Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13225 

description and analysis of final rules 

that will have significant economic 

impact on a substantial number of small 

entities. This Final Rule concerns an 

interpretation of current Commission 

regulations and practices. The 

Commission certifies that it will not 

have a significant economic impact 

upon participants in Commission 

proceedings. An analysis under the RFA 

is not required. 

VII. Document Availability 

13. In addition to publishing the full 

text of this document in the Federal 

Register, the Commission provides all 

interested persons an opportunity to 

view and/or print the contents of this 

document via the Internet through the 

Commission’s Home Page (http://

www.ferc.gov) and in the Commission’s 

Public Reference Room during normal 

business hours (8:30 a.m. to 5:00 p.m. 

Eastern time) at 888 First Street NE., 

Room 2A, Washington, DC 20426. 

14. From the Commission’s Home 

Page on the Internet, this information is 

available on eLibrary. The full text of 

this document is available on eLibrary 

in PDF and Microsoft Word format for 

viewing, printing, and/or downloading. 

To access this document in eLibrary, 

type the docket number excluding the 

last three digits of this document in the 

docket number field. 

15. User assistance is available for 

eLibrary and the Commission’s Web site 

during normal business hours from 

FERC Online Support at (202) 502–6652 

(toll free at 1–866–208–3676) or email at 

ferconlinesupport@ferc.gov, or the 

Public Reference Room at (202) 502– 

8371, TTY (202) 502–8659. Email the 

Public Reference Room at public.

referenceroom@ferc.gov. 

VIII. Effective Date 

16. The Commission is issuing this 

rule as a Final Rule without a period for 

public comment. Under 5 U.S.C. 

553(b)(3)(A), notice and comment 

procedures are unnecessary for 

‘‘interpretative rules, general statements 

of policy, or rules of agency 

organization, procedure, or 

practice. . . .’’ This rule merely 

provides the public with guidance 

concerning the existing regulation and 

reminds the general public of the roles 

available to the public at the 

Commission’s open meetings. The rule 

will not significantly affect regulated 

entities or the general public. 

17. These regulations are effective 

April 13, 2015. 

List of Subjects in 18 CFR Part 375 

Open Meetings. 

Issued: March 9, 2015. 

By the Commission. 

Kimberly D. Bose, 

Secretary. 

In consideration of the foregoing, the 

Commission amends Part 375, Chapter I, 

Title 18, Code of Federal Regulations, as 

follows: 

PART 375—THE COMMISSION 

■ 1. The authority citation for Part 375 

continues to read as follows: 

Authority: 5 U.S.C. 551–557; 15 U.S.C. 

717–717w, 3301–3432; 16 U.S.C. 791–825r, 

2601–2645; 42 U.S.C. 7101–7352 

■ 2. Section 375.203 is amended by 

adding paragraphs (b)(1)(i) and (ii) and 

revising paragraph (b)(2) to read as 

follows: 

§ 375.203 Open meetings. 

* * * * * 

(b) * * * 

(1) * * * 

(i) ‘‘Observe’’ does not include 

participation or disruptive conduct, and 

persons engaging in such conduct will 

be removed from the meeting. 

(ii) The right of the public to observe 

open meetings does not alter those rules 

which relate to the filing of motions, 

pleadings, or other documents. Unless 

such pleadings conform to the other 

procedural requirements, pleadings 

based upon comments or discussions at 

open meetings, as a general rule, will 

not become part of the official record, 

will receive no consideration, and no 

further action by the Commission will 

be taken thereon. 

(2) To the extent their use does not 

interfere with the conduct of open 

meetings, electronic audio and visual 

recording equipment may be used by a 

seated observer at an open meeting. 

* * * * * 

[FR Doc. 2015–05689 Filed 3–12–15; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 11 and 101 

[Docket No. FDA–2011–F–0172] 

Nutrition Labeling of Standard Menu 

Items in Restaurants and Similar Retail 

Food Establishments; Small Entity 

Compliance Guide; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a 

guidance for industry entitled 

‘‘Nutrition Labeling of Standard Menu 

Items in Restaurants and Similar Retail 

Food Establishments—Small Entity 

Compliance Guide’’. The small entity 

compliance guide (SECG) is intended to 

help small entities comply with the 

final rule entitled ‘‘Nutrition Labeling of 

Standard Menu Items in Restaurants 

and Similar Retail Food 

Establishments.’’ 

DATES: The SECG will be available as of 

March 13, 2015. Submit either 

electronic or written comments on FDA 

guidances at any time. 

ADDRESSES: Submit written requests for 

single copies of the SECG to the Office 

of Nutrition, Labeling and Dietary 

Supplements, Food Labeling and 

Standards Staff, Center for Food Safety 

and Applied Nutrition (HFS–305), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the SECG. 

Submit electronic comments on the 

SECG to http://www.regulations.gov. 

Submit written comments on the SECG 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Y. Reese, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2371. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 1, 

2014 (79 FR 71156), we issued a final 

rule requiring nutrition labeling of 

standard menu items in restaurants and 

similar retail food establishments (the 

final rule). The final rule, which is 

codified at 21 CFR 101.11, is effective 

December 1, 2015. 

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 have a significant 

economic impact on a substantial 

number of small entities. 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 the 

SECG to explain the actions that a small 

entity must take to comply with the 

rule. 


tkelley on DSK3SPTVN1PROD with RULES
13226 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 

We are issuing the SECG consistent 

with our good guidance practices 

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

SECG represents our current thinking on 

nutrition labeling of standard menu 

items in restaurants and similar retail 

food establishments. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This SECG refers to collections of 

information described in FDA’s final 

rule that published in the Federal 

Register of December 1, 2014 (79 FR 

71156), and that will be effective on 

December 1, 2015. As stated in the final 

rule, these collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). In 

compliance with the PRA (44 U.S.C. 

3507(d)), the Agency has submitted the 

information collection provisions of the 

final rule to OMB for review. FDA will 

publish a document in the Federal 

Register announcing OMB’s decision to 

approve, modify, or disapprove the 

information collection provisions in this 

final rule. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

III. Comments 

Interested persons may submit either 

electronic comments regarding the 

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

written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the SECG at either http://

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/default.htm or 

http://www.regulations.gov. Use the 

FDA Web site listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: March 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05590 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, 556, 

and 558 

[Docket No. FDA–2014–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval actions for new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) during November and 

December 2014. FDA is also informing 

the public of the availability of 

summaries of the basis of approval and 

of environmental review documents, 

where applicable. The animal drug 

regulations are also being amended to 

reflect a change of sponsorship of eight 

NADAs and nine ANADAs, and to make 

correcting amendments for a drug 

labeler code. 

DATES: This rule is effective March 13, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9019, 

george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

amending the animal drug regulations to 

reflect approval actions for NADAs and 

ANADAs during November and 

December 2014, as listed in table 1. In 

addition, FDA is informing the public of 

the availability, where applicable, of 

documentation of environmental review 

required under the National 

Environmental Policy Act (NEPA) and, 

for actions requiring review of safety or 

effectiveness data, summaries of the 

basis of approval (FOI Summaries) 

under the Freedom of Information Act 

(FOIA). These public documents may be 

seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. Persons with access to the 

Internet may obtain these documents at 

the CVM FOIA Electronic Reading 

Room: http://www.fda.gov/AboutFDA/

CentersOffices/OfficeofFoods/CVM/

CVMFOIAElectronicReadingRoom/

default.htm. Marketing exclusivity and 

patent information may be accessed in 

FDA’s publication, Approved Animal 

Drug Products Online (Green Book) at: 

http://www.fda.gov/AnimalVeterinary/

Products/

ApprovedAnimalDrugProducts/

default.htm. 

In addition, Pennfield Oil Co., 14040 

Industrial Rd., Omaha, NE 68144, has 

transferred ownership of, and all rights 

and interest in, the following approved 

applications to Pharmgate LLC, 161 

North Franklin Turnpike, Suite 2C, 

Ramsey, NJ 07446: 

File No. Product name 21 CFR Cite 

065–480 ........ Chlortetracycline Soluble Powder .................................................................................................. 520.441. 

138–934 ........ PENNCHLOR SP (chlortetracycline, sulfamethazine, penicillin) Type A medicated articles ....... 558.145. 

138–935 ........ PENNCHLOR (chlortetracycline) Type A medicated articles ........................................................ 558.128. 

138–938 ........ PENNOX (oxytetracycline) Type A medicated articles ................................................................. 558.450. 

138–939 ........ NEO–OXY (neomycin sulfate and oxytetracycline) Type A medicated articles ........................... 558.455. 

140–680 ........ TYLAN (tylosin phosphate) Type A medicated articles ................................................................ 558.625. 

140–681 ........ TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated articles .................. 558.630. 

141–137 ........ PENITRACIN (bacitracin methylenedisalicylate) 50 Type A medicated article ............................ Not codified. 

200–026 ........ PENNOX 343 (oxytetracycline) ..................................................................................................... 520.1660d. 

200–154 ........ PENNOX 200 (oxytetracycline) ..................................................................................................... 558.450. 

200–295 ........ PENNCHLOR 64 (chlortetracycline) .............................................................................................. 558.128. 

200–314 ........ PENNCHLOR S (chlortetracycline) ............................................................................................... 558.140. 

200–354 ........ PENNCHLOR (chlortetracycline)/COBAN (monensin) .................................................................. 558.355. 

200–356 ........ PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) ............................................................. 558.600. 


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