83 FR 17329 - Controlled Substances Quotas
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 76 (April 19, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 76 (April 19, 2018)
| Page Range | 17329-17333 | |
| FR Document | 2018-08111 |
[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)] [Proposed Rules] [Pages 17329-17333] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08111] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1303 [Docket No. DEA-480] RIN 1117-AB48 Controlled Substances Quotas AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration (DEA) is publishing this proposed rule to strengthen controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before May 4, 2018. Comments received by mail will be considered timely if they are postmarked on or before the last day of the comment period. The electronic Federal Docket Management System will accept electronic comments until Midnight Eastern Time at the end of that day. ADDRESSES: To ensure proper handling of comments, please reference ``Docket No. DEA-480'' on all correspondence, including any attachment. 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 to 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 that duplicate the electronic submission are not necessary and are discouraged. Should you, however, 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, Attention: 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- 8953. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received 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 and in DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. 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 posted online or made available in the public docket, you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket 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 posted online or made available in the public docket, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION paragraph. Legal Authority Provisions of the Controlled Substances Act, 21 U.S.C. 801 et seq., authorize the Attorney General to issue rules and regulations relating to registration and control of the manufacture, distribution, and dispensing of controlled substances and listed chemicals. 21 U.S.C. 821. Pursuant to this authority, the Attorney General, through the Drug Enforcement Administration (DEA), has issued and administers regulations setting aggregate production quotas for each basic class of controlled substances in schedules I and II, manufacturing quotas for individual manufacturers, and procurement quotas for manufacturers to produce other controlled substances or to convert the substances into dosage form. See 21 CFR part 1303. The current regulations, issued initially in 1971, need to be updated to reflect changes in the manufacture of controlled substances, changing patterns of substance abuse and markets in illicit drugs, and the challenges presented by the current national crisis of controlled substance abuse. This proposed rule modifies the regulations to strengthen controls over diversion--that is, the redirection of controlled substances which may have lawful uses into illicit channels--and makes other improvements in the controlled substance regulatory quota system. The quota process, in general terms, is a critical element of the Controlled Substances Act's regulatory system that seeks to prevent or limit diversion by preventing the accumulation of controlled substances in amounts exceeding legitimate need. The measures the proposed rule adopts to strengthen the system include authorizing the requisition from quota applicants of additional information helpful in detecting and preventing diversion, and ensuring that DEA's determinations regarding the appropriate quotas are adequately informed by input from other federal agencies, from the states, and from quota applicants. [[Page 17330]] Section-by-Section Analysis Section 1303.11--Aggregate Production Quotas Section 1303.11 in the existing regulations directs the Administrator of DEA to determine the total quantity of each basic class of controlled substance listed in schedule I or II needed in the calendar year for the medical, scientific, research and industrial needs of the United States, for lawful export, and for the establishment and maintenance of reserve stocks. Section 1303.11(b)(1)- (4) identifies a number of factors that are categorically to be considered in determining aggregate production quotas--relating to total net disposal, net disposal trends, inventories and inventory trends, and demand--followed by a final catchall factor, (5), regarding factors to be considered as the Administrator finds relevant. The proposed rule would make two additions to the list of factors that must regularly be considered in setting the aggregate production quotas because of their importance. First, it would add to the list the extent of any diversion of the controlled substance in the class. This is relevant to ensure that the allowed aggregate production quota is limited to that needed to provide adequate supplies for the United States' legitimate needs. Second, the proposed rule would amend the list of factors to be considered in establishing these quotas to include relevant information from the Department of Health and Human Services (HHS) and its components, including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS), as well as relevant information obtained from the states. Pursuant to 42 U.S.C. 242(a), HHS studies the use and misuse of controlled substances and provides, through the FDA, an annual report to the Attorney General concerning the quantities of controlled substances necessary to support the medicinal needs of the United States. The CDC and the CMS may also have relevant information, including information about the prevalence and patterns of drug abuse and the diversion of controlled substances to illicit use. The amendment would ensure that information will be requested from the relevant HHS components and will be considered in setting the aggregate production quotas. Regarding the states, the proposed rule would provide that the Administrator will consider information from the states in setting the aggregate production quotas and make additional changes enhancing their role in Sec. 1303.11(c). The states are critically situated to provide information about the extent of legitimate and illegitimate use of controlled substances because of their responsibilities for drug enforcement within their jurisdictions, including through the Prescription Drug Monitoring Programs, their responsibilities for administration of their health care systems, and their responsibilities for dealing with the human and social costs of drug abuse and diversion. States may have relevant information indicating that individual procurement quota requests reflect quantities which will in fact be diverted to illicit use, which may in turn yield an exaggerated picture of the aggregate production quotas needed for legitimate purposes. The proposed rule accordingly includes amendments to Sec. 1303.11(c) which provide for (i) transmitting notices of proposed aggregate production quotas, and final aggregate production quota orders, to the state attorney general, and (ii) holding a hearing if necessary to resolve an issue of material fact raised by a state's objection to a proposed aggregate production quota as excessive in relation to legitimate United States need. Section 1303.12--Procurement Quotas Section 1303.12 in the regulations directs the Administrator to issue procurement quotas for manufacturers that use controlled substances to put them into dosage form or to make other substances. The section requires applicants for procurement quotas to state what basic class of controlled substance is needed, the purpose or purposes for which the class is desired, the quantity desired for each purpose during the next calendar year, and the quantities used and estimated to be used for each purpose during the current and preceding two calendar years. If the applicant's purpose is to manufacture another basic class of controlled substance, the applicant also must state the quantity of the other basic class that the applicant has applied to manufacture, and the quantity of the first basic class necessary to manufacture a specified quantity of the second basic class. The proposed rule would amend Sec. 1303.12(b) to clarify that the Administrator may require additional comparable information from applicants that may help to detect or prevent diversion, including customer identities and amounts of the controlled substance sold to each customer. Section 1303.13--Adjustments of Aggregate Production Quotas Section 1303.13 authorizes the Administrator, at any time, to increase or reduce the aggregate production quotas for basic classes of controlled substances that were previously fixed pursuant to Sec. 1303.11. The proposed rule would make amendments to Sec. 1303.13 that parallel some of the amendments made to Sec. 1303.11. Specifically, it includes changes in the extent of any diversion of the controlled substance among the factors to be considered in adjusting the aggregate production quota, requires transmission of adjustment notices and final adjustment orders to the state attorney general, and provides for a hearing if necessary to resolve an issue of material fact raised by a state's objection to a proposed adjusted quota as excessive for legitimate United States need. Section 1303.22--Procedure for Applying for Individual Manufacturing Quotas The proposed rule would amend Sec. 1303.22 to clarify that the Administrator may require additional information from individual manufacturing quota applicants that may help to detect or prevent diversion, including customer identities and amounts of the controlled substance sold to each customer. Section 1303.23--Procedures for Fixing Individual Manufacturing Quotas The proposed rule would amend Sec. 1303.23 to provide that the factors the Administrator may deem relevant in fixing individual manufacturing quotas include the extent and risk of diversion of controlled substances. Section 1303.32--Purpose of Hearing The proposed rule includes an amendment relating to hearings in Sec. 1303.32(a), conforming to the amendments to Sec. Sec. 1303.11(c) and 1303.13(c) concerning hearings based on state objections. Other Matters In addition to the significant changes discussed above, the proposed rule would correct a number of typographic errors in the current regulations. Request for Comments Some of the proposed rule's provisions, including those relating to seeking information from other federal agencies and the states, and those relating to the holding of hearings based on state objections, are exempt from the notice and comment requirements of the Administrative Procedure Act as ``rules [[Page 17331]] of agency organization, procedure, or practice.'' 5 U.S.C. 553(b)(A). Regarding the other matters addressed in the proposed rule, DEA particularly seeks comments on the provisions regarding the factors the Administrator shall consider when adjusting the aggregate production quotas (21 CFR 1303.13(b)(1)) and the additional information the Administrator may require from applicants (21 CFR 1303.12(b) and 21 CFR 1303.22). Insofar as soliciting public comment is necessary or useful, DEA publishes this proposed rule with a 15-day public comment period. This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history. HHS and DEA have developed extensive information concerning the nature and magnitude of the crisis. See www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html; www.cdc.gov/drugoverdose/data (CDC Epidemic Data); www.cdc.gov/nchs/products/databriefs/db294.htm (CDC Overdose Data); www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.pdf (SAMHSA Data); www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis (NIDA Data); Drug Enforcement Administration, 2017 National Drug Threat Assessment (Oct. 2017), at v, 25-43 (2017 DEA Data). Salient facts include the following: Drug overdoses are now the leading cause of injury-related death in the United States, eclipsing deaths from motor vehicle accidents, firearms, homicide, or suicide. There were more than 63,600 overdose deaths in 2016, with opioids as the main driver of such deaths. Overdoses involving opioids killed more than 42,000 people in 2016, with prescription opioids accounting for 40% of the total. Opioid overdose deaths were more than five times higher in 2016 than 1999. 2017 DEA Data at v, 25; CDC Overdose Data; CDC Epidemic Data. The misuse of controlled prescription drugs, and particularly prescription opioids, has been central to this deadly epidemic. In 2016, of Americans aged 12 or older, an estimated 3.3 million had misused prescription pain relievers during the preceding month and approximately 11.8 million had misused opioids in the past year. Prescription opioid misuse is more common than use of any category of illicit drug in the United States except for marijuana. SAMHSA Data at 14, 16, 20-21. Users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue. About 80% of heroin users first misused prescription opioids. Thus, it may be inferred that current users of heroin and fentanyl largely entered the gateway as part of the populations who previously misused prescription opioids. See NIDA Data. Street prices for controlled prescription opioids are typically 5 to 10 times their retail value, with steady increases with the relative strength of the drug, fueling the market for prescription medications diverted into illegal channels. For example, hydrocodone combination products--a schedule II prescription drug and also the most prescribed controlled prescription drug in the country--can be purchased for $5 to $7 per tablet on the street. Slightly stronger drugs like oxycodone combined with acetaminophen (e.g., Percocet) can be purchased for $7 to $10 per tablet on the street. Even stronger prescription drugs are sold for as much as $1 per milligram (mg). For example, 30 mg oxycodone (immediate release) and 30 mg oxymorphone (extended release) cost $30 to $40 per tablet on the street. Due in part to the large number of people who abuse licit controlled prescription drugs, other opioids are now being disguised and sold as controlled prescription drugs. The economic impact of prescription drug abuse was estimated to be $78.5 billion in 2013. Specific costs included increased health care and substance abuse treatment costs, criminal justice costs, and employment-related costs including lost earnings from premature death, reduced compensation, and lost employment. These costs, largely reflecting prescription opioid abuse, represent a substantial and growing economic burden on society. 2017 DEA Data at 40. This proposed rule's reforms, which will help to control the diversion of controlled substances feeding the crisis described above, must be implemented without delay to permit timely action by the Drug Enforcement Administration, informed by adequate input from manufacturers, other federal agencies, and the states. The affected determinations include the following: Section 1303.11 in the regulations requires the DEA Administrator to publish notice of the proposed aggregate production quotas for 2019 well in advance in 2018. The proposed rule's amendments to Sec. 1303.11 would expand the factors to be considered by the Administrator to include the extent of diversion and enhance the input and role of other federal agencies and the states in the quota-setting process. Having these reforms in place expeditiously will facilitate the sound proposal and determination of aggregate production quotas for 2019. Section 1303.12 requires the Administrator to set manufacturers' procurement quotas for 2019 well in advance in 2018; manufacturers' applications were due by April 1, 2018. The proposed rule would amend Sec. 1303.12 to allow the Administrator to require procurement quota applicants to provide additional information that may help to detect or prevent the diversion of controlled substances ostensibly obtained for legitimate dosage form manufacturing. Having this reform in place expeditiously will facilitate the sound determination of procurement quotas for 2019 and help to ensure that controlled substances sought for dosage form manufacturing will not be diverted. Section 1303.13 allows the Administrator to increase or reduce aggregate production quotas at any time. The proposed amendments would expand the factors to be considered by the Administrator in adjusting aggregate production quotas to include changes in the extent of diversion and make other changes to enhance the input and role of the states in the aggregate production quota adjustment process. Having these reforms in place expeditiously, as well as the amendments to other sections authorizing the requisition of more information from manufacturers bearing on the extent of diversion, will facilitate the sound determination of aggregate production quota adjustments by the Administrator, which may be undertaken at any time. Sections 1303.22 and 1303.23 require the Administrator to set individual manufacturing quotas for 2019 well in advance in 2018, based on applications the manufacturers must submit by May 1, 2018. The proposed rule's amendments to these sections would authorize the Administrator to require applicants to provide additional information that may help to detect or prevent diversion, and add the extent and risk of diversion to the factors the Administrator may deem relevant in fixing individual manufacturing quotas. Having these reforms in place expeditiously will facilitate the sound determination of the individual manufacturing quotas for 2019. In sum, the death of over 63,600 Americans from drug overdoses in 2016, and the other human, social, and [[Page 17332]] economic costs detailed above, make imperative the immediate use of all available tools to prevent the diversion of controlled substances. Delay in the finalization and implementation of this proposed rule would impede putting into effect the diversion countermeasures it authorizes, which will help to stem a source of the flow of controlled substances with legitimate uses into illicit channels. Such delay would prevent in the meantime the alleviation of the toll on human life and health, and the devastating social and economic costs, which shortfalls in the existing regulations facilitate. Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), has reviewed this proposed rule and by approving it certifies that the rule will not have a significant economic impact on a substantial number of small entities. The DEA estimates that 325 manufacturers may be affected by the proposed rule, of which 301 manufacturers (92.6% of the total) are small entities. There will not be a significant economic impact on a substantial number of these small entities or any others because, as the ensuing certifications discuss, any overall cost of the rule is not significant. Executive Orders 12866, 13563, and 13771--Regulatory Planning and Review, and Reducing Regulation and Controlling Regulatory Costs This regulation has been drafted and reviewed in accordance with Executive Order 12866, ``Regulatory Planning and Review,'' section 1(b), Principles of Regulation, and Executive Order 13563, ``Improving Regulation and Regulatory Review.'' DEA has determined that this proposed rule is not a ``significant regulatory action'' under Executive Order 12866, section 3(f). The DEA analyzed the economic impact of each provision of this proposed rule. Section 1303.11 would be amended to make two additions to the list of factors to be considered by the Administrator in setting the aggregate production quotas. First, it would add the extent of any diversion of the controlled substance in the class. Second, it would add relevant information from HHS and its components, as well as from the states. The DEA has always considered any information obtained from other federal and state government agencies when fixing the aggregate production quotas for a controlled substance. While the DEA may receive additional information that is valuable in detecting and preventing diversion, the DEA has no reason to believe that there will be adverse economic impact or other consequences sufficient to implicate Executive Order (E.O.) 12866. Additionally, sections 1303.11 and 1303.13 would be amended to require the DEA to transmit copies of aggregate production quotas and any adjustments to those quotas published in the Federal Register directly to state attorney general. While the DEA anticipates some labor burden to transmit aggregate production quota notices and orders to each state attorney general, the DEA estimates that this activity will result in a minimal yearly cost to the DEA and that the DEA has sufficient resources to absorb this minimal cost. Additionally, sections 1303.11, 1303.13, and 1303.32 would be amended to explicitly state that the DEA Administrator shall hold a hearing if he or she determines it is necessary to resolve an issue of material fact raised by a state objecting to the proposed quantity for the class as excessive for legitimate United States need. The estimated yearly cost of this revision will be dependent on the amount of hearings the DEA Administrator determines to be necessary to resolve an issue of material fact raised by a state regarding the aggregate production quota. Hearings regarding aggregate production quotas are infrequent and the DEA estimates that hearings of this type will continue to be infrequent under this proposed rule. For these reasons, the DEA does not expect a material increase in the number of hearings or in the associated costs to DEA or the states. Sections 1303.12 and 1303.22 would be amended to explicitly state that the Administrator may require additional information from an individual manufacturing or procurement quota applicant, including customer identities and amounts of controlled substances sold to each of their customers. Currently, the DEA can and does request additional information of this nature from quota applicants if deemed necessary. While affording the Administrator express regulatory authority to require such information may result in the receipt of additional information that is valuable in detecting and preventing diversion, it is not expected that the difference will have adverse economic impact or other consequences sufficient to implicate E.O. 12866. Sections 1303.11, 1303.13, and 1303.23 would be amended to add the requirement that DEA consider diversion of a controlled substance when fixing aggregate production quotas, adjusting aggregate production quotas, and fixing individual manufacturing quotas. When fixing and adjusting the aggregate production quota, or fixing an individual manufacturing quota for a controlled substance, the DEA has always considered all available information regarding the diversion of that controlled substance. While the proposed rule's amendments, as discussed above, may result in the receipt and consideration of additional information relating to diversion, it is not expected that the difference will have adverse economic impact or other consequences sufficient to implicate E.O. 12866. This proposed rule is not expected to be an E.O. 13771 regulatory action because this proposed rule is not significant under E.O. 12866. Executive Order 13132--Federalism This regulation 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, it is determined that this proposed rule does not have sufficient federalism implications to warrant the preparation of a federalism assessment. Executive Order 12988--Civil Justice Reform This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988. Paperwork Reduction Act This proposed rule codifies current agency practice under existing approved information collections, and does not impose new information collection requirements under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. Unfunded Mandates Reform Act of 1995 This proposed rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rulemaking is not a major rule as defined by section 251 of the Congressional Review Act. 5 U.S.C. 804. This proposed rule will not result in an [[Page 17333]] annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, or innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. List of Subjects in 21 CFR Part 1303 Administrative practice and procedure, Drug traffic control. Accordingly, for the reasons stated in the preamble, part 1303 of title 21 of the Code of Federal Regulations is proposed to be amended as follows: PART 1303--QUOTAS 0 1. The authority citation for part 1303 continues to read as follows: Authority: 21 U.S.C. 821, 826, 871(b). 0 2. In Sec. 1303.11: 0 a. Remove the word ``and'' at the end of paragraph (b)(4). 0 b. Redesignate paragraph (b)(5) as paragraph (b)(7). 0 c. Add new paragraphs (b)(5) and (6). 0 d. In paragraph (c), add the phrase ``and transmitted to each state attorney general'' before the period in the second sentence, add the phrase ``except that the Administrator shall hold a hearing if he determines it is necessary to resolve an issue of material fact raised by a state objecting to the proposed quantity for the class as excessive for legitimate United States need'' before the period in the fourth sentence, remove the word ``such'' in the fifth sentence, add the phrase ``, the Administrator'' before ``shall issue'' in the sixth sentence, and add the phrase ``and transmitted to each state attorney general'' before the period in the final sentence. The additions read as follows: Sec. 1303.11 Aggregate production quotas. * * * * * (b) * * * (5) The extent of any diversion of the controlled substance in the class; (6) Relevant information obtained from the Department of Health and Human Services, including from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services, and relevant information obtained from the states; and * * * * * 0 3. In Sec. 1303.12(b), add after the fifth sentence a new sentence to read as follows: Sec. 1303.12 Procurement quotas. * * * * * (b) * * * The Administrator may require additional information from an applicant which, in the Administrator's judgment, may be helpful in detecting or preventing diversion, including customer identities and amounts of the controlled substance sold to each customer. * * * * * * * * 0 4. In Sec. 1303.13: 0 a. Revise paragraph (b)(1). 0 b. In paragraph (c), add the phrase ``and transmitted to each state attorney general'' before the period in the second sentence, add the phrase ``, except that the Administrator shall hold a hearing if he determines it is necessary to resolve an issue of material fact raised by a state objecting to the proposed adjusted quota as excessive for legitimate United States need'' before the period in the fourth sentence, remove the word ``such'' in the fifth sentence, and add the phrase ``and transmitted to each state attorney general'' before the period in the final sentence. The revision reads as follows: Sec. 1303.13 Adjustments of aggregate production quotas. * * * * * (b) * * * (1) Changes in the demand for that class, changes in the national rate of net disposal of the class, changes in the rate of net disposal of the class by registrants holding individual manufacturing quotas for that class, and changes in the extent of any diversion in the class; * * * * * Sec. 1303.21 [Amended] 0 5. In Sec. 1303.21(a), remove ``Sec. Sec. '' in the second sentence and add in its place ``Sec. ''. 0 6. In Sec. 1303.22: 0 a. In paragraph (c)(2), remove the word ``econolic'' and add in its place the word ``economic''. 0 b. Add paragraph (d). The addition reads as follows: Sec. 1303.22 Procedure for applying for individual manufacturing quotas. * * * * * (d) The Administrator may require additional information from an applicant which, in the Administrator's judgment, may be helpful in detecting or preventing diversion, including customer identities and amounts of the controlled substance sold to each customer. Sec. 1303.23 [Amended] 0 7. In Sec. 1303.23, add the phrase ``the extent of any diversion of the controlled substance,'' after ``strikes),'' in paragraph (a)(2), and add the phrase ``any risk of diversion of the controlled substance,'' after ``strikes),'' in paragraph (b)(2). Sec. 1303.32 [Amended] 0 8. In Sec. 1303.32(a), add the phrase ``and shall, if determined by the Administrator to be necessary under Sec. 1303.11(c) or 1303.13(c) based on objection by a state,'' before ``hold a hearing''. Dated: April 13, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-08111 Filed 4-18-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Proposed Rules 17329
V–228 [Amended] view on Regulations.gov. If you have identified and located as set forth above
From Dells, WI; Madison, WI;to INT received a Comment Tracking Number, will be redacted and the comment, in
Madison 138° and Badger, WI, 193°(T)/ your comment has been successfully redacted form, will be posted online and
191°(M) radials. From INT DuPage, IL, submitted and there is no need to placed in DEA’s public docket file.
359°(T)/357°(M) and Northbrook, IL, 291° resubmit the same comment. Paper Please note that the Freedom of
radials; Northbrook; INT Northbrook 110° comments that duplicate the electronic
and Gipper, MI, 290° radials; to Gipper. Information Act applies to all comments
submission are not necessary and are received. If you wish to inspect the
Issued in Washington, DC, on April 11, discouraged. Should you, however,
2018.
agency’s public docket file in person by
wish to mail a paper comment in lieu appointment, please see the FOR
Rodger A. Dean Jr., of an electronic comment, it should be
FURTHER INFORMATION paragraph.
Manager, Airspace Policy Group. sent via regular or express mail to: Drug
[FR Doc. 2018–08033 Filed 4–18–18; 8:45 am] Enforcement Administration, Attention: Legal Authority
BILLING CODE 4910–13–P DEA Federal Register Representative/
DRW, 8701 Morrissette Drive, Provisions of the Controlled
Springfield, Virginia 22152. Substances Act, 21 U.S.C. 801 et seq.,
DEPARTMENT OF JUSTICE FOR FURTHER INFORMATION CONTACT: authorize the Attorney General to issue
Michael J. Lewis, Diversion Control rules and regulations relating to
Drug Enforcement Administration Division, Drug Enforcement registration and control of the
Administration; Mailing Address: 8701 manufacture, distribution, and
21 CFR Part 1303 Morrissette Drive, Springfield, Virginia dispensing of controlled substances and
22152; Telephone: (202) 598–8953. listed chemicals. 21 U.S.C. 821.
[Docket No. DEA–480]
SUPPLEMENTARY INFORMATION: Pursuant to this authority, the Attorney
RIN 1117–AB48 General, through the Drug Enforcement
Posting of Public Comments
Administration (DEA), has issued and
Controlled Substances Quotas Please note that all comments administers regulations setting aggregate
AGENCY: Drug Enforcement received are considered part of the production quotas for each basic class of
Administration, Department of Justice. public record. They will, unless controlled substances in schedules I and
reasonable cause is given, be made II, manufacturing quotas for individual
ACTION: Notice of proposed rulemaking.
available by the Drug Enforcement
manufacturers, and procurement quotas
SUMMARY: The Drug Enforcement Administration (DEA) for public
for manufacturers to produce other
Administration (DEA) is publishing this inspection online at http://
www.regulations.gov and in DEA’s controlled substances or to convert the
proposed rule to strengthen controls substances into dosage form. See 21 CFR
over diversion of controlled substances public docket. Such information
includes personal identifying part 1303.
and make other improvements in the
quota management regulatory system for information (such as your name, The current regulations, issued
the production, manufacturing, and address, etc.) voluntarily submitted by initially in 1971, need to be updated to
procurement of controlled substances. the commenter. reflect changes in the manufacture of
DATES: Written comments must be
If you want to submit personal controlled substances, changing patterns
postmarked, and electronic comments identifying information (such as your of substance abuse and markets in illicit
name, address, etc.) as part of your drugs, and the challenges presented by
must be sent, on or before May 4, 2018.
comment, but do not want it to be the current national crisis of controlled
Comments received by mail will be
posted online or made available in the substance abuse. This proposed rule
considered timely if they are
public docket, you must include the
postmarked on or before the last day of modifies the regulations to strengthen
phrase ‘‘PERSONAL IDENTIFYING
the comment period. The electronic controls over diversion—that is, the
INFORMATION’’ in the first paragraph
Federal Docket Management System redirection of controlled substances
of your comment. You must also place
will accept electronic comments until which may have lawful uses into illicit
all the personal identifying information
Midnight Eastern Time at the end of that channels—and makes other
you do not want posted online or made
day. improvements in the controlled
available in the public docket in the first
ADDRESSES: To ensure proper handling paragraph of your comment and identify substance regulatory quota system.
of comments, please reference ‘‘Docket what information you want redacted. The quota process, in general terms, is
No. DEA–480’’ on all correspondence, If you want to submit confidential a critical element of the Controlled
including any attachment. The Drug business information as part of your Substances Act’s regulatory system that
Enforcement Administration encourages comment, but do not want it to be
that all comments be submitted seeks to prevent or limit diversion by
posted online or made available in the preventing the accumulation of
electronically through the Federal public docket, you must include the
eRulemaking Portal which provides the controlled substances in amounts
phrase ‘‘CONFIDENTIAL BUSINESS
ability to type short comments directly exceeding legitimate need. The
INFORMATION’’ in the first paragraph
into the comment field on the web page measures the proposed rule adopts to
of your comment. You must also
or to attach a file for lengthier prominently identify confidential strengthen the system include
comments. Please go to http:// business information to be redacted authorizing the requisition from quota
daltland on DSKBBV9HB2PROD with PROPOSALS
www.regulations.gov and follow the within the comment. If a comment has applicants of additional information
online instructions at that site for so much confidential business helpful in detecting and preventing
submitting comments. Upon completion information that it cannot be effectively diversion, and ensuring that DEA’s
of your submission you will receive a redacted, all or part of that comment determinations regarding the
Comment Tracking Number for your may not be posted online or made appropriate quotas are adequately
comment. Please be aware that available in the public docket. informed by input from other federal
submitted comments are not Personal identifying information and agencies, from the states, and from
instantaneously available for public confidential business information quota applicants.
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![Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Proposed Rules 17333
annual effect on the economy of $100 § 1303.12 Procurement quotas. substance,’’ after ‘‘strikes),’’ in
million or more; a major increase in * * * * * paragraph (a)(2), and add the phrase
costs or prices; or significant adverse (b) * * * The Administrator may ‘‘any risk of diversion of the controlled
effects on competition, employment, require additional information from an substance,’’ after ‘‘strikes),’’ in
investment, productivity, or innovation, applicant which, in the Administrator’s paragraph (b)(2).
or on the ability of United States-based judgment, may be helpful in detecting
§ 1303.32 [Amended]
enterprises to compete with foreign- or preventing diversion, including
based enterprises in domestic and customer identities and amounts of the ■ 8. In § 1303.32(a), add the phrase ‘‘and
export markets. controlled substance sold to each shall, if determined by the
customer. * * * Administrator to be necessary under
List of Subjects in 21 CFR Part 1303 § 1303.11(c) or 1303.13(c) based on
* * * * * objection by a state,’’ before ‘‘hold a
Administrative practice and ■ 4. In § 1303.13:
procedure, Drug traffic control. ■ a. Revise paragraph (b)(1).
hearing’’.
Accordingly, for the reasons stated in ■ b. In paragraph (c), add the phrase Dated: April 13, 2018.
the preamble, part 1303 of title 21 of the ‘‘and transmitted to each state attorney Robert W. Patterson,
Code of Federal Regulations is proposed general’’ before the period in the second Acting Administrator.
to be amended as follows: sentence, add the phrase ‘‘, except that [FR Doc. 2018–08111 Filed 4–18–18; 8:45 am]
the Administrator shall hold a hearing BILLING CODE 4410–09–P
PART 1303—QUOTAS if he determines it is necessary to
resolve an issue of material fact raised
■ 1. The authority citation for part 1303 by a state objecting to the proposed DEPARTMENT OF HOMELAND
continues to read as follows: adjusted quota as excessive for SECURITY
Authority: 21 U.S.C. 821, 826, 871(b). legitimate United States need’’ before
the period in the fourth sentence, Coast Guard
■ 2. In § 1303.11: remove the word ‘‘such’’ in the fifth
■ a. Remove the word ‘‘and’’ at the end sentence, and add the phrase ‘‘and 33 CFR Part 100
of paragraph (b)(4). transmitted to each state attorney
■ b. Redesignate paragraph (b)(5) as [Docket Number USCG–2018–0224]
general’’ before the period in the final
paragraph (b)(7). sentence. RIN 1625–AA08
■ c. Add new paragraphs (b)(5) and (6). The revision reads as follows:
■ d. In paragraph (c), add the phrase Special Local Regulation;
§ 1303.13 Adjustments of aggregate Monongahela, Allegheny, and Ohio
‘‘and transmitted to each state attorney production quotas.
general’’ before the period in the second Rivers, Pittsburgh PA
sentence, add the phrase ‘‘except that * * * * *
(b) * * * AGENCY: Coast Guard, DHS.
the Administrator shall hold a hearing ACTION: Notice of proposed rulemaking.
(1) Changes in the demand for that
if he determines it is necessary to
class, changes in the national rate of net
resolve an issue of material fact raised SUMMARY: The Coast Guard proposes to
disposal of the class, changes in the rate
by a state objecting to the proposed establish a special local regulation for
of net disposal of the class by registrants
quantity for the class as excessive for parts of the navigable waters of the
holding individual manufacturing
legitimate United States need’’ before Allegheny, Monongahela, and Ohio
quotas for that class, and changes in the
the period in the fourth sentence, Rivers. This action is necessary to
extent of any diversion in the class;
remove the word ‘‘such’’ in the fifth provide for the safety of life on these
sentence, add the phrase ‘‘, the * * * * * navigable waters during the weekend of
Administrator’’ before ‘‘shall issue’’ in § 1303.21 [Amended] the Kenny Chesney concert at Heinz
the sixth sentence, and add the phrase ■ 5. In § 1303.21(a), remove ‘‘§§ ’’ in the Field. This proposed rulemaking would
‘‘and transmitted to each state attorney second sentence and add in its place prohibit persons and vessels from
general’’ before the period in the final ‘‘§ ’’. loitering, anchoring, stopping, mooring,
sentence. ■ 6. In § 1303.22: remaining, or drifting in any manner
The additions read as follows: ■ a. In paragraph (c)(2), remove the that impedes safe passage of another
word ‘‘econolic’’ and add in its place vessel to any launching ramp, marina,
§ 1303.11 Aggregate production quotas. or fleeting area unless authorized by the
the word ‘‘economic’’.
* * * * * ■ b. Add paragraph (d). Captain of the Port Marine Safety Unit
(b) * * * The addition reads as follows: Pittsburgh or a designated
(5) The extent of any diversion of the representative. In addition, this
controlled substance in the class; § 1303.22 Procedure for applying for proposed rulemaking would prohibit
individual manufacturing quotas. persons and vessels from loitering,
(6) Relevant information obtained
from the Department of Health and * * * * * anchoring, stopping, or drifting more
Human Services, including from the (d) The Administrator may require than 100 feet from any riverbank unless
Food and Drug Administration, the additional information from an authorized by the Captain of the Port
Centers for Disease Control and applicant which, in the Administrator’s Marine Safety Unit Pittsburgh or a
judgment, may be helpful in detecting designated representative. We invite
daltland on DSKBBV9HB2PROD with PROPOSALS
Prevention, and the Centers for
Medicare and Medicaid Services, and or preventing diversion, including your comments on this proposed
relevant information obtained from the customer identities and amounts of the rulemaking.
states; and controlled substance sold to each
DATES: Comments and related material
customer.
* * * * * must be received by the Coast Guard on
■ 3. In § 1303.12(b), add after the fifth § 1303.23 [Amended] or before May 4, 2018.
sentence a new sentence to read as ■ 7. In § 1303.23, add the phrase ‘‘the ADDRESSES: You may submit comments
follows: extent of any diversion of the controlled identified by docket number USCG–
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Document Created: 2018-04-19 00:40:39
Document Modified: 2018-04-19 00:40:39
| 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 | Proposed Rules | |
| Action | Notice of proposed rulemaking. | |
| Dates | Written comments must be postmarked, and electronic comments must be sent, on or before May 4, 2018. Comments received by mail will be considered timely if they are postmarked on or before the last day of the comment period. The electronic Federal Docket Management System will accept electronic comments until Midnight Eastern Time at the end of that day. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 83 FR 17329 | |
| RIN Number | 1117-AB48 | |
| CFR Associated | Administrative Practice and Procedure and Drug Traffic Control |
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