5470 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–D–0075] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Voluntary Labeling Indicating Whether 

Foods Have or Have Not Been Derived 

From Genetically Engineered Plants 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Voluntary Labeling Indicating Whether 

Foods Have or Have Not Been Derived 

From Genetically Engineered Plants’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 9, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Voluntary 

Labeling Indicating Whether Foods 

Have or Have Not Been Derived From 

Genetically Engineered Plants’’ to OMB 

for review and clearance under 44 

U.S.C. 3507. 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. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0807. The 

approval expires on January 31, 2019. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: January 25, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01786 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1855] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Studies on Consumer Perceptions of 

Modified Risk Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 March 3, 

2016. 

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–NEW and 

title ‘‘Experimental Studies on 

Consumer Perceptions of Modified Risk 

Tobacco Products.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

Experimental Studies on Consumer 

Perceptions of Modified Risk Tobacco 

Products OMB Control Number 0910– 

NEW 

FDA’s Center for Tobacco Products 

proposes to conduct experimental 

studies to develop generalizable 

scientific knowledge to help inform its 

implementation of section 911 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 387k), wherein 

FDA will be evaluating information 

submitted to the Agency about how 

consumers understand and perceive 

tobacco products marketed as modified 

risk tobacco products (MRTPs). Section 

911 of the FD&C Act authorizes FDA to 

grant orders to persons to allow the 

marketing of MRTPs. The term 

‘‘modified risk tobacco product’’ means 

any tobacco product that is sold or 

distributed for use to reduce harm or the 

risk of tobacco-related disease 

associated with commercially marketed 

tobacco products. FDA must issue an 

order authorizing the marketing of an 

MRTP if the Agency determines that the 

product, as it is actually used by 

consumers, will significantly reduce 

harm and the risk of tobacco-related 

disease to individual tobacco users and 

benefit the health of the population as 

a whole taking into account both users 

of tobacco products and persons who do 

not currently use tobacco products 

(section 911(g)(1) of the FD&C Act). 

FDA may also issue an order 

authorizing the marketing of an MRTP 

that reduces or eliminates exposure to a 

harmful substance if, among other 

requirements, the Agency determines 

that the order would be appropriate to 

promote the public health, the issuance 

of the order is expected to benefit the 

population as a whole taking into 

account both users and nonusers of 

tobacco products, and the existing 

evidence demonstrates that a 

measurable and substantial reduction in 

morbidity and mortality among 

individual tobacco users is reasonably 

likely to be shown in subsequent studies 

(section 911(g)(2) of the FD&C Act). In 

addition, section 911 requires that any 

advertising or labeling concerning 

modified risk products enable the 

public to comprehend the information 

concerning modified risk and to 

understand the relative significance of 

such information in the context of total 

health and in relation to all of the 

diseases and health related conditions 

associated with the use of tobacco 

products (section 911(h)(1) of the FD&C 

Act). The proposed research will inform 

the Agency’s efforts to implement the 

provisions of the FD&C Act related to 

MRTPs. 

FDA proposes to conduct 

experimental studies in order to develop 

generalizable scientific information to 

better understand how consumers 

perceive and understand these products, 

how exposure to claims about modified 

risk or exposure influence intentions to 

try or purchase the product, and how 

individual characteristics such as 

current tobacco use and/or brand loyalty 

might influence these outcomes. 

Moreover, information from the 

experimental studies may assist FDA to 

determine the appropriate methods and 


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