Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 49107-49108 [2018-21209]
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
believe that these plant-based products
are nutritionally equivalent to their
dairy counterparts and can replace them
as a food choice? Are expectations of
nutritional equivalency a factor in
parents’ and caregivers’ decisions to
purchase these plant-based products as
part of young children’s or other family
members’ balanced diet? Please provide
any data or evidence to support your
answer.
3. Do these plant-based products vary
in nutrient composition, even when
manufactured using the same type of
plant ingredients (e.g., soy or almond)?
If so, how? What are consumers’
expectations regarding the nutrient
compositions of different brands of each
subclass (e.g., soy or almond) of plantbased products? What impact, if any,
does the compositional variation have
on purchase and consumption
decisions? Please provide any data or
evidence to support your answer.
4. We are aware that the United States
Department of Agriculture’s National
Nutrient Database for Standard
Reference (USDA Nutrient Database)
provides information about the
nutritional content of dairy foods as
well as some plant-based products that
resemble dairy foods (Ref. 2). However,
we believe the USDA Nutrient Database
may not be a full representation of all
the varieties of dairy foods, including
milk, cultured milk, yogurt, cheese, and
of the plant-based products
manufactured to resemble these dairy
foods, currently in the United States
marketplace. We are interested in any
data regarding the nutritional profiles of
different dairy foods, such as, for
example, milk, modified milk, cultured
milk, yogurt, and cheese products, and
any data regarding the nutritional
profiles of the various plant-based
products that resemble dairy foods,
including fortified versions of those
plant-based products. We are
particularly interested in obtaining data
that compares the amounts of protein,
calcium, vitamin D, and potassium in
these plant-based products and their
dairy counterparts.
5. How do the protein qualities of
plant-based products compare to their
dairy counterparts? How does the
variation, if any, impact consumer
perception, and purchasing and
consumption decisions? Please provide
any data or evidence to support your
answer.
E. The Role of Plant-Based Products and
Dairy Foods in Meeting the
Recommendations in the Dietary
Guidelines
The Dietary Guidelines contain
nutritional and dietary information and
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guidelines for the public. The Dietary
Guidelines are based on the
preponderance of current scientific and
medical knowledge and are intended to
help individuals ages 2 years and older
consume a healthy, nutritionally
adequate diet. As part of these
recommendations, the Dietary
Guidelines refer to several ‘‘food
groups,’’ including a ‘‘dairy group,’’
which includes fortified soy beverages.
[Note: Although the Dietary Guidelines
refer to a ‘‘dairy group,’’ as indicated in
section I.A., by ‘‘dairy foods,’’ FDA is
referring to foods such as milk, cheese,
and yogurt, and not to their plant-based
counterparts.]
The Dietary Guidelines state that
healthy eating patterns in the dairy
group include fat-free and low-fat (1
percent) dairy, including milk, yogurt,
cheese, or fortified soy beverages (see
Ref. 1 at page 23). The Dietary
Guidelines explain that soy beverages
fortified with calcium, vitamin A, and
vitamin D, are included as part of the
dairy group because they are similar to
fortified low- and non-fat milk based on
nutrient composition and in their use in
meals. The Dietary Guidelines also state
that other plant-based beverages sold as
‘‘milks’’ (such as almond, rice, coconut,
and hemp ‘‘milks’’) are not included as
part of the dairy group because their
overall nutritional content is not similar
to that of milk and fortified soy
beverages (id.).
According to the Dietary Guidelines,
the key nutrient contributions in the
dairy group include calcium,
phosphorus, vitamin A, vitamin D (in
products fortified with vitamin D),
riboflavin, vitamin B12, protein,
potassium, zinc, choline, magnesium,
and selenium (id.).
1. Do consumers understand that
certain plant-based products might have
a nutritional content that is not
adequate to place them in the dairy
group as described in the Dietary
Guidelines? How does this influence
their purchasing behavior with respect
to plant-based products and dairy
foods? Please provide any data or
evidence to support your answer.
2. Do consumers who purchase or
consume plant-based products instead
of dairy foods, such as yogurt or cheese,
believe that these plant-based products
meet the dairy group recommendation
described in the Dietary Guidelines?
Please provide any data or evidence to
support your answer.
III. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
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49107
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. U.S. Department of Health and Human
Services and U.S. Department of
Agriculture. ‘‘Dietary Guidelines for
Americans, 2015–2020.’’ Eighth Edition.
December 2015. Accessed online at
https://health.gov/dietaryguidelines/
2015/guidelines/.
2. U.S. Department of Agriculture. National
Nutrient Database for Standard Reference
(Release 23), Food items with NDB
Numbers: 01077, 01079, 01082, 01085,
16222, 16229, 16230, 14091, and 14639
accessed online at https://www.nal.usda.
gov/fnic/foodcomp/search on August 1,
2018.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21200 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–0073; FDA–
2018–N–0074; FDA–2010–N–0155; FDA–
2014–N–0987; FDA–2016–D–1164; FDA–
2014–N–2029; FDA–2012–N–0369; FDA–
2017–N–6730; FDA–2009–N–0025; FDA–
2014–N–2294; and FDA–2018–N–1129]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Irradiation in the Production, Processing, and Handling of Food ...........................................................................
State Enforcement Notifications ..............................................................................................................................
Veterinary Feed Directive ........................................................................................................................................
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................
Quality Facility Attestation .......................................................................................................................................
Administrative Practices and Procedures; Formal Evidentiary Public Hearing ......................................................
Regulations Under the Federal Import Milk Act ......................................................................................................
Medical Device Reporting ........................................................................................................................................
Animal Food Labeling; Declaration of Certifiable Color Additives ..........................................................................
Evaluation of the Food and Drug Administration’s Fresh Empire Multicultural Youth Tobacco Prevention Campaign .....................................................................................................................................................................
National Agriculture and Food Defense Strategy Survey .......................................................................................
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–21209 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0438]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Early Food Safety
Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 29,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0583. Also
include the FDA docket number found
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use
OMB Control Number 0910–0583—
Extension
Since May 29, 1992, when FDA
issued a policy statement on foods
derived from new plant varieties,
including those varieties that are
developed through biotechnology, we
have encouraged developers of new
plant varieties to consult with us early
in the development process to discuss
possible scientific and regulatory issues
that might arise (57 FR 22984).
The guidance, entitled
‘‘Recommendations for the Early Food
Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use,’’
(available at https://www.fda.gov/Food/
GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/
ucm096156.htm) continues to foster
early communication by encouraging
developers to submit to us their
evaluation of the food safety of their
new protein. Such communication
helps to ensure that any potential food
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Date approval
expires
0910–0186
0910–0275
0910–0363
0910–0796
0910–0854
0910–0191
0910–0212
0910–0437
0910–0721
7/31/2021
7/31/2021
7/31/2021
7/31/2021
7/31/2021
8/31/2021
8/31/2021
8/31/2021
8/31/2021
0910–0788
0910–0855
8/31/2021
8/31/2021
safety issues regarding a new protein in
a new plant variety are resolved early in
development, prior to any possible
inadvertent introduction into the food
supply of the new protein.
We believe that any food safety
concern related to such material
entering the food supply would be
limited to the potential that a new
protein in food from the plant variety
could cause an allergic reaction in
susceptible individuals or could be a
toxin. The guidance describes the
recommended procedures for early food
safety evaluation of new proteins
produced by new plant varieties,
including bioengineered food plants,
and the procedures for communicating
with us about the safety evaluation.
Interested persons may use Form FDA
3666 to transmit their submission to the
Office of Food Additive Safety in the
Center for Food Safety and Applied
Nutrition. Form FDA 3666 is entitled,
‘‘Early Food Safety Evaluation of a New
Non-Pesticidal Protein Produced by a
New Plant Variety (New Protein
Consultation),’’ (https://www.fda.gov/
downloads/AboutFDA/ReportsManuals
Forms/Forms/UCM350010.pdf) and may
be used in lieu of a cover letter for a
New Protein Consultation (NPC). Form
FDA 3666 prompts a submitter to
include certain elements of an NPC in
a standard format and helps the
respondent organize their submission to
focus on the information needed for our
safety review. The form, and elements
that would be prepared as attachments
to the form, may be submitted in
electronic format via the Electronic
Submission Gateway, or may be
submitted in paper format, or as
electronic files on physical media with
paper signature page. The information is
used by us to evaluate the food safety of
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]]>Agencies
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49107-49108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-0073; FDA-2018-N-0074; FDA-2010-N-0155; FDA-
2014-N-0987; FDA-2016-D-1164; FDA-2014-N-2029; FDA-2012-N-0369; FDA-
2017-N-6730; FDA-2009-N-0025; FDA-2014-N-2294; and FDA-2018-N-1129]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for
[[Page 49108]]
each information collection are shown in table 1. Copies of the
supporting statements for the information collections are available on
the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Irradiation in the Production, 0910-0186 7/31/2021
Processing, and Handling of Food.......
State Enforcement Notifications......... 0910-0275 7/31/2021
Veterinary Feed Directive............... 0910-0363 7/31/2021
Generic Clearance for the Collection of 0910-0796 7/31/2021
Qualitative Data on Tobacco Products
and Communications.....................
Quality Facility Attestation............ 0910-0854 7/31/2021
Administrative Practices and Procedures; 0910-0191 8/31/2021
Formal Evidentiary Public Hearing......
Regulations Under the Federal Import 0910-0212 8/31/2021
Milk Act...............................
Medical Device Reporting................ 0910-0437 8/31/2021
Animal Food Labeling; Declaration of 0910-0721 8/31/2021
Certifiable Color Additives............
Evaluation of the Food and Drug 0910-0788 8/31/2021
Administration's Fresh Empire
Multicultural Youth Tobacco Prevention
Campaign...............................
National Agriculture and Food Defense 0910-0855 8/31/2021
Strategy Survey........................
------------------------------------------------------------------------
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21209 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P
