Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period, 4225-4226 [2017-00724]

Download as PDF Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Proposed Rules northwest by the 22-mile radius of Devils Lake VOR/DME. * * * * AGL ND E5 * AGL ND E5 Devils Lake, ND [Amended] Devils Lake Regional Airport, ND (Lat. 48°06′53″ N., long. 98°54′30″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.) That airspace extending upward from 700 feet above the surface within an 8.7-mile radius of Devils Lake Regional Airport and that airspace extending upward from 1,200 feet above the surface within a 22-mile radius of Devils Lake VOR/DME. * * * * * AGL ND E5 Gwinner, ND [Amended] Gwinner-Roger Melroe Field, ND (Lat. 46°13′06″ N., long. 97°38′36″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Gwinner-Roger Melroe Field Airport. * * * * * AGL ND E5 Hettinger, ND [Amended] Hettinger Municipal Airport, ND (Lat. 46°00′54″ N., long. 102°39′22″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Hettinger Municipal Airport; and that airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 46°20′00″ N., long. 102°58′00″ W., to lat. 46°20′00″ N., long. 102°44′00″ W., to lat. 45°45′00″ N., long. 102°09′00″ W., to lat. 45°45′00″ N., long. 102°58′00″ W., to the point of beginning, excluding that airspace within V–491. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS * * * * * AGL ND E5 Pembina, ND [Amended] Pembina Municipal Airport, ND (Lat. 48°56′33″ N., long. 97°14′27″ W.) Humboldt VORTAC (Lat. 48°52′09″ N., long. 97°07′02″ W.) Grand Forks AFB, ND (Lat. 47°57′41″ N., long. 97°24′03″ W.) Devils Lake VOR/DME (Lat. 48°06′55″ N., long. 98°54′45″ W.) That airspace extending upward from 700 feet above the surface within a 6.2-mile radius of Pembina Municipal Airport, and within 1.8 miles each side of Humboldt VORTAC 132/312° radials extending from the 6.2-mile radius to 7 miles southeast of the airport; and that airspace extending upward from 1,200 feet above the surface beginning at lat. 49°00′00″ N., long. 97°30′01″ W.; to lat. 48°48′00″ N., long. 97°30′01″ W.; to lat. 48°18′34″ N., long. 98°39′53″ W.; thence clockwise around a 15.3-mile radius of Devils Lake VOR/DME to V–430; thence east along V–430 to the intersection of a 34-mile radius of Grand Forks AFB; thence clockwise along the 34-mile radius of Grand Forks AFB to the North Dakota/Minnesota state boundary; thence north along the state boundary to the United States/Canada border; thence west along the United States/Canada border to the point of beginning, excluding that airspace within all Federal airways. * * * VerDate Sep<11>2014 * Rugby, ND [Amended] Rugby Municipal Airport, ND (Lat. 48°23′25″ N., long. 100°01′27″ W.) That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Rugby Municipal Airport; and that airspace extending upward from 1,200 feet above the surface within a 13-mile radius of Rugby Municipal Airport, and within 8.1 miles north and 4.2 miles south of the 115° bearing from the airport extending from the 13-mile radius to 16.1 miles east of the airport, and within 8.5 miles south and 3.8 miles north of the 314° bearing from the airport extending from the 13-mile radius to 16.1 miles northwest of the airport, excluding that airspace within Minot, ND, and Rolla, ND, Class E airspace areas, and excluding all Federal airways. * * * AGL ND E5 * * Valley City, ND [Amended] * AGL ND E5 * * Wahpeton, ND [Amended] Harry Stern Airport, ND (Lat. 46°14′40″ N., long. 96°36′26″ W.) That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Harry Stern Airport and that airspace extending upward from 1,200 feet above the surface within a 25-mile radius of Harry Stern Airport bounded on the east by the Minnesota border and on the west by V– 181. Issued in Fort Worth, Texas, on December 15, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2017–00286 Filed 1–12–17; 8:45 am] BILLING CODE 4910–13–P * 17:29 Jan 12, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA–2016–D–3401] Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notification of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a 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’’ that appeared in the Federal Register of November 23, 2016. The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: We are extending the comment period on the notice that published in the Federal Register of November 23, 2016 (81 FR 84516). Submit either electronic or written comments by February 13, 2017. ADDRESSES: You may submit comments as follows: SUMMARY: * Barnes County Municipal Airport, ND (Lat. 46°56′28″ N., long. 98°01′05″ W.) That airspace extending upward from 700 feet above the surface within a 6.4 mile radius of Barnes County Municipal Airport; and that airspace extending upward from 1,200 feet above the surface within a 7.9-mile radius of the airport, and within 4 miles southwest and 8.3 miles northeast of the 133° bearing from the airport extending from the 7.9-mile radius to 21.8 miles southeast of the airport. * 4225 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 E:\FR\FM\13JAP1.SGM 13JAP1 4226 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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– 2016–D–3401 for ‘‘Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry.’’ 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.’’ 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 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 VerDate Sep<11>2014 16:35 Jan 12, 2017 Jkt 241001 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 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. 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 84516), we published a notice announcing the availability of a 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.’’ The draft guidance explains the scientific review approach we plan to use for evaluating scientific evidence submitted to us in citizen petitions to determine whether a particular isolated or synthetic non-digestible carbohydrate that is added to food 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 33742). Only those isolated or synthetic nondigestible carbohydrates that meet the definition can be declared as a dietary fiber on a Nutrition and Supplement Facts label. We provided a 60-day comment period that was scheduled to close on January 23, 2017. Elsewhere in this issue of the Federal Register, we have published a notice to reopen the comment period for a related notice that appeared in the Federal Register of November 23, 2016 (81 FR 84595). We requested scientific data, information and comments in the related November 23, 2016, notice to help us evaluate the potential beneficial physiological effects on human health of PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 26 specific isolated or synthetic nondigestible carbohydrates that are added to food so that we may determine whether any of them should be added to our definition of dietary fiber in our Nutrition Facts and Supplement Facts label final rule. The November 23, 2016, 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. The original comment period for this notice closed on January 9, 2017. We have received requests to extend the comment period for the isolated or synthetic non-digestible carbohydrates draft guidance. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the draft guidance. We have considered the requests and are extending the comment period for the draft guidance until February 13, 2017. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance. The extended comment period deadline February 13, 2017, for the draft guidance also coincides with the reopened comment period for our related request for scientific data, information, and comments for the November 23, 2016, notice. Dated: January 10, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–00724 Filed 1–12–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF STATE 22 CFR Part 121 [Public Notice: 9852] Notice of Inquiry; Request for Comments Regarding United States Munitions List Category XII Department of State. Notice of Inquiry, request for comments. AGENCY: ACTION: The Department of State requests comments from the public regarding recent revisions to Category XII of the United States Munitions List (USML). In light of the ongoing transition of the USML to a more ‘‘positive list’’ pursuant to the President’s Export Control Reform (ECR) SUMMARY: E:\FR\FM\13JAP1.SGM 13JAP1

Agencies

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Proposed Rules]
[Pages 4225-4226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00724]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-3401]


Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition; Draft Guidance for 
Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice of availability of a 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'' that appeared in the 
Federal Register of November 23, 2016. The draft guidance, when 
finalized, will describe our views on the scientific evidence needed 
and the approach to evaluating the scientific evidence on the 
physiological effects of isolated or synthetic non-digestible 
carbohydrates that are added to foods that are beneficial to human 
health. We are taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: We are extending the comment period on the notice that published 
in the Federal Register of November 23, 2016 (81 FR 84516). 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: 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

[[Page 4226]]

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-2016-D-3401 for ``Scientific Evaluation of the Evidence on the 
Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates Submitted as a Citizen Petition; Draft 
Guidance for Industry.'' 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.'' 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 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 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 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.

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 84516), we published a notice announcing the availability of a 
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.'' The draft 
guidance explains the scientific review approach we plan to use for 
evaluating scientific evidence submitted to us in citizen petitions to 
determine whether a particular isolated or synthetic non-digestible 
carbohydrate that is added to food 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 33742). 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. We provided a 60-day 
comment period that was scheduled to close on January 23, 2017.
    Elsewhere in this issue of the Federal Register, we have published 
a notice to reopen the comment period for a related notice that 
appeared in the Federal Register of November 23, 2016 (81 FR 84595). We 
requested scientific data, information and comments in the related 
November 23, 2016, notice to help us evaluate the potential beneficial 
physiological effects on human health of 26 specific isolated or 
synthetic non-digestible carbohydrates that are added to food so that 
we may determine whether any of them should be added to our definition 
of dietary fiber in our Nutrition Facts and Supplement Facts label 
final rule. The November 23, 2016, 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. The 
original comment period for this notice closed on January 9, 2017.
    We have received requests to extend the comment period for the 
isolated or synthetic non-digestible carbohydrates draft guidance. The 
requests conveyed concern that the current 60-day comment period does 
not allow sufficient time to develop meaningful or thoughtful comments 
to the draft guidance.
    We have considered the requests and are extending the comment 
period for the draft guidance until February 13, 2017. We believe that 
this extension allows adequate time for interested persons to submit 
comments without significantly delaying finalizing the guidance. The 
extended comment period deadline February 13, 2017, for the draft 
guidance also coincides with the reopened comment period for our 
related request for scientific data, information, and comments for the 
November 23, 2016, notice.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00724 Filed 1-12-17; 8:45 am]
BILLING CODE 4164-01-P