82_FR_4357 82 FR 4348 - Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period

82 FR 4348 - Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 9 (January 13, 2017)

Page Range4348-4349
FR Document2017-00725

The Food and Drug Administration (FDA or we) is reopening the comment period for the document requesting scientific data, information, and comments entitled ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates'' that appeared in the Federal Register of November 23, 2016 (81 FR 84595). In the document, we requested 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. We also announced in the document the availability for comment of a scientific literature review document that we conducted that summarizes clinical studies associated with 26 specific isolated or synthetic non- digestible carbohydrates. We are taking this action in response to requests to allow interested persons additional time to submit comments.

Federal Register, Volume 82 Issue 9 (Friday, January 13, 2017)
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4348-4349]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00725]


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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; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the document requesting scientific data, 
information, and comments entitled ``Evaluation of the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates'' that appeared in the Federal Register of November 23, 
2016 (81 FR 84595). In the document, we requested 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. We also 
announced in the document the availability for comment of a scientific 
literature review document that we conducted that summarizes clinical 
studies associated with 26 specific isolated or synthetic non-
digestible carbohydrates. We are taking this action in response to 
requests to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by February 13, 
2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic 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 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 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

[[Page 4349]]

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 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.'' We will review 
this copy, including the claimed confidential information, in our 
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: In the Federal Register of November 23, 2016 
(81 FR 84595), we published a document requesting scientific data, 
information, and comments that would help us evaluate the beneficial 
physiological effects to human health of isolated or synthetic non-
digestible carbohydrate that are added to food. We requested 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'' that is found in the 
Nutrition and Supplement Facts label final rule, which appeared in the 
Federal Register of May 27, 2016 (81 FR 33741). Only those isolated or 
synthetic non-digestible carbohydrates that meet the definition can be 
declared as a dietary fiber on a Nutrition and Supplement Facts label. 
The notice also announced the availability of a document entitled 
``Science Review of Isolated and Synthetic Non-Digestible 
Carbohydrates,'' which summarizes a scientific literature review that 
we conducted of clinical studies associated with the 26 specific 
isolated or synthetic non-digestible carbohydrates. We provided a 45-
day comment period that ended on January 9, 2017.
    We have received requests to extend the period during which 
interested parties may submit scientific data, information, and 
comments regarding isolated or synthetic non-digestible carbohydrates 
generally and regarding our scientific literature review summary 
document specifically. The requests conveyed concern that the original 
45-day comment period would not allow sufficient time to develop 
meaningful or thoughtful scientific data, information, or comments.
    We have considered the requests but were unable to issue a notice 
extending the comment period before January 9, 2017. Consequently, we 
are reopening the comment period for an additional 30 days. Interested 
parties have until February 13, 2017, to submit scientific data, 
information, or comments to the docket. We believe that this action 
allows adequate time for interested persons to submit additional 
scientific data, information and comments.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00725 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                    4348                                       Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices

                                                                                                      TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
                                                                                                                                                                               Number of                                                Average
                                                                                                                                                    Number of                                            Total annual
                                                                                           Activity                                                                          responses per                                            burden per              Total hours
                                                                                                                                                   respondents                                            responses
                                                                                                                                                                               respondent                                              response

                                                    Information for the Proposed Proper Name for Applicable
                                                       Biological Products Submitted Under Section 351(k) of
                                                       the PHS Act ......................................................................                              3                           2                          6                     420              2,520

                                                          Total ..............................................................................    ........................   ........................   ........................   ........................         19,320
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                       This guidance also refers to                                            DEPARTMENT OF HEALTH AND                                                       • Federal eRulemaking Portal: http://
                                                    previously approved collections of                                         HUMAN SERVICES                                                               www.regulations.gov. Follow the
                                                    information found in FDA regulations.                                                                                                                   instructions for submitting comments.
                                                    The collection of information related to                                   Food and Drug Administration                                                 Comments submitted electronically,
                                                    the submission of a BLA under section                                                                                                                   including attachments, to http://
                                                                                                                               [Docket No. FDA–2016–N–3389]
                                                    351(k) of the PHS Act (biosimilar                                                                                                                       www.regulations.gov will be posted to
                                                    products and interchangeable products)                                     Evaluation of the Beneficial                                                 the docket unchanged. Because your
                                                    has been approved under OMB control                                        Physiological Effects of Isolated or                                         comment will be made public, you are
                                                    number 0910–0719. The guidance also                                        Synthetic Non-Digestible                                                     solely responsible for ensuring that your
                                                    refers to a previously approved                                            Carbohydrates; Request For Scientific                                        comment does not include any
                                                    collection of information found in FDA                                     Data, Information, and Comments;                                             confidential information that you or a
                                                    regulations that is expected to change as                                  Reopening of Comment Period                                                  third party may not wish to be posted,
                                                    a result of the guidance and the                                                                                                                        such as medical information, your or
                                                    retrospective application of the naming                                    AGENCY:           Food and Drug Administration,                              anyone else’s Social Security number, or
                                                    convention. The collections of                                             HHS.                                                                         confidential business information, such
                                                    information in 21 CFR part 601 related                                     ACTION:       Notice; reopening of comment                                   as a manufacturing process. Please note
                                                    to the submission of a biologics license                                   period.                                                                      that if you include your name, contact
                                                    application (BLA) and changes to an                                                                                                                     information, or other information that
                                                    approved application have been                                             SUMMARY:    The Food and Drug                                                identifies you in the body of your
                                                    approved under OMB control number                                          Administration (FDA or we) is                                                comments, that information will be
                                                    0910–0338. As a result of the guidance,                                    reopening the comment period for the                                         posted on http://www.regulations.gov.
                                                                                                                               document requesting scientific data,                                           • If you want to submit a comment
                                                    the estimated number of additional
                                                                                                                               information, and comments entitled                                           with confidential information that you
                                                    responses for the annual burden for                                                                                                                     do not wish to be made available to the
                                                                                                                               ‘‘Evaluation of the Beneficial
                                                    changes to an approved application                                                                                                                      public, submit the comment as a
                                                                                                                               Physiological Effects of Isolated or
                                                    under § 601.12 would be increased by                                                                                                                    written/paper submission and in the
                                                                                                                               Synthetic Non-Digestible
                                                    approximately 25 responses.                                                                                                                             manner detailed (see ‘‘Written/Paper
                                                                                                                               Carbohydrates’’ that appeared in the
                                                       FDA is issuing this final guidance                                      Federal Register of November 23, 2016                                        Submissions’’ and ‘‘Instructions’’).
                                                    subject to OMB approval of the                                             (81 FR 84595). In the document, we                                           Written/Paper Submissions
                                                    collections of information. Before                                         requested scientific data, information,
                                                    implementing the information                                               and comments to help us determine                                               Submit written/paper submissions as
                                                    collection provisions of the guidance,                                     whether a particular isolated or                                             follows:
                                                    FDA will publish a notice in the Federal                                   synthetic non-digestible carbohydrate                                           • Mail/Hand delivery/Courier (for
                                                    Register announcing OMB’s decision to                                                                                                                   written/paper submissions): Division of
                                                                                                                               should be added to our definition of
                                                    approve, modify, or disapprove the                                                                                                                      Dockets Management (HFA–305), Food
                                                                                                                               ‘‘dietary fiber’’ for purposes of being
                                                    collections of information, including                                                                                                                   and Drug Administration, 5630 Fishers
                                                                                                                               declared as dietary fiber on a Nutrition
                                                    OMB control number(s) for newly                                                                                                                         Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                                               Facts or Supplement Facts label. We                                             • For written/paper comments
                                                    approved collections.                                                      also announced in the document the                                           submitted to the Division of Dockets
                                                                                                                               availability for comment of a scientific                                     Management, FDA will post your
                                                    III. Electronic Access
                                                                                                                               literature review document that we                                           comment, as well as any attachments,
                                                      Persons with access to the Internet                                      conducted that summarizes clinical                                           except for information submitted,
                                                    may obtain the guidance at http://www.                                     studies associated with 26 specific                                          marked and identified, as confidential,
                                                    fda.gov/Drugs/GuidanceCompliance                                           isolated or synthetic non-digestible                                         if submitted as detailed in
                                                    RegulatoryInformation/Guidances/                                           carbohydrates. We are taking this action                                     ‘‘Instructions.’’
                                                    default.htm, http://www.fda.gov/                                           in response to requests to allow                                                Instructions: All submissions received
                                                    BiologicsBloodVaccines/Guidance                                            interested persons additional time to                                        must include the Docket No. FDA–
                                                    ComplianceRegulatoryInformation/                                           submit comments.                                                             2016–N–3389 for ‘‘Evaluation of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Guidances/default.htm, or https://                                         DATES: Submit either electronic or                                           Beneficial Physiological Effects of
                                                    www.regulations.gov.                                                       written comments by February 13, 2017.                                       Isolated or Synthetic Non-Digestible
                                                      Dated: January 10, 2017.                                                 ADDRESSES: You may submit comments                                           Carbohydrates; Request for Scientific
                                                                                                                               as follows:                                                                  Data, Information, and Comments.’’
                                                    Leslie Kux,
                                                                                                                                                                                                            Received comments will be placed in
                                                    Associate Commissioner for Policy.                                         Electronic Submissions                                                       the docket and, except for those
                                                    [FR Doc. 2017–00694 Filed 1–12–17; 8:45 am]                                  Submit electronic comments in the                                          submitted as ‘‘Confidential
                                                    BILLING CODE 4164–01–P                                                     following way:                                                               Submissions,’’ publicly viewable at


                                               VerDate Sep<11>2014        19:06 Jan 12, 2017         Jkt 241001       PO 00000        Frm 00070        Fmt 4703       Sfmt 4703       E:\FR\FM\13JAN1.SGM              13JAN1


                                                                                    Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices                                            4349

                                                    http://www.regulations.gov or at the                    information, and comments to help us                   DEPARTMENT OF HEALTH AND
                                                    Division of Dockets Management                          determine whether a particular isolated                HUMAN SERVICES
                                                    between 9 a.m. and 4 p.m., Monday                       or synthetic non-digestible carbohydrate
                                                    through Friday.                                         should be added to our definition of                   Food and Drug Administration
                                                       • Confidential Submissions—To                        ‘‘dietary fiber’’ that is found in the
                                                    submit a comment with confidential                                                                             [Docket No. FDA–2017–N–0086]
                                                                                                            Nutrition and Supplement Facts label
                                                    information that you do not wish to be                  final rule, which appeared in the                      Suggestions, Recommendations, and
                                                    made publicly available, submit your                    Federal Register of May 27, 2016 (81 FR                Comments for Topics That May Be
                                                    comments only as a written/paper                        33741). Only those isolated or synthetic               Considered by the Food and Drug
                                                    submission. You should submit two                       non-digestible carbohydrates that meet                 Administration Combination Product
                                                    copies total. One copy will include the                                                                        Policy Council; Establishment of a
                                                                                                            the definition can be declared as a
                                                    information you claim to be confidential                                                                       Docket
                                                                                                            dietary fiber on a Nutrition and
                                                    with a heading or cover note that states
                                                                                                            Supplement Facts label. The notice also
                                                    ‘‘THIS DOCUMENT CONTAINS                                                                                       AGENCY:   Food and Drug Administration,
                                                    CONFIDENTIAL INFORMATION.’’ We                          announced the availability of a                        HHS.
                                                    will review this copy, including the                    document entitled ‘‘Science Review of
                                                                                                            Isolated and Synthetic Non-Digestible                  ACTION: Notice; establishment of docket;
                                                    claimed confidential information, in our                                                                       request for comments.
                                                    consideration of comments. The second                   Carbohydrates,’’ which summarizes a
                                                    copy, which will have the claimed                       scientific literature review that we                   SUMMARY:   The Food and Drug
                                                    confidential information redacted/                      conducted of clinical studies associated               Administration (FDA) is establishing a
                                                    blacked out, will be available for public               with the 26 specific isolated or synthetic             docket to receive suggestions,
                                                    viewing and posted on http://                           non-digestible carbohydrates. We                       recommendations, and comments for
                                                    www.regulations.gov. Submit both                        provided a 45-day comment period that                  topics from interested parties, including
                                                    copies to the Division of Dockets                       ended on January 9, 2017.                              academic institutions, regulated
                                                    Management. If you do not wish your                        We have received requests to extend                 industry, patient representatives, and
                                                    name and contact information to be                      the period during which interested                     other interested organizations, on policy
                                                    made publicly available, you can                        parties may submit scientific data,                    issues that may be considered by the
                                                    provide this information on the cover                   information, and comments regarding                    FDA Combination Product Policy
                                                    sheet and not in the body of your                                                                              Council (Council). These comments will
                                                                                                            isolated or synthetic non-digestible
                                                    comments and you must identify this                                                                            help the Agency identify and address
                                                                                                            carbohydrates generally and regarding
                                                    information as ‘‘confidential.’’ Any                                                                           combination product policy issues that
                                                                                                            our scientific literature review summary               need clarification through guidance,
                                                    information marked as ‘‘confidential’’
                                                                                                            document specifically. The requests                    notice and comment procedures, or
                                                    will not be disclosed except in
                                                    accordance with 21 CFR 10.20 and other                  conveyed concern that the original 45-                 other means.
                                                    applicable disclosure law. For more                     day comment period would not allow
                                                                                                                                                                   DATES: Submit either electronic or
                                                    information about FDA’s posting of                      sufficient time to develop meaningful or
                                                                                                                                                                   written comments by April 13, 2017.
                                                    comments to public dockets, see 80 FR                   thoughtful scientific data, information,
                                                                                                                                                                   ADDRESSES: You may submit comments
                                                    56469, September 18, 2015, or access                    or comments.
                                                                                                                                                                   as follows:
                                                    the information at: http://www.fda.gov/                    We have considered the requests but
                                                    regulatoryinformation/dockets/                          were unable to issue a notice extending                Electronic Submissions
                                                    default.htm.                                            the comment period before January 9,                     Submit electronic comments in the
                                                       Docket: For access to the docket to                  2017. Consequently, we are reopening                   following way:
                                                    read background documents or the                        the comment period for an additional 30                  • Federal eRulemaking Portal:
                                                    electronic and written/paper comments                   days. Interested parties have until                    https://www.regulations.gov. Follow the
                                                    received, go to http://                                 February 13, 2017, to submit scientific                instructions for submitting comments.
                                                    www.regulations.gov and insert the                      data, information, or comments to the                  Comments submitted electronically,
                                                    docket number, found in brackets in the                 docket. We believe that this action                    including attachments, to https://
                                                    heading of this document, into the                                                                             www.regulations.gov will be posted to
                                                                                                            allows adequate time for interested
                                                    ‘‘Search’’ box and follow the prompts                                                                          the docket unchanged. Because your
                                                                                                            persons to submit additional scientific
                                                    and/or go to the Division of Dockets                                                                           comment will be made public, you are
                                                    Management, 5630 Fishers Lane, Rm.                      data, information and comments.
                                                                                                                                                                   solely responsible for ensuring that your
                                                    1061, Rockville, MD 20852.                                Dated: January 10, 2017.                             comment does not include any
                                                    FOR FURTHER INFORMATION CONTACT:                        Leslie Kux,                                            confidential information that you or a
                                                    Paula R. Trumbo, Center for Food Safety                 Associate Commissioner for Policy.                     third party may not wish to be posted,
                                                    and Applied Nutrition (HFS–830), Food                   [FR Doc. 2017–00725 Filed 1–12–17; 8:45 am]            such as medical information, your or
                                                    and Drug Administration, 5001 Campus                    BILLING CODE 4164–01–P                                 anyone else’s Social Security number, or
                                                    Dr., College Park, MD 20740, 240–402–                                                                          confidential business information, such
                                                    2579.                                                                                                          as a manufacturing process. Please note
                                                    SUPPLEMENTARY INFORMATION: In the                                                                              that if you include your name, contact
                                                    Federal Register of November 23, 2016                                                                          information, or other information that
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    (81 FR 84595), we published a                                                                                  identifies you in the body of your
                                                    document requesting scientific data,                                                                           comments, that information will be
                                                    information, and comments that would                                                                           posted on https://www.regulations.gov.
                                                    help us evaluate the beneficial                                                                                  • If you want to submit a comment
                                                    physiological effects to human health of                                                                       with confidential information that you
                                                    isolated or synthetic non-digestible                                                                           do not wish to be made available to the
                                                    carbohydrate that are added to food. We                                                                        public, submit the comment as a
                                                    requested such scientific data,                                                                                written/paper submission and in the


                                               VerDate Sep<11>2014   19:06 Jan 12, 2017   Jkt 241001   PO 00000   Frm 00071   Fmt 4703   Sfmt 4703   E:\FR\FM\13JAN1.SGM   13JAN1



Document Created: 2017-01-13 02:44:21
Document Modified: 2017-01-13 02:44:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; reopening of comment period.
DatesSubmit either electronic or written comments by February 13, 2017.
ContactPaula 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.
FR Citation82 FR 4348 

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