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)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4348-4349 | |
| FR Document | 2017-00725 |
[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] ----------------------------------------------------------------------- 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
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![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](https://thefederalregister.org/doc/82_FR_4357/page/2.svg)
Document Created: 2017-01-13 02:44:21
Document Modified: 2017-01-13 02:44:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; reopening of comment period. | |
| Dates | Submit either electronic or written comments by February 13, 2017. | |
| 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. | |
| FR Citation | 82 FR 4348 |
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