30534 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Rules and Regulations 

Commodity Exchange Act, as added by 

the Dodd-Frank Wall Street Reform and 

Consumer Protection Act. That 

document inadvertently failed to 

remove several obsolete provisions in 

§ 1.33(a)(2) and (b)(3). Accordingly, the 

Commission is making a correcting 

amendment to § 1.33 that removes the 

second paragraph (a)(2)(ii), removes 

paragraph (a)(2)(v), and removes the 

introductory clause to paragraph (b)(3). 

List of Subjects in 17 CFR Part 1 

Agricultural commodity, Agriculture, 

Brokers, Committees, Commodity 

futures, Conflicts of interest, Consumer 

protection, Definitions, Designated 

contract markets, Directors, Major swap 

participants, Minimum financial 

requirements for intermediaries, 

Reporting and recordkeeping 

requirements, Swap dealers, Swaps. 

Accordingly, 17 CFR part 1 is 

corrected by making the following 

correcting amendments: 

PART 1—GENERAL REGULATIONS 

UNDER THE COMMODITY EXCHANGE 

ACT 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 7 U.S.C. 1a, 2, 5, 6, 6a, 6b, 6c, 

6d, 6e, 6f, 6g, 6h, 6i, 6k, 6l, 6m, 6n, 6o, 6p, 

6r, 6s, 7, 7a-1, 7a-2, 7b, 7b-3, 8, 9, 10a, 12, 

12a, 12c, 13a, 13a-1, 16, 16a, 19, 21, 23, and 

24 (2012). 

■ 2. Amend § 1.33 as follows: 

■ a. Revise paragraph (a)(2); and 

■ b. Revise paragraph (b)(3) 

introductory text. 

The revisions read as follows: 

§ 1.33 Monthly and confirmation 

statements. 

(a) * * * 

(2) For each commodity option 

position and foreign option position— 

(i) All commodity options and foreign 

options purchased, sold, exercised, or 

expired during the monthly reporting 

period, identified by underlying futures 

contract or underlying commodity, 

strike price, transaction date, and 

expiration date; 

(ii) The open commodity option and 

foreign option positions carried for such 

customer or foreign futures or foreign 

options customer as of the end of the 

monthly reporting period, identified by 

underlying futures contract or 

underlying commodity, strike price, 

transaction date, and expiration date; 

(iii) All open commodity option and 

foreign option positions marked to the 

market and the amount each position is 

in the money, if any; and 

(iv) Any related customer funds 

carried in such customer’s account(s) or 

any related foreign futures or foreign 

options secured amount carried in the 

account(s) of a foreign futures or foreign 

options customer. 

* * * * * 

(b) * * * 

(3) A written confirmation of each 

commodity option transaction, 

containing at least the following 

information: 

* * * * * 

Dated: June 15, 2018. 

Robert N. Sidman, 

Deputy Secretary of the Commission. 

[FR Doc. 2018–13256 Filed 6–28–18; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 514 

[Docket No. FDA–2012–N–0447] 

Antimicrobial Animal Drug Sales and 

Distribution Reporting; Small Entity 

Compliance Guide; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for industry #252 entitled 

‘‘Antimicrobial Animal Drug Sales and 

Distribution Reporting Small Entity 

Compliance Guide.’’ The small entity 

compliance guide (SECG) is intended to 

help small entities comply with the 

final rule we issued in the Federal 

Register of May 11, 2016, entitled 

‘‘Antimicrobial Animal Drug Sales and 

Distribution Reporting.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 29, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2012–N–0447 for ‘‘Antimicrobial 

Animal Drug Sales and Distribution 

Reporting; Small Entity Compliance 

Guide.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff 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 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Rules and Regulations 30535 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the SECG to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

Sujaya Dessai, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5671, 

sujaya.dessai@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sponsors of approved or conditionally 

approved applications for new animal 

drugs containing an antimicrobial active 

ingredient are required by section 512 of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360b), as 

amended by section 105 of the Animal 

Drug Use Fee Amendments of 2008 

(ADUFA 105) (Pub. L. 110–316), to 

submit to us an annual report on the 

amount of each such ingredient in the 

drug that is sold or distributed for use 

in food-producing animals. We are also 

required by ADUFA 105 to publish 

annual summary reports of the data we 

receive from animal drug sponsors. In 

accordance with the law, sponsors of 

the affected antimicrobial new animal 

drug products began submitting their 

sales and distribution data to us on an 

annual basis, and we have published 

summaries of such data for each 

calendar year beginning with 2009. 

In the Federal Register of May 11, 

2016 (81 FR 29129), we published a 

final rule entitled ‘‘Antimicrobial 

Animal Drug Sales and Distribution 

Reporting’’ that amended our existing 

records and reports regulation in part 

514 (21 CFR part 514) to incorporate the 

sales and distribution data reporting 

requirements specific to antimicrobial 

new animal drugs that were added to 

the FD&C Act by ADUFA 105. The rule 

also added an additional reporting 

provision intended to improve our 

understanding of antimicrobial animal 

drug sales intended for use in specific 

food-producing animal species. In 

accordance with the new rule, the 

sponsor of each approved or 

conditionally approved new animal 

drug product that contains an 

antimicrobial active ingredient must 

submit an annual report to us on the 

amount of each such ingredient in the 

drug product that is sold or distributed 

for use in food-producing animals, 

including information on any 

distributor-labeled product. The final 

rule, which is codified at §§ 514.80 and 

514.87, became effective July 11, 2016. 

We examined the economic 

implications of the final rule as required 

by the Regulatory Flexibility Act (5 

U.S.C. 601–612) and determined that 

the final rule will not have a significant 

economic impact on a substantial 

number of small entities (81 FR 29129 

at 29138). Nonetheless, we determined 

not to certify that finding due to the 

remote possibility that, in the future, a 

very small company could enter the 

market and sponsor an application for 

an antimicrobial new animal drug 

product that would be sold or 

distributed for use in food-producing 

animals. Thus, in compliance with 

section 212 of the Small Business 

Regulatory Enforcement Fairness Act 

(Pub. L. 104–121, as amended by Pub. 

L. 110–28), we are making available this 

SECG to explain the actions that a 

potential future market entrant small 

entity must take to comply with the 

rule. 

We are issuing this SECG consistent 

with our good guidance practices 

regulation (21 CFR 10.115(c)(2)). The 

SECG represents the current thinking of 

FDA on this topic. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

§ 514.87 have been approved under 

OMB control number 0910–0659. The 

collections of information in § 514.80 

have been approved under OMB control 

number 0910–0284. 

III. Electronic Access 

Persons with access to the internet 

may obtain the SECG at either https:// 

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14085 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 9 

[Docket No. TTB–2016–0012; T.D. TTB–151; 

Ref: Notice No. 166] 

RIN 1513–AC33 

Establishment of the Dahlonega 

Plateau Viticultural Area 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Final rule; Treasury decision. 

SUMMARY: The Alcohol and Tobacco Tax 

and Trade Bureau (TTB) establishes the 

approximately 133-square mile 

Dahlonega Plateau viticultural area in 

portions of Lumpkin and White 

counties in Georgia. The Dahlonega 

Plateau viticultural area is not located 

within any other established viticultural 

area. TTB designates viticultural areas 

to allow vintners to better describe the 

origin of their wines and to allow 

consumers to better identify wines they 

may purchase. 

DATES: This final rule is effective July 

30, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Dana Register, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street NW, Box 

12, Washington, DC 20005; phone 202– 

453–1039, ext. 022. 


sradovich on DSK3GMQ082PROD with RULES