Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients; Public Meeting; Request for Comments, 42098-42100 [2017-18812]

Download as PDF 42098 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Crew Members .................................. Interview protocol ............................. 250 1 10/60 42 Total ........................................... ........................................................... ........................ ........................ ........................ 44 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–18814 Filed 9–5–17; 8:45 am] Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients; Public Meeting; Request for Comments BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of public meeting; request for comments. ACTION: Food and Drug Administration, HHS. Notice; correction. The Food and Drug Administration (FDA) is correcting a document entitled ‘‘B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application’’ that appeared in the Federal Register of August 3, 2017 (82 FR 36150). The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food and Drug Administration, Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301– 796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, August 3, 2017, in FR Doc. 2017–16377, on page 36150, the following correction is made: 1. On page 36150, in the second column, in the header of the document, ‘‘Docket No. FDA–2017–N–0002’’ is corrected to read ‘‘Docket No. FDA– 2017–N–4642’’. asabaliauskas on DSKBBXCHB2PROD with NOTICES Dated: August 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–18813 Filed 9–5–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ‘‘Development of a List of Pre-DSHEA Dietary Ingredients.’’ The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA’s future development of such a list. DATES: The public meeting will be held on October 3, 2017, from 8 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by December 4, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at FDA’s Center for Food Safety and Applied Nutrition, Wiley Auditorium, 5001 Campus Dr., College Park, MD 20740. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 4, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction SUMMARY: Food and Drug Administration, HHS. [Docket No. FDA–2017–N–4642] ACTION: [Docket No. FDA–2017–N–4625] AGENCY: Food and Drug Administration AGENCY: Food and Drug Administration Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2017–N–4625 for ‘‘Development of a List of Pre-DSHEA Dietary Ingredients; Public Meeting; Request for Comments.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices asabaliauskas on DSKBBXCHB2PROD with NOTICES 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 Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS–009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 1731, email: Juanita.yates@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 12, 2016 (81 FR 53486), we issued a notice announcing the availability of a revised draft guidance for industry entitled, ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.’’ 1 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 1 https://www.fda.gov/food/guidanceregulation/ guidancedocumentsregulatoryinformation/ dietarysupplements/ucm257563.htm. VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications). The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. L. 103–417) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, among other provisions: (1) Section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)), which defines the term ‘‘dietary supplement’’ and (2) section 413 of the FD&C Act (21 U.S.C. 350(b)), which describes requirements for NDIs. Under DSHEA, dietary ingredients marketed in the United States before October 15, 1994, are not NDIs and therefore are not subject to the premarket notification requirements in section 413 of the FD&C Act. The revised draft guidance addressed, among other things, considerations related to determining when a dietary ingredient is not new and therefore does not require a NDI notification. In the revised draft guidance, we stated our willingness to compile an authoritative list of pre-October 15, 1994, dietary ingredients based on independent and verifiable data to be supplied by industry. Although we are aware that several trade associations and industry groups have independently developed their own unofficial lists of ingredients that they believe were marketed before October 15, 1994 (sometimes referred to as ‘‘grandfathered’’ or ‘‘old’’ dietary ingredients), we are unable to verify the accuracy of those lists and therefore have never recognized or sanctioned any of them. We also have never compiled our own list. An authoritative list would provide benefits to both industry and FDA. By providing clarity as to which ingredients do not require notifications, it would alleviate the burden on industry of preparing and submitting unnecessary notifications. Similarly, by eliminating unnecessary notifications, an authoritative list would enable us to more efficiently use our limited resources to review notifications for truly ‘‘new’’ ingredients. In addition, an authoritative list would allow us to better focus our enforcement efforts in alignment with our strategic priorities of consumer safety, product integrity, and accurate information. We have received and are reviewing comments on the 2016 revised draft guidance. The comments generally support the idea that we should develop a list of pre-DSHEA dietary ingredients, but reflect opinions both on the standard of evidence for demonstrating that an ingredient is pre-DSHEA and on the process by which ingredients should PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 42099 be added to the list. We believe that public discussion of these issues will be beneficial as we work toward development of a list of pre-DSHEA dietary ingredients. II. Topics for Discussion at the Public Meeting The public meeting will have two separate panels. Each panel will be followed by an opportunity for open public comment. In addition, there will be an opportunity for interested stakeholders to submit additional written comments following the meeting. The first panel will discuss what standard of evidence is necessary to determine that an ingredient was marketed before October 15, 1994. This panel may address, among other things, what types and quantity of evidence may suffice to demonstrate that a dietary ingredient was marketed in the United States prior to October 15, 1994, as well as how specifically or generally an ingredient on the list may be identified depending on the evidence presented for that ingredient. In addition, this discussion may also address whether certain botanical preparations can be accepted as ‘‘old’’ if the plant is demonstrated to be ‘‘old,’’ and whether certain classes of ingredients can be considered ‘‘old’’ based on common documentation. During the open comment period following this first panel, we will specifically invite comment about whether there are any considerations specific to certain classes or types of ingredients that should be taken into account as we develop the list. The second panel will discuss issues related to the process that should be used to develop the list. This includes, but is not limited to, the processes for nominating and reviewing ingredients; whether an outside panel should be convened and, if so, the composition and role of that panel; how information that is claimed to be confidential should be treated; and what the ultimate list should look like. The topics discussed at the public meeting, both during the panel discussions and during open public comment periods, as well as written comments submitted after the meeting, will help us determine how to develop this list of old dietary ingredients. III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following Web site: https://www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConferences/ default.htm. Please provide complete E:\FR\FM\06SEN1.SGM 06SEN1 asabaliauskas on DSKBBXCHB2PROD with NOTICES 42100 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by midnight Eastern Time on September 25, 2017. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later than September 18, 2017. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. All requests to make oral presentations must be received by September 18, 2017. We will determine the amount of time allotted to each presenter and will select and notify participants by September 25, 2017. Streaming Webcast of the Public Meeting: This public meeting will also be webcast. Please visit the following Web site to register: https:// www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/ default.htm. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the Internet at https://www.fda.gov/Food/ DietarySupplements/default.htm. Dated: August 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–18812 Filed 9–5–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ‘‘CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.’’ This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA’s efforts to support the integration of patient experience in drug development programs, including through implementation of the ‘‘PatientFocused Drug Development’’ provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development. DATES: The public workshop will be held on October 30, 2017, from 8 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 (the Great Room), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Francis Kalush, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–5429, PASERARE-DISEASES@fda.hhs.gov SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop entitled SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 ‘‘CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.’’ The purpose of the public workshop, consistent with FDA’s broad effort to more comprehensively include patients’ perspectives and experiences with a disease or condition in the drug development process, including through implementation of the ‘‘Patient-Focused Drug Development’’ provisions of the Cures Act, is to aid in bridging the gap between rare disease patients’ stories and data needed to support drug development. This public workshop will include presentations on strategies, tools, and best practices on key aspects of rare diseases drug development and engaging with FDA. There will be an opportunity for questions and answers following each presentation. Registration: There is no registration fee to attend the public workshop. Early registration is recommended because seating is limited, and registration will be on a first-come, first-served basis. There will be no onsite registration. Persons interested in attending this public workshop must register online at https://www.fda.gov/Drugs/NewsEvents/ ucm565398.htm before September 30, 2017. For those without internet access, please contact Francis Kalush (see FOR FURTHER INFORMATION CONTACT) to register. If you need special accommodations due to a disability, please contact Francis Kalush (see FOR FURTHER INFORMATION CONTACT) no later than October 23, 2017. Transcripts: A transcript of the public workshop will be available for review at the Dockets Management Staff (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the internet at https://www.regulations.gov approximately 30 days after the public workshop. Transcripts will also be available in either hard copy or on CD– ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at https:// www.fda.gov. Dated: August 30, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–18810 Filed 9–5–17; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42098-42100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18812]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4625]


Development of a List of Pre-Dietary Supplement Health and 
Education Act Dietary Ingredients; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
following public meeting entitled ``Development of a List of Pre-DSHEA 
Dietary Ingredients.'' The purpose of the meeting is to give interested 
stakeholders an opportunity to discuss issues related to FDA's future 
development of such a list.

DATES: The public meeting will be held on October 3, 2017, from 8 a.m. 
to 5 p.m. Submit either electronic or written comments on this public 
meeting by December 4, 2017. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public meeting will be held at FDA's Center for Food 
Safety and Applied Nutrition, Wiley Auditorium, 5001 Campus Dr., 
College Park, MD 20740.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 4, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-4625 for ``Development of a List of Pre-DSHEA Dietary 
Ingredients; Public Meeting; Request for Comments.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential

[[Page 42099]]

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 
Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety 
and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1731, email: 
Juanita.yates@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 12, 2016 (81 FR 53486), we issued 
a notice announcing the availability of a revised draft guidance for 
industry entitled, ``Dietary Supplements: New Dietary Ingredient 
Notifications and Related Issues.'' \1\ 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). 
The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. 
L. 103-417) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
by adding, among other provisions: (1) Section 201(ff) of the FD&C Act 
(21 U.S.C. 321(ff)), which defines the term ``dietary supplement'' and 
(2) section 413 of the FD&C Act (21 U.S.C. 350(b)), which describes 
requirements for NDIs. Under DSHEA, dietary ingredients marketed in the 
United States before October 15, 1994, are not NDIs and therefore are 
not subject to the premarket notification requirements in section 413 
of the FD&C Act. The revised draft guidance addressed, among other 
things, considerations related to determining when a dietary ingredient 
is not new and therefore does not require a NDI notification.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm.
---------------------------------------------------------------------------

    In the revised draft guidance, we stated our willingness to compile 
an authoritative list of pre-October 15, 1994, dietary ingredients 
based on independent and verifiable data to be supplied by industry. 
Although we are aware that several trade associations and industry 
groups have independently developed their own unofficial lists of 
ingredients that they believe were marketed before October 15, 1994 
(sometimes referred to as ``grandfathered'' or ``old'' dietary 
ingredients), we are unable to verify the accuracy of those lists and 
therefore have never recognized or sanctioned any of them. We also have 
never compiled our own list.
    An authoritative list would provide benefits to both industry and 
FDA. By providing clarity as to which ingredients do not require 
notifications, it would alleviate the burden on industry of preparing 
and submitting unnecessary notifications. Similarly, by eliminating 
unnecessary notifications, an authoritative list would enable us to 
more efficiently use our limited resources to review notifications for 
truly ``new'' ingredients. In addition, an authoritative list would 
allow us to better focus our enforcement efforts in alignment with our 
strategic priorities of consumer safety, product integrity, and 
accurate information.
    We have received and are reviewing comments on the 2016 revised 
draft guidance. The comments generally support the idea that we should 
develop a list of pre-DSHEA dietary ingredients, but reflect opinions 
both on the standard of evidence for demonstrating that an ingredient 
is pre-DSHEA and on the process by which ingredients should be added to 
the list. We believe that public discussion of these issues will be 
beneficial as we work toward development of a list of pre-DSHEA dietary 
ingredients.

II. Topics for Discussion at the Public Meeting

    The public meeting will have two separate panels. Each panel will 
be followed by an opportunity for open public comment. In addition, 
there will be an opportunity for interested stakeholders to submit 
additional written comments following the meeting.
    The first panel will discuss what standard of evidence is necessary 
to determine that an ingredient was marketed before October 15, 1994. 
This panel may address, among other things, what types and quantity of 
evidence may suffice to demonstrate that a dietary ingredient was 
marketed in the United States prior to October 15, 1994, as well as how 
specifically or generally an ingredient on the list may be identified 
depending on the evidence presented for that ingredient. In addition, 
this discussion may also address whether certain botanical preparations 
can be accepted as ``old'' if the plant is demonstrated to be ``old,'' 
and whether certain classes of ingredients can be considered ``old'' 
based on common documentation. During the open comment period following 
this first panel, we will specifically invite comment about whether 
there are any considerations specific to certain classes or types of 
ingredients that should be taken into account as we develop the list.
    The second panel will discuss issues related to the process that 
should be used to develop the list. This includes, but is not limited 
to, the processes for nominating and reviewing ingredients; whether an 
outside panel should be convened and, if so, the composition and role 
of that panel; how information that is claimed to be confidential 
should be treated; and what the ultimate list should look like.
    The topics discussed at the public meeting, both during the panel 
discussions and during open public comment periods, as well as written 
comments submitted after the meeting, will help us determine how to 
develop this list of old dietary ingredients.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following Web site: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete

[[Page 42100]]

contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by midnight Eastern Time on September 25, 2017. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted.
    If you need special accommodations due to a disability, please 
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later 
than September 18, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session and 
which topic(s) you wish to address. We will do our best to accommodate 
requests to make public comments. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations and request time for a joint presentation. All requests 
to make oral presentations must be received by September 18, 2017. We 
will determine the amount of time allotted to each presenter and will 
select and notify participants by September 25, 2017.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please visit the following Web site to register: 
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    FDA has verified the Web site addresses, as of the date this 
document publishes in the Federal Register, but Web sites are subject 
to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
Internet at https://www.fda.gov/Food/DietarySupplements/default.htm.

    Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18812 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P

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