The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability, 45465-45466 [2015-18655]

Download as PDF Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Proposed Rules FIGURE 1 TO PARAGRAPHS (h) AND (j) OF THIS AD—PART NUMBERS AND SERIAL NUMBERS OF AFFECTED FORWARD ENGINE MOUNTS AND ATTACHMENT PINS—Continued FIGURE 2 TO PARAGRAPH (i) OF THIS AD—AIRPLANE MANUFACTURER SERIAL NUMBERS—Continued Airplane manufacturer serial Nos. 4753 4754 4755 4757 4761 4762 4772 4773 4774 4775 4779 4782 4783 4784 4786 4788 4790 4791 4798 4804 4813 Serial No. Attachment Pin (P/N 740–2022–501) Forward Engine Mount (P/N 745–2010–503) 1467SC 1445SC 1462SC 1464SC 1466SC 1470SC 1459SC 1463SC 1475SC 1458SC 1477SC 1474SC 1478SC 1479SC 1472SC 13813001 13755001 13789001 13793001 13811001 13819001 13783001 13791001 13829001 13781001 13833001 13827001 13835001 13837001 13823001 (i) Exception to Paragraph (g) of This AD For airplanes with manufacturer serial numbers identified in figure 2 to paragraph (i) of this AD: If it can be conclusively determined that an engine has not been replaced after March 1, 2011 (the date of manufacture of the first airplane with affected engine mounts), the airplane is not affected by the requirements of paragraphs (g) and (h) of this AD. FIGURE 2 TO PARAGRAPH (i) OF THIS AD—AIRPLANE MANUFACTURER SERIAL NUMBERS Lhorne on DSK7TPTVN1PROD with PROPOSALS Airplane manufacturer serial Nos. 4593 4602 4620 4637 4638 4642 4643 4644 4660 4677 4690 4696 4700 4701 4703 4706 4707 4710 4716 4719 4725 4726 4731 4736 4737 4741 4746 4751 4752 VerDate Sep<11>2014 13:52 Jul 29, 2015 Jkt 235001 (k) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1405; fax 425–227–1149. Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the EASA; or Airbus’s EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature. (3) Required for Compliance (RC): If any service information contains procedures or tests that are identified as RC, those Frm 00017 Fmt 4702 Sfmt 4702 procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator’s maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in a serviceable condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC. (l) Special Flight Permits Prohibited Special flight permits, as described in Section 21.197 and Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199), are not allowed. (j) Parts Installation Prohibition As of the effective date of this AD, no person may install on any airplane any engine mount attachment pin having P/N 740–2022–501 with a serial number identified in figure 1 to paragraphs (h) and (j) of this AD. PO 00000 45465 (m) Related Information (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015–0004, dated January 13, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA–2015–2963. (2) For Airbus service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email account.airworth-eas@ airbus.com; Internet http://www.airbus.com. For Goodrich Aerostructures service information identified in this AD, contact UTC Aerospace Systems, ATTN: Christopher Newth—V2500 A1/A5 Project Engineer, Aftermarket—Aerostructures; 850 Lagoon Drive, Chula Vista, CA; telephone 619–498– 7505; email christopher.newth@utas.utc.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. Issued in Renton, Washington, on July 17, 2015. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2015–18533 Filed 7–29–15; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA–2015–D–1839] The Food and Drug Administration’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\30JYP1.SGM 30JYP1 45466 ACTION: Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Proposed Rules Notification of availability. The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ‘‘FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.’’ The draft guidance, when finalized, will explain to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 28, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS– 820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist the office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Carole Adler, 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: SUMMARY: Lhorne on DSK7TPTVN1PROD with PROPOSALS I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance represents the current thinking of FDA on our policy on declaring small amounts of nutrients and dietary ingredients on nutrition labels. It does VerDate Sep<11>2014 13:52 Jul 29, 2015 Jkt 235001 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. The draft guidance, when finalized, will explain our nutrition labeling policy on declaring the nutrient values in conventional foods and dietary ingredient values in dietary supplements in certain cases. Specifically, declaring small amounts of nutrients and dietary ingredients in the nutrition labeling may result in a conflict between 21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 101.9(g)(5). In such cases, we are recommending manufacturers declare nutrients and dietary ingredients in accordance with § 101.9(c)(1) through (8). If the draft guidance is finalized, we intend to consider the use of our enforcement discretion with respect to the compliance requirements in § 101.9(g)(4)(ii)) and § 101.9(g)(5) when a conflict exists with § 101.9(c)(1) through (8). We also are considering whether changes to our nutrition labeling regulations are needed, including changes to § 101.9(c) or (g), or both. If we determine that rulemaking is needed, we will consider whether to revise or withdraw the draft guidance. II. Paperwork Reduction Act of 1995 The draft 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 § 101.9 have been approved under OMB control number 0910–0381. III. Comments Interested persons may submit either electronic comments regarding the draft guidance to http://www.regulations.gov or written comments regarding the draft guidance 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 draft guidance document PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 at http://www.fda.gov/FoodGuidances 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: July 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18655 Filed 7–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG–138526–14] RIN 1545–BM46 Issue Price Definition for Tax-Exempt Bonds; Correction Internal Revenue Service (IRS), Treasury. ACTION: Partial withdrawal of notice of proposed rulemaking, notice of proposed rulemaking, and notice of public hearing; correction. AGENCY: This document contains corrections to partial withdrawal of notice of proposed rulemaking, notice of proposed rulemaking, and notice of public hearing; correction (REG– 138526–14) that were published in the Federal Register on Wednesday, June 24, 2015 (80 FR 36301). The partial withdrawal of notice of proposed rulemaking, notice of proposed rulemaking, and notice of public hearing are relating to the definition of issue price for purposes of the arbitrage restrictions under section 148 of the Internal Revenue Code (Code). DATES: Written or electronic comments and requests for a public hearing for the notice of proposed rulemaking published at 80 FR 36301, June 24, 2015, are still being accepted and must be received by September 22, 2015. FOR FURTHER INFORMATION CONTACT: Lewis Bell at (202) 317–6980 (not a tollfree number). SUPPLEMENTARY INFORMATION: SUMMARY: Background The notice of proposed rulemaking that is the subject of this correction is under section 148 of the Internal Revenue Code. Need for Correction As published in the Wednesday, June 24, 2015 (80 FR 36301) partial withdrawal of notice of proposed rulemaking, notice of proposed E:\FR\FM\30JYP1.SGM 30JYP1

Agencies

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Proposed Rules]
[Pages 45465-45466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18655]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2015-D-1839]


The Food and Drug Administration's Policy on Declaring Small 
Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 45466]]


ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary 
Ingredients on Nutrition Labels: Guidance for Industry.'' The draft 
guidance, when finalized, will explain to manufacturers of conventional 
foods and dietary supplements our policy on determining the amount to 
declare on the nutrition label for certain nutrients and dietary 
ingredients that are present in a small amount.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 28, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist the office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carole Adler, 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

    We are announcing the availability of a draft guidance for industry 
entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and 
Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' We 
are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance represents the 
current thinking of FDA on our policy on declaring small amounts of 
nutrients and dietary ingredients on nutrition labels. 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.
    The draft guidance, when finalized, will explain our nutrition 
labeling policy on declaring the nutrient values in conventional foods 
and dietary ingredient values in dietary supplements in certain cases. 
Specifically, declaring small amounts of nutrients and dietary 
ingredients in the nutrition labeling may result in a conflict between 
21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 
101.9(g)(5). In such cases, we are recommending manufacturers declare 
nutrients and dietary ingredients in accordance with Sec.  101.9(c)(1) 
through (8). If the draft guidance is finalized, we intend to consider 
the use of our enforcement discretion with respect to the compliance 
requirements in Sec.  101.9(g)(4)(ii)) and Sec.  101.9(g)(5) when a 
conflict exists with Sec.  101.9(c)(1) through (8).
    We also are considering whether changes to our nutrition labeling 
regulations are needed, including changes to Sec.  101.9(c) or (g), or 
both. If we determine that rulemaking is needed, we will consider 
whether to revise or withdraw the draft guidance.

II. Paperwork Reduction Act of 1995

    The draft 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 Sec.  101.9 have been approved under OMB 
control number 0910-0381.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments 
regarding the draft guidance 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 draft guidance 
document at http://www.fda.gov/FoodGuidances 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: July 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18655 Filed 7-29-15; 8:45 am]
 BILLING CODE 4164-01-P