64296 Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 

Dated: December 11, 2018. 

Bruce Summers, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2018–27140 Filed 12–13–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 956 

[Doc. No. AMS–SC–18–0028; SC–18–956–1] 

Sweet Onions Grown in the Walla 

Walla Valley of Southeast Washington 

and Northeast Oregon; Proposed 

Amendments to Marketing Order 956 

and Referendum Order 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule and referendum 

order. 

SUMMARY: This document proposes 

amendments to Marketing Order No. 

956, which regulates the handling of 

sweet onions grown in the Walla Walla 

Valley of Southeast Washington and 

Northeast Oregon. The Walla Walla 

Sweet Onion Marketing Committee 

(Committee) recommended changing the 

Committee’s size, quorum, and voting 

requirements. The Committee also 

recommended changing the term of 

office and staggered term limits so that 

the term of office for producers and 

handlers would be two fiscal periods 

instead of three fiscal periods, and onehalf instead of one-third of the producer 

and handler member terms would 

expire every year. 

DATES: The referendum will be 

conducted from December 17, 2018, 

through December 31, 2018. The 

representative period for the referendum 

is June 1, 2017, through May 31, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Geronimo Quinones, Marketing 

Specialist, or Patty Bennett, Director, 

Marketing Order and Agreement 

Division, Specialty Crops Program, 

AMS, USDA, 1400 Independence 

Avenue SW, Stop 0237, Washington, DC 

20250–0237; Telephone: (202) 720– 

2491, Fax: (202) 720–8938, or Email: 

Geronimo.Quinones@usda.gov or 

Patty.Bennett@usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Richard Lower, 

Marketing Order and Agreement 

Division, Specialty Crops Program, 

AMS, USDA, 1400 Independence 

Avenue SW, STOP 0237, Washington, 

DC 20250–0237; Telephone: (202) 720– 

2491, Fax: (202) 720–8938, or Email: 

Richard.Lower@usda.gov. 

SUPPLEMENTARY INFORMATION: This 

proposal, pursuant to 5 U.S.C. 553, 

proposes amendments to regulations 

issued to carry out a marketing order as 

defined in 7 CFR 900.2(j). This proposal 

is issued under Marketing Order No. 

956, as amended (7 CFR part 956), 

regulating the handling of sweet onions 

grown in the Walla Walla Valley of 

Southeast Washington and Northeast 

Oregon. Part 956 (referred to as the 

‘‘Order’’) is effective under the 

Agricultural Marketing Agreement Act 

of 1937, as amended (7 U.S.C. 601–674), 

hereinafter referred to as the ‘‘Act.’’ The 

Committee locally administers the 

Order and is comprised of sweet onion 

producers and handlers operating 

within the area of production and a 

public member. 

Section 608c(17) of the Act and the 

applicable rules of practice and 

procedure governing the formulation of 

marketing agreements and orders (7 CFR 

part 900) authorizes amendment of the 

Order through this informal rulemaking 

action. 

The Department of Agriculture 

(USDA) is issuing this rule in 

conformance with Executive Orders 

13563 and 13175. This action falls 

within a category of regulatory actions 

that the Office of Management and 

Budget (OMB) exempted from Executive 

Order 12866 review. Additionally, 

because this proposed rule does not 

meet the definition of a significant 

regulatory action, it does not trigger the 

requirements contained in 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). 

This proposal has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule is not intended 

to have retroactive effect. This rule shall 

not be deemed to preclude, preempt, or 

supersede any State program covering 

sweet onions grown in the Walla Walla 

Valley of Southeast Washington and 

Northeast Oregon. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 

with USDA a petition stating that the 

order, any provision of the order, or any 

obligation imposed in connection with 

the order is not in accordance with law 

and request a modification of the order 

or to be exempted therefrom. A handler 

is afforded the opportunity for a hearing 

on the petition. After the hearing, USDA 

would rule on the petition. The Act 

provides that the district court of the 

United States in any district in which 

the handler is an inhabitant, or has his 

or her principal place of business, has 

jurisdiction to review USDA’s ruling on 

the petition, provided an action is filed 

no later than 20 days after the date of 

entry of the ruling. 

Section 1504 of the Food, 

Conservation, and Energy Act of 2008 

(2008 Farm Bill) (Pub. L. 110–246) 

amended section 608c(17) of the Act, 

which in turn required the addition of 

supplemental rules of practice to 7 CFR 

part 900 (73 FR 49307; August 21, 

2008). The amendment of section 

608c(17) of the Act and the 

supplemental rules of practice authorize 

the use of informal rulemaking (5 U.S.C. 

553) to amend Federal fruit, vegetable, 

and nut marketing agreements and 

orders. USDA may use informal 

rulemaking to amend marketing orders 

based on the nature and complexity of 

the proposed amendments, the potential 

regulatory and economic impacts on 

affected entities, and any other relevant 

matters. 

AMS has considered these factors and 

has determined that the amendments 

proposed are not unduly complex and 

the nature of the proposed amendments 

is appropriate for utilizing the informal 

rulemaking process to amend the Order. 

The proposed amendments were 

unanimously recommended by the 

Committee following deliberations at 

two public meetings held on November 

14, 2017, and March 3, 2018. The 

proposals would amend the Order by 

changing the Committee’s size, quorum, 

and voting requirements. This action 

would also change the term of office and 

staggered term limits so that the term of 

office for producers and handlers would 

be two fiscal periods instead of three 

fiscal periods, and one-half instead of 

one-third of the producer and handler 

member terms would expire every year. 

If the proposed amendments are 

finalized, the Committee would hold 

nominations for producer and handler 

member and alternate positions. All the 

Committee’s producer and handler 

positions would be filled by new 

nominations. Members and alternates 

who are currently serving could be 

nominated to serve on the new 

Committee. 

A proposed rule soliciting comments 

on the proposed amendments was 

issued on July 19, 2018, and published 

in the Federal Register on July 24, 2018 

(83 FR 34953). One comment in support 

of the amendments was received. AMS 

will conduct a producer referendum to 

determine support for the proposed 


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Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 64297 

amendments. If appropriate, a final rule 

will then be issued to effectuate the 

amendments favored by producers in 

the referendum. 

Proposal 1—Reduce Committee Size 

Section 956.20 provides that the 

Committee consists of ten members, six 

of whom shall be producers, three of 

whom shall be handlers, and one public 

member. This proposal would amend 

§ 956.20 by reducing the size of the 

Committee from ten to seven members, 

four of whom shall be producers, two of 

whom shall be handlers, and one public 

member. The requirement that each 

member have an alternate with the same 

qualifications as the member would 

remain unchanged. 

Since promulgation of the Order in 

1995, the number of Walla Walla sweet 

onion producers and handlers operating 

in the industry has decreased, which 

makes it difficult to find enough 

members and alternates to fill all 

positions on the Committee. Decreasing 

the Committee’s size from ten members 

to seven members would make it more 

reflective of today’s industry. Reducing 

the size of the Committee would enable 

it to more effectively fulfill membership 

and quorum requirements. These 

changes should help the Committee 

streamline its operations and increase 

its effectiveness. 

Proposal 2—Revise Term of Office and 

Staggered Term Limits 

Section 956.21 requires Committee 

members and their alternates to serve 

for three fiscal periods in staggered 

terms with one-third of the terms 

expiring each year. 

This proposal would change § 956.21 

by revising the terms of office for the 

producer and handler members from 

three fiscal periods to two fiscal periods 

beginning on June 1 so that one-half of 

the Committee membership changes 

every year. The staggered terms would 

also change so that one-half instead of 

one-third of the producer and handler 

member terms expire every year. The 

proposed term limit changes would only 

apply to producer and handler 

members; the public member term 

would remain at three years. 

Proposal 3—Revise Quorum and Voting 

Requirements 

Currently, Section 956.28(a) states 

that six members of the Committee shall 

constitute a quorum, and six concurring 

votes shall be required to pass any 

motion or approve any Committee 

action, except that recommendations 

made pursuant to § 956.61 shall require 

seven concurring votes. 

The proposed changes would modify 

§ 956.28 to state that four rather than six 

members would constitute a quorum, 

and four rather than six concurring 

votes would be required to pass any 

motion or approve any Committee 

action, except for recommendations 

made pursuant to § 956.61, which 

would require five rather than seven 

concurring votes. These changes would 

help streamline the Committee’s 

operations and increase its 

effectiveness. 

Final Regulatory Flexibility Analysis 

Pursuant to the requirements set forth 

in the Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612), AMS has considered 

the economic impact of this action on 

small entities. Accordingly, AMS has 

prepared this final regulatory flexibility 

analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

businesses subject to such actions in 

order that small businesses will not be 

unduly or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. 

There are eight handlers of Walla 

Walla sweet onions subject to regulation 

under the Order and approximately 15 

producers in the regulated production 

area. Small agricultural service firms are 

defined by the Small Business 

Administration (SBA) as those having 

annual receipts of less than $7,500,000, 

and small agricultural producers are 

defined as those having annual receipts 

of less than $750,000 (13 CFR 121.201). 

The Committee reported that 

approximately 390,000 50-pound bags 

or equivalents of Walla Walla sweet 

onions were shipped into the fresh 

market in 2017. Based on information 

reported by USDA’s Market News 

Service, the average 2017 marketing 

year f.o.b. shipping point price for the 

Walla Walla sweet onions was $14.90 

per 50-pound equivalent. Multiplying 

the $14.90 average price by the 

shipment quantity of 390,000 50-pound 

equivalents yields an annual crop 

revenue estimate of $5,811,000. The 

average annual revenue for each of the 

eight handlers is therefore calculated to 

be $726,375 ($5,811,000 divided by 

eight), which is less than the SBA 

threshold of $7,500,000. Consequently, 

all the Walla Walla sweet onion 

handlers could be classified as small 

entities. 

In addition, based on information 

provided by the National Agricultural 

Statistics Service (NASS), the average 

producer price for Walla Walla sweet 

onions for the 2012 through 2016 

marketing years is $15.27 per 50-pound 

equivalent. NASS has not released data 

regarding the 2017 marketing year at 

this time. Multiplying the 2012–2016 

marketing year average price of $15.27 

by the 2017 marketing year shipments of 

390,000 50-pound equivalents yields an 

annual crop revenue estimate of 

$5,955,300. The estimated average 

annual revenue for each of the 15 

producers is therefore calculated to be 

approximately $397,020 ($5,955,300 

divided by 15), which is less than the 

SBA threshold of $750,000. In view of 

the foregoing, the majority of Walla 

Walla sweet onion producers and all of 

the Walla Walla sweet onion handlers 

may be classified as small entities. 

The proposed amendments would 

change the Committee’s size, quorum, 

and voting requirements. The proposed 

amendments would also change the 

term of office and staggered term limits 

so that the term of office for producers 

and handlers would be two fiscal 

periods instead of three fiscal periods, 

and one-half instead of one-third of the 

producer and handler member terms 

would expire every year. 

The Committee’s proposed 

amendments were unanimously 

recommended at two public meetings 

on November 14, 2017, and March 3, 

2018. If these proposals are approved in 

a referendum, there would be no direct 

financial effects on producers or 

handlers. The number of producers and 

handlers operating in the industry has 

decreased, which makes it difficult to 

find enough members to fill positions 

on the Committee. Decreasing the 

Committee’s size would make it more 

reflective of today’s industry. 

If the proposed amendments are 

finalized, the Committee would hold 

nominations for producer and handler 

member and alternate positions. All the 

Committee’s producer and handler 

positions would be filled by new 

nominations. Members and alternates 

who are currently serving could be 

nominated to serve on the new 

Committee. 

The Committee believes these changes 

will serve the needs of the Committee 

and the industry. No economic impact 

is expected if the proposed amendments 

are approved because they would not 

establish any new regulatory 

requirements on handlers nor would 

they have any assessment or funding 

implications. There would be no change 

in financial costs, reporting, or 

recordkeeping requirements if the 

proposals are approved. 

Alternatives to the proposals, 

including making no changes at this 


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64298 Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 

1This order shall not become effective unless and 

until the requirements of § 900.14 of the rules of 

practice and procedure governing proceedings to 

formulate marketing agreements and marketing 

orders have been met. 

time, were considered by the 

Committee. Due to changes in the 

industry, AMS believes the proposals 

are justified and necessary to ensure the 

Committee’s ability to locally 

administer the program. Reducing the 

size of the Committee would enable it 

to fulfill membership and quorum 

requirements fully, thereby ensuring a 

more efficient and orderly flow of 

business. 

Paperwork Reduction Act 

In accordance with the Paperwork 

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

Chapter 35), the Order’s information 

collection requirements have been 

previously approved by OMB and 

assigned OMB No. 0581–0178 

(Vegetable and Specialty Crops). No 

changes in those requirements are 

necessary because of this action. Should 

any changes become necessary, they 

would be submitted to OMB for 

approval. 

This proposed rule would impose no 

additional reporting or recordkeeping 

requirements on either small or large 

Walla Walla Valley sweet onion 

handlers. As with all Federal marketing 

order programs, reports and forms are 

periodically reviewed to reduce 

information requirements and 

duplication by industry and public 

sector agencies. 

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. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this action. 

The Committee’s meetings were 

widely publicized throughout the 

production area. All interested persons 

were invited to attend the meetings and 

encouraged to participate in Committee 

deliberations on all issues. Like all 

Committee meetings, the November 14, 

2017, and March 3, 2018, meetings were 

public, and all entities, both large and 

small, were encouraged to express their 

views on the proposals. 

A proposed rule concerning this 

action was published in the Federal 

Register on July 24, 2018 (83 FR 34953). 

A copy of the proposed rule was sent 

via email to the Committee manager for 

dispersal to all Committee members and 

interested parties. The rule was also 

made available through the internet by 

USDA and the Office of the Federal 

Register. A 60-day comment period 

ending September 24, 2018, was 

provided to allow interested persons to 

respond to the proposal. One comment 

was received in support of the 

amendments. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://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. 

Findings and Conclusions 

The findings and conclusions and 

general findings and determinations 

included in the proposed rule set forth 

in the July 24, 2018, issue of the Federal 

Register are hereby approved and 

adopted. 

Marketing Order 

Annexed hereto and made a part 

hereof is the document entitled ‘‘Order 

Amending the Order Regulating the 

Handling of Sweet Onions Grown in the 

Walla Walla Valley of Southeast 

Washington and Northeast Oregon.’’ 

This document has been decided upon 

as the detailed and appropriate means of 

effectuating the foregoing findings and 

conclusions. It is hereby ordered that 

this entire rule be published in the 

Federal Register. 

Referendum Order 

It is hereby directed that a producer 

referendum be conducted in accordance 

with the procedure for the conduct of 

referenda (7 CFR 900.400–407) to 

determine whether the annexed Order 

Amending the Order Regulating the 

Handling of Sweet Onions Grown in the 

Walla Walla Valley of Southeast 

Washington and Northeast Oregon is 

approved by producers who have 

engaged in the production of sweet 

onions within the production area 

during the representative period. The 

representative period for the conduct of 

such referendum is hereby determined 

to be June 1, 2017, to May 31, 2018. 

The agents of the Secretary to conduct 

such referendum are designated to be 

Dale Novotny and Barry Broadbent, 

Northwest Marketing Field Office, 

Marketing Order and Agreement 

Division, Specialty Crops Program, 

AMS, USDA; Telephone: (503) 326– 

2724, Fax: (503) 326–7440, or Email: 

DaleJ.Novotny@usda.gov and 

Barry.Broadbent@usda.gov, 

respectively. 

Order Amending the Order Regulating 

the Handling of Sweet Onions Grown in 

the Walla Walla Valley of Southeast 

Washington and Northeast Oregon 1

Findings and Determinations 

The findings hereinafter set forth are 

supplementary to the findings and 

determinations which were previously 

made in connection with the issuance of 

the Order; and all said previous findings 

and determinations are hereby ratified 

and affirmed, except insofar as such 

findings and determinations may be in 

conflict with the findings and 

determinations set forth herein. 

1. The Order, as amended, and as 

hereby proposed to be further amended, 

and all the terms and conditions thereof, 

would tend to effectuate the declared 

policy of the Act; 

2. The Order, as amended, and as 

hereby proposed to be further amended, 

regulates the handling of sweet onions 

grown in the Walla Walla Valley of 

Southeast Washington and Northeast 

Oregon and is applicable only to 

persons in the respective classes of 

commercial and industrial activity 

specified in the Order; 

3. The Order, as amended, and as 

hereby proposed to be further amended, 

is limited in application to the smallest 

regional production area which is 

practicable, consistent with carrying out 

the declared policy of the Act, and the 

issuance of several marketing orders 

applicable to subdivisions of the 

production area would not effectively 

carry out the declared policy of the Act; 

4. The Order, as amended, and as 

hereby proposed to be further amended, 

prescribes, insofar as practicable, such 

different terms applicable to different 

parts of the production area as are 

necessary to give due recognition to the 

differences in the production and 

marketing of onions produced or packed 

in the production area; and 

5. All handling of onions produced or 

packed in the production area as 

defined in the Order is in the current of 

interstate or foreign commerce or 

directly burdens, obstructs, or affects 

such commerce. 

Order Relative to Handling 

It is therefore ordered, that on and 

after the effective date hereof, all 

handling of sweet onions grown in the 

Walla Walla Valley of Southeast 

Washington and Northeast Oregon shall 

be in conformity to, and in compliance 

with, the terms and conditions of the 


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Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules 64299 

said Order as hereby proposed to be 

amended as follows: 

The provisions of the proposed 

marketing order amending the Order 

contained in the proposed rule issued 

by the Administrator on July 19, 2018, 

and published in the Federal Register 

(83 FR 34953) on July 24, 2018, will be 

and are the terms and provisions of this 

order amending the Order and are set 

forth in full herein. 

List of Subjects in 7 CFR Part 956 

Onions, Marketing agreements, 

Reporting and recordkeeping 

requirements. 

Dated: December 11, 2018. 

Bruce Summers, 

Administrator, Agricultural Marketing 

Service. 

For the reasons discussed in the 

preamble, 7 CFR part 956 is proposed to 

be amended as follows. 

PART 956—SWEET ONIONS GROWN 

IN THE WALLA WALLA VALLEY OF 

SOUTHEAST WASHINGTON AND 

NORTHEAST OREGON 

■ 1. The authority citation for 7 CFR 

part 956 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. Amend § 956.20 by revising 

paragraph (a) to read as follows: 

§ 956.20 Establishment and membership. 

(a) The Walla Walla Sweet Onion 

Marketing Committee, consisting of 

seven members, is hereby established. 

The Committee shall consist of four 

producer members, two handler 

members, and one public member. Each 

member shall have an alternate who 

shall have the same qualifications as the 

member. 

* * * * * 

■ 3. Revise § 956.21 to read as follows: 

§ 956.21 Term of office. 

(a) Except as otherwise provided in 

paragraph (b) of this section, the term of 

office of grower and handler Committee 

members and their respective alternates 

shall be two fiscal periods beginning on 

June 1 or such other date as 

recommended by the Committee and 

approved by the Secretary. The terms 

shall be determined so that one-half of 

the grower membership and one-half of 

the handler membership shall terminate 

each year. Members and alternates shall 

serve during the term of office for which 

they are selected and have been 

qualified, or during that portion thereof 

beginning on the date on which they 

qualify during such term of office and 

continuing until the end thereof, or 

until their successors are selected and 

have qualified. 

(b) The term of office of the initial 

members and alternates shall begin as 

soon as possible after the effective date 

of this subpart. One-half of the initial 

industry grower and handler members 

and alternates shall serve for a one-year 

term and one-half shall serve for a twoyear term. The initial as well as all 

successive terms of office of the public 

member and alternate member shall be 

for three years. 

(c) The consecutive terms of office for 

all grower and handler members shall 

be limited to two two-year terms. There 

shall be no such limitation for alternate 

members. 

■ 4. Amend § 956.28 by revising 

paragraph (a) to read as follows: 

§ 956.28 Procedure. 

(a) Four members of the Committee 

shall constitute a quorum, and four 

concurring votes shall be required to 

pass any motion or approve any 

Committee action, except that 

recommendations made pursuant to 

§ 956.61 shall require five concurring 

votes. 

* * * * * 

[FR Doc. 2018–27143 Filed 12–13–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 180712626–8840–01] 

RIN 0694–AH61 

Review of Controls for Certain 

Emerging Technologies 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Advance notice of proposed 

rulemaking (ANPRM), Extension of 

comment period. 

SUMMARY: The Bureau of Industry and 

Security (BIS) is extending the comment 

period for its November 19, 2018, 

advanced notice of proposed 

rulemaking (ANPRM), ‘‘Review of 

Controls for Certain Emerging 

Technologies’’ until January 10, 2019. In 

response to requests received from 

members of the public, BIS believes it 

is appropriate to extend the comment 

period to provide interested parties 

additional time to submit their 

responses to the ANPRM. 

DATES: The comment period announced 

in the notice that was published on 

November 19, 2018 (83 FR 58201) is 

extended. Comments on the ANPRM 

must now be received by BIS on or 

before January 10, 2019. 

ADDRESSES: You may submit comments 

through either of the following: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. The identification 

number for this rulemaking is BIS 2018– 

0024. 

• Address: By mail or delivery to 

Regulatory Policy Division, Bureau of 

Industry and Security, U.S. Department 

of Commerce, Room 2099B, 14th Street 

and Pennsylvania Avenue NW, 

Washington, DC 20230. Refer to RIN 

0694–AH61. 

FOR FURTHER INFORMATION CONTACT: 

Kirsten Mortimer, Office of National 

Security and Technology Transfer 

Controls, Bureau of Industry and 

Security, Department of Commerce. 

Phone: (202) 482–0092; Fax (202) 482– 

3355; Email: Kirsten.Mortimer@

bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On November 19, 2018 (83 FR 58201), 

the Bureau of Industry and Security 

(BIS) published an advanced notice of 

proposed rulemaking, ‘‘Review of 

Controls for Certain Emerging 

Technologies,’’ which included a 

comment period deadline of December 

19, 2018. Since publication, BIS has 

received requests for additional time to 

submit comments. In response to those 

requests, BIS is extending the public 

comment period until January 10, 2019. 

A description of the specific topics and 

issues that BIS would like addressed is 

outlined in the November 19, 2018 

Federal Register ANPRM. 

Dated: December 10, 2018. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2018–27148 Filed 12–13–18; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 601 

[Docket No. FDA–2013–N–0500] 

Withdrawal of Proposed Rule on 

Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; withdrawal. 


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