10022 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Proposed Rules 

reimbursement of research and 

development costs, maintenance costs, 

or user fees. 

(n) For purposes of this section, rights 

to, or obligations of, research and 

development cost reimbursement, 

maintenance cost reimbursement, or 

user fees cannot be transferred from any 

individual or entity unless specifically 

approved in writing by the Board. 

(o) Applicants requesting 

reimbursement for research and 

development costs, maintenance costs, 

or user fees, may present their request 

in person to the Board prior to 

consideration for approval. 

(p) Index-based weather plans of 

insurance are not eligible for 

reimbursement from FCIC for 

maintenance costs or research and 

development costs. Submitters of 

approved index-based weather plans of 

insurance may collect user fees from 

other approved insurance providers in 

accordance with Procedures Handbook 

17050—Approved Procedures for 

Submission of Index-based Weather 

Plans of Insurance. 

§ 400.713 Non-reinsured supplemental 

(NRS) policy. 

(a) Unless otherwise specified by 

FCIC, any NRS policy that covers the 

same agricultural commodity as any 

policy reinsured by FCIC under the Act 

must be provided to RMA to ensure it 

does not shift any loss under the FCIC 

reinsured policy. Failure to provide 

such NRS policy or endorsement to 

RMA prior to its issuance shall result in 

the denial of reinsurance, A&O subsidy 

and risk subsidy on the underlying FCIC 

reinsured policy for which such NRS 

policy was sold. 

(b) Three hard copies, and an 

electronic copy in a format approved by 

RMA, of the new or revised NRS policy 

and related materials must be submitted 

at least 150 days prior to the first sales 

closing date applicable to the NRS 

policy. At a minimum, examples that 

demonstrate how liability and 

indemnities are determined under 

differing scenarios must be included. 

(1) Hard copies of the NRS must be 

sent to the Deputy Administrator for 

Product Management (or successor), 

USDA/Risk Management Agency, 

Beacon Facility Mail Stop 0812, 9240 

Troost Ave., Kansas City, MO 64131– 

3055. 

(2) Electronic copies of the NRS must 

be sent to the Deputy Administrator for 

Product Management (or successor) at 

DeputyAdministrator@rma.usda.gov. 

(c) RMA will review the NRS policy. 

If any of the conditions found in 

paragraphs (c)(1) through (5) of this 

section are found to occur, FCIC will 

deny reinsurance, A&O subsidy and risk 

subsidy on the underlying FCIC 

reinsured policy for which such NRS 

policy was sold. 

(1) If the NRS policy materially 

increases or shifts risk to the underlying 

policy or plan of insurance reinsured by 

FCIC. 

(i) An NRS policy will be considered 

to materially increase or shift risk to the 

underlying policy or plan of insurance 

reinsured by FCIC if it creates an 

incentive for moral hazard such as a 

financial incentive to increase the 

number or size of losses or, allows for 

aggregate indemnities in excess of the 

expected value of the insured 

commodity. 

(ii) The NRS must include language 

that clearly states no indemnity will be 

paid in excess of the initial value of the 

insured commodity. 

(2) The NRS reduces or limits the 

rights of the insured with respect to the 

underlying policy or plan of insurance 

reinsured by FCIC. An NRS policy will 

be considered to reduce or limit the 

rights of the insured with respect to the 

underlying policy or plan of insurance 

if it alters the terms or conditions of the 

underlying policy or otherwise 

preempts procedures issued by FCIC. 

(3) The NRS disrupts the marketplace. 

An NRS policy will be considered to 

disrupt the marketplace if it encourages 

planting more acres of the insured 

commodity in excess of normal market 

demand, adversely affects the sales or 

administration of reinsured policies, 

undermines producers’ confidence in 

the Federal crop insurance program, or 

harms public perception of the Federal 

crop insurance program. 

(4) The NRS is an impermissible 

rebate. An NRS may be considered to be 

an impermissible rebate if FCIC 

determines that the premium rates 

charged are insufficient to cover the 

expected losses and a reasonable reserve 

or it offers other benefits that are 

generally provided at a cost. 

(5) The NRS policy is conditioned 

upon or provides incentive for the 

purchase of the underlying policy or 

plan of insurance reinsured by FCIC 

with a specific agent or approved 

insurance provider. 

(d) RMA will respond not less than 60 

days before the first sales closing date or 

provide notice why RMA is unable to 

respond within the time frame allotted. 

(e) NRS policies reviewed by RMA 

will not need to be submitted for a five 

year period unless a change is made to 

the NRS or the underlying policy or the 

loss ratio for the NRS policy exceeds 

2.0. Once any changes are made to 

either policy or the five year period has 

concluded, the NRS must be 

resubmitted for review. 

Signed in Washington, DC, on February 13, 

2015. 

Brandon Willis, 

Manager, Federal Crop Insurance 

Corporation. 

[FR Doc. 2015–03604 Filed 2–23–15; 8:45 am] 

BILLING CODE 3410–08–P 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Parts 1, 15, 17, 19, 32, 37, 38, 

140, and 150 

RIN 3038–AD99; 3038–AD82 

Position Limits for Derivatives and 

Aggregation of Positions 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Notice of proposed rulemaking; 

provision of Table 11a; and reopening of 

comment periods. 

SUMMARY: On December 12, 2013, the 

Commodity Futures Trading 

Commission (‘‘Commission’’) published 

in the Federal Register a notice of 

proposed rulemaking (the ‘‘Position 

Limits Proposal’’) to establish 

speculative position limits for 28 

exempt and agricultural commodity 

futures and options contracts and the 

physical commodity swaps that are 

economically equivalent to such 

contracts. On November 15, 2013, the 

Commission published in the Federal 

Register a notice of proposed 

rulemaking (the ‘‘Aggregation 

Proposal’’) to amend existing 

regulations setting out the Commission’s 

policy for aggregation under its position 

limits regime. The Commission’s Energy 

and Environmental Markets Advisory 

Committee has scheduled a public 

meeting to be held on February 26, 

2015, which will consider, among other 

matters, exemptions for bona fide 

hedging positions. In conjunction with 

the meeting of the Commission’s Energy 

and Environmental Markets Advisory 

Committee, the Commission will post 

an agenda and associated materials, if 

any, on the Commission’s Web site; 

additionally, access to a video webcast 

of the meeting will be added to the Web 

site. In addition, and in connection with 

the meeting, the Commission is 

providing counts of the unique persons 

over percentages of the 28 proposed 

position limit levels (currently provided 

in Table 11 of the Position Limits 

Proposal based on counts from the 

period of January 1, 2011, to December 

31, 2012 period) in a new table, Table 


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Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Proposed Rules 10023 

1 7 U.S.C. 1 et seq. 

2See 17 CFR part 150. Part 150 of the 

Commission’s regulations establishes federal 

position limits on futures and option contracts in 

nine enumerated agricultural commodities. 

3See 17 CFR 150.2. 

4See 17 CFR 150.3. 

5See 17 CFR 150.4. 

6See Position Limits for Derivatives, 78 FR 75680 

(Dec. 12, 2013). 

7See Aggregation of Positions, 78 FR 68946 (Nov. 

15, 2013). 

8See id. at 68947. 

9See 79 FR 2394 (Jan. 14, 2014). 

11a, based on counts from the period of 

January 1, 2013, to December 31, 2014. 

To provide commenters with a 

sufficient period of time to respond to 

questions raised and points made at the 

Energy and Environmental Markets 

Committee meeting, as well as to 

provide an opportunity to comment on 

Table 11a, the Commission will reopen 

the comment periods for an additional 

30 days. The Commission is providing 

notice that comments may be made on 

the issues addressed at the meeting or 

in the associated materials posted to the 

Commission’s Web site, as they pertain 

to energy commodities. Furthermore, 

comments may be made on Table 11a, 

showing counts of the unique persons 

over percentages of the 28 proposed 

position limit levels based on counts 

from the period of January 1, 2013, to 

December 31, 2014. 

DATES: The comment periods for the 

Aggregation Proposal published 

November 15, 2013, at 78 FR 68946, and 

for the Position Limits Proposal 

published December 12, 2013, at 78 FR 

75680, will reopen on February 26, 

2015, and will close on March 28, 2015. 

ADDRESSES: You may submit comments, 

identified by RIN 3038–AD99 for the 

Position Limits Proposal or RIN 3038– 

AD82 for the Aggregation Proposal, by 

any of the following methods: 

• Agency Web site: http:// 

comments.cftc.gov; 

• Mail: Christopher Kirkpatrick, 

Secretary of the Commission, 

Commodity Futures Trading 

Commission, Three Lafayette Centre, 

1155 21st Street NW., Washington, DC 

20581; 

• Hand Delivery/Courier: Same as 

Mail, above; or 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow 

instructions for submitting comments. 

Please submit your comments using 

only one method. All comments must be 

submitted in English, or if not, 

accompanied by an English translation. 

Comments will be posted as received to 

http://www.cftc.gov. You should submit 

only information that you wish to make 

available publicly. If you wish the 

Commission to consider information 

that may be exempt from disclosure 

under the Freedom of Information Act, 

a petition for confidential treatment of 

the exempt information may be 

submitted under § 145.9 of the 

Commission’s regulations (17 CFR 

145.9). 

The Commission reserves the right, 

but shall have no obligation, to review, 

pre-screen, filter, redact, refuse or 

remove any or all of your submission 

from http://www.cftc.gov that it may 

deem to be inappropriate for 

publication, such as obscene language. 

All submissions that have been redacted 

or removed that contain comments on 

the merits of the rulemaking will be 

retained in the public comment file and 

will be considered as required under the 

Administrative Procedure Act and other 

applicable laws, and may be accessible 

under the Freedom of Information Act. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Sherrod, Senior Economist, 

Division of Market Oversight, (202) 418– 

5452, ssherrod@cftc.gov; or Riva Spear 

Adriance, Senior Special Counsel, 

Division of Market Oversight, (202) 418– 

5494, radriance@cftc.gov; Commodity 

Futures Trading Commission, Three 

Lafayette Centre, 1155 21st Street NW., 

Washington, DC 20581. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Commission has long established 

and enforced speculative position limits 

for futures and options contracts on 

various agricultural commodities as 

authorized by the Commodity Exchange 

Act (‘‘CEA’’).1 The part 150 position 

limits regime 2 generally includes three 

components: (1) the level of the limits, 

which set a threshold that restricts the 

number of speculative positions that a 

person may hold in the spot-month, 

individual month, and all months 

combined,3 (2) exemptions for positions 

that constitute bona fide hedging 

transactions and certain other types of 

transactions,4 and (3) rules to determine 

which accounts and positions a person 

must aggregate for the purpose of 

determining compliance with the 

position limit levels.5 The Position 

Limits Proposal generally sets out 

proposed changes to the first and 

second components of the position 

limits regime and would establish 

speculative position limits for 28 

exempt and agricultural commodity 

futures and option contracts, and 

physical commodity swaps that are 

‘‘economically equivalent’’ to such 

contracts (as such term is used in CEA 

section 4a(a)(5)).6 The Aggregation 

Proposal generally sets out proposed 

changes to the third component of the 

position limits regime.7

The Commission published the 

Position Limits Proposal and the 

Aggregation Proposal separately because 

it believes that the proposed 

amendments regarding aggregation of 

positions could be appropriate 

regardless of whether the Position 

Limits Proposal is finalized.8 If the 

Aggregation Proposal is finalized first, 

the modifications would apply to the 

current position limits regime for 

futures and option contracts on nine 

enumerated agricultural commodities. If 

the Position Limits Proposal is 

subsequently finalized, the 

modifications in the Aggregation 

Proposal would apply to the position 

limits regime for 28 exempt and 

agricultural commodity futures and 

options contracts and the physical 

commodity swaps that are economically 

equivalent to such contracts. 

In order to provide interested parties 

with an opportunity to comment on the 

Aggregation Proposal during the 

comment period on the Position Limits 

Proposal, the Commission extended the 

comment period for the Aggregation 

Proposal to February 10, 2014, the same 

end date as the comment period for the 

Position Limits Proposal.9

Subsequent to publication of the 

Position Limits Proposal and the 

Aggregation Proposal, the Commission 

directed staff to schedule a June 19, 

2014, public roundtable to consider 

certain issues regarding position limits 

for physical commodity derivatives. The 

roundtable focused on hedges of a 

physical commodity by a commercial 

enterprise, including gross hedging, 

cross-commodity hedging, anticipatory 

hedging, and the process for obtaining a 

non-enumerated exemption. Discussion 

included the setting of spot month 

limits in physical-delivery and cashsettled contracts and a conditional spotmonth limit exemption. Further, the 

roundtable included discussion of: The 

aggregation exemption for certain 

ownership interests of greater than 50 

percent in an owned entity; and 

aggregation based on substantially 

identical trading strategies. As well, the 

Commission invited comment on 

whether to provide parity for wheat 

contracts in non-spot month limits. In 

conjunction with the roundtable, staff 

questions regarding these topics were 

posted on the Commission’s Web site. 

To provide commenters with a 

sufficient period of time to respond to 

questions raised and points made at the 

roundtable, the Commission published a 

document in the Federal Register on 

May 29, 2014 (79 FR 30762), reopening 


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10024 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Proposed Rules 

10Questions, presentation materials, and a video 

webcast have been made available at http:// 

www.cftc.gov/PressRoom/Events/ 

opaevent_aac120914. 

11See 79 FR 71973 (Dec. 4, 2014). The 

Commission also provided notice and clarification 

that, in addition to commenting on the agenda 

issues noted in the December 4, 2014, Federal 

Register release providing notice of the reopened 

comment period, comments could be made on the 

issues addressed at the meeting or in associated 

materials posted to the Commission’s Web site, as 

they pertained to agricultural commodities, 

including hedges of a physical commodity by a 

commercial enterprise; and the process for 

estimating deliverable supplies used in the setting 

of spot month limits, as each pertained to 

agricultural commodities. See also 80 FR 200 (Jan. 

5, 2015). 

12See 78 FR 75680 at 75731 (Dec. 12, 2013). 

13As is the case for Table 11, the Commission 

notes that Table 11a is presented using the 

proposed initial limit levels, without regard to 

alternatives presented in the proposed rule. See 78 

FR at 75839 for the proposed initial limit levels for 

the spot month. The Commission also proposed 

alternatives methods for setting initial levels for the 

spot month. See FR at 75727–8. The proposed 

initial limit levels for the non-spot months are 

found at 78 FR 76787 (Dec. 19, 2013). The 

Commission also proposed an alternative method to 

establish higher initial limit levels in the non-spot 

months. See FR 78 at 75734. 

the comment periods for the Position 

Limit Proposal and the Aggregation 

Proposal for three weeks, from June 12, 

2014 to July 3, 2014. The Commission 

published a document in the Federal 

Register on July 3, 2014 (79 FR 37973), 

further extending the comment periods 

to August 4, 2014. 

The Commission’s Agricultural 

Advisory Committee met on December 

9, 2014. The agenda adopted for the 

meeting included consideration, among 

other matters, of two issues associated 

with the Position Limits rulemaking: 

Deliverable supply and exemptions for 

bona fide hedging positions. In 

conjunction with the meeting of the 

Commission’s Agricultural Advisory 

Committee, the Commission posted 

questions and presentation materials on 

the Commission’s Web site; 

additionally, access to a video webcast 

of the meeting was added to the Web 

site.10 To provide interested persons 

with a sufficient period of time to 

respond to questions raised and points 

made at the Agricultural Advisory 

Committee meeting, the Commission 

reopened both the Position Limit 

Proposal and the Aggregation Proposal 

for an additional 45-day comment 

period.11

Comment letters received on the 

Position Limits Proposal are available at 

http://comments.cftc.gov/ 

PublicComments/ 

CommentList.aspx?id=1436. Comment 

letters received on the Aggregation 

Proposal are available at http:// 

comments.cftc.gov/PublicComments/ 

CommentList.aspx?id=1427. 

II. Reopening of Comment Period 

The Commission’s Energy and 

Environmental Markets Advisory 

Committee has scheduled a meeting on 

February 26, 2015. The agenda adopted 

for the meeting includes consideration 

of exemptions for bona fide hedging 

positions. In conjunction with the 

meeting of the Commission’s Energy 

and Environmental Markets Advisory 

Committee, the Commission will post 

associated materials on the 

Commission’s Web site; additionally, 

access to a video webcast of the meeting 

will be added to the Web site. To 

provide interested persons with a 

sufficient period of time to respond to 

questions raised and points made at the 

Energy and Environmental Markets 

Advisory Committee meeting, the 

Commission is reopening both the 

Position Limit Proposal and the 

Aggregation Proposal for an additional 

30-day comment period. The 

Commission is providing notice that, in 

addition to commenting on the agenda 

issues, comments may be made on the 

issues addressed at the meeting or in 

associated materials posted to the 

Commission’s Web site, as they pertain 

to energy commodities, including 

hedges of a physical commodity by a 

commercial enterprise, as pertains to 

energy commodities. 

In addition, and in connection with 

the Energy and Environmental Markets 

Advisory Committee meeting, the 

Commission is providing counts of the 

unique persons exceeding the 28 

proposed position limit levels (currently 

provided in Table 11 of the Positions 

Limits Proposal based on counts from 

the period of January 1, 2011, to 

December 31, 2012 period 12) by certain 

specified percentages in a new table, 

Table 11a, based on counts from the 

period of January 1, 2013, to December 

31, 2014. As was the case with Table 11, 

to provide the public with additional 

information regarding the number of 

large position holders in the past two 

calendar years, Table 11a provides 

counts of unique persons over 60, 80, 

100, and 500 percent of the levels of the 

position limits proposed for 28 core 

referenced futures products.13 Note that 

the 500 percent line is omitted from 

Table 11a for contracts where no person 

held a position over that level. The 

Commission notes that in addition to 

commenting on the agenda issues and 

on the issues addressed at the meeting 

or in associated materials posted to the 

Commission’s Web site, as they pertain 

to energy commodities, comments may 

be made on Table 11a. 

TABLE 11a—UNIQUE PERSONS OVER PERCENTAGES OF PROPOSED POSITION LIMIT LEVELS, JANUARY 1, 2013, TO

DECEMBER 31, 2014 

Commodity type/core referenced futures contract Percent of 

level 

Unique persons over level 

Spot month 

(physicaldelivery) 

Spot month 

(cash-settled) Single month All months 

Legacy Agricultural 

CBOT Corn (C) .................................................................... 60 206 — 12 25 

80 147 — 4 7 

100 49 — (*) 5 

500 4 — — — 

CBOT Oats (O) .................................................................... 60 (*) — 11 12 

80 (*) — 6 8 

100 — — (*) 5 

CBOT Soybeans (S) ............................................................ 60 127 — 14 18 

80 90 — 9 11 

100 31 — 6 9 

500 9 — — — 

CBOT Soybean Meal (SM) .................................................. 60 53 — 42 54 

80 31 — 12 19 


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TABLE 11a—UNIQUE PERSONS OVER PERCENTAGES OF PROPOSED POSITION LIMIT LEVELS, JANUARY 1, 2013, TO

DECEMBER 31, 2014—Continued 

Commodity type/core referenced futures contract Percent of 

level 

Unique persons over level 

Spot month 

(physicaldelivery) 

Spot month 

(cash-settled) Single month All months 

100 16 — 6 11 

500 (*) — — — 

CBOT Soybean Oil (SO) ..................................................... 60 82 — 31 38 

80 51 — 10 18 

100 18 — 5 11 

500 (*) — — — 

CBOT Wheat (W) ................................................................. 60 39 — 35 33 

80 30 — 12 17 

100 10 — 8 11 

500 (*) — — — 

ICE Cotton No. 2 (CT) ......................................................... 60 16 — 15 22 

80 10 — 10 14 

100 7 — 8 10 

500 4 — — — 

KCBT Hard Winter Wheat (KW) .......................................... 60 17 — 32 39 

80 7 — 16 27 

100 (*) — 12 12 

MGEX Hard Red Spring Wheat (MWE) .............................. 60 7 — 33 36 

80 4 — 20 29 

100 (*) — 15 21 

Other Agricultural 

CBOT Rough Rice (RR) ...................................................... 60 9 — 6 5 

80 7 — 4 4 

100 (*) — (*) (*) 

CME Milk Class III (DA) ....................................................... 60 NA 5 (*) 26 

80 NA 4 — 15 

100 NA (*) — 10 

CME Feeder Cattle (FC) ...................................................... 60 NA 113 8 14 

80 NA 70 (*) 8 

100 NA 28 — 5 

CME Lean Hog (LH) ............................................................ 60 NA 98 19 34 

80 NA 74 8 24 

100 NA 45 (*) 14 

CME Live Cattle (LC) ........................................................... 60 51 — 14 29 

80 7 — 7 16 

100 5 — (*) 8 

ICUS Cocoa (CC) ................................................................ 60 4 — 47 42 

80 4 — 38 30 

100 (*) — 21 21 

ICE Coffee C (KC) ............................................................... 60 14 — 30 32 

80 10 — 13 16 

100 6 — 8 11 

500 (*) — — — 

ICE FCOJ–A (OJ) ................................................................ 60 5 — 7 7 

80 5 — 4 4 

100 5 — 4 4 

ICE Sugar No. 11 (SB) ........................................................ 60 55 — 41 39 

80 42 — 31 29 

100 16 — 21 22 

500 (*) — — — 

ICE Sugar No. 16 (SF) ........................................................ 60 5 — 6 13 

80 5 — 6 11 

100 4 — 5 11 

Energy 

NYMEX Henry Hub Natural Gas (NG) ................................ 60 187 236 (*) 7 

80 142 205 (*) (*) 

100 83 187 — (*) 

500 (*) 46 — — 

NYMEX Light Sweet Crude Oil (CL) ................................... 60 135 100 (*) 12 

80 95 87 (*) 7 

100 44 65 — (*) 

500 — — — — 

NYMEX NY Harbor ULSD (HO) .......................................... 60 76 68 13 16 


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14Table notes: (1) Aggregation exemptions were 

not used in computing the counts of unique 

persons; (2) the position data was for futures, 

futures options and swaps that are significant price 

discovery contracts (SPDCs). 

TABLE 11a—UNIQUE PERSONS OVER PERCENTAGES OF PROPOSED POSITION LIMIT LEVELS, JANUARY 1, 2013, TO

DECEMBER 31, 2014—Continued 

Commodity type/core referenced futures contract Percent of 

level 

Unique persons over level 

Spot month 

(physicaldelivery) 

Spot month 

(cash-settled) Single month All months 

80 49 63 7 9 

100 31 44 (*) 6 

500 — 5 — — 

NYMEX RBOB Gasoline (RB) ............................................. 60 97 57 26 30 

80 67 52 15 17 

100 36 37 11 12 

500 — (*) — — 

Metals 

COMEX Copper (HG) .......................................................... 60 12 — 61 62 

80 9 — 37 40 

100 4 — 29 30 

COMEX Gold (GC) .............................................................. 60 13 — 22 24 

80 9 — 14 14 

100 5 — 10 11 

COMEX Silver (SI) ............................................................... 60 9 — 34 32 

80 4 — 20 21 

100 (*) — 16 16 

NYMEX Palladium (PA) ....................................................... 60 9 — 12 13 

80 5 — 9 5 

100 (*) — 4 4 

NYMEX Platinum (PL) ......................................................... 60 11 — 29 29 

80 7 — 18 18 

100 (*) — 9 9 

Legend: 

* means fewer than 4 unique owners exceeded the level. 

— means no unique owner exceeded the level. 

NA means not applicable.14

Both comment periods will reopen on 

February 26, 2015, and will close on 

March 28, 2015. 

Issued in Washington, DC, on February 19, 

2015, by the Commission. 

Christopher J. Kirkpatrick, 

Secretary of the Commission. 

Note: The following appendix will not 

appear in the Code of Federal Regulations. 

Appendix to Position Limits for 

Derivatives and Aggregation of 

Positions Reopening of Comment 

Periods—Commission Voting Summary 

On this matter, Chairman Massad and 

Commissioners Wetjen, Bowen, and 

Giancarlo voted in the affirmative. No 

Commissioner voted in the negative. 

[FR Doc. 2015–03834 Filed 2–24–15; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 310 

[Docket Nos. FDA–2003–N–0196 (Formerly 

2003N–0233), FDA–1978–N–0018 (Formerly 

1978N–0038 and 78N–0038), and FDA–1996– 

N–0006 (Formerly 96N–0277)] 

Over-the-Counter Sunscreen Drug 

Products—Regulatory Status of 

Enzacamene 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order; request for 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

issuing a proposed sunscreen order 

(proposed order) under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act), as amended by the 

Sunscreen Innovation Act (SIA). The 

proposed order announces FDA’s 

tentative determination that 

enzacamene is not generally recognized 

as safe and effective (GRASE) and is 

misbranded when used in over-thecounter (OTC) sunscreen products 

because the currently available data are 

insufficient to classify it as GRASE and 

not misbranded, and additional 

information is needed to allow us to 

determine otherwise. 

DATES: Submit either electronic or 

written comments on this proposed 

order by April 13, 2015. Sponsors may 

submit written requests for a meeting 

with FDA to discuss this proposed order 

by March 27, 2015. See section VI for 

the proposed effective date of a final 

order based on this proposed order. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 


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