Advice About Eating Fish: For Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; Availability, 32747-32749 [2019-14524]
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Federal Register / Vol. 84, No. 131 / Tuesday, July 9, 2019 / Notices
2. Question #5: Additional evidencebased CDSME programs added to the
list (reflective of approved programs
included in the FY2019 Funding
Opportunity Announcement).
3. Question #7: Information regarding
funding source(s) requested to assess
progress toward developing a
sustainable program delivery
infrastructure that is not solely reliant
on ACL discretionary dollars.
• Participant Information Survey:
1. Participant I.D. modified to reduce
risk of personally identifiable
information exposure.
2. Question #10: Added question
regarding veteran status to further
describe program participants, as well
as to assist with partnerships with
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3. Question #12: In tandem with
Question #11, this item will allow for
further assessment of caregiver status.
4. Question #14: Anxiety Disorder and
Depression are listed separately (vs.
being combined). Also included Yes/No
response options for each chronic
condition listed to improve data
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5. Question #15: Response options
have been delineated as sub-bullets (vs.
being grouped into a single item) to
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6. Question #16: Added question
regarding social isolation, a construct
Number of
respondents
Respondent/data collection activity
Program facilitators (Program Information Cover Sheet, Attendance Log).
Program participants (Participant Information Survey) ...........
Data entry staff (Program Information Cover Sheet, Attendance Log, Participant Information Survey).
Total .................................................................................
Dated: June 27, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–14564 Filed 7–8–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0595]
Advice About Eating Fish: For Women
Who Are or Might Become Pregnant,
Breastfeeding Mothers, and Young
Children, From the Environmental
Protection Agency and Food and Drug
Administration; Revised Fish Advice;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of revised
fish advice entitled ‘‘Advice About
Eating Fish: For Women Who Are or
Might Become Pregnant, Breastfeeding
Mothers, and Young Children.’’ The
revised advice updates advice that FDA
and the U.S. Environmental Protection
Agency (EPA) jointly issued in January
2017. The advice is intended to help
women who are or might become
pregnant, breastfeeding mothers, and
parents of children over 2 years make
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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Jkt 247001
Responses per
respondent
Annual burden
hours
Once per program .................
.33
445.5
13,500
65
1 .............................................
Once per program times
1,350 programs.
.20
.17
2,700
229.5
........................
................................................
........................
3,375
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
Frm 00049
Hours per
response
1,350
informed choices about fish that are
nutritious and safe to eat. We are
revising the advice in accordance with
a recent directive from Congress. FDA is
seeking public comment on the
development of educational materials
on the updated fish advice for women
who are or might become pregnant,
breastfeeding mothers, and parents of
young children.
DATES: Although you can comment on
the fish advice at any time, to ensure
that FDA considers your comments on
the development of educational
materials before it begins work on such
materials, submit either electronic or
written comments on the requested
information by September 9, 2019.
ADDRESSES: You may submit comments
as follows.
PO 00000
which has been demonstrated to have
an association with health-related risks
for older adults. This question will also
be asked upon completion of the last
program session.
7. Question #17: This question will be
asked at baseline and upon completion
of the last program session to measure
change.
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
Fmt 4703
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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–
2014–N–0595 for ‘‘Advice About Eating
Fish: For Women Who Are or Might
Become Pregnant, Breastfeeding
Mothers, and Young Children.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
E:\FR\FM\09JYN1.SGM
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Federal Register / Vol. 84, No. 131 / Tuesday, July 9, 2019 / Notices
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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
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.’’ FDA
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 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:
William R. Jones, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1422,
William.Jones@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 19,
2017 (82 FR 6571), FDA, in coordination
with EPA, announced the availability of
revised advice entitled ‘‘Advice About
Eating Fish’’ (the ‘‘2017 advice’’). The
2017 advice encourages women who are
pregnant and breastfeeding to consume
VerDate Sep<11>2014
17:47 Jul 08, 2019
Jkt 247001
8 to 12 ounces of a variety of fish per
week, from choices that are lower in
mercury. The 2017 advice presents
recommendations for how often the
target audience should consume
different fish, using a color-coded chart
of more than 60 different fish. The chart
presents fish in categories of ‘‘Best
Choices,’’ from which we recommend
the target audience eat a variety of 2 to
3 servings a week; ‘‘Good Choices,’’
from which we recommend the target
audience eat 1 serving a week; and
‘‘Choices to Avoid.’’
On February 15, 2019, the
Consolidated Appropriations Act, 2019
(Pub. L. 116–6) became law. Section 773
of Public Law 116–6 directs the
Commissioner of Food and Drugs to, by
July 1, 2019, and ‘‘following the review
required under Executive Order 12866
(5 U.S.C. 601 note; relating to regulatory
planning and review),’’ issue ‘‘advice
revising the advice’’ provided in the
notice of availability entitled ‘‘Advice
About Eating Fish, From the
Environmental Protection Agency and
Food and Drug Administration, Revised
Fish Advice, Availability’’ (82 FR 6571)
in a manner that is ‘‘consistent with
nutrition science recognized by FDA on
the net effects of seafood consumption.’’
This notice announcing the availability
of revised fish advice entitled ‘‘Advice
About Eating Fish: For Women Who Are
or Might Become Pregnant,
Breastfeeding Mothers, and Young
Children’’ responds to that directive.
II. The Revised Fish Advice
The revised fish advice, like the 2017
advice, is intended to encourage fish
consumption by emphasizing the
benefits of eating fish and to help
women who are or might become
pregnant, breastfeeding mothers, and
parents of children over 2 years make
informed choices among types of fish.
Specifically, the revised advice, now
renamed as ‘‘Advice About Eating Fish:
For Women Who Are or Might Become
Pregnant, Breastfeeding Mothers, and
Young Children,’’ includes a statement
that eating fish when pregnant or
breastfeeding can provide health
benefits and states that fish and other
protein-rich foods have nutrients that
can help children’s growth and
development. The revisions also include
a statement that, as part of a healthy
eating pattern, eating fish may offer
heart health benefits and lower the risk
of obesity. The revised advice also
makes clear that many types of fish are
both nutritious and lower in mercury.
The revised advice also discusses
nutritional value of fish, as outlined in
the 2015–2020 Dietary Guidelines for
Americans. Based on information in the
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Dietary Guidelines, the revised advice
states that fish are part of a healthy
eating pattern and provide protein,
healthy omega-3 fats (called
docosahexaenoic acid and
eicosapentaenoic acid), more vitamin
B12 and vitamin D than any other type
of food, iron, and other minerals like
selenium, zinc, and iodine.
Finally, the revised advice continues
to provide information to help women
who are or might become pregnant,
breastfeeding mothers, and parents of
children over 2 years choose varieties of
fish that are lower in mercury.
You may submit comments on the
advice at any time.
III. Consolidated Appropriations Act,
2019
The fish advice provides information
for use by consumers. It is not intended
to have the force and effect of law, does
not implement, interpret, or prescribe
law or policy, and does not describe
procedural or practice requirements. As
required by section 773 of Public Law
116–6, the revised advice was reviewed
by the Office of Management and
Budget under Executive Order 12866.
The advice was revised in accordance
with the directive in section 773 of
Public Law 116–6 that the advice be
updated ‘‘in a manner that is consistent
with nutrition science recognized by
FDA on the net effects of seafood
consumption.’’ FDA considered the
totality of the evidence, including
nutrition science on the net effects of
seafood consumption, when updating
the fish advice. The overall changes we
made include clarifying the target
audience to make clear it applies to
women who could become or are
pregnant, women who are breastfeeding,
and parents who are feeding children 2
years and older and adding highlights of
key consumer messages, including that
eating fish can provide health benefits
when pregnant or breastfeeding, that
many types of fish are both nutritious
and lower in mercury, and that the
consumption advice is based on
mercury levels. Specifically, with
respect to health benefits, the advice
now highlights benefits related to risk of
heart disease and obesity, benefits
supporting children’s growth and
development, and the substantive
nutritional contributions to a healthy
diet from protein, omega-3 fats, vitamin
B12, vitamin D, iron, selenium, zinc,
and iodine.
The primary focus of the revisions is
to further align the advice with the
2015–2020 Dietary Guidelines for
Americans, which establishes Federal,
evidence-based policy on diet and
health. The revised advice supports the
E:\FR\FM\09JYN1.SGM
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Federal Register / Vol. 84, No. 131 / Tuesday, July 9, 2019 / Notices
recommendations of the 2015–2020
Dietary Guidelines for Americans,
developed for people 2 years and older,
which reflects current science on
nutrition to improve public health. The
Dietary Guidelines for Americans
focuses on dietary patterns and the
effects of food and nutrient
characteristics on health. FDA
recognizes the nutrition science that is
reflected in the guidelines, including
nutrition science that was based on
scientific analysis that considered
evidence regarding the net effects of
seafood consumption. In addition, the
guidelines recommend eating fish as
part of a healthy eating pattern because
there are benefits in doing so.
The process to develop the 2020–2025
Dietary Guidelines is under way, and
per the Agricultural Act of 2014, will
include a comprehensive review of
scientific evidence and development of
guidance for infants and toddlers from
birth to 24 months, as well as for
women who are pregnant. Additionally,
EPA is in the process of updating its
Integrated Risk Information System
(IRIS) Assessment for Methylmercury.
FDA will consider the final products
from these efforts, as appropriate, in any
future updates to the fish advice.
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IV. Request for Comments
FDA intends to develop educational
materials such as simple factsheets,
posters, infographics, and social media
tool-kits on the updated fish advice for
women who are or might become
pregnant, breastfeeding mothers, and
parents of young children. Specific
materials will also be developed for
health care professionals, health
educators, nutritionists, and dietitians.
These resources will be printable and
could be used in physician’s offices,
public health clinics, and stores.
FDA is seeking public comment on:
(1) Additional target populations that
should be considered who may benefit
from this advice;
(2) Additional information that
should be included in these educational
resources; and
(3) Additional effective means of
disseminating and broadening the reach
of this information.
While FDA welcomes comment at any
time, we would appreciate comments on
these questions by September 9, 2019.
V. Electronic Access
Persons with access to the internet
may obtain the advice at either https://
www.fda.gov/food/resources-you-food,
or https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the advice.
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17:47 Jul 08, 2019
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Dated: July 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14524 Filed 7–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2281]
Incorporating Alternative Approaches
in Clinical Investigations for New
Animal Drugs; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comment.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public meeting
entitled ‘‘Incorporating Alternative
Approaches in Clinical Investigations
for New Animal Drugs.’’ This public
meeting and request for comments is
intended to support FDA guidance
development as required by the Animal
Drug and Animal Generic Drug User Fee
Amendments of 2018. The topics to be
discussed will inform the development
of guidance to assist sponsors in
incorporating complex adaptive and
other novel investigation designs, data
from foreign countries, real world
evidence (including ongoing
surveillance activities, observational
studies, and registry data), biomarkers,
and surrogate endpoints into proposed
clinical investigation protocols and
applications for new animal drugs
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). FDA is
seeking comments from stakeholders,
including representatives of regulated
industry, consumer groups, academia,
veterinarians, and food producers.
DATES: The public meeting will be held
on July 16, 2019, from 8:30 a.m. to 5
p.m. Submit either electronic or written
comments on this public meeting by
August 17, 2019.
ADDRESSES: The public meeting will be
held at Johns Hopkins University—
Montgomery County, Gilchrist Hall,
9601 Medical Center Dr., Rockville, MD
20850. Free parking is available on site.
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 August 17, 2019. The
https://www.regulations.gov electronic
filing system will accept comments
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
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until 11:59 p.m. Eastern Time at the end
of August 17, 2019. 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–
2019–N–2281 for ‘‘Incorporating
Alternative Approaches in Clinical
Investigations for New Animal Drugs.’’
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
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Notices]
[Pages 32747-32749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0595]
Advice About Eating Fish: For Women Who Are or Might Become
Pregnant, Breastfeeding Mothers, and Young Children, From the
Environmental Protection Agency and Food and Drug Administration;
Revised Fish Advice; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of revised fish advice entitled ``Advice About Eating
Fish: For Women Who Are or Might Become Pregnant, Breastfeeding
Mothers, and Young Children.'' The revised advice updates advice that
FDA and the U.S. Environmental Protection Agency (EPA) jointly issued
in January 2017. The advice is intended to help women who are or might
become pregnant, breastfeeding mothers, and parents of children over 2
years make informed choices about fish that are nutritious and safe to
eat. We are revising the advice in accordance with a recent directive
from Congress. FDA is seeking public comment on the development of
educational materials on the updated fish advice for women who are or
might become pregnant, breastfeeding mothers, and parents of young
children.
DATES: Although you can comment on the fish advice at any time, to
ensure that FDA considers your comments on the development of
educational materials before it begins work on such materials, submit
either electronic or written comments on the requested information by
September 9, 2019.
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): 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-2014-N-0595 for ``Advice About Eating Fish: For Women Who Are or
Might Become Pregnant, Breastfeeding Mothers, and Young Children.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential
[[Page 32748]]
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 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.'' FDA 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 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: William R. Jones, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1422, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 19, 2017 (82 FR 6571), FDA, in
coordination with EPA, announced the availability of revised advice
entitled ``Advice About Eating Fish'' (the ``2017 advice''). The 2017
advice encourages women who are pregnant and breastfeeding to consume 8
to 12 ounces of a variety of fish per week, from choices that are lower
in mercury. The 2017 advice presents recommendations for how often the
target audience should consume different fish, using a color-coded
chart of more than 60 different fish. The chart presents fish in
categories of ``Best Choices,'' from which we recommend the target
audience eat a variety of 2 to 3 servings a week; ``Good Choices,''
from which we recommend the target audience eat 1 serving a week; and
``Choices to Avoid.''
On February 15, 2019, the Consolidated Appropriations Act, 2019
(Pub. L. 116-6) became law. Section 773 of Public Law 116-6 directs the
Commissioner of Food and Drugs to, by July 1, 2019, and ``following the
review required under Executive Order 12866 (5 U.S.C. 601 note;
relating to regulatory planning and review),'' issue ``advice revising
the advice'' provided in the notice of availability entitled ``Advice
About Eating Fish, From the Environmental Protection Agency and Food
and Drug Administration, Revised Fish Advice, Availability'' (82 FR
6571) in a manner that is ``consistent with nutrition science
recognized by FDA on the net effects of seafood consumption.'' This
notice announcing the availability of revised fish advice entitled
``Advice About Eating Fish: For Women Who Are or Might Become Pregnant,
Breastfeeding Mothers, and Young Children'' responds to that directive.
II. The Revised Fish Advice
The revised fish advice, like the 2017 advice, is intended to
encourage fish consumption by emphasizing the benefits of eating fish
and to help women who are or might become pregnant, breastfeeding
mothers, and parents of children over 2 years make informed choices
among types of fish. Specifically, the revised advice, now renamed as
``Advice About Eating Fish: For Women Who Are or Might Become Pregnant,
Breastfeeding Mothers, and Young Children,'' includes a statement that
eating fish when pregnant or breastfeeding can provide health benefits
and states that fish and other protein-rich foods have nutrients that
can help children's growth and development. The revisions also include
a statement that, as part of a healthy eating pattern, eating fish may
offer heart health benefits and lower the risk of obesity. The revised
advice also makes clear that many types of fish are both nutritious and
lower in mercury.
The revised advice also discusses nutritional value of fish, as
outlined in the 2015-2020 Dietary Guidelines for Americans. Based on
information in the Dietary Guidelines, the revised advice states that
fish are part of a healthy eating pattern and provide protein, healthy
omega-3 fats (called docosahexaenoic acid and eicosapentaenoic acid),
more vitamin B12 and vitamin D than any other type of food, iron, and
other minerals like selenium, zinc, and iodine.
Finally, the revised advice continues to provide information to
help women who are or might become pregnant, breastfeeding mothers, and
parents of children over 2 years choose varieties of fish that are
lower in mercury.
You may submit comments on the advice at any time.
III. Consolidated Appropriations Act, 2019
The fish advice provides information for use by consumers. It is
not intended to have the force and effect of law, does not implement,
interpret, or prescribe law or policy, and does not describe procedural
or practice requirements. As required by section 773 of Public Law 116-
6, the revised advice was reviewed by the Office of Management and
Budget under Executive Order 12866.
The advice was revised in accordance with the directive in section
773 of Public Law 116-6 that the advice be updated ``in a manner that
is consistent with nutrition science recognized by FDA on the net
effects of seafood consumption.'' FDA considered the totality of the
evidence, including nutrition science on the net effects of seafood
consumption, when updating the fish advice. The overall changes we made
include clarifying the target audience to make clear it applies to
women who could become or are pregnant, women who are breastfeeding,
and parents who are feeding children 2 years and older and adding
highlights of key consumer messages, including that eating fish can
provide health benefits when pregnant or breastfeeding, that many types
of fish are both nutritious and lower in mercury, and that the
consumption advice is based on mercury levels. Specifically, with
respect to health benefits, the advice now highlights benefits related
to risk of heart disease and obesity, benefits supporting children's
growth and development, and the substantive nutritional contributions
to a healthy diet from protein, omega-3 fats, vitamin B12, vitamin D,
iron, selenium, zinc, and iodine.
The primary focus of the revisions is to further align the advice
with the 2015-2020 Dietary Guidelines for Americans, which establishes
Federal, evidence-based policy on diet and health. The revised advice
supports the
[[Page 32749]]
recommendations of the 2015-2020 Dietary Guidelines for Americans,
developed for people 2 years and older, which reflects current science
on nutrition to improve public health. The Dietary Guidelines for
Americans focuses on dietary patterns and the effects of food and
nutrient characteristics on health. FDA recognizes the nutrition
science that is reflected in the guidelines, including nutrition
science that was based on scientific analysis that considered evidence
regarding the net effects of seafood consumption. In addition, the
guidelines recommend eating fish as part of a healthy eating pattern
because there are benefits in doing so.
The process to develop the 2020-2025 Dietary Guidelines is under
way, and per the Agricultural Act of 2014, will include a comprehensive
review of scientific evidence and development of guidance for infants
and toddlers from birth to 24 months, as well as for women who are
pregnant. Additionally, EPA is in the process of updating its
Integrated Risk Information System (IRIS) Assessment for Methylmercury.
FDA will consider the final products from these efforts, as
appropriate, in any future updates to the fish advice.
IV. Request for Comments
FDA intends to develop educational materials such as simple
factsheets, posters, infographics, and social media tool-kits on the
updated fish advice for women who are or might become pregnant,
breastfeeding mothers, and parents of young children. Specific
materials will also be developed for health care professionals, health
educators, nutritionists, and dietitians. These resources will be
printable and could be used in physician's offices, public health
clinics, and stores.
FDA is seeking public comment on:
(1) Additional target populations that should be considered who may
benefit from this advice;
(2) Additional information that should be included in these
educational resources; and
(3) Additional effective means of disseminating and broadening the
reach of this information.
While FDA welcomes comment at any time, we would appreciate
comments on these questions by September 9, 2019.
V. Electronic Access
Persons with access to the internet may obtain the advice at either
https://www.fda.gov/food/resources-you-food, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the advice.
Dated: July 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14524 Filed 7-8-19; 8:45 am]
BILLING CODE 4164-01-P
