45722 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 

it establishes temporary restricted 

airspace at Fort Sill, OK, enhancing 

safety and accommodating essential 

military training during the U.S. Army’s 

MFIX 2018 exercise being held 

December 4 through 15, 2017. 

History 

On February 23, 2017, the FAA 

published in the Federal Register a 

notice of proposed rulemaking (NPRM) 

(82 FR 11417), Docket No. FAA–2016– 

9591, to establish a temporary restricted 

area designated to support hazardous 

training activities conducted during 

MFIX 2018 within the Fort Sill, OK, 

special use airspace (SUA) complex. 

Interested parties were invited to 

participate in this rulemaking effort by 

submitting written comments on the 

proposal. No comments were received. 

The Rule 

The FAA is amending 14 CFR part 73 

to establish temporary restricted area R– 

5602 in support of MFIX 2018 during 

the period of December 4 through 15, 

2017, to contain hazardous laser 

activities demonstrating counter UAS 

capabilities. To effectively segregate 

nonparticipant air traffic from the 

hazardous activities associated with 

MFIX 2018 at Fort Sill, OK, the R–5602 

lateral boundaries overlie the R–5601A, 

R–5601B, and a portion of R–5601F 

restricted areas and extend 

approximately 8 nautical miles (NM) 

east beyond the R–5601A and R–5601F 

eastern boundaries. R–5602 extends 

upward from 40,000 feet mean sea level 

(MSL) to 60,000 feet MSL, is activated 

daily by a Notice to Airmen (NOTAM), 

and is in effect only during the period 

of December 4 through December 15, 

2017. This rule adds ‘‘daily’’ to the 

‘‘Time of designation’’ for clarity. 

Since R–5602 is a temporary area, it 

will not be depicted on the Dallas–Ft. 

Worth Sectional Aeronautical Chart or 

the IFR Enroute High Altitude Chart, H– 

6. However, a notice and graphic 

depiction will be published on the 

FAA’s SUA Web site at http://

www.faa.gov/sua and in the Notices to 

Airmen Publication (NTAP) available 

online at http://www.faa.gov/air_traffic/ 

publications/notices/. 

Regulatory Notices and Analyses 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore: (1) Is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action of establishing a temporary 

restricted area R–5602 which partially 

overlays portions of the R–5601 

restricted area complex at Fort Sill, OK, 

qualifies for FAA adoption in 

accordance with FAA Order 1050.1F, 

paragraphs 8–2 and 9–2, Adoption of 

Other Agencies’ National 

Environmental Policy Act Documents, 

and Written Re-evaluations, and 

7400.2L, paragraph 32–2–3. The 

purpose of temporarily creating and 

utilizing the temporary Restricted Area 

(RA) is to safely segregate private and 

commercial aircraft from above-thehorizon hazardous laser activities while 

supporting the U.S. Army MFIX 2018 

planned for November 27 through 

December 15, 2017 (the proposed 

temporary RA R–5602 would be active 

from December 4 through 15, 2017). The 

FAA, after conducting an independent 

review and evaluation of the United 

States Army’s August 2017 Final 

Supplemental Environmental 

Assessment for the Temporary Creation 

and Utilization of Restricted Area R– 

5602 at Fort Sill, Oklahoma, has 

determined that the Army’s 

Supplemental EA and its supporting 

documentation adequately assesses and 

discloses the environmental impacts of 

the proposed action, including 

evaluation of the establishment of 

airspace for temporary restricted 

airspace area R–5602. Based on the 

evaluation for potential environmental 

impact in the above-mentioned EA, the 

FAA, as the Cooperating Agency, 

concluded that adoption of the EA for 

the Temporary Creation and Utilization 

of Restricted Area R–5602 is authorized 

in accordance with 40 CFR 1506.3, 

Adoption. Accordingly, FAA adopts the 

Army’s Supplemental EA and takes full 

responsibility for the scope and content 

that address the FAA’s airspace 

establishment action. 

List of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73 as follows: 

PART 73—SPECIAL USE AIRSPACE 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 73.56 Oklahoma (Amended) 

■ 2. § 73.56 is amended as follows: 

* * * * * 

R–5602 Fort Sill, OK [Temporary] 

Boundaries. Beginning at lat. 

34°49′30′′ N., long. 98°08′43′′ W.; to lat. 

34°36′36′′ N., long. 98°08′43′′ W.; to lat. 

34°36′36′′ N., long. 98°17′01′′ W.; to lat. 

34°38′15′′ N., long. 98°17′01′′ W.; to lat. 

34°38′15′′ N., long. 98°37′57′′ W.; to lat. 

34°40′54′′ N., long. 98°37′56′′ W.; to lat. 

34°42′07′′ N., long. 98°37′20′′ W.; to lat. 

34°43′21′′ N., long. 98°36′02′′ W.; to lat. 

34°43′30′′ N., long. 98°35′40′′ W.; to lat. 

34°45′03′′ N., long. 98°29′46′′ W.; to lat. 

34°46′15′′ N., long. 98°25′01′′ W.; to lat. 

34°47′00′′ N., long. 98°17′46′′ W.; to lat. 

34°46′45′′ N., long. 98°17′01′′ W.; to lat. 

34°49′30′′ N., long. 98°17′01′′ W.; to the 

point of beginning. 

Designated altitudes. 40,000 feet MSL 

to 60,000 feet MSL. 

Time of designation. December 4–15, 

2017, daily, by NOTAM. 

Controlling agency. FAA, Fort Worth 

ARTCC. 

Using agency. U.S. Army, 

Commanding General, U.S. Army Fires 

Center of Excellence, Fort Sill, OK. 

Issued in Washington, DC, on September 

22, 2017. 

Rodger A. Dean, Jr., 

Manager, Airspace Policy Group. 

[FR Doc. 2017–20954 Filed 9–29–17; 8:45 am] 

BILLING CODE 4910–13–P 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR Parts 227 and 230 

[Release No. 33–10416] 

Regulation Crowdfunding and 

Regulation A Relief and Assistance for 

Victims of Hurricane Harvey, Hurricane 

Irma, and Hurricane Maria 

AGENCY: Securities and Exchange 

Commission. 

ACTION: Interim final temporary rule. 

SUMMARY: We are adopting interim final 

temporary rules for issuers subject to 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 45723 

1 17 CFR 227.202. 

2 17 CFR 227 et seq. 

3 15 U.S.C. 77a et seq. 

4 17 CFR 230.257. 

5 17 CFR 230.251 through 230.263. 

6 15 U.S.C. 77z–3. 

7See Rule 202(c) of Regulation Crowdfunding. 17 

CFR 227.202(c). 

8See Rule 257(f) of Regulation A. 17 CFR 

230.257(f). 

9SEC Rel. No. 33–9741 (Mar. 25, 2015) [80 FR 

21806 (Apr. 20, 2015)]. 

10These figures overstate the number of issuers 

with obligations to file annual reports under 

Regulation Crowdfunding, because they do not 

exclude issuers that have failed to raise the target 

amount or have exited the reporting regime. 

reporting obligations pursuant to 

Regulation Crowdfunding and 

Regulation A in order to address the 

needs of companies directly or 

indirectly affected by Hurricane Harvey, 

Hurricane Irma, or Hurricane Maria. The 

temporary rules extend the filing 

deadlines for specified reports and 

forms due pursuant to Regulation 

Crowdfunding and Regulation A for 

certain issuers. 

DATES: These rules are effective from 

September 28, 2017, through November 

22, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Zachary O. Fallon, Special Counsel, or 

Amy Reischauer, Special Counsel, 

Office of Small Business Policy, 

Division of Corporation Finance, at 

(202) 551–3460, U.S. Securities and 

Exchange Commission, 100 F Street NE., 

Washington, DC 20549–3628. 

SUPPLEMENTARY INFORMATION: We are 

adopting amendments to Rule 202 1 of 

Regulation Crowdfunding 2 under the 

Securities Act of 1933 (the ‘‘Securities 

Act’’) 3 and Rule 257 4 of Regulation A 5

under the Securities Act as interim final 

temporary rules. 

I. Introduction 

In late August 2017, Hurricane Harvey 

caused catastrophic damage along the 

Texas and Louisiana coast, in early 

September 2017, Hurricane Irma caused 

catastrophic damage to the U.S. Virgin 

Islands, Puerto Rico and the Florida 

coast, and, in mid-September 2017, 

Hurricane Maria caused additional 

catastrophic damage to the U.S. Virgin 

Islands and Puerto Rico. The storms and 

subsequent flooding have displaced 

individuals and businesses and 

disrupted communications and 

transportation across the affected 

regions. We are adopting these interim 

final temporary rules to address the 

needs of companies directly or 

indirectly affected by Hurricane Harvey, 

Hurricane Irma, or Hurricane Maria or 

their respective aftermaths that are 

subject to reporting obligations pursuant 

to Regulation Crowdfunding or 

Regulation A. 

Section 28 of the Securities Act 

provides that the Commission may, by 

rule or regulation, ‘‘conditionally or 

unconditionally exempt any person, 

security, or transaction, or any class or 

classes of persons, securities, or 

transactions, from any provision or 

provisions of this title or of any rule or 

regulation issued under this title, to the 

extent that such exemption is necessary 

or appropriate in the public interest, 

and is consistent with the protection of 

investors.’’ 6

II. Temporary Relief From Filing 

Requirements for Issurers Subject to the 

Reporting Obligations of Regulation 

Crowfunding or Regulation A 

The lack of communications, 

transportation, electricity, facilities, and 

available staff and professional advisors 

as a result of Hurricane Harvey, 

Hurricane Irma, and Hurricane Maria 

could hamper the efforts of companies 

with reporting obligations to meet their 

filing deadlines pursuant to Regulation 

Crowdfunding or Regulation A. At the 

same time, investors have an interest in 

the timely availability of required 

information about these companies. 

While the Commission believes that the 

temporary relief from filing 

requirements provided by the 

amendments to Rule 202 of Regulation 

Crowdfunding 7 and Rule 257 of 

Regulation A 8 is both necessary in the 

public interest and consistent with the 

protection of investors, we remind 

companies that are the subject of the 

relief provided in these interim final 

temporary rules to continue to evaluate 

their obligations to make materially 

accurate and complete disclosures in 

accordance with the anti-fraud 

provisions of the federal securities laws. 

Accordingly, pursuant to Section 28 

of the Securities Act, we are adopting 

interim final temporary rules providing 

that an issuer subject to the reporting 

requirements of either Regulation 

Crowdfunding or Regulation A is 

exempt from any requirement to file 

specified reports or forms with the 

Commission where the conditions 

below are satisfied: 

(a) The issuer is not able to meet a 

filing deadline due to Hurricane Harvey, 

Hurricane Irma, or Hurricane Maria or 

their respective aftermaths; 

(b)(i) For issuers affected by Hurricane 

Harvey, the issuer files with the 

Commission, on or before October 27, 

2017, the report or form required to be 

filed pursuant to either Regulation 

Crowdfunding or Regulation A during 

the period from and including August 

25, 2017 to and including October 26, 

2017; 

(ii) For issuers affected by Hurricane 

Irma, the issuer files with the 

Commission, on or before November 8, 

2017, the report or form required to be 

filed pursuant to either Regulation 

Crowdfunding or Regulation A during 

the period from and including 

September 6, 2017 to and including 

November 7, 2017; or 

(ii) For issuers affected by Hurricane 

Maria, the issuer files with the 

Commission, on or before November 22, 

2017, the report or form required to be 

filed pursuant to either Regulation 

Crowdfunding or Regulation A during 

the period from and including 

September 20, 2017 to and including 

November 21, 2017; and 

(c) In any such report or form, the 

issuer discloses that it is relying on the 

interim final temporary rules and states 

the reasons why, in good faith, it could 

not file such report or form on a timely 

basis. 

For Regulation Crowdfunding, the 

relief includes annual reports on Form 

C–AR, progress updates on Form C–U, 

and termination of reporting on Form 

C–TR. For Regulation A, the relief 

includes post-qualification amendments 

required at least every 12 months after 

the qualification date to include 

updated financial statements, annual 

reports on Form 1–K, semi-annual 

reports on Form 1–SA, special financial 

reports on Forms 1–K or 1–SA, current 

reports on Form 1–U, and exit reports 

on Form 1–Z. 

III. Economic Analysis 

Regulation Crowdfunding and 

Regulation A permit offers and sales of 

securities without registration under the 

Securities Act, subject to certain 

limitations and conditions, including 

compliance with ongoing reporting 

requirements. Based on staff analysis, 

approximately 150 filers publicly filed 

Regulation A offering statements 

between June 19, 2015 (the effective 

date of the most recent Regulation A 

amendments 9) and August 31, 2017 that 

have been qualified as of September 15, 

2017. Approximately 418 issuers 

initiated Regulation Crowdfunding 

offerings with Form C filings between 

May 16, 2016 and August 31, 2017, 

excluding issuers that have withdrawn 

offerings.10 Approximately 28 registered 

intermediaries, including registered 

funding portals and registered brokerdealers, have participated in Regulation 

Crowdfunding offerings with Form C 

filings between May 16, 2016 and 

August 31, 2017, which includes 

offerings that may have been 


jstallworth on DSKBBY8HB2PROD with RULES
45724 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 

11Regulation A issuers that file Form 1–Z to 

suspend reporting are required to disclose the 

number of shareholders of record. 

12Section 2(b) of the Securities Act [15 U.S.C. 

77b(b)] requires the Commission, when engaging in 

rulemaking where it is required to consider or 

determine whether an action is necessary or 

appropriate in the public interest, to consider, in 

addition to the protection of investors, whether the 

action will promote efficiency, competition, and 

capital formation. 

13 5 U.S.C. 553(b)(3)(B). 

14 5 U.S.C. 553(d)(3). 

15This finding also satisfies the requirements of 

5 U.S.C. 808(2), allowing the interim final 

temporary rules to become effective 

notwithstanding the requirement of 5 U.S.C. 801 (if 

a federal agency finds that notice and public 

comment are impractical, unnecessary or contrary 

to the public interest, a rule shall take effect at such 

time as the federal agency promulgating the rule 

determines). The interim final temporary rules also 

do not require analysis under the Regulatory 

Flexibility Act. See 5 U.S.C. 604(a) (requiring a final 

regulatory flexibility analysis only for rules 

required by the APA or other law to undergo notice 

and comment). 

16 44 U.S.C. 3501 et seq. 

subsequently terminated or failed to 

reach the target amount. 

We lack the data to estimate the 

number of investors in Regulation A or 

Regulation Crowdfunding offerings that 

could be affected if issuers rely on the 

relief provided by the interim final 

temporary rules, because information on 

the number of investors is generally not 

required to be disclosed in periodic or 

current reports required under 

Regulation A or in periodic reports or 

progress updates required under 

Regulation Crowdfunding.11

We are mindful of the costs and 

benefits of the interim final temporary 

rules.12 We believe the interim final 

temporary rules will benefit issuers that 

have an obligation to file specified 

reports with the Commission pursuant 

to either Regulation Crowdfunding or 

Regulation A and have been adversely 

affected by Hurricane Harvey, Hurricane 

Irma, or Hurricane Maria or their 

respective aftermaths by permitting 

them to take additional time to meet 

their reporting obligations. We expect 

the relief provided by the interim final 

temporary rules will benefit issuers that, 

absent the relief, would not be able to 

avail themselves of the exemption from 

registration under Regulation 

Crowdfunding or Regulation A because 

the timely filing of required reports is a 

condition to the exemptions. In the 

absence of this relief, issuers could 

incur prohibitively high costs in an 

attempt to meet filing deadlines given 

the lack of communications, 

transportation, electricity, facilities, and 

available staff and professional advisors. 

The requirement for an issuer to 

disclose that it is relying on Rule 202(c) 

of Regulation Crowdfunding or Rule 

257(f) of Regulation A and to state the 

reasons why, in good faith, it could not 

file a report or form on a timely basis 

may impose minimal additional costs 

on issuers availing themselves of this 

relief. However, we believe that these 

minimal costs are justified in light of the 

significant negative implications of not 

being able to rely on the exemption and 

the prohibitively high costs an issuer 

may incur in attempting to file in a 

timely manner. 

We also acknowledge that there may 

be costs imposed on investors, 

intermediaries, and other market 

participants due to delayed access to 

information about offerings conducted 

in reliance on Regulation A and 

Regulation Crowdfunding. Generally, 

reporting requirements strengthen 

investor protection and decrease the 

extent of information asymmetries 

between issuers and investors. Ongoing 

reporting provides investors with 

periodically updated information, 

allowing them to assess investment 

opportunities based on the information 

provided and their level of risk 

tolerance, resulting in better informed 

investment decisions and improved 

allocative efficiency. Given that the 

interim final temporary rules allow for 

delayed reporting for a limited time 

period and only under specified 

conditions, we do not believe such costs 

will be significant. 

The interim final temporary rules will 

not substantially affect competition or 

capital formation. We acknowledge the 

possibility that the interim final 

temporary rules may have a minor 

impact on efficiency. On the one hand, 

as noted above, the delay in reporting 

could marginally affect allocative 

efficiency to the extent that it allows 

information asymmetries between 

investors and issuers to persist for the 

length of time of the delay. On the other 

hand, we expect efficiency gains to the 

extent that the interim final temporary 

rules allow issuers to continue to rely 

on either of the exemptions from 

registration that would not be available 

if one of the required reports that is a 

condition to the exemptions was not 

filed in a timely manner, or to the extent 

the issuers are able to avoid paying a 

premium to service providers in an 

attempt to file in a timely manner by 

delaying reporting during the specified 

relief period. 

As an alternative to the relief 

specified in the interim final temporary 

rules, we could have considered a 

longer or shorter relief period. While a 

shorter period would have reduced the 

costs to investors of asymmetric 

information, it would also reduce the 

benefits of the interim final temporary 

rules to issuers. Similarly, a longer 

period would increase the costs to 

investors. We believe that the 

approximately nine-week delay in the 

interim final temporary rules is 

appropriate given the potential impact 

Hurricane Harvey, Hurricane Irma, or 

Hurricane Maria or their respective 

aftermaths could have on the efforts of 

companies to meet filing deadlines 

pursuant to Regulation Crowdfunding 

and Regulation A. 

IV. Procedural and Other Matters 

The Administrative Procedure Act 

(‘‘APA’’) generally requires an agency to 

publish notice of a rulemaking in the 

Federal Register and provide an 

opportunity for public comment. This 

requirement does not apply, however, if 

the agency ‘‘for good cause finds . . . that 

notice and public procedure are 

impracticable, unnecessary, or contrary 

to the public interest.’’ 13 The APA also 

generally requires that an agency 

publish an adopted rule in the Federal 

Register at least 30 days before it 

becomes effective. This requirement 

does not apply, however, if the agency 

finds good cause for making the rule 

effective sooner.14

Given the temporary nature of the 

relief contemplated by the interim final 

temporary rules and the significant and 

immediate impacts of Hurricane Harvey, 

Hurricane Irma, and Hurricane Maria 

and their aftermaths on issuers in 

affected areas, as discussed above, the 

Commission finds that good cause exists 

to dispense with notice and comment as 

impracticable and unnecessary, and to 

act immediately to amend Rule 202 of 

Regulation Crowdfunding and Rule 257 

of Regulation A.15 Further, the interim 

final temporary rules will not affect the 

burden or cost estimates associated with 

existing collections of information 

under Regulation Crowdfunding and 

Regulation A for purposes of the 

Paperwork Reduction Act of 1995.16

V. Statutory Basis and Text of 

Amendments 

We are adopting amendments to Rule 

202 of Regulation Crowdfunding and 

Rule 257 of Regulation A under the 

authority set forth in the Securities Act 

(15 U.S.C. 77a et seq.), particularly, 

Section 28 thereof. 

List of Subjects 

17 CFR Part 227 

Crowdfunding, Funding portals, 

Intermediaries, Reporting and 

recordkeeping requirements, Securities. 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 45725 

17 CFR Part 230 

Reporting and recordkeeping 

requirements, Securities. 

In accordance with the foregoing, title 

17, chapter II of the Code of Federal 

Regulations is amended as follows: 

PART 227—REGULATION 

CROWDFUNDING, GENERAL RULES 

AND REGULATIONS 

■ 1. The authority citation for part 227 

is revised to read as follows: 

Authority: 15 U.S.C. 77d, 77d–1, 77s, 77z– 

3, 78c, 78o, 78q, 78w, 78mm, and Pub. L. 

112–106, secs. 301–305, 126 Stat. 306 (2012). 

■ 2. Amend § 227.202 by adding 

paragraph (c) to read as follows: 

§ 227.202 Ongoing reporting requirements. 

* * * * * 

(c) Temporary relief from certain 

reporting requirements. (1) An issuer 

that is not able to meet a filing deadline 

for any report or form required to be 

filed by this section (Rule 202), Rule 

203(a)(3) (§ 227.203(a)(3)), or Rule 

203(b) (§ 227.203(b)), as applicable: 

(i) During the period from and 

including August 25, 2017 to and 

including October 26, 2017 due to 

Hurricane Harvey and its aftermath 

shall be deemed to have satisfied the 

filing deadline for such report or form 

if the issuer files such report or form 

with the Commission on or before 

October 27, 2017; 

(ii) During the period from and 

including September 6, 2017 to and 

including November 7, 2017 due to 

Hurricane Irma and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 8, 

2017; or 

(ii) During the period from and 

including September 20, 2017 to and 

including November 21, 2017 due to 

Hurricane Maria and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 22, 

2017. 

(2) In any report or form filed 

pursuant to paragraph (c)(1) of this 

section, the issuer must disclose that it 

is relying on this paragraph (c) (Rule 

202(c) of Regulation Crowdfunding) and 

state the reasons why, in good faith, it 

could not file such report or form on a 

timely basis. 

PART 230—GENERAL RULES AND 

REGULATIONS, SECURITIES ACT OF 

1933 

■ 3. The authority citation for part 230 

continues to read in part as follows: 

Authority: 15 U.S.C. 77b, 77b note, 77c, 

77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, 

78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o–7 note, 

78t, 78w, 78ll(d), 78mm, 80a–8, 80a–24, 80a– 

28, 80a–29, 80a–30, and 80a–37, and Pub. L. 

112–106, sec. 201(a), sec. 401, 126 Stat. 313 

(2012), unless otherwise noted. 

* * * * * 

■ 4. Amend § 230.257 by adding 

paragraph (f) to read as follows: 

§ 230.257 Periodic and current reporting; 

exit report. 

* * * * * 

(f) Temporary relief from ongoing 

reporting requirements. (1) An issuer 

that is not able to meet a filing deadline 

for any report or form required to be 

filed by Rule 252(f)(2)(i) 

(§ 230.252(f)(2)(i)) or this section (Rule 

257), as applicable: 

(i) During the period from and 

including August 25, 2017 to and 

including October 26, 2017 due to 

Hurricane Harvey and its aftermath 

shall be deemed to have satisfied the 

filing deadline for such report or form 

if the issuer files such report or form 

with the Commission on or before 

October 27, 2017; 

(ii) During the period from and 

including September 6, 2017 to and 

including November 7, 2017 due to 

Hurricane Irma and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 8, 

2017; or 

(ii) During the period from and 

including September 20, 2017 to and 

including November 21, 2017 due to 

Hurricane Maria and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 22, 

2017. 

(2) In any report or form filed 

pursuant to paragraph (f)(1) of this 

section, the issuer must disclose that it 

is relying on this paragraph (f) (Rule 

257(f) of Regulation A) and state the 

reasons why, in good faith, it could not 

file such report or form on a timely 

basis. 

By the Commission. 

Dated: September 27, 2017. 

Brent J. Fields, 

Secretary. 

[FR Doc. 2017–21094 Filed 9–28–17; 4:15 pm] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2017–N–5153] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

High Intensity Ultrasound System for 

Prostate Tissue Ablation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the high intensity ultrasound 

system for prostate tissue ablation into 

class II (special controls). The special 

controls that apply to the device type 

are identified in this order and will be 

part of the codified language for the 

high intensity ultrasound system for 

prostate tissue ablation’s classification. 

We are taking this action because we 

have determined that classifying the 

device into class II (special controls) 

will provide a reasonable assurance of 

safety and effectiveness of the device. 

We believe this action will also enhance 

patients’ access to beneficial innovative 

devices, in part by reducing regulatory 

burdens. 

DATES: This order is effective October 2, 

2017. The classification was applicable 

on October 9, 2015. 

FOR FURTHER INFORMATION CONTACT: John 

Baxley, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G210, Silver Spring, 

MD 20993–0002, 301–796–6549, 

john.baxley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

high intensity ultrasound system for 

prostate tissue ablation as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 


jstallworth on DSKBBY8HB2PROD with RULES