Reference Amounts Customarily Consumed: List of Products for Each Product Category; Draft Guidance for Industry; Availability, 1344-1345 [2016-32006]
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Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 3128, Silver Spring,
MD 20993, CBERPublicEvents@
fda.hhs.gov. For questions email:
CBERPublicEvents@fda.hhs.gov (Subject
line: Tick-Borne Diseases and Blood
Safety Workshop).
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the public workshop
is to discuss tick-borne pathogens that
continue to emerge as threats to blood
safety, the effectiveness of current and
potential mitigation strategies, and the
general approach to decision making on
blood safety interventions.
mstockstill on DSK3G9T082PROD with NOTICES
II. Topics for Discussion at the Public
Workshop
The workshop will include
presentations and panel discussions on
the following topics: (1) Biology,
epidemiology, and clinical burden of
Anaplasma phagocytophilum (the
etiologic agent of human granulocytic
anaplasmosis) and other emerging tickborne agents; (2) the performance
characteristics of currently available
diagnostic assays for agents of concern;
(3) known and potential risks of
transfusion transmission posed by
emergent tick-borne agents; (4) current
and potential mitigation strategies; and
(5) considerations in decision making
for safety interventions. The day will
conclude with a roundtable discussion.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
Web site at: https://
www.eventbrite.com/e/emerging-tickborne-diseases-and-blood-safety-publicworkshop-tickets-28654127266. Please
provide complete 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 workshop must
register by March 23, 2017. Early
registration is recommended because
seating is limited. If time and space
permit, onsite registration on the day of
the public workshop will be provided
beginning at 7:30 a.m.
If you need special accommodations
due to a disability, please contact
Kimberly Jones or Pauline Cottrell by
email sent to CBERPublicEvents@
fda.hhs.gov at least 7 days in advance.
Requests for sign language
interpretation or Computer Aided
VerDate Sep<11>2014
21:06 Jan 04, 2017
Jkt 241001
Realtime Translation (CART)/captioning
should be made 2 weeks in advance of
the event, no later than March 23, 2017.
A request for either interpreting or
captioning is to be sent directly to the
FDA Interpreting Services Staff email
account: interpreting.services@
oc.fda.gov.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305) Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A link to
the transcript will also be available on
the Internet at https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
ucm525485.htm.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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’’).
Food and Drug Administration
Written/Paper Submissions
Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–32029 Filed 1–4–17; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2016–D–4098]
Reference Amounts Customarily
Consumed: List of Products for Each
Product Category; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Reference Amounts Customarily
Consumed: List of Products for Each
Product Category.’’ The draft guidance,
when finalized, will provide examples
of products that belong to product
categories included in the tables of
Reference Amounts Customarily
Consumed (RACCs) per Eating Occasion
established in our regulations.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
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 March 6, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–4098 for ‘‘Reference Amounts
Customarily Consumed: List of Products
for Each Product Category.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
E:\FR\FM\05JAN1.SGM
05JAN1
Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
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 https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the Office
of Nutrition and Food Labeling, Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Jillonne Kevala, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1450.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Reference Amounts Customarily
Consumed: List of Products for Each
Product Category.’’ We are issuing the
draft guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
VerDate Sep<11>2014
21:06 Jan 04, 2017
Jkt 241001
thinking of the FDA on which products
belong to product categories included in
the tables of RACCs per Eating Occasion
established in § 101.12(b) (21 CFR
101.12(b)). This draft guidance does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternate approach if it
satisfies the requirements of the
applicable statutes and regulations.
We intend for this draft guidance,
when finalized, to help industry comply
with the statutory requirement, under
section 403(q)(1)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)),
that food that is intended for human
consumption and offered for sale bear
nutrition information that provides a
serving size that reflects the amount of
food customarily consumed and is
expressed in a common household
measure that is appropriate to the food.
To comply with this requirement,
manufacturers must determine and label
their food products with the appropriate
label serving size based on the amount
of the product customarily consumed.
In the Federal Register of May 27,
2016, we issued a final rule entitled
‘‘Food Labeling: Serving Sizes of Foods
That Can Reasonably Be Consumed At
One Eating Occasion; Dual-Column
Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts
Customarily Consumed; Serving Size for
Breath Mints; and Technical
Amendments’’ (81 FR 34000). The final
rule amends our regulations in
§ 101.12(b) to update or modify certain
pre-existing RACCs, and to establish
RACCs for new product categories.
The draft guidance, when finalized,
will help manufacturers identify the
appropriate food category to which their
product belongs, on which information
manufacturers will be able to base the
label serving size. The RACCs
established in § 101.12(b) are divided
into two tables: One for infants and
young children 1 through 3 years of age,
and another for the general food supply
(i.e., individuals four years and older).
The draft guidance, when finalized, will
provide examples of products that
belong to product categories for which
a RACC has been established in
§ 101.12(b). The tables in the draft
guidance are not meant to be an allinclusive list of products that are
available on the market for each product
category.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
1345
sentence to find the most current
version of the guidance.
Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–32006 Filed 1–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0567]
[Pediatric Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of meeting;
establishment of a public docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pediatric Advisory
Committee (PAC). The general function
of the committee is to provide advice
and recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comments.
SUMMARY:
The meeting will be held on
March 6, 2017, from 8:30 a.m. to 5:30
p.m. and March 7, 2017, from 8:30 a.m.
to 12 p.m. The deadline for submitting
comments to the public docket is
February 17, 2017. Comments received
on or before February 17, 2017, will be
provided to the committee. Comments
received after that date will be taken
into consideration by the Agency.
ADDRESSES: The meeting will be held at
DoubleTree by Hilton Hotel Washington
DC—Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910. The hotel’s
telephone number is 301–589–5200.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at https://
doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelwashington-dc-silver-spring-DCASSDT/
about/amenities.html.
You may submit comments as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\05JAN1.SGM
05JAN1
Agencies
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1344-1345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-32006]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4098]
Reference Amounts Customarily Consumed: List of Products for Each
Product Category; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Reference
Amounts Customarily Consumed: List of Products for Each Product
Category.'' The draft guidance, when finalized, will provide examples
of products that belong to product categories included in the tables of
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion
established in our regulations.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider 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
March 6, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-4098 for ``Reference Amounts Customarily Consumed: List of
Products for Each Product Category.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential
[[Page 1345]]
with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' We 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 https://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1450.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Reference Amounts Customarily Consumed: List of Products for
Each Product Category.'' We are issuing the draft guidance consistent
with our good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the current thinking of the
FDA on which products belong to product categories included in the
tables of RACCs per Eating Occasion established in Sec. 101.12(b) (21
CFR 101.12(b)). This draft guidance does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations.
We intend for this draft guidance, when finalized, to help industry
comply with the statutory requirement, under section 403(q)(1)(A)(i) of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
343(q)(1)(A)(i)), that food that is intended for human consumption and
offered for sale bear nutrition information that provides a serving
size that reflects the amount of food customarily consumed and is
expressed in a common household measure that is appropriate to the
food. To comply with this requirement, manufacturers must determine and
label their food products with the appropriate label serving size based
on the amount of the product customarily consumed.
In the Federal Register of May 27, 2016, we issued a final rule
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed At One Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments'' (81
FR 34000). The final rule amends our regulations in Sec. 101.12(b) to
update or modify certain pre-existing RACCs, and to establish RACCs for
new product categories.
The draft guidance, when finalized, will help manufacturers
identify the appropriate food category to which their product belongs,
on which information manufacturers will be able to base the label
serving size. The RACCs established in Sec. 101.12(b) are divided into
two tables: One for infants and young children 1 through 3 years of
age, and another for the general food supply (i.e., individuals four
years and older). The draft guidance, when finalized, will provide
examples of products that belong to product categories for which a RACC
has been established in Sec. 101.12(b). The tables in the draft
guidance are not meant to be an all-inclusive list of products that are
available on the market for each product category.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32006 Filed 1-4-17; 8:45 am]
BILLING CODE 4164-01-P