45434 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

1 5 U.S.C. 553(d). 

2 44 U.S.C. 3501 et seq. 

1We originally adopted the Filer Manual on April 

1, 1993, with an effective date of April 26, 1993. 

Release No. 33–6986 (April 1, 1993) [58 FR 18638]. 

We implemented the most recent update to the Filer 

Manual on July 17, 2017. See Release No. 33–10385 

(July 6, 2017) [82 FR 35062]. 

2See Rule 301 of Regulation S–T (17 CFR 

232.301). 

3See Release No. 33–10385 in which we 

implemented revisions to reflect EDGAR Release 

17.2. For additional history of EDGAR Filer Manual 

revisions, please see the citations therein. 

make this rulemaking effective upon 

publication in the Federal Register.1

III. Paperwork Reduction Act 

The Commission may not conduct or 

sponsor, and a respondent is not 

required to respond to, a collection of 

information contained in a rulemaking 

unless the information collection 

displays a currently valid control 

number issued by the Office of 

Management and Budget (‘‘OMB’’) 

pursuant to the Paperwork Reduction 

Act.2 This rulemaking contains no 

collection of information for which the 

Commission is obligated to obtain a 

control number from OMB. 

List of Subjects in 17 CFR Part 38 

Commodity futures, Reporting and 

recordkeeping requirements. 

For the reasons stated in the 

preamble, the Commodity Futures 

Trading Commission amends 17 CFR 

part 38 as follows: 

PART 38—DESIGNATED CONTRACT 

MARKETS 

■ 1. The authority citation for part 38 

continues to read as follows: 

Authority: 7 U.S.C. 1a, 2, 6, 6a, 6c, 6d, 6e, 

6f, 6g, 6i, 6j, 6k, 6l, 6m, 6n, 7, 7a–2, 7b, 

7b–1, 7b–3, 8, 9, 15, and 21, as amended by 

the Dodd-Frank Wall Street Reform and 

Consumer Protection Act, Pub. L. 111–203, 

124 Stat. 1376. 

■ 2. In § 38.1051, add paragraph (n)(3) 

to read as follows: 

§ 38.1051 General requirements. 

* * * * * 

(n) * * * 

(3) Delegation of authority. The 

Commission hereby delegates, until it 

orders otherwise, to the Director of the 

Division of Market Oversight or such 

other employee or employees as the 

Director may designate from time to 

time, the authority to provide each 

designated contract market with its 

percentage of the total annual trading 

volume of all designated contract 

markets regulated by the Commission, 

as set forth in paragraph (n)(2) of this 

section. The Director of the Division of 

Market Oversight may submit to the 

Commission for its consideration any 

matter that has been delegated pursuant 

to this section. Nothing in this section 

prohibits the Commission, at its 

election, from exercising the authority 

delegated in this section. 

Issued in Washington, DC, on September 

26, 2017, by the Commission. 

Christopher J. Kirkpatrick, 

Secretary of the Commission. 

Note: The following appendix will not 

appear in the Code of Federal Regulations. 

Appendix to Commission Delegated 

Authority Provisions for Designated 

Contract Markets’ System Safeguards 

Requirements—Commission Voting 

Summary 

On this matter, Chairman Giancarlo and 

Commissioners Bowen, Quintenz, and 

Behnam voted in the affirmative. No 

Commissioner voted in the negative. 

[FR Doc. 2017–20924 Filed 9–28–17; 8:45 am] 

BILLING CODE 6351–01–P 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR Part 232 

[Release Nos. 33–10413; 34–81592; 39– 

2518; IC–32818] 

Adoption of Updated EDGAR Filer 

Manual 

AGENCY: Securities and Exchange 

Commission. 

ACTION: Final rule. 

SUMMARY: The Securities and Exchange 

Commission (the ‘‘Commission’’) is 

adopting revisions to the Electronic Data 

Gathering, Analysis, and Retrieval 

System (‘‘EDGAR’’) Filer Manual and 

related rules to reflect updates to the 

EDGAR system. The EDGAR system is 

scheduled to be upgraded on September 

11, 2017. 

DATES: Effective September 29, 2017, 

except that amendatory instruction 4 to 

§ 232.301 is effective June 1, 2018. The 

incorporation by reference of the 

EDGAR Filer Manual is approved by the 

Director of the Federal Register as of 

September 29, 2017. 

FOR FURTHER INFORMATION CONTACT: In 

the Division of Investment Management, 

for questions concerning Forms N– 

PORT and N–CEN, contact Heather 

Fernandez at (202) 551–6708; in the 

Division of Corporation Finance, for 

questions concerning Forms S–1, S–3, 

S–4, S–8, S–11, F–1, F–3, F–4, 8–K, 10, 

10–K, 10–Q, 20–F, and 40–F, contact 

Heather Mackintosh at (202) 551–8111; 

in the Office of Financial Management, 

for questions about negative account 

balances, contact Andrew Grimaldi at 

(202) 551–7304. 

SUPPLEMENTARY INFORMATION: We are 

adopting an updated EDGAR Filer 

Manual, Volume I and Volume II. The 

Filer Manual describes the technical 

formatting requirements for the 

preparation and submission of 

electronic filings through the EDGAR 

system.1 It also describes the 

requirements for filing using 

EDGARLink Online and the Online 

Forms/XML Web site. 

The revisions to the Filer Manual 

reflect changes within Volume I, 

entitled EDGAR Filer Manual, Volume I: 

‘‘General Information,’’ Version 29 

(September 2017), and Volume II, 

entitled EDGAR Filer Manual, Volume 

II: ‘‘EDGAR Filing,’’ Version 43 

(September 2017). The updated manual 

will be incorporated by reference into 

the Code of Federal Regulations. 

The Filer Manual contains all the 

technical specifications for filers to 

submit filings using the EDGAR system. 

Filers must comply with the applicable 

provisions of the Filer Manual in order 

to assure the timely acceptance and 

processing of filings made in electronic 

format.2 Filers may consult the Filer 

Manual in conjunction with our rules 

governing mandated electronic filing 

when preparing documents for 

electronic submission.3

The EDGAR system will be upgraded 

to Release 17.3 on September 11, 2017, 

and will introduce the following 

changes: 

In Release No. 33–10231 (October 13, 

2016) [81 FR 81870], the Commission 

adopted changes to the reporting 

requirements for investment companies. 

Among the changes was the adoption of 

Form N–PORT, which requires 

investment companies to report 

information about portfolio holdings 

monthly in a structured format. EDGAR 

Release 17.3 will provide a pilot 

program whereby filers may submit 

TEST versions of the following form 

types: 

• Public Monthly Portfolio 

Investments Report on Form N–PORT 

(NPORT–P). 

• Amended Public Monthly Portfolio 

Investments Report on Form N–PORT 

(NPORT–P/A). 

• Non-Public Monthly Portfolio 

Investments Report on Form N–PORT 

(NPORT–NP). 

• Amended Non-Public Monthly 

Portfolio Investments Report on Form 

N–PORT (NPORT–NP/A). 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45435 

4 5 U.S.C. 553(b)(A). 

5 5 U.S.C. 601–612. 

6 5 U.S.C. 553(d)(3). 

7 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a). 

8 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll. 

9 15 U.S.C. 77sss. 

10 15 U.S.C. 80a–8, 80a–29, 80a–30, and 80a–37. 

• Portfolio Holdings Exhibit to Form 

N–PORT (NPORT–EX). 

• Amended Portfolio Holdings 

Exhibit to Form N–PORT (NPORT– 

EX/A). 

In Release No. 33–10231 the 

Commission also adopted new Form 

N–CEN, which will require investment 

companies, other than face amount 

certificate companies, to provide an 

annual report of census-type 

information in a structured format. 

EDGAR Release 17.3 will permit 

investment companies to submit TEST 

versions of the following form types: 

• Annual Report for Registered 

Investment Companies (N–CEN). 

• Amendment to Annual Report for 

Registered Investment Companies 

(N–CEN/A). 

• EDGAR Release 17.3 will also 

introduce two additional submission 

form types: 

• Notice under Exchange Act Rule 

12b–25 of the inability to timely file 

Form N–CEN (NT–NCEN). 

• Amendment to Notice under 

Exchange Act Rule 12b–25 of the 

inability to timely file Form N–CEN 

(NT–NCEN/A). 

EDGAR will only accept TEST 

submissions of form types NPORT–P, 

NPORT–P/A, NPORT–NP, NPORT– 

NP/A, NPORT–EX, NPORT–EX/A, N– 

CEN, and N–CEN/A from September 11, 

2017, through December 31, 2017, and 

then again from March 1, 2018 until 

May 31, 2018. Beginning June 1, 2018, 

EDGAR will accept both TEST and LIVE 

submissions of form types NPORT–P, 

NPORT–P/A, NPORT–NP, NPORT– 

NP/A, NPORT–EX, NPORT–EX/A, N– 

CEN, and N–CEN/A. The EDGAR Filer 

Manual will be revised to provide 

instructions for making TEST N–PORT 

and N–CEN filings. Corresponding 

changes will be made to Chapter 8 

(Preparing and Transmitting Online 

Submissions) of the EDGAR Filer 

Manual, Volume II: ‘‘EDGAR Filing.’’ 

In Release No. 33–10332 (March 31, 

2017) [82 FR 17545] the Commission 

made rule and form changes to 

effectuate inflation adjustments and 

other technical amendments required 

under Titles I & III of the JOBS Act. 

Among the technical changes was the 

revision to Commission forms so that 

registrants can designate whether they 

are an Emerging Growth Company and 

whether they have elected not to use the 

extended transition period for 

complying with any new or revised 

financial accounting standards. 

Updates are being made in EDGAR 

Release 17.3 so that the same 

disclosures can be provided for any coregistrants. The following EDGARLink 

Online submission form types will be 

revised to reflect the two fields for each 

co-registrant: S–1, S–1/A, S–3, S–3/A, 

S–4, S–4/A, S–8, S–11, S–11/A, F–1, 

F–1/A, F–3, F–3/A, F–4, F–4/A, 10–12B, 

10–12B/A, 10–12G, 10–12G/A, 8–K, 

8–K/A, 8–K12B, 8–K12B/A, 8–K12G3, 

8–K12G3/A, 8–K15D5, 8–K15D5/A, 

10–Q, 10–Q/A, 10–QT, 10–QT/A, 10–K, 

10–K/A, 10–KT, 10–KT/A, 20–F, 20–F/ 

A, 20FR12B, 20FR12B/A, 20FR12G, 

20FR12G/A, 40–F, 40–F/A, 40FR12B, 

40FR12B/A, 40FR12G, and 40FR12G/A. 

Corresponding changes will be made to 

Chapter 7 (Preparing and Transmitting 

EDGARLink Online Submissions) of the 

EDGAR Filer Manual, Volume II: 

‘‘EDGAR Filing.’’ 

The ‘‘Balance Information’’ and 

‘‘Account Activity Statement’’ screen of 

the EDGAR Filing Web site will be 

updated with the following text: ‘‘A 

negative balance amount indicates that 

money is owed to the SEC and the 

account is past due. For more 

information on making filing fee 

payments, see https://www.sec.gov/ 

paymentoptions.’’ Corresponding 

changes will be made to Chapter 5 

(Maintenance of Company Data) of the 

EDGAR Filer Manual Volume I: 

‘‘General Information.’’ 

Along with the adoption of the Filer 

Manual, we are amending Rule 301 of 

Regulation S–T to provide for the 

incorporation by reference into the Code 

of Federal Regulations of today’s 

revisions. This incorporation by 

reference was approved by the Director 

of the Federal Register in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

The updated EDGAR Filer Manual 

will be available for Web site viewing 

and printing; the address for the Filer 

Manual is https://www.sec.gov/info/ 

edgar/edmanuals.htm. You may also 

obtain paper copies of the EDGAR Filer 

Manual from the following address: 

Public Reference Room, U.S. Securities 

and Exchange Commission, 100 F Street 

NE., Washington, DC 20549, on official 

business days between the hours of 10 

a.m. and 3 p.m. 

Since the Filer Manual and the 

corresponding rule changes relate solely 

to agency procedures or practice, 

publication for notice and comment is 

not required under the Administrative 

Procedure Act (‘‘APA’’).4 It follows that 

the requirements of the Regulatory 

Flexibility Act 5 do not apply. 

The effective date for the updated 

Filer Manual and the rule amendments 

is September 29, 2017. In accordance 

with the APA,6 we find that there is 

good cause to establish an effective date 

less than 30 days after publication of 

these rules. The EDGAR system upgrade 

to Release 17.3 is scheduled to become 

available on September 11, 2017. The 

Commission believes that establishing 

an effective date less than 30 days after 

publication of these rules is necessary to 

coordinate the effectiveness of the 

updated Filer Manual with these system 

upgrades. 

Statutory Basis 

We are adopting the amendments to 

Regulation S–T under Sections 6, 7, 8, 

10, and 19(a) of the Securities Act of 

1933,7 Sections 3, 12, 13, 14, 15, 23, and 

35A of the Securities Exchange Act of 

1934,8 Section 319 of the Trust 

Indenture Act of 1939,9 and Sections 8, 

30, 31, and 38 of the Investment 

Company Act of 1940.10

List of Subjects in 17 CFR Part 232 

Incorporation by reference, Reporting 

and recordkeeping requirements, 

Securities. 

Text of the Amendment 

In accordance with the foregoing, title 

17, chapter II of the Code of Federal 

Regulations is amended as follows: 

PART 232—REGULATION S–T— 

GENERAL RULES AND REGULATIONS 

FOR ELECTRONIC FILINGS 

■ 1. The authority citation for part 232 

continues to read in part as follows: 

Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 

77s(a), 77z–3, 77sss(a), 78c(b), 78l, 78m, 78n, 

78o(d), 78w(a), 78ll, 80a–6(c), 80a–8, 80a–29, 

80a–30, 80a–37, and 7201 et seq.; and 18 

U.S.C. 1350, unless otherwise noted. 

* * * * * 

■ 2. The amendment to § 232.301 

published November 18, 2016 (81 FR 

82019) is withdrawn. 

■ 3. Effective September 29, 2017, 

§ 232.301 is revised to read as follows: 

§ 232.301 EDGAR Filer Manual. 

Filers must prepare electronic filings 

in the manner prescribed by the EDGAR 

Filer Manual, promulgated by the 

Commission, which sets fort the 

technical formatting requirements for 

electronic submissions. The 

requirements for becoming an EDGAR 

Filer and updating company data are set 

forth in the updated EDGAR Filer 

Manual, Volume I: ‘‘General 

Information,’’ Version 29 (September 

2017). The requirements for filing on 

EDGAR are set forth in the updated 


asabaliauskas on DSKBBXCHB2PROD with RULES
45436 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

1As 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. 58 FR 35460, July 1, 1993. 

2http://www.accessdata.fda.gov/drugsatfda_

docs/appletter/2017/208854Orig1s000ltr.pdf (last 

accessed 04/13/2017). 

EDGAR Filer Manual, Volume II: 

‘‘EDGAR Filing,’’ Version 43 (September 

2017). Additional provisions applicable 

to Form N–SAR filers are set forth in the 

EDGAR Filer Manual, Volume III: ‘‘N– 

SAR Supplement,’’ Version 6 (January 

2017). All of these provisions have been 

incorporated by reference into the Code 

of Federal Regulations, which action 

was approved by the Director of the 

Federal Register in accordance with 5 

U.S.C. 552(a) and 1 CFR part 51. You 

must comply with these requirements in 

order for documents to be timely 

received and accepted. The EDGAR 

Filer Manual is available for Web site 

viewing and printing; the address for 

the Filer Manual is https://www.sec.gov/ 

info/edgar/edmanuals.htm. You can 

obtain paper copies of the EDGAR Filer 

Manual from the following address: 

Public Reference Room, U.S. Securities 

and Exchange Commission, 100 F Street 

NE., Washington, DC 20549, on official 

business days between the hours of 

10:00 a.m. and 3:00 p.m. You can also 

inspect the document at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

call 202–741–6030, or go to: https://

www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

§ 232.301 [Amended] 

■ 4. Effective June 1, 2018, amend 

§ 232.301 by removing the fourth 

sentence. 

By the Commission. 

Dated: September 13, 2017. 

Brent J. Fields, 

Secretary. 

[FR Doc. 2017–20654 Filed 9–28–17; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–468] 

Schedules of Controlled Substances: 

Removal of Naldemedine From Control 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration removes the substance 

naldemedine (4R,4aS,7aR,12bS)-3- 

(cyclopropylmethyl)-4a,7,9-trihydroxyN-(2-(3-phenyl-1,2,4-oxadiazol-5- 

yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro1H-4,12-methanobenzofuro[3,2- 

e]isoquinoline-6-carboxamide) 

including its salts from the schedules of 

the Controlled Substances Act. Prior to 

the effective date of this rule, 

naldemedine was a schedule II 

controlled substance because it can be 

derived from opium alkaloids. This 

action removes the regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to controlled 

substances, including those specific to 

schedule II controlled substances, on 

persons who handle (manufacture, 

distribute, reverse distribute, dispense, 

conduct research, import, export, or 

conduct chemical analysis) or propose 

to handle naldemedine. 

DATES: The effective date of this rule is 

September 29, 2017. 

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 

Pursuant to 21 U.S.C. 811(a)(2), the 

Attorney General may, by rule, ‘‘remove 

any drug or other substance from the 

schedules if he finds that the drug or 

other substance does not meet the 

requirements for inclusion in any 

schedule.’’ The Attorney General has 

delegated scheduling authority under 21 

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

Drug Enforcement Administration 

(DEA). 28 CFR 0.100. 

The Controlled Substances Act (CSA) 

provides that proceedings for the 

issuance, amendment, or repeal of 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) 1, or (3) on the petition 

of any interested party. 21 U.S.C. 811(a). 

This action was initiated at the request 

of the Acting Assistant Secretary for 

Health of the HHS and by a petition by 

the drug sponsor to DEA to remove 

naldemedine from the list of scheduled 

controlled substances of the CSA, and is 

supported by, inter alia, a 

recommendation from the Assistant 

Secretary of the HHS and an evaluation 

of all relevant data by the DEA. This 

action removes the regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to controlled 

substances, including those specific to 

schedule II controlled substances, on 

persons who handle or propose to 

handle naldemedine. 

Background 

Naldemedine, known chemically as 

(4R,4aS,7aR,12bS)-3- 

(cyclopropylmethyl)-4a,7,9-trihydroxyN-(2-(3-phenyl-1,2,4-oxadiazol-5- 

yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro1H-4,12-methanobenzofuro[3,2- 

e]isoquinoline-6-carboxamide, is an 

opium alkaloid derivative. Naldemedine 

is a high-affinity antagonist at the mu, 

kappa, and delta opioid receptors. On 

March 23, 2016, a new drug application 

(NDA) was submitted by Shionogi Inc. 

(Sponsor) to the Food and Drug 

Administration (FDA) for approval of 

naldemedine for the treatment of opioid 

induced constipation in patients with 

chronic non-cancer pain. The FDA 

approved naldemedine for marketing on 

March 23, 2017, under the trade name 

Symproic® (0.2 mg tablets).2

Naldemedine is indicated for the 

treatment of opioid-induced 

constipation (OIC) in adults with 

chronic non-cancer pain. Opioidinduced constipation is caused by an 

activation of mu-opioid receptors in the 

gastrointestinal tract. Naldemedine, a 

peripheral acting mu-opioid antagonist, 

can prevent OIC. 

DEA and HHS Eight Factor Analyses 

On June 8, 2016, the DEA received a 

petition from the drug sponsor 

requesting that the DEA amend 21 CFR 

1308.12(b)(1) to exclude naldemedine as 

a schedule II substance from the 

Controlled Substances Act (CSA). The 

petitioner stated that naldemedine is a 

potent peripherally acting mu-opioid 

receptor antagonist. In accordance with 

21 CFR 1308.43(c), the DEA accepted 

the petition for filing on August 5, 2016. 

On March 22, 2017, the HHS provided 

the DEA with a scientific and medical 

evaluation document prepared by the 

FDA entitled ‘‘Basis for the 

Recommendation to Decontrol 

Naldemedine and its Salts from the 

Controlled Substances Act.’’ After 

considering the eight factors in 21 

U.S.C. 811(c), including consideration 

of the substance’s abuse potential, 

legitimate medical use, and dependence 

liability, the Assistant Secretary of the 

HHS recommended that naldemedine 


asabaliauskas on DSKBBXCHB2PROD with RULES