This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

51149 

Vol. 82, No. 212 

Friday, November 3, 2017 

DEPARTMENT OF AGRICULTURE 

Office of the Secretary of Agriculture 

7 CFR Part 1 

Rules of Practice and Procedure 

Governing Formal Rulemaking 

Proceedings Instituted by the 

Secretary 

AGENCY: Office of the Secretary of 

Agriculture, USDA. 

ACTION: Final rule. 

SUMMARY: The U.S. Department of 

Agriculture (USDA) is adopting a final 

rule to establish rules of practice and 

procedure governing formal rulemaking 

proceedings instituted by the Secretary. 

This final rule applies to rulemakings 

that are not subject to the rules of 

practice and procedure for the 

promulgation of, or an amendment to, 

marketing orders or research and 

promotion orders. 

DATES: This final rule is effective on 

December 4, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Rupa Chilukuri, Trial Attorney, Office 

of the General Counsel, telephone: 202– 

720–4982, email: Rupa.Chilukuri@

ogc.usda.gov. 

SUPPLEMENTARY INFORMATION: USDA is 

issuing this final rule to establish rules 

of practice and procedure for formal 

rulemakings to implement certain 

statutes under the Secretary’s purview 

in a new subpart P under 7 CFR part 1. 

The Agricultural Marketing Service 

has rules of practice and procedure to 

formulate marketing agreements and 

marketing orders under 7 CFR part 900. 

Those rules of practice and procedure 

are applicable to proceedings under the 

Agricultural Marketing Agreement Act 

of 1937, as amended (50 Stat. 246). In 

addition, rules of practice and 

procedure also exist for proceedings 

under the Cotton Research and 

Promotion Act, as amended (7 U.S.C. 

2101–2119), the Egg Research and 

Consumer Information Act, as amended 

(7 U.S.C. 2701–2718), the Pork 

Promotion, Research, and Consumer 

Information Act (7 U.S.C. 4801–4819), 

and the Potato Research and Promotion 

Act, as amended (7 U.S.C. 2611–2627). 

Those rules appear under 7 CFR part 

1200. 

This new subpart largely reflects 

language in 7 CFR part 900 and 7 CFR 

part 1200. For purposes of efficiency 

and modernization, this subpart also 

includes: A provision requiring that 

interested persons notify the 

Administrator of their intent to 

participate in the hearing, a provision 

requiring pre-hearing submissions of 

direct testimony, and a provision 

allowing the notice of hearing to include 

alternative procedures. 

5 U.S.C. 553, 601, and 804 

This final rule establishes agency 

rules of practice and procedure. Under 

the Administrative Procedure Act, prior 

notice and opportunity for comment are 

not required for the promulgation of 

agency rules of practice and procedure. 

5 U.S.C. 553(b)(3)(A). Only substantive 

rules require publication 30 days prior 

to their effective date. 5 U.S.C. 553(d). 

Therefore, this final rule is effective 

upon publication in the Federal 

Register. 

Furthermore, under 5 U.S.C. 804, this 

rule is not subject to congressional 

review under the Small Business 

Regulatory Enforcement Fairness Act of 

1996, Public Law 104–121. In addition, 

because prior notice and opportunity for 

comment are not required to be 

provided for this final rule, this rule is 

exempt from the requirements of the 

Regulatory Flexibility Act, 5 U.S.C. 601 

et seq. 

Executive Orders 12866 and 13563 

This rule does not meet the definition 

of a significant regulatory action under 

section 3(f) of Executive Order 12866, 

Regulatory Planning and Review, as 

supplemented by Executive Order 

13563. Because this rule is not a 

significant regulatory action, it has not 

been reviewed by the Office of 

Management and Budget. 

Executive Order 13771 

Additionally, because this rule does 

not meet the definition of a significant 

regulatory action it does not trigger the 

requirements of Executive Order 13771. 

See OMB’s Memorandum titled 

‘‘Interim Guidance Implementing 

Section 2 of the Executive Order of 

January 30, 2017 titled ‘Reducing 

Regulation and Controlling Regulatory 

Costs’’’ (February 2, 2017). 

Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule is not intended to 

have retroactive effect. This rule will 

not preempt any State or local laws, 

regulations, or policies, unless they 

present an irreconcilable conflict with 

this rule. There are no administrative 

proceedings that must be exhausted 

before parties may file suit in court 

challenging this rule. 

Executive Order 13132 

This rule has been reviewed in 

accordance with the requirements of 

Executive Order 13132, Federalism. The 

review reveals that this rule does not 

contain policies with federalism 

implications sufficient to warrant 

federalism consultation under Executive 

Order 13132. 

Executive Order 13175 

This rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this regulation would not have 

substantial and direct effects on tribal 

governments and would not have 

significant tribal implications. 

Paperwork Reduction Act 

This rule contains no information 

collections or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects in 7 CFR Part 1 

Administrative practice and 

procedure. 

■ Accordingly, Subpart P is added to 

Part 1 of Subtitle A of Title 7 of the 

Code of Federal Regulations to read as 

follows: 

PART 1—ADMINISTRATIVE 

REGULATIONS 

Subpart P—Rules of Practice and 

Procedure Governing Formal Rulemaking 

Proceedings Instituted by the Secretary 

Sec. 

1.800 Words in the singular form. 

1.801 Scope and applicability of this 

subpart. 


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1.802 Definitions. 

1.803 Institution of proceedings. 

1.804 Notification by interested persons. 

1.805 Docket number. 

1.806 Judge. 

1.807 Direct testimony submitted as written 

documents. 

1.808 Motions and requests. 

1.809 Conduct of the hearing. 

1.810 Oral and written arguments. 

1.811 Certification of the transcript. 

1.812 Copies of the transcript. 

1.813 Administrator’s recommended 

decision. 

1.814 Submission to Secretary. 

1.815 Decision by the Secretary. 

1.816 Filing, extension of time, effective 

date of filing, and computation of time. 

1.817 Ex parte communications. 

1.818 Additional documents to be filed 

with hearing clerk. 

1.819 Hearing before Secretary. 

Authority: Pub. L. 89–554, 80 Stat. 378, 5 

U.S.C. 301. 

Subpart P—Rules of Practice and 

Procedure Governing Formal 

Rulemaking Proceedings Instituted by 

the Secretary 

§ 1.800 Words in the singular form. 

Words in this subpart in the singular 

form shall be deemed to import the 

plural, and vice versa, as the context 

may require. 

§ 1.801 Scope and applicability of this 

subpart. 

Except for proceedings covered by 7 

CFR part 900, and by 7 CFR part 1200, 

the rules of practice and procedure in 

this subpart shall be applicable to all 

formal rulemaking proceedings. 

§ 1.802 Definitions. 

As used in this subpart: 

Administrator means the 

Administrator of the Agency 

administering the statute involved, or 

any officer or employee of the Agency 

to whom authority has heretofore been 

delegated, or to whom authority may 

hereafter be delegated, to act for the 

Administrator. 

Department means the U.S. 

Department of Agriculture. 

Federal Register means the 

publication provided for by the Federal 

Register Act, approved July 26, 1935 (44 

U.S.C. 1501–1511), and acts 

supplementing and amending it. 

Hearing means that part of the 

proceeding that involves the submission 

of evidence. 

Hearing clerk means the Hearing 

Clerk, U.S. Department of Agriculture, 

Washington, DC 

Judge means any administrative law 

Judge appointed pursuant to 5 U.S.C. 

3105 and assigned to conduct the 

hearing. 

Party means: 

(1) Any employee or contractor of the 

Department acting in an official 

capacity; or 

(2) A person who intends to cross 

examine a witness at the hearing and 

has notified the person named in the 

notice of hearing by specified dates of 

his or her intent to participate in the 

hearing as a ‘‘party’’ pursuant to § 1.804. 

Proceeding means a proceeding before 

the Secretary arising under a statute in 

which the Secretary uses formal 

rulemaking procedures as set forth in 

this subpart. 

Secretary means the Secretary of 

Agriculture of the United States, or any 

officer or employee of the Department to 

whom authority has heretofore been 

delegated, or to whom authority may 

hereafter be delegated, to act for the 

Secretary. 

Witness means any person who: 

(1) Has notified the person named in 

the notice of hearing by the specified 

date of his or her intent to participate 

in the hearing as a witness pursuant to 

§ 1.804; and 

(2) Who submits written direct 

testimony on the proposed regulations 

pursuant to § 1.807; and 

(3) Testifies orally at the hearing. 

§ 1.803 Institution of proceedings. 

(a) Filing and contents of the notice of 

hearing. A proceeding under this 

subpart shall be instituted by the 

Secretary or designee through filing the 

notice of hearing with the hearing 

clerk.The notice of hearing shall state: 

(1) The legal authority under which 

the rule is proposed. 

(2) The scope and nature of the 

hearing, including witness instructions 

for testifying, including the means and 

timing of the submission of pre-hearing 

documents, and scheduling, as 

necessary. 

(3) The terms or substance of the 

proposed rule or a description of the 

subjects and issues involved. 

(4) The time and place of such 

hearing. 

(5) The final date for notification of 

intent to participate as a party or 

witness in the hearing pursuant to 

§ 1.804. 

(6) The person to whom notification 

of intent to participate as a party or 

witness is to be provided pursuant to 

§ 1.804, and the means by which such 

notifications are to be provided. 

(7) Any alternative procedures 

established pursuant to paragraph (d) of 

this section. 

(b) Giving notice of hearing. (1) The 

Administrator shall give or cause to be 

given notice of hearing in the following 

manner: 

(i) By publication of the notice of 

hearing in the Federal Register. 

(ii) By posting of the notice of hearing 

to the USDA Web site. 

(2) Legal notice of the hearing shall be 

deemed to be given if notice is given in 

the manner provided by paragraph 

(b)(1)(i) of this section. 

(c) Record of notice. A copy of the 

notice of hearing published in the 

Federal Register pursuant to paragraph 

(b)(1)(i) of this section shall be filed 

with the hearing clerk and submitted to 

the Judge at the hearing. 

(d) Alternative procedures. The 

Administrator may establish alternative 

procedures for the proceeding that are 

in addition to or in lieu of one or more 

procedures in this subpart, provided 

that the procedures are consistent with 

5 U.S.C. 556 and 557. The alternative 

procedures must be described in the 

notice of hearing, as required in 

paragraph (a)(7) of this section. 

§ 1.804 Notification by interested persons. 

(a) Any person desiring to participate 

as a party or witness at the hearing shall 

notify the person named in the notice of 

hearing, as prescribed in the notice of 

hearing, on or before the date specified 

in the notice of hearing. A person may 

be both a party and a witness. 

(b) The notification must clearly state 

whether the interested person is 

participating at the hearing as a party, 

witness, or both. 

(c) If a party or witness will be 

participating with or through a 

representative or counsel, the 

notification must so state and provide 

the name of the representative or 

counsel. 

(d) Persons who fail to comply with 

this section and any specified 

instructions in the notice of hearing 

shall be deemed to have waived their 

right to participate in the hearing. 

Failure to comply with this section shall 

result in the exclusion of any filed 

written testimony. 

§ 1.805 Docket number. 

Each proceeding, immediately 

following its institution, shall be 

assigned a docket number by the 

hearing clerk and thereafter the 

proceeding may be referred to by such 

number. 

§ 1.806 Judge. 

(a) Assignment. No Judge who has any 

pecuniary interest in the outcome of a 

proceeding shall serve as Judge in such 

proceeding. 

(b) Power of Judge. Subject to review 

by the Secretary, as provided elsewhere 

in this subpart, the Judge in any 

proceeding shall have power to: 

(1) Rule upon motions and requests; 


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(2) Change the time and place of 

hearings, and adjourn the hearing from 

time to time or from place to place; 

(3) Administer oaths and affirmations 

and take affidavits; 

(4) Examine and cross-examine 

witnesses and receive evidence; 

(5) Admit or exclude evidence; 

(6) Hear oral argument on facts or law; 

and 

(7) Do all acts and take all measures 

necessary for the maintenance of order 

at the hearings and the efficient conduct 

of the proceeding. 

(c) Who may act in absence of the 

Judge. In case of the absence of the 

Judge or that Judge’s inability to act, the 

powers and duties to be performed by 

the Judge under this subpart in 

connection with a proceeding may, 

without abatement of the proceeding 

unless otherwise ordered by the 

Secretary, be assigned to any other 

Judge. 

(d) Disqualification of Judge. The 

Judge may at any time withdraw as 

Judge in a proceeding if such Judge 

deems himself or herself to be 

disqualified. Upon the filing by an 

interested person in good faith of a 

timely and sufficient affidavit of 

personal bias or disqualification of a 

Judge, the Secretary shall determine the 

matter as a part of the record and 

decision in the proceeding, after making 

such investigation or holding such 

hearings, or both, as the Secretary may 

deem appropriate in the circumstances. 

§ 1.807 Direct testimony submitted as 

written documents. 

Any person desiring to participate as 

a witness at the hearing shall submit 

direct testimony as written documents 

as prescribed by the following: 

(a) Direct testimony by a witness, 

including accompanying exhibits, must 

be submitted as specified in the notice 

of the hearing pursuant to § 1.803. 

Exhibits constituting part of such direct 

testimony, referred to in the direct 

testimony and made a part thereof must 

be attached to the direct testimony. 

Direct testimony submitted with 

exhibits must state the issue(s) to which 

the exhibit relates; if no such statement 

is made, the Judge, at the hearing, shall 

determine the relevance of the exhibit to 

the issues published in the Federal 

Register. 

(b) The direct testimony submitted 

shall contain: 

(1) A concise statement of the witness’ 

interest in the proceeding and his or her 

position regarding the issues presented. 

If the direct testimony is presented by 

a witness who is not a party, the witness 

shall state the witness’ relationship to 

the party on behalf of whom the 

testimony is proffered; and 

(2) Facts that are relevant and 

material. 

(c) Copies of all direct testimony, 

including accompanying exhibits, must 

be submitted as prescribed by the notice 

of hearing. 

(d) Upon receipt, direct testimony 

shall be assigned a number and stamped 

with that number and the docket 

number. 

§ 1.808 Motions and requests. 

(a) General. (1) Parties shall file all 

motions and requests with the hearing 

clerk except that those made during the 

course of the hearing may be filed with 

the Judge or may be stated orally and 

made a part of the transcript. 

(2) Except as provided in § 1.816(b), 

such motions and requests shall be 

addressed to, and ruled on by, the Judge 

if made prior to certification of the 

transcript pursuant to § 1.811 or by the 

Secretary if made thereafter. 

(b) Certification to Secretary. The 

Judge may, in his or her discretion, 

submit or certify to the Secretary for 

decision any motion, request, objection, 

or other question addressed to the 

Judge. 

§ 1.809 Conduct of the hearing. 

(a) Time and place. The hearing shall 

be held at the time and place 

established in the notice of hearing. If 

the Judge subsequently changes the time 

or place, the Judge shall file a notice of 

such changes with the hearing clerk, 

and the Administrator shall give or 

cause to be given notice in the Federal 

Register in the same manner as 

provided in § 1.803. If the change in 

time or place of hearing is made less 

than five days prior to the date 

previously established for the hearing, 

the Judge, either in addition to, or in 

lieu of, causing the notice of the change 

to be given, shall announce the change 

at the time and place previously 

established for the hearing. 

(b) Appearances—(1) Right to appear. 

Any interested person shall be given an 

opportunity to appear, as a witness, 

with or without, authorized counsel or 

representative, and to be heard with 

respect to matters relevant and material 

to the proceeding, provided that such 

interested person complies with 

§§ 1.804, 1.807, and any alternative 

procedures included in the hearing 

notice pursuant to § 1.803. In addition 

to compliance with any witness 

instructions set forth in the notice of 

hearing, any witness who desires to be 

heard in person at any hearing shall, 

before proceeding to testify do so under 

oath or affirmation. 

(2) Appearance with or through 

counsel or representative. (i) A witness 

may appear with counsel or a 

representative if the witness identifies 

the counsel or representative in the 

notification submitted pursuant to 

§ 1.804. 

(ii) The counsel or representative 

shall, before proceeding with the 

witness testimony, state for the record 

the authority to act as such counsel or 

representative, and the names, 

addresses, and occupations of such 

counsel or representative. 

(iii) The witness or his or her counsel 

or representative shall give such other 

information respecting the witness’ 

appearance as the Judge may request. 

(3) Debarment of counsel or 

representative. (i) Whenever, while a 

proceeding is pending before the Judge, 

such Judge finds that a person, acting as 

counsel or representative for any party 

or witness, is guilty of unethical or 

unprofessional conduct, the Judge may 

order that such person be precluded 

from further acting as counsel or 

representative in such proceeding. 

(ii) Except as provided in paragraph 

(b)(3)(iii) of this section, an appeal to 

the Secretary may be taken from any 

such order, but the proceeding shall not 

be delayed or suspended pending 

disposition of the appeal. 

(iii) In case the Judge has ordered that 

a person be precluded from further 

action as counsel or representative in 

the proceeding, the Judge within a 

reasonable time thereafter shall submit 

to the Secretary a report of the facts and 

circumstances surrounding such order 

and shall recommend what action the 

Secretary should take respecting the 

appearance of such person as counsel or 

representative in other proceedings 

before the Secretary. Thereafter the 

Secretary may, after notice and an 

opportunity for hearing, issue such 

order respecting the appearance of such 

person as counsel or representative in 

proceedings before the Secretary as the 

Secretary finds to be appropriate. 

(4) Failure to appear. If any interested 

person, who complied with §§ 1.804, 

1.807, fails to appear at the hearing, that 

person shall be deemed to have waived 

the right to be heard in the proceeding 

and such failure to appear shall result 

in the exclusion of that person’s written 

testimony. 

(c) Order of procedure. (1) The Judge 

shall, at the opening of the hearing prior 

to the taking of testimony, note as part 

of the record the notice of hearing as 

published in the Federal Register. 

(2) Evidence shall then be received 

with respect to the matters specified in 

the notice of the hearing in such order 

as the Judge shall announce. 


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(d) Evidence—(1) General. The 

hearing shall be publicly conducted, 

and the testimony given at the hearing 

shall be reported verbatim. 

(i) Every witness shall, before 

proceeding to testify, be sworn or make 

an affirmation. 

(ii) When necessary, in order to 

prevent undue prolongation of the 

hearing, the Judge may: 

(A) Limit the number of times any 

witness may testify to the same matter 

or the amount of corroborative or 

cumulative evidence. 

(B) Limit cross examination of a 

witness by time, scope, or as 

appropriate, provided that the Judge 

announces the time limit at the 

beginning of the hearing, prior to the 

taking of testimony. 

(iii) The Judge shall exclude from the 

record evidence which is immaterial, 

irrelevant, or unduly repetitious, or 

which is not of the sort upon which 

responsible persons are accustomed to 

rely. 

(2) Objections. If a party objects to the 

admission or rejection of any evidence 

or to any other ruling of the Judge 

during the hearing, such party shall 

state briefly the grounds of such 

objection, whereupon an automatic 

exception will follow if the objection is 

overruled by the Judge. The ruling of the 

Judge on any objection shall be a part 

of the transcript. Only objections made 

before the Judge may subsequently be 

relied upon in the proceeding. 

(3) Upon proper motion, the Judge 

may accept direct testimony submitted 

pursuant to § 1.807 into evidence 

without a witness reading the direct 

testimony into evidence. Such direct 

testimony shall become a part of the 

record subject to exclusion of irrelevant 

and immaterial parts thereof. A party 

shall be deemed to have waived the 

right to introduce pre-hearing written 

direct testimony and documents if such 

party fails to present a witness to 

introduce those documents. The witness 

introducing direct testimony and 

documents shall do so under oath or 

affirmation and shall: 

(i) State his or her name, address and 

occupation. 

(ii) State qualifications for introducing 

the direct testimony. If an expert, the 

witness shall briefly state the scientific 

or technical training which qualifies the 

witness as an expert. 

(iii) Identify the direct testimony and 

documents previously submitted 

pursuant to § 1.807 of this subpart. 

(iv) Submit to direct and cross 

examination determined to be necessary 

and appropriate by the Judge. 

(4) Cross examination. For purposes 

of this section, the Administrator’s or 

his or her representative’s interest shall 

be considered adverse to all parties. The 

Judge may: 

(i) Require the cross-examiner to 

outline the intended scope of the cross 

examination, which shall generally be 

limited to the scope of the direct 

testimony. 

(ii) Prohibit parties from crossexamining witnesses unless the Judge 

has determined that the cross-examiner 

has an adverse interest on the facts at 

issue to the party or witness. 

(iii) Limit the number of times any 

party or parties having a common 

interest may cross-examine an adverse 

witness on the same matter. 

(5) Proof and authentication of official 

records or documents. An official record 

or document, when admissible for any 

purpose, shall be admissible as evidence 

without the presence of the person who 

made or prepared the same. The Judge 

shall exercise discretion in determining 

whether an official publication of such 

record or document shall be necessary, 

or whether a copy would be 

permissible. If permissible such a copy 

shall be attested to by the person having 

legal custody of it, and accompanied by 

a certificate that such person has the 

custody. 

(6) Exhibits. (i) All written statements, 

documents, charts, tabulations, or data 

offered into evidence at the hearing 

shall, after identification by the witness 

or his or her counsel or representative 

and upon satisfactory showing of 

authenticity, relevancy, and materiality, 

be numbered as exhibits and received in 

evidence and made a part of the record. 

(ii) Such exhibits shall be submitted 

in quadruplicate and in documentary 

form. 

(7) Official notice. (i) Subject to 

paragraph (d)(7)(ii) of this section, 

official notice at the hearing may be 

taken of such matters as are judicially 

noticed by the courts of the United 

States and of any other matter of 

technical, scientific, or commercial fact 

of established character. 

(ii) Interested persons shall be given 

an adequate period of time, at the 

hearing or subsequent to it, of matters so 

noticed and shall be given adequate 

opportunity to show that such facts are 

inaccurate or are erroneously noticed. 

(8) Offer of proof. (i) Whenever 

evidence is excluded from the record, 

the party offering such evidence may 

make an offer of proof, which shall be 

included in the transcript. 

(ii) The offer of proof shall consist of 

a brief statement describing the 

evidence to be offered. If the evidence 

consists of a brief oral statement, it shall 

be inserted into the transcript; if the 

evidence consists of an exhibit(s), it 

shall be inserted into the record for the 

purpose of an offer of proof. In such 

event, it shall be considered a part of the 

record if the Secretary determines that 

the Judge’s ruling in excluding the 

evidence was erroneous. 

(iii) The Judge shall not allow the 

insertion of such evidence in toto if the 

taking of such evidence will consume a 

considerable length of time at the 

hearing. In such event, if the Secretary 

determines that the Judge erred in 

excluding the evidence, and that such 

error was substantial, the hearing may 

be reopened to permit the taking of such 

evidence. 

§ 1.810 Oral and written arguments. 

(a) Oral argument before the Judge. 

Oral argument before the Judge shall be 

in the discretion of the Judge. Such 

argument, when permitted, may be 

limited by the Judge to any extent that 

the Judge finds necessary for the 

expeditious disposition of the 

proceeding and shall be made part of 

the transcript. 

(b) Briefs, proposed findings, and 

conclusions. (1) The Judge shall 

announce at the hearing a reasonable 

period of time within which interested 

persons may file with the hearing clerk 

proposed findings and conclusions, and 

written arguments or briefs, based upon 

the evidence received at the hearing, 

citing, where practicable, the page or 

pages of the transcript of the testimony 

where such evidence appears. 

(2) Factual material other than that 

adduced at the hearing or subject to 

official notice shall not be alluded to 

therein, and, in any case, shall not be 

considered in the formulation of the 

rule. 

(3) If the person filing a brief desires 

the Secretary to consider any objection 

made by such person to a ruling of the 

Judge, as provided in § 1.809(d), that 

person shall include in the brief a 

concise statement concerning each such 

objection, referring, where practicable, 

to the pertinent pages of the transcript. 

§ 1.811 Certification of the transcript. 

(a) The Judge shall notify the hearing 

clerk of the close of a hearing and of the 

time for filing transcript corrections, 

written arguments, briefs, proposed 

findings, and proposed conclusions. 

(b)(1) After the hearing, the 

Administrator, shall transmit to the 

hearing clerk an original and three 

copies of the transcript of the testimony 

and the original and all copies of the 

exhibits not already on file with the 

hearing clerk. 

(2) The Judge shall attach to the 

original transcript of the testimony a 

certificate stating that, to the best of the 


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Judge’s knowledge and belief, the 

transcript is a true transcript of the 

testimony given at the hearing, except in 

such particulars as the Judge shall 

specify, and that the exhibits 

transmitted are all the exhibits as 

introduced at the hearing with such 

exceptions as the Judge shall specify. A 

copy of such certificate shall be attached 

to each of the copies of the transcript of 

testimony. 

(3) In accordance with such certificate 

the hearing clerk shall note upon the 

official record copy, and cause to be 

noted on other copies of the transcript, 

each correction detailed therein by 

adding or crossing out (but without 

obscuring the text as originally 

transcribed) at the appropriate place any 

words necessary to make the same 

conform to the correct meaning, as 

certified by the Judge. 

(4) The hearing clerk shall obtain and 

file certifications to the effect that such 

corrections have been effectuated in 

copies other than the official record 

copy. 

§ 1.812 Copies of the transcript. 

(a) During the period in which the 

proceeding has an active status in the 

Department, a copy of the transcript and 

exhibits shall be kept on file with the 

hearing clerk where it shall be available 

for examination during official hours of 

business. Thereafter the transcript and 

exhibits shall be made available by the 

hearing clerk for examination during 

official hours of business after prior 

request and reasonable notice to the 

hearing clerk. 

(b) A copy of the transcripts of the 

hearing shall be made available to any 

person at actual cost of duplication. 

§ 1.813 Administrator’s recommended 

decision. 

(a) Preparation. As soon as practicable 

following the termination of the period 

allowed for the filing of written 

arguments or briefs and proposed 

findings and conclusions the 

Administrator shall file with the hearing 

clerk a recommended decision. 

(b) Contents. The Administrator’s 

recommended decision shall include: 

(1) A preliminary statement 

containing a description of the history 

of the proceedings, a brief explanation 

of the material issues of fact, law and 

proposed findings and conclusions 

about such issues, including the reasons 

or basis for such proposed findings. 

(2) A ruling upon proposed findings 

or conclusions submitted by interested 

persons. 

(3) An appropriate proposed rule 

effectuating the Administrator’s 

recommendations. 

(c) Exceptions to recommended 

decision. (1) Immediately following the 

filing of the recommended decision, the 

Administrator shall give notice thereof 

and opportunity to file exceptions 

thereto by publication in the Federal 

Register. 

(2) Within the period of time specified 

in such notice, any interested person 

may file with the hearing clerk 

exceptions to the Administrator’s 

proposed rule and a brief in support of 

such exceptions. 

(3) Such exceptions shall be in 

writing, shall refer, where practicable, to 

the related pages of the transcript, and 

may suggest appropriate changes in the 

proposed rule. 

(d) Omission of recommended 

decision. The procedure provided in 

this section may be omitted only if the 

Secretary finds on the basis of the 

record that due and timely execution of 

the Secretary’s functions imperatively 

and unavoidably requires such 

omission. 

§ 1.814 Submission to Secretary. 

(a) Upon the expiration of the period 

allowed for filing exceptions or upon 

request of the Secretary, the hearing 

clerk shall transmit to the Secretary the 

record of the proceeding. 

(b) Such record shall include: 

(1) All motions and requests filed 

with the hearing clerk and rulings 

thereon. 

(2) The certified transcript. 

(3) Any proposed findings or 

conclusions or written arguments or 

briefs that may have been filed. 

(4) The Administrator’s recommended 

decision, if any. 

(5) Filed exceptions. 

§ 1.815 Decision by the Secretary. 

After due consideration of the record, 

the Secretary shall render a decision. 

Such decision shall become a part of the 

record and shall include: 

(a) A statement of findings and 

conclusions, including the reasons or 

basis for such findings, upon all the 

material issues of fact or law presented 

on the record. 

(b) A ruling upon proposed findings 

and proposed conclusions not 

previously ruled upon in the record. 

(c) A ruling upon exceptions filed by 

interested persons. 

(d) Either a denial of the proposal to 

issue a rule, or, if the findings upon the 

record so warrant, a rule, the provisions 

of which shall be set forth and such rule 

shall be complete. 

§ 1.816 Filing, extension of time, effective 

date of filing, and computation of time. 

(a) Number of copies. Except as 

provided otherwise, all documents or 

papers required or authorized by the 

foregoing provisions hereof to be filed 

with the hearing clerk shall be filed in 

quadruplicate. Any documents or 

papers so required or authorized to be 

filed with the hearing clerk shall be 

filed with the Judge during the course 

of an oral hearing. 

(b) Extension of time. (1) The time for 

filing of any document or paper 

required or authorized by the foregoing 

provisions to be filed may be extended 

by the Judge (before the record is so 

certified by the Judge) or by the 

Administrator (after the record is so 

certified by the Judge but before it is 

transmitted to the Secretary), or by the 

Secretary (after the record is transmitted 

to the secretary) upon request filed, and 

if, in the judgment of the Judge, 

Administrator, or the Secretary, as the 

case may be, there is good reason for the 

extension. 

(2) All rulings made pursuant to this 

paragraph shall be filed with the hearing 

clerk. 

(c) Effective date of filing. Any 

document or paper required or 

authorized in this subpart to be filed 

shall be deemed to be filed at the time 

it is received by the Hearing Clerk. 

(d) Computation of time. (1) Each day, 

including Saturdays, Sundays, and legal 

public holidays, shall be included in 

computing the time allowed for filing 

any document or paper. 

(2) That when the time for filing a 

document or paper expires on a 

Saturday, Sunday, or legal public 

holiday, the time allowed for filing the 

document or paper shall be extended to 

include the following business day. 

§ 1.817 Ex parte communications. 

(a) For the purposes of this section, ex 

parte communication means any oral or 

written communication not on the 

public record with respect to which 

reasonable prior notice to all interested 

parties is not given, but which shall not 

include requests for status reports 

(including requests on procedural 

matters) on a proceeding. 

(b) At no stage of the proceeding 

following the issuance of a notice of 

hearing and prior to the issuance of the 

Secretary’s decision thereon shall an 

employee of the Department who is or 

may reasonably be expected to be 

involved in the decision process of the 

proceeding discuss ex parte the merits 

of the proceeding with any person 

having an interest in the proceeding or 

with any representative of such person. 

This prohibition does not include 

communications about: 

(1) Procedural matters and status 

reports. 


jstallworth on DSKBBY8HB2PROD with RULES
51154 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Rules and Regulations 

1Though DEA has used the term ‘‘final order’’ 

with respect to temporary scheduling orders in the 

past, this notification adheres to the statutory 

language of 21 U.S.C. 811(h), which refers to a 

‘‘temporary scheduling order.’’ No substantive 

change is intended. 

2As discussed in a memorandum of 

understanding entered into by the Food and Drug 

Administration (FDA) and the National Institute on 

Drug Abuse (NIDA), the FDA acts as the lead agency 

within the Department of Health and Human 

Service (HHS) in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 58 FR 35460, July 1, 1993. 

(2) The merits of the proceeding if all 

parties known to be interested in the 

proceeding have been given notice and 

an opportunity to participate. A 

memorandum of any such discussion 

shall be included in the record of the 

proceeding. 

(c) No interested person outside the 

Department shall make or knowingly 

cause to be made to an employee of the 

Department who is or may reasonably 

be expected to be involved in the 

decisional process of the proceeding, an 

ex parte communication relevant to the 

merits of the proceeding except as 

provided in paragraph (a) of this 

section. 

(d) If an employee of the Department 

who is or may reasonably be expected 

to be involved in the decisional process 

of the proceeding receives or makes or 

knowingly causes to be made a 

communication prohibited by this 

section, the Department shall place on 

the public record of the proceeding: 

(1) All such written communications; 

(2) Memoranda stating the substance 

of all such oral communications; and 

(3) All written responses, and 

memoranda, stating the substance of all 

oral responses thereto. 

(e) Upon receipt of a communication 

knowingly made or knowingly caused to 

be made by a party in violation of this 

section, the Department may, to the 

extent consistent with the interest of 

justice and the policy of the underlying 

statute, require the party to show cause 

why his claim or interest in the 

proceeding should not be dismissed, 

denied, disregarded, or otherwise 

adversely affected on account of such 

violation. 

(f) This section does not constitute 

authority to withhold information from 

Congress. 

§ 1.818 Additional documents to be filed 

with hearing clerk. 

In addition to the documents or 

papers required or authorized by the 

foregoing provisions of this subpart to 

be filed with the hearing clerk, the 

hearing clerk shall receive for filing and 

shall have custody of all papers, reports, 

records, orders, and other documents 

which relate to the administration of 

any order and which the Secretary is 

required to issue or to approve. 

§ 1.819 Hearing before Secretary. 

(a) The Secretary may act in the place 

and stead of a Judge in any proceeding 

herein. When the Secretary so acts, the 

hearing clerk shall transmit the record 

to the Secretary at the expiration of the 

period provided for the filing of 

proposed findings of fact, conclusions, 

and orders, and the Secretary shall then, 

after due consideration of the record, 

issue the final decision in the 

proceeding. 

(b) The Secretary may issue a 

tentative decision in which event the 

parties shall be afforded an opportunity 

to file exceptions before the issuance of 

the final decision. 

Stephen Alexander Vaden, 

Principal Deputy General Counsel, Office of 

the General Counsel. 

[FR Doc. 2017–23877 Filed 11–2–17; 8:45 am] 

BILLING CODE 3410–90–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–472] 

Schedules of Controlled Substances: 

Temporary Placement of FUB–AMB 

Into Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Temporary amendment; 

temporary scheduling order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this temporary scheduling order to 

schedule the synthetic cannabinoid, 

methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3- 

methylbutanoate [FUB–AMB, MMB– 

FUBINACA, AMB–FUBINACA], and its 

optical, positional, and geometric 

isomers, salts, and salts of isomers into 

schedule I. This action is based on a 

finding by the Administrator that the 

placement of this synthetic cannabinoid 

into schedule I of the Controlled 

Substances Act is necessary to avoid an 

imminent hazard to the public safety. 

As a result of this order, the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule I controlled substances will be 

imposed on persons who handle 

(manufacture, distribute, reverse 

distribute, import, export, engage in 

research, conduct instructional 

activities or chemical analysis, or 

possess), or propose to handle, FUB– 

AMB. 

DATES: This temporary scheduling order 

is effective November 3, 2017, until 

November 4, 2019. If this order is 

extended or made permanent, the DEA 

will publish a document in the Federal 

Register. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Lewis, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

Section 201 of the Controlled 

Substances Act (CSA), 21 U.S.C. 811, 

provides the Attorney General with the 

authority to temporarily place a 

substance into schedule I of the CSA for 

two years without regard to the 

requirements of 21 U.S.C. 811(b) if he 

finds that such action is necessary to 

avoid an imminent hazard to the public 

safety. 21 U.S.C. 811(h)(1). In addition, 

if proceedings to control a substance are 

initiated under 21 U.S.C. 811(a)(1), the 

Attorney General may extend the 

temporary scheduling 1 for up to one 

year. 21 U.S.C. 811(h)(2). 

Where the necessary findings are 

made, a substance may be temporarily 

scheduled if it is not listed in any other 

schedule under section 202 of the CSA, 

21 U.S.C. 812, or if there is no 

exemption or approval in effect for the 

substance under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(FDCA), 21 U.S.C. 355. 21 U.S.C. 

811(h)(1). The Attorney General has 

delegated scheduling authority under 21 

U.S.C. 811 to the Administrator of the 

DEA. 28 CFR 0.100. 

Background 

Section 201(h)(4) of the CSA 21 U.S.C. 

811(h)(4), requires the Administrator to 

notify the Secretary of the Department 

of Health and Human Services (HHS) of 

his intention to temporarily place a 

substance into schedule I of the CSA.2

The Acting Administrator transmitted 

notice of his intent to place FUB–AMB 

into schedule I on a temporary basis to 

the Assistant Secretary for Health by 

letter dated May 19, 2017. The Assistant 

Secretary responded to this notice by 

letter dated June 9, 2017, and advised 

that based on a review by the Food and 

Drug Administration (FDA), there were 

no active investigational new drug 

applications or approved new drug 


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