Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II, 11037-11045 [2014-04333]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Proposed Rules]
[Pages 11037-11045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04333]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-389]


Schedules of Controlled Substances: Rescheduling of Hydrocodone 
Combination Products From Schedule III to Schedule II

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes to 
reschedule hydrocodone combination products from schedule III to 
schedule II of the Controlled Substances Act. This proposed action is 
based on a rescheduling recommendation from the Assistant Secretary for 
Health of the Department of Health and Human Services and an evaluation 
of all other relevant data by the DEA. If finalized, this action would 
impose the regulatory controls and administrative, civil, and criminal 
sanctions applicable to schedule II controlled substances on persons 
who handle (manufacture, distribute, dispense, import, export, engage 
in research, conduct instructional activities, or possess) or propose 
to handle hydrocodone combination products.

DATES: Interested persons may file written comments on this proposal 
pursuant to 21 CFR 1308.43(g). Electronic comments must be submitted, 
and written comments must be postmarked, on or before April 28, 2014. 
Commenters should be aware that the electronic Federal Docket 
Management System will not accept comments after midnight Eastern Time 
on the last day of the comment period.

[[Page 11038]]

    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, may file a request for 
hearing or waiver of an opportunity for a hearing or to participate in 
a hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 
1316.45, 1316.47, 1316.48 or 1316.49, as applicable. Requests for 
hearing, notices of appearance, and waivers of an opportunity for a 
hearing or to participate in a hearing must be received on or before 
March 31, 2014.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-389'' on all electronic and written correspondence. 
The DEA 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 www.regulations.gov 
and follow the on-line instructions at that site for submitting 
comments. Paper comments that duplicate electronic submissions are not 
necessary. Should you, however, wish to submit written comments, in 
lieu of electronic comments, they should be sent via regular or express 
mail to: Drug Enforcement Administration, Attention: DEA Federal 
Register Representative/ODW, 8701 Morrissette Drive, Springfield, 
Virginia 22152. All requests for a hearing and waivers of participation 
must be sent to: Drug Enforcement Administration, Attention: Hearing 
Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Office of Diversion 
Control, 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 and will be made available for 
public inspection online at 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. 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 containing personal identifying 
information or confidential business information identified as directed 
above will be made publicly available in redacted form.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at www.regulations.gov for easy 
reference. If you wish to personally inspect the comments and materials 
received or the supporting documentation the DEA used in preparing the 
proposed action, these materials will be available for public 
inspection by appointment. To arrange a viewing, please see the ``For 
Further Information Contact'' paragraph above.

Request for Hearing, Notice of Appearance at Hearing, or Waiver of an 
Opportunity for a Hearing or To Participate in a Hearing

    Pursuant to the provisions of the Controlled Substances Act (CSA), 
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 a 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. Requests for hearing and notices of appearance 
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 the 
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 1316.49, 
including 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)(1), 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 [title 21] for the schedule in which such drug is to be placed * 
* *.'' Requests for a hearing, notices of appearance at a hearing, and 
waivers of an opportunity for a hearing or to participate in a hearing 
must be submitted 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), parts 1300 to 1321. 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, 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 all scheduled substances is published at 21 CFR Part 1308. 21 
U.S.C. 812(a).

[[Page 11039]]

    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 [21 U.S.C. 812(b)] for the 
schedule in which such drug is to be placed * * *.'' Pursuant to 28 CFR 
0.100(b), the Attorney General has delegated this scheduling authority 
to the Administrator of the DEA.
    The CSA provides that the scheduling of any drug or other substance 
may be initiated by the Attorney General (1) on his own motion; (2) at 
the request of the Secretary of the Department of Health and Human 
Services (HHS); or (3) on the petition of any interested party. 21 
U.S.C. 811(a). This proposed action was initiated by a petition to 
reschedule hydrocodone combination products (HCPs) \1\ from schedule 
III to schedule II of the CSA, and is supported by, inter alia, a 
recommendation from the Assistant Secretary for Health of the HHS.\2\ 
If finalized, this action would impose the regulatory controls and 
administrative, civil, and criminal sanctions of schedule II controlled 
substances on any person who handles, or proposes to handle, HCPs.
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    \1\ Hydrocodone combination products (HCPs) are pharmaceuticals 
containing specified doses of hydrocodone in combination with other 
drugs in specified amounts. These products are approved for 
marketing for the treatment of pain and for cough suppression.
    \2\ As set forth in a memorandum of understanding entered into 
by the HHS, 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 the 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.
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Background

    Hydrocodone was listed in schedule II of the CSA upon the enactment 
of the CSA in 1971. Public Law 91-513, 84 Stat. 1236, sec. 202(c), 
schedule II, paragraph (a), clause (1) (codified at 21 U.S.C. 812(c)); 
initially codified at 21 CFR 308.12(b)(1)(x) (36 FR 7776, April 24, 
1971) (currently codified at 21 CFR 1308.12(b)(1)(vi)). At that time, 
HCPs in specified doses (containing no greater than 15 milligrams (mg) 
hydrocodone per dosage unit or not more than 300 mg hydrocodone per 100 
milliliters) were listed in schedule III of the CSA when formulated 
with specified amounts of an isoquinoline alkaloid of opium or one or 
more therapeutically active nonnarcotic ingredients. Public Law 91-513, 
84 Stat. 1236, sec. 202(c), schedule III, paragraph (d), clauses (3) 
and (4) (codified at 21 U.S.C. 812(c)); initially codified at 21 CFR 
308.13(e)(3) and (4) (36 FR 7776, April 24, 1971) (currently codified 
at 21 CFR 1308.13(e)(1)(iii) and (iv)). Any other products that contain 
single-entity hydrocodone or combinations of hydrocodone and other 
substances outside the range of specified doses are listed in schedule 
II of the CSA.\3\
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    \3\ In the United States there are currently no approved, 
marketed, products containing hydrocodone in combination with other 
active ingredients that fall outside schedule III of the CSA. 
Further, until recently, there were no approved hydrocodone single-
entity schedule II products. In Oct. 2013, the FDA approved 
ZohydroTM ER, a single-entity, extended release schedule 
II product. The sponsor of this product in a press release dated 
Oct. 25, 2013, stated that ZohydroTM ER will be launched 
in approximately four months. Accordingly, all of the historical 
data regarding hydrocodone from different national and regional 
databases that support this proposal should refer to HCPs only, 
regardless of whether the database utilizes the term ``hydrocodone'' 
or ``hydrocodone combination products.''
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Proposed Determination To Transfer HCPs to Schedule II

    Pursuant to 21 U.S.C. 811(a), proceedings to add a drug or 
substance to those controlled under the CSA, or to transfer a drug 
between schedules, may be initiated on the petition of any interested 
party. In response to a petition the DEA had received requesting that 
HCPs be controlled in schedule II of the CSA, in 2004 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 
HCPs, pursuant to 21 U.S.C 811(b) and (c). In 2008 the HHS provided to 
the DEA its recommendation that HCPs remain controlled in schedule III 
of the CSA. In response, in 2009, the DEA requested that the HHS re-
evaluate their data and provide another scientific and medical 
evaluation and scheduling recommendation based on additional data and 
analysis.
    On July 9, 2012, President Obama signed the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA). 
Section 1139 of the FDASIA \4\ directed the Food and Drug 
Administration (FDA) to hold a public meeting to ``solicit advice and 
recommendations'' pertaining to the scientific and medical evaluation 
in connection with its scheduling recommendation to the DEA regarding 
drug products containing hydrocodone, combined with other analgesics or 
as an antitussive. Additionally the Secretary was required to solicit 
stakeholder input ``regarding the health benefits and risks, including 
the potential for abuse'' of hydrocodone combination products and the 
impact of up-scheduling of these products. Accordingly, on January 24-
25, 2013, the FDA held a public Advisory Committee meeting at which the 
DEA made a presentation. The Advisory Committee included members with 
scientific and medical expertise in the subject of opioid abuse, and a 
patient representative. Members included representatives from National 
Institute on Drug Abuse (NIDA) and the Centers for Disease Control 
(CDC). There was also an opportunity for the public to provide comment. 
The Advisory Committee voted 19 to 10 in favor of recommending that 
hydrocodone combination products be placed into schedule II. According 
to the FDA, 768 comments were submitted by patients, patient groups, 
advocacy groups, and professional societies to the FDA.
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    \4\ FDASIA, SEC1139. SCHEDULING OF HYDROCODONE. (a) IN 
GENERAL.--Not later than 60 days after the date of enactment of this 
Act, if practicable, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall hold a 
public meeting to solicit advice and recommendations to assist in 
conducting a scientific and medical evaluation in connection with a 
scheduling recommendation to the Drug Enforcement Administration 
regarding drug products containing hydrocodone, combined with other 
analgesics or as an antitussive. (b) STAKEHOLDER INPUT.--In 
conducting the evaluation under subsection (a), the Secretary shall 
solicit input from a variety of stakeholders including patients, 
health care providers, harm prevention experts, the National 
Institute on Drug Abuse, the Centers for Disease Control and 
Prevention, and the Drug Enforcement Administration regarding the 
health benefits and risks, including the potential for abuse and the 
impact of up-scheduling of these products.
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    Upon evaluating the scientific and medical evidence, along with the 
above considerations (e.g., recommendation of the Advisory Committee, 
the public comments, consideration of the health benefits and risks, 
and information about the impact of rescheduling) mandated by the 
FDASIA, the HHS on December 16, 2013, submitted to the Administrator of 
the DEA its scientific and medical evaluation (henceforth called HHS 
review) entitled, ``Basis for the Recommendation to Place Hydrocodone 
Combination Products in Schedule II of the Controlled Substances Act.'' 
Pursuant to 21 U.S.C. 811(b), this document contained an eight-factor 
analysis of the abuse potential of HCPs, along with the HHS's 
recommendation to control HCPs under schedule II of the CSA.
    The HHS stated that the comments received during the open public 
hearing, to the docket, and the discussion of the Advisory Committee

[[Page 11040]]

members of the FDA Advisory Committee meeting provided support for its 
conclusion that individuals are taking HCPs in amounts sufficient to 
create a hazard to their health or to the safety of other individuals 
or to the community; that there is significant diversion of HCPs; and 
that individuals are taking HCPs on their own initiative rather than on 
the basis of medical advice from a practitioner licensed by law to 
administer such drugs. The HHS stated it has also given careful 
consideration to the fact that the members of the Advisory Committee 
voted 19 to 10 in favor of rescheduling HCPs from schedule III to 
schedule II under the CSA. The HHS considered the increasing trends, 
the public comments, the recommendation of the Advisory Committee, the 
health benefits and risks, and the information available about the 
impact of rescheduling, and concluded that HCPs have high potential for 
abuse.

Summary of Eight Factor Analyses

    The DEA has reviewed the scientific and medical evaluation and 
scheduling recommendation provided by the HHS, and all other relevant 
data, and completed its own eight-factor review document pursuant to 21 
U.S.C. 811(c). Included below is a brief summary of each factor as 
considered by the DEA in its proposed rescheduling action. Both the DEA 
and HHS analyses are available in their entirety in the public docket 
for this proposed rule (Docket No. DEA-389) at www.regulations.gov 
under ``Supporting and Related Material.'' Full analysis of, and 
citations to, information referenced in this summary may also be found 
in the supporting material.

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 provides the following criteria to 
determine whether a particular drug or substance has a potential for 
abuse: \5\
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    \5\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No 91-1444, 91st Cong., Sess.1 (1970) reprinted in 
U.S.C.C.A.N. 4566, 4601.
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    (a) Individuals are taking the drug or other substance in amounts 
sufficient to create a hazard to their health or to the safety of other 
individuals or to the community; or
    (b) There is a significant diversion of the drug or other substance 
from legitimate drug channels; or
    (c) Individuals are taking the drug or other substance on their own 
initiative rather than on the basis of medical advice from a 
practitioner licensed by law to administer such drugs; or
    (d) The drug is so related in its action to a drug or other 
substance already listed as having a potential for abuse to make it 
likely that it will have the same potential for abuse as such 
substance, 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.
    The DEA considered the HHS's evaluation and all other relevant 
data, including data related to the above mentioned criteria, and finds 
that:
    (a) Individuals are using HCPs in amounts sufficient to create a 
hazard to their health, to the safety of other individuals, or to the 
community.
    The HHS states that there are increasing trends in the adverse 
effects from abuse of HCPs, including emergency department (ED) visits, 
admissions to addiction treatment centers, and deaths in selected 
States. In 2011, HCPs were listed in 3,376 admissions for drug 
treatment as the primary drug of abuse and in 6,601 admissions listing 
HCPs in addition to other drugs in the Treatment Episode Data Set 
(TEDS).\6\ HCPs are prescribed in an unprecedented manner and their 
total prescriptions exceed prescriptions for any other opioid 
analgesic; this characteristic drives their abuse potential and sets 
them apart from other opioid analgesics in terms of abuse risks.
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    \6\ TEDS is a program coordinated and managed by the SAMHSA. 
This database includes information on treatment admissions that are 
routinely collected by states to monitor their individual substance 
abuse treatment systems. Thus, TEDS includes data primarily from 
treatment facilities that receive public funds. TEDS includes 
information on demographic variables including age, gender, race and 
ethnicity. TEDS also reports on the top three drugs of abuse at the 
time of admission. TEDS does not include all drugs that may have 
been abused prior to admission. States and jurisdictions can choose 
whether or not to report the detailed listing.
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    Drug Abuse Warning Network (DAWN) \7\ data indicate that abuse of 
HCPs, similar to oxycodone products \8\ (schedule II), has been 
associated with large numbers of admissions to the ED. For example, in 
2011 the total number of ED visits related to nonmedical use of HCPs 
and oxycodone products were 82,479 and 151,218, respectively.\9\ The 
American Association of Poison Control Centers' National Poison Data 
System \10\ (NPDS; formerly known as Toxic Exposure Surveillance System 
or TESS) reported that HCPs were involved in 30,792 and 29,391 annual 
toxic exposures in 2011 and 2012, respectively. The corresponding data 
for oxycodone products was 19,423 and 18,495. The majority of exposures 
for both drug products were for intentional reasons.\11\
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    \7\ The Drug Abuse Warning Network (DAWN) is a nationally 
representative public health surveillance system that continuously 
monitors drug-related visits to hospital EDs. The DAWN data are used 
to monitor trends in drug misuse and abuse in the United States. 
DAWN captures both ED visits that are directly caused by drugs and 
those in which drugs are a contributing factor but not the direct 
cause of the ED visit.
    \8\ Unless otherwise specified, for purposes of this document 
``oxycodone products'' refers to both its single-entity and its 
combination products. All oxycodone products are schedule II 
controlled substances.
    \9\ In DAWN, nonmedical use of pharmaceuticals includes taking 
more than the prescribed dose of a prescription pharmaceutical or 
more than the recommended dose of an over-the-counter pharmaceutical 
or supplement; taking a pharmaceutical prescribed for another 
individual; deliberate poisoning with a pharmaceutical by another 
person; and documented misuse or abuse of a prescription drug, an 
over-the-counter pharmaceutical, or a dietary supplement.
    \10\ The American Association of Poison Control Centers (AAPCC) 
maintains the national database of information logged by the United 
States' 57 Poison Control Centers (PCCs). Case records in this 
database are from self-reported calls: they reflect only information 
provided when the public or healthcare professionals report an 
actual or potential exposure to a substance (e.g., an ingestion, 
inhalation, or topical exposure, etc.), or request information/
educational materials. Exposures do not necessarily represent a 
poisoning or overdose. The AAPCC is not able to completely verify 
the accuracy of every report made to member centers. Additional 
exposures may go unreported to PCCs and data referenced from the 
AAPCC should not be construed to represent the complete incidence of 
national exposures to any substance(s).
    \11\ According to the AAPCC's NPDS database, ``intentional 
reasons'' include suspected suicide, misuse, abuse, and intentional 
unknown.
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    The HHS mentions that nationwide estimates of overdose deaths due 
to HCPs cannot be quantified, but the available data for a limited 
number of States suggest that HCPs contribute to a substantial number 
of overdose deaths each year. According to the HHS, DAWN medical 
examiner (ME) data for five States from 2004 through 2010 reported an 
increase of 63% and 133% in deaths related to HCPs and oxycodone 
products, respectively. According to the Florida Department of Law 
Enforcement (FDLE),\12\ HCPs have

[[Page 11041]]

been associated with large numbers of deaths in Florida. For example, 
in 2012, HCPs were associated with 777 deaths, while oxycodone products 
were associated with 1,426.
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    \12\ The Florida Department of Law Enforcement Medical Examiners 
Commission publishes an Annual Medical Examiners Report, the Annual 
and Interim Drugs in Deceased Persons Report. In order for a death 
to be considered ``drug-related'' at least one drug identified must 
be in the decedent; each identified drug is a drug occurrence. The 
State's medical examiners were asked to distinguish between whether 
the drugs were the ``cause'' of death or merely ``present'' in the 
body at the time of death. A drug is only indicated as the cause of 
death when, after examining all evidence and the autopsy and 
toxicology results, the medical examiner determines the drug played 
a causal role in the death. It is not uncommon for a decedent to 
have multiple drugs listed as a cause of death. Although a medical 
examiner may determine a drug is present or detected in the 
decedent, the drug may not have played a causal role in the death. A 
decedent may have multiple drugs listed as present.
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    As summarized below, a review of drug abuse indicators for HCPs 
over the past several years further indicates that these products, 
similar to oxycodone products, are among the most widely diverted and 
abused drugs in the country and have high potential for abuse.
    (b) There is a significant diversion of HCPs from legitimate drug 
channels.
    According to forensic laboratory data as reported by the National 
Forensic Laboratory System 13 14 (NFLIS) and the System to 
Retrieve Information from Drug Evidence \15\ (STRIDE), HCPs, similar to 
oxycodone products, are among the top 10 most frequently encountered 
drugs. From 2002 through 2010, total cases (from both NFLIS and STRIDE) 
for both HCPs and oxycodone products gradually increased with some 
decline in 2011 and 2012. From 2002 through 2008, annual total cases 
involving HCPs (range: 9,106 in 2002 to 33,611 in 2008) consistently 
exceeded those for oxycodone products (range: 7,993 in 2002 to 28,343 
in 2008). In 2009, total cases for HCPs (37,894) were similar to that 
for oxycodone products (37,680). From 2010 through 2012, total cases 
for oxycodone products (47,238 in 2010 and 41,915 in 2012) exceeded 
those for HCPs (39,261 in 2010 and 34,832 in 2012). The DEA has 
documented a large number of diversion and trafficking cases involving 
HCPs. DEA investigations conducted from 2005 through 2007 determined 
that HCPs were diverted from rogue Internet pharmacies.
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    \13\ The NFLIS is a program of the DEA, Office of Diversion 
Control. NFLIS systematically collects drug identification results 
and associated information from drug cases submitted to and analyzed 
by State and local forensic laboratories. NFLIS represents an 
important resource in monitoring illicit drug abuse and trafficking, 
including the diversion of legally manufactured pharmaceuticals into 
illegal markets. NFLIS is a comprehensive information system that 
includes data from forensic laboratories that handle approximately 
90% of an estimated 1.0 million distinct annual State and local drug 
analysis cases. NFLIS includes drug chemistry results from completed 
analyses only.
    \14\ While NFLIS data is not direct evidence of abuse, it can 
lead to an inference that a drug has been diverted and abused. See 
76 FR 77330, 77332, Dec. 12, 2011.
    \15\ STRIDE is a database of drug exhibits sent to DEA 
laboratories for analysis. Exhibits from the database are from the 
DEA, other federal agencies, and local law enforcement agencies.
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    (c) Individuals are using HCPs on their own initiative rather than 
on the basis of medical advice.
    According to the data from the National Survey on Drug Use and 
Health \16\ (NSDUH), the lifetime (i.e., ever used) users of HCPs for 
nonmedical purposes exceeded those for oxycodone products in the United 
States. For example, in 2004, over 17.7 million Americans age 12 years 
or older reported lifetime nonmedical use of HCPs as compared to over 
11.9 million reported for oxycodone products. In 2012, the 
corresponding data for HCPs and oxycodone products were over 25.6 and 
16 million, respectively. The NSDUH also reported large increases from 
2004 through 2012 in the number of individuals using HCPs and oxycodone 
products for nonmedical purposes.
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    \16\ The National Survey on Drug Use and Health, formerly known 
as the National Household Survey on Drug Abuse (NHSDA), is conducted 
annually by the Department of Health and Human Service's Substance 
Abuse and Mental Health Services Administration (SAMHSA). It is the 
primary source of estimates of the prevalence and incidence of 
nonmedical use of pharmaceutical drugs, illicit drugs, alcohol, and 
tobacco use in the United States. The survey is based on a 
nationally representative sample of the civilian, non-
institutionalized population 12 years of age and older. The NSDUH 
provides yearly national and state level estimates of drug abuse, 
and includes prevalence estimates by lifetime (i.e., ever used), 
past year, and past year abuse or dependence.
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    The past year initiates (i.e., the first use of a substance within 
the 12 months prior to the interview date) of HCPs exceeded those of 
oxycodone products from 2002 through 2005. Past year initiates for HCPs 
were over 1.3, 1.4, 1.3 and 1.3 million in 2002, 2003, 2004 and 2005, 
respectively. The corresponding data for oxycodone products were over 
0.47, 0.5, 0.6 and 0.45 million. According to a report by the NSDUH, 
the combined data from 2002 through 2005 indicate that 57.7% of persons 
who first used pain relievers nonmedically in the past year used HCPs 
while 21.7% used oxycodone products. The NSDUH data from 2002 through 
2006 also indicate that the lifetime users of HCPs have a higher 
propensity than that of lifetime users of oxycodone immediate release 
products (single-entity and combination products combined) to have used 
for nonmedical purposes any pain relievers in the past year.
    According to the Monitoring the Future \17\ (MTF) survey, from 2002 
through 2011 the annual prevalence of nonmedical use of 
Vicodin[supreg], an HCP, ranged from about 8% to 10.5% among high 
school seniors (12th graders) and exceeded that of OxyContin[supreg] 
(4% to 5.5%), an oxycodone extended release product. In 2012, the 
annual prevalence rate for nonmedical use of OxyContin[supreg] was 
1.6%, 3.0%, and 4.3% among 8th, 10th and 12th graders, respectively. 
The corresponding rates for Vicodin[supreg] were 1.3%, 4.4% and 7.5%. 
According to the MTF, the annual prevalence of nonmedical use of 
Vicodin[supreg] in college students and young adults was 3.8% and 6.3% 
in 2012. The corresponding data for OxyContin[supreg] were 1.2% and 
2.3%. The aforementioned data from drug abuse surveys (NSDUH and MTF) 
collectively indicate high prevalence of abuse of HCPs among Americans 
including students thereby indicating their high abuse potential.
---------------------------------------------------------------------------

    \17\ Monitoring the Future (MTF) is a national survey conducted 
by the Institute for Social Research at the University of Michigan 
under a grant from the NIDA that tracks drug use trends among 
American adolescents among the 8th, 10th, and 12th grades.
---------------------------------------------------------------------------

    (d) HCPs are so related in their action to a drug or other 
substance already listed as having a potential for abuse to make it 
likely that they will have the same potential for abuse as such 
substance, thus making it reasonable to assume that there may be 
significant diversion from legitimate channels, significant use 
contrary to or without medical advice, or that they have a substantial 
capability of creating hazards to the health of the user or to the 
safety of the community.
    Hydrocodone possesses abuse liability effects substantially similar 
to morphine (schedule II) in both animals and humans. Hydrocodone, 
similar to morphine, is a [mu] opioid receptor agonist and shares 
pharmacological properties with morphine. Hydrocodone substitutes for 
morphine in animals trained to discriminate the presence and absence of 
morphine. Hydrocodone, similar to morphine, is self-administered by 
animals. Hydrocodone substitutes for morphine in opioid-dependent 
subjects. Clinical abuse liability studies have also demonstrated that 
HCPs (Hycodan[supreg] or hydrocodone in combination with acetaminophen) 
are similar to morphine with respect to physiological effects, 
subjective effects, and drug ``liking'' scores.
    Hydrocodone/acetaminophen and oxycodone/acetaminophen combination 
products at equi-miotic doses, in general, produce similar profiles of 
psychopharmacological effects. These two opioid products produced 
prototypic opiate-like effects and psychomotor impairment of similar 
magnitudes.
    Collectively these data demonstrate that HCPs have a high potential 
for abuse similar to other schedule II opioid analgesic drugs such as 
morphine and oxycodone products.

[[Page 11042]]

2. Scientific Evidence of the Drug's Pharmacological Effects, if Known

    The HHS states that hydrocodone's pharmacological effects are 
similar to other [micro] opioid receptor agonists. It is effective as 
an antitussive agent and as an analgesic drug. Opioid analgesics have 
an important role in the management of pain. HCPs contain other 
nonnarcotic active ingredients such as acetaminophen, nonsteroidal 
anti-inflammatory drugs (NSAIDs) (aspirin and ibuprofen), 
chlorpheniramine or homatropine methylbromide. The mechanism of 
analgesic and antitussive effects of HCPs are different from those of 
nonnarcotic active ingredients present in HCPs. Acetaminophen and 
NSAIDs are less effective against severe pain, but have a recognized 
role in a variety of pain settings.
    HCPs, similar to other opioid analgesics such as oxycodone 
products, are associated with a substantial number of overdose, 
suicide, abuse, and dependence reports. Overdose of HCPs, similar to 
other opioid analgesics, can lead to respiratory depression and death. 
Common adverse effects of NSAIDs include gastrointestinal, 
cardiovascular, renal and renovascular adverse events, and hepatic 
injury. Acetaminophen has low incidence of gastrointestinal side 
effects and is a common household analgesic available over the counter. 
Overdoses of acetaminophen can cause severe hepatic damage and death. 
Opioid/acetaminophen combination products are linked to numerous liver 
injuries.

3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance

    The HHS provided additional scientific information with focus on 
chemical and toxicological properties of hydrocodone and nonnarcotic 
components of HCPs. Hydrocodone is a semisynthetic opioid. The 
bitartrate salt form of hydrocodone is the main active component in all 
currently marketed HCPs. Nonnarcotic drugs present as co-ingredients 
are acetaminophen, aspirin, ibuprofen, chlorpheniramine or homatropine 
methylbromide. Hydrocodone and nonnarcotic drugs present in HCPs have 
potential to produce adverse effects.

4. Its History and Current Pattern of Abuse

    Soon after introduction for clinical use, there were reports of 
hydrocodone abuse and addiction. By the 1950s, it was established that 
hydrocodone has an abuse liability similar to that of morphine. Data 
regarding the pharmacological effects of hydrocodone and its high 
potential for abuse were available prior to the enactment of the CSA 
and the placement of hydrocodone in schedule II reflects that knowledge 
base. In the United States, popularity of hydrocodone as a drug of 
abuse increased in the 1990s coinciding with its increased use as an 
analgesic. Currently HCPs are widely diverted and abused throughout the 
United States as demonstrated in national and regional drug-abuse-
related databases. HCPs and oxycodone products (schedule II) are the 
two most common opioid analgesic products encountered by law 
enforcement.
    Data from DEA field offices indicate that HCPs are diverted and are 
among the most sought after licit drugs in every geographic region of 
the country. DEA case investigations document numerous methods of 
diversion of HCPs. These methods involve drug theft, doctor shopping, 
fraudulent oral (call-in) prescriptions, fraudulent prescriptions, 
diversion by registrants, and various other drug trafficking schemes. 
HCPs are abused by individuals of diverse ages from adolescents to 
older populations. According to the NSDUH, in 2012, of the 37 million 
people in the United States who used pain relievers nonmedically in 
their lifetime, over 25.6 million (representing 9.9% of the United 
States population age 12 years or older) reported lifetime nonmedical 
use of HCPs. The MTF surveys indicate that from 2002 through 2012, 8.1% 
to 10.5% of high school seniors used Vicodin[supreg], an HCP, for 
nonmedical purposes. In 2012, the annual prevalence of nonmedical use 
of Vicodin[supreg] in college students and young adults was 3.8% and 
6.3%, respectively.
    Several published epidemiological studies indicate that HCPs are 
widely abused. For example, a published epidemiological study reviewed 
prescription opioid abuse data collected by drug abuse experts 
(representatives of the nation's methadone programs, treatment centers, 
impaired health care professional programs, NIDA grantees and high-
prescribing physicians) and found that HCPs are one of the most 
commonly abused prescription opioid drugs. Rates of abuse, expressed as 
cases per 100,000 population, were the highest for hydrocodone and 
extended release oxycodone products, while the rest of the opioid 
analgesics, including immediate release oxycodone products, had lower 
rates. Another published epidemiological study also indicates that the 
rate of intentional exposure (abuse, intentional misuse, suicide or 
intentional unknown) was highest for HCPs at 3.75 per 100,000 
population followed by oxycodone products at 1.81 per 100,000. HCPs 
were involved in 55% of all of the intentional exposure cases, whereas 
oxycodone products were involved in 27%. In addition, published data on 
toxic exposure calls received by Texas poison centers from 1998 through 
2009 showed that toxic exposure calls related to ingestion of the 
combination of HCPs, carisoprodol and alprazolam (commonly referred 
under street names such as ``Holy Trinity,'' ``Houston Cocktail,'' or 
``Trio'') have increased from 2000 through 2007 with some decline in 
2009.

5. The Scope, Duration, and Significance of Abuse

    The HHS mentions that abuse of HCPs is considerable and is 
associated with considerable negative public health impact. The extent 
of nonmedical use of HCPs by adolescents is higher than for oxycodone 
products. These data are of significant concern as this may reflect 
particular risk for younger individuals. The HHS also states that 
because of the large number of prescriptions, large amounts of HCPs are 
potentially available for illicit use. Large numbers of adversely 
affected individuals and the severity of the adverse effects related to 
abuse of HCPs suggest that individuals are taking these products in 
amounts sufficient to create a hazard to their health and to the safety 
of other individuals and the community. Abuse of HCPs is associated 
with progressively increasing trends in serious adverse effects, 
including ED visits, admissions for abuse treatment, and in mortality 
data in selected States. The HHS cites the widespread prescriptions for 
HCPs as one of the reasons for these adverse outcomes. According to the 
HHS, data suggests that HCPs have high potential for abuse.
    The DEA notes that initial reports of abuse of HCPs in the U.S. 
were published in the 1960s. Since the 1990s, the diversion and abuse 
of HCPs has escalated in the country. By the late 1990s, there were 
large increases in the diversion and abuse of HCPs. HCPs, similar to 
oxycodone products, are widely diverted and abused pharmaceutical 
opioid analgesics. HCPs are associated with significant illicit 
activity and abuse. Federal, State and local forensic laboratory data 
rank HCPs as one of the two most frequently encountered opioid 
pharmaceuticals in submissions to the laboratories. For example, in 
2012, there were over 34,000 exhibits for HCPs (NFLIS). All DEA field 
divisions across the U.S. have reported that HCPs are among the most 
sought after pharmaceuticals.

[[Page 11043]]

    In 2012, according to the poison control centers data (NPDS), there 
were over 29,390 toxic exposures involving HCPs. In 2002, there were 
over 25,000 DAWN ED visits associated with HCPs and it was ranked sixth 
among all controlled substances. According to DAWN, the nonmedical use 
related ED visits for HCPs were 86,258; 95,972; and 82,480 in 2009, 
2010, and 2011, respectively. A number of data sources indicate that 
abuse of HCPs is associated with a large number of deaths. According to 
NSDUH, there were large numbers of lifetime and past year initiates of 
HCPs for nonmedical purposes and these numbers exceeded those of 
oxycodone. According to the MTF, about 8% to 10% of high school seniors 
reported nonmedical use of Vicodin[supreg], an HCP, in recent years.
    DEA case investigations document numerous methods of diversion of 
HCPs. These methods involve drug theft, doctor shopping, fraudulent 
oral (call-in) prescriptions, fraudulent prescriptions, diversion by 
registrants, and various other drug trafficking schemes.

6. What, if Any, Risk There Is to the Public Health

    Despite the medical value of HCPs as antitussive and analgesic 
drugs, the misuse and abuse of these products present numerous risks to 
the public health. Many of the risk factors associated with these 
products are common risks shared with other [mu] opioid receptor 
agonists. These include the risks of developing tolerance, dependence 
and addiction, and the attendant problems associated with these risks 
including death. According to the CDC, from 1999 to 2010, the number of 
drug poisoning deaths \18\ involving any opioid analgesic (e.g., 
oxycodone, methadone, or hydrocodone) markedly increased (over four-
fold), from 4,030 to 16,651, and accounted for 43% of the 38,329 drug 
poisoning deaths and 39% of the 42,917 total poisoning deaths \19\ in 
2010. In 1999, opioid analgesics were involved in 24% of the 16,849 
drug poisoning deaths and 20% of the 19,741 total poisoning deaths.
---------------------------------------------------------------------------

    \18\ Drug poisoning deaths include unintentional and intentional 
poisoning deaths resulting from overdoses of a drug, being given the 
wrong drug, using the drug in error, or using a drug inadvertently.
    \19\ Total poisoning deaths include those resulting from drugs, 
and those associated with solid or liquid biologics, gases or 
vapors, or other substances. Poisoning deaths are from all manners, 
including unintentional, suicide, homicide, and undetermined intent.
---------------------------------------------------------------------------

    The HHS reviewed the HCPs related adverse events that were reported 
to the FDA Adverse Events Reporting System (FAERS) \20\ from 1969 
through 2012 and compared them to those associated with oxycodone 
products. The most common adverse events reported for HCPs included 
terms such as complete suicide, intentional overdose, drug abuse, drug 
dependence, and drug abuser.\21\ The HHS found that both HCPs and 
oxycodone products are associated with substantial numbers of reports 
of overdose, suicide, abuse, and dependence reports. Both products have 
large numbers of adverse events reported that reflect abuse, misuse and 
injury due to inappropriate use. HCPs had fewer such reports than 
oxycodone products.
---------------------------------------------------------------------------

    \20\ FAERS is a computerized information database designed to 
support FDA's surveillance program for the post-marketing safety of 
all drug and therapeutic biologic products. FDA receives adverse 
drug reaction reports from manufacturers as required by regulation. 
Health care professionals and consumers voluntarily submit reports 
through the MedWatch program. All reported adverse terms are coded 
according to standardized international terminology, MedDRA (the 
Medical Dictionary for Regulatory Activities). These numbers are 
crude reports and may include duplicates. These reports were not 
individually reported to determine the association between the drug 
and the adverse event reported and may contain concomitant use of 
other medications.
    \21\ The top 20 most frequently reported adverse event terms 
associated with all hydrocodone reports (a report may contain more 
than one adverse event) received from 1969 to 2012 in the FAERS, in 
decreasing frequency, were: Completed suicide, overdose, cardio-
respiratory arrest, toxicity to various agents, cardiac arrest, 
respiratory arrest, drug ineffective, intentional overdose, nausea, 
intentional drug misuse, vomiting, death, drug abuse, accidental 
overdose, pain, dizziness, medication error, drug dependence, 
headache, and drug abuser.
---------------------------------------------------------------------------

    According to the DAWN, ED mentions associated with HCPs and 
oxycodone products are the highest among all opioid analgesics 
suggesting that both HCPs and oxycodone products have a great adverse 
risk to the public health. According to the HHS, DAWN ME data for five 
States from 2004 through 2010 reported an increase of 63% and 133% in 
deaths related to HCPs and oxycodone products, respectively. According 
to the FDLE, HCPs have been associated with large numbers of deaths in 
Florida in recent years. According to the NPDS annual reports, since 
2002, annual figures for toxic exposures (within the category of opioid 
analgesic drugs) were the largest for HCPs, followed by oxycodone 
products (see summary of Factor 1 above). From 2006 through 2012, NPDS 
reported a total of 84,798 single substance exposures related to HCPs 
resulting in 195 deaths. The corresponding data for oxycodone products 
is 57,219 exposures and 173 deaths.

7. Its Psychic or Physiological Dependence Liability

    According to the HHS, data from animal and human studies indicate 
the dependence potential of hydrocodone. The severe dependence 
potential is reflected by the number of individuals admitted to 
addiction treatment centers citing HCPs as their substance of abuse. 
The HHS also states that the treatment admissions linked to abuse of 
HCPs are increasing. The HHS concluded that abuse of HCPs may lead to 
severe psychological or physical dependence.
    The DEA notes that as evident from the NSDUH data from 2002 through 
2006, the propensity of the lifetime users of HCPs to develop substance 
use disorders on any pain relievers is higher than that of lifetime 
users of any pain relievers, as well as lifetime users of oxycodone 
products other than OxyContin[supreg] (i.e., oxycodone immediate 
release single-entity products and immediate release combination 
products). The FAERS data (from 1969 through August 28, 2008) indicate 
that the abuse and dependence reports associated with HCPs expressed as 
a percentage of all its adverse events (13.3%) were similar (both in 
magnitude and temporal distribution) to that for oxycodone products 
other than OxyContin[supreg] (13.6%).
    The DEA also notes that according to several published 
epidemiological surveys and retrospective review of medical records of 
addiction treatment populations, HCPs are among the most abused opioid 
pharmaceuticals in prescription opioid dependent individuals in the 
country and are frequently mentioned as the primary drug of abuse in 
these subjects.
    The above data collectively indicate that HCPs, similar to 
oxycodone products, have high potential to cause severe psychological 
or physiological dependence.

8. Whether the Substance Is an Immediate Precursor of a Substance 
Already Controlled Under the CSA

    HCPs are not immediate precursors of a substance already controlled 
under the CSA, as defined in 21 U.S.C. 811(e).

Conclusion

    Based on consideration of the scientific and medical evaluation and 
accompanying recommendation of the HHS, and based on the DEA's 
consideration of its own eight-factor analysis, the DEA finds that 
these facts and all other relevant data constitute substantial evidence 
of high potential for abuse of HCPs. As such, the DEA hereby proposes 
to transfer HCPs from

[[Page 11044]]

schedule III to schedule II under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA outlines the findings required to transfer a drug or other 
substance between schedules (I, II, III, IV, or V) of the CSA. 21 
U.S.C. 811(a); 21 U.S.C. 812(b). After consideration of the analysis 
and rescheduling recommendation of the Assistant Secretary for Health 
of the HHS and review of available data, the Administrator of the DEA, 
pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(2), finds that:
    1. HCPs have a high potential for abuse similar to that of schedule 
II substances;
    2. HCPs have a currently accepted medical use in treatment in the 
United States. According to the HHS, several pharmaceutical products 
containing hydrocodone in combination with acetaminophen, aspirin, 
NSAIDS, and homatropine are approved by FDA for use as analgesics for 
pain relief and for the symptomatic relief of cough and upper 
respiratory symptoms associated with allergies and colds; and
    3. Abuse of HCPs may lead to severe psychological or physical 
dependence similar to that of schedule II substances.
    Based on these findings, the Administrator of the DEA concludes 
that HCPs warrant control in schedule II of the CSA. 21 U.S.C. 
812(b)(2).

Requirements for Handling HCPs

    If this rule is finalized as proposed, persons who handle HCPs 
would be subject to the CSA's schedule II regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, including the following:
    Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities with) HCPs, or who desires to handle HCPs, 
would be required to be registered with the DEA to conduct such 
activities pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance 
with 21 CFR parts 1301 and 1312.
    Security. HCPs would be subject to schedule II security 
requirements and would need to be handled and stored pursuant to 21 
U.S.C. 821, 823, 871(b) and in accordance with 21 CFR 1301.71-1301.93.
    Labeling and Packaging. All labels and labeling for commercial 
containers of HCPs would need to comply with 21 U.S.C. 825, 958(e), and 
be in accordance with 21 CFR part 1302.
    Quotas. A quota assigned pursuant to 21 U.S.C. 826 and in 
accordance with 21 CFR part 1303 would be required in order to 
manufacture HCPs.
    Inventory. Any person who becomes registered with the DEA after the 
effective date of the final rule would be required to take an initial 
inventory of all stocks of controlled substances (including HCPs) on 
hand on the date the registrant first engages in the handling of 
controlled substances, pursuant to 21 U.S.C. 827, 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).
    After the initial inventory, every DEA registrant would be required 
to take a new inventory of all stocks of controlled substances on hand 
every two years, pursuant to 21 U.S.C. 827, 958, and in accordance with 
21 CFR 1304.03, 1304.04, and 1304.11.
    Records. Every DEA registrant would be required to maintain records 
with respect to HCPs pursuant to 21 U.S.C. 827, 958, and in accordance 
with 21 CFR parts 1304, 1307, and 1312.
    Reports. Every DEA registrant would be required to submit reports 
regarding HCPs to the Automation of Reports and Consolidated Order 
System (ARCOS) pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 
1304.33.
    Orders for HCPs. Every DEA registrant who distributes HCPs would be 
required to comply with order form requirements, pursuant to 21 U.S.C. 
828, and in accordance with 21 CFR part 1305.
    Prescriptions. All prescriptions for HCPs would need to comply with 
21 U.S.C. 829, and would be required to be issued in accordance with 21 
CFR part 1306, and part 1311 subpart C.
    Importation and Exportation. All importation and exportation of 
HCPs would need to be in compliance with 21 U.S.C. 952, 953, 957, 958, 
and in accordance with 21 CFR part 1312.
    Liability. Any activity involving HCPs not authorized by, or in 
violation of, the CSA, would be unlawful, and may 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 
procedures and 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 Civil Justice 
Reform 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 (5 U.S.C. 601-612) (RFA), 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. The purpose of this 
proposed rule is to place HCPs into schedule II of the CSA. No less 
restrictive measures (i.e., non-control or control in a lower schedule) 
would enable the DEA to meet its statutory obligation under the CSA.
    HCPs are widely prescribed drugs for the treatment of pain and 
cough suppression. Handlers of HCPs primarily include manufacturers, 
distributors, exporters, pharmacies, practitioners, mid-level 
practitioners, and hospitals/clinics.\22\ It is possible

[[Page 11045]]

that other registrants, such as importers, researchers, analytical 
labs, teaching institutions, etc., also handle HCPs. However, based on 
its understanding of its registrant population, the DEA assumes for 
purposes of this analysis that for all business activities other than 
manufacturers, distributors, exporters, pharmacies, practitioners, mid-
level practitioners, and hospitals/clinics, that the volume of HCPs 
handled is nominal, and therefore de minimis to the economic impact 
determination of this proposed rescheduling action.
---------------------------------------------------------------------------

    \22\ For purposes of performing regulatory analysis, the DEA 
uses the definition of a ``practitioner'' as a physician, 
veterinarian, or other individual licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which he/she 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacist, pharmacy, 
or hospital (or other person other than an individual).
---------------------------------------------------------------------------

    Because HCPs are so widely prescribed, for the purposes of this 
analysis, the DEA conservatively assumes all distributors, exporters, 
pharmacies, practitioners, mid-level practitioners, and hospitals/
clinics currently registered with the DEA to handle schedule III 
controlled substances are also handlers of HCPs. The DEA estimated the 
number of manufacturers and exporters handling HCPs directly from DEA 
records. In total, the DEA estimates that nearly 1.5 million controlled 
substance registrations, representing approximately 376,189 entities, 
would be affected by this rule.
    The DEA does not collect data on company size of its registrants. 
The DEA used DEA records and multiple subscription-based and public 
data sources to relate the number of registrations to the number of 
entities and the number of entities that are small entities. The DEA 
estimates that of the 376,189 entities that would be affected by this 
rule, 366,351 are ``small entities'' in accordance with the RFA and 
Small Business Administration size standards. 5 U.S.C. 601(6); 15 
U.S.C. 632.\23\
---------------------------------------------------------------------------

    \23\ The estimated break-down is as follows: 50 manufacturers, 4 
exporters, 683 distributors, 50,774 pharmacies, and 314,840 
practitioners/mid-level practitioners/hospitals/clinics.
---------------------------------------------------------------------------

    The DEA examined the registration, security (including storage), 
labeling and packaging, quota, inventory, recordkeeping and reporting, 
ordering, prescribing, importing, exporting, and disposal requirements 
for the 366,351 small entities estimated to be affected by the proposed 
rule. The DEA estimates that only the physical security requirements 
will have material economic impact and such impacts will be limited to 
manufacturers, exporters, and distributors. Many manufacturers and 
exporters are likely to have sufficient space in their existing vaults 
to accommodate HCPs. However, the DEA understands that some 
manufacturers, exporters, and distributors will need to build new 
vaults or expand existing vaults to store HCPs in compliance with 
schedule II controlled substance physical security requirements. Due to 
the uniqueness of each business, the DEA made assumptions based on 
research and institutional knowledge of its registrant community to 
quantify the costs associated with physical security requirements for 
manufacturers, exporters and distributors.
    The DEA estimates there will be significant economic impact on 1 
(2.0%) of the affected 50 small business manufacturers, and 54 (7.9%) 
of the affected 683 small business distributors. The DEA estimates no 
significant impact on the remaining affected 4 small business 
exporters, 50,774 small business pharmacies, or 314,840 small business 
practitioners/mid-level practitioners/hospitals/clinics. In summary, 55 
of the 366,351 (0.015%) affected small entities are estimated to 
experience significant impact, (i.e., incur costs greater than 1% of 
annual revenue) if the proposed rule were finalized. The percentage of 
small entities with significant economic impact is below the 30% 
threshold for all registrant business activities. The DEA's assessment 
of economic impact by size category indicates that the proposed rule 
will not have a significant effect on a substantial number of these 
small entities.
    The DEA's assessment of economic impact by size category indicates 
that the proposed rule to reschedule HCPs as schedule II controlled 
substances will not have a significant economic impact on a substantial 
number of small entities. The DEA will consider written comments 
regarding the DEA's economic analysis of the impact of such 
rescheduling, including this certification, and requests that 
commenters describe the specific nature of any impact on small entities 
and provide empirical data to illustrate the extent of such impact.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, the DEA has determined and certifies 
pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 
1501 et seq.), 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 provisions of the UMRA of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement 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, 21 CFR part 1308 is proposed to be 
amended to read as follows:

PART 1308--SCHEDULES CONTROLLED SUBSTANCES

0
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.


Sec.  1308.13  [Amended]

0
2. Amend Sec.  1308.13 by removing paragraphs (e)(1)(iii) and (iv) and 
redesignating paragraphs (e)(1)(v) through (viii) as (e)(1)(iii) 
through (v), respectively.

    Dated: February 21, 2014.
Michele M. Leonhart,
Administrator.
[FR Doc. 2014-04333 Filed 2-26-14; 8:45 am]
BILLING CODE 4410-09-P