81 FR 68434 - Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 192 (October 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 192 (October 4, 2016)
| Page Range | 68434-68435 | |
| FR Document | 2016-23931 |
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)] [Notices] [Pages 68434-68435] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23931] ----------------------------------------------------------------------- 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[Docket No. FDA-2011-D-0376] Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,'' that appeared in the Federal Register of August 12,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 DATES: We are extending the comment period on the draft guidance published August 12, 2016 (81 FR 53486).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
![68434 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
Notice of this meeting is given under DATES: Fax written comments on the requirement for a paper copy. These
the Federal Advisory Committee Act (5 collection of information by November types of documents are listed in public
U.S.C. app. 2). 3, 2016. docket 97S–0251 as required by 21 CFR
Dated: September 28, 2016. ADDRESSES: To ensure that comments on 11.2. Our ability to receive and process
Janice M. Soreth, the information collection are received, information submitted electronically is
Acting Associate Commissioner, Special OMB recommends that written limited by our current information
Medical Programs. comments be faxed to the Office of technology capabilities and the
[FR Doc. 2016–23895 Filed 10–3–16; 8:45 am] Information and Regulatory Affairs, requirements of the Electronic Records;
BILLING CODE 4164–01–P
OMB, Attn: FDA Desk Officer, FAX: Electronic Signatures final regulation.
202–395–7285, or emailed to oira_ Our guidance entitled ‘‘Guidance for
submission@omb.eop.gov. All Industry #108: How to Submit
DEPARTMENT OF HEALTH AND comments should be identified with the Information in Electronic Format to
HUMAN SERVICES OMB control number 0910–0454. Also CVM Using the FDA Electronic
include the FDA docket number found Submission Gateway’’ outlines general
Food and Drug Administration in brackets in the heading of this standards to be used for the submission
[Docket No. FDA–2013–N–0519] document.
of any electronic information to CVM
FOR FURTHER INFORMATION CONTACT: FDA using the FDA Electronic Submission
Agency Information Collection PRA Staff, Office of Operations, Food Gateway (ESG). The likely respondents
Activities; Submission for Office of and Drug Administration, Three White are sponsors for new animal drug
Management and Budget Review; Flint North, 10A63, 11601 Landsdown applications.
Comment Request; Guidance for St., North Bethesda, MD 20852,
Industry on How To Submit PRAStaff@fda.hhs.gov. In the Federal Register of April 8,
Information in Electronic Format to the 2016 (81 FR 20647), FDA published a
SUPPLEMENTARY INFORMATION: In
Center for Veterinary Medicine Using 60-day notice requesting public
compliance with 44 U.S.C. 3507, FDA
the Food and Drug Administration has submitted the following proposed comment on the proposed collection of
Electronic Submission Gateway collection of information to OMB for information. FDA received one
AGENCY: Food and Drug Administration, review and clearance. comment; however, it did not pertain to
HHS. the information collection.
Guidance for Industry on How to
ACTION: Notice. FDA estimates the burden of this
Submit Information in Electronic
Format to the Center for Veterinary collection of information as follows:
SUMMARY: The Food and Drug
Administration (FDA) is announcing Medicine Using the Food and Drug
that a proposed collection of Administration Electronic Submission
information has been submitted to the Gateway—21 CFR 11.2 OMB Control
Office of Management and Budget Number 0910–0454—Extension
(OMB) for review and clearance under We accept certain types of
the Paperwork Reduction Act of 1995. submissions electronically with no
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section FDA Form No. responses per burden per Total hours
respondents responses
respondent response
11.2 .................................................... 3538 29 1.3 38 .08 ....................... 3.0
(5 minutes) ..........
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our DEPARTMENT OF HEALTH AND revised draft guidance for industry
experience with the submission of HUMAN SERVICES entitled ‘‘Dietary Supplements: New
electronic information to us using the Dietary Ingredient Notifications and
FDA ESG and the number of electronic Food and Drug Administration Related Issues,’’ that appeared in the
registration or change requests received [Docket No. FDA–2011–D–0376] Federal Register of August 12, 2016. We
between January 1, 2014, and December are taking this action in response to
31, 2014. Dietary Supplements: New Dietary requests to extend the comment period
Ingredient Notifications and Related to allow interested persons additional
Dated: September 26, 2016.
Issues; Revised Draft Guidance for time to submit comments.
Leslie Kux, Industry; Extension of Comment
Associate Commissioner for Policy. Period DATES: We are extending the comment
[FR Doc. 2016–23897 Filed 10–3–16; 8:45 am] period on the draft guidance published
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration, August 12, 2016 (81 FR 53486). Submit
BILLING CODE 4164–01–P
HHS. either electronic or written comments
ACTION:Notice of availability; extension by December 12, 2016.
of comment period.
ADDRESSES: You may submit comments
SUMMARY: The Food and Drug as follows:
Administration (FDA or we) is
extending the comment period for the
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![Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 68435
Electronic Submissions information you claim to be confidential including in particular (but not limited
Submit electronic comments in the with a heading or cover note that states to) section III. Comments on these
following way: ‘‘THIS DOCUMENT CONTAINS issues, the revised draft guidance, and
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The the relevant portions of the 2011 draft
www.regulations.gov. Follow the Agency will review this copy, including guidance, will contribute to our final
instructions for submitting comments. the claimed confidential information, in guidance on new dietary ingredient
Comments submitted electronically, its consideration of comments. The notifications and related issues. The
including attachments, to http:// second copy, which will have the comment period was scheduled to end
www.regulations.gov will be posted to claimed confidential information on October 11, 2016.
the docket unchanged. Because your redacted/blacked out, will be available We received requests for 30- and 90-
comment will be made public, you are for public viewing and posted on http:// day extensions of the comment period.
solely responsible for ensuring that your www.regulations.gov. Submit both In general, the requests conveyed
comment does not include any copies to the Division of Dockets concern that the current 60-day
confidential information that you or a Management. If you do not wish your comment period does not allow
third party may not wish to be posted, name and contact information to be sufficient time for interested parties to
such as medical information, your or made publicly available, you can develop a meaningful or thoughtful
anyone else’s Social Security number, or provide this information on the cover response to the draft guidance. Some
confidential business information, such sheet and not in the body of your requests mentioned that the requests for
as a manufacturing process. Please note comments and you must identify this comment may necessitate indepth
that if you include your name, contact information as ‘‘confidential.’’ Any research and/or require supporting data
information, or other information that information marked as ‘‘confidential’’ to provide meaningful responses.
identifies you in the body of your will not be disclosed except in We considered the requests and are
comments, that information will be accordance with 21 CFR 10.20 and other extending the comment period for the
posted on http://www.regulations.gov. applicable disclosure law. For more draft guidance for 60 days until
• If you want to submit a comment information about FDA’s posting of December 12, 2016. We believe that this
with confidential information that you comments to public dockets, see 80 FR extension allows adequate time for
do not wish to be made available to the 56469, September 18, 2015, or access interested persons to submit comments
public, submit the comment as a the information at: http://www.fda.gov/ without significantly delaying finalizing
written/paper submission and in the regulatoryinformation/dockets/ the guidance.
manner detailed (see ‘‘Written/Paper default.htm. Dated: September 28, 2016.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Leslie Kux,
read background documents or the
Written/Paper Submissions Associate Commissioner for Policy.
electronic and written/paper comments
received, go to http:// [FR Doc. 2016–23931 Filed 10–3–16; 8:45 am]
Submit written/paper submissions as
www.regulations.gov and insert the BILLING CODE 4164–01–P
follows:
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the
‘‘Search’’ box and follow the prompts DEPARTMENT OF HEALTH AND
Dockets Management (HFA–305), Food HUMAN SERVICES
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Food and Drug Administration
• For written/paper comments 1061, Rockville, MD 20852.
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Cara [Docket No. FDA–2016–N–2873]
Management, FDA will post your Welch, Office of Dietary Supplement
Programs, Center for Food Safety and Workshop on Promoting Semantic
comment, as well as any attachments,
Applied Nutrition (HFS–810), Food and Interoperability of Laboratory Data;
except for information submitted,
Drug Administration, 5001 Campus Dr., Public Workshop; Request for
marked and identified, as confidential,
College Park, MD 20740, 240–402–2333. Comments
if submitted as detailed in
‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the AGENCY: Food and Drug Administration,
Instructions: All submissions received Federal Register of August 12, 2016, we HHS.
must include the Docket No. FDA– published a notice announcing the ACTION: Notice of public workshop;
2011–D–0376 for ‘‘Dietary Supplements: availability of a revised draft guidance request for comments.
New Dietary Ingredient Notifications for industry entitled ‘‘Dietary
and Related Issues; Revised Draft Supplements: New Dietary Ingredient SUMMARY: The Centers for Disease
Guidance for Industry.’’ Received Notifications and Related Issues.’’ The Control and Prevention (CDC), the Food
comments will be placed in the docket revised draft guidance, when finalized, and Drug Administration (FDA), the
and, except for those submitted as will help industry in evaluating whether National Library of Medicine (NLM) of
‘‘Confidential Submissions,’’ publicly to submit a premarket safety notification the National Institutes of Health (NIH),
viewable at http://www.regulations.gov for a new dietary ingredient (NDI), or for the Office of the National Coordinator
or at the Division of Dockets a dietary supplement containing an NDI, for Health Information Technology
Management between 9 a.m. and 4 p.m., and in preparing such premarket safety (ONC), and the Centers for Medicare
Monday through Friday. notifications (also referred to as NDI and Medicaid Services (CMS) are
mstockstill on DSK3G9T082PROD with NOTICES
• Confidential Submissions—To notifications). section III of the notice announcing the following public
submit a comment with confidential (81 FR 53486 at 53489), ‘‘Other Issues workshop entitled ‘‘CDC/FDA/NLM/
information that you do not wish to be for Consideration,’’ listed specific issues ONC/CMS Workshop on Promoting
made publicly available, submit your to be addressed. Semantic Interoperability of Laboratory
comments only as a written/paper The notice provided a 60-day period Data.’’ The purpose of this public
submission. You should submit two for the submission of comments workshop is to receive and discuss
copies total. One copy will include the pertaining to the revised draft guidance, input from stakeholders regarding
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Document Created: 2016-10-04 03:03:15
Document Modified: 2016-10-04 03:03:15
| 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 of availability; extension of comment period. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 68434 |
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