Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments, 84595-84596 [2016-27950]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices guidance entitled ‘‘Over-the-Counter Sunscreens: Safety and Effectiveness Data’’ that was issued on November 23, 2015 (see 80 FR 72975) and incorporates editorial changes and clarifying language based on FDA’s consideration of comments received on that draft guidance. The draft guidance and related public comments are available at http://www.regulations.gov by searching Docket No. FDA–2015–D–4021. This guidance addresses the current thinking of FDA about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the SIA (Pub. L. 113–195), enacted November 26, 2014, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351 et seq.), is GRASE and not misbranded when used under specified conditions. The guidance also addresses FDA’s current thinking about an approach to safetyrelated final formulation testing that it anticipates adopting in the future. FDA is issuing this guidance in partial implementation of the SIA which, among other things, established new procedures and review timelines for FDA to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients is GRASE and not misbranded when used under the conditions specified in a final sunscreen order, in accordance with sections 586A, 586B, and 586C of the FD&C Act (21 U.S.C. 360fff–1, 360fff–2, and 360fff–3). The SIA directed FDA to issue guidance on four topics, including guidance regarding safety and effectiveness data in accordance with section 586D of the FD&C Act (21 U.S.C. 360ffff–4). Many of the safety topics addressed in this guidance were discussed at a public Nonprescription Drug Advisory Committee meeting held on September 4 and 5, 2014, http:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ NonprescriptionDrugsAdvisory Committee/ucm380890.htm. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on the topics it addresses. This guidance 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. VerDate Sep<11>2014 18:04 Nov 22, 2016 Jkt 241001 II. The Paperwork Reduction Act of 1995 This guidance contains collections of information that are exempt from the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). Section 586D(a)(1)(C) of the FD&C Act, as amended by the SIA, states that the PRA shall not apply to collections of information made for purposes of guidance under that subsection. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: November 17, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28124 Filed 11–22–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Food and Drug Administration, HHS. Notice; request for scientific data, information, and comments. ACTION: The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would help us evaluate the beneficial physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods. We are requesting such scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ‘‘dietary fiber’’ for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label. SUMMARY: Submit either electronic or written scientific data, information, and comments by January 9, 2017. DATES: ADDRESSES: You may submit comments as follows: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Electronic Submissions Submit electronic scientific data, information, and comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comments 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 http://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 [Docket No. FDA–2016–N–3389] AGENCY: 84595 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– 2016–N–3389 for ‘‘Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://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 E:\FR\FM\23NON1.SGM 23NON1 84596 Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices 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 http:// 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 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://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 http:// 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. FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2579. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES I. Background FDA regulations did not define the term ‘‘dietary fiber’’ before 2016. In the Federal Register of May 27, 2016 (81 FR 33742), we published a final rule amending our Nutrition and Supplement Facts label regulation. The final rule, among other things, defines dietary fiber as non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are VerDate Sep<11>2014 18:04 Nov 22, 2016 Jkt 241001 beneficial to human health (21 CFR 101.9(c)(6)(i)). The final rule also identifies seven isolated or synthetic non-digestible carbohydrates that we determined to have beneficial effects for human health when added to foods (§ 101.9(c)(6)(i)). The seven isolated or synthetic non-digestible carbohydrates are: [beta]-glucan soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)); psyllium husk (as described in § 101.81(c)(2)(ii)); cellulose, guar gum, pectin, locust bean gum; and hydroxypropyl methylcellulose. Foods and dietary supplements that contain any of these seven isolated or synthetic non-digestible carbohydrates must include the amounts of these dietary fibers in a serving of food in the dietary fiber declarations on the products’ Nutrition and Supplement Facts labels. Interested parties can ask us to list additional isolated or synthetic nondigestible carbohydrates in the definition of dietary fiber in § 101.9(c)(6)(i) if we determine that the new isolated or synthetic non-digestible carbohydrate meets our dietary fiber definition. For example, a manufacturer who wants FDA to amend the definition of dietary fiber to include another added non-digestible carbohydrate could submit a citizen petition under 21 CFR 10.30. Elsewhere in this issue of the Federal Register, we have published a notice announcing the availability of a draft guidance document entitled, ‘‘Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry.’’ The draft guidance describes the type of evidence and the scientific evaluation process we plan to use in determining the strength of the evidence for the relationship between an isolated or synthetic non-digestible carbohydrate that is added to food and a physiological effect that is beneficial to human health. In addition to issuing the draft guidance and determining that the seven isolated or synthetic nondigestible carbohydrates identified in the final rule’s definition of dietary fibers have physiological effects that are beneficial to human health, we have conducted a scientific literature review of clinical studies associated with 26 isolated or synthetic non-digestible carbohydrates, such as gum acacia, carboxymethyl cellulose, inulin, polydextrose, and xanthan gum, that are not listed as a dietary fiber in § 101.9(c)(6)(i). Our review is consistent with the factors we provide in the draft guidance entitled, ‘‘Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of PO 00000 Frm 00050 Fmt 4703 Sfmt 9990 Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (§ 10.30); Guidance for Industry’’ to evaluate whether the available scientific evidence is sufficient to support a physiological effect that is beneficial to human health, based on the factors set forth in the draft guidance. We have summarized the clinical studies that we have identified for these 26 non-digestible carbohydrates and have provided summaries of the studies and related references in a document entitled ‘‘Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates.’’ The purpose of this Federal Register notice is to invite interested parties to submit additional scientific data, information, and comments regarding: • The physiological endpoints that we have addressed in the science review for each of the 26 non-digestible carbohydrates, and • Other beneficial physiological endpoints and the relevant scientific data for a particular fiber. We have identified the main endpoints, such as cholesterol or glucose levels, but ask for scientific data on additional physiological endpoints (blood pressure) for which a non-digestible carbohydrate may have a beneficial physiological effect. II. Reference The following reference is on display at the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA, 2016. ‘‘Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates.’’ Available at: http:// www.fda.gov/Food/IngredientsPackaging Labeling/LabelingNutrition/ucm 525656.htm. Dated: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–27950 Filed 11–22–16; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84595-84596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3389]


Evaluation of the Beneficial Physiological Effects of Isolated or 
Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, 
Information, and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for scientific data, information, and comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is requesting 
scientific data, information, and comments that would help us evaluate 
the beneficial physiological effects to human health of isolated or 
synthetic non-digestible carbohydrates that are added to foods. We are 
requesting such scientific data, information, and comments to help us 
determine whether a particular isolated or synthetic non-digestible 
carbohydrate should be added to our definition of ``dietary fiber'' for 
purposes of being declared as dietary fiber on a Nutrition Facts or 
Supplement Facts label.

DATES: Submit either electronic or written scientific data, 
information, and comments by January 9, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic scientific data, information, and comments in the 
following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comments 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 http://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-2016-N-3389 for ``Evaluation of the Beneficial Physiological 
Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request 
for Scientific Data, Information, and Comments.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://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

[[Page 84596]]

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 http://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 comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://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 http://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.

FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2579.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA regulations did not define the term ``dietary fiber'' before 
2016. In the Federal Register of May 27, 2016 (81 FR 33742), we 
published a final rule amending our Nutrition and Supplement Facts 
label regulation. The final rule, among other things, defines dietary 
fiber as non-digestible soluble and insoluble carbohydrates (with three 
or more monomeric units), and lignin that are intrinsic and intact in 
plants; isolated or synthetic non-digestible carbohydrates (with three 
or more monomeric units) determined by FDA to have physiological 
effects that are beneficial to human health (21 CFR 101.9(c)(6)(i)). 
The final rule also identifies seven isolated or synthetic non-
digestible carbohydrates that we determined to have beneficial effects 
for human health when added to foods (Sec.  101.9(c)(6)(i)). The seven 
isolated or synthetic non-digestible carbohydrates are: [beta]-glucan 
soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)); psyllium husk 
(as described in Sec.  101.81(c)(2)(ii)); cellulose, guar gum, pectin, 
locust bean gum; and hydroxypropyl methylcellulose. Foods and dietary 
supplements that contain any of these seven isolated or synthetic non-
digestible carbohydrates must include the amounts of these dietary 
fibers in a serving of food in the dietary fiber declarations on the 
products' Nutrition and Supplement Facts labels.
    Interested parties can ask us to list additional isolated or 
synthetic non-digestible carbohydrates in the definition of dietary 
fiber in Sec.  101.9(c)(6)(i) if we determine that the new isolated or 
synthetic non-digestible carbohydrate meets our dietary fiber 
definition. For example, a manufacturer who wants FDA to amend the 
definition of dietary fiber to include another added non-digestible 
carbohydrate could submit a citizen petition under 21 CFR 10.30. 
Elsewhere in this issue of the Federal Register, we have published a 
notice announcing the availability of a draft guidance document 
entitled, ``Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance 
for Industry.'' The draft guidance describes the type of evidence and 
the scientific evaluation process we plan to use in determining the 
strength of the evidence for the relationship between an isolated or 
synthetic non-digestible carbohydrate that is added to food and a 
physiological effect that is beneficial to human health.
    In addition to issuing the draft guidance and determining that the 
seven isolated or synthetic non-digestible carbohydrates identified in 
the final rule's definition of dietary fibers have physiological 
effects that are beneficial to human health, we have conducted a 
scientific literature review of clinical studies associated with 26 
isolated or synthetic non-digestible carbohydrates, such as gum acacia, 
carboxymethyl cellulose, inulin, polydextrose, and xanthan gum, that 
are not listed as a dietary fiber in Sec.  101.9(c)(6)(i). Our review 
is consistent with the factors we provide in the draft guidance 
entitled, ``Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition (Sec.  10.30); Guidance 
for Industry'' to evaluate whether the available scientific evidence is 
sufficient to support a physiological effect that is beneficial to 
human health, based on the factors set forth in the draft guidance. We 
have summarized the clinical studies that we have identified for these 
26 non-digestible carbohydrates and have provided summaries of the 
studies and related references in a document entitled ``Evaluation of 
the Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates.'' The purpose of this Federal Register notice 
is to invite interested parties to submit additional scientific data, 
information, and comments regarding:
     The physiological endpoints that we have addressed in the 
science review for each of the 26 non-digestible carbohydrates, and
     Other beneficial physiological endpoints and the relevant 
scientific data for a particular fiber. We have identified the main 
endpoints, such as cholesterol or glucose levels, but ask for 
scientific data on additional physiological endpoints (blood pressure) 
for which a non-digestible carbohydrate may have a beneficial 
physiological effect.

II. Reference

    The following reference is on display at the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA, 2016. ``Evaluation of the Beneficial Physiological Effects 
of Isolated or Synthetic Non-Digestible Carbohydrates.'' Available 
at: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm525656.htm.

    Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27950 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P