Research Determination

OMB Control Number 0910-0932
Expiration Date 05/31/2027

The Center for Tobacco Products (CTP) Research Involving Human
Subjects Committee’s (RIHSC) final determination is that the National
Youth Tobacco Survey (NYTS) meets the definition of “public health
surveillance activities,” and therefore it does not constitute research as
defined by the 2018 Common Rule. As such, the NYTS is not required to
be subject to FDA IRB’s review.

Public reporting burden for this collection of information is estimated to average 30 minutes per
survey, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. 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. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this
burden to: Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M,
11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov, ATTN: PRA
(0910-0932).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov