80 FR 13225 - Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 49 (March 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 49 (March 13, 2015)
| Page Range | 13225-13226 | |
| FR Document | 2015-05590 |
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)] [Rules and Regulations] [Pages 13225-13226] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05590] ======================================================================= ----------------------------------------------------------------------- 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. [[Page 13226]] 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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/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
![Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13225
description and analysis of final rules By the Commission. announcing the availability of a
that will have significant economic Kimberly D. Bose, guidance for industry entitled
impact on a substantial number of small Secretary. ‘‘Nutrition Labeling of Standard Menu
entities. This Final Rule concerns an Items in Restaurants and Similar Retail
In consideration of the foregoing, the
interpretation of current Commission Food Establishments—Small Entity
Commission amends Part 375, Chapter I,
regulations and practices. The Compliance Guide’’. The small entity
Title 18, Code of Federal Regulations, as
Commission certifies that it will not compliance guide (SECG) is intended to
follows:
have a significant economic impact help small entities comply with the
upon participants in Commission PART 375—THE COMMISSION final rule entitled ‘‘Nutrition Labeling of
proceedings. An analysis under the RFA Standard Menu Items in Restaurants
is not required. ■ 1. The authority citation for Part 375 and Similar Retail Food
VII. Document Availability continues to read as follows: Establishments.’’
Authority: 5 U.S.C. 551–557; 15 U.S.C. DATES: The SECG will be available as of
13. In addition to publishing the full 717–717w, 3301–3432; 16 U.S.C. 791–825r,
text of this document in the Federal March 13, 2015. Submit either
2601–2645; 42 U.S.C. 7101–7352
Register, the Commission provides all electronic or written comments on FDA
■ 2. Section 375.203 is amended by guidances at any time.
interested persons an opportunity to
adding paragraphs (b)(1)(i) and (ii) and
view and/or print the contents of this ADDRESSES: Submit written requests for
revising paragraph (b)(2) to read as
document via the Internet through the single copies of the SECG to the Office
follows:
Commission’s Home Page (http:// of Nutrition, Labeling and Dietary
www.ferc.gov) and in the Commission’s § 375.203 Open meetings. Supplements, Food Labeling and
Public Reference Room during normal * * * * * Standards Staff, Center for Food Safety
business hours (8:30 a.m. to 5:00 p.m. (b) * * * and Applied Nutrition (HFS–305), Food
Eastern time) at 888 First Street NE., (1) * * * and Drug Administration, 5100 Paint
Room 2A, Washington, DC 20426. (i) ‘‘Observe’’ does not include Branch Pkwy., College Park, MD 20740.
14. From the Commission’s Home participation or disruptive conduct, and Send two self-addressed adhesive labels
Page on the Internet, this information is persons engaging in such conduct will to assist that office in processing your
available on eLibrary. The full text of be removed from the meeting. request. See the SUPPLEMENTARY
this document is available on eLibrary (ii) The right of the public to observe INFORMATION section for electronic
in PDF and Microsoft Word format for open meetings does not alter those rules access to the SECG.
viewing, printing, and/or downloading. which relate to the filing of motions, Submit electronic comments on the
To access this document in eLibrary, pleadings, or other documents. Unless SECG to http://www.regulations.gov.
type the docket number excluding the such pleadings conform to the other Submit written comments on the SECG
last three digits of this document in the procedural requirements, pleadings to the Division of Dockets Management
docket number field. based upon comments or discussions at (HFA–305), Food and Drug
15. User assistance is available for open meetings, as a general rule, will Administration, 5630 Fishers Lane, Rm.
eLibrary and the Commission’s Web site not become part of the official record, 1061, Rockville, MD 20852.
during normal business hours from will receive no consideration, and no FOR FURTHER INFORMATION CONTACT:
FERC Online Support at (202) 502–6652 further action by the Commission will
(toll free at 1–866–208–3676) or email at Daniel Y. Reese, Center for Food Safety
be taken thereon. and Applied Nutrition (HFS–820), Food
ferconlinesupport@ferc.gov, or the (2) To the extent their use does not
Public Reference Room at (202) 502– and Drug Administration, 5100 Paint
interfere with the conduct of open Branch Pkwy., College Park, MD 20740,
8371, TTY (202) 502–8659. Email the meetings, electronic audio and visual
Public Reference Room at public. 240–402–2371.
recording equipment may be used by a
referenceroom@ferc.gov. seated observer at an open meeting. SUPPLEMENTARY INFORMATION:
VIII. Effective Date * * * * * I. Background
[FR Doc. 2015–05689 Filed 3–12–15; 8:45 am]
16. The Commission is issuing this In the Federal Register of December 1,
BILLING CODE 6717–01–P
rule as a Final Rule without a period for 2014 (79 FR 71156), we issued a final
public comment. Under 5 U.S.C. rule requiring nutrition labeling of
553(b)(3)(A), notice and comment standard menu items in restaurants and
procedures are unnecessary for DEPARTMENT OF HEALTH AND similar retail food establishments (the
‘‘interpretative rules, general statements HUMAN SERVICES final rule). The final rule, which is
of policy, or rules of agency codified at 21 CFR 101.11, is effective
Food and Drug Administration
organization, procedure, or December 1, 2015.
practice. . . .’’ This rule merely We examined the economic
21 CFR Parts 11 and 101
provides the public with guidance implications of the final rule as required
concerning the existing regulation and [Docket No. FDA–2011–F–0172] by the Regulatory Flexibility Act (5
reminds the general public of the roles U.S.C. 601–612) and determined that
available to the public at the Nutrition Labeling of Standard Menu the final rule will have a significant
Commission’s open meetings. The rule Items in Restaurants and Similar Retail economic impact on a substantial
will not significantly affect regulated Food Establishments; Small Entity number of small entities. In compliance
entities or the general public. Compliance Guide; Availability with section 212 of the Small Business
tkelley on DSK3SPTVN1PROD with RULES
17. These regulations are effective AGENCY: Food and Drug Administration, Regulatory Enforcement Fairness Act
April 13, 2015. HHS. (Pub. L. 104–121, as amended by Pub.
List of Subjects in 18 CFR Part 375 ACTION: Notification of availability. L. 110–28), we are making available the
SECG to explain the actions that a small
Open Meetings. SUMMARY: The Food and Drug entity must take to comply with the
Issued: March 9, 2015. Administration (FDA or we) is rule.
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![13226 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations
We are issuing the SECG consistent will be posted to the docket at http:// correcting amendments for a drug
with our good guidance practices www.regulations.gov. labeler code.
regulation (21 CFR 10.115(c)(2)). The DATES: This rule is effective March 13,
IV. Electronic Access
SECG represents our current thinking on 2015.
nutrition labeling of standard menu Persons with access to the Internet
items in restaurants and similar retail may obtain the SECG at either http:// FOR FURTHER INFORMATION CONTACT:
food establishments. It does not create www.fda.gov/Food/Guidance George K. Haibel, Center for Veterinary
or confer any rights for or on any person Regulation/GuidanceDocuments Medicine (HFV–6), Food and Drug
and does not operate to bind FDA or the RegulatoryInformation/default.htm or Administration, 7519 Standish Pl.,
public. An alternative approach may be http://www.regulations.gov. Use the Rockville, MD 20855, 240–276–9019,
used if such approach satisfies the FDA Web site listed in the previous george.haibel@fda.hhs.gov.
requirements of the applicable statutes sentence to find the most current
SUPPLEMENTARY INFORMATION: FDA is
and regulations. version of the guidance.
amending the animal drug regulations to
II. Paperwork Reduction Act of 1995 Dated: March 6, 2015. reflect approval actions for NADAs and
Leslie Kux, ANADAs during November and
This SECG refers to collections of
Associate Commissioner for Policy. December 2014, as listed in table 1. In
information described in FDA’s final
[FR Doc. 2015–05590 Filed 3–12–15; 8:45 am] addition, FDA is informing the public of
rule that published in the Federal
BILLING CODE 4164–01–P the availability, where applicable, of
Register of December 1, 2014 (79 FR
documentation of environmental review
71156), and that will be effective on
December 1, 2015. As stated in the final required under the National
DEPARTMENT OF HEALTH AND Environmental Policy Act (NEPA) and,
rule, these collections of information are
HUMAN SERVICES for actions requiring review of safety or
subject to review by the Office of
Management and Budget (OMB) under effectiveness data, summaries of the
Food and Drug Administration basis of approval (FOI Summaries)
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). In under the Freedom of Information Act
21 CFR Parts 510, 520, 522, 524, 556, (FOIA). These public documents may be
compliance with the PRA (44 U.S.C. and 558
3507(d)), the Agency has submitted the seen in the Division of Dockets
information collection provisions of the [Docket No. FDA–2014–N–0002] Management (HFA–305), Food and Drug
final rule to OMB for review. FDA will Administration, 5630 Fishers Lane, Rm.
New Animal Drugs; Approval of New 1061, Rockville, MD 20852, between 9
publish a document in the Federal
Animal Drug Applications; Change of a.m. and 4 p.m., Monday through
Register announcing OMB’s decision to
Sponsor Friday. Persons with access to the
approve, modify, or disapprove the
information collection provisions in this AGENCY: Food and Drug Administration, Internet may obtain these documents at
final rule. An Agency may not conduct HHS. the CVM FOIA Electronic Reading
or sponsor, and a person is not required Room: http://www.fda.gov/AboutFDA/
Final rule; technical
ACTION:
CentersOffices/OfficeofFoods/CVM/
to respond to, a collection of amendments.
information unless it displays a CVMFOIAElectronicReadingRoom/
currently valid OMB control number. SUMMARY: The Food and Drug default.htm. Marketing exclusivity and
Administration (FDA) is amending the patent information may be accessed in
III. Comments animal drug regulations to reflect FDA’s publication, Approved Animal
Interested persons may submit either approval actions for new animal drug Drug Products Online (Green Book) at:
electronic comments regarding the applications (NADAs) and abbreviated http://www.fda.gov/AnimalVeterinary/
SECG to http://www.regulations.gov or new animal drug applications Products/
written comments to the Division of (ANADAs) during November and ApprovedAnimalDrugProducts/
Dockets Management (see ADDRESSES). It December 2014. FDA is also informing default.htm.
is only necessary to send one set of the public of the availability of In addition, Pennfield Oil Co., 14040
comments. Identify comments with the summaries of the basis of approval and Industrial Rd., Omaha, NE 68144, has
docket number found in brackets in the of environmental review documents, transferred ownership of, and all rights
heading of this document. Received where applicable. The animal drug and interest in, the following approved
comments may be seen in the Division regulations are also being amended to applications to Pharmgate LLC, 161
of Dockets Management between 9 a.m. reflect a change of sponsorship of eight North Franklin Turnpike, Suite 2C,
and 4 p.m., Monday through Friday, and NADAs and nine ANADAs, and to make 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.
tkelley on DSK3SPTVN1PROD with RULES
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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Document Created: 2015-12-18 11:41:25
Document Modified: 2015-12-18 11:41:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The SECG will be available as of March 13, 2015. Submit either electronic or written comments on FDA guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 13225 | |
| CFR Citation | 21
CFR
101 21 CFR 11 |
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