Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment Period, 68434-68435 [2016-23931]

Download as PDF 68434 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 28, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016–23895 Filed 10–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0519] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. SUMMARY: Fax written comments on the collection of information by November 3, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0454. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. DATES: Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway—21 CFR 11.2 OMB Control Number 0910–0454—Extension We accept certain types of submissions electronically with no requirement for a paper copy. These types of documents are listed in public docket 97S–0251 as required by 21 CFR 11.2. Our ability to receive and process information submitted electronically is limited by our current information technology capabilities and the requirements of the Electronic Records; Electronic Signatures final regulation. Our guidance entitled ‘‘Guidance for Industry #108: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway’’ outlines general standards to be used for the submission of any electronic information to CVM using the FDA Electronic Submission Gateway (ESG). The likely respondents are sponsors for new animal drug applications. In the Federal Register of April 8, 2016 (81 FR 20647), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment; however, it did not pertain to the information collection. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Section FDA Form No. 11.2 .................................................... 1 There 3538 Number of responses per respondent 29 Average burden per response Total annual responses 1.3 38 .08 ....................... (5 minutes) .......... Total hours 3.0 are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimates on our experience with the submission of electronic information to us using the FDA ESG and the number of electronic registration or change requests received between January 1, 2014, and December 31, 2014. Dated: September 26, 2016. Leslie Kux, Associate Commissioner for Policy. mstockstill on DSK3G9T082PROD with NOTICES Number of respondents [FR Doc. 2016–23897 Filed 10–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0376] Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for the SUMMARY: VerDate Sep<11>2014 19:01 Oct 03, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 revised draft guidance for industry entitled ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,’’ that appeared in the Federal Register of August 12, 2016. We are taking this action in response to requests to extend the comment period to allow interested persons additional time to submit comments. We are extending the comment period on the draft guidance published August 12, 2016 (81 FR 53486). Submit either electronic or written comments by December 12, 2016. DATES: ADDRESSES: You may submit comments as follows: E:\FR\FM\04OCN1.SGM 04OCN1 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 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’’). mstockstill on DSK3G9T082PROD with NOTICES 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– 2011–D–0376 for ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry.’’ 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 comments only as a written/paper submission. You should submit two copies total. One copy will include the VerDate Sep<11>2014 19:01 Oct 03, 2016 Jkt 241001 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: Cara Welch, Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (HFS–810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2333. SUPPLEMENTARY INFORMATION: In the Federal Register of August 12, 2016, we published a notice announcing the availability of a revised draft guidance for industry entitled ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.’’ The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications). section III of the notice (81 FR 53486 at 53489), ‘‘Other Issues for Consideration,’’ listed specific issues to be addressed. The notice provided a 60-day period for the submission of comments pertaining to the revised draft guidance, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 68435 including in particular (but not limited to) section III. Comments on these issues, the revised draft guidance, and the relevant portions of the 2011 draft guidance, will contribute to our final guidance on new dietary ingredient notifications and related issues. The comment period was scheduled to end on October 11, 2016. We received requests for 30- and 90day extensions of the comment period. In general, the requests conveyed concern that the current 60-day comment period does not allow sufficient time for interested parties to develop a meaningful or thoughtful response to the draft guidance. Some requests mentioned that the requests for comment may necessitate indepth research and/or require supporting data to provide meaningful responses. We considered the requests and are extending the comment period for the draft guidance for 60 days until December 12, 2016. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance. Dated: September 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–23931 Filed 10–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2873] Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS) are announcing the following public workshop entitled ‘‘CDC/FDA/NLM/ ONC/CMS Workshop on Promoting Semantic Interoperability of Laboratory Data.’’ The purpose of this public workshop is to receive and discuss input from stakeholders regarding SUMMARY: E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68434-68435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0376]


Dietary Supplements: New Dietary Ingredient Notifications and 
Related Issues; Revised Draft Guidance for Industry; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the revised draft guidance for industry entitled 
``Dietary Supplements: New Dietary Ingredient Notifications and Related 
Issues,'' that appeared in the Federal Register of August 12, 2016. We 
are taking this action in response to requests to extend the comment 
period to allow interested persons additional time to submit comments.

DATES: We are extending the comment period on the draft guidance 
published August 12, 2016 (81 FR 53486). Submit either electronic or 
written comments by December 12, 2016.

ADDRESSES: You may submit comments as follows:

[[Page 68435]]

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-2011-D-0376 for ``Dietary Supplements: New Dietary Ingredient 
Notifications and Related Issues; Revised Draft Guidance for 
Industry.'' 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 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: Cara Welch, Office of Dietary 
Supplement Programs, Center for Food Safety and Applied Nutrition (HFS-
810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 
20740, 240-402-2333.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 12, 2016, 
we published a notice announcing the availability of a revised draft 
guidance for industry entitled ``Dietary Supplements: New Dietary 
Ingredient Notifications and Related Issues.'' The revised draft 
guidance, when finalized, will help industry in evaluating whether to 
submit a premarket safety notification for a new dietary ingredient 
(NDI), or for a dietary supplement containing an NDI, and in preparing 
such premarket safety notifications (also referred to as NDI 
notifications). section III of the notice (81 FR 53486 at 53489), 
``Other Issues for Consideration,'' listed specific issues to be 
addressed.
    The notice provided a 60-day period for the submission of comments 
pertaining to the revised draft guidance, including in particular (but 
not limited to) section III. Comments on these issues, the revised 
draft guidance, and the relevant portions of the 2011 draft guidance, 
will contribute to our final guidance on new dietary ingredient 
notifications and related issues. The comment period was scheduled to 
end on October 11, 2016.
    We received requests for 30- and 90-day extensions of the comment 
period. In general, the requests conveyed concern that the current 60-
day comment period does not allow sufficient time for interested 
parties to develop a meaningful or thoughtful response to the draft 
guidance. Some requests mentioned that the requests for comment may 
necessitate indepth research and/or require supporting data to provide 
meaningful responses.
    We considered the requests and are extending the comment period for 
the draft guidance for 60 days until December 12, 2016. We believe that 
this extension allows adequate time for interested persons to submit 
comments without significantly delaying finalizing the guidance.

    Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23931 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P