Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules 35153 

were previously approved by OMB and 

assigned OMB No. 0581–0178, 

Vegetable and Specialty Crops. 

Termination of the reporting 

requirements under the Order would 

reduce the reporting and recordkeeping 

burden on Irish potato handlers in 

Southeastern states and should further 

reduce industry expenses. 

Because handlers would no longer be 

required to file forms with the 

Committee, this proposed rule would 

not impose any additional reporting or 

recordkeeping requirements on either 

small or large entities. 

In addition, USDA has not identified 

any relevant Federal rules that 

duplicate, overlap, or conflict with this 

rule. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

Additionally, interested persons are 

invited to submit information on the 

regulatory and information collection 

impacts of this action on small 

businesses. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: https://

www.ams.usda.gov/rules-regulations/ 

moa/small-businesses. Any questions 

about the compliance guide should be 

sent to Richard Lower at the previously 

mentioned address in the FOR FURTHER

INFORMATION CONTACT section. 

This proposal invites comments on 

the termination of Marketing Order No. 

953, which regulates the handling of 

Irish potatoes grown in Southeastern 

states. All written comments received 

within the 60-day comment period will 

be considered before a final 

determination is made in this matter. 

Based on the foregoing, and pursuant 

to section 608c(16)(A) of the Act and 

§ 953.66 of the Order, USDA is 

considering termination of the Order. If 

USDA decides to terminate the Order, 

trustees would be appointed to 

conclude and liquidate the affairs of the 

Committee and would continue in that 

capacity until discharged by USDA. In 

addition, USDA would notify Congress 

60 days in advance of termination 

pursuant to section 608c(16)(A) of the 

Act. 

List of Subjects in 7 CFR Part 953 

Marketing agreements, Potatoes, 

Reporting and recordkeeping 

requirements. 

PART 953—[REMOVED] 

■ For the reasons set forth in the 

preamble, under the authority of 7 

U.S.C. 601–674, AMS proposes that 7 

CFR part 953 be removed. 

Dated: July 19, 2018. 

Bruce Summers, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2018–15890 Filed 7–24–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 1208 

[Document No. AMS–SC–18–0041] 

Processed Raspberry Promotion, 

Research and Information Order; 

Continuance Referendum 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Notification of referendum 

order. 

SUMMARY: This document directs that a 

referendum be conducted among 

eligible producers of raspberries for 

processing and importers of processed 

raspberries to determine whether they 

favor continuance of the Agricultural 

Marketing Service’s (AMS) regulations 

regarding a national processed raspberry 

research and promotion program. 

DATES: The referendum will be 

conducted from September 10 through 

October 5, 2018. The Department will 

provide the option for ballots to be 

returned electronically. Further details 

will be provided in the ballot 

instructions. Mail ballots must be 

postmarked by October 5. Ballots 

delivered via express mail or email must 

show proof of delivery by no later than 

11:59 p.m. Eastern Time (ET) on 

October 5, 2018, to be counted. 

ADDRESSES: Copies of the processed 

raspberry program may be obtained 

from: Referendum Agent, Promotion 

and Economics Division, Specialty 

Crops Program, AMS, USDA, 1400 

Independence Avenue SW, Room 1406– 

S, Stop 0244, Washington, DC 20250– 

0244, telephone: (202) 720–9915; 

facsimile: (202) 205–2800; or contact 

Hakim Fobia at (202) 720–4835 or via 

electronic mail: Hakim.Fobia@

ams.usda.gov. 

FOR FURTHER INFORMATION CONTACT: 

Hakim Fobia, Marketing Specialist, 

Promotion and Economics Division, 

Specialty Crops Program, AMS, USDA, 

1400 Independence Avenue SW, Room 

1406–S, Stop 0244, Washington, DC 

20250–0244; telephone: (202) 720–9915, 

(202) 720–4835 (direct line); facsimile: 

(202) 205–2800; or electronic mail: 

Hakim.Fobia@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the Commodity Promotion, Research, 

and Information Act of 1996 (7 U.S.C. 

7411–7425) (1996 Act), it is hereby 

directed that a referendum be conducted 

to ascertain whether continuance of the 

Processed Raspberry Promotion, 

Research and Information Order (7 CFR 

part 1208) is favored by eligible 

producers of raspberries for processing 

and importers of processed raspberries. 

The program is authorized under the 

1996 Act. 

The representative period for 

establishing voter eligibility for the 

referendum shall be the period from 

January 1 through December 31, 2017. 

Persons who produced 20,000 pounds 

or more of raspberries for processing in 

the United States or imported 20,000 

pounds or more of processed raspberries 

into the United States during the 

representative period and were subject 

to assessment during that period are 

eligible to vote. Persons who received 

an exemption from assessments 

pursuant to § 1208.53 for the entire 

representative period are ineligible to 

vote. The referendum will be conducted 

from September 10 through October 5, 

2018. The Department will provide the 

option for ballots to be returned 

electronically. Further details will be 

provided in the ballot instructions. 

Section 518 of the 1996 Act (7 U.S.C. 

7417) authorizes continuance referenda. 

Under § 1208.71(b), the U.S. Department 

of Agriculture (USDA) must conduct a 

referendum every seven years to 

determine whether eligible producers of 

raspberries for processing and importers 

of processed raspberries favor 

continuance of the program. A 

referendum also may be held by a 

request of 10 percent or more of all the 

eligible producers and importers, by 

request of the National Processed 

Raspberry Council, which administers 

the program, or by the Secretary of 

Agriculture. In March 2018, USDA 

received a petition requesting a 

referendum from more than the required 

10 percent of eligible entities, thus 

USDA will hold a referendum. The 

program will continue if it is favored by 

a majority of eligible producers and 

importers voting in the referendum. 

In accordance with the Paperwork 

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

chapter 35), the referendum ballot has 

been approved by the Office of 

Management and Budget (OMB) and 

assigned OMB No. 0581–0093. It has 


daltland on DSKBBV9HB2PROD with PROPOSALS
35154 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules 

been estimated that approximately 200 

entities will be eligible to vote in the 

referendum. It will take an average of 15 

minutes for each voter to read the voting 

instructions and complete the 

referendum ballot. 

Referendum Order 

Hakim Fobia, Marketing Specialist, 

and Heather Pichelman, Director, 

Promotion and Economics Division, 

Specialty Crops Program, AMS, USDA, 

Stop 0244, Room 1406–S, 1400 

Independence Avenue SW, Washington, 

DC 20250–0244, are designated as 

referendum agents for this referendum. 

The referendum procedures at 7 CFR 

1208.100 through 1208.108, issued 

pursuant to the 1996 Act, will be used 

to conduct the referendum. 

The referendum agents will mail the 

ballots to be cast in the referendum and 

voting instructions to all known, eligible 

producers and importers prior to the 

first day of the voting period. Persons 

who produced 20,000 pounds or more 

of raspberries for processing in the 

United States or imported 20,000 

pounds or more of processed raspberries 

into the United States during the 

representative period and were subject 

to assessment during that period are 

eligible to vote. Persons who received 

an exemption from assessments 

pursuant to § 1208.53 during the entire 

representative period are ineligible to 

vote. Any eligible producer of 

raspberries for processing or importer of 

processed raspberries who does not 

receive a ballot should contact a 

referendum agent no later than one 

week before the end of the voting 

period. Mail ballots must be postmarked 

by October 5. Ballots delivered via 

express mail or email must show proof 

of delivery by no later than 11:59 p.m. 

ET on October 5, 2018, to be counted. 

List of Subjects in 7 CFR Part 1208 

Administrative practice and 

procedure, Advertising, Consumer 

information, Marketing agreements, 

Raspberry promotion, Reporting and 

recordkeeping requirements. 

Authority: 7 U.S.C. 7411–7425; 7 U.S.C. 

7401. 

Dated: July 20, 2018. 

Bruce Summers, 

Administrator. 

[FR Doc. 2018–15894 Filed 7–24–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2018–N–2689] 

Facilitating Competition and 

Innovation in the Biological Products 

Marketplace; Public Hearing; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing a public hearing on FDA’s 

approach to enhancing competition and 

innovation in the biological products 

marketplace, including by facilitating 

greater availability of biosimilar and 

interchangeable products. 

DATES: The public hearing will be held 

on Tuesday, September 4, 2018, from 9 

a.m. to 5 p.m. The public hearing may 

be extended or may end early, 

depending on the level of public 

participation. Persons seeking to attend 

or to present at the public hearing must 

register by Tuesday, August 14, 2018. 

Section III provides attendance and 

registration information. Electronic or 

written comments will be accepted after 

the public hearing until Friday, 

September 21, 2018. 

ADDRESSES: The public hearing will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for public hearing participants 

(non-FDA employees) is through 

Building 1, where routine security 

check procedures will be performed. For 

parking and security information, please 

refer to https://www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before Friday, September 21, 2018. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of Friday, September 21, 

2018. Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked, and 

identified as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–2689 for ‘‘Facilitating 

Competition and Innovation in the 

Biological Products Marketplace; Public 

Hearing; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 


daltland on DSKBBV9HB2PROD with PROPOSALS