Schedules of Controlled Substances: Exempt Anabolic Steroid Products
| Published date | 16 December 2020 |
| Citation | 85 FR 81388 |
| Record Number | 2020-25288 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
81388
Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations
730-AMOC@faa.gov. Before using any
approved AMOC, notify your appropriate
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International Validation Branch, FAA; or
ANAC; or ANAC’s authorized Designee. If
approved by the ANAC Designee, the
approval must include the Designee’s
authorized signature.
(j) Related Information
For more information about this AD,
contact Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200
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telephone and fax 206–231–3218;
Kathleen.Arrigotti@faa.gov.
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ˆncia Nacional de Aviac
¸a
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(ANAC) AD 2020–04–01R01, effective May
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Issued on December 1, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020–27619 Filed 12–15–20; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–671]
Schedules of Controlled Substances:
Exempt Anabolic Steroid Products
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Order with opportunity for
comment.
SUMMARY
: The Drug Enforcement
Administration is denying applications
to designate four in-process
preparations containing trenbolone
acetate as exempt anabolic steroid
products under the Controlled
Substances Act.
DATES
: This order is effective December
16, 2020. Written comments must be
postmarked, and electronic comments
must be sent, on or before February 16,
2021.
ADDRESSES
: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–671’’ on all electronic and
written correspondence, including any
attachments.
Electronic comments: The Drug
Enforcement Administration (DEA)
encourages all comments be submitted
electronically through the Federal
eRulemaking Portal which provides the
ability to type short comments directly
into the comment field on the web page
or attach a file for lengthier comments.
Please go to http://www.regulations.gov/
and follow the online instructions at
that site for submitting comments. Upon
completion of your submission, you will
receive a Comment Tracking Number for
your comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments
that duplicate electronic submissions
are not necessary and are discouraged.
Should you wish to mail a paper
comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
FOR FURTHER INFORMATION CONTACT
:
Terrence L. Boos, Drug and Chemical
Evaluation, Diversion Control Division,
Drug Enforcement Administration;
Mailing Address: 8701 Morrissette
Drive, Springfield, Virginia 22152;
Telephone: (571) 362–3249.
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 DEA for public inspection
online at http://www.regulations.gov.
Such information includes personal
identifying information (such as your
name, address, etc.) voluntarily
submitted by the commenter. The
Freedom of Information Act 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 the personal
identifying information you do not want
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 confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information and confidential
business information identified as
directed above will generally be made
publicly available in redacted form. If a
comment has so much confidential
business information or personal
identifying information that it cannot be
effectively redacted, all or part of that
comment may not be made publicly
available. Comments posted to http://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number)
included in the text of your electronic
submission that is not identified as
directed above as confidential.
An electronic copy of this document
is available at http://
www.regulations.gov for easy reference.
Legal Authority
Anabolic steroids are listed in
schedule III of the Controlled
Substances Act (CSA). 21 U.S.C. 802(41)
and 812(c), Schedule III(e). The CSA
further provides that the Attorney
General may, by regulation, exempt
from any or all CSA provisions any
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‘‘compound, mixture, or preparation
which contains any anabolic steroid,
which is intended for administration to
a human being or an animal, and which,
because of its concentration,
preparation, formulation or delivery
system, does not present any significant
potential for abuse.’’ 21 U.S.C.
811(g)(3)(C). The authority to exempt
these products has been delegated from
the Attorney General to the
Administrator of the Drug Enforcement
Administration (DEA) (28 CFR 0.100(b)),
who in turn, re-delegated this authority
to the Assistant Administrator of
Diversion Control (DC) (28 CFR part 0,
Appendix to Subpart R, section 7(g)).
The procedures for implementing this
section are found at 21 CFR 1308.33.
Findings of Fact
DEA received an application from Ivy
Animal Health, Inc. (Ivy), dated March
27, 2015, seeking to exempt two
anabolic steroid-containing product
preparations containing trenbolone
acetate from control under the CSA.
Letter from Ivy Animal Health, Inc. to
DEA (Mar. 27, 2015), at 1. Specifically,
the product preparations were
Component TE–H in-process
granulation and Component TE–H in-
process pellets in bulk containers. Id.
Ivy based its application on the
grounds that DEA had previously
exempted other in-process granulations
and pellets containing trenbolone
acetate, and the Component TE–H
‘‘product formulations contain the same
active ingredients Trenbolone acetate
and Estradiol’’ as the other in-process
materials that are currently exempt. Id.
Ivy’s application further stated that
‘‘[t]he presence of Estradiol in the
formulation with Trenbolone acetate
renders the Component TE–H in process
granulation and pellets unusable for
anabolic steroid abuse.’’ Id. at 4–5. Ivy
noted that DEA has ‘‘previously
identified Component TE–S in process
granulation and in process pellets as
exempt from the CSA as the presence of
Estradiol in the formulation prevented
significant potential for abuse.’’ Id. at 5.
Upon review of the application, DEA
accepted it for filing. On April 29, 2015,
DEA provided a copy of Ivy’s
application to the Secretary of Health
and Human Services (HHS) and
requested an evaluation and a
recommendation.
DEA also received an application
from Ivy Animal Health, Inc., dated
April 30, 2015, seeking to exempt two
anabolic steroid-containing product
preparations containing trenbolone
acetate from control under the CSA.
Letter from Ivy Animal Health, Inc. to
DEA (Apr. 30, 2015), at 1. Specifically,
the product preparations were
Component T–H in-process granulation
and Component T–H in-process pellets
in bulk containers. Id.
Ivy based its application on the
grounds that DEA had ‘‘previously
identified Component TE–S in process
granulation and in process pellets as
exempt from the CSA as the formulation
prevented significant potential for
abuse.’’ Id. The application noted that
the ‘‘combination of [trenbolone acetate]
with the excipient materials under the
manufacturing process conditions
removes significant potential for abuse
of the anabolic steroid in the
granulation mixture and resultant in
process pellets.’’ Id. Ivy further noted
that this formulation ‘‘is identical to that
of the Component
®
T–H packaged
product pellets and presents no more
potential for abuse than that of the
excluded packaged implant product.’’
Id. at 4. Ivy claimed that for Component
T–H in-process granulation and
Component T–H in-process pellets,
‘‘[c]omplicated manipulation of the
material, including dissolution,
separation, and reconstituting, would be
required to convert the in process
material to Trenbolone acetate and
prepare it for injection or some other
delivery method.’’ Id. at 5.
Upon review of the application, DEA
accepted it for filing. On June 4, 2015,
DEA provided a copy of Ivy’s
application to the Secretary of HHS and
requested an evaluation and a
recommendation.
On October 8, 2019, the Assistant
Secretary for Health (ASH) provided
HHS’s evaluation and recommendation
to DEA for both applications. Letter
from Assistant Secretary for Health,
HHS, to Acting Administrator, DEA, at
1 (Oct. 8, 2019) (ASH Letter). HHS
found that ‘‘[a]lthough there is no
evidence that trenbolone is being
obtained from in-process materials there
is evidence that it is being abused.’’ Id.
HHS noted the availability of ‘‘protocols
or kits to purify trenbolone from
marketed cattle pellets’’ and concluded
that these ‘‘do-it-yourself kits’’ makes
the ‘‘in-process materials easy to abuse.’’
Id.
With respect to the inclusion of
estradiol in Component TE–H in-
process granulation and Component
TE–H in-process pellets, HHS found
that ‘‘protocols and kits have been
developed to purify trenbolone from
estradiol.’’ Id. Although HHS had
previously ‘‘recommended that DEA
exempt in-process substances
containing trenbolone and estradiol’’ on
the basis that ‘‘inclusion of estradiol
deterred abuse,’’ because these kits and
protocols are now available, ‘‘it can no
longer be concluded that the addition of
estradiol to a substance containing
trenbolone acetate deters the abuse of
trenbolone acetate.’’ Id.
HHS thus concluded ‘‘that the
products Component T–H in-process
granulation and Component T–H in-
process pellets, and Component TE–H
in-process granulation and Component
TE–H in-process pellets do not fit into
the category of having no significant
potential for abuse based on
concentration, preparation, formulation,
or delivery system.’’ Id. The ASH thus
recommended that Ivy’s ‘‘products be
denied exemption from scheduling
under the CSA.’’ Id.
Further, after a review of the available
kits and protocols, DEA finds this
information credible, easy to
understand, and requires no specialized
skill or experience to carry out the
required steps. Thus, DEA concludes
that trenbolone acetate can be easily
separated from estradiol and other
excipient materials used to make
Component TE–H in-process
granulation, Component TE–H in-
process pellets, Component T–H in-
process granulation, and Component T–
H in-process pellets. The composition of
these in-process materials containing
significant quantities of trenbolone
acetate does not prevent significant
potential for abuse.
Conclusions of Law
Based on the evaluation and
recommendation of the ASH, as well as
DEA’s review of available evidence of
diversion of these types of products, the
Assistant Administrator does not find
that ‘‘because of [their] concentration,
preparation, formulation, or delivery
system,’’ Ivy’s Component TE–H in-
process granulation, Component TE–H
in-process pellets, Component T–H in-
process granulation, and Component T–
H in-process pellets ‘‘ha[ve] no
significant potential for abuse.’’ 21 CFR
1308.33(a).
Therefore, the Assistant
Administrator, Diversion Control
Division, hereby orders that the above
products containing anabolic steroids
not be exempted from application of any
section of the CSA, and they are not to
be included in the list of products
described in 21 CFR 1308.34. These in-
process materials remain controlled as
an anabolic steroid in schedule III.
Unless specifically excepted, to the
extent Ivy handles trenbolone acetate in
the manufacturing process, Ivy must
comply with all applicable registration,
security and recordkeeping
requirements set forth in the CSA and
DEA regulations. Exemptions granted or
denied under 21 CFR 1308.33 are
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Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations
product- and manufacturer-specific, and
the present order does not address any
other product currently listed in 21 CFR
1308.34.
This order does not apply to the final,
packaged, and labeled products
‘‘containing an anabolic steroid, that are
expressly intended for administration
through implants to cattle or other
nonhuman species’’ where the products
‘‘have been approved by the Secretary of
Health and Human Services for such
administration.’’ 21 CFR 1308.26(a).
Under 21 U.S.C. 802(41)(B)(i), such
products are excepted from the
definition of an anabolic steroid without
undergoing the exemption process
described in 21 CFR 1308.33, and
without any evaluation or determination
of their abuse potential.
Opportunity for Comment
Pursuant to 21 CFR 1308.33, any
interested person may submit written
comments on, or objections to, the
denial of an exemption for any product
listed in this order, within 60 days of
the date of publication of this order, as
specified above. If any comments or
objections raise significant issues
regarding any finding of fact or
conclusion of law upon which this
order is based, the Assistant
Administrator, Diversion Control
Division, may reconsider the
application in light of the comments
and objections filed. 21 CFR 1308.33.
Thereafter, the Assistant Administrator
shall amend his original order as he
determines appropriate. Id.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–25288 Filed 12–15–20; 8:45 am]
BILLING CODE 4410–09–P
AGENCY FOR INTERNATIONAL
DEVELOPMENT
22 CFR Part 228
[AID–2020–0004]
RIN 0412–AB02
Procurement of Certain Essential
Medical Supplies To Address the
COVID–19 Pandemic; Correction
AGENCY
: Agency for International
Development.
ACTION
: Correcting amendments.
SUMMARY
: On October 23, 2020, the
United States Agency for International
Development (USAID) issued a
Temporary Final Rule (TFR) amending
our regulations to allow USAID to waive
‘‘Source and Nationality’’ rules to
provide for increased flexibility,
targeting, and speed of procurement of
Emergency Medical Supplies (EMS)
required to address the COVID–19
pandemic worldwide. That TFR
inadvertently resulted in the deletion of
defined terms. This document corrects
the TFR by restoring those definitions.
DATES
: The rule is effective on
December 16, 2020, through April 30,
2021, and is applicable beginning
October 23, 2020.
FOR FURTHER INFORMATION CONTACT
:
Natalie J. Freeman (or designee),
Attorney Advisor, Office of the General
Counsel, USAID, 1300 Pennsylvania
Ave. NW, Washington, DC 20523,
GCFEDREGMailbox@usaid.gov.
SUPPLEMENTARY INFORMATION
: This
document corrects 22 CFR 228.01,
which was amended by the TFR
published in the Federal Register on
October 23, 2020 (85 FR 67443). The
TFR revised the definitions in § 228.01
by adding a new definition for
‘‘Essential medical supplies.’’ This new
definition was intended to be added to
the existing list in alphabetical order,
but it inadvertently resulted in the
deletion of the terms previously defined
in § 228.01. After publication,
stakeholders notified USAID of the
missing definitions, which are used
throughout 22 CFR part 228. This
document effectuates the intent of the
TFR by restoring the definitions in
§ 228.01 and adding the definition of
‘‘Essential medical supplies’’ to the
alphabetical list. This correction does
not otherwise affect the changes made
by the TFR to 22 CFR part 228, or its
effective dates of October 23, 2020,
through April 30, 2021.
List of Subjects in 22 CFR Part 228
Government procurement.
For the reasons discussed above, 22
CFR part 228 is corrected by making the
following correcting amendments:
PART 228—RULES FOR
PROCUREMENT OF COMMODITIES
AND SERVICES FINANCED BY USAID
■1. The authority citation for 22 CFR
part 228 continues to read as follows:
Authority: Sec. 621, Pub. L. 87–195, 75
Stat. 445 (22 U.S.C. 2381), as amended, E.O.
12163, Sept. 29, 1979, 44 FR 56673: 3 CFR
1979 Comp., p. 435.
■2. Revise § 228.01 to read as follows:
§ 228.01 Definitions.
As used in this part, the following
terms shall have the following
meanings:
Advanced developing countries mean
those countries that are categorized by
the World Bank as upper middle income
countries according to their gross
national income per capita, except for
those countries in which USAID
provides assistance. USAID will
maintain a list of advanced developing
countries primarily based on the most
recent World Bank determinations, and
will make the list available in USAID’s
Automated Directives System, ADS 310.
This list will include determinations
made under § 228.17 of this part.
Available for purchase means for
commodities, that the commodity is
offered for sale in a country in the
authorized principal geographic code at
the time of purchase from the supplier,
irrespective of the place of manufacture
or production, unless it is a prohibited
source country. If applicable, the
commodity must also be able to be
serviced, and, if warrantied, have a
valid warranty. For services, available
for purchase means the service is
offered from a vendor which has
complied with nationality and foreign
government-owned organization
requirements of this regulation, and is
otherwise organized in a country in the
authorized principal geographic code
designated in an implementing
instrument. This definition does not
apply to procurements under the
geographic Code 935, see § 228.03 of
this part, because that geographic code
is for any country or area except for
prohibited source countries.
Commission means any payment or
allowance by a supplier to any person
for the contribution which that person
has made to secure the sale or contract
for the supplier or which that person
makes to securing on a continuing basis
similar sales or contracts for the
supplier.
Commodities or goods means any
material, article, supply, good, or
equipment.
Commodity-related services means
delivery services and/or incidental
services.
Cooperating country or recipient
country means the country receiving the
USAID assistance subject to this part
228, and includes all the countries
receiving assistance under a regional
program or project.
Delivery means the transfer to, or for
the account of, an importer of the right
to possession of a commodity, or, with
respect to a commodity-related service,
the rendering to, or for the account of,
an importer of any such service.
Delivery service means any service
customarily performed in a commercial
export or import transaction which is
necessary to affect a physical transfer of
commodities to the cooperating/
recipient country. Examples of such
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