83 FR 49107 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49107-49108 | |
| FR Document | 2018-21209 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49107-49108] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49107
believe that these plant-based products guidelines for the public. The Dietary 9 a.m. and 4 p.m., Monday through
are nutritionally equivalent to their Guidelines are based on the Friday; they are also available
dairy counterparts and can replace them preponderance of current scientific and electronically at https://
as a food choice? Are expectations of medical knowledge and are intended to www.regulations.gov. FDA has verified
nutritional equivalency a factor in help individuals ages 2 years and older the website addresses, as of the date this
parents’ and caregivers’ decisions to consume a healthy, nutritionally document publishes in the Federal
purchase these plant-based products as adequate diet. As part of these Register, but websites are subject to
part of young children’s or other family recommendations, the Dietary change over time.
members’ balanced diet? Please provide Guidelines refer to several ‘‘food 1. U.S. Department of Health and Human
any data or evidence to support your groups,’’ including a ‘‘dairy group,’’ Services and U.S. Department of
answer. which includes fortified soy beverages. Agriculture. ‘‘Dietary Guidelines for
3. Do these plant-based products vary [Note: Although the Dietary Guidelines Americans, 2015–2020.’’ Eighth Edition.
in nutrient composition, even when refer to a ‘‘dairy group,’’ as indicated in December 2015. Accessed online at
manufactured using the same type of section I.A., by ‘‘dairy foods,’’ FDA is https://health.gov/dietaryguidelines/
plant ingredients (e.g., soy or almond)? referring to foods such as milk, cheese, 2015/guidelines/.
If so, how? What are consumers’ and yogurt, and not to their plant-based 2. U.S. Department of Agriculture. National
expectations regarding the nutrient counterparts.] Nutrient Database for Standard Reference
compositions of different brands of each The Dietary Guidelines state that (Release 23), Food items with NDB
Numbers: 01077, 01079, 01082, 01085,
subclass (e.g., soy or almond) of plant- healthy eating patterns in the dairy
16222, 16229, 16230, 14091, and 14639
based products? What impact, if any, group include fat-free and low-fat (1 accessed online at http://www.nal.usda.
does the compositional variation have percent) dairy, including milk, yogurt, gov/fnic/foodcomp/search on August 1,
on purchase and consumption cheese, or fortified soy beverages (see 2018.
decisions? Please provide any data or Ref. 1 at page 23). The Dietary
Dated: September 25, 2018.
evidence to support your answer. Guidelines explain that soy beverages
4. We are aware that the United States fortified with calcium, vitamin A, and Leslie Kux,
Department of Agriculture’s National vitamin D, are included as part of the Associate Commissioner for Policy.
Nutrient Database for Standard dairy group because they are similar to [FR Doc. 2018–21200 Filed 9–27–18; 8:45 am]
Reference (USDA Nutrient Database) fortified low- and non-fat milk based on BILLING CODE 4164–01–P
provides information about the nutrient composition and in their use in
nutritional content of dairy foods as meals. The Dietary Guidelines also state
well as some plant-based products that that other plant-based beverages sold as DEPARTMENT OF HEALTH AND
resemble dairy foods (Ref. 2). However, ‘‘milks’’ (such as almond, rice, coconut, HUMAN SERVICES
we believe the USDA Nutrient Database and hemp ‘‘milks’’) are not included as
may not be a full representation of all part of the dairy group because their Food and Drug Administration
the varieties of dairy foods, including overall nutritional content is not similar [Docket Nos. FDA–2018–N–0073; FDA–
milk, cultured milk, yogurt, cheese, and to that of milk and fortified soy 2018–N–0074; FDA–2010–N–0155; FDA–
of the plant-based products beverages (id.). 2014–N–0987; FDA–2016–D–1164; FDA–
manufactured to resemble these dairy According to the Dietary Guidelines, 2014–N–2029; FDA–2012–N–0369; FDA–
foods, currently in the United States the key nutrient contributions in the 2017–N–6730; FDA–2009–N–0025; FDA–
marketplace. We are interested in any dairy group include calcium, 2014–N–2294; and FDA–2018–N–1129]
data regarding the nutritional profiles of phosphorus, vitamin A, vitamin D (in
different dairy foods, such as, for Agency Information Collection
products fortified with vitamin D),
example, milk, modified milk, cultured Activities; Announcement of Office of
riboflavin, vitamin B12, protein,
milk, yogurt, and cheese products, and Management and Budget Approvals
potassium, zinc, choline, magnesium,
any data regarding the nutritional and selenium (id.). AGENCY: Food and Drug Administration,
profiles of the various plant-based 1. Do consumers understand that HHS.
products that resemble dairy foods, certain plant-based products might have ACTION: Notice.
including fortified versions of those a nutritional content that is not
plant-based products. We are adequate to place them in the dairy SUMMARY: The Food and Drug
particularly interested in obtaining data group as described in the Dietary Administration (FDA) is publishing a
that compares the amounts of protein, Guidelines? How does this influence list of information collections that have
calcium, vitamin D, and potassium in their purchasing behavior with respect been approved by the Office of
these plant-based products and their to plant-based products and dairy Management and Budget (OMB) under
dairy counterparts. foods? Please provide any data or the Paperwork Reduction Act of 1995.
5. How do the protein qualities of evidence to support your answer. FOR FURTHER INFORMATION CONTACT: Ila
plant-based products compare to their 2. Do consumers who purchase or S. Mizrachi, Office of Operations, Food
dairy counterparts? How does the consume plant-based products instead and Drug Administration, Three White
variation, if any, impact consumer of dairy foods, such as yogurt or cheese, Flint North, 10A–12M, 11601
perception, and purchasing and believe that these plant-based products Landsdown St., North Bethesda, MD
consumption decisions? Please provide meet the dairy group recommendation 20852, 301–796–7726, PRAStaff@
any data or evidence to support your described in the Dietary Guidelines? fda.hhs.gov.
answer. Please provide any data or evidence to
amozie on DSK3GDR082PROD with NOTICES1
support your answer. SUPPLEMENTARY INFORMATION: The
E. The Role of Plant-Based Products and following is a list of FDA information
Dairy Foods in Meeting the III. References collections recently approved by OMB
Recommendations in the Dietary The following references are on under section 3507 of the Paperwork
Guidelines display at the Dockets Management Staff Reduction Act of 1995 (44 U.S.C. 3507).
The Dietary Guidelines contain (see ADDRESSES) and are available for The OMB control number and
nutritional and dietary information and viewing by interested persons between expiration date of OMB approval for
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![49108 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
each information collection are shown at https://www.reginfo.gov/public/do/ information unless it displays a
in table 1. Copies of the supporting PRAMain. An Agency may not conduct currently valid OMB control number.
statements for the information or sponsor, and a person is not required
collections are available on the internet to respond to, a collection of
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Irradiation in the Production, Processing, and Handling of Food ........................................................................... 0910–0186 7/31/2021
State Enforcement Notifications .............................................................................................................................. 0910–0275 7/31/2021
Veterinary Feed Directive ........................................................................................................................................ 0910–0363 7/31/2021
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................ 0910–0796 7/31/2021
Quality Facility Attestation ....................................................................................................................................... 0910–0854 7/31/2021
Administrative Practices and Procedures; Formal Evidentiary Public Hearing ...................................................... 0910–0191 8/31/2021
Regulations Under the Federal Import Milk Act ...................................................................................................... 0910–0212 8/31/2021
Medical Device Reporting ........................................................................................................................................ 0910–0437 8/31/2021
Animal Food Labeling; Declaration of Certifiable Color Additives .......................................................................... 0910–0721 8/31/2021
Evaluation of the Food and Drug Administration’s Fresh Empire Multicultural Youth Tobacco Prevention Cam-
paign ..................................................................................................................................................................... 0910–0788 8/31/2021
National Agriculture and Food Defense Strategy Survey ....................................................................................... 0910–0855 8/31/2021
Dated: September 25, 2018. in brackets in the heading of this safety issues regarding a new protein in
Leslie Kux, document. a new plant variety are resolved early in
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: development, prior to any possible
[FR Doc. 2018–21209 Filed 9–27–18; 8:45 am] Domini Bean, Office of Operations, inadvertent introduction into the food
BILLING CODE 4164–01–P Food and Drug Administration, Three supply of the new protein.
White Flint North, 10A–12M, 11601 We believe that any food safety
Landsdown St., North Bethesda, MD concern related to such material
DEPARTMENT OF HEALTH AND 20852, 301–796–5733, PRAStaff@ entering the food supply would be
HUMAN SERVICES fda.hhs.gov. limited to the potential that a new
protein in food from the plant variety
Food and Drug Administration SUPPLEMENTARY INFORMATION: In could cause an allergic reaction in
compliance with 44 U.S.C. 3507, FDA susceptible individuals or could be a
[Docket No. FDA–2012–N–0438] has submitted the following proposed toxin. The guidance describes the
collection of information to OMB for recommended procedures for early food
Agency Information Collection review and clearance.
Activities; Submission for Office of safety evaluation of new proteins
Management and Budget Review; Early Food Safety Evaluation of New produced by new plant varieties,
Comment Request; Early Food Safety Non-Pesticidal Proteins Produced by including bioengineered food plants,
Evaluation of New Non-Pesticidal New Plant Varieties Intended for Food and the procedures for communicating
Proteins Produced by New Plant Use with us about the safety evaluation.
Varieties Intended for Food Use Interested persons may use Form FDA
OMB Control Number 0910–0583— 3666 to transmit their submission to the
AGENCY: Food and Drug Administration, Extension Office of Food Additive Safety in the
HHS. Since May 29, 1992, when FDA Center for Food Safety and Applied
ACTION: Notice. issued a policy statement on foods Nutrition. Form FDA 3666 is entitled,
derived from new plant varieties, ‘‘Early Food Safety Evaluation of a New
SUMMARY: The Food and Drug including those varieties that are Non-Pesticidal Protein Produced by a
Administration (FDA or we) is developed through biotechnology, we New Plant Variety (New Protein
announcing that a proposed collection have encouraged developers of new Consultation),’’ (https://www.fda.gov/
of information has been submitted to the plant varieties to consult with us early downloads/AboutFDA/ReportsManuals
Office of Management and Budget in the development process to discuss Forms/Forms/UCM350010.pdf) and may
(OMB) for review and clearance under possible scientific and regulatory issues be used in lieu of a cover letter for a
the Paperwork Reduction Act of 1995. that might arise (57 FR 22984). New Protein Consultation (NPC). Form
DATES: Fax written comments on the The guidance, entitled FDA 3666 prompts a submitter to
collection of information by October 29, ‘‘Recommendations for the Early Food include certain elements of an NPC in
2018. Safety Evaluation of New Non-Pesticidal a standard format and helps the
ADDRESSES: To ensure that comments on Proteins Produced by New Plant respondent organize their submission to
the information collection are received, Varieties Intended for Food Use,’’ focus on the information needed for our
OMB recommends that written (available at https://www.fda.gov/Food/ safety review. The form, and elements
comments be faxed to the Office of GuidanceRegulation/Guidance that would be prepared as attachments
amozie on DSK3GDR082PROD with NOTICES1
Information and Regulatory Affairs, DocumentsRegulatoryInformation/ to the form, may be submitted in
OMB, Attn: FDA Desk Officer, Fax: 202– ucm096156.htm) continues to foster electronic format via the Electronic
395–7285, or emailed to oira_ early communication by encouraging Submission Gateway, or may be
submission@omb.eop.gov. All developers to submit to us their submitted in paper format, or as
comments should be identified with the evaluation of the food safety of their electronic files on physical media with
OMB control number 0910–0583. Also new protein. Such communication paper signature page. The information is
include the FDA docket number found helps to ensure that any potential food used by us to evaluate the food safety of
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Document Created: 2018-09-28 01:23:20
Document Modified: 2018-09-28 01:23:20
| 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. | |
| 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] | |
| FR Citation | 83 FR 49107 |
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