January 5, 2017. The Assistant Secretary responded to this notice by letter dated January 17, 2017, and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for 4-fluoroisobutyryl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of 4-fluoroisobutyryl fentanyl into schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). 4- Fluoroisobutyryl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for 4- fluoroisobutyryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of 4-fluoroisobutyryl fentanyl in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to issue a temporary order to schedule 4- fluoroisobutyryl fentanyl was published in the Federal Register on March 23, 2017. 82 FR 14842. --------------------------------------------------------------------------- \2\ 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. --------------------------------------------------------------------------- To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). A substance meeting the statutory requirements for temporary scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for 4-fluoroisobutyryl fentanyl, summarized below, indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's three-factor analysis, and the Assistant Secretary's January 17, 2017, letter, are available in their entirety under the tab ``Supporting Documents'' of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2017-0004 (Docket Number DEA-452). Factor 4. History and Current Pattern of Abuse The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. 4-Fluoroisobutyryl fentanyl has recently been encountered by law enforcement and public health officials and the adverse health effects and outcomes are demonstrated by fatal overdose cases. The documented negative effects of 4-fluoroisobutyryl fentanyl are consistent with those of other opioids. On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on December 21, 2016. STARLiMS registered 21 reports containing 4-fluoroisobutyryl fentanyl, all reported in 2016, from Florida, Maryland, Mississippi, New Jersey, New York, Texas, and the District of Columbia. According to STARLiMS, the first laboratory submission of 4-fluoroisobutyryl fentanyl occurred in March 2016 in Maryland. The DEA is not aware of any laboratory identifications of 4-fluoroisobutyryl fentanyl prior to 2016. The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state and local forensic laboratories across the country. According to NFLIS, the only report of 4-fluoroisobutyryl fentanyl from state or local forensic laboratories was recorded in August 2016 in Pennsylvania. Due to normal lag time in reporting, NFLIS data from August through November 2016 is incomplete.\3\ --------------------------------------------------------------------------- \3\ Information was obtained from NFLIS on December 21, 2016. --------------------------------------------------------------------------- Evidence suggests that the pattern of abuse of fentanyl analogues, including 4-fluoroisobutyryl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of 4-fluoroisobutyryl fentanyl have been encountered in powder form and packaged similar to that of heroin. 4-Fluoroisobutyryl fentanyl has been encountered as a single substance as well as in combination with other substances of abuse, including heroin, fentanyl, furanyl fentanyl, methamphetamine, and cocaine. 4-Fluoroisobutyryl fentanyl has been connected to fatal overdoses, in which insufflation and intravenous routes of administration are documented. Factor 5. Scope, Duration and Significance of Abuse Reports collected by the DEA demonstrate 4-fluoroisobutyryl fentanyl is being abused for its opioid properties. This abuse of 4- fluoroisobutyryl fentanyl has resulted in morbidity and mortality (see DEA 3-Factor Analysis for full discussion). The DEA has received reports for at least 62 confirmed fatalities associated with 4- fluoroisobutyryl fentanyl. Information on these deaths, occurring as early as August 2016, was collected from post-mortem toxicology and medical examiner reports by the DEA. These deaths were reported from, and occurred in, Maryland. NFLIS and STARLiMS have a total of 22 drug reports in which 4-fluoroisobutyryl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2016 from law enforcement encounters in Florida, Maryland, Mississippi, New Jersey, New York, Pennsylvania, Texas, and the District of Columbia. It is likely that the prevalence of 4-fluoroisobutyryl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate this substance from fentanyl. The population likely to abuse 4-fluoroisobutyryl fentanyl overlaps with [[Page 20546]] the population abusing prescription opioid analgesics and heroin. This is evidenced by the routes of drug administration and drug use history documented in 4-fluoroisobutyryl fentanyl fatal overdose cases. Because abusers of 4-fluoroisobutyryl fentanyl are likely to obtain this substance through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e. use a drug for the first time) 4-fluoroisobutyryl fentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.). Factor 6. What, if Any, Risk There Is to the Public Health 4-Fluoroisobutyryl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other [micro]-opioid receptor agonists. The toxic effects of 4-fluoroisobutyryl fentanyl in humans are demonstrated by overdose fatalities involving this substance. Abusers of 4-fluoroisobutyryl fentanyl may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. Based on information received by the DEA, the abuse of 4- fluoroisobutyryl fentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are great. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. 4-Fluoroisobutyryl fentanyl has been associated with numerous fatalities. At least 62 confirmed overdose deaths involving 4- fluoroisobutyryl fentanyl abuse have been reported from Maryland in 2016. As the data demonstrates, the potential for fatal and non-fatal overdose exists for 4-fluoroisobutyryl fentanyl; thus, 4- fluoroisobutyryl fentanyl poses an imminent hazard to the public safety. Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety In accordance with 21 U.S.C. 811(h)(3), based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of 4-fluoroisobutyryl fentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 4- fluoroisobutyryl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated January 5, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place this substance into schedule I. A notice of intent was subsequently published in the Federal Register on March 23, 2017. 82 FR 14842. Conclusion In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule 4-fluoroisobutyryl fentanyl into schedule I of the CSA, and finds that placement of this synthetic opioid into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling 4- fluoroisobutyryl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done ``on the record after opportunity for a hearing'' conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). Requirements for Handling Upon the effective date of this temporary order, 4-fluoroisobutyryl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, 4-fluoroisobutyryl fentanyl must 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, as of May 3, 2017. Any person who currently handles 4-fluoroisobutyryl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle 4- fluoroisobutyryl fentanyl as of May 3, 2017, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after May 3, 2017 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA. 2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle 4-fluoroisobutyryl fentanyl, must surrender all quantities of currently held 4- fluoroisobutyryl fentanyl. 3. Security. 4-Fluoroisobutyryl fentanyl is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of May 3, 2017. [[Page 20547]] 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of 4-fluoroisobutyryl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from May 3, 2017, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of 4- fluoroisobutyryl fentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including 4- fluoroisobutyryl fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 6. Records. All DEA registrants must maintain records with respect to 4-fluoroisobutyryl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 and Sec. 1307.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements. 7. Reports. All DEA registrants who manufacture or distribute 4- fluoroisobutyryl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, and 1312 as of May 3, 2017. 8. Order Forms. All DEA registrants who distribute 4- fluoroisobutyryl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of May 3, 2017. 9. Importation and Exportation. All importation and exportation of 4-fluoroisobutyryl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of May 3, 2017. 10. Quota. Only DEA registered manufacturers may manufacture 4- fluoroisobutyryl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of May 3, 2017. 11. Liability. Any activity involving 4-fluoroisobutyryl fentanyl not authorized by, or in violation of the CSA, occurring as of May 3, 2017, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Matters Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1). Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety. Further, the DEA believes that this temporary scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking. Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). This action will 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. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the Congressional Review Act, ``any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the public interest to schedule this substance immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place this substance into schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule. 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 amends 21 CFR part 1308 as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 0 2. Amend Sec. 1308.11 by adding paragraph (h)(16) to read as follows: Sec. 1308.11 Schedule I * * * * * (h) * * * [[Page 20548]] ------------------------------------------------------------------------ ------------------------------------------------------------------------ (16) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4- (9824) yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: 4- fluoroisobutyryl fentanyl, para-fluoroisobutyryl fentanyl) ------------------------------------------------------------------------ Dated: April 27, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017-08943 Filed 5-2-17; 8:45 am] BILLING CODE 4410-09-P
![20544 Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Rules and Regulations
Minimum limits of— Maximum limits of—
Suitable Skinned and
Grade Test weight Sound Damaged Foreign
malting Wild oats Other grains broken Thin barley
per bushel barley 1 kernels 1 material
types (percent) (percent) kernels (percent)
(pounds) (percent) (percent) (percent)
(percent) (percent)
U.S. No. 1 47.0 97.0 98.0 2.0 1.0 0.5 2.0 4.0 7.0
U.S. No. 2 45.0 97.0 98.0 3.0 1.0 1.0 3.0 6.0 10.0
U.S. No. 3 43.0 95.0 96.0 4.0 2.0 2.0 5.0 8.0 15.0
U.S. No. 4 43.0 95.0 93.0 5.0 3.0 3.0 5.0 10.0 15.0
1 Injured-by-frost kernels and injured-by-mold kernels are not considered damaged kernels or considered against sound barley.
Note: Malting barley must not be infested must be graded in accordance with standards § 810.205 Grades and grade requirements
in accordance with § 810.107(b) and must not established for the class Barley. for Two-rowed Malting barley.
contain any special grades as defined in
§ 810.206. Six-rowed Malting barley varieties ■ 6. Section 810.205 is revised to read
not meeting the requirements of this section as follows:
Minimum limits of— Maximum limits of—
Suitable Skinned and
Grade Test weight Sound Damaged Foreign
malting Wild oats Other grains broken Thin barley
per bushel barley 1 kernels 1 material
types (percent) (percent) kernels (percent)
(pounds) (percent) (percent) (percent)
(percent) (percent)
U.S. No. 1 50.0 97.0 98.0 2.0 1.0 0.5 2.0 4.0 5.0
U.S. No. 2 48.0 97.0 98.0 3.0 1.0 1.0 3.0 6.0 7.0
U.S. No. 3 48.0 95.0 96.0 4.0 2.0 2.0 5.0 8.0 10.0
U.S. No. 4 48.0 95.0 93.0 5.0 3.0 3.0 5.0 10.0 10.0
1 Injured-by-frost kernels and injured-by-mold kernels are not considered damaged kernels or considered against sound barley.
Note: Malting barley must not be infested fentanyl), and its isomers, esters, ethers, Legal Authority
in accordance with § 810.107(b) and must not salts and salts of isomers, esters, and
contain any special grades as defined in ethers, into schedule I pursuant to the Section 201 of the Controlled
§ 810.206. Six-rowed Malting barley and Six- Substances Act (CSA), 21 U.S.C. 811,
rowed Blue Malting barley varieties not
temporary scheduling provisions of the
Controlled Substances Act. This action provides the Attorney General with the
meeting the requirements of this section must
be graded in accordance with standards is based on a finding by the authority to temporarily place a
established for the class Barley. Administrator that the placement of 4- substance into schedule I of the CSA for
fluoroisobutyryl fentanyl into schedule I two years without regard to the
Mark C. Craig, of the Controlled Substances Act is requirements of 21 U.S.C. 811(b) if he
Acting Administrator, Grain Inspection, necessary to avoid an imminent hazard finds that such action is necessary to
Packers and Stockyards Administration. to the public safety. As a result of this avoid an imminent hazard to the public
[FR Doc. 2017–08942 Filed 5–2–17; 8:45 am] order, the regulatory controls and safety. 21 U.S.C. 811(h)(1). In addition,
BILLING CODE 3410–KD–P administrative, civil, and criminal if proceedings to control a substance are
sanctions applicable to schedule I initiated under 21 U.S.C. 811(a)(1), the
controlled substances will be imposed Attorney General may extend the
DEPARTMENT OF JUSTICE on persons who handle (manufacture, temporary scheduling 1 for up to one
distribute, reverse distribute, import, year. 21 U.S.C. 811(h)(2).
Drug Enforcement Administration export, engage in research, conduct
instructional activities or chemical Where the necessary findings are
21 CFR Part 1308 analysis, or possess), or propose to made, a substance may be temporarily
handle, 4-fluoroisobutyryl fentanyl. scheduled if it is not listed in any other
[Docket No. DEA–452] schedule under section 202 of the CSA,
DATES: This temporary scheduling order 21 U.S.C. 812, or if there is no
Schedules of Controlled Substances: is effective May 3, 2017, until May 3,
Temporary Placement of 4- exemption or approval in effect for the
2019, unless it is extended for an substance under section 505 of the
Fluoroisobutyryl Fentanyl into additional year or a permanent
Schedule I Federal Food, Drug, and Cosmetic Act
scheduling proceeding is completed.
(FDCA), 21 U.S.C. 355. 21 U.S.C.
AGENCY: Drug Enforcement The DEA will publish a document in the
811(h)(1). The Attorney General has
Administration, Department of Justice. Federal Register announcing an
delegated scheduling authority under 21
ACTION: Temporary scheduling order. extension or permanence.
U.S.C. 811 to the Administrator of the
FOR FURTHER INFORMATION CONTACT: DEA. 28 CFR 0.100.
SUMMARY: The Administrator of the Drug
nlaroche on DSK30NT082PROD with RULES
Michael J. Lewis, Diversion Control
Enforcement Administration is issuing
Division, Drug Enforcement 1 Though DEA has used the term ‘‘final order’’
this temporary scheduling order to
Administration; Mailing Address: 8701 with respect to temporary scheduling orders in the
schedule the synthetic opioid, N-(4-
Morrissette Drive, Springfield, Virginia past, this notice adheres to the statutory language
fluorophenyl)-N-(1-phenethylpiperidin- of 21 U.S.C. 811(h), which refers to a ‘‘temporary
22152; Telephone: (202) 598–6812.
4-yl)isobutyramide (4-fluoroisobutyryl scheduling order.’’ No substantive change is
fentanyl or para-fluoroisobutyryl SUPPLEMENTARY INFORMATION: intended.
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![20548 Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Rules and Regulations
(16) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters
and ethers (Other names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl fentanyl) ........................................................................ (9824)
Dated: April 27, 2017. Copies of this Federal Register notice or that the employee is eligible for workers’
Chuck Rosenberg, and news releases: Electronic copies of compensation or other benefits.
Acting Administrator. these documents are available at
[FR Doc. 2017–08943 Filed 5–2–17; 8:45 am] OSHA’s Web page at http:// Subpart C—Recordkeeping Forms and
BILLING CODE 4410–09–P www.osha.gov. Recording Criteria
SUPPLEMENTARY INFORMATION: On
■ 3. Revise the heading of subpart C to
December 19, 2016, OSHA issued a final read as set forth above.
DEPARTMENT OF LABOR rule titled, ‘‘Clarification of Employer’s
■ 4. In § 1904.4, remove the note to
Continuing Obligation to Make and
Occupational Safety and Health Maintain an Accurate Record of Each § 1904.4(a) and revise paragraph (a)
Administration Recordable Injury and Illness.’’ See 81 introductory text to read as follows:
FR 91792. The final rule, which became § 1904.4 Recording criteria.
29 CFR Part 1904 effective on January 18, 2017, resulted (a) Basic requirement. Each employer
[Docket No. OSHA–2015–0006] in various amendments to OSHA’s required by this part to keep records of
recordkeeping regulations clarifying that fatalities, injuries, and illnesses must
RIN 1218–AC84 the duty to make and maintain accurate record each fatality, injury and illness
Clarification of Employer’s Continuing records of work-related injuries and that:
Obligation To Make and Maintain an illnesses is an ongoing obligation. On
March 1, 2017 (Cong. Rec. pp. H1421– * * * * *
Accurate Record of Each Recordable ■ 5. Revise § 1904.29(b)(3) to read as
Injury and Illness H1430), the House of Representatives
passed a resolution of disapproval (H.J. follows:
AGENCY: Occupational Safety and Health Res. 83) of the rule under the § 1904.29 Forms.
Administration (OSHA), Labor. Congressional Review Act (5 U.S.C. 801
* * * * *
ACTION: Final rule. et seq.). The Senate then passed H.J.
(b) * * *
Res. 83 on March 22, 2017. President
SUMMARY: Under the Congressional (3) How quickly must each injury or
Trump signed the resolution into law as
Review Act, Congress has passed, and illness be recorded? You must enter
Public Law 115–21 on April 3, 2017.
the President has signed, Public Law each recordable injury or illness on the
Accordingly, OSHA is hereby removing
115–21, a resolution of disapproval of OSHA 300 Log and 301 Incident Report
the affected amendments to the
OSHA’s final rule titled, ‘‘Clarification within seven (7) calendar days of
recordkeeping regulations from the
of Employer’s Continuing Obligation to receiving information that a recordable
Code of Federal Regulations.
Make and Maintain an Accurate Record injury or illness has occurred.
of each Recordable Injury and Illness.’’ List of Subjects in 29 CFR Part 1904 * * * * *
OSHA published the rule, which Health statistics, Occupational safety ■ 6. Revise the heading and paragraphs
contained various amendments to and health, Safety, Reporting and (a) and (b)(1) of § 1904.32 to read as
OSHA’s recordkeeping regulations, on recordkeeping requirements, State follows:
December 19, 2016. The amendments plans.
became effective on January 18, 2017. § 1904.32 Annual summary.
Because Public Law 115–21 invalidates Accordingly, the Occupational Safety
(a) Basic requirement. At the end of
the amendments to OSHA’s and Health Administration amends part
each calendar year, you must:
recordkeeping regulations contained in 1904 of title 29 of the Code of Federal
(1) Review the OSHA 300 Log to
the rule promulgated on December 19, Regulations as follows:
verify that the entries are complete and
2016, OSHA is hereby removing those PART 1904—RECORDING AND accurate, and correct any deficiencies
amendments from the Code of Federal REPORTING OCCUPATIONAL identified;
Regulations. INJURIES AND ILLNESSES (2) Create an annual summary of
DATES: This final rule becomes effective injuries and illnesses recorded on the
on May 3, 2017. ■ 1. Revise the authority citation for part OSHA 300 Log;
FOR FURTHER INFORMATION CONTACT: 1904 to read as follows: (3) Certify the summary; and
Press inquiries: Mr. Frank Meilinger, Authority: 29 U.S.C. 657, 658, 660, 666,
(4) Post the annual summary
Director, Office of Communications, 669, 673, Secretary of Labor’s Order No. 1– (b) * * *
OSHA, U.S. Department of Labor, Room 2012 (77 FR 3912, Jan. 25, 2012). (1) How extensively do I have to
N–3647, 200 Constitution Avenue NW., ■ 2. Revise § 1904.0 to read as follows: review the OSHA 300 Log entries at the
Washington, DC 20210; telephone (202) end of the year? You must review the
693–1999; email meilinger.francis2@ § 1904.0 Purpose. entries as extensively as necessary to
dol.gov. The purpose of this rule (part 1904) is make sure that they are complete and
Technical inquiries: Ms. Mandy to require employers to record and correct.
nlaroche on DSK30NT082PROD with RULES
Edens, Director, Directorate of Technical report work-related fatalities, injuries, * * * * *
Support and Emergency Management, and illnesses. ■ 7. Revise the heading and paragraph
OSHA, U.S. Department of Labor, Room Note to § 1904.0: Recording or reporting a (b) of § 1904.33 to read as follows:
N–3653, 200 Constitution Avenue NW., work-related injury, illness, or fatality does
Washington, DC 20210; telephone (202) not mean that the employer or employee was § 1904.33 Retention and updating.
693–2270; email edens.mandy@dol.gov. at fault, that an OSHA rule has been violated, * * * * *
VerDate Sep<11>2014 13:33 May 02, 2017 Jkt 241001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\03MYR1.SGM 03MYR1](https://thefederalregister.org/doc/82_FR_20628/page/5.svg)
Document Created: 2018-11-08 08:36:46
Document Modified: 2018-11-08 08:36:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Temporary scheduling order. | |
| Dates | This temporary scheduling order is effective May 3, 2017, until May 3, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 20544 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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