This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

67103 

Vol. 79, No. 218 

Wednesday, November 12, 2014 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 1208 

[Document Number AMS–FV–14–0042] 

Processed Raspberry Promotion, 

Research, and Information Order; Late 

Payment and Interest Charges on Past 

Due Assessments 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposal invites 

comments on prescribing late payment 

and interest charges on past due 

assessments under the Processed 

Raspberry Promotion, Research, and 

Information Order (Order). The Order is 

administered by the National Processed 

Raspberry Council (Council) with 

oversight by the U.S. Department of 

Agriculture (USDA). Under the Order, 

assessments are collected from domestic 

producers and importers and used for 

research and promotion projects 

designed to maintain and expand the 

market for processed raspberries. This 

proposal would implement authority 

contained in the Order that allows the 

Council to collect late payment and 

interest charges on past due 

assessments. Three additional changes 

are proposed to reflect current practices 

and update the Order and regulations. 

This action would contribute to 

effective administration of the program. 

DATES: Comments must be received by 

December 12, 2014. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this proposal. Comments 

may be submitted on the Internet at: 

http://www.regulations.gov or to the 

Promotion and Economics Division, 

Fruit and Vegetable Program, AMS, 

USDA, 1400 Independence Avenue 

SW., Room 1406–S, Stop 0244, 

Washington, DC 20250–0244; facsimile: 

(202) 205–2800. All comments should 

reference the document number and the 

date and page number of this issue of 

the Federal Register and will be made 

available for public inspection, 

including name and address, if 

provided, in the above office during 

regular business hours or it can be 

viewed at http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Tarun Harit, Program Management 

Specialist, Promotion and Economics 

Division, Fruit and Vegetable 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 electronic mail: Tarun.Harit@

ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This 

proposal is issued under the Order (7 

CFR part 1208). The Order is authorized 

under the Commodity Promotion, 

Research, and Information Act of 1996 

(1996 Act) (7 U.S.C. 7411–7425). 

Executive Order 12866 and Executive 

Order 13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts and equity). 

Executive Order 13563 emphasizes the 

importance of quantifying both costs 

and benefits, reducing costs, 

harmonizing rules and promoting 

flexibility. This action has been 

designated as a ‘‘non-significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866. Accordingly, 

the Office of Management and Budget 

(OMB) has waived the review process. 

Executive Order 13175 

This action 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. 

Executive Order 12988 

This proposal has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. Section 524 of 

the 1996 Act (7 U.S.C. 7423) provides 

that it shall not affect or preempt any 

other Federal or State law authorizing 

promotion or research relating to an 

agricultural commodity. 

Under section 519 of the 1996 Act (7 

U.S.C. 7418), a person subject to an 

order may file a written petition with 

USDA stating that an order, any 

provision of an order, or any obligation 

imposed in connection with an order, is 

not established in accordance with the 

law, and request a modification of an 

order or an exemption from an order. 

Any petition filed challenging an order, 

any provision of an order, or any 

obligation imposed in connection with 

an order, shall be filed within two years 

after the effective date of an order, 

provision, or obligation subject to 

challenge in the petition. The petitioner 

will have the opportunity for a hearing 

on the petition. Thereafter, USDA will 

issue a ruling on the petition. The 1996 

Act provides that the district court of 

the United States for any district in 

which the petitioner resides or conducts 

business shall have the jurisdiction to 

review a final ruling on the petition, if 

the petitioner files a complaint for that 

purpose not later than 20 days after the 

date of the entry of USDA’s final ruling. 

Background 

This proposal invites comments on 

prescribing late payment and interest 

charges on past due assessments under 

the Order. The Order is administered by 

the Council with oversight by USDA. 

Under the Order, assessments are 

collected from domestic producers and 

importers and used for research and 

promotion projects designed to maintain 

and expand markets for processed 

raspberries. Processed raspberries 

include raspberries that have been 

frozen, dried, pureed, made into juice, 

or altered by mechanical processes. This 

proposal would implement authority 

contained in the Order and the 1996 Act 

that allows the Council to collect late 

payment and interest charges on past 

due assessments. This action was 

unanimously recommended by the 

Council and would contribute to 

effective administration of the program. 

Section 1208.52(a) of the Order 

specifies that the funds to cover the 

Council’s expenses shall be paid from 

assessments on producers and 

importers, donations from persons not 

subject to assessments, and from other 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
67104 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Proposed Rules 

1Noncitrus Fruits and Nuts 2013 Summary, July 

2014, USDA, National Agricultural Statistics 

Service, p. 37. 

funds available to the Council. 

Paragraph (b) specifies that the 

collection of assessments on domestic 

processed raspberries is the 

responsibility of the first receiving 

handler of the raspberries for 

processing. Section 1208.52 (6)(e) 

specifies that ‘‘a late payment charge 

shall be imposed on any handler or 

importer who fails to remit to the 

Council, the total amount for which any 

such first handler or importer is liable 

on or before the due date established by 

the Council. In addition to the late 

payment charge, an interest charge shall 

be imposed on the outstanding amount 

for which the first handler or importer 

is liable. The rate of interest shall be 

prescribed in regulations issued by the 

Secretary.’’ 

The Order was implemented in May 

2012. Assessment collection began in 

September 2012. Domestic assessments 

are due to the Council once annually by 

October 31. Import assessments are 

collected monthly by the U.S. Customs 

and Border Protection (Customs). If 

Customs does not collect the 

assessment, the importer must pay the 

assessment directly to the Council. 

Entities that produce less than 20,000 

pounds of raspberries for processing 

annually or import less than 20,000 

pounds of processed raspberries 

annually are exempt from assessment. 

Assessment funds are used by the 

Council for activities designed to benefit 

all industry members. Thus, it is 

important that all assessed entities pay 

their assessments in a timely manner. 

Entities who fail to pay their 

assessments on time would be able to 

reap the benefits of Council programs at 

the expense of others. In addition, they 

would be able to utilize funds for their 

own use that should otherwise be paid 

to the Council to finance Council 

programs. 

Council Recommendation 

Thus, the Council met on January 15, 

2014, and unanimously recommended 

specifying rates of late payment charges 

and interest on past due assessments in 

the Order’s regulations. Specifically, the 

Council recommended that a late 

payment charge be imposed on any 

handler or importer who fails to make 

timely remittance to the Council of the 

total assessments for which the handler 

or importer is liable. The late payment 

would be imposed on any assessments 

not received within 30 calendar days of 

the date they are due. This would be a 

one-time late payment charge equal to 

10 percent of the assessments due before 

interest charges have accrued. The 

Council also recommended that 1 

percent per month interest on the 

outstanding balance, including any late 

payment and accrued interest, be added 

to any accounts for which payment has 

not been received within 30 calendar 

days after the date assessments are due. 

Interest would continue to accrue 

monthly until the unpaid balance was 

paid to the Council. 

This action would help facilitate 

program administration by providing an 

incentive for entities to remit 

assessments in a timely manner, with 

the intent of creating a fair and equitable 

process among all assessed entities. 

Accordingly, a new subpart C would be 

added to the Order for rules and 

regulations, and a new § 1208.520 

would be added to subpart C. 

This proposal would also make three 

additional changes to the Order. This 

proposed rule would revise the terms 

crop and fiscal years as defined in 

§§ 1208.3 and 1208.7, respectively. The 

crop and fiscal years are changed in the 

Order from the 12-month period April 1 

through March 31 to October 1 through 

September 30. The new time frames 

help facilitate program operations 

because domestic assessments are due 

by October 31, so those funds can be 

used to support current year activities. 

Revising the terms would bring the 

Order in line with current practices. 

This proposal would also change the 

OMB control numbers in §§ 1208.78 and 

1208.108. In § 1208.78, the OMB control 

number 0581–0257 would be omitted 

because it is no longer relevant. In 

§§ 1208.108, the OMB control number 

would be changed from 0581–NEW to 

0581–0093, the control number assigned 

by the OMB. 

Initial Regulatory Flexibility Act 

Analysis 

In accordance with the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601– 

612), AMS is required to examine the 

impact of the proposed rule on small 

entities. Accordingly, AMS has 

considered the economic impact of this 

action on small entities. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

businesses subject to such actions so 

that small businesses will not be 

disproportionately burdened. The Small 

Business Administration defines, in 13 

CFR part 121, small agricultural 

producers as those having annual 

receipts of no more than $750,000 and 

small agricultural service firms (first 

handlers and importers) as those having 

annual receipts of no more than $7.0 

million. 

According to the Council, it is 

estimated that there are 160 producers 

of raspberries for processing and 30 first 

handlers of processed raspberries in the 

United States. Dividing the processed 

raspberry crop value for 2013 reported 

by the National Agricultural Statistics 

Service (NASS) of $60,883,000 1 by the 

number of producers yields an average, 

annual producer revenue of $380,520. It 

is estimated that in 2013, 75 percent of 

the first handlers shipped under $7.0 

million worth of processed raspberries. 

Likewise, based on Customs data, it is 

estimated there are 140 importers of 

processed raspberries. Using 2013 

Customs data, nearly all importers, or 99 

percent, import less than $7.0 million 

worth of processed raspberries annually. 

Thus, the majority of domestic 

producers, first handlers and importers 

of processed raspberries would be 

considered small entities. 

Regarding the value of the 

commodity, as mentioned above, based 

on 2013 NASS data, the value of the 

domestic processed raspberry crop was 

about $61 million. According to 

Customs data, the value of 2013 imports 

was about $65 million. 

This proposal invites comments on 

prescribing late payment and interest 

charges on past due assessments under 

the Order. The Order is administered by 

the Council with oversight by USDA. 

Under the Order, assessments are 

collected from domestic producers of 

raspberries for processing and importers 

of processed raspberries. Processed 

raspberries include raspberries that have 

been frozen, dried, pureed, made into 

juice, or altered by mechanical 

processes. This proposed rule would 

add a new § 1208.520 that would 

specify a late payment charge of 10 

percent of the assessments due and 

interest at a rate of 1 percent per month 

on the outstanding balance, including 

any late payment and accrued interest. 

This section would be included in a 

new Subpart C—Rules and Regulations. 

This action was unanimously 

recommended by the Council and is 

authorized under section 1208.52(e) of 

the Order and section 517(e) of the 1996 

Act. 

Regarding the economic impact of this 

proposed rule on affected entities, this 

action would impose no costs on 

handlers and importers who pay their 

assessments on time. It would merely 

provide an incentive for entities to remit 

their assessments in a timely manner. 

For all entities who are delinquent in 

paying assessments, both large and 

small, the charges would be applied the 

same. As for the impact on the industry 

as a whole, this action would help 

facilitate program administration by 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Proposed Rules 67105 

providing an incentive for entities to 

remit their assessments in a timely 

manner, with the intent of creating a fair 

and equitable process among all 

assessed entities. 

Additionally, as previously 

mentioned, the Order provides for an 

exemption for entities that produce or 

import less than 20,000 pounds of 

processed raspberries annually. About 

140 producers of raspberries for 

processing and 80 importers of 

processed raspberries pay assessments 

under the Order. 

Regarding alternatives, one option to 

the proposed action would be to 

maintain the status quo and not 

prescribe late payment and interest 

charges for past due assessments. 

However, the Council determined that 

implementing such charges would help 

facilitate program administration by 

encouraging entities to pay their 

assessments in a timely manner. The 

Council reviewed rates of late payment 

and interest charges prescribed in other 

research and promotion programs and 

concluded that a 10 percent late 

payment charge and interest at a rate of 

1 percent per month on the outstanding 

balance would be appropriate. 

In accordance with the Paperwork 

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

Chapter 35), the information collection 

and recordkeeping requirements that are 

imposed by the Order have been 

approved under OMB control number 

0581–0093. This proposed rule would 

not result in a change to the information 

collection and recordkeeping 

requirements previously approved and 

would impose no additional reporting 

and recordkeeping burden on domestic 

producers, first handlers, and importers 

of processed raspberries. 

As with all Federal promotion 

programs, reports and forms are 

periodically reviewed to reduce 

information requirements and 

duplication by industry and public 

sector agencies. Finally, USDA has not 

identified any relevant Federal rules 

that duplicate, overlap, or conflict with 

this proposed 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. 

Regarding outreach efforts, the 

Council met on January 15, 2014, and 

unanimously made its recommendation. 

All of the Council’s meetings, including 

meetings held via teleconference, are 

open to the public and interested 

persons are invited to participate and 

express their views. 

We have performed this initial RFA 

regarding the impact of this proposed 

action on small entities and we invite 

comments concerning potential effects 

of this action on small businesses. 

While this proposed rule set forth 

below has not received the approval of 

USDA, it has been determined that it is 

consistent with and would effectuate 

the purposes of the 1996 Act. 

A 30-day comment period is provided 

to allow interested persons to respond 

to this proposal. Thirty-days is deemed 

appropriate because the Council would 

like to implement this incentive as soon 

as possible to facilitate the collection of 

assessments on a timely basis. All 

written comments received in response 

to this proposed rule by the date 

specified will be considered prior to 

finalizing this action. 

List of Subjects in 7 CFR Part 1208 

Administrative practice and 

procedure, Advertising, Consumer 

information, Marketing agreements, 

Raspberry promotion, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, 7 CFR part 1208 is proposed 

to be amended as follows: 

PART 1208—PROCESSED 

RASPBERRY PROMOTION, 

RESEARCH, AND INFORMATION 

ORDER 

■ 1. The authority citation for 7 CFR 

part 1208 continues to read as follows: 

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

7401. 

■ 2. Section 1208.3 is revised to read as 

follows: 

§ 1208.3 Crop year. 

Crop year means the 12-month period 

from October 1 through September 30 or 

such other period approved by the 

Secretary. 

■ 3. Section 1208.7 is revised to read as 

follows: 

§ 1208.7 Fiscal period. 

Fiscal period means the 12-month 

period from October 1 through 

September 30 or such other period as 

approved by the Secretary. 

■ 4. Section 1208.78 is revised to read 

as follows: 

§ 1208.78 OMB control numbers. 

The control numbers assigned to the 

information collection requirements by 

the Office of Management and Budget 

pursuant to the Paperwork Reduction 

Act of 1995, 44 U.S.C. Chapter 35, are 

OMB control number 0505–0001, and 

OMB control number 0581–0093. 

■ 5. Section 1208.108 is revised to read 

as follows: 

§ 1208.108 OMB control number. 

The control number assigned to the 

information collection requirement in 

this subpart by the Office of 

Management and Budget pursuant to the 

Paperwork Reduction Act of 1995, 44 

U.S.C. Chapter 35, is OMB control 

number 0581–0093. 

■ 6. Subpart C—Rules and Regulations 

is added to read as follows: 

Subpart C—Rules and Regulations 

§ 1208.520 Late payment and interest 

charges for past due assessments. 

(1) A late payment charge shall be 

imposed on any handler or importer 

who fails to make timely remittance to 

the Council of the total assessments for 

which such handler or importer is 

liable. The late payment will be 

imposed on any assessments not 

received within 30 calendar days of the 

date they are due. This one-time late 

payment charge shall be 10 percent of 

the assessments due before interest 

charges have accrued. 

(2) In addition to the late payment 

charge, 1 percent per month interest on 

the outstanding balance, including any 

late payment and accrued interest, will 

be added to any accounts for which 

payment has not been received by the 

Council within 30 calendar days after 

the date the assessments are due. Such 

interest will continue to accrue monthly 

until the outstanding balance is paid to 

the Council. 

Dated: November 5, 2014. 

Rex A. Barnes, 

Associate Administrator. 

[FR Doc. 2014–26677 Filed 11–10–14; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. FDA–2014–N–1205] 

Orthopedic Devices; Reclassification 

of Thoracolumbosacral Rigid Pedicle 

Screw Systems; Classification and 

Effective Date of Requirement for 

Premarket Approval for Dynamic 

Stabilization Systems 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing in 

this administrative order to reclassify 

rigid pedicle screw systems, a 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS