81 FR 53486 - Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 156 (August 12, 2016)

Page Range		53486-53489
FR Document		2016-19306

The Food and Drug Administration (FDA or we) is announcing the issuance of a revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The revised draft guidance supersedes FDA's July 2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary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).

Federal Register, Volume 81 Issue 156 (Friday, August 12, 2016)

[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53486-53489]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-19306]

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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Related Issues; Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
issuance of a revised draft guidance for industry entitled ``Dietary
Supplements: New Dietary Ingredient Notifications and Related Issues.''
The revised draft guidance supersedes FDA's July 2011 draft guidance on
the same topic. The revised draft guidance, when finalized, will help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).

DATES: Although you may comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that FDA considers your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
October 11, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.

[[Page 53487]]

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.
Submit written requests for single copies of the draft guidance to
the Division of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus
Drive, College Park, MD 20740. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance.

FOR FURTHER INFORMATION CONTACT: Ali Abdel-Rahman, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-1853.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a revised draft guidance for
industry entitled ``Dietary Supplements: New Dietary Ingredient
Notifications and Related Issues.'' This draft guidance supersedes the
July 2011 draft guidance on this topic (76 FR 39111; July 5, 2011) and
is being issued consistent with our good guidance practices regulation
(21 CFR 10.115). The draft guidance, when finalized, will represent our
current thinking on this topic. It will not create or confer any rights
for or on any person and will not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
On October 25, 1994, the Dietary Supplement Health and Education
Act of 1994 (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by
adding, among other provisions: (1) Section 201(ff) (21 U.S.C.
321(ff)), which defines the term ``dietary supplement'' and (2) section
413 (21 U.S.C. 350b), which describes requirements for NDIs. Among
other things, section 413 of the FD&C Act requires the manufacturer or
distributor of an NDI, or of a dietary supplement containing the NDI,
to submit a premarket notification to FDA (as delegate for the
Secretary of Health and Human Services) at least 75 days before
introducing the NDI or dietary supplement into interstate commerce,
unless the NDI and any other ingredients in the dietary supplement have
been present in the food supply as an article used for food in a form
in which the food has not been chemically altered (21 U.S.C.
350b(a)(1)). The notification must contain the information, including
any citation to published articles, which is the manufacturer or
distributor's basis for concluding that a dietary supplement containing
the NDI will reasonably be expected to be safe.
This draft guidance has several purposes. First, it is intended to
help dietary supplement manufacturers and distributors decide whether
to submit an NDI notification. In addition, the draft guidance is
intended to provide recommendations on how to conduct a safety
assessment for an NDI notification and what to include in the
notification. In question and answer form, the draft guidance presents
FDA's views on what qualifies as an NDI; when an NDI notification is
required; the procedures for submitting an NDI notification; the types
of data and information that manufacturers and distributors should
consider when evaluating the safety of a dietary supplement containing
an NDI; and what should be included in an NDI notification. In
addition, the draft guidance contains questions and answers about parts
of the dietary supplement definition (section 201(ff) of the FD&C Act)
that can affect whether a particular substance may be marketed as a
dietary ingredient in a dietary supplement.
We issued the original version of this draft guidance in the
Federal Register of July 5, 2011 (the 2011 draft guidance). We gave
interested parties an opportunity to submit comments by October 3,
2011. In the Federal Register of September 9, 2011 (76 FR 55927), we
extended the comment period to December 2, 2011. We received numerous
comments on the 2011 draft guidance.
Based on those comments and on meetings with industry and other
stakeholders, we realized that the 2011 draft guidance contained gaps
and unclear statements that were subject to confusion and
misinterpretation. Therefore, we decided to clarify and better explain
our thinking on some critical issues, in addition to explaining their
public health significance, and to

[[Page 53488]]

request additional comments on these issues before publishing a final
guidance. We have revised certain questions and answers and added a
number of new questions and answers.
The major topics on which we have revised or added questions and
answers are as follows:
Chemical alteration--Dietary supplements containing an NDI
are exempt from the notification requirement when they contain only
dietary ingredients that have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered. Section IV.B of the revised draft guidance explains
FDA's interpretation of ``present in the food supply as an article used
for food'' and the public health basis for that interpretation. In
addition, section IV.B has been revised to address the question of what
constitutes ``chemical alteration'' more fully and to explain FDA's
reasoning on this issue, as well as discussing additional examples of
when chemical alteration occurs and when it does not. Because no
guidance document can cover every possible manufacturing scenario, the
draft guidance encourages industry to consult with FDA in advance on
such matters.
Manufacturing changes that create an NDI--A related issue
addressed in section IV.A of the draft guidance is when a manufacturing
change alters the structure or properties of an ingredient and creates
an NDI for which a notification must be submitted. The revised draft
guidance provides examples of manufacturing changes that alter the
identity of the ingredient, the key factor in determining whether they
also change the regulatory status of the ingredient.
Synthetic substances--Section IV.D of the revised draft
guidance contains an expanded discussion clarifying FDA's views on when
synthetic copies of botanical and other dietary ingredients qualify as
dietary ingredients under the FD&C Act. FDA's thinking is based on the
text of section 201(ff)(1) of the FD&C Act, which defines some types of
dietary ingredients by identity and others by function.
New dietary ingredient definition and list of
``grandfathered'' dietary ingredients--In section IV.A of the draft
guidance, we revised our response to the question about whether there
is an authoritative list of dietary ingredients marketed before October
15, 1994 (a so-called ``grandfathered list'' or ``old dietary
ingredient list''). Dietary ingredients marketed before that date are
not NDIs and therefore are not subject to the premarket notification
requirement in section 413 of the FD&C Act. Although there is currently
no authoritative list of ``grandfathered'' ingredients, the revised
answer notes that FDA is prepared to compile such a list based on
independent and verifiable data to be submitted by industry. The
revised answer also discusses FDA's thinking on the regulatory status
of dietary ingredients that would be on such a list, as well as the
status of dietary ingredients not on such a list.
We also revised several questions and answers in section IV.A to
clarify various matters regarding FDA's interpretation of the terms
``marketed'' and ``dietary ingredient'' in section 413(d) of the FD&C
Act, which defines an NDI as a dietary ingredient that was not marketed
in the United States before October 15, 1994, and we added more
examples of documentation that can be used to show that a dietary
ingredient was marketed prior to October 15, 1994.
Structuring notifications efficiently and relying on data
from prior notifications and master files--We added several questions
and answers in section IV.C of this draft guidance to suggest ways
manufacturers and distributors can reduce the number of NDI
notifications they must file and to clarify when data and information
from a previous notification or ``master file'' may be used in a
notification. For example, the answer to a new question clarifies that
firms may submit an NDI notification that covers the use of the NDI in
multiple dietary supplements and includes safety data for a range of
doses and/or differing conditions of use. This answer also explains
that a firm may submit a confidential ``master file'' containing
specifications, manufacturing procedures, and other identity
information for an NDI, and may incorporate information from the master
file into its own NDI notification or may authorize another firm to
rely on information from the master file in a notification for a
dietary supplement containing the NDI. We also added a question and
answer to describe when a firm may rely on data in another
notification. In addition, section IV.C now includes a question and
answer with six examples distinguishing situations in which separate
notifications are required for different dietary supplements containing
the same NDI from situations in which a single NDI notification covers
multiple dietary supplements containing the same NDI. Finally, section
IV.C now clarifies that, although a combination of NDIs is itself an
NDI, a combination of grandfathered dietary ingredients is not, even if
that combination has not been used in a dietary supplement before.
Identity information to include in an NDI notification--We
revised several questions and answers in section VI.A in consideration
of comments regarding chemical and botanical information necessary to
determine the identity of an NDI. We also added a new question and
answer with recommendations about what chemistry information should be
included in a notification for an enzyme NDI. In addition, since some
of the standard references on nomenclature of plants and microorganisms
have been renamed or updated since the 2011 draft guidance, we updated
the citations to refer to the most recent edition.
Electronic submission--We updated the question and answer
in section V.A about electronic submission of NDI notifications. The
updated answer states that we are accepting NDI notifications
electronically and provides the Internet address for the electronic
submission gateway. As before, the answer notes that firms still have
the option to submit paper notifications to FDA using the procedure
described in 21 CFR 190.6.
PDF form for NDI notifications submitted on paper--Because
our electronic submission gateway for NDI notifications is now
available, we have decided not to provide a competing form for paper
notifications. Therefore, we have removed ``Appendix B: 75-Day Pre-
Market New Dietary Ingredient Notification Form'' from the draft
guidance.
Safety information to include in an NDI notification--We
revised several questions and answers in sections VI.B and VI.C to
clarify our thinking on compiling and evaluating scientific evidence
about the safety of NDIs and dietary supplements that contain NDIs. In
section VI.B, we clarified our thinking on the use of foreign history
of use data. We also added a recommendation to consult ``Principles and
Methods for the Risk Assessment of Chemicals in Food,'' a joint
publication of the World Health Organization and the Food and
Agriculture Organization of the United Nations, as a useful source of
information on conducting human clinical studies for NDIs and dietary
supplements. In response to comments, we removed all references to
FDA's ``Redbook'' guidance, which contains recommendations on toxicity
studies and other scientific evidence needed to determine the safety of
food additives. We also revised section VI.B to explain that the NDI
safety standard is different from the standards for other FDA-regulated
products and clarify that evidence for an NDI safety evaluation should
be compiled to meet that standard. Although the revised draft

[[Page 53489]]

guidance no longer cites the Redbook, we continue to recommend the use
of the dietary exposure assessment methodology and some toxicology
tests that are also used for the evaluation of food additives because
these are standard scientific methods not specific to any particular
safety assessment paradigm. Finally, we added a new question at the end
of section VI.C to emphasize that this draft guidance contains
recommendations about safety information to include in an NDI
notification, but these recommendations are not requirements.
Other changes--We made clarifying changes, explanatory
changes, and editorial changes throughout the document. We also updated
references and links and added new references where appropriate.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. This draft guidance contains proposed collections
of information. ``Collection of information'' is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a
60-day notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, we intend to publish
a 60-day notice on the proposed collections of information in this
draft guidance in a future issue of the Federal Register.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 111 have been approved under OMB control
number 0901-0606, and the collections of information in Sec. 190.6
have been approved under OMB control number 0910-0330.

III. Other Issues for Consideration

Although FDA welcomes comments on any aspect of this draft
guidance, we particularly invite comment on the following:
What processes alter the identity of an ingredient
marketed prior to October 15, 1994, and thus create an NDI? We are
especially interested in recommendations for clearer examples or
criteria to differentiate changes in manufacturing methods and starting
materials that alter the identity of the ingredient from changes that
do not.
What processes ``chemically alter'' an ingredient within
the meaning of section 413(a)(1) of the FD&C Act, and why? Conversely,
what processes do not cause chemical alteration, and why? Are there
certain processes, such as tinctures, that sometimes result in chemical
alteration and sometimes do not? What criteria should be used to
evaluate whether an ingredient has been chemically altered? We are
especially interested in receiving scientific information that shows
whether a particular process actually results in chemical alteration.
What method of compiling independent and verifiable data
on the marketing of dietary ingredients before October 15, 1994, would
be most effective? How should an authoritative list of
``grandfathered'' ingredients based on such data be developed and
implemented?
As FDA considers the development of final guidance, we will review
comments received on this revised version, as well as comments on the
2011 draft guidance that are still relevant.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the draft guidance.

V. References

The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. 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.

1. International Programme on Chemical Safety, ``Principles and
Methods for the Risk Assessment of Chemicals in Food,''
Environmental Health Criteria 240 (2009), available at: http://www.who.int/foodsafety/publications/chemical-food/en/.
2. The official name of the Redbook is ``Guidance for Industry and
Other Stakeholders: Toxicological Principles for the Safety
Assessment of Food Ingredients,'' available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm.

Dated: August 9, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19306 Filed 8-11-16; 8:45 am]
BILLING CODE 4164-01-P

53488 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices

request additional comments on these requirement in section 413 of the FD&C • Identity information to include in
issues before publishing a final Act. Although there is currently no an NDI notification—We revised several
guidance. We have revised certain authoritative list of ‘‘grandfathered’’ questions and answers in section VI.A
questions and answers and added a ingredients, the revised answer notes in consideration of comments regarding
number of new questions and answers. that FDA is prepared to compile such a chemical and botanical information
The major topics on which we have list based on independent and verifiable necessary to determine the identity of
revised or added questions and answers data to be submitted by industry. The an NDI. We also added a new question
are as follows: revised answer also discusses FDA’s and answer with recommendations
• Chemical alteration—Dietary thinking on the regulatory status of about what chemistry information
supplements containing an NDI are dietary ingredients that would be on should be included in a notification for
exempt from the notification such a list, as well as the status of an enzyme NDI. In addition, since some
requirement when they contain only dietary ingredients not on such a list. of the standard references on
dietary ingredients that have been We also revised several questions and nomenclature of plants and
present in the food supply as an article answers in section IV.A to clarify microorganisms have been renamed or
used for food in a form in which the various matters regarding FDA’s updated since the 2011 draft guidance,
food has not been chemically altered. interpretation of the terms ‘‘marketed’’ we updated the citations to refer to the
Section IV.B of the revised draft and ‘‘dietary ingredient’’ in section most recent edition.
guidance explains FDA’s interpretation 413(d) of the FD&C Act, which defines • Electronic submission—We updated
of ‘‘present in the food supply as an an NDI as a dietary ingredient that was the question and answer in section V.A
article used for food’’ and the public not marketed in the United States before about electronic submission of NDI
health basis for that interpretation. In October 15, 1994, and we added more notifications. The updated answer states
addition, section IV.B has been revised examples of documentation that can be that we are accepting NDI notifications
to address the question of what used to show that a dietary ingredient electronically and provides the Internet
constitutes ‘‘chemical alteration’’ more was marketed prior to October 15, 1994. address for the electronic submission
fully and to explain FDA’s reasoning on • Structuring notifications efficiently gateway. As before, the answer notes
this issue, as well as discussing and relying on data from prior that firms still have the option to submit
additional examples of when chemical notifications and master files—We paper notifications to FDA using the
alteration occurs and when it does not. added several questions and answers in procedure described in 21 CFR 190.6.
Because no guidance document can section IV.C of this draft guidance to • PDF form for NDI notifications
cover every possible manufacturing suggest ways manufacturers and submitted on paper—Because our
scenario, the draft guidance encourages distributors can reduce the number of electronic submission gateway for NDI
industry to consult with FDA in NDI notifications they must file and to notifications is now available, we have
advance on such matters. clarify when data and information from decided not to provide a competing
• Manufacturing changes that create a previous notification or ‘‘master file’’ form for paper notifications. Therefore,
an NDI—A related issue addressed in may be used in a notification. For we have removed ‘‘Appendix B: 75-Day
section IV.A of the draft guidance is example, the answer to a new question Pre-Market New Dietary Ingredient
when a manufacturing change alters the clarifies that firms may submit an NDI Notification Form’’ from the draft
structure or properties of an ingredient notification that covers the use of the guidance.
and creates an NDI for which a NDI in multiple dietary supplements • Safety information to include in an
notification must be submitted. The and includes safety data for a range of NDI notification—We revised several
revised draft guidance provides doses and/or differing conditions of use. questions and answers in sections VI.B
examples of manufacturing changes that This answer also explains that a firm and VI.C to clarify our thinking on
alter the identity of the ingredient, the may submit a confidential ‘‘master file’’ compiling and evaluating scientific
key factor in determining whether they containing specifications, evidence about the safety of NDIs and
also change the regulatory status of the manufacturing procedures, and other dietary supplements that contain NDIs.
ingredient. identity information for an NDI, and In section VI.B, we clarified our
• Synthetic substances—Section IV.D may incorporate information from the thinking on the use of foreign history of
of the revised draft guidance contains an master file into its own NDI notification use data. We also added a
expanded discussion clarifying FDA’s or may authorize another firm to rely on recommendation to consult ‘‘Principles
views on when synthetic copies of information from the master file in a and Methods for the Risk Assessment of
botanical and other dietary ingredients notification for a dietary supplement Chemicals in Food,’’ a joint publication
qualify as dietary ingredients under the containing the NDI. We also added a of the World Health Organization and
FD&C Act. FDA’s thinking is based on question and answer to describe when the Food and Agriculture Organization
the text of section 201(ff)(1) of the FD&C a firm may rely on data in another of the United Nations, as a useful source
Act, which defines some types of notification. In addition, section IV.C of information on conducting human
dietary ingredients by identity and now includes a question and answer clinical studies for NDIs and dietary
others by function. with six examples distinguishing supplements. In response to comments,
• New dietary ingredient definition situations in which separate we removed all references to FDA’s
and list of ‘‘grandfathered’’ dietary notifications are required for different ‘‘Redbook’’ guidance, which contains
ingredients—In section IV.A of the draft dietary supplements containing the recommendations on toxicity studies
guidance, we revised our response to same NDI from situations in which a and other scientific evidence needed to
the question about whether there is an single NDI notification covers multiple determine the safety of food additives.
mstockstill on DSK3G9T082PROD with NOTICES

authoritative list of dietary ingredients dietary supplements containing the We also revised section VI.B to explain
marketed before October 15, 1994 (a so- same NDI. Finally, section IV.C now that the NDI safety standard is different
called ‘‘grandfathered list’’ or ‘‘old clarifies that, although a combination of from the standards for other FDA-
dietary ingredient list’’). Dietary NDIs is itself an NDI, a combination of regulated products and clarify that
ingredients marketed before that date grandfathered dietary ingredients is not, evidence for an NDI safety evaluation
are not NDIs and therefore are not even if that combination has not been should be compiled to meet that
subject to the premarket notification used in a dietary supplement before. standard. Although the revised draft

VerDate Sep<11>2014 18:42 Aug 11, 2016 Jkt 238001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\12AUN1.SGM 12AUN1

Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices 53489

guidance no longer cites the Redbook, are especially interested in fda.gov/Food/GuidanceRegulation/
we continue to recommend the use of recommendations for clearer examples GuidanceDocumentsRegulatory
the dietary exposure assessment or criteria to differentiate changes in Information/IngredientsAdditivesGRAS
Packaging/ucm2006826.htm.
methodology and some toxicology tests manufacturing methods and starting
that are also used for the evaluation of materials that alter the identity of the Dated: August 9, 2016.
food additives because these are ingredient from changes that do not. Jeremy Sharp,
standard scientific methods not specific • What processes ‘‘chemically alter’’ Deputy Commissioner for Policy, Planning,
to any particular safety assessment an ingredient within the meaning of Legislation, and Analysis.
paradigm. Finally, we added a new section 413(a)(1) of the FD&C Act, and [FR Doc. 2016–19306 Filed 8–11–16; 8:45 am]
question at the end of section VI.C to why? Conversely, what processes do not BILLING CODE 4164–01–P
emphasize that this draft guidance cause chemical alteration, and why? Are
contains recommendations about safety there certain processes, such as
information to include in an NDI tinctures, that sometimes result in DEPARTMENT OF HEALTH AND
notification, but these recommendations chemical alteration and sometimes do HUMAN SERVICES
are not requirements. not? What criteria should be used to
• Other changes—We made clarifying evaluate whether an ingredient has been Health Resources and Services
changes, explanatory changes, and chemically altered? We are especially Administration
editorial changes throughout the interested in receiving scientific
document. We also updated references information that shows whether a Agency Information Collection
and links and added new references particular process actually results in Activities: Submission to OMB for
where appropriate. chemical alteration. Review and Approval; Public Comment
• What method of compiling Request; Health Center Program
II. Paperwork Reduction Act of 1995 Application Forms
independent and verifiable data on the
Under the Paperwork Reduction Act marketing of dietary ingredients before AGENCY: Health Resources and Services
of 1995 (the PRA) (44 U.S.C. 3501– October 15, 1994, would be most Administration, HHS.
3520), Federal agencies must obtain effective? How should an authoritative ACTION: Notice.
approval from the Office of Management list of ‘‘grandfathered’’ ingredients
and Budget (OMB) for each collection of based on such data be developed and SUMMARY: In compliance with Section
information they conduct or sponsor. implemented? 3507(a)(1)(D) of the Paperwork
This draft guidance contains proposed As FDA considers the development of Reduction Act of 1995, the Health
collections of information. ‘‘Collection final guidance, we will review Resources and Services Administration
of information’’ is defined in 44 U.S.C. comments received on this revised (HRSA) has submitted an Information
3502(3) and 5 CFR 1320.3(c) and version, as well as comments on the Collection Request (ICR) to the Office of
includes Agency requests or 2011 draft guidance that are still Management and Budget (OMB) for
requirements that members of the public relevant. review and approval. Comments
submit reports, keep records, or provide submitted during the first public review
information to a third party. Section IV. Electronic Access
of this ICR will be provided to OMB.
3506(c)(2)(A) of the PRA (44 U.S.C. Persons with access to the Internet OMB will accept further comments from
3506(c)(2)(A)) requires Federal Agencies may obtain the guidance at either http:// the public during the review and
to publish a 60-day notice in the www.fda.gov/FoodGuidances or http:// approval period.
Federal Register soliciting public www.regulations.gov. Use the FDA Web DATES: Comments on this ICR should be
comment on each proposed collection of site listed in the previous sentence to received no later than September 12,
information before submitting the find the most current version of the 2016.
collection to OMB for approval. To draft guidance.
ADDRESSES: Submit your comments,
comply with this requirement, we V. References
intend to publish a 60-day notice on the including the ICR Title, to the desk
proposed collections of information in The following references are on officer for HRSA, either by email to
this draft guidance in a future issue of display in the Division of Dockets OIRA_submission@omb.eop.gov or by
the Federal Register. Management (see ADDRESSES) and are fax to 202–395–5806.
This draft guidance also refers to available for viewing by interested FOR FURTHER INFORMATION CONTACT: To
previously approved collections of persons between 9 a.m. and 4 p.m., request a copy of the clearance requests
information found in FDA regulations. Monday through Friday; they are also submitted to OMB for review, email the
These collections of information are available electronically at http:// HRSA Information Collection Clearance
subject to review by OMB under the www.regulations.gov. FDA has verified Officer at paperwork@hrsa.gov or call
PRA. The collections of information in the Web site addresses, as of the date (301) 443–1984.
21 CFR part 111 have been approved this document publishes in the Federal SUPPLEMENTARY INFORMATION:
under OMB control number 0901–0606, Register, but Web sites are subject to Information Collection Request Title:
and the collections of information in change over time. Health Center Program Application
§ 190.6 have been approved under OMB 1. International Programme on Chemical Forms OMB No. 0915–0285—Revision.
control number 0910–0330. Safety, ‘‘Principles and Methods for the Abstract: Health centers (those
Risk Assessment of Chemicals in Food,’’ entities funded under Public Health
III. Other Issues for Consideration Environmental Health Criteria 240 Service Act section 330 and Health
mstockstill on DSK3G9T082PROD with NOTICES

Although FDA welcomes comments (2009), available at: http://www.who.int/ Center Program look-alikes) deliver
on any aspect of this draft guidance, we foodsafety/publications/chemical-food/ comprehensive, high quality, cost-
en/. effective primary health care to patients
particularly invite comment on the 2. The official name of the Redbook is
following: ‘‘Guidance for Industry and Other regardless of their ability to pay. Health
• What processes alter the identity of Stakeholders: Toxicological Principles centers are an essential primary care
an ingredient marketed prior to October for the Safety Assessment of Food provider for America’s most vulnerable
15, 1994, and thus create an NDI? We Ingredients,’’ available at: http://www. populations. Health centers provide

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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.
Dates		Although you may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 11, 2016.
Contact		Ali Abdel-Rahman, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1853.
FR Citation		81 FR 53486

81 FR 53486 - Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 156 (August 12, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration