The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for Industry; Availability, 43061-43062 [2016-15477]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations C. Impairment of hearing as described under the criteria in 102.10 or 102.11. 111.10 [Reserved] 111.11 [Reserved] 111.12 Myasthenia gravis, characterized by A or B despite adherence to prescribed treatment for at least 3 months (see 111.00C): A. Disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting in: 1. One myasthenic crisis requiring mechanical ventilation; or 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter. 111.13 Muscular dystrophy, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.14 Peripheral neuropathy, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.15 [Reserved] 111.16 [Reserved] 111.17 Neurodegenerative disorders of the central nervous system, such as Juvenileonset Huntington’s disease and Friedreich’s ataxia, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.18 Traumatic brain injury, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities, persisting for at least 3 consecutive months after the injury. 111.19 [Reserved] 111.20 Coma or persistent vegetative state, persisting for at least 1 month. 111.21 Multiple sclerosis, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.22 Motor neuron disorders, characterized by A or B: A. Disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting in: 1. Acute respiratory failure requiring invasive mechanical ventilation; or VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter. [FR Doc. 2016–15306 Filed 6–30–16; 8:45 am] BILLING CODE 4191–02–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; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a guidance for industry entitled ‘‘FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.’’ The guidance explains 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. SUMMARY: The guidance is available on July 1, 2016. Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: DATES: 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 PO 00000 Frm 00079 Fmt 4700 Sfmt 4700 43061 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2015–D–1839. 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 Division of Dockets Management 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.’’ The Agency will review this copy, including the claimed confidential information, in its 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 Division of Dockets Management. If you do not wish your name and 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 E:\FR\FM\01JYR1.SGM 01JYR1 43062 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling (HFS–820), Center for Food Safety and Applied Nutrition, 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 guidance. 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: asabaliauskas on DSK3SPTVN1PROD with RULES I. Background We are announcing the availability of a final guidance for industry entitled ‘‘FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.’’ We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance 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. In the Federal Register of July 30, 2015, we made available a draft guidance for industry entitled ‘‘FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.’’ The draft guidance would 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. We gave interested parties an opportunity to submit comments by September 28, 2015, for us to consider before beginning work on the final VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 version of the guidance. We received a few comments on the draft guidance, yet most pertained to the Nutrition Facts label itself or to specific nutrients rather than our policy on the declaration of small amounts. We only made editorial changes to the guidance, which include updates to the list of nutrients in 21 CFR 101.9(g)(4) and (g)(5) consistent with the final rule entitled, ‘‘Food Labeling; Revision of the Nutrition and Supplement Facts Labels’’ that appeared in the Federal Register on May 27, 2016 (81 FR 33742). The guidance announced in this document finalizes the draft guidance dated July 2015. II. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/FoodGuidances or https:// www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: June 24, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–15477 Filed 6–30–16; 8:45 am] BILLING CODE 4164–01–P this interim final rule must be received by August 30, 2016. ADDRESSES: Please send your comments on the interim final rule to one of the following addresses: • https://www.regulations.gov (via the online comment form for this document as posted within Docket No. TTB–2016– 0006 at Regulations.gov, the Federal erulemaking portal); • U.S. Mail: Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; or • Hand delivery/courier in lieu of mail: Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Suite 400, Washington, DC 20005. See the Public Participation section of this document for specific instructions and requirements for submitting comments. FOR FURTHER INFORMATION CONTACT: Andrew L. Malone, Public Guidance Program Manager, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; (202) 453–1039, ext. 188. SUPPLEMENTARY INFORMATION: Background DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 16 [Docket No. TTB–2016–0006; T.D. TTB–138] RIN 1513–AC28 Civil Monetary Penalty Inflation Adjustment—Alcoholic Beverage Labeling Act Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Interim final rule (Treasury decision); Request for comments. AGENCY: This interim final rule implements the provisions of the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, with respect to the civil penalty provision of the Alcoholic Beverage Labeling Act of 1988 (ABLA). Specifically, this interim final rule increases the maximum civil monetary penalty for violations of the provisions of the ABLA from $10,000 to $19,787, in accordance with Federal law. DATES: The effective date of this interim final rule is July 1, 2016. Comments on SUMMARY: PO 00000 Frm 00080 Fmt 4700 Sfmt 4700 Statutory Authority for Federal Civil Monetary Penalty Inflation Adjustments The Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), Public Law 101–410, 104 Stat. 890, 28 U.S.C. 2461 note, requires the regular adjustment and evaluation of civil monetary penalties to maintain their deterrent effect and helps to ensure that penalty amounts imposed by the Federal Government are properly accounted for and collected. A ‘‘civil monetary penalty’’ is defined in the Inflation Adjustment Act as any penalty, fine, or other such sanction that is: (1) For a specific monetary amount as provided by Federal law, or has a maximum amount provided for by Federal law; (2) assessed or enforced by an agency pursuant to Federal law; and (3) assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts. The Debt Collection Improvement Act of 1996 (the Improvement Act of 1996), Public Law 104–134, section 31001(s), 110 Stat. 1321, enacted on April 26, 1996, amended the Inflation Adjustment Act by requiring civil monetary penalties to be adjusted for inflation. Specifically, the Improvement Act of 1996 required, among other things, that the head of each Federal agency adjust each civil monetary penalty provided by law within the jurisdiction of the E:\FR\FM\01JYR1.SGM 01JYR1

Agencies

[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Rules and Regulations]
[Pages 43061-43062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15477]


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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; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
announcing the availability of a guidance for industry entitled ``FDA's 
Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients 
on Nutrition Labels: Guidance for Industry.'' The guidance explains 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: The guidance is available on July 1, 2016. Submit either 
electronic or written comments on FDA guidances at any time.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-1839. 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 Division of Dockets 
Management 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 Division of Dockets Management. If you do not 
wish your name and 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

[[Page 43062]]

comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Office of Nutrition and Food Labeling (HFS-820), Center for Food Safety 
and Applied Nutrition, 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 guidance.

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 final guidance for industry 
entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and 
Dietary Ingredients on Nutrition Labels.'' We are issuing this guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The guidance 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.
    In the Federal Register of July 30, 2015, we made available a draft 
guidance for industry entitled ``FDA's Policy on Declaring Small 
Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.'' The 
draft guidance would 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. We gave interested parties an 
opportunity to submit comments by September 28, 2015, for us to 
consider before beginning work on the final version of the guidance. We 
received a few comments on the draft guidance, yet most pertained to 
the Nutrition Facts label itself or to specific nutrients rather than 
our policy on the declaration of small amounts. We only made editorial 
changes to the guidance, which include updates to the list of nutrients 
in 21 CFR 101.9(g)(4) and (g)(5) consistent with the final rule 
entitled, ``Food Labeling; Revision of the Nutrition and Supplement 
Facts Labels'' that appeared in the Federal Register on May 27, 2016 
(81 FR 33742). The guidance announced in this document finalizes the 
draft guidance dated July 2015.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: June 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15477 Filed 6-30-16; 8:45 am]
 BILLING CODE 4164-01-P
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